ML23152A235

PR-020, 032 & 035 - 63FR43516 - Medical Use of Byproduct Material; Proposed Revision

ML23152A235
Person / Time
Issue date:	08/13/1998
From:	Annette Vietti-Cook NRC/SECY
To:
References
65FR43516, PR-032, PR-035, PR-020
Download: ML23152A235 (1)

Text

{{#Wiki_filter:ADAMS Template: SECY-067 DOCUMENT DATE: 08/13/1998 TITLE: PR-020, 032 & 035 - 63FR43516 - MEDICAL USE OF BYPRODUCT MATERIAL; PROPOSED REVISION CASE

REFERENCE:

PR-020, 032 & 035 63FR43516 KEYWORD: RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete

DOCKET NO. PR-020, 032 & 035 (63FR43516) In the Matter of MEDICAL USE OF BYPRODUCT MATERIAL; PROPOSED REVISION DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 08/07/98 08/05/98 FEDERAL REGISTER NOTICE - PROPOSED RULE 08/07/98 08/05/98 FEDERAL REGISTER NOTICE - DRAFT POLICY STATEMENT 08/24/98 08/11/98 COMMENT OF CAROLS. MARCUS, PH.D., M.D. ( 377) 09/02/98 08/17/98 COMMENT.OF EUGENE T. DAVIDSON, M.D. ( 378) 09/02/98 08/21/98 COMMENT OF ALEX H. FRANK, M.D. ( 379) 09/02/98 08/24/98 COMMENT OF AMERICAN COLLEGE OF RADIATION ONCOLOGY (JAMES E. MARKS, M.D., CHAIR) ( 380) 09/02/98 08/25/98 COMMENT OF JOHN HICKMAN ( 381) 09/02/98 08/19/98 COMMENT OF AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS (HELENA W. RODBARD, M.D., PRESIDENT) ( 382) .09/21/98 09/15/98 COMMENT OF MARK BERNER ( 383) 09/23/98 09/15/98 COMMENT OF VERNON JOE FICKEN, PH.D. ( 384) 09/28/98 09/22/98 COMMENT OF RAD. ONCOLOG. &MED. PHYSICISTS AT WAYNE ST. UNIV. (GARY A. EZZELL, PH.D.) ( 385) 09/28/98 08/20/98 COMMENT OF ROBERT M. HOFFMANN, M.D. ( 386) 09/28/98 08/31/98 COMMENT OF SOCIETY FOR CARDIAC ANGIOGRAPHY & INTERVENTIONS (MORTON J. KERN, M.D., PRESIDENT) ( 387) 09/29/98 09/24/98 COMMENT OF RONALD SCALA ( 388) 10/05/98 09/30/98 COMMENT OF ROBERT SASSO ( 389) 10/06/98 09/25/98 COMMENT OF DAVID WALTER, DIR., RAD. MAT. LIC. ( 390) 10/06/98 09/29/98 COMMENT OF KEITH JONES, PH.D. ( 391)

DOCKET NO. PR-020, 032 &035 (63FR43516) DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 10/07/98 09/21/98 COMMENT OF AMERICAN THYROID ASSOCIATION (PAUL W. LADENSON, M.D., ET AL.) ( 392) 10/15/98 10/05/98 COMMENT OF MOBILE TESTING (JOHN CARPENTER, DIRECTOR) ( 393) 10/16/98 10/02/98 COMMENT OF RAD. ONCOLOGISTS AT WAYNE ST. UNIV. SCHOOL OF MED. (LAURIE GASPAR, M.D.) ( 394) i0/19/98 10/14/98 COMMENT OF MICHAEL L. GORIS, M.D., PH.D. ( 395) 10/19/98 10/14/9~ COMMENT OF ENVIRONMENTAL SAFETY FACILITY - STANFORD UNIV. (JOHN A. HOLMES, ASSOC. DIRECTOR) ( 396) 10/23/98 10/16/98 COMMENT OF JAMES A. PONTO ( 397) 10/23/98 10/23/98 COMMENT OF HELEN G. KRUPANSKY ( 398) 10/23/98 10/20/98 COMMENT OF (JAMES A. PONTO) ( 399) 10/26/98 10/21/98 COMMENT OF THE HOWARD UNIVERSITY RADIATION SAFETY COMMITTEE (MARLENE H. MCKETTY, PH.D., CHAIR) ( 400) 10/26/98 10/23/98 COMMENT OF MACK L. RICHARD ( 401) 10/27/98 10/15/98 COMMENT OF RAD. SAFETY COMMITTEE OF MERITCARE HEALTH SYSTEM (ROBERT ARUSELL, M.D.) ( 402) 10/27/98 / 10/22/98 COMMENT OF BRUCE THOMADSEN, PH.D. ( 403)

• 10/29/98 10/14/98 COMMENT OF SENATOR MAX CLELAND ( 404) 10/29/98 10/20/98 COMMENT OF REPRESENTATIVE KAREN L. THURMAN ( 405) 10/29/98 10/28/98 COMMENT OF AMERICAN ASSOCIATION OF PHYSICISTS IN MEDICINE (LAWRENCE N. ROTHENBERG, PH.D.) ( 406) 10/30/98 10/26/98 COMMENT OF THOMAS HILL ( 407}

11/02/98 10/27/98 COMMENT OF MICHAEL T. GILLIN, PH.D. ( 408} 11/03/98 10/19/98 COMMENT OF FRED F. CIAROCHI, M.D. ( 409) 11/03/98 10/21/98 COMMENT OF WILLIAM QUE, PH.D. ( 410) 11/03/98 10/21/98 COMMENT OF JAY A. HAROLDS, M.D. ( 411) 11/03/98 10/19/98 POSTCARD FM HELEN G. KRUPANSKY TO COMM. DICUS URGING THAT ENDOCRINOLOGISTS SHOULD BE ALLOWED TO ADMINISTER 1-131 IN THEIR OFFICES--COMMENT NO. 398

DOCKET NO. PR-020, 032 & 035 (63FR43516) DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 11/03/98 10/23/98 LTR FM BRUCE THOMADSEN TO CATHERINE HANEY ENCLOSING CY OF COMMENT PREVIOUSLY SUBMITTED (NO. 403) & EXPRESSING THAT PR-35 REV. MUCH IMPROVED. 11/03/98 10/21/98 COMMENT OF WILLIAM G. VANDERIET, PH.D. ( 412) 11/03/98 10/29/98 COMMENT OF STEVEN J. HARWOOD, M.D. ( 413) 11/04/98 10/30/98 COMMENT OF SOCIETY OF NUCLEAR MEDICINE/SOUTHWESTERN CHAPTER (LAMK LAMKI, M.D., PRESIDENT) ( 414) . 11/04/98 10/30/98 COMMENT OF JOHN W. LAUDE, M.D., MEDICAL DIR. ( 415) 11/09/98 10/30/98 COMMENT OF RICHARD MCKEOWN ( 416) 11/09/98 10/30/98 COMMENT OF RICHARD MCKEOWN ( 417) 11/09/98 11/03/98 COMMENT OF ANOTHER RULEMAKIN6 (PR-050, 052 & 072; 63FR56098) (CODED INCORRECTLY) ( 418) 11/09/98 11/04/98 COMMENT OF AMER. PHARMACEUTICAL ASSOC., SECT. ON NUC. PHARM. (BRIGETTE MCGHEE) ( 419) ' 11/09/98 11/05/98 COMMENT OF THE NATIONAL ELECTRICAL MANUFACTURERS ASSOCIATION (RICHARD EATON) ( 420) 11/09/98 11/06/98 COMMENT OF BARBARA L. HAMRICK ( 421) 11/09/98 11/06/98 COMMENT OF STEVE MATTMULLER ( 422) 11/09/98 10/07/98 COMMENT OF KEVIN E. MCCARTHY, M.D. ( 423) 11/09/98 11/06/98 LTR FM ROLAND G. FLETCHER, CHAIR, ORGANIZATION OF AGREEMENT STATES, TO CHAIRMAN JACKSON REQUESTING EXTENSION OF COMMENT PERIOD 11/10/98 11/02/98 COMMENT OF D. R. STONE ( 424) 11/10/98 11/04/98 COMMENT OF AMERICAN ASSOCIATION OF PHYSICISTS IN MEDICINE (LAWRENCE N. ROTHENBERG, PH.D., PRES) ( 425) 11/10/98 11/10/98 COMMENT OF KIRK WHATLEY ( 426) 11/12/98 11/06/98 COMMENT OF ARA TAHMASSIAN, PH.D. ( 427) 11/12/98 11/06/98 COMMENT OF GRETCHEN WHITE, ET AL. ( 428) 11/12/98 11/09/98 COMMENT OF BITTY B. GOETZ, ET AL. ( 429)

DOCKET NO. PR-020, 032 & 035 (63FR43516) DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 11/12/98 11/10/98 COMMENT OF DAVID BELK, DIRECTOR ( 430) 11/12/98 11/10/98 COMMENT OF JAfl'IES A. TERRY, PH.D. ( 431) 11/12/98 11/11/98 COMMENT OF WILLIAM A. VAN DECKER, M.D. ( 432) 11/12/98 11/11/98 COMMENT OF EDWIN M. LEIDHOLDT, JR., PH.D. ( 433) 11/12/98 11/11/98 COMMENT OF RAD. SAFETY COMMITTEE OF FLITCHER ALLEN HLTH. CARE (JONATHAN FAIRBANKS, M.D., CHAIR) ( 434) 11/12/98 11/11/98 COMMENT OF JAMES H. GOODWIN, ET AL. ( 435) 11/12/98 11/12/98 COMMENT OF THOMAS ROLAND, M.D. ( 436) 11/12/98 11/12/98 COMMENT OF TEXAS RADIATION ADVISORY BOARD (JACKS. KROHMER, PH.D., CHAIR) ( 437) 11/12/98 11/12/98 COMMENT OF COULTER PHARMACEUTICAL, INC. (VIRGINIA K. LANGMUIR, M.D.) ( 438) 11/12/98 11/12/98 COMMENT OF COUNCIL ON RADIONUCLIDES & RADIOPHARMACEUTICALS (ROY BROWN) ( 439) 11/12/98 11/04/98 LTR FM KATHY ALLEN, ILLINOIS DEPARTMENT OF NUCLEAR SAFETY, TO SECY REQUESTING EXTENSION OF COMMENT PERIOD 11/12/98 11/06/98 LTR FM KEITH H. DINGER, PRESIDENT, HEALTH PHYSICS SOCIETY, TO CHAIRMAN JACKSON REQUESTING 60 DAY EXTENSION OF COMMENT PERIOD 11/13/98 11/12/98 COMMENT OF THE AMERICAN BOARD OF NUCLEAR MEDICINE (RICHARD L. WAHL, M.D., CHAIRMAN) ( 440) 11/13/98 11/03/98 COMMENT OF MICHAEL T. GILLIN, PH.D. ( 441) 11/13/98 11/13/98 COMMENT OF TOM DEFRANCO ( 442) 11/13/98 11/10/98 COMMENT OF TEXAS DEPARTMENT OF HEALTH (RICHARD A. RATLIFF) ( 443) 11/13/98 11/12/98 COMMENT OF RADIATION SAFETY BRANCH OF NIH (ROBERT A. ZDON) ( 444) 11/13/98 10/30/98 LTR FM ACNP/SNM AND SIX OTHER ORGANIZATIONS TO CHAIRMAN JACKSON REQUESTING EXTENSION OF COMMENT PERIOD

DOCKET NO. PR-020, 032 &035 (63FR43516) DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 11/13/98 11/12/98 COMMENT OF LAUREN MCGAUGHEY ( 445) 11/13/98 11/12/98 COMMENT OF ELIZABETH L. DRINNON ( 446) 11/13/98 11/12/98 COMMENT OF THOMAS E. HILL ( 447) 11/13/98 11/02/98 COMMENT OF RADIATION SAFETY COMMITTEE OF MEMORIAL HOSPITAL (FRANK KIMSEY, M.D., ET AL.) ( 448) 11/13/98 11/06/98 COMMENT OF RAD. SAFETY COMM. AT UNIV. OF CA, SAN FRANCISCO (MICHAEL BANDA, PH.D.) ( 449) .11/13/98 11/09/98 COMMENT OF DENISE J. NOONAN, PH.D. ( 4p0) 11/13/98 11/09/98 COMMENT OF NORMAN L. MCELROY ( 451) 11/13/98 11/10/98 _ COMMENT OF GEOFFREY S. IBBOTT, PH.D. ( 452) 11/13/98 11/11/98 COMMENT OF COLORADO DEPARTMENT OF PUBLIC HEALTH & ENVIRONMENT (ROBERT M. QUILLIN) ( 453) 11/13/98 11/09/98 COMMENT OF BILL F. BYRD, M.D. ( 454) 11/13/98 11/13/98 COMMENT OF ASSOCIATES IN MEDICAL PHYSICS, LLC (PAUL EARLY, PRESIDENT) ( 455) 11/16/98 11/05/98 COMMENT OF THE AMERICAN BOARD OF RADIOLOGY (WILLIAM J. CASARELLA, M.D., PRES.) ( 456) 11/16/98 11/09/98 COMMENT OF AMERICAN COLLEGE OF NUCLEAR PHYSICIANS, CA CHAPTER (MARVIN B. COHEN, M.D., PRESIDENT) ( 457) 11/16/98 11/09/98 COMMENT OF MAYO CLINIC (RICHARD J. VITTER, PH.D.) ( 458) 11/16/98 11/11/98 COMMENT OF KATHERINE L. SEIFERT ( 459) 11/16/98 11/11/98 COMMENT OF RADIATION SAFETY COMMITTEE (ROY CHEW, PH.D., VICE PRESIDENT) ( 460) 11/16/98 11/12/98 COMMENT OF BUREAU OF RADIATION PROTECTION (ROGER L. SUPPES) ( 461) 11/16/98 11/12/98 COMMENT OF JEROME W. STAIGER ( 462) 11/16/98 11/12/98 COMMENT OF NAOMI ALAZRAKI, M.D. ( 463) 11/16/98 11/12/98 COMMENT OF COOK GROUP, INC. (STEVE FERGUSON) ( 464) 11/16/98 11/12/98 COMMENT OF CHARLES E. FINNEY ( 465) I

DOCKET NO. PR-020, 032 & 035 (63FR43516) DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 11/16/98 11/12/98 COMMENT OF NEBRASKA HHS REGULATION AND LICENSURE (GINA DUNNING) ( 466) 11/16/98 11/11/98 COMMENT OF KENNETH H. DOUGLASS, PH.D. ( 467) 11/16/98 11/11/98 COMMENT OF ROBERT D. FORREST ( 468) 11/16/98 11/09/98 COMMENT OF NATIONAL PHYSICS CONSULTANTS, LTD. (DAVID CLOSE) ( 469) 11/16/98 11/12/98 COMMENT OF JOHN P. JACOBUS ( 470) 11/17/98 11/12/98 E-MAIL FM KIRK WHATLEY TO CATHERINE HANEY SUBMITTING ADDITIONAL COMMENTS (COMMENT NO. 426) 11/17/98 11/12/98 COMMENT OF KANSAS DEPARTMENT OF HEALTH & ENVIRONMENT (THOMAS A. CONLEY) ( 471) 11/17/98 11/13/98 COMMENT OF GENE MISKIN ( 472) 11/17/98 11/10/98 COMMENT OF RAD. SAFETY COMMITTEE OF WILLIAM BEAUMONT HOSPITAL (CHERYL CULVER SCHULTZ) ( 473) 11/18/98 08/19/98 COMMENT OF TRANSCRIPTS OF PR-35 PUBLIC MTNG. IN SAN FRANCISCO (8/19 AND 8/20/98, PP. 1 - 479) ( 474) 11/18/98 09/16/98 COMMENT OF TRANSCRIPTS OF PR-35 PUBLIC MTNG.-KANSAS CITY, MO (9/16 AND 9/17/98, PP. 1 - 483) ( 475) 11/18/98 10/21/98 COMMENT OF TRANSCRIPTS OF PR-35 PUBLIC MTNG. IN ROCKVILLE, MD (10/21 AND 10/22/98, PP. 1 - 531) ( 476) 11/18/98 10/01/98 LTR FM SENATOR HERB KOHL TO DENNIS K. RATHBUN ENCLOSING LTR FM DR. W. BRUCY FYE WHO SUPPORTS RISK-BASED APPROACH IN TRNG. & EXPERIENCE REQ. 11/18/98 10/26/98 LTR FM WILLIAM D. TRAVERS TOW. BRUCE FYE, M.A., M.D., F.A.C.C. RESPONDING TO HIS 8/28/98 LTR\TQ SENATOR HERB KOHL RE TRAINING & EXPERIENCE REQ. 11/18/98 10/13/98 LTR FM REP. CONSTANCE A. MORELLA TO CHAIRMAN ENCL. LTR FM HELENA W. RODBARD, PRES., AACE, RE TRAINING

                         & EXPERIENCE REQUIREMENTS FOR 1-131 TREATMENT 11/18/98    11/1?/98   LTR FM CHAIRMAN JACKSON TO REP. CONSTANCE A.

MORELLA RESPONDING TO HER 10/13/98 LTR TMTG CONCERNS OF CONSTITUENTS RE TREATMENT WITH 1-131 11/18/98 11/10/98 COMMENT OF THE UNIVERSITY OF CINCINNATI (VICTORIA MORRIS) ( 477)

DOCKET NO. PR-020, 032 & 035 (63FR43516) DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 11/18/98 11/09/98 COMMENT OF STEPHEN L. WEINRIB, M.D. ( 478) 11/18/98 11/13/98 COMMENT OF THE ENDOCRINE soc1m, AACE AND ATA (DAVIDS. COOPER, M.D., ET AL.) ( 479) 11/19/98 10/29/98 COMMENT OF DEPT. OF RADIATION PHYSICS, ST. JOSEPH'S MED. CTR. (MARIA CHAN, PH.D.) ( 480) 11/19/98 11/11/98 COMMENT OF RICHARD L. WAHL, M.D. ( 481) 11/19/98 11/11/98 COMMENT OF THE AMERICAN BOARD OF NUCLEAR MEDICINE (WILLIAM H. BLAHO, M.D., PRESIDENT) ( 482) .11/19/98 11/12/98- COMMENT OF DEPARTMENT OF VETERANS AFFAIRS (THOMAS V. HOLOHAN, M.D.) ( 483) 11/19/98 11/12/98 COMMENT OF WILLIAM VAN DECKER, M.D. ( 484) 11/19/98 11/12/98 COMMENT OF CARI BORRAS ( 485) 11/19/98 11/12/98 COMMENT OF AMERICAN SOCIETY OF NUCLEAR CARDIOLOGY (KENNETH A. BROWN, M.D., PRES. ET AL) ( 486) 11/19/98 11/12/98 COMMENT OF AMERICAN COLLEGE OF CARDIOLOGY (SPENCER B. KING, III, M.D., PRES.) ( 487)

                                                                 ~

11/20/98 11/12/98 COMMENT OF ANN COWGILL, M.D., ET AL. ( 488) .11/23/98 11/18/98 COMMENT OF AMERICAN COLLEGE OF NUCLEAR PHYSICIANS (ROBERT L. MECKELNBURG, M.D., PRES.) ( 489) 11/23/98 11/16/98 COMMENT OF NORMAN L. MCELROY ( 490) 11/24/98 11/17/98 FEDERAL REGISTER NOTICE - PROPOSED RULE; REOPENING

                            , OF PUBLIC COMMENT PERIOD, 11/24/98    11/17/98   FEDERAL REGISTER NOTICE - DRAFT POLICY STATEMENT; REOPENING OF PUBLIC COMMENT PERIOD 11/25/98    11/20/98   COMMENT OF MARK ROTMAN ( 491) 11/25/98    11/24/98   LTR FM HOYLE TOR. G. FLETCHER, CHAIR, OAS RESPONDING TO HIS 11/06/98 LTR REQ. EXTENSION OF COMMENT PERIOD. ADVISED 30-DAY EXTENSION APPROVED.

11/25/98 11/24/98 LTR FM HOYLE TOK. H. DINGER, PRES. HEALTH PHYSICS soc1m RESP. TO HIS 11/06/98 LTR REQ. 60-DAY EXT. OF COMMENT PERIOD. ADVISED 30-DAY EXT. APPROVED

DOCKET NO. PR-020, 032 & 035 (63FR43516) DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 11/25/98 11/24/98- LTR FM HOYLE TO,DAVID NICHOLS, ACNP/SNM RESPONDING TO 10/30/98 LTR JOINTLY /S/'D BY 8 OR6ANIZATIONS REQ. EXT. OF COMMENT PERIOD. 30-DAY EXT. APPROVED. 11/25/98 11/24/98 LTR FM HOYLE TOW. J. CASARELLA, M.D., PRES. AMER. BOARD OF RADIOLOGY RESP. TO HIS 11/05/98 LTR REQ. SIGNIFICANT EXT. OF COMMENT PERIOD. (NO. 456) 11/25/98 11/24/98 LTR FM HOYLE TOM. B. COHEN, M.D., PRES. CA CH., ACNP, RESP. TO HIS 11/09/98 LTR REQ. 1 YEAR EXT. OF COMMENT PERIOD. 30-DAY EXT. APPR'D. (NO. 457) 11/27/98 11/25/98 COMMENT OF R. J. HOFFMAN ( 492) 11/27/98 11/06/98 COMMENT OF CRAIG REED ( 493) 11/27/98 11/11/98 LTR FM M. KOPELOW, M.D. TO C. HANEY REC. ROSE TESTIMONY ON P6. 10 OF 9/16/98 TRANSCRIPT. PER DR. KOPELOW, ROSE NOT REP OF ACCME. (COMMENT NO. 475) 11/30/98 11/23/98 COMMENT OF MERCK CO., INC. (EDWIN A. WURTZ, PH.D.) ( 494) 12/01/98 11/30/98 LTR FM HOYLE TO MARK ROTMAN RESPONDING TO HIS 11/20/98 LTR REQ. EXTENSION OF COMMENT PERIOD. ADVISED 30-DAY EXT. APPROVED. (COMMENT NO. 491) I 12/04/98 11/05/98 COMMENT OF AMERICAN COLLEGE OF RADIOLOGY (PHILIP 0. ALDERSON, M.D.) ( 495) 12/04/98 05/01/98 COMMENT OF AMER. COLLEGE OF NUC. PHYSICIANS/SOC. OF NUC. MED. (DAVID NICHOLS) ( 496) 12/04/98 11/09/98 COMMENT OF CURT DEMARIS ( 497) 12/04/98 11/10/98 COMMENT OF ACNP/SNM, CORAR, NEI (DAVID C. NICHOLS, ET AL.) ( 498) 12/04/98 09/17/98 COMMENT OF BRIAND. MILLER, M.D. ( 499) 12/08/98 09/16/98 POSITION PAPER PRESENTED BY AACE AT PUBLIC MEETING IN KANSAS CITY, MO ON 9/16 & 9/17/98. APPENDED TO COMMENT NO. 475. 12/08/98 09/16/98 NRC SLIDE PRESENTATION OF ACCREDITATION PROGRAMS IN NUCLEAR MEDICINE IN KANSAS CITY, MO ON 9/16/98. DOCUMENT APPENDED TO COMMENT NO. 475. 12/08/98 10/21/98 POSITION PAPER PRESENTED BY AACE AT THE PUBLIC MEETING IN ROCKVILLE, MD ON 10/21 & 10/22/98. DOCUMENT APPENDED TO COMMENT NO. 476.

DOCKET NO. PR-020, 032 & 035 (63FR43516) DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 12/08/98 10/21/98 SPREAD SHEET ANALYSIS OF PRELIMINARY ESTIMATE OF COST OF PR-35 FOR HOSP. NUC. MED. SVC. BY MARK ROTMAN, REP. ACNP/SNM. APPENDED TO COMMENT 476 12/08/98 10/21/98 CAROLS. MARCUS, PH.D., M.D. PRESENTATION OF RISK ANALYSIS: RISK-RISK, ABSOLUTE RISK ... IN ROCKVILLE ON 10/21/98. APPENDED TO COMMENT NO. 476 12/08/98 05/31/98 PRESENTATION OF AMERICAN BRACHYTHERAPY SOCIETY ON INTRAVASCULAR BRACHYTHERAPY AT THE ANNUAL MEETING 05/31 TO 06/02/98. APPENDED TO COMMENT NO. 476 12/08/98 10/21/98 CHART OF CLINICAL TRIALS USING INTRAVASCULAR BRACHYTHERAPY OF THE INHIBITION OF RESTENOSIS. APPENDED TO COMMENT NO. 476 12/08/98 10/25/98 CERTIFICATION COUNCIL OF NUCLEAR CARDIOLOGY CANDIDATE BULLETIN ANNOUNCING CERTIFICATION EXAM. IN NUCLEAR CARDIOLOGY. APPENDED TO COMMENT 476. 12/08/98 12/02/98 LTR FM M. B. COHEN, M.D., TO CHM RE NUREGS & PR-35 DEFICIENCIES. REQ. PUB. OF REPLY TO 2 QUEST. IN FR. URGES 1 YR DELAY FOR RECONSIDERATION OF PR-35 12/08/98 12/04/98 LTR FM SEN. JOSEPH I. LIEBERMAN TO CHAIRMAN ENCL. LTR FM JONATHAN ALEXANDER, M.D. URGING REDUCTION IN TRNG. &EXP. HRS. FOR NUC. CARD. FM 1200 TO 120 12/11/98 12/10/98 COMMENT OF CAROLS. MARCUS, PH.D., M.D. ( 500) 12/14/98 10/31/98 COMMENT OF TRANSCRIPT OF 1998 ALL AGREEMENT STATES MEETING (10/31/98, PP. 613 - 713) ( 501) 12/15/98 12/14/98 COMMENT OF PERRY W. GRIGSBY, M.D. ( 502) 12/15/98 12/15/98 COMMENT OF RICHARD MCKEOWN ( 503) 12/16/98 12/14/98 COMMENT OF HEALTH PHYSICS SOCIETY (KEITH H. DINGER, PRESIDENT) ( 504) 12/16/98 12/16/98 COMMENT OF AMER. COLLEGE OF NUC. PHYSICIANS/SOC. OF NUC. MED. (ROBERT L. MECKELNBURG, M.D., PRES.) ( 505) 12/16/98 12/14/98 COMMENT OF MALLINCKRODT INC. (ROY W. BROWN, DIRECTOR) ( 506) 12/16/98 12/16/98 COMMENT OF MALLINCKRODT INC. (ROY W. BROWN, DIRECTOR) ( 507)

DOCKET NO. PR-020, 032 & 035 (63FR43516) DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 12/16/98 12/14/98 COMMENT OF AMERICAN BOARD OF HEALTH PHYSICS (GEORGE J. VARGO, PH.D.) ( 508) 12/17/98 12/15/98 COMMENT OF MICHAEL A. VINCE, PH.D. ( 509) 12/17/98 12/15/98 COMMENT OF ACCREDITATION COUNCIL FOR GRADUATE MED. EDUCATION (CHARLES H. ROS~) ( 510) 12/17/98 12/16/98 COMMENT OF AMERICAN ASSOCIATION FOR NUCLEAR CARDIOLOGY (CHARLES H. ROSE, EXECUTIVE DIRECTOR) ( 511) 12/17/98 12/16/98 COMMENT OF AMERICAN ASSOCIATION FOR NUCLEAR CARDIOLOGY (CHARLES H. ROSE, EXECUTIVE DIRECTOR) ( 512) 12/17/98 12/16/98 COMMENT OF AMERICAN ASSOCIATION FOR NUCLEAR CARDIOLOGY (CHARLES H. ROSE, EXECUTIVE DIRECTOR) ( 513) 12/17/98 12/16/98 COMMENT OF AMERICAN ASSOCIATION FOR NUCLEAR CARDIOLOGY (CHARLES H. ROSE, EXECUTIVE DIRECTOR) ( 514) 12/17/98, 12/16/98 COMMENT OF AMERICAN ASSOCIATION FOR NUCLEAR CARDIOLOGY (CHARLES H. ROSE, EXECUTIVE DIRECTOR) ( 515) 12/17/98 12/16/98 COMMENT OF AMERICAN ASSOCIATION FOR NUCLEAR CARDIOLOGY, INC. (CHARLES H. ROSE, EXECUTIVE DIRECTOR) ( 516) 12/17/98 12/16/98 COMMENT OF AMERICAN ASSOCIATION FOR NUCLEAR CARDIOLOGY (CHARLES H. ROSE, EXECUTIVE DIRECTOR) ( 517) 12/17/98 12/16/98 COMMENT OF AMERICAN ASSOCIATION FOR NUCLEAR CARDIOLOGY (CHARLES H. ROSE, EXECUTIVE DIRECTOR) ( 518)t 12/17/98 12/16/98 COMMENT OF AMERICAN ASSOCIATION FOR NUCLEAR CARDIOLOGY (CHARLES H. ROSE, EXECUTIVE DIRECTOR) ( 519) 12/17/98 12/16/98 COMMENT OF AMERICAN ASSOCIATION FOR NUCLEAR CARDIOLOGY (CHARLES H. ROSE, EXECUTIVE DIRECTOR) ( 520) 12/17/98 09/28/98 COMMENT OF LEO JABLONSKI ( 521) 12/17/98 12/15/98 COMMENT OF P. SRIDHAR RAO ( 522) 12/17/98 12/16/98 COMMENT OF ILLINOIS DEPARTMENT OF NUCLEAR SAFETY (KATHY ALLEN) ( 523) 12/17/98 12/15/98 COMMENT OF AMERICAN ACADEMY OF HEALTH PHYSICS (RONALD L. KATHREN, PRES., AAHP) ( 524) 12/17/98 12/16/98 COMMENT OF COUNCIL ON RADIONUCLIDES AND RADIOPHARMACEUTICALS (ROY W. BROWN, CHAIRMAN) ( 525)

DOCKET NO. PR-020, 032 & 035 (63FR43516) DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 12/18/98 12/14/98 LTR FM SEN. DICK DURBIN TOD. K. RATHBUN ENCL LTRS FM CONSTITUENTS RE REVISIONS TO TRNG. & EXPERIENCE REQUIREMENTS FOR THE MEDICAL USE OF RADIOISOTOPES 12/18/98 12/11/98 COMMENT OF AMERICAN ASSOCIATION OF PHYSICISTS IN MEDICINE (LAWRENCE N. ROTHENBERG, PH.D., PRES) ( 526) 12/21/98 12/17 /98 COMMENT OF THE COMMUNITY HOSPITAL (ERIC ZICKGRAF, PH.D.) ( 527) 12/21/98 10/29/98 COMMENT OF LAUREN MCGAUGHEY ( 528) 12/21/98 10/29/98 COMMENT OF LAUREN MCGAUGHEY ( 529) 12/21/98 12/13/98 COMMENT OF DONALD M. FOSTER, PH.D. ( 530) 12/21/98 12/14/98 COMMENT OF ROBERT J. LULL, M.D. ( 531) 12/21/98 12/15/98 COMMENT OF MORRIS I. BANK, PH.D. ( 5~2) 12/21/98 J 12/15/98 COMMENT OF AMER. SOC. FOR THERAP. RAD. & ONC./AMER. COL. RAD. (LARRY E. KUN, M.D., CHAIR, ET AL.) ( 533) 12/21/98 12/15/98 COMMENT OF THE Af:tERICAN BOARD OF NUCLEAR MEDICINE (RICHARD L. WAHL., M.D., CHAIRMAN) ( 534) 12/21/98 12/16/98 COMMENT OF MARYE. MOORE ( 535) 12/21/98 12/16/98 COMMENT OF MICHAEL J. BOHAN ( 536) 12/21/98 12/16/98 COMMENT OF CERTIFICATION BOARD OF NUCLEAR CARDIOLOGY (AMIE. ISKANDRIAN, M.D., PRESIDENT) ( 537) 12/21/98 12/16/98 COMMENT OF AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS (HELENA W. RODBARD, M.D., PRESIDENT) ( 538) 12/21/98 12/14/98 COMMENT OF SENATOR CHRISTOPHER S. BOND ( 539) 12/22/98 12/15/98 COMMENT OF DEPT. OF HLTH. &HUMAN SERVICES, PUBLIC HLTH. SVC. (ROBERT A. ZOON) ( 540) 12/22/98 12/15/98 COMMENT OF RALPH P. LIETO ( 541) 12/22/98 12/15/98 COMMENT OF PETER J. MAS ( 542) 12/22/98 12/16/98 COMMENT OF THE CLEVELAND CLINIC FOUNDATION (STUART W. KLINE) ( 543) 12/22/98 12/16/98 COMMENT OF KENT N. LAMBERT ( 544) I

( DOCKET NO. PR-020, 032 & 035 (63FR43516) DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION .OF DOCUMENT 12/22/98 12/16/98 COMMENT OF ALAN S. .BAKER ( 545) 12/22/98 12/16/98 COMMENT OF MICHAEL VESTER ( 546)

     \

12/22/98 12/16/98 COMMENT OF THOMAS A. SCHUMACHER ( 547) 12/23/98 12/17/98 COMMENT OF PAUL J. EARLY ( 548) 12/23/98 12/16/98 COMMENT OF CARL BERGSAGEL ( 549) 12/28/98 12/16/98 COMMENT OF SHAWN SEELEY ( 550) 12/28/98 12/23/98 COMMENT OF MICHAEL SHEITT (DUPLICATE OF COMMENT NO. 552) (RULEMAKING WEBSITE V,ERSION) ( 551) 12/29/98 12/16/98 COMMENT OF MICHAEL SHEITT ( 552) 12/29/98 12/16/98 COMMENT OF NUCLEAR ENERGY INSTITUTE (FELIX M. KILLAR, JR., DIRECTOR) ( 553) 01/07/99 12/07/98 COMMENT OF KIRKSEY WHATLEY ( 554) 01/07/99 01/06/99 SUBIR NAG, M.D. TMTG ABSTRACT OF ARTICLE ON AMER. B~CHYTHERAPY SOCIETY PERSPECTIVE ON INTRAVASCULAR BRACHYTHERAPY. APPENDED TO COMMENT NO. 476 01/19/99 01/01/99 COMMENT OF JAMES F. KRONAUGE, PH.D. ( 555) 01/27/99 01/2~/99 COMMENT OF PETER G. VERNIG ( 556) 02/03/99 01/04/99 COMMENT OF P. TODD MAKLER, JR., M.D. ( 557) I 02/0.3/99 01/05/99 COMMENT OF CAROLS. MARCUS, PH.D., M.D. ( 558) 02/03/99 01/05/99 COMMENT OF JACK EDWARD JUNI, M.D. ( 559) 02/03/99 01/05/99 COMMENT OF DOUGLAS VAN NOSTRAND, M.D. ( 560) 02/03/99 01/06/99 COMMENT OF CAROLS. MARCUS, PH.D., M.D. ( 561) 02/03/99 .01/06/99 COMMENT OF WYNN A. VOLKERT, PH.D. ( 562) 02/03/99 01/08/99 COMMENT OF DANNY R. ALLEN, PRESIDENT ( 563) 02/03/99 01/11/99 COMMENT OF KEVIN J. DONOHOE, M.D. ( 564) 02/03/99 01/11/99 COMMENT OF GERALD M. KOLODNY, M.D. ( 565) 02/03/99 01/11/99 COMMENT OF THOMAS J. HILL, M.D. ( 566)

DOCKET NO. PR-020, 032 & 035 (63FR43516) DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 02/03/99 01/11/99 COMMENT OF J. ANTHONY PARKER, M.D., PH.D. ( 567) 02/03/99 01/13/99 COMMENT OF LYNNET. ROY, DIRECTOR ( 568) 02/03/99 01/20/99 COMMENT OF ALVIN J. LORMAN ( 569) 02/03/99 01/21/99 COMMENT OF HANI A.' NABI, M.D., PH.D. ( 570) 02/03/99 01/06/99 COMMENT OF MICHAEL H. COUREY ( 574) 03/10/99 03/05/99 COMMENT OF HARISH VAIDYA ( 571) 03/12/99 02/22/99 COMMENT OF CMDI CENTRAL MINNESOTA DIAGNOSTIC, INC. (GLENN ERICKSON, PRESIDENT) ( 572) 03/12/99 02/23/99 COMMENT OF FRANS J. TH. WACKERS, M.D. ( 573) 04/01/99 03/12/99 COMMENT OF AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS (HELENA W. RODBARD, M.D., PRES.) ( 575) 04/12/99 04/08/99 COMMENT OF AMERICAN SOCIETY OF NUCLEAR CARDIOLOGY (TIMOTHY M. BATEMAN, M.D., PRESIDENT) ( 576) 04/27/99 04/23/99 COMMENT OF THE AMERICAN COLLEGE OF CARDIOLOGY (ARTHUR GARSON, JR., M.D., PRESIDENT) ( 577) 04/27/99 03/30/99 COMMENT OF BRUCE F. BOWER, M.D. ( 578) 06/02/99 05/27/99 COMMENT OF PETER 6. VERNIG ( 579) 06/04/99 06/02/99 COMMENT OF SANDRA SZENDY ( 580) 06/08/99 05/25/99 COMMENT OF SOCIETY OF NUCLEAR MEDICINE (JAY A. HAROLDS, M.D., PRESIDENT) ( 581) 06/08/99 06/01/99 COMMENT OF AMERICAN SOCIETY OF NUCLEAR CARDIOLOGY (TIMOTHY M. BATEMAN, M.D., PRESIDENT) ( 582) 06/15/99 06/03/99 COMMENT OF AMERICAN COLLEGE OF CARDIOLOGY (ARTHUR GARSON, JR., M.D., PRESIDENT) ( 583) 08/02/99 07/22/99 COMMENT OF THE AMERICAN BOARD OF NUCLEAR MEDICINE (EDWARD B. SILBERSTEIN, M.D.) ( 584) 08/11/99 07/06/99 COMMENT OF RADIOLOGY ASSOCIATES, PROF. L.L.C. (ROBERJ A. DURST, M.D., PRESIDENT) ( 585) 10/13/99 10/12/99 COMMENT OF PETER 6. VERNIG ( 586)

DOCKET NO. PR-020, 032 & 035 (63FR43516) DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 10/18/99 10/12/99 COMMENT OF AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS (RICHARD A. DICKEY, M.D., PRESIDENT) ( 587) 10/18/99 10/14/99 COMMENT OF NICHOLAS J. SARLIS, M.D., PH.D. ( 588) 10/18/99 10/14/99 COMMENT OF OSTEOPOROSIS l -ENDOCRINE CENTER OF SOUTHERN NEVADA (W. REID LITCHFIELD, M.D., .ETAL.) ( 589) 10/18/99 10/15/99 COMMENT OF GHANDI M. SAADEH, M.D. ( 590) 10/19/99 10/18/99 COMMENT OF HARVEY V. LANKFORD, M.D. ( 591) 10/19/99 10/18/99 COMMENT OF SJOBERG KHO, M.D. ( 592) 10/19/99 10/18/99 COMMENT OF RICHARDT. KLOOS, M.D. ( 593) 10/19/99 10/19/99 COMMENT OF WAYNE A. EVRON, M.D. ( 594) 10/21/99 10/20/99 COMMENT OF CLAUDIA B. FISH, M.D. ( 595) 10/21/99 10/15/99 COMMENT OF RUGGERO BATTAN, M.D. ( 596) 10/22/99 10/18/99 COMMENT OF DANIEL EINHORN, M.D., DIRECTOR ( 597) 10/22/99 10/18/99 COMMENT OF VED V. GOSSAIN, M.D. ( 598) 10/28/99 10/15/9~ COMMENT OF RICHARDS. LONGLEY, M.D. ( 599) 10/28/99 10/21/99 _ COMMENT OF THE HONORABLE JO ANN EMERSON ( 600) 10/29/99 10/21/99 COMMENT OF SENATOR SPENCER ABRAHAM ( 601) 10/29/99 10/18/99 COMMENT OF DR. STEPHEN F. HODGSON ( 602) 11/03/99 10/04/99 COMMENT OF AMERICAN COLLEGE OF RADIOLOGY (CHARLES K. SHOWALTER) ( 603) 11/08/99 09/03/99 COMMENT OF AMER. COLLEGE OF NUC. PHYSICIANS/SOC. OF NUC. MED. (R.F. CARRITTA &J.M. WOOLFENDEN MOS) ( 604) 11/15/99 11/04/99 COMMENT OF BILL LAW, JR., M.D. ( 605) 11/17/99 10/27/99 COMMENT OF THE HONORABLE ROBERT E. ANDREWS ( 606) 11/19/99 11/02/99 COMMENT OF A. RODMAN BARBER, M.D. ( 607) 1_2/27 /99 12/20/99 COMMENT OF AMERICAN COLLEGE OF CARDIOLOGY (ARTHUR GARSON, JR., M.D., PRES.) ( 608) 03/21/00 02/09/00 COMMENT OF DAVID A. DIAMOND, M.D. ( 609)

UNIVERSITY OF WISCONSIN-MADISON MEDICAL SCHOOL 0 1*; l October 22, 1998 H ADJ' Secretary U.S. Nuclear Regulatory Commission Washington DC 20555-0001

                                                                                                       ~O 3:/.d 3!,

Attention: Rulemakings and Adjudications Staff {"13FR'/351~) I wish to comment on the proposed revision to 10 CFR Part 35 published in the Federal Register August 13, 1998. While I currently serve as the Chair of the University of Wisconsin's Radiation Safety Committee, the comments below reflect my own opinions, and not necessarily those of the University. General Comments:

1. Radiation Safety Committee-In the "Resolution" section on p age 43526 of the Federal Register, the NRC proposes deleting the RSC and transferring its functions to licensee management. While the deleting of the prescriptive membership is a positive step (my experience is that the prescribed members seldom brought much to the committee), management persons seldom have any knowledge (and often dangerous misconceptions) regarding radiation or radioactive materials. This leaves the RSO working alone without support, and possible against the management staff.

I would suggest the reinstatement of the Radiation Safety Committee.

2. The American Association of Physicists in Medicine (AAPM) has published several excellent reports lately that impact on radiation safety. Of particular interest are:

High dose-rate brachytherapy treatment delivery: report of the AAPM Radiation Therapy Committee Task Group No. 59. Medical Physics. 25(4):375-403, 1998; Code of practice for brachytherapy physics: report of the AAPM Radiation Therapy Committee Task Group No. 56. Medical Physics. 24(10):1557-98, 1997; Comprehensive QA for radiation oncology: report of AAPM Radiation Therapy Committee Task Group 40. Medical Physics. 21(4):581-618, 1994. CX) O') O') These reports make many suggestions relevant to safe practice with respect to radioactive materials. The proposed part 35 seems not to reflect these reports that define the state of practice and codes of conduct. Specific Comments: 35.404(a) This section requires a survey of a brachytherapy patient immediately after insertion of the sources to confirm that no source has been misplaced. This directive proves unworkable. With the sources in the patient, the background around the patient is too high to detect an errant source. Inclusion of this impossible task will lead to a false sense of safety and false statements that a(n effective) survey was performed. 0 i Department of Medical Physics CC - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1530 Medical Sciences Center 1300 University Avenue Madison, WI 53706-1532 608/262-2170 FAX 608/262-2413

35.432(b) This paragraph allows the use of manufacturer-provided calibrations for brachytherapy sources. The use of such calibrations without verification by the licensee poses serious hazards for the patient. The medical physicist should be required to assay the sources before use. In this day, such a requirement should pose no problem for facilities performing brachytherapy. The AAPM Task Groups recommend sampling 10% of sources used for permanent implants. This is not a large number, but is better than none. Certainly all temporary implant sources should be assayed. 35.610(c) This paragraph requires posting at a device control console the location of the procedures required by 35.610(a), yet 35.610(b) required the procedures themselves be posted by the console, making 35.610(c) unnecessary. 35.633(c)(l)(A) This section requires calibration of the guide tubes for remote afterloaders. Many uses of the afterloaders base dosimetry on the position of dummy markers that pass through the guide tubes, but where the length of the guide tubes themselves has no affect on the dosimetry. Calibrating the tubes serves no function, and what exactly would be calibrated remains unclear. The section should require calibration of any accessories that affect patient dosimetry. 35.633(c)(l)(B) This section requires calibration of the timer accuracy and linearity. Proper timer function is critical for correct patient dose, and that depends on timer consistency and linearity. Timer accuracy implies that a minute on the timer corresponds to one true minute. Such correspondence is irrelevant to dosimetry as long as the timer functions the same at the time of treatment as at the time at of calibration, and responds linearly. If one minute on the timer actually corresponds to two minutes, that factor of two cancels when incorporated in the calibration and the treatment. Consistency and linearity can be very well measured with ionization chambers; accuracy cannot be measured well by most hospitals. A stopwatch measurement tells more about the reaction time of the operator than the function of the unit. 35.643(a)(l) and (2) Section (2) requires periodic checks at the beginning of each day of use, while (1) requires the periodic check at the beginning of each week. Section (2) would cover the requirement of (1) if the first treatment day fell on Monday. If the first treatment day of a week fell on some other day, what is served by requiring periodic checks on that Monday without a treatment? This requirement should be dropped. Subpart JMuch of this section is redundant with, but not identical to, the training listed in the individual sections. The requirements in the two sections should be identical, or only listed once. 35.900(a)(6) The listing of certifications for the RSO for the American Board of Medical Physics should also include that board's Medical Health Physics certification. Subpart L Some records are to be kept for 3 years, other for 5. Making all record keeping durations the same could simplify compliance.

 ~            ,~.---::-;::;~*-----/4~:::----

Bruce Thomadsen, Ph.D. Part 35 comments 2

MeritCare Health System 720 4th St. N. DOCK [ f [ Q

   ~ MeritCare Fargo, ND 58122 IJ SH RC e_ ~ L. Gilbertson, MD., Presidmt

[ *

                                                              ~ 1 :p
                                                              ~

Meri_tcare Medical Group 737 Broadway 98 OCT ~ ){ 4 ;14'argo, ND 58123 Gregory J. Pos~ MD., Presidmt Or-;:. MeritCare Hospital 10/15/98 RG 720 4th St. N. ADJL: Fargo, ND 58122

                                                                      , \FF Secretary, U.S. Nuclear Regulatory Commission Attention: Rulemakings and Adjudications Staff Washington , DC 20555-0001 The Radiation Safety Committee of MeritCare Health System has reviewed the proposed revisions to 10 CFR Part 35 and has the following comments:

1. MeritCare Health System opposes the deletion of the Radiation Safety Committee from the rule. The RSC is an effective means to generate consensus and support for a large Radiation Safety Program. MHS intends to maintain an active RSC and recommends that the Commission allows either the RSC or RSO to acknowledge responsibility for the program .

2. MeritCare Health System supports verification of vendor stated calibrations of brachytherapy sources before patient use and recommends that the NRG adopt the verification methods stated in the AAPM Task Group 40 report.

3. MeritCare Health System recommends that record-keeping requirements be left in individual sections, but be summarized in one place.

4. MeritCare Health System recommends that reporting requirements be left in individual sections, but be summarized in one place .

• 5. MeritCare Health System recommends that sections dealing with patient notification be deleted from the rule, as they overlap with existing medical practice standards and current risk-management policies.

6. MeritCare Health System supports the deletion of the Quality Management Program with its burdensome reporting requirements while retaining the revised requirements for patient identity confirmation, written directives, and dose verification that do seNe to ensure appropriate patient care.

7. MeritCare Health System supports the acknowledgment of the role of the authorized medical physicist, as opposed to only a teletherapy physicist.

Si ~ , ="'-v-&..r.i! U ~rusell, RSC Chairman MeritCare Health System 8 1998 ra *f'i('T

October 23, 1998 DOCKET PRO t;/) 3:J.J--35

                                                                                )>    0

( (p3FR'l35l(Q) O:::o "Tl L ( * :T° COMMENTS ON PROPOSED RULE C,--=_*. 0 REVISION OF 10 CFR 35 D C::o (J) ;T(

                                                                                                    ~rr, General Comments                                                                     r

-::J-,

('"') f"T1

                                                                                            -0            C)

Rationale for Revision - In 1987, IO CFR 35 was revised to include prescriptive requirements in the rule that were previously incorporated into most medical licenses via refo'ren,ce to ~ commitments made in license applications. It appears that the currently propmied-revision to an extent reverts back to the pre-1987 regulations in that it places the burden on the licensee to establish procedures to meet the proposed regulations. One major difference is that the licensee will no longer be required to submit said procedures to the NRC. While this may appear to provide licensees with more latitude with respect to implementation of their radiation safety programs, some drawbacks are evident. NUREG -1556, Vol. 9 was published in conjunction with the proposed rule. That document describes the procedures which the NRC feels are necessary to comply with the revised rule. Many of the procedures described in the NUREG document are very similar to what licensees currently utilize to meet the existing rule. Problems may arise in situations where licensees deviate from the procedures specified in the NUREG document. NRC inspectors will be required to determine if such deviations are appropriate and to what degree procedures can deviate from those specified in the NUREG document before they are interpreted to be in non-compliance with the rule. This places a considerable burden on NRC inspectors. Furthermore, licensees cannot be certain about the adequacy of their procedures until an inspection is conducted. For large licensees (e.g., broad scope licensees), a revision of this type may have a less significant impact. These types of licenses are usually administered by a full time radiation safety officer (RSO) who can devote considerable time to assure compliance with the procedures outlined in the NUREG document or develop equivalent procedures to meet the rule. Unfortunately, smaller

• licensees may not have the expertise or time to devote to procedure development. That being the case, small licensees may fail to develop adequate procedures and/or fail to follow those in the NUREG. Smaller licensees may find the current prescriptive requirements easier to follow.

An alternative might be to allow licensees to establish a radiation safety committee to implement, periodically review, and change the various procedures as necessary. If licensees opted not to establish such a committee, they could submit the procedures ( or commit to those in the NUREG) to the NRC in the same way QMPs are submitted and changed under the existing rules. These would be considered living documents which could be changed as necessary providing the NRC is notified when such changes occurred. Elimination of the Radiation Safety Committee - There are some definite problems with the elimination of the radiation safety committee (RSC). Within the past couple of years, the NRC redefined medical use to include research in addition to what was considered standard clinical use (e.g., diagnosis and therapy). The intent of this change was to_allow smaller medical licensees to Page 1 of IO C 2 8 ,998 card.,.~~ 1.-.~~

participate in certain research activities. One caveat to this change was that the licensee must have research procedures reviewed and approved by a human subject protection committee (commonly called an institutional review board or IRB). In some cases, this arrangement may be acceptable; however, some research applications of radionuclides can be quite complex and possibly beyond the expertise of some IR.Bs. Review of such research proposals by an RSC may uncover certain problems which could be brought to the attention of the IRB. The RSC should also have the authority to restrict or prohibit research uses which in their opinion may carry unacceptable risks. In addition, the RSO may be involved in the research activities and as such may not be totally objective in his/her review. Another issue that may arise is a disagreement between the RSO and management. While it is understood that the NRC will hold management accountable for any compliance problems, the RSO may at times require the support of the RSC to convince management of the need to implement certain procedures or procure specific equipment the RSO feels is warranted. Management may be more receptive to recommendations from a committee rather than an individual, particularly if significant costs are involved. Rather than eliminate the requirement for an RSC, it might be more appropriate to reduce the meeting requirements for the RSC. For example, it may not be necessary for RSCs in smaller hospitals to meet on a quarterly basis. A semi-annual or possibly annual meeting might suffice to review procedures and perform an ALARA review. If research applications were to be considered, the RSC could hold meetings as frequently as deemed necessary. Furthermore, the membership of the RSC should be driven by the extent of licensed activities. For example, a nursing representative should not be required for a licensee that only performs diagnostic nuclear medicine studies. The specialties represented on the RSC should be submitted to the NRC with appropriate justification. It should not be necessary to submit actual names of RSC members. Subpart A

• Section 3 5. 1O(g) - Licensees should be allowed to implement changes in license conditions which reference deleted sections of part 3 5 without requiring a license renewal or amendment. The licensee should be required to document such changes and implement any procedures necessary to comply with relevant sections of the revised rule. The basis for this comment relates to the fact that if the NRC determines that a specific section of part 35 is no longer necessary, then a license condition tied to that part of the rule should also not be necessary. Licensees may be reluctant to amend their licenses due to the fees related to the amendment. References to the previous rule will lead to confusion for both licensees and NRC inspectors.

Section 35.12(d) - Broad scope licensees which have appropriate possession limits, chemical/physical forms, etc. in their existing licenses should not be required to amend said licenses simply because the application is an emerging technology covered under 3 5 .1000. It appears that 35.12(e) attempts to address broad scope licensees. This section should be clarified or added to the list of exemptions for broad scope licenses in 3 5. 15. Page 2 of 10

Subpart B Footnote to Section 35.40(a) - This footnote specifies that oral directives and/or oral revisions to written directives be documented in writing within 48 hours of the oral directive or revision. This requirement would be unnecessarily restrictive in some circumstances (e.g., over a weekend or holiday) and possibly too lenient in other cases (e.g., during the week). It is recommended that the provision of written directives following oral directives and the revision of written directives following oral revisions be required the next working day. Section 35.40(b)(l) - Even for 1311 as sodium iodide, it would appear reasonable to include the radiopharmaceutical and the route of administration. It seems practical to maintain consistency for what is required in a written directive. Section 35.40(b)(4) - Inclusion of the "overall treatment period" is not necessary for teletherapy treatments. The number of fractions essentially determines the overall treatment period. In some cases, patients may miss a treatment due to certain circumstances. If the physician specifies an overall treatment period in terms of a date which coincides with the number of fractions (e.g., 1 fraction per day for the next 10 days) and the patient misses one of the fractions, the written directive would have to be revised. Extending the treatment time for one or two missed fractions will have no impact on the effectiveness of the treatment. Physicians typically follow the treatment of their patients~ therefore, if a significant number of fractions are missed, the physician would need to make a medical decision regarding how best to modify the written directive to account for missed fractions. Medical decisions are beyond the intent of part 3 5. Section 35.50 - Attempts to specify training requirements for the radiation safety officer (RSO) of a license issued under part 3 5 is very difficult due to the large variation in the authorized uses under such licenses. For example, it may be acceptable for an authorized user (e.g., nuclear medicine physician) to serve as the RSO for a medical license which authorizes only nuclear medicine applications~ however, that same physician may not be acceptable as an RSO for a medical license that includes brachytherapy, research, etc. (i.e., a broad scope license). Certification does not guarantee that an individual is qualified to serve as an RSO for a medical license. For example, an individual with comprehensive certification by the American Board of Health Physics (ABHP) may not be qualified if he/she has had no practical experience in a medical environment. Attempting to develop an examination to qualify RSOs is equally difficult. It would require various examinations, depending upon the scope of the license. For example, the examination to qualify as an RSO for a license which only authorizes diagnostic use should be considerably less complex than one for an RSO at an institution where brachytherapy is performed. Furthermore, what of licensees who wish to expand their licenses from diagnostic uses to more complex therapeutic applications (e.g., brachytherapy)? Would this expansion require a re-examination of the RSO? Furthermore, an individual with a B.S., M.S., or Ph.D. degree in Health Physics should not be required to pass an examination to qualify as an RSO. Page 3 of 10

The RSO is the primary individual responsible for the implementation of the radiation safety program under a medical license. The NRC should require the licensee to submit the RSO's credentials for review and approval. In this way, the NRC can compare the RSO's credentials with the scope of the license. Section 3 5. 51 - An individual with a B. S., M. S., or Ph.D. degree in Medical Physics should not be required to pass an examination to qualify as an authorized medical physicist. Section 35.55 - An individual with a B.S., M.S., or Ph.D. degree in Nuclear Pharmacy should not be required to pass an examination to qualify as an authorized nuclear pharmacist. Subpart C General Comment - It appears that the contents of35.63 should appear before 35.60 in the rule. 35.63 describes how dosages of byproduct material are to be determined while 35.60 describes more specific information as to how this is to be done. 35.61 also appears to be out of place. It addresses survey instrument issues while the preceding and following sections discuss requirements for measuring doses. The contents of 3 5. 61 should probably precede the contents of

35. 65.

Section 35.60(a) - The wording of this section is similar to that of 35.63(c), but is not exactly the same. It seems to be redundant and inconsistent and should probably be deleted from 35.60. Section 35.6l(a)(l) - Some interpretation of this section is necessary. The section implies that licensees are required to utilize instruments that will measure dose equivalent rates up to 1000 mrem/lir; however, that is not explicitly stated. The section can be interpreted to mean that calibration is required if the instrument is capable of measuring up to 1000 mrem/hr. Licensees utilizing unit doses in diagnostic quantities probably do not need a survey instrument that is capable of measuring up to 1000 mrem/hr. This section should be clarified. Section 35.63(c) - As stated previously, the wording of this section is not consistent with 35.60(a). The wording of this section is somewhat confusing. It first states that the determination of the dosage " . . . must be made by direct measurement. . ." In the same sentence, it states that the determination of the dosage can be made ". . . by a combination of measurements and calculations." The question this raises is whether the "measurement" mentioned in the latter part of the sentence must be made by the licensee (i.e., a "direct measurement") or a measurement provided by the supplier. For example, if a licensee draws doses from a vendor supplied, multidose vial, can the measurement of the activity provided by the vendor be utilized with appropriate volume and decay corrections, or is the licensee required to perform the measurement (i.e., a "direct measurement")? If the answer to this question is "no," then the term "direct measurement(s)" should be utilized in both parts of the sentence. On the other hand, if the licensee can use the vendor's measurement, then clarification should be provided. Page 4 of 10

Section 35.65(c) - The activity in parenthesis is in units of"A.Ci." Obviously, the intended unit is

 µCi.

Section 35.67(g) - Sealed sources that meet the criteria specified in 35.67(f)(I), (2), and (3) should not be subject to semi-annual inventory requirements. Otherwise, even short-lived, gaseous, and/or low activity sources are required to be inventoried. Section 35.70(a) - Requiring daily surveys only in areas where radiopharmaceuticals requiring a written directive are prepared for use or administered is too lenient. Busy nuclear medicine departments may handle curie quantities of radioactivity on a daily basis. While it can be argued that the short half-life of diagnostic radiopharmaceuticals reduces the potential hazard, a daily survey provides useful information regarding the handling practices of the individuals preparing and administering diagnostic radiopharmaceuticals (e.g., ALARA considerations). Furthermore, nuclear medicine departments that infrequently use radiopharmaceuticals requiring a written directive will inevitably forget to perform a daily survey on days they do handle same. Section 35.80(a)(3) - This survey meter check was removed (perhaps inadvertently) from 35.61. There does not appear to be any compelling reason to include it in this section and not in 3 5. 61 . The fact that a survey instrument is being utilized for a mobile service does not appear to warrant the addition of this requirement. The survey meter check should either be deleted from or included in both sections. Section 35.92(a)(2) - It seems that the NRC addressed the removal or obliteration of radiation labels in previous guidance. Specifically, it was determined that removal or obliteration of such labels was only required on the "outermost" container (i.e., labels within an opaque, outer container need not be removed or defaced). This section should be revised to clarify that point. Subpart D

• Section 35. IO0(b) - This section references training requirements for 35.292. It appears that the reference should be to 35.290.

Sections 35.290(b)(3) & 35.292(b)(3) - Unless the NRC has evidence that a significant number of improperly trained authorized users are performing studies under 35.100 and/or 35.200, the examination requirements are not warranted. Subpart E Section 35.3 IO(a) - The provision ofradiation safety instruction " ... initially and at least annually . .. " can be a tremendous burden for some licensees. For example, if radiopharmaceutical therapy patients are assigned to specific rooms or areas within a hospital, this requirement is manageable. On the other hand, if radiopharmaceutical patients are assigned to rooms throughout the hospital, one must attempt to initially train and annually retrain every nurse in the hospital. Page 5 of IO

Given such problems as nursing staff turnover and temporary nurses, compliance with this requirement is almost impossible. Furthermore, nurses may need to be trained regarding different training modalities (e.g., radiopharmaceutical therapy, manual brachytherapy, LOR, etc.). Unless such nurses deal with all types of treatment modalities routinely, they become confused as to what radiation safety procedure applies to a specific treatment modality. The solution to this problem is to require that the radiation safety precautions either be posted near the patient's room (e.g., on the door or in the room), or the precautions should be placed in the patient's chart. Section 35.3 l 5(a) - The requirements in this section raise some interesting questions. In some cases, a patient may be released under 35.75, but due to another medical condition, the patient may be hospitalized. According to the current wording of35.315(a), if the patient is hospitalized for reasons other than the requirements of35 .75, no safety precautions are required. This causes a number of problems. Since licensees are required to provide "take home" instructions for these

• patients, nursing staff may be aware of such instructions and become confused as to the applicability of such instructions in the hospital setting. Some of these patients excrete significant quantities of radioactive material during the first few hours or days following radiopharmaceutical administration (e.g., thyroid carcinoma or hyperthyroid patients). Waste from such patients' rooms may be detected at local landfills or waste processing facilities (e.g., incinerators) if such waste is not properly collected and held for decay.

The aforementioned considerations warrant the implementation of radiation safety precautions whenever patients receiving therapeutic quantities of radiopharmaceuticals are hospitalized. Rather than the prescriptive requirements in 3 5. 315(a), it is recommended that the following wording be incorporated into that section:

 "(a) For each patient that has received therapeutic quantities of radiopharmaceuticals and is hospitalized, the licensee shall implement appropriate safety precautions. Such precautions shall include the consideration for patient isolation (e.g., assignment to a private room), posting a "Radioactive Materials" sign and visitation restrictions as necessary, and preventing the removal of contaminated objects except items used exclusively by the patient from the patient's room."

A description of how a licensee complies with this section could be included as part of the license application. It also is commensurate with the idea that such precautions should be performance based. Section 35.390(b)(4) - Unless the NRC has evidence that a significant number ofimproperly trained authorized users are performing procedures under 35.300, the examination requirement is not warranted. Subpart F Page 6 of 10

Section 35.410(a) - Same comment as for section 35.3 l0(a). Section 35.415(a)- Same comment as section 35.315(a). Section 35.415(b)(4) - The purpose ofthis requirement is not clear. Under what circumstances would it be necessary to surgically remove applicators or sources on an emergent basis? In case of a medical emergency (e.g., heart attack, stroke, etc.) removal of applicators or sources prior to the provision of emergency medical care (e.g. resuscitation) would jeopardize the patient. Response (e.g., evacuation of patient) to large scale emergencies such as fires or explosions should not be delayed for the removal of applicators or sources. Section 35.490(b)(3) - Unless the NRC has evidence that a significant number of improperly trained authorized users are performing procedures under 35.400, the examination requirement is not warranted .

• Subpart H Section 35.610{a)(l) - This section is too prescriptive to cover the variety of devices listed. For example, it is not necessary to secure both the console and the console keys. Securing one or the other should provide adequate security. Furthermore, securing treatment rooms housing teletherapy or GSR units when they are not in use or unattended is not necessary if the console or console keys are secured. It is highly unlikely that unauthorized individuals would remove such devices given their bulk and weight. In keeping with the idea of a performance based rule, this section should be worded as follows:

 "(l) Prevention of unauthorized use or removal of the device when not in use or unattended;"

Section 3 5. 610(d) - Once again, this section is too prescriptive for the variety of devices listed .

• While it may be possible to perform a drill simulating the removal of a patient from a teletherapy unit, such a drill is not practical for an HOR (few people will volunteer to have a catheter inserted for the sake of a drill to simulate the removal of the catheter and subsequent removal of the patient from the treatment room). It is recommended that the first sentence in this section be reworded as follows:

 "(d) A licensee shall provide instruction and practice drills or demonstrations, initially and at least annually . . ."

Section 35.615(e)- The wording of this section is too subjective. If a decoupled or jammed source is difficult to remove, the licensee could be cited under this section (i.e., the word "expeditious" is too subjective). Furthermore, this section could cause a physician to withhold what he/she considers the best treatment for a given patient because the removal of a decoupled or jammed source might be more difficult for one type of treatment versus another. This could be interpreted to interfere with what the physician feels is in the best interest of the patient. Page 7 of 10

Section 35.615(£)(1) - In larger institutions, dosimetrists and residents work closely with medical physicists and physicians in planning and delivering LDR treatments. This section should be reworded to allow individuals working under the supervision of an authorized user who have been trained in the operation of the LDR device to be physically present during the initiation of the treatment providing an authorized user or authorized medical physicist is immediately available. Due to the low dose rates involved, such a requirement would not jeopardize the patient. Section 35.615(£)(2) - It is not necessary for both an authorized user and an authorized medical physicist to be physically present during the initiation and continuation ofHDR treatments. The physical presence of an authorized medical physicist is sufficient providing an authorized user or a physician trained to respond to HDR related emergencies could be summoned to the HDR console within a period of two minutes. This could be easily accomplished when the HDR unit is located within a radiation oncology department where authorized users are present. In emergency situations, the authorized user could be summoned to the HDR unit if necessary. Section 35.615(f)(3)(i) - Same comment as the previous section. Section 35.643(a)(l) - This section is not necessary if the requirement specified in 35.643(a)(2) is retained. There would be no point in performing weekly spot checks if the same checks are to be performed prior to the use of the device. Section 35.643(a)(2) - This section is too specific. It does not matter if the spot checks are performed "at the beginning of each day of use. " The emphasis should be that the spot checks be performed prior to the use of the device on a given day. For example, if an HDR treatment was scheduled for 3:00 p.m. on a given day, the spot checks could be performed any time that day before the treatment. It would not be necessary to perform the spot checks "at the beginning of the day." Section 35.645(a)(l) - This is the same basic comment as indicated above for 35.643(a}(l). It is not necessary to perform monthly spot checks if the same checks are to be performed prior to the use of the device. Section 35.645(a)(2) - Same comment as above for 35.643(a)(2). Section 35.690(b)(4) - Unless the NRC has evidence that a significant number ofimproperly trained authorized users are performing procedures under 35.600, the examination requirement is not warranted. Subpart L General Comment 1 - The requirement to record the "name of the individual" that performed a certain activity (e.g., survey, disposal, etc.) appears throughout this subpart. It is common practice to utilize initials to identify the individual performing such operations. That being the Page 8 of 10

case, the words "name of the individual,, should be replaced with "identification of the individual,, throughout this subpart. Initials are one way to identify an individual. General Comment 2 - Most of the records require a retention period of 3 years. Rather than state the retention period under each section, it seems that a separate section which simply states that all records in this subpart are to be maintained for a period of 3 years unless otherwise specified would make more sense. Section 35.2026 - This section is too prescriptive. Broad scope and possibly other licensees will probably continue to make*and document changes via their radiation safety committee. In that case, the documentation method changes (e.g., documented in meeting minutes). In accordance with the revision of the rule, documentation of radiation safety program changes should be performance based. The second sentence in this section should be deleted or less prescriptive. Section 35.2070 - This section addresses records associated with "surveys for ambient radiation exposure rate,\ however, reference is made to recording removable contamination in dpm/100 cm2

• 3 5.70 does not require removable contamination surveys, thus reference to records of same should be deleted.

Section 35.2406(c)(2) - In some permanent implant cases, all of the sources will be utilized. That being the case there will be no sources to return to storage. The part of the first sentence of this section should read, "(2) The number and activity of any unused sources returned to storage, the date ... " SubpartM Section 35.3045(c){l)(vi) & (vii) - These two section appear to be redundant. They could be combined into one section. Appendix A to 10 CFR 35 - Examinine Organization or Entity- As mentioned numerous times in the aforementioned comments, the examination requirements do not appear warranted unless the NRC has evidence that a significant number of RSOs, physicians, nuclear pharmacists, and/or medical physicists are inadequately trained to serve in those capacities. The approval process outlined in this section appears to be very labor intensive for the NRC. Furthermore, it would appear to be more practical to require the minimum training and experience requirements to be commensurate with the scope and complexity of the licensed activities. For example, the minimum level of training and experience for an RSO administering a broad scope medical license should be more expansive than that of an RSO for a small hospital. This is more appropriately dealt with in the licensing process rather than utilizing prescriptive requirements in the regulations. Comments prepared by: Mack L. Richard, M.S., Radiation Safety Officer (RSO) Page 9 of 10

Indiana University Medical Center (IUMC) Comments reviewed, edited, and supported by: Jeffiey S. Mason, Indiana University Medical Center 541 Clinical Drive Indianapolis, IN 46202-5111 Page IO of IO

HOWARD UNIVERSITY 10CKET N BEA OFFICE OF THE VICE PRESIDENT FOR HEALTH AFFAIRS 0 ROPOSED AUL 0 f; 3;2 J- 35 "98 OCT 26 P4 :24 (~'3FR'l./35H,)

                                                                                  ~., ;;

COMMENT Hv , ADJ1.) r-- Proposed Changes to 10 CFR Part 35 The Howard University Radiation Safety Committee is of the opinion that if requirements are not mandated, in an effort to save money, Hospitals and Universities will not fully comply with all of the established rules and regulations. The operation of the radiation safety program will be dependent solely upon the wishes of administrative personnel who may not feel that radiation safety is a priority. The decision to eliminate the radiation safety committee could be detrimental to the radiation safety program. October 21 , 1998 M Marlene H. McKetty, Ph.D., C airperson Howard University Radiation Safety Committee QC 2 8 1998 2041 GEORGIA AVE. , N.W. SUITE 6000 (202) 865-7470 Washington, DC 20060 FAX (202) 667-5694

RE 0 S& FF OF ECOMMIS

THE UNIVERSITY OF IOWA HOSPITALS AND CLINICS

                                              }: JAMES A. PONTO, MS, RPh, BCNP i} Chief Nuclear Pharmacist and Professor (Clinical)

I]* Division o! Nuclear Medicine / Dept. of Rad* :l! [ TE0

                                              ): 200 Hawkins Dr.        Room 3832 JPP I@ II J Iowa City, Iowa 52242-1077                       US: lRC office:  319/356-2741 FAX:     319/356-2220 email:   james-ponto@uiowa.edu DOCKET            9ER                   ........, "98 OCT 23 P3 :08 10-20-98                                PROPOSED RULE                 Jo ?>~t135
                                                                  &3FR '{35/to OF,=,

Secretary Ru, I ~ U.S. Nuclear Regulary Commission ADJUDIL, . r ' ,rr-Attn: Rulemakings and Adjudications Staff Washington, DC 20555-0001 RE: Medical Use of Byproduct Material; Draft Policy Statement

Dear sirs/madams:

I would like to take this opponunity to offer my comments on NRC's "Medical Use of Byproduct Material; Draft Policy Statement" published in the Federal Register (Yol. 63, No. 156, Thursday, August 13, 1998, pages 43580-43586). I noted the second sentence of the second full paragraph in the middle column of page 43584 of the FR: "NRC has the responsibility, as described above, for regulating actual medical use of byproduct material from the standpoint of reducing unnecessary radiation exposures to the public, patients, and occupational workers." What is, and who determines, unnecessary radiation exposures to patients? Only physicians can judge necessity regarding patient exposures. If the patient exposure is unnecessary and harm is done, then the physician may be guilty of malpractice (monetary awards, civil penalties, possible loss of medical license, etc.). NRC regulations won't prevent malpractice, and NRC penalties are the least of the guilty physician's worries. If the patient exposure is unnecessary but no harm is done, then the physician may be still guilty of fraud (billing for unnecesary procedures). But if no harm is done, what is the purpose of NRC regulation? Regarding the proposed medical policy statements:

• #1) I think that this statement is fine; this falls within NRC's responsibilites.

 #2) I like the statement that NRC will not intrude into medical judgements affecting patients.

But I think that the last phrase is unnecessary, as it simply restates the content of Policy Statement #1. Therefore. I suggest deleting the last phrase of this MPS. Hence, it wc11ld simply state: "NRC will not intrude into medical judgements affecting patients."

 #3) I think that this statement is unnecessary because it won't solve anything -- medical events caused by failure to use radionuclides in accordance with the physician's directions are infrequent and are at the level of human error. NRC attempts to regulate the assurance of following physician directions (ie, regulate human error) are naive. More patients are harmed and even killed every year in other areas of medical therapy that are already more heavily regulated (eg, blood transfusions, chemotherapy, etc) than is radiation, BECAUSE OF HUMAN ERROR.

While some of these errors may be more related to systems error than to individual human error, NRC lacks expertise in the area of systems error managment. Instead of drafting prescriptive regulations that have little or no positive impact but only cause more record-keeping, cost, inspection citations, etc., NRC should work with experts in the area of systems error managment (such as ISMP = Institute for Safe Medical Practices) and then promote system error management techniques through education rather than through prescriptive regulation. Therefore, I suggest deleting this MPS. OCT 2 8 19~8 Aet<nowtedged by caro

 .S. CLEAR REGULATORY COMMISSION RULEMAKINGS &ADJUDICATIONS STAFF OFACE Of THE SECRETARY OF THE COMMISSION Document Statistics Postm     Date _.--+-.......,_.......,.__ _ _

Cop esRecelYed _____ Add~Copies R s . Distrl:>utiorl,.,..---ji--l=,~ r-l--"'

 -'-"'-~ I    '/21--- -- -

2

 #4) I think that this is a nice way of saying nothing. As past history has shown, NRC "will consider" many things but then summarily reject them. On the other hand, this statement doesn't result in anything being worse off. So, although worthless, this statement is acceptable.

Thank you for your consideration of these comments. Sincerely,

DOCKEfED US WC

          ~0/   3:J... .f 35

( b3FR'135l6J "98 oc 23 P2 :4 4 OF Helen G. Krupansky r.: - B l "

                                     , 1.., I P.O. Box 129                  . ADJU.J11 36 Walker Ln.

Waretowo, NJ 08758 -0/1..Cj

{ JAMES A. PONTO, MS, RPb, BCNP I THE UNIVERSITY OF IOWA III Cbie~Nuclear Pbarmac~ _and Professor (Clinical) HOSPITALS AND CLINICS If Divis10n o! Nuclear Me! e , en:-qti Radiology

                                              , , , 200 Hawkins Dr.       in     1..JP'P f Iowa City, Iowa 52242-10 ~      * :,

office: 319/356-2741 FAX: 319/356-2220 email: james-ponto@uiowa.edu "98 OCT 23 P2 :11 10-16-98 Jo, 3~ J- 'oFF; Secretary ( IP3PRJ,f 3§Jt,,) F,-,, U.S. Nuclear Regulary Commission ADJU Attn: Rulemakings and Adjudications Staff Washington, DC 20555-0001 RE: Medical Use of Byproduct Material; Proposed Revision. RIN 3150-AF74

Dear sirs/madams:

I would like to take this opportunity to offer my comments on NRC's "Medical Use of Byproduct Material; Proposed Revision" published in the Federal Register (Vol. 63, No. 156, Thursday, August 13, 1998, pages 435 16-43580). My comments will be limited to those sections dealing with radiopharmaceuticals; I offer no comments regarding brachytherapy or teletherapy. In general, NRC has made some progress moving toward performance-based approach for rule-making by eliminating a few prescriptive requirements. However, many unnecessary prescriptive requirements still remain. I am also disappointed that the proposed revision contains minimal, albeit some, progress in risk-informed approach to regulating low-risk vs. high-risk activities. This relative overall lack of progress in risk-informed, performance-based rule-making is in contrast to the Commission's expressed desire as stated in its SRM-COMSECY 057. Comments on specific sections are as follow:

• 35.2 Definitions. I suggest deletion of "Diagnostic clinical procedures manual". Diagnostic radiopharmaceuticals are drugs (as defined and regulated by the FDA). Therefore, like all other drugs, radiopharmaceuticals must be ordered by the patient's physician via a prescription or analogous drug order. This is state law regarding the practices of medicine and pharmacy. If allowed by institutional bylaws, a physician may create routine standing orders for certain specified situations -- eg, anesthesia for certain types of operations, pain relievers following certain surgeries, anti-nausea medication following certain chemotherapy, etc. These specific sets of standing orders are similar to what NRC calls the diagnostic clinical procedures manual.

It is not necessary to create a new name -- just call it what it already is: a radiopharmaceutical prescription/order. A radiopharmaceutical prescription/order can either be written for an individual patient (eg, a written directive for therapeutic radiopharmaceuticals) or in the form of specific standing orders. 35.19. This section authorizes the Commission, upon its own initiative or upon application from any interested person, to grant exemptions from the regulations that will not endanger life or property or the common defense and security and are otherwise in the public interest. I submit that essentially all diagnostic nuclear medicine procedures should be exempted from regulation because they will not endanger life or property, they will not endanger the common defense and security, and they are otherwise in the public interest [such exemptions would increase the availability and decrease the cost of valuable nuclear medicine diagnostic procedures]. Aeknnw1edqed card---~- OCi 2 S 1998

lJ.S. UCLEAR REGULATORY COMMISSION RULEMAKINGS &ADJUDICATIONS STAFF OFFlCEOFfflESECRETARY OF THE COMMISSION Document Statistics Postmark Date __._.;;:;,.,-;.~.........- - - -- - Copies Received---'--.....-- - - Add~ Copies Reprod Special Distribution _____,!_:....=.;,,=:,,:+-~=:c;-- ~ 1-1:.~ ~~ =

?~~,~~         'D=s' - - - - - - -

2 35.20. I support deletion of ALARA from Part 35. 35.22. I support deletion of Radiation Safety Committee. Radiation safety committees are not always necessary for specific licenses of limited scope. I can support, however, the requirement for one or more committees as a license condition for specific licenses of broad scope. However, the licensee should have flexibility in meeting radiation safety objectives, including criteria for membership, meeting frequency, record-keeping/minutes, etc. 35.24 Authority and responsibilities for the radiation protection program. This section seems to contain quite prescriptive requirements given the statement (on FR page 43531): "The Commission believes that the licensee should have the flexibility in developing, maintaining, and implementing its radiation protection program... " In general, I can support the assignment of responsibilites to the Radiation Safety Officer if adequate authority is simultaneously given to the RSO. My concern here is that, if a problem occurred, such a written agreement could later be used by administration to make the RSO into a scapegoat. The written agreement seems to be more of a legal, contractual matter than it is a radiation safety matter. 35.27 Supervison. I suggest deletion of (a)(2) and (b)(2) having to do with requiring the supervised individual to follow the instructions of the authorized user, etc. This is already covered to some extent in 35.27 (d) having to do with the responsibility of the supervised individual's actions falling back on to the licensee, and given the statement (on FR page 43531):

 "The Commission believes that the licensee should have the flexibility in developing, maintaining, and implementing its radiation protection program... ". Moreover, 35.24 (c) already requires that "The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements... " Also, by state law, supervising physicians are responsible for the actions of health professionals working under their supervison. Another concern here is that, in the event of human error, the supervised individual could be made into a scapegoat for failing to comply with this requirement. NRC cannot regulate away human error. On the other hand, if a supervised individual purposely ignored instructions, such actions would be grounds for disciplinary action and possibly criminal prosecution. NRC cannot regulate away purposeful misconduct.

• 35.27 Supervison. (continued). I suggest deletion of (c) having to do with a policy for supervised individuals to request clarification as needed from the supervising authorized user or pharmacist.

This requirement, although possibly appropriate for monkeys and bureaucrats, is not necessary for intelligent, trained health professionals. Although some local transit authorities are now requiring their public employees to say "please" and "thank you", social interaction cannot be effectively regulated. Additionally, this matter is already covered to some extent in 35.27 (d) having to do with the responsibility of the supervised individual's actions falling back on to the licensee, and given the statement (on FR page 43531): "The Commission believes that the licensee should have the flexibility in developing, maintaining, and implementing its radiation protection program... ". Moreover, 35.24 (c) already requires that "The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements ... " Also, by state law, supervising physicians and pharmacists are responsible for the actions of individuals working under their supervison. Another concern here is that, in the event of human error, the supervised individual could be made into a scapegoat for failing to comply with this requirement. NRC cannot regulate away human error. On the other hand, if a supervised individual purposely proceeded without clarification, such actions would be grounds for disciplinary action and possibly criminal prosecution. NRC cannot regulate away purposeful misconduct. 35.27 Supervison. (continued). I suggest deletion of (d) having to do with licensee responsibility for acts and omissions of supervised individuals. This is already covered to some extent given

3 the statement (on FR page 43531): "The Commission believes that the licensee should have the flexibility in developing, maintaining, and implementing its radiation protection program... " . Moreover, 35.24 (c) already requires that "The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements... " Also, by state law, supervising physicians and pharmacists are responsible for the actions of individuals working under their supervison. Another concern here is that, in the event of human error, the licensee could be unfairly penalized for failing to comply with this requirement. NRC cannot regulate away human error. On the other hand, if a supervised individual purposely engaged in improper acts or omissions, such actions would be grounds for disciplinary action and possibly criminal prosecution. NRC cannot regulate away purposeful misconduct. 35.32 Quality Management Program. I agree that the quality management program should be deleted. Quality management is not unique for radioactive materials -- it also applies to much more hazardous procedures such as chemotherapy. Moreover, these requirements are already implemented as a routine standard of care in medicine. Even if a quality management rule were to be retained, such a rule would never regulate away human error.

• 35.41 Procedures for administrations requiring a written directive. I suggest that this entire section specifically exempt radiopharmaceuticals. These requirements for radiopharmaceuticals are unnecessary. Administrations of radiopharmaceuticals are performed only by trained healthcare professionals. Administration of drugs, including radiopharmaceuticals, is already regulated by state law. Furthermore, this is already covered to some extent given the statement (on FR page 43531): "The Commission believes that the licensee should have the flexibility in developing, maintaining, and implementing its radiation protection program ... " . Moreover, 35.24 (c) already requires that "The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements ... " Also, by state law, supervising physicians are responsible for the actions of health professionals working under their supervison. Another concern here is that, in the event of human error, the licensee could be unfairly penalized for failing to comply with the implementation portion of this requirement. NRC cannot regulate away human error. On the other hand, if a supervised individual purposely engaged in improper acts or omissions, such actions would be grounds for disciplinary action and possibly criminal prosecution. NRC cannot regulate away purposeful misconduct.

35.59 Recentness of training. If training and experience have not been obtained within the 7 years preceeding the date of application, how much related continuing education and experience must the individual have? Would this be a case-by-case evaluation involving the ACMUI? 35.60 Possesion, use, calibration, and check of instruments to measure the activity of photon-emitting radionuclides. I support the exemption of unit dosages from mandatory activity measurement. This duplication is unnecesary and anti-ALARA. 35.60 Possesion, use, calibration, and check of instruments to measure the activity of photon-emitting radionuclides (continued). I support the acceptability of using other instruments rather than just a dose calibrator to measure activity dosages. This opens the door for technological advances in this area. I also support the changes described for linearity testing: perform annually rather than quarterly, and perform over the range of medical use rather than over the range of activities measured. Based on instrument reliability and the presence of daily constancy checks, annual testing is adequate. Also, performance only over the range of medical use is adequate and keeping with ALARA. 35.63 Determination of dosages for unsealed byproduct material for medical use. I support item (b) wherein the activity of unit dosages may be determined from decay correction. Hence,

4 possession and use of a dose calibrator or other instrumentation may not be required by certain licensees. 35.63 Determination of dosages for unsealed byproduct material for medical use (continued). I suggest that (d) be revised to state "prescribed dosage or dosage range". For example, the package insert lists a dosage range for Tc-99m sestamibi as 10-30 mCi. Nearly all facilities obtain unit dosages of Tc-99m sestamibi from commercial nuclear pharmacies. Depending on scheduling delays, patient delays, etc, the dosage activity may easily decay by more than 20% from its labeled amount. On the other hand, if a patient arrives early, the dosage activity may be more than 20% high because it hasn't yet decayed all the way down to its calibrated activity. [35.63 (b) requires either direct measurement or decay correction of unit dosages]. Adjusting such a unit dosage, either upward or downward, to have its activity fall within 20% of one arbitrary value within an acceptable dosage range is not only a waste of time, but it increases the likelihood of bacterial or particulate contamination of the dosage. Moreover, such unnecessary adjustments of dosage are anti-ALARA for the individual handling it. One other example: The package insert lists a dosage range for Tc-99m exametazime (HMP AO) as 10-20 mCi. For the detection and evaluation of seizure focus in epileptic patients, the

• radiopharmaceutical should be injected during the seizure (ie, within about a 30-second time window). But the time that a seizure will occur is unknown. Thus a dosage is keep at bedside, ready for injection, and everyone waits, sometimes for hours, until a seizure occurs; the radiopharmaceutical is then injected immediately during the seizure. Noting the time of injection, the administered activity can be determined by decay-correcting the original activity.

The exact activity is irrelevant -- it just needs to be somewhere in the range of 10-20 mCi. So from a practical point of view, an initial dosage of 20 mCi can be administered any time up to 6 hours, when it would be decayed down to 10 mCi. 35.69 Labeling and shielding of vials and syringes. I suggest deletion of this entire section. Item (a)(l) is unnecessary for two reasons. First, these labeling requirements are unnecessary because they are already regulated by state law regarding preparation and dispensing of drugs. Second, this is already covered to some extent given the statement (on FR page 43531): "The Commission believes that the licensee should have the flexibility in developing, maintaining, and implementing its radiation protection program... ". Moreover, 35.24 (c) already requires that "The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements... " Item (a)(2) is unnecessary given the statement (on FR page 43531): "The Commission believes that the licensee should have the flexibility in developing, maintaining, and implementing its radiation protection program... ". Moreover, 35.24 (c) already requires that "The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements ... " Item (b) is unnecessary given the statement (on FR page 43531): "The Commission believes that the licensee should have the flexibility in developing, maintaining, and implementing its radiation protection program... ". Moreover, 35.24 (c) already requires that "The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements ... " Furthermore, 35.27 (a)(l) requires that the licensee instruct individuals in radiation protection procedures, regulations, etc. Another concern here is that, in the event of human error, the licensee could be unfairly penalized for failing to comply with the implementation portion of this requirement. NRC cannot regulate away human error. On the other hand, if an individual purposely engaged in improper acts or omissions, such actions would be grounds for disciplinary action and possibly criminal prosecution. NRC cannot regulate away purposeful misconduct

35. 70 Surveys for ambient radiation exposure rate. I support the deletion of survey requirements for areas of use of diagnostic radiopharmaceuticals not requiring a written directive.

5 35.70 Surveys for ambient radiation exposure rate (continued). I suggest that this entire section can be deleted. It is unnecesary given the statement (on FR page 43531): "The Commission believes that the licensee should have the flexibility in developing, maintaining, and implementing its radiation protection program... ". Moreover, 35.24 (c) already requires that "The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements... " Another concern here is that, in the event of human error, the licensee could be unfairly penalized for failing to comply with the implementation portion of this requirement NRC cannot regulate away human error. On the other hand, if an individual purposely engaged in improper acts or omissions, such actions would be grounds for disciplinary action and possibly criminal prosecution. NRC cannot regulate away purposeful misconduct 35.70 Surveys for ambient radiation exposure rate [if my suggestion above is not accepted]. I suggest revision of Item (a) regarding time of survey. I suggest that surveys are more appropriately performed after preparation or administration rather than at the end of the day. For example, if a spill occurred during preparation or administration in the morning, and the spill was unnoticed, it could be inadvertently spread before it was detected at the end of the day. 35.75. Release of individuals containing radiopharmaceuticals or implants. I suggest deletion of Item (b) and Item (d). Provision of information is part of medical judgement and medical practice. As such, it is already regulated by state law. It should be physician judgement whether to instruct the patient with written instructions or with some other type of instruction. The breast-feeding requirements are especially intrusive into medical practice. Furthermore, this is unnecesary given the statement (on FR page 43531): "The Commission believes that the licensee should have the flexibility in developing, maintaining, and implementing its radiation protection program ... ". Moreover, 35.24 (c) already requires that "The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements... " Another concern here is that, in the event of human error, the licensee could be unfairly penalized for failing to comply with the implementation portion of this requirement NRC cannot regulate away human error. On the other hand, if an individual purposely engaged in improper acts or omissions, such actions would be grounds for disciplinary action and possibly criminal prosecution. NRC cannot regulate away purposeful misconduct. 35.90 Storage of volatiles and gases. I support deletion of this section. It is unnecessary. 35.92 Decay in storage. I support the revision that allows decay in storage for radionuclides with half-lives up to 120 days. I support the deletion of the requirement to separate and monitor each generator column. I support the deletion of storage for more than 10 half-lives. In NRC's commentary (on FR page 43536), concern was raised about detection of sulfur-35. It should be emphasized that S-35 is not a component in any FDA-approved radiopharmaceutical for routine use. Furthermore, the medical use of S-35 is exceedingly rare if existent at all. If S-35 were to be used, decay in storage could be adequately addressed by Part 20 and by 35.24. 35.120 Possession of survey instruments. I support deletion of this section because it is unnecessary. 35.204. Permissable molybdenum-99 concentration. I suggest deletion of this entire section. Molybdenum-99. concentration is subject to USP standards and enforced by FDA through the adulteration provisions in the Food, Drug & Cosmetic Act. This is an intrusion into the practices of pharmacy and medicine.

6 35.290 Training for uptake, dilution, and excretion studies. Why is the authorized user limited to a physician? I suggest that an authorized user dentist or podiatrist (cf. 35.2 Definitions) be added. 35.290 Training for uptake, dilution, and excretion studies (continued). Item (b)(l)(ii)(B) is not consistent with 35.60. I suggest deleting "Calibrating dose calibrators". This is especially relevant for unit-dosages where measuring the activity is not required. 35.290 Training for uptake, dilution, and excretion studies (continued). Item (b)(l)(ii)(C) is not consistent with 35.63. I suggest changing "Calculating, measuring," to "Determining". This is especially relevant for unit-dosages where measuring the activity is not required. 35.292 Training for imaging and localization studies. Why is the authorized user limited to a physician? I suggest that an authorized user dentist or podiatrist (cf. 35.2 Definitions) be added. 35.292 Training for imaging and localization studies (continued). Item (b)(l)(ii)(B) is not consistent with 35.60. I suggest deleting "Calibrating dose calibrators ". This is especially relevant for unit-dosages where measuring the activity is not required. 35.292 Training for imaging and localization studies (continued). Item (b)(l)(ii)(C) is not consistent with 35.63. I suggest changing "Calculating, measuring," to "Determining". This is especially relevant for unit-dosages where measuring the activity is not required. 35.292 Training for imaging and localization studies (continued). Item (b)(l)(ii)(F) may not be consistent with 35.63 in that the licensee may obtain all unit dosages from a Part 32 licensee. Moreover, this is a direct intrusion into the regulation of the practices of pharmacy and medicine. I suggest deletion of this item. 35.315 Safety precautions. I suggest deletion of Item (a)(l). In some cases, it may be perfectly acceptable for two patients, each receiving radionuclides, to share the same room. Furthermore, this is unnecesary given the statement (on FR page 43531): "The Commission believes that the licensee should have the flexibility in developing, maintaining, and implementing its radiation protection program... ". Moreover, 35.24 (c) already requires that "The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements ... " 35.390 Training for use of unsealed byproduct material for therapy or for use of unsealed byproduct material that requires a written directive. Item (b)(l)(ii)(B) is not consistent with 35.60. I suggest deleting "Calibrating dose calibrators". This is especially relevant for unit-dosages where measuring the activity is not required. 35.390 Training for use of unsealed byproduct material for therapy or for use of unsealed byproduct material that requires a written directive (continued). Item (b)(l)(ii)(C) is not consistent with 35.63. I suggest changing "Calculating, measuring," to "Determining". This is especially relevant for unit-dosages where measuring the activity is not required. 35.1000 Other medical uses of byproduct material or radiation from byproduct material. This section has been added to accomodate emerging technologies. I suggest that this section specifically exempt radiopharmaceuticals. Radiopharmaceuticals are regulated by the FDA under RDRC (radioactive drug research committee), IND (investigational new drug exemptions), NDA (new drug applications), and PLA (biologic product license applications). Thus, all radiopharmaceuticals should readily fit under Subpart D or Subpart E. 35.2024. Records of authority and responsibilities for radiation protection programs. Item (b) seems to contain quite prescriptive requirements given the statement (on FR page 43531): "The

7 Commission believes that the licensee should have the flexibility in developing, maintaining, and implementing its radiation protection program... " In general, I can support the assignment of responsibilites to the Radiation Safety Officer if adequate authority is simultaneously given to the RSO. My concern here is that, if a problem occurred, such a written agreement could later be used by administration to make the RSO into a scapegoat. This seems to be more of a legal, contractual matter than it is a radiation safety matter. I suggest deleting this item. 35.2026 Records of radiation protection program safety changes. This section seems to contain quite prescriptive requirements given the statement (on FR page 43531): "The Commission believes that the licensee should have the flexibility in developing, maintaining, and implementing its radiation protection program... " I suggest that the second sentence of this section be deleted. 35.2040. Records of written directives. I suggest that this section be revised to specifically exempt radiopharmaceuticals. Records of written directives (ie, prescription orders) are unnecessary for radiopharmaceuticals because state laws already require retention of prescription records. 35.2045 Records of medical events. This section seems to contain quite prescriptive requirements given the statement (on FR page 43531): "The Commission believes that the licensee should have the flexibility in developing, maintaining, and implementing its radiation protection pro gram... " I suggest that the second sentence of this section be deleted. 35.2060 Records of instrument calibrations. This section seems to contain quite prescriptive requirements given the statement (on FR page 43531): "The Commission believes that the licensee should have the flexibility in developing, maintaining, and implementing its radiation protection program... " I suggest that everything after the first sentence of this section be deleted. 35.2060 Records of instrument calibrations [if my suggestion above is not accepted]. Items (a), (b), (c), and (d) require the "name of the individual" who performed the test. I believe that other forms of identification may also be acceptable as an alternative to the individual's name; for example, the individual's initials. Therefore, I suggest that these items be revised to change "name of the individual" to "identity of the individual". 35.2061 Records of radiation survey instrument calibrations. This section seems to contain quite prescriptive requirements given the statement (on FR page 43531): "The Commission believes that the licensee should have the flexibility in developing, maintaining, and implementing its radiation protection program... " I suggest that everything after the first sentence of this section be deleted. 35.2061 Records of radiation survey instrument calibrations [if my suggestion above is not accepted]. Item (b) requires the "name of the individual" who performed the test. I believe that other forms of identification may also be acceptable as an alternative to the individual's name; for example, the individual's initials. Therefore, I suggest that this item be revised to change "name of the individual" to "identity of the individual". 35.2063 Records of dosages of unsealed byproduct material for medical use. I suggest that this entire section be deleted because it is unnecessary. Radiopharmaceuticals are drugs, and thus prescribing and dispensing records are required by state laws relating to the practices of medicine and pharmacy. 35.2063 Records of dosages of unsealed byproduct material for medical use [if my suggestion above is not accepted]. This section seems to contain quite prescriptive requirements given the statement (on FR page 43531): "The Commission believes that the licensee should have the

8 flexibility in developing, maintaining, and implementing its radiation protection program... " I suggest that everything after the first sentence of this section be deleted. 35.2063 Records of dosages of unsealed byproduct material for medical use [if my suggestion above is not accepted]. Item (b)(5) requires the "name of the individual" who determined the dosage. I believe that other forms of identification may also be acceptable as an alternative to the individual's name; for example, the individual's initials. Therefore, I suggest that this item be revised to change "name of the individual" to "identity of the individual". 35.2070 Records of surveys for ambient radiation exposure rate. This section seems to contain quite prescriptive requirements given the statement (on FR page 43531): "The Commission believes that the licensee should have the flexibility in developing, maintaining, and implementing its radiation protection program... " I suggest that everything after the first sentence of this section be deleted. 35.2070 Records of surveys for ambient radiation exposure rate [if my suggestion above is not accepted]. This section requires the "name of the individual" who performed the survey. I believe that other forms of identification may also be acceptable as an alternative to the individual's name; for example, the individual's initials. Therefore, I suggest that this section be revised to change "name of the individual" to "identity of the individual". 35.2075 Records of the release of individuals containing radiopharmaceuticals or implants. This section seems to contain quite prescriptive requirements given the statement (on FR page 43531): "The Commission believes that the licensee should have the flexibility in developing, maintaining, and implementing its radiation protection program... " I suggest that Items (b) and (c) of this section be deleted. 35.2075 Records of the release of individuals containing radiopharmaceuticals or implants [if my suggestion above is not accepted]. Item (c) is especially abhorrent. Provision of information is part of medical judgement and medical practice. As such, it is already regulated by state law. It should be physician judgement whether to instruct the patient with written instructions or with some other type of instruction. These breast-feeding requirements are especially intrusive into medical practice. I suggest that Item (c) of this section be deleted. 35.2080 Records of administrative and technical requirements that apply to the provision of mobile services. This section seems to contain quite prescriptive requirements given the statement (on FR page 43531): "The Commission believes that the licensee should have the flexibility in developing, maintaining, and implementing its radiation protection program... " I suggest that Item (b) of this section be deleted. 35.2080 Records of administrative and technical requirements that apply to the provision of mobile services [if my suggestion above is not accepted]. Item (b) requires the "name of the individual" who performed the survey. I believe that other forms of identification may also be acceptable as an alternative to the individual's name; for example, the individual's initials. Therefore, I suggest that this item be revised to change "name of the individual" to "identity of the individual". 35.2092 Records of waste disposal. This section seems to contain quite prescriptive requirements given the statement (on FR page 43531 ): "The Commission believes that the licensee should have the flexibility in developing, maintaining, and implementing its radiation protection program... " I suggest that everything after the first sentence of this section be deleted. 35.2092 Records of waste disposal [if my suggestion above is not accepted]. This section requires the "name of the individual" who performed the disposal. I believe that other forms of

9 identification may also be acceptable as an alternative to the individual's name; for example, the individual's initials. Therefore, I suggest that this section be revised to change "name of the individual" to "identity of the individual". 35.2204 Records of molybdenum-99 concentrations. I suggest that this section be deleted. Molybdenum-99 concentration is subject to USP standards and enforced by FDA through the adulteration provisions of the Food, Drug & Cosmetic Act. This is an intrusion into the practices of pharmacy and medicine. 35.2204 Records of molybdenum-99 concentrations [if my suggestion above is not accepted]. This section seems to contain quite prescriptive requirements given the statement (on FR page 43531): "The Commission believes that the licensee should have the flexibility in developing, maintaining, and implementing its radiation protection program... " I suggest that everything after the first sentence of this section be deleted. 35.2204 Records of molybdenum-99 concentrations [if my suggestion above is not accepted]. This section requires the "name of the individual" who made the measurement. I believe that other forms of identification may also be acceptable as an alternative to the individual's name; for example, the individual's initials. Therefore, I suggest that this section be revised to change "name of the individual" to "identity of the individual". 35.2310 Records of instruction and training. This section seems to contain quite prescriptive requirements given the statement (on FR page 43531): "The Commission believes that the licensee should have the flexibility in developing, maintaining, and implementing its radiation protection program... " I suggest that everything after the first sentence of this section be deleted. 35.2310 Records of instruction and training [if my suggestion above is not accepted]. This section requires the "name of the individual" who performed the instruction. I believe that other forms of identification may also be acceptable as an alternative to the individual's name; for example, the individual's initials. Therefore, I suggest that this section be revised to change "name of the individual" to "identity of the individual". 35.2404 Records of radiation surveys of patients and human research subjects. This section seems to contain quite prescriptive requirements given the statement (on FR page 43531): "The Commission believes that the licensee should have the flexibility in developing, maintaining, and implementing its radiation protection program... " I suggest that everything after the first sentence of this section be deleted. 35.2404 Records of radiation surveys of patients and human research subjects [if my suggestion above is not accepted]. This section requires the "name of the individual" who performed the survey. I believe that other forms of identification may also be acceptable as an alternative to the individual's name; for example, the individual's initials. Therefore, I suggest that this section be revised to change "name of the individual" to "identity of the individual". 35.3045 Reports of medical events. Items (c)(l)(viii), (c)(l)(ix), (c)(2)(d), and (c)(2)(e) pertain to patient notification. I suggest that all requirements relating to patient notification be deleted. The method and extent of patient notification is solely a matter of physician judgement within the context of the physician-patient relationship. These requirements are an intrusion into the practice of medicine. 35.3047 Report of a dose to an embyro/fetus or a nursing child. I suggest that this entire section be deleted. This section is unnecessary because such events are adequately covered under 35.3045(2)(iii) dose to the wrong individual.

10 35.3047 Report of a dose to an embyro/fetus or a nursing child [if my suggestion above is not accepted]. NRC states (FR page 43547) that "Information required by this section is needed so that NRC can comply with Section 208 of the Energy Reorganization Act of 1974 (Public Law 93-438), as amended, to submit an annual report to Congress a report [sic] of unscheduled incidents or events which the Commission considers significant from the standpoint of public health and safety, e.g., abnormal occurrences." A dose of 500 mrem to an embryo/fetus or a nursing child is NOT A SIGNIFICANT PUBLIC HEALTH AND SAFETY ISSUE! This section is in stark contrast to the Commission's expressed desire for risk-informed, performance-based rule-making as stated in its SRM-COMSECY-96-057. This is an prime example of exaggerated over-regulation compared to the risks. The only radiation doses that truly present a significant public health and safety issue are those which result in actual non-stochastic effects. Therefore, I suggest that NRC considers only those medical events that result in actual non-stochastic effects as abnormal occurrences. If Congress really wanted to receive reports of every public health and safety issue (in general; not limited to radiation) related to pregnancy and nursing, then every instance of a pregant woman smoking a cigarette or consuming an alcoholic beverage would be an abnormal occurrence. 35.3047 Report of a dose to an embyro/fetus or a nursing child [if my suggestion above is not accepted]. I suggest that Items (a) and (b) be revised to be compatible with 35.3045; ie, 5 rem total effective dose equivalent or 50 rem to an organ or tissue. Also, I suggest that all requirements relating to mother notification be deleted. The method and extent of mother notification is solely a matter of physician judgement within the context of the physician-patient relationship. These requirements are an intrusion into the practice of medicine. A final comment regarding NRC's abnormal occurrence policy (discussed on FR pages 43547-43548): In its SRM-COMSECY-96-057, the Commission expressed its desire for risk-informed, performance-based rule-making; Section 208 of the Energy Reorganization Act of 1974 (Public Law 93-438), as amended, requires that NRC submit an annual report to Congress of unscheduled incidents or events which the Commission considers significant from the standpoint of public health and safety, e.g., abnormal occurrences. The logical course of action thus appears to be re-defining abnormal occurrences as those events which have either high risk for affecting public health and safety (ie, are life-threatening) or actually result in adverse effects on public health and safety (ie, disability or death). In the context of medical radiation, these abnormal occurrences would be limited to unplanned or medically unjustified doses of radiation that result in non-stochastic radiation effects. These abnormal occurrences would be just a small fraction of medical events as defined in 35.3045(a). This definition of abnormal occurrence would be simple, straight-forward, fair, realistic, and compatible with both Congress' and the Commission's desires. Thank you for your consideration of these comments. Sincerely,

Stanford, California 94305-8006

                                    '98   OCT 19 P3 :QS HEALTH PHYSICS                                                                    John A. Holmes Environmental Safety Facility                                                  Associate Director Oak Road                      OH,( ,,                                          Environmental Health & Safety Phone: (4'+6) 723-3201         RU1f *                                          ( ~) 725-1413 Gso                    ADJur;             1:**t                        050 October 14, 1998 Secretary, U.S. Nuclear Regulatory Commission Washington, D.C., 20555-0001 Attention: Rulemakings and Adjudications Staff

Reference:

Federal Register, August 13, 1998 (Volume 63, Number 156, page 43516 ff.)

Dear Sir:

This letter is in reference to the proposed changes to 10 CFR Part 35, "Medical Use of Byproduct Material".

1. We agree with commenters at the Public Meeting in San Francisco that a "committee of peers can have more influence on internal enforcement of policies than an administrator". Elimination of the requirement of a Radiation Safety Committee may be appropriate for very small operations authorized under the proposed 35.100, part 35.500, and possibly under part 35.200. However, we believe that the committee should remain mandatory for activities under part 35.300 and 35.400 or for larger operations involving imaging .

• 2. We believe that the Nuclear Regulatory Commission (hereinafter called "the Commission) should take this opportunity to make a significant change in the method of licensing of clinical uses of radioactive materials, namely, in the sections related to specific medical licenses and/or licenses of broad scope including medical uses (10CFR Part 33).

Specifically, we propose that the Commission recognize, as meeting license requirements in specific medical areas 35.100, 35.200, 35.300, etc., institutions that possess accreditation by recognized accreditation organizations that specify standards for operation of clinical services, for example, American College of Radiology, American College of Nuclear Physicians, American College of Radiation Oncology, or other similar professional accreditation groups. The regulation should include a reference to a list of accreditation organizations whose standards for safety meet or exceed those of the Commission and which perform regular on site accreditation inspections to ensure that the standards are met. We propose that the Commission would review the safety elements in the accreditation program to ensure that all Commission standards are met before approving it. The list of approved programs would be maintained on the web in a similar manner that is currently proposed for training accreditation. oCi 2 i 1998 Ac1mowlecined by card .... _, __......... * .. -

   .S. NUCLEAR REGULATORY COMMISSIO U..EMAKINGS &ADJUDICATIONS STAFF OFFICE OF THE SECRETARY E COMMISSION Document oate _        LtJ/t"(q ~

voples Reooived . - - / ~ctcf'i r,0w,1~ RP.prnr11. &

~~,5~

I ,(/~/

 ?z>te I 12ID.S                    "

Page2 RE: Proposed Changes to 10CFR35 We propose that the Commission grant licenses to those institutions that furnish evidence that they possess such accreditation and that the Commission inspection program be changed to randomly accompanying accreditation inspectors. That inspection by the Commission would be limited to verification that the accreditation program (including accreditation inspections) continues to meet Commission safety standards. We propose that this would be a substitute for separate Commission-conducted inspections at licensee sites. Further, as a safeguard we propose that such licenses include a condition that the licensee be required to provide copies of their re-accreditation and notify the Commission within 30 days, if their accreditation is changed, suspended, or terminated. Likewise, the Commission would notify the licensees if the approval of an accreditation program has been rescinded. Those licensees or areas of usage under a license that are not under a accreditation program approved by the Commission would continue to be licensed under the current licensing and accreditation system. This proposal would encourage more self-regulation utilizing the accreditation programs in the various specialties that utilize radioactive materials that are regulated by the Commission. This licensing process would promote development of comprehensive safety programs that would review the quality of the medical service as well as the particular safety issues normally inspected by the Commission. Such a comprehensive review is an important element in the benefit vs risk assessment required for a "risked based" regulation. The reviewers and inspectors under the accreditation program would possess expert safety and clinical knowledge in their area of oversight; they might include requirements to have a member of the inspection team undergo training by the Commission. The change would also minimize redundant inspections of the limited safety issues that are to be regulated by the Commission under the proposed regulation. This could reduce the cost of such redundant reviews both to the licensees and to the agency. We believe that this step would also address many of the concerns raised in the report by the NAS/IOM Report of 1996 entitled," Radiation in Medicine -A Need for Regulatory Reform". It would be similar to accreditation of other areas of radiation medicine. This proposal also fits into the general goals of more streamlined regulatory processes in the "Reinvention of Government" initiative. Further, it could stimulate similar reforms at the Agreement State level and, overall, would greatly benefit the public which utilizes the services provided by licensees by encouraging high quality clinical practices as well as safety. John A. Holmest ~ Radiation Safety Officer

Page 3 RE: Proposed Changes to 10CFR35 Dr. Peter Blitzer Executive Director American College of Radiation Oncology c/o Radiation Therapy Regional Center 1419 S.E. Terrace Cape Coral, FL 33990 Charlie Showalter American College of Radiology 1891 Preston White Drive Reston, VA 20291 Edgar D. Bailey Radiologic Health Branch Department of Health Services State of California 714/744 P Street P.O. Box 942732 Sacramento, CA 94234-7230

STANFORD UNIVERSITY SCHOOL OF MEDICINE STANFORD UNIVERSITY MEDICAL CENTER 300 PASTEUR DRIVE STANFORD, CALIFORNIA 94305-5281 DIVISION OF NUCLEAR MEDICINE Administration (650) 723-6882 ROOM H-0101 (650) 725-4711 FAX (650) 498-5047 OCKEf N October 14, 1998 ROPOSED )> 0 2~:;---

                                                                                     ,~-+ --*.
                                                                                     \~

Secretary ~ Attention: Rulemakings and Adjudications Staff Nuclear Regulartory Commission Washinton, D.C. 20555-001 RE: Proposed Revision of 10 C.f.r. Part 35; 63 Fed. Reg. 43516

Dear Sir/Madam:

I am writing this letter in support of the existing rules governing patient release as detailed in 10 CFR 35.75. As you are well aware, the old regulations (which allowed a maximum of 30 mCi administered dose or 5 mR/hr dose rate at one meter) were recently amended after extensive review of the implications. It was clear that the radiation burden placed on the general population because of outpatient treatment did not constitute any significant additional risk. The amended regulations take into account exposure based limits rather than activity based limits. The exposure based approach is close to the original intent (protecting the population) and will result in significant savings in cost while maintaining the standard of patient care. Inpatient rooms will be available for patients who really need them, and patients released because of the new regulations will have the psychosocial benefits of being with their families instead of being confined to an impersonal hospital environment. Several institutions including ours have been administering high doses of 1-1 31 and utilized the exposure based approach since the new rules came into effect. There have been;10 reported problems. As a physician who treats and takes care of patients being treated with radioactive substances, I strongly support the current patient release guidelines philosophy. Sincer Mi ris, MD, PhD Professor of Radiolody MLG/cp OCT 2 1 1998

The Detroit Medical Center t OCr - iEO

   -              Wayne State University
                                                                                  !J ' ,,',,.r\., c 1111:Im Harper                                                  '98 OCT 16 P3 :19 Hospital Arthur T. Porter, M.D.                                                  ,-.,r* ,_r                              Arthur T. Porter, M.D.

Or ' " i-1

• Chief, Department of Radiation Oncology . ' Professor & Chairman, HUL _*. ' Department of Bridget R. Brambs Director, Department of Radiation Oncology ADJU i 11
• I Radiation Oncology Wayne State University School of Medicine Jeffrey D. Forman, M.D.

DOCKET BER Associate Chairman October 2, 1998 PROPOSEDRll.E :J. o 3:t i" 36" Clinical Faculty Amr Aref, M.D. ft?3F'1? 4351') Wayne Court, M.D., Ph.D. Syamala B. Devi, M.D. Secretary John J. Feldmeier, D.0 Jim Fontanesi, M.D. U.S. Nuclear Regulatory Commission Laurie E. Gaspar, M.D.

 ~   Washington, DC 20555-0001                                                                                                     lhn H. Han, M.D., Ph.D.

Sue Han, M.D. Paul B. Lattin, D.O. RE: Comment on proposed change to 10 CFR Part 35 Yosh Maruyama, M.D. Physics Faculty

Dear Sir/Madam:

Colin Orton, Ph.D. Division Head Richard Maughan, Ph.D. I am writing on behalf of radiation oncologists at our institution regarding the proposed Gary Ezzell, M.S. changes to 10 CFR Part 35. Section 35.615(t)(4) proposes that an authorized user and an Azucena Garzon, M.S. Patrick N. McDermott, Ph.D. authorized physicist be physical present throughout all patient treatments with a gamma Carmen Mesina, M.S. stereotactic radiosurgery unit. As one of two radiation oncologists in my center who spends Cathy Warmelink, M.S. Jacek Wierzbicki, Ph.D. a significant amount of time treating brain tumors, I have some concerns about this change. Mark Yudelev, M.S . Cancer Biology Faculty

• urrently, we always have two individuals who are trained in emergency procedures particular Kenneth V. Honn, Ph.D.

to the gamma unit. As an attending radiation oncologist I am always involved in the gamma Division Head Julian E. Mesina, Ph.D. knife treatment plan. I am always available to be present in the gamma knife if required. James M. Onoda, Ph.D. However, I do not see a benefit to my patient whether it is me or someone else trained in the Informatics Faculty setting of stereotactic coordinates and emergency procedures. Don P. Ragan, Ph.D. Division Head Falah Shamsa, Ph.D. Yours sincerely, Radiation Therapy Faculty

          ~

Diane Chadwell, M.A. Division Head Laurie Gaspar, M.D. Clinical Chief & Associate Professor Radiation Oncology Center Wayne State University School of Medicine LWG/cf p:\fiddlerc\gaspar\letters\ 1Ocfr OCT 2. 998 AcknowledQed by card ................. .. Harper Hospital, Gershenson Radiation Oncology Center 3990 John R Detroit, Michigan 48201 313.745.9191 Fax 313.745.2314

lJ.S.NUCLEA u

           - 10/13/q~

I

.,      _Reorod1   Ce,
 ~ ff                  g~
  ?DR, 1?1vs_'_  ~~1     '

MOBILE "98 OCT 15 A9 :30 TESTING Secretary, US NRC Washington, DC 20555-0001 Attn: Rulemakings and Adjudication Staff 1 0/5/98 Re: Proposed Rulemaking for 10CFR35, Medical Uses of Byproduct Material" Proposed 10CFR35. 57 deals with the "grandfathering" of current RSO's of materials licenses who do not satisfy the requirements in the proposed 10CFR35.50. However, it states that S35.57 will be deleted two years after the Final Rule is published. Clarifying questions: What is the status of an individual who satisfies S35.57 but not S35.50 at that future time? Will this person be able to continue as an RSC? What is the status of this individual in an application for a new license at this future date? Re: Draft NUREG-1556, Vol.9

• 1.

2. The increase in the acceptable surf ace contamination level from 2000 to 20000 dpm/100cm2 for Tc99m is appropriate. Equipment availability and calibration at the proposed level wil l be improved as discovery of possible contamination is unchanged. The Draft is very user friendly. Table C.l is an especially helpful checklist. This should also improve the completeness of submitted license applications increasing overall efficiency of all parties. Sincerely, C/&L~ John Carpenter Director 1575 N. Rivercenter Dr. Suite 144 OCT 2 1 1998 Milwaukee, WI 53212 Aeknowfedoed by card .._ *...,......- ~ (414) 283-8494

lJ.5. NUCLEAR RE U RULEMAKINGS & C FICEOF 0 THE

                                                                                               °98 OCT -7 P1 :22 Paul W. Ladenson, M.D., Secretary American Thyroid Association OFh RULi:* ,,

11 sr Johns Hopkins Hospital AD.JI .JC-* T 600 N. Wolfe Street Blalock 904 Baltimore, Maryland 21287-4904 Telephone: 410 955-3663 Fax: 410 955-8172 Email: ladenson@jhu.edu September 21, 1998 The Honorable Dr. Shirley Ann Jackson, Chairwoman Commissioner Nuclear Regulatory Commission Room 17D1 One White Flint North Building 11555 Rockville Pike Rockville, Maryland 20852-2738

Dear Dr. Jackson:

We are writing on behalf of the American Thyroid Association to express our concern and opposition about a proposal to change training requirements for eligibility to use radioactive iodine in the diagnosis and treatment of thyroid diseases. Specialists in Endocrinology and Metabolism were responsible for introducing this important tool into clinical practice more than 60 years ago. Members of our discipline have been continuously in the forefront of those investigating and refining the uses of radioactive iodine throughout he latter half of this century. In many institutions and communities, endocrinologists are the physicians with primary responsibility for prescribing and administering this treatment to patients with hyperthyroidism, thyroid cancer, and goiter. We oppose the recent proposal to increase the didactic training requirement from 80 to

• D E y S: c 'f 120 hours for three reasons. First, there is no evidence that the current didactic training curriculum is inadequate for endocrinologists. Second, we are concerned that this increased training requirement will discourage trainees in our specialty from acquiring

tP 98 2..J ,9 certification to administer radioactive iodine, reducing the number of qualified practitioners and limiting access to care in some communities. Third, we believe that the quality and cost-effectiveness of care for will suffer if fewer endocrinologists are able to provide the continuity of care that occurs when patients with thyroid diseases are diagnosed, prepared, treated with radioactive iodine, and followed thereafter by the single same specialist.

t ,998 Ackno edged card .....--... * * ..........

U.S. NUCLEAR R GU JO COMMI ION RULEMAKINGS & ADJUDICATIO S STAFF OFFICE OF THE SECRETARY OF THE COMMISSIO Do,.., P stmar Date /01 '1~ 'R,,,e_tJ ~ ;Jf"IS.r, ~ 'tu.h-,Ja.te Pl __ _ A 'I '~~,~

We appreciate your consideration of the American Thyroid Association's views. Sip~ Ul4ulu,,,vi ~ Paul W. Ladenson, M.D., Secretary American Thyroid Association Orlo H. Clark, M.D. President, American Thyroid Association cc: John Dunn, M.D. Chairman, American Thyroid Association Martin I. Surks, M.D . President Elect, American Thyroid Association The Honorable Greata J. Dicus Nuclear Regulatory Commission Room 18Hl One White Flint North Building 11555 Rockville Pike Rockville, Maryland 20852-2738 The Honorable Edward McGaffigan, Jr. Nuclear Regulatory Commission Room 18Gl One White Flint North Building 11555 Rockville Pike Rockville, Maryland 20852-2738 The Honorable Nils J. Diaz Nuclear Regulatory Commission Room 18Fl One White Flint North Building 11555 Rockville Pike Rockville, Maryland 20852-2738

Cl! .I Ri , 1 ! REC 'D 9 SEP 25 id I 8: I 8

DOCKE: T N BER 0 ROPOSED RULE c<O ..3 :2. ~ 35

 *

• St. John Medical Center 'J C,'3PR1/~ 51 DOCKETED

 '  '  Medical Excellence

• Compassionate Care US NRC September 29, '~8) 9 alCT -6 P4 '.31 u.s Nuclear Regulatory Commission OF1-1v.. . r:r:.. f-Washington, D.C. 20555-0001 RU,_ ,_

Attn. Rulemakings and Adjudicat io ns Staff AOJUL,:: Dear Sirs; I have reviewed your proposed rev1s1ons of Part 35 regulations (as published in the Federal Register on 8/13/ 98) and am generally supportive of these changes. I have the fo ll owi ng specific comments:

1. It is not clear in my mind what will happen to current authorized users who are not certified by a specialty board.

Will these individuals be required to pass an examination in Radiation Safety before being allowed to continue as authorized users?

2. Part 35.404(a). In general, it is not possible to determine if implant sources have been misplaced by surveying the patient.

If the radioactive material has been inserted in the patient in a room other than the patient's room than that area can be surveyed after the patient has been removed but as long as the patient is present any survey is dominated by the sources in the patient. Some years ago the NRC reported on a misadministration that involved a radioactive source falling from an applicator while it was being inserted and remaining under the patient's buttocks for the duration of the implant. The licensee responded that a better survey would have picked up this problem. This is a fallacy. I think the only method that is likely to ensure that sources are where they are supposed to be is to take AP and Lateral x-rays of the applicator after the radioactive material has been inserted, however, this action will also result in higher exposures to hospital employees.

3. Part 35.415 (b). This section seems to have been written for high dose rate applicators and not for conventional low dose rate brachytherapy. With these sources the dose rate to employees is the same whether the source is in the patient or on the window sill so I instruct our nurses to pick up the source with tongs or tape (anything to prevent actually touching the source) and to place it on the window sill, then to notify the authorized user.

In addition, if it were ever necessary to surgically remove an applicator there is plenty of time to take the patient to surgery and do the procedure safely and to still avoid a recordable event or misadministration. oc 9 1998 Acknowledged by card"............_,..__ 1923 South Utica Avenue

• Tulsa, Oklahoma 74104-6502 * (918) 744-2345
• www.sjmc.org Sponsor-ed by St. John Health System

IJ.S NUCLEAR REGULATORY co , -~ J MAKINGS &ADJUDICl'l OFFICE OF THE S ~ ~ *.f OFTHECOM Docurmm

JostmRr1< Date _3 r,0p1es Received_

(~'IIqI '8' . Add'I Copies Reproo b Spe ial Distribution_ ~ , , - J J ~ ~ , PD r< 17< ,ns

4. Part 35.415(c). Why should both the Authorized User and the RSO be notified in the event of a medical emergency? And why should the notification be "as soon as possible" for emergencies when there is a possibility of doing something positive but "immediate" if the patient is dead. I think that the timeliness of notification should be the same for both types of event and that the Authorized User should be notified first and then let that person decide if the RSO also needs to be notified at that time. Of course the RSO should eventually be notified of all events.

5. Part 35.432 (d). In general, a dosimetry system used for calibration of a teletherapy source does not have the sensitivity to accurately measure the output of a low dose rate brachytherapy source. The goal of confirming the activity of brachytherapy sources could be better met by either intercomparing the sources with sources calibrated at NIST(using a Nuclear Medicine dose calibrator, for instance) or by use of a calibrated well chamber.

In addition, I think that you should address the issue of what fraction of a shipment of sources needs to be assayed-for a shipment of 100 I-125 seeds for a prostate implant, how many should be checked? Checking all of them increases employee exposure with very little benefit.

6. Part 35.432(f) and 35.632(e). This seems more prescriptive than necessary. I think that it would be more appropriate to require that the posted values be within 1% of the mathematically corrected values. The difference is as follows: for the current wording Cs-137 source strength would have to be calculated twice a year but could still be off up to 1% at either the beginning or end of those times. Whereas, with the suggested replacement wording Cs-137 source strengths could be calculated at the beginning of the year but as of July 1 and the 1% goal still met.

The 1% goal should also be r e -evaluated as this is a higher required accuracy than any other regulation. Also, is this 1.000% or a round down to 1% (1% decay for Cs-137 is about 5 months).

7. Part 35.3045. This section is still subject to a great deal of interpretation by licensees and by the NRC staff. It should be made clear that "Medical Events" are major deviations from a planned treatment that have or could have significant effects on the patient-either as a reduction in the possibility of tumor control or as an increase in the possibility of complications.

My own experience several years ago was that the NRC staff used the Misadministration rule to classify an event that delivered less than an extra 100 mRem whole body to an implant patient as a misadministration because there was no other way of penalizing my institution even though there was no possibility that the event had any effect on the patient. (Both the local inspector and his supervisor agreed with us that it was not a misadministration). Part 35.3045(a). What does "reasonable" mean. An NRC inspector could interpret this to mean that patients should be

sedated during an implant so that there is no "direct intervention". Part 35.3045(a)(3). This section still leaves a lot to be desired about how such cases are to be evaluated by the licensee and by the NRC staff. For example, in a 100 seed prostate implant it is highly likely that seeds will end up in periprostatic tissue. Since the dose around a seed is very high and this tissue is not in the prescribed site (ie., the prostate) this circumstance would seem to constitute a Medical Event. Likewise, if a seed is implanted in a vein and ends up in the lungs-is this a Medical Event? At the very least the term "or tissue" should be deleted and this section clarified that the dose is to be averaged over the whole skin or whole organ. In addition, since "Medical Events" necessarily are related to medical care, licensees should be able to appeal to medical experts an NRC staff determination that an event is a "Medical Event". zcerely yours, Ke~b~!',L.r:::, RSO & Teletherapy Physicist

STATE OF ALABAMA DEPARTMENT OF

                                                                                              *9a  OCT -6 A9 :10 PUBLIC                             HEALTH Donald E. Williamson, MD                         OFr; State Health Officer                        RG .

AO.JU[: * * \I F September 25, 1998 U.S. Nuclear Regulatory Commission DOCKET Attn: Cathy Haney, NMSS 0 ROPOSEO )32J3S Mail Stop T8F5 t./3511-) Washington, DC 20555-0001

Dear Ms. Haney:

RE: Part 35 Draft I know that you are aware of my thoughts on the current draft of Part 35, but I'm putting them into writing so they can go on the record. I have three main areas of concern in this draft.

1) I am troubled by the compatability issue. I feel there is a fundamental flaw in the compatibility categorization. I am assuming that if there is a rule, it is there because there is a health and safety issue that needs specific addressing. How that issue is addressed can vary from licensee to licensee. And the rule that covers that issue might vary in state law from state to state.

So I have a problem with the sections that are designated D (H&S). I am bothered that this (H&S) classification has nothing to do with compatibility, but does apply to adequacy. Compatibility classifications should measure a program's compatibility, but this opens the door to attack the adequacy of a program, even if there is no apparent health and safety problem in the state. I find this unacceptable. Although you will see that my state has maintained compatibility on rules for which we have licensees that would be affected, the primary goal of the state radiation protect program is maintaining the health and safety of its citizens. If a state has an idea that works better than the NRCs, compatibility takes a back seat. Compatibility issues like this can penalize a state for being a leader in radiation safety. Do not let the interpretation of a rule become the point of contention on adequacy, instead of the actual health and safety of the public in the state. If the NRC still finds it necessary to use this classifcation, it is your responsibility to clearly define the "significant safety issues" that led to the H&S classification. I believe that the Agreement States must have that information to properly understand the reasoning behind the classification, so that they can comment on them before these classifications go into effect.

2) I question why the NRC has the time and money to prepare radiation safety competency tests for all authorized users, medical physicists and pharmacists, but cannot do the same for the The RSA Tower

• 201 Monroe Street
• Montgomery, AL 36104 P.O. Box 303017
• Montgomery, AL 36130-3017 OCT 998 Acknowledged by card .....-............-----

technologists that actually administer the radiopharmaceuticals or radiation dose. All states have had minimum training qualificaations for the users, physicists and pharmacists for years, but many ofus haven't got minimum training requirements for techs. Think about it. The technologist is the last line of defense in assuring that the patient gets the correct dose and undergoes the correct procedure. Not having minimum training requirements for them is like not requiring minimum training for nurses. I urge the final rule to include a set of minimum training requirements. These can be based on requirements set forth by accepted certifying groups like the Society of Nuclear Medicine or the Society of Radiologic Technologists.

3) As you know, I believe that 35.75 needs to be reviewed. I am not against releasing patients who have been dosed with activities greater than the old 30 mCi, or if exposures exceed 5 mrem/hr at a meter. But this rule is not based on any actual expusure data that I have seen. If there is any data, please send me copies of it. It appears to be based solely on the economics involved with patient release, not possible exposures to members of the public. I believe that the release should be based on actual known physical factors such as exposure rates, physical decay

• and biological half-lives. I believe a simple way to accomplish this is to leave the current guide 8.39 the way it is, but drop the section 1.3 that deals with patient specific criteria to change the dose calculations. By allowing patient specific dose calculations that incorporate social lifestyle factors in the decision for release, you are allowing the patient to determine the time of release based on their wishes, and the licensee cannot be held responsible for any public exposures, regardless of how high they might actually be.

If this revision is not done, then at a minimum, the authorized user must: A) Be bound to understand and calculate the radiation dose from a patient; B) Be responsible personally for evaluating the patients working and living conditions and for instructing the patient in ALARA precautions; and, C) Be personally and professionally satisfied that patients compliance is highly likely to assure that no member of the general public will receive more than 500mrem. This way the authorized user is staking their professional reputation on the decision, and not just trying to save money. Thank you for this chance to comment on the proposed rule. Please feel free to contact me if you have any questions. Sincerely, David Walter, Director Radioactive Materials Licensing Alabama Office of Radiation Control

A Mountainside Hospital ATLANTIC HEALTH SYSTEM Secretary *gs OCT -5 P2 :Q9 U.S. Nuc l ear Regu la t ory Comm issio n Washington, D.C. 20555 - 0001 attn: Rulemakings and Adjudication September 30, 1998 Gentlemen, I am writing with regard to the proposed revision to 10 CFR 35, "Medical Uses of Byproduct Material" . My comments are being made from the perspective of someone who has spent the past 23 years dealing with radiation safety issues in community hospitals. I hope you may find some merit in them.

1. Deletion of the requirement for having a Radiation Safety Committee (RSC).

While this is probably beneficial to small licensees operating out of physicians ' offices, for hospitals and large institutions deleting the RSC in favor of establishing " administrative procedures " would be a mistake. The RSC meeting is the one forum in which the licensee's management, authorized users and radiation safety personnel can resolve safety issues honestly and openly . The existence of the RSC greatly helps to keep the lines of communication open among these groups and serves to remind all members that regulatory compliance is a responsibility that shared by all committee members .

2. Deletion of the Quality Management Program (QMP). The intent of the NRC is unclear regarding this proposal. The NRC says that it wishes to delete the QMP, however, " some elements of the current QMP program would continue to be implemented ". If the intent is to permit licensees to develop their own policies and procedures to prevent patient misadministrations rather than submitting QMP programs requiring prior approval by the NRC, then I am in favor of this proposal. If this is not the case, then further clarification is needed .

3. Section 35.92. It is appropriate to maintain the requirement that byproduct material be held for a minimum of 10 half - lives . This helps to insure that radioactive waste is not prematurely disposed of, either through human error or because of a malfunction of a l icensee ' s survey meter which could erroneously indicate background radiation levels when in fact this is not the case.

4. Section 35.315. The requirement for a private room with a private sanitary facility should be maintained for patients undergoing high activity radiopharmaceutical therapy . This will greatly reduce the chance of contamination spreading to other areas, patients and staff and will help to maintain radiation exposure ALARA.

5. Section 35.415. The requirement of not quartering brachytherapy patients with non - brachytherapy patients should be maintained . This will eliminate radiation exposure for the non - brachy patients and their visitors and will allay any emotional or psychological misgivings the non - brachy patient may experience by sharing a room with a patient who is "radioactive ".

K 7 1%8 1 Boy Avenue, Montclair. New Jersey 07042 (973) 429-6000

I I~ /><I.le!., I ~c:I.d,

 ~p -=-=--
     ~-,;;,1

PG. 2

6. Section 35.432. The licensee should not be required to perform full calibrations of brachytherapy sources. Every manufacturer should be required to calibrate each source that it produces according to the requirements of the NRC and should issue a certificate of calibration to the end user. This is desireable for many reasons:

1. It will eliminate duplication of effort on the part of both the manufacturer and the licensee, 2. It should help to guarantee more uniformity in dose prescription by eliminating site-to-site variation in calibration and/or errors, 3. It greatly reduces the radiation exposure for the licensee ' s staff, thereby promoting ALARA, 4. It should be easier to regulate in that calibration procedures need to be validated for only a few manufacturers rather than several hundred licensees, 5. It places the same level of responsibility upon the radiological manufacturers as is placed upon the pharmaceutical companies that produce non-radioactive medicines. Can you imagine a hospital, pharmacy, or doctor ' s office having to validate the amount of medication being dispensed in every pill e to every patient?

Section 35.615. Safety procedures for remote afterloaders. The requirement for having both the Authorized User (AU) and the Authorized Medical Physicist (AMP) present for all patient treatments is overly prescriptive. The AU must be present for all treatments in the event of an emergency requiring medical intervention. In addition, since remote afterloaders are FDA-approved medical devices, it is the responsibility of the AU (not the AMP) to disconnect the patient from the machine and remove the implanted applicator. The AU, assisted by a properly trained radiation therapy technologist, is capable of delivering all treatments as well as performing emergency procedures. In the case of our HDR unit, all that is required to return the source to its shielded position is to either press an emergency stop button or turn a mechanical crank that is easily accessed in the head of the machine. Such actions do not require the prescence of the AMP. The current precautions place an unwarranted burden upon the medical physics staff, especially in the community hospital setting. I have personally monitored hundreds of successful HDR treatments and can testify that the traditional role of the physician and the technologist in delivering safe HDR treatments and in dealing with emergency situations is indeed warranted. I hope that the NRC will reconsider its position in this matter. In terms of protecting HDR patients from the possibility of undergoing a misadministration, the general public would be better served if the NRC would stipulate that only the AMP be permitted to generate an HDR treatment plan. The level of complexity and the chance for error in this area certainly warrants this consideration. Sadly, this has not been addressed in the Part 35 revision.

8. Section 35.643. Periodic spot checks for high dose rate remote afterloaders. In general, it is felt that performance of spot checks at the beginning of each week of use in addition to each day of use is overly prescriptive. In over 5 years of HDR operation we have performed checks on each day of use and have found that this more than adequately fulfills our needs. "Up-time" on our unit has been in excess of 99% and the additional weekly stipulation is not justified.

PG. 3 Another area of concern is the inclusion of a daily spot check of the output of the HOR unit. Again, it is felt that this is unnecessarily restrictive. Provided each HOR source has been fully calibrated prior to first use and source position is checked on each day of use, the only factor related to output variation involves radioactive decay. We therefore question the value of performing such measurements at intervals of less than one month. Our specific concern is that a daily spot check measurement, taken under less than full calibration conditions, will yield an erroneous result that may lie outside the permissible regulatory limit of acceptable output variation. We will then be forced to disprove the spot check anomaly (i.e. by performing a full calibration) prior to initiating patient treatments. The appropriateness of a monthly output spot check can be seen in the e sults of our current procedure. Since May of 1993, we have performed 44 onthly output checks of 23 different HOR sources. The monthly variation

• between the expected output to the measured output has been less than 1%.

With regard to the rest of this section, we agree that the various electrical and operational parameters should be included in a check-out procedure at the beginning of each day of use. Thank you for your kind consideration in this matter. I hope this information will be of value to you in your deliberations. Yours Truly, i.~ µ l~ Robert Sasso, M.S., D.A.B.R. Medical Physicist/RSO cc: Dr. Richard Stabile, Radiation Oncology Dr. Charles Whelan, Nuclear Medicine

UPMC HEALTH SYSTEM September 24, 1998 UPMC Presbyterian/UPMC Shadyside UPMC Presbyterian 200 Lothrop Street Pittsburgh , PA 15213-2582 Secretary U.S. Nuclear Regulatory Commission ~l!.J 3:1. J 35 UPMC Shadyside Washington, DC 20555-0001 ( ft>3fT<'/ -g5 Jfo) 5230 Centre Avenue Pittsburgh , PA 15232 Attention: Rulemakings and Adjudications Staff

                                                                                     )>       0 O:n~

S=c

                                                                                      -- r .

v; RE: Proposed rule, rewrite of 10 CFR 35 rl7 N I..O

Dear Sirs:

• I I offer the following comments with respect to the proposed revision of 10 CFR 35 as found in the Federal Register publication of August 13, 1998, Proposed Rulemaking for 10 CFR PART 35, "Medical Uses of Byproduct Material" and Proposed Revision ofNRC's Medical Use Policy Statement. I have outlined the comments referenced to the resolutions section with some reference to Part 35 rule numbers. Then comments regarding specific rule changes are offered.

A. Training and Experience, Unsealed Byproduct Material: I agree that training and experience for authorized participation in the use byproduct material was in need of revision. Specifically, it can be argued with merit that 200 hours didactic and combined 1000 hours of clinical and work experience is restrictive for an authorized user (AU) that will be reading films only. However, not all nuclear medicine practices reside in a hospital with a Radiation Safety Officer (RSO) and Radiation Safety Committee (RSC). The reduction of didactic and clinical experience proposed will enable small specialized clinics to permit many physicians to participate. However, it must be recalled that the technologist is working under the supervision of the AU. Therefore, at least one AU must be knowledgeable of regulations, physics, safety and health effects to assume the responsibility of this supervision. Additionally, if the AU is serving the function ofRSO by virtue of being an authorized user, the possibility that no licensed person is available with sufficient knowledge to prevent unintended use or assure compliance is great. It may be suggested that two categories of authorized users be made. One would require 200 hours training and sufficient clinical preceptorship. A second would have the reduced qualifications. It could be required that at least one AU meeting the strict criteria be named on each license, and assume responsibility for supervision of technologists and other AUs. However, reducing the training requirements per this revision represents a dangerous reduction in control of radioactive material. Also, which takes precedence, 35.292 or 35.920? Both were included in the proposed revision mailing. A. Training and Experience, Sealed Byproduct Material for Therapy: which takes precedence, 35.490 or 35.940? Doth were included in the proposed revision mailing. t 1 0 1998

US. NUCLEAR REGULATORV RUL AJONGS ADJUOICATI FFICE THE ECRET F THE CO MISSI tiSb ___ q~ 5/c}8' pie ReOEWOO _ _ _ / A . f/~ :J/a.J: 1 < ~ , rp-z/), t<ID.s

B. Quality Management Program: This addition to the regulations was probably the most intrusive and yet least effective set of standards in Part 35. It is fully supported that the revision delete this requirement. C. Reportable Events: agreement in full D. Precursor Events: agreement in full E. Radiation Safety Committee: Not only do I disagree with the resolution to delete the requirement for a Radiation Safety Committee, I advocate requiring a Radiation Safety Committee for all licensees. In a medical facility, the RSC is often the only mechanism and authority by which radiation safety procedures are enacted, and ensured. Without an Radiation Safety Committee the RSO would be dangerously stripped of what is often the sole vehicle of analysis and report regarding the radiation safety program. Without RSC, accountability of and to

• administration would soon be lost completely. Regardless ofNRC's requirement to grant authorities to the RSO, without the RSC, there would be no structure to assure this authority.

The present rule requiring the structure and accountability for radiation safety to the facility administration assures that upper management takes seriously the philosophy of radiation safety. It must be maintained. It is a dangerous and incorrect premise to assume that other hospital committees will encompass the area of radiation safety compliance. In a clinic, radiation safety decisions and responsibilities often overlap with conflicts of interest since management, RSO, authorized user and owner may all be the same person. An accountable radiation safety committee, and documentation of its activities, will assure that these decisions are made in the interest of radiation safety and regulatory compliance. F. Notification Following a Misadministration or Medical Event: I agree in part, but see not reason to candy coat the term "misadministration". Call it what it is.

• G. General Comments: I agree with the shift to performance based practice and inspections, but disagree with the complete dismantling of the license system. Without a written commitment to procedures, investigated and approved by the NRC, it will soon become impossible to hold accountable the licensee to compliance. This approach will become a perception argument, where the licensee will contend that their efforts fulfill the intent of rule, while NRC's perception may be otherwise. Without written commitments, identification and resolution of deficiencies will be impossible.

Specific Rules: 10 CFR Part 35.6: While this is not a new regulation, it needs to be clarified. Too often in the past specific (non-broad scope) licensees were prohibited from participating in human research that complied to all the wording in 35.6. NRC should clarify when byproduct use under 35.6 is and is not permitted. For instance, an FDA sanctioned research study using brachytherapy sources should be limited to institutions with 35.400 authorization. But, on several occasions, participation has been denied, or NRC has required amendments to the license, of non-broad scope programs that should have been permitted under 35.6.

10 CFR Part 35.27, Supervision: This rule encompasses several areas of supervision that should be clarified. It is necessary that an authorized user supervise the use of byproduct materials by technologists involved in patient care. It is also necessary to extend supervision to physicians in training to become authorized users. However, the rule as stated permits any physician to participate in byproduct use, whether it is diagnostic nuclear imaging, radiopharmaceutical therapy, sealed source therapy, HOR brachytherapy or teletherapy. This leaves open the prospect of having physicians performing these duties without ever gaining the didactic training to safely administer the uses, and therefor never attain licensure. They also are permitted to perform the duties without the supervising AU required to be present. It is impractical to require strict training and experience for authorized users when a supervised physician can perform the same duty without ever gaining the same level of knowledge. If this knowledge is truly necessary, then the supervising AU should be required to be present during the administration, reading etc. Additionally, the supervised physician should be required to attain licensure in specified period of time, and provide documentation that he/she is in the process of attaining the training necessary to become an authorized user. 10 CFR Part 35.50(c): I agree with this rule but feel an explanation is warranted. It should be explained that invoking 35.S0(c) may necessitate naming more than one person as RSO to encompass the uses of byproduct material in the facility. If this is not permitted by NRC, it should be stressed that the named RSO must have all the necessary areas of experience. For instance, a cardiologist authorized user may not meet the qualifications ofRSO ifbrachytherapy is performed under the license. 10 CFR Part 35.57: I agree with this "grandfather provision. 10 CFR Part 35.65: There are several typographical errors in sections (a), (b) and (c) regrading the quantities stated. 10 CFR Part 35.67(g): I disagree with the change from quarterly to semi-annual inventory of sources. Quarterly inventory requirements do not represent an overly restrictive or burdensome procedure, and assures the possession, and security of potentially dangerous materials. 10 CFR Part 35.70: I disagree with the change in requirements from any radiopharmaceutical to only those requiring a written directive. The distinction as to whether a material requires a written directive pertains to the potential for harm to the patient administered the dose. It makes no claim as to the safety of the material should control be lost. A 150 mCi dose calibrator linearity source is potentially harmful if left unsecured. Just because it is not included in the written directive category, doesn't preclude it causing harm. 10 CFR Part 35.92: I agree with this change. The requirement for 10 half lives was in no way a guarantee that the waste met background level requirements. It did however cause numerous citations when discarded waste was well below background levels but the IO half life requirement was not satisfied.

10 CFR Part 35.643: While NRC has been noticeably lax in HDR regulations, considering it has been in use since 1985, this section's requirements are beyond burdensome. The HDR source, like cobalt is a sealed source with a physical half life. Installation calibration measurements, and the manufacturer nominal calibration, satisfy all needs in assuring correct dosimetry and administration. Requiring an output calibration check weekly is completely unnecessary. Additionally, the weekly check is required if the unit is to be used that week, but it is often not known when the unit will be pressed into service. Daily timer constancy is also burdensome and unnecessary. This item is verified at installation and needs no further monitoring. 10 CFR Part 35.1000: This is a very appropriate "catch-all" for emerging technology. But, some thought should be given to naming authorized users for 35.1000 items. Will this be by NRC discretion or is there a set of criteria. For instance, who may use radioactive stents used for intraluminal vascular brachytherapy? Some guidance should be offered when these technologies become usable applications.

• I appreciate your consideration of my comments in your final rulemaking. And please take seriously the deletion of the Radiation Safety Committee as a dangerous and unwise change from the status quo. Should you have any questions regarding this material, please feel free to contact me at (412) 623-1052.

Sincerely, Ronald Scala, M.S. Certified Radiological Physicist Radiation Safety Officer UPMC Shadyside Hospital cc: rscfile

DOCKET NUMBER 0 ROPOSEO RULE o?o 3 ~ J. 3.!J (p'3 l=R4-35lt-The Society for Cardiac Angiography and Interventions 4101 Lake Boone Trail, Suite 201, Raleigh, North Carolina 27607 Phone: (919) 787-5181 / Toll Free: (800) 992-SCAI / Fax: (919) 787-4916 / Website: www.scai.org August 31, 1998 Officers Morton}. Kem, M.D., FSCAI President Jeffrey J. Popma, M.D., FSCAI ~ President-Elect 0 Rita M. Watson, M.D., FSCAI Carl Paperiello, Ph.D. C/) rr, Cn 0

                                                                                                                                 -0             { J).;:ii::

Treasurer Director, Office of Materials Safety and Safeguards z* Carl L. Tommaso, M.D., FSCAI N  :;ur:7 U.S. Nuclear Regulatory Commission co (.-) - i Secretary fTf David P. Faxon, M.D., FSCAI 11545 Rockville Pike -0 0

                                                                                                                                 .t:,.

Immediate Past President Washington, D.C. 20555-0001 o-J Trustees

Dear Dr. Paperiello:

J.J. Adolfo Cosentino, M.D., FSCAI Michael J. Cowley, M.D., FSCAI Gregory J. Dehmer, M.D., FSCAI The Society for Cardiac Angiography & Interventions is a professional organization John S. Douglas, Jr., M.D., FSCAI John J. Hirshfeld, Jr., M.D., FSCAI representing the invasive and interventional cardiologist. The organization has John McB. Hodgson, M.D., FSCAI approximately 2,500 members and a strong liaison with the American College of Jeffrey J. Popma, M.D., FSCAI Carlos E. Ruiz, M.D., Ph.D., FSCAI Cardiology and other allied health professionals working in cardiac catheterization EricJ. Topol, M.D., FSCAI Bonnie H. Weiner, M.D., FSCAI laboratories. In collaboration with the ACC, we have been actively involved in discussions concerning intravascular brachytherapy. I would like to clearly state that Trustee for Life we are completely in support of the American College of Cardiology's position, as William C. Sheldon, M.D., FSCAI described in Dr. Spencer King's May 1, 1998 letter to you. Committee Chairs oseph D. Babb, M.D., FSCAI Intravascular brachytherapy is an experimental procedure that is currently being arles E. Chambers, M.D., FSCAI studied at a number of large medical centers throughout the United States, under an David A. Clark, M.D., FSCAI G. William Cotes, M.D., FSCAI IDE application and [RB approval. The technique is evolving rapidly, with a growing Michael J. Cowley, M.D., FSCAI number of devices and radioisotopes. The variety of devices range from high dose Gregory J. Dehmer, M.D., FSCAI David P. Faxon, M.D., FSCAI sources, such as the l O Ci lr 192 catheter requiring an afterloader and a brachytherapy Ted E. Feldman, M.D., FSCAI Frank}. Hildner, M.D., FSCAI suite, to 1/2 Ci Ir guidewires with portable afterloaders, y90 beads in hand-held catheter John McB. Hodgson, M.D., FSCAI devices, and Re188 liquid-filled angioplasty balloon catheters. The radiation exposure Alice K. Jacobs, M.D., FSCAI Morton J. Kem, M.D., FSCAI ranges widely between devices, and potential complications and risks to both the Ronald J. Krone, M.D., FSCAI patient and personnel are currently poorly defined. For these reasons, it is not Warren K. Laskey, M.D., FSCAI Douglass A. Morrison, M.D., FSCAI possible to determine the safety risks nor the training requirements necessary to Jeffrey J. Popma, M.D., FSCAI perform these treatments. It is likely that, as the research evolves, one or more of Albert E. Raizner, M.D., FSCAI Carlos E. Ruiz, M.D., PhD, FSCAI these devices will prove to be the most efficacious. However, it is unclear at this time Carl L. Tommaso, M.D., FSCAI Bonnie H. Weiner, M.D., FSCAI which devices and techniques will ultimately prove to be effective. In addition, the risks of the technique are intimately related not only to radiation, but to the Staff performance of the delivery catheters in the coronary and peripheral vessels. The Mary Alice Dilday skills and knowledge necessary to perform these procedures are therefore, also poorly Executive Direcwr Hilary Waldenberg Lamb, MPA defined and are not directly translatable from brachytherapy. Associate Executive Direcwr Kristin). Becker, CMP SEP 3 o 1998 Conference Manager Amy E. Berginski .......edged by card ....... Acknuw, 211 11111ntr 1111 I ss::e* Public Relations

U.S. NUCLEAR REGUlAl RULEMAKINGS & 0FRCEOF'RiE-- OFTHE \IVIIIIIIIIIIOa'ION Postm8rk Date Copie.,ReoM:1 0ocurat--

            ~

__q i 'f<ulI_

~~     )   --=-==--- - -

Carl Paperiello, Ph .D August 3 I , 1998 Page 2 For these reasons, we strongly urge that the NRC classify intravascular brachytherapy as an emerging technology, under the provisions described in 10CFR s. 35.900 of the proposed new rules. Ifwe can provide further information that would assist you in evaluating intravascular brachytherapy at this time, please let us know. Thank you for the opportunity to comment on this exciting new technology. Sincerely, Morton J. Kern, M.D., FSCAI President, Society for Cardiac Angiography & Interventions Director, J.G. Mudd Cardiac Catheterization Laboratory MJK/dls e-mail: kemm@slu.edu cc: Mary Alice Dilday

• Dr. Albert Raizner Dr. David Faxon Dr. Jeffrey Popma Dr. Spencer King Wayne Powell, ACC SAINT LOUIS UNIVERSITY 11,*alll, Sri,*m*es C1*11te1*

Sc hool of 11e,liriu,, Department of l11ter11al 1frrli1* i11,* , Di, isiou uf Carrliolo<<v The J. Gerard .l ludd Ca rdi,,. Catheterization Laborato;~ Jf,35 Vi. 1w v... Ill Gr Hlwt, PO l!ox 15250 * ~ St. Loni* . MO 631 250  !. '"¥,

                        .,.,JI.,                                               .*  *......

NO . 020 JO 3~~3~ Iii

                                                                       *   ( r,3~R. '135/i,,J       DOC KET ED USNRC Northeast Cardiology Associate'                  SEP 28 P4 :08
                                                   ! EYll:AGAl:liN WOODS

• 700 MT, H0,01£ AVENUE ll!IANGOA, MAINIJ 04401 Qff*, ,I

     ~o*c*t P, .-.~i=N, N,D,, ....... c .c:.
                                                                                            &Yi~t r;:fi"X..
                                                                                          "Ar-I,.\.   - '
                                                                                                                       ,   1, ,r- F-0SSIC!' IIIIANAG!II ft08EIIT C . CAPOOILUl'O, M,D ,                                                    ~                    Lucn.LE Gl,.,.OltO CHAO< C. c;,.u,,  M . Q, GLl:N 0 , GolUtllON, M.D. , F.A.C,C ,                                                                    00UCS L, l<AVMIAUGH, PA-C A0911ff M, .. o.-.-MANN, M.0,. l".A.C.C.                                                                ~RAIR      .I  p,,,,._,,. _P&..r.
    .IO"N H, Jt:NTH:11, M,D .* l'.A.C.C.                                                                     $1,1$1,N PHIL,L,1111'1*\NOlll(MAlill, PA*C:

ALl~IE A. PASHft, M,0, JOHN II' . IIAYMONO, PA*C ft- fl"° f", lt-CNTH .. 1-, M.O., P-.A.C.C. l,Jl;811,t, 1111,.L.HOIIN, .,A*C MATT"CW W. IIDWI:, M.D., F.A,C:: ,C:, M. THIEODDRI: SILV.:11, M.D . , l'.A,l;,1; . M , ALll!G""' wire*. ,.,..c WOL,.UANG.J. T. S-A, M.CI.

    ,OETl:11 N. V*11 L&S, 111,0,, r,A.C .C.

August 20, 1998 f'*uo 111. ,,..,.. .-,n,.N. M n . ir

• r.: ~

WII..LIAM T . WITMa.11. M .0 . Senator Susan Collins 172 Russell Senate Office Building J~ anri (: ~rrP.P.fS, N .E. Washington, D.C. 20510

Dear Senator Collins:

I am writing about concerns I have with diagnostic nuclear cardiology and experimental intravascular brachytherapy. The nuclear regulatory commission (NRC) is currently in the process of revising its 1egulatiuus guvcrrning the medical use of i!iotopes in an effon to make the training and experience requirements more reflective of the level of radiation risk they present. ln tbe area nf nutlear cardiology. the NRC'8 advisory council for medic.al use of isotope~ has endorsed streamlining the radiation safety training and experience requirements for diagnostic nuclear cardiology to 120 hours because of the 01inimal ,*isk to patients and pul>Hc safety . The: current level I believe is 1,200 hours. I am strongly in favor of a more reasonable level of re1ulation of training needed for these diapostic tests and strongly support the NRC stafr s proposed reduction to 120 hours. Radio isotopes have been used for ~everal decade11 rn r.reate images of the heart with minimal risk to patients and to public safety. These images help cardiovascular specialists evaluate heart function and blood flow . The cardiology community co O') bas developed effective training programs for cardiovascular specialists who perform nuclear ~ cardiology procedures. 'lbesc physicians are also training in the use of medical isotopes during 0 C"') their residencies. Rcftcctin1 the safety of nuclear cardioloaY procedures and the tn1inin& which cardiovascular specialists receive in this area, the NRC's advisory committee on medical use of isotopes supports streamlining the training md experience requirements for these procedures to 120 hours. lntravascular brachytherapy is an experimental procedure which currently is only bein~ performed in large academic medical centers under strict oversight. Because the procedure is experimr'.ntal and becau1c differi?nt modalities are being teated, I agree with the NRC that it is premature to sec any definitive training and experience requirements in this area. I strongly support lh~ NRc*s risk-based approach. Intravascular brachytberapy is an experimental prcccdure which prevents arteries from re-closing after b~~r_,~pon angi_oplasty or

08 : 29 N0.020 August 20. 19'J8 Page Two other similar procedures. In this procedure. a cardiova11cuJar speciali"t r.xrn~~ rhP. c-.orona.ry artery walls to a low level radioactive source while clearing the arterial blockage. Because it is still experimental, this procedure is only being performed in l&rF academic medical uulea:; under the approval of institutional review boards using strict protocols. Cardiologista are teaming with medical physicists and radiation oncologists to detcnnine the best inethod for using intravascular brachytherapy. It is too early for the NRC to set any definitive traininl and experience .reqwremems for physicians using intravascular brachytherapy. I suggest that the NRC reserve jw:lgcmont in this area until the technology has developed to the point where regulatory standards can be developed with confldcncc based on the risks of the radio isotope selected. It 1s my understanding that the radiology community is telling members of conif'ess that these changes proposed by the NRC will jeopardize patient care and cause incidents deleterious to patient care to occur with greater frequency. I am unaware of any evidence that suppon1 tbeae clairns. I atrongly urge you to contact the NRC in support of its risk-based approach to revising its training and experience requirements for the medical use of radio isotopes. Sincerely yours, Robert ~fmann. M.D. RMH/kd

The Detroit Medical Center

                                                               ~o   3:1,, .,;- 35 DOCKETED Wayne State University IJSHRC

( tp 3 FR '13 5 I to) Harper "98 SEP 28 A9 :42 Hospital Gershenson Radiation Oncology Center Of -I RUL :\ ADJUC,l September 22, 1998 Secretary

• U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 RE: Comment on proposed change to 10 CFR Part 35

Dear Sir:

I am writing on behalf of the radiation oncologists and medical physicists at our institution regarding one of the proposed changes to 10 CFR Part 35. Section 35.615(t)(4) require that an authorized user and an authorized medical physicist be physically present throughout all patient treatments with a gamma stereotactic radiosurgery unit. It is not clear what compelling need is served by this rule. At our institution, we require that a physician capable of dealing with potential patient medical needs be present and that there be two individuals at all times present who have been trained in emergency procedures particular to the gamma unit. These individuals would be responsible for removing the patient from the beams and closing the unit's shielding door (if possible) in case of electrical or hydraulic failure. The physician could be an authorized user, attending neurosurgeon, fellow, etc. The point here is that the emergency response in case of equipment failure, like that for a teletherapy unit, revolves around removing the patient from the radiation field. There is no need for the authorized user, per se, to be present in order to deal with a radiation emergency. It seems inconsistent for the Commission to allow a physician other than the authorized user to attend the continuation ofan remote afterloaded brachytherapy procedure (35.615(t)(2,3), but then require the authorized user to be present at the radiosurgery unit where there is even less likelihood for physician intervention. In addition, since radiosurgery is an interdisciplinary procedure often involving neurosurgeons, why cannot the neurosurgeon be present to attend to the patient's medical needs? SEP 2 9 1998 Harper Hospital Acknowledged y card**---- 3990 John R Detroit, Michigan 48201 313.745.8040

U.S. NUCLEAR REGULATORY COMMISSION AULEMAKINGS & ADJUDICATIONS TAFF OFICE OF THE SECRETAAY OF Tl-IF COMMISS Postnark ~ Add'!

Since the NRC's jurisdiction is radiation safety, the regulations should require that the personnel delivering the treatment can deal with radiation emergencies. Removing a patient from a gamma unit that has failed requires technical training, not medical intervention. The proposed wording of 35.615(f)(4) is unnecessarily restrictive. Sincerely,

                                                               ~iJJI Gary A. Ezzell, Ph.D.

Coordinator, Radiation Oncology Physics Assistant Professor, Wayne State University

• BARBARA ANN

                              ~OS CANCER INSTITUTE Gary A. Ezzell, Ph.D Wertz Clinical Cancer Cmttr 4/00Jol,n R Detroit, MicAigan 48201-1379 4953 Micl,igan Cancer Foundation Meyer L. Prentis Comprdimsive Cancer Center of Metropolitan Detroit Tl,e Detroit Medical Center Woyire State U*iversiry

                                                         ~o    '3~ ,1- 36

[ lP3FR ll 3511, DOCKET D USNRC Vernon Joe Ficken, Ph.D. 2808 Kensington Terrace Edmond, OK 73013 '98 SEP 23 Pl2 :28 405-341-1092, FAX 405-340-1169 vjficken@iamerica.net on1t September 15, 1998 RUu_ , ADJ L,v I US Nuclear Regulatory Commission Washington, DC 20555

Subject:

comment regarding revision of 10CFR35.27 pertaining to Supervision 35.27 is a section of the regulation that should be deleted in its entirety (or modified to require licensee to request NRC approval) for the following reasons.

1. There is no requirement for a licensee to notify the NRC that it operates in the manner permitted in this section and thus there is no formal way for the NRC: to know who is using byproduct materials at a given facility or to inspect the facility for compliance with its internal policies regarding supervision.

2. This section permits an individual to use byproduct materials without the knowledge of the NRC. This appears contrary to all other sections of the requirements pertaining to individuals using byproduct materials.

3. This section is likely to result in a situation where an individual that is not necessarily qualified to use radioactive materials to do so. Continuance of this rule, regardless of the statements in section 35.27(d), also places the NRC in a position of responsibility by allowing a licensee to operate in this manner *

• 4. Trainees such as physicians, pharmacists, physicists and technologists use byproduct materials only under the direct supervision of an authorized user. This section is not required for trainees. Given removal of trainees from consideration in this matter, the only reason to have a "supervised user status" is to permit an individual with qualification less than those prescribed elsewhere in the various sections of Part 35 to use byproduct materials. On this basis, the rule as described in 35.27 is contradictory to other sections and must be removed (as has already been done by many agreement states) or revised to require that a licensee apply for supervised user program within its license application. The NRC should develop very specific requirements for the supervision program with specific time frame for completion of such status for a supervised user entering such a program.

Sincerely, vJ/fM>?~~ Vernon Joe Ficken, Ph.D, FACNP SEP 2 1998

REGULATORY C N 1uu:wuUM:J$ &ADJUDICATI OFTI-IF 5E'CR OF THE COMhJll 10 nt St ti _ -..!..i q 11/1'6' HOOIWBCl / (p

Kettering Medical Center DOCKETED USNRC DOCKET "98 SEP 21 AlO :43

                              . ROPOSED RUlE             ~o 3 ~ J 35 (1P3 Fl('/3Slt.)

September 15, 1998 Secretary, U.S. Nuclear Regulatory Commission Washington, DC 20555 Attention: Rulemakings and Adjudications Staff

Dear Madam/Sir:

Upon review of both NUREG-1556, VOL. 9: Consolidated Guidance About Material Licenses and PROPOSED RULEMAKING FOR 10 CPR PART 35. "MEDICAL USES OF BYPRODUCT MATERIAL, I wish to provide both a comment and suggestion. Since 1972, I have worked in the medical field with radioactive materials. For the first 18 years, I practiced nuclear medicine technology but have been involved in radiation safety for the past 8 years. I believe that the investigational levels used in monitoring external exposures as listed in Table L.1 Investigational Levels (NUREG-1556) should be changed. Those levels do not reflect the current limits as defined in 10 CFR Part 20. Only the whole body level is correct in terms of current regulations. The extremities limits listed are too high and the skin of whole body is too low. Also, the lens of the eye should be separately listed to correctly reflect the current regulations .

• Historically, the Investigational Levels I and II were 10% and 30% of the allowable annual dose limits in the Model ALARA program (Reg. Guide 10.8, rev. 2) for most medical programs. When those occupational dose limits were changed in 1994 with the revision of 10 CFR Part 20, many medical programs changed the Investigational Levels I and II to reflect the new regulations. In providing annual radiation safety instructions, I find that radiation workers can better relate to these investigational levels if these limits are expressed in terms of a percentage of the current allowable limits; therefore, I would propose the following revision:

Table L.1 Investigational Levels 0.. Part of Body Investigational Level I Investigational Level II C/l (mrem per calendar quarter) (mrem per calendar quarter) whole body , head and 125 375 trunk, active blood forming organs, gonads lens of eye 375 1125 skin or any extremity 1250 3750 3535 Southern Blvd. 937-298-4331 Kettering, Ohio Internet: www.*kctthealth.com 45429 Fax:937-296-4226 ALLIANCl fOR HEALTH

                                                                                                          \

U.S. NUCLEAR REGULATORY COMMISSI RULEMAKINGS &ADJUDICATIONS STAFF OFRCE OFTffE SECRETARY OF THE COMMISSION

M.Bemer 9/15/98 Thank you for allowing me the opportunity to comment on these documents. Respectfully submitted, Mark Bemer, MBA, CNMT Radiation Safety Specialist Radiation Safety Office Kettering Medical Center 3535 Southern Blvd. Kettering, OH 45429 937-298-3399, Ext. 7704

OFFICERS Helena W. Rodbard, HO. FACE RockviU.,MO President lticlwd A. Dklloy, HD, FACP, FACE Hlcl<ory,NC Pm Ident-Elect Paul S. Je.lllnpr, MD, FACE Hollywood. FL DOCKET NUMBER Vk:e President PROPOSED RULE ~o 3~ ~3~- Ei:o~ ~ Rhoda H. Cobln, HD, FACE LC --,,-, M;dlan<I Parle.NJ Treuunr <,3Ff< L/3 ,s 1i,) c,c c:, Hosteln Gharlb, MD, FACE R.ochatar, MN On

• V, c o SeuWl3ry H.Jack Baskin, MD, FACE

                                                                                                    ~      -c,  rT'1
                                                                                                                --0     U>o Ortmdo.FL                                                                                                                z :X Immediate Put Prtsklent                                                                                            I     :;of'Tl (I; N BOARO OF DIRECTORS
                                                                                                            -n          ,- )-1 fTl TERMS EXPIRE 19'J'J                                                                                 ' -0          C) vJ
                                                                                                     ....        0
                                                                                                     "'n '       N
                                                                                                     *I Darnel Elnhom, MD, FACE SanOl<ao,CA                                                 Position Paper .

John J, Janide, HD, FACE Port Ctarioue, FL Cl&r111& Levetan, MO. FACE S. Presented to The Nuclear Regulatory Commission -..,..oc l'uquale J, Palumbo, HD, FACE Scoasdale,AZ Medical Rulemaking Workshop TERMS EXPIRE 2000 Donald A. Bersman, MD, FACE August 19 and 20, 1998 N<wYoric.NY Samuel E. Crockett, MD, FACE Ortando,FL ANA Hotel Daniel S. Dulclc, MD, FACE Cape Glrwuu. MO San -Francisco, California Suphon F. Hodpo,,, MD, FACE Rochestar, MN Stewin M, Pelak, MD, FACE Houston.TX Kri1hna M. Pin~anen~ MO. FACE Tompe,AZ David A. Westbrock, MD, FACE Dayt S EXPIRE 2001

                 .0., MACE Caria, II. Hunllton, Jr., MD, FACE Houston.TX John A. Seibel, MD, FACE Albuquerque, NM BUI Law,Jr,. MD, FACE Knoxville, TN Phllip Levy, MD, FACE Phoenix.AZ John 8. Taurtclot, MD Bethada,MD Nelson B. Watts, HD, FACE Atlmta.GA FELLOW-IN-TRAINING Elbe M. Brett, M.D.

N<wYoric.NY EX-OFFICIO Eupne T. Davktson, MO. MACE Hollywood, FL John S. llulu>ra, MD, FACE Ablnpn.fll,. Paul H. Sa11n111r, MD, FACE Bn,nx,NY Craia:W'tert.1m, HD, FACE Nuhvill<.TN Donald C, Jonu Chief Executm: Officer Acknowledged by card ..~... ~ 4 1998

                                             'I'fie riJoice of C[inha['L1ufoc1i110/:ogy

lJ. . NUCLEAR RE ULA1VH Y v v1v111111 ,..., RULEMAKINGS & ADJUDICATIONS STAFF OFFICE OF THE SECRETAR OF THE COMMISSION Document Statistics

Jl.merican Jl.ssociation of Cfinica[ 'Endocrinofogists 1000 RIVERSIDE AVENUE

• U ITE 205
• JAC K SONVILLE, FLO RIDA 3ZZ04
• PHO NE: (904) 353 -7878
• FAX : (904) 353-8185
• http)/www.aacc.com POSITION PAPER
• ions to 10 CFR Part 35 Medical Uses of B roduct Material The Nuclear Regulatory Commission (NRC) is considering a proposal to increase the number of training and experience hours from 80 to 120 for treatment of hyperthyroidism and thyroid carcinoma with lodine-131 and require licensees to pass an examination in order to qualify for certification. The American Association of Clinical Endocrinologists (AACE) respectfully submits that this revision is unwarranted and will be detrimental to patients as it will expose them to increased safety hazards, cause undue stress, inconvenience, and increase cost. It will also discourages endocrinologists from providing this form of treatment when in fact endocrinologists, with their broad base of experience and training in all forms of thyroid disease and access to various forms of thyroid testing, are in the best position to judge the timing and appropriateness of radioiodine treatment.

The following points outline AACE's position with respect to this issue: WHAT TREATMENTS, SPECIFIC TO ENDOCRINOLOGISTS, DO THE REVISIONS UNDER 10 CFR PART 35-MEDICAL USES OF BYPRODUCT MATERIALS AFFECT?

• Use of lodine-131 for the treatment of hyperthyroidism
• Use oflodine-131 for the treatment of thyroid carcinoma
• Proposed changes included in § 35.390 "Training for therapeutic use of unsealed byproduct material (including any dosages of sodium iodide 1-131 in quantities greater than 30 microcuries)" would replace current, acceptable standards found in § 35.932.

HOW WILL PATIENTS BE IMPACTED BY THE PROPOSED CHANGES? The clinical endocrinologists is the physician best trained to take care of patients with thyroid disease, and part of their responsibility is to protect their own patients from unnecessary burdens. Increasing the requirement for licensure will result in fewer endocrinologists being able to take care of their own patients and will ultimately place undue strain on the patient, including:

• Increased potential safety hazards for the patient There is much more personal and focused attention given to the patient in the endocrinologist's office. In other settings, the patient is one of dozens of people waiting to be treated with a variety of doses for a variety of diseases. Thus, the possibility of error in communication and for the misadministration ofl-131 is greatly increased .
• Increased costs to the patient Referral to another physician increases costs of services by adding another layer of specialty consultation.

Furthermore, the cost of administering 1- 131 in a hospital setting may double or triple the cost of an endocrinologist administering 1- 131 in his or her office. The costs in a hospital setting are double or triple the cost of an endocrinologist administering 1-131 in his/her own office.

                                        '11ie   r hue Lf ( fimca[ 1- ndocrinofot1)

• Increased emotional trauma during treatment Patient anxiety and fear will be increased as a result of patients being required to go to the nuclear medicine departments where other patients are being treated for all manner of diseases, including cancer.

This is an unnecessary exposure of the patient to psychological trauma and can be a deterrent to the patient seeking appropriate care.

• Increased hassles visiting yet another specialist With fewer endocrinologists administering 1-131, patients will have to endure yet another layer of specialty consultation, resulting in:

1. Delays in treatment

2. Inconvenience and loss of time from work

3. Significant increase in the cost of treatment

4. Exposure to unfamiliar settings and personnel.

WHAT IMPACT DO THE ABOVE REFERENCED REVISIONS HAVE ON QUALITY OF CARE?

• Changing the requirements for the administration oflodine-131 is.against the NRC' s own guidelines of "minimizing intrusion into medial judgements affecting patients and into other areas traditionally considered to be a part of the practice of medicine." Such revisions may be warranted if there were repeated problems with the safe handling ofl-131; however, no such problems have been documented. In fact, endocrinologists have maintained an impeccable safety record.
• Changing requirements will decrease the patient's access to quality care. If an endocrinologist does not have ready access to radioiodine, it means that treatment must be interrupted by referring the patient to another specialist which often results in inappropriate or prolonged use of less desirable non-isotopic alternative methods of treatment. *
• Referral to another physician is time consuming, and often inconvenient for patients. It also involves the possibility of an error in communication or in administration of radioiodine .
• With their extensive training in thyroid physiology and experience in diagnosis and treatment of patients with various thyroid disorders, endocrinologists are likely to recognize silent thyroiditis, jodbasedow phenomena, thyrotoxicosis factitia, or other conditions that may mimic Graves' disease and lead to inappropriate treatment. In fact, Mitchell S. Aleman, M.D., F.A.C.E., a board certified endocrinologist licensed to use I-131 for treatment ofhyperthyroidsim, currently treats patients in a private nuclear medicine clinic owned and operated by three physicians who are board certified in Nuclear Medicine. He states, "these physicians were impressed with the knowledge of radiation biology and safety I had acquired from the 80 hour course ... and had no hesitancy in precepting me as required under the current regulations and ....recommended me for licensing under their radioactive materials license."

DO CURRENT TRAINING AND EXPERIENCE REQUIREMENTS JEOPARDIZE SAFETY? No. In fact, the NRC specifically stated that endocrinologists would be no less cautious than other specialties who wish to treat patients with radioiodine when AACE proposed and subsequently developed an 80 hour nuclear medicine training course (1997, Baskin). Furthermore, no published misadministrations by endocrinologists were reported to the NRC with respect to use of 1-131 for hyperthyroidism from 1985- 1997. (Data from NRC website).

_ _ 08/ 25 /98 TUE 10 : 23 FAX 916 323 6491 RADIOLOGI C HEALTH BRANCH ~ 001 Department of Health Services DOCKETED US .R C "98 SEP -2 P2 :30 Fax OFF- f t AUL[\; * .. -, ADJUD,C I ~r1 I *.FF From: John Hickman, Chief Medical To: Cathy Haney Licensing, State of Ca.

              ....      301-415-5369                                Pages:        1 P,.._ [Click here and type phone number}                            08/25/98 Dat.:
              --=       Part 35 revisions                           CC:

Date: Tuesday,August25,1998 ...... Jhldona1@rhb.dh8.calwmet.gov Please Reply pleaae Identify e-mail address

• Comments: I was hoping to talk with you at the San Francisco meeting but was not able to be at the right place at the right time.

I am concerned with the item of supervision. We have a policy that declares the authorized user as the responsible person for the prescription, adrninistratior\ analytical process, and interpretation of results and patient infonnation. This can be a major problem with physicians who wish to only interpret the results. An additional problem that we face is the presence of the supervisor. We require the physical presence for the oral administration of therapeutic radiopharmaceuticals. The other administrations can be covered by ugeneral supervision" . The area of general supervision is loose and not defined. In reviewing the proposed 35, I find the section on supervision to be confusing, I can appreciate the written directive as being a part of the supecvision but the signature and date are important to making the determination that supervision was present From my understanding, the licensee is the supervisor. If the licensee is the supervisor then are authorized users also supervisors or are they to be supervised by the licensee. Is the licensee the appricant? The issue of "telesupervision" should be addressed. Many authorized users find that with present technology that they can stay in their office 100 miles from the treatment site and believe that they supervise the procedure. We do not agree. The emerging technologies Will present us with challenges and the regulations Should be focused on the future as much as possible to accommodate the reasonable but to assure protection of public health and continuing radiation safety.

                                                                                                  £-.-"\ 4 iI   SEP 2 5 1998

tatJStics A epr ~ th~I~ 1n~ >

      'R I ]).s I

DOCKET PROPOSED RULE ,,.10,) 3~ 1- '35 ft>3 F~ '-13 51 (p American College of Radiation Once ogy--,-,_ _ _ _ __ 2021 Spring Road, Suite 600

• Oak Brook, IL 60521 * (630) ~ 3
• FAX (630) 571-7837 c_C 77 \d

  ~: -~lill~~d:'le Haney            .                               8-24-98                        F,~-:         oo
 ~ ::::::::=~ ~e of Nuclear Matenal Safety and Safeguards                                            * -        v, Nuclear Regulatory Commission                                                                        qJ Washington D.C. 20555                                                                        cJ        1
                                                                                                         .,     N N

Dear Cathy Haney,

(..j C> You should be aware that the American Board of Radiology began certifying qualified individuals in radiation oncology instead of therapeutic radiology in 1986 and that a Residency Review Committee for Radiation Oncology began operating separately from the Residency Review Committee for Radiology in 1993. Accordingly, part 2 of paragraph b under sections 35.490 and 35.690 should refer to the Residency Review Committee for Radiation Oncology

• instead of Radiology and references to therapeutic radiology elsewhere in the document should be amended to also include radiation oncology.

Consistent with the American College of Radiation Oncology's original position enunciated at the public meeting of the Advisory Committee on Medical Uses oflsotopes in Rockville, MD in March of this year, we think part 2, paragraph b of section 35.490 should read, "Three years of supervised clinical experience in radiation oncology as part of a formal training program approved by the Residency Review Committee for Radiation Oncology". We do not believe that one year of formal training and an additional two years of (informal) clinical experience under an authorized user is practical or sufficient to produce a qualified user of by-product material for brachytherapy or teletherapy. It is hard to imagine that any director of an ACGME approved residency program in Radiation Oncology would accept an individual for one year of formal training and then say, "Go find an authorized user to complete your training as required by the Nuclear Regulatory Commission" .

• ACRO holds fast to the position that a minimum of three years of formal clinical training in Radiation Oncology is necessary before an individual can begin to prescribe and use sealed sources for brachytherapy or teletherapy. Any period of formal training and supervised experience less than three years will surely lead to a number of untoward medical events by incompletely trained and part-time therapeutic users of by-product material. Those of us who have spent our careers training residents in Radiation Oncology and realize how difficult it is to gain sufficient knowledge and skill to be a safe therapeutic user of isotopes in the treatment of cancer and benign disease, can't understand why you want to diminish formal training and experience requirements in Radiation Oncology from three years to one. Our total concern, like yours, is public safety.

Sincerely yours,

                                                                  . ~ JI!}()~/ fJ1 /J James E. Marks, M.D.

Chair, Board of Chancellors American College of Radiation Oncology SEP 2 4 1998 Acknowledged by card * -- - -

U.S. NUCLEAR REGULATORY COMMISSION RULEMAKINGS & ADJUDICATIO S STAFF OFFICE OF THE SECRETARY OF THE COMMISSION Ooc11T1esnt Postmark Data Coples Rece' ad _ __.,._

                         ~ 'Ru 1d ~ ~ k. ,r.e.-,6.Lf~ 11/~/, 6" pies Re

RIVERVIEW CANCER CARE MEDICAL ASSOCIATES AT RIVERVIEW MEDICAL-PROFESSIONAL PARK DOCKET NUA1JB1::R...... MEDICAL ONCOLOGY AND HEMATOLOGY (518) 399-4600 poQ John W. Jaski_, M.D. _ Stewart A. Silvers, M.D. fl POSED RULE ~O 3A J ~ 1vatore L. P1p1to, M.D. Elizabeth A. Valentine , M.D. 3 Allan D. Eisemann, M.D. ft,?,~P..J./ 35/(,, RADIATION ONCOLOGY (518) 399-2400 Alex H. Frank, M.D. Lance I. Hellman, M.D. Wade J . Gebara, M.D. August 21 , 1998 ejJJ~

                                                                                       ?=~1:           ~

0:-,- rT D Donald A. Cool , M .D. -e' V) rr, C: O _) U.S. Nuclear Regulatory Commission To -0 (/) ("") I -z:::ir:: 11545 Rockville Pike 'J) N  :::0 rr1 Rockville , Maryland 20852 2738 "I . l' i

                                                                                                       -0 n --

r, C) N RE: 10 CFR Part 35 )..' - Ll 17 0 77

Dear Dr. Cool :

I have communicated with you in the past on this issue and would like to again express my concerns about proposed revisions in 10 CFR Part 35 . As a Board Certified Internist and Therapeutic Radiologist, I feel I have a good perspective on the significance of training requirements. After practicing Radiation Oncology for 10 years in both the university and private setting, I feel the current training requirements are the minimum that should be required for handling radioactive materials and administering ionizing radiation to humans. In fact, I favor an increase in health physics training for radiologists though I know it is unlikely that would be mandated. Please keep in mind that patient safety has been well served by the requirements in 10 CFR 35 . I hope your agency will see fit to continue the requirements , at least at their current level. AH F/mg Dictated: 8/21 /98 Transcribed : 8/26/98 Acknowledged by card SEP 2 4 1998 896 RIVERVIEW ROAD* REXFORD, NY 12148-1399

• FAX (518) 399-6716 31 MYRTLE STREET* SARATOGA SPRINGS, NY 12866-1090 * (518) 587-7670
• FAX (518) 587-0612

U.S. N CLEAR REGULATORY COMMISSION AUL MAKINGS & ADJUDICATIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSION Document Statisti.:s ,**Postmerl<Date ff ;2i 78 - 'd~ ~ ~ ~-4rl t!:f/4/41r C I _ A . Re~roduced .A 1 IC * ~ f' *~ .......:...;;.~ '------ - I

the Watson DOC KETE D US RC Clinic __________ LLP___~_a _s_EP_-2_ P_2 _:3o_ _ _ _ l")QCKET N BER OFF- 1 1-  : (' Au8ulsit 11.1, 1998 ROPOSED RULE ~o1 '3~ -1 .35 ADJUL> I FF (1,3Fl<l/3 s1,) The Honorable Shirley Ann Jackson Chairwoman, U.S. Nuclear Regulatory Commission Room 18 Hl, 1 White Flint North Bldg. 11555 Rockville Pike Rockville, MD 20852-2738

Dear Chairwoman Jackson:

This letter is in regard for the endocrinologist's need to administer radioactive iodine to patients with thyro-toxicosis of any type and patients with thyroid cancer. The errors in administration have not been those of endocrinologists, but have been by physicians who are specializing in nuclear medicine, but do not treat thyroid disease except with this one form of therapy. Because these other physicians do not know the patient like the endocrinologist who has seen the patient in consultation, the safety is with the endocrinologist administering the medication. The endocrinologist has already seen the patient prior to the treatment to give the appropriate preparation, evaluation and therapy. Thus, the patient i s well known to the endocrinologist and little in the way of any problems in patient identification occurs. Also, another consultant fee is not added by having a nuclear medicine specialist or radiologist give the drug. The cost, in a lot of cases, is quite a bit less with the out-patient treatment which endocrinologists commonly utilize. At our Clinic, 15 millicuries of 1131 administration costs $852.28 , hospital administration by Radiology of the same dose costs

       $1900 -- more than twice the cost.

co Your consideration of this matter would be appreciated (7') (7') regarding regulations that are being considered by the Nuclear Regulatory Commission. Sincerely yours, Z,, ') ~~- Eugene r .Davidson, M.D. FACP, MACE DLBnuclearL.226 d:8/11/98 c: The Honorable Charles Canady t 0 rt\ The Federal Building ~ ** 16tfil~l~£tPif?l~<ifJ7m~"atcf *.Cr1 0 8~~~61?

• Lakeland, Florid a :3 :380+5000 * (941) 680-70{fil Accredited b1*Accreditation Association for Ambu/a/01:r Health Care, Inc.

                                                                                                         .~

(.) ul a:

EG

     &        if!

F ETA OFT'"'E COMMISSIO

                                                                                                                            @)

UNIVERSITY OF CALIFOR NIA, LOS AN GELES ... UC LA DO Cf{ET ED BERKELEY

• DAVIS
• IRVINE
• ws ANGELES
• RIVERSIDE
• SAN DIEGO
• sV~~&sco SANTA BARBARA
• SANTA CRUZ

                                                               '98 AUG 24 A11 :      ********

UCLA SCHOOL OF MEDICINE August 11 , 1998 HARBOR - UCLA MEDICAL CENTER OFH-: DEPARTMENT OF RADIOLOGY RU l 1000 CARSON STREET TORRANCE, CALIFORNIA 90509 ADJUl,: Secretary, U.S. Nuclear Regulatory Commission Washington, DC 20555 DOCKET PRO  ;?o 3~ ~ 35 tp3F!e'/-351b)

Dear Sir/Madam:

Please accept these comments concerning the 500 mrem Patient Discharge Rule, as part of my comments on the Proposed 10 CFR Part 35. Although these comments were written for CRCPD, they apply to NRC as well. Copies of references are attached. Thank you for your attention and consideration. Sincerely,

             ~

Carol S. Marcus, Ph.D., M.D. Director, Nuclear Medicine Outpt. Clinic Harbor-UCLA Medical Center And Professor, Radiological Sciences, UCLA Cc: Chairman Shirley Ann Jackson Commissioner Nils J. Diaz Commissioner Edward McGaffigan Joel Lubenau (for Greta Dicus) Hugh Thompson, Deputy EDO Carl Paperiello, Ph.D. Don Cool, Ph.D. Kathy Haney CSM: NRCSECS-11-98.CSM AUG 2 7 1998 Acknowledged by card .............................-

U.S. UCLEAR REGULATORY COMM1v RULEMAKINGS &ADJUDICATIONS ST OFRCE OF THE SECRETARY OF THE COMMISSIO\J Orcument Statisfr ~

COMMENTS REGARDING CRCPD'S (FAILED) PROPOSED RESOLUTION CONCERNING NRC'S "500 MREM PATIENT DISCHARGE RULE" Carol S. Marcus, Ph.D., M.D., Director Nuclear Medicine Outpt. Clinic Harbor-UCLA Medical Center Building N-2 1000 West Carson Street Torrance,CA 90509 Phone: (310) 222-2845 FAX: (310) 533-7159 Email: csmarcus@ucla.edu August 11, 1998

The resolution proposed during CRCPD's May '98 national conference regarding NRC's 500 mrem Patient Discharge Rule Is very troublesome and disconcerting. It Is a credit to CRCPD that it was not accepted, but ongoing shenanigans at NRC suggest that this Issue Is In fact not dead, and that a faction of NRC staff and management are plotting to overthrow the rule. The purpose of this commentary Is to discredit the "whereases" of this resolution, and the resolution itself, and recommend that Agreement States adopt the California version of the 500-mrem patient Discharge Rule. California recently adopted the recommendation of Its Nuclear Medicine Council, and produced a policy far superior to that of NRC. The California Policy may be obtained from me or from the California Radiologic Health Branch. The first "whereas" states that "The current 10 CFR Part 35.75 has no provision to verify that a released patient maintains exposure to an

• Individual member of the general public to less than 500 ml/I/rems ... ". This "whereas" Is Incorrect The provision for verification consists of (1) a scientifically valid model for calculating the activity of radionuclide in a patient and the likely maximum radiation exposure therefrom to another Individual, and (2) a provision that the physician has a high degree of professional satisfaction that the patient will comply with Instructions to the extent necessary to keep doses below 500 mrem. The models have been verified by direct measurement and form the basis for internal dosimetry. In this regard, they have been accepted by the Medical Internal Radiation Dose (MIRO) Committee of the Society of Nuclear Medicine, are the basis of Oak Ridge's Radiation Internal Dose Information Center (RIDIC) activities, have been incorporated into dosimetry documents by ICRP (e.g.

ICRP no. 53), are used by NCRP (e.g. Commentary no. 7), and are required by FDA for review of all diagnostic and therapeutic radiopharmaceutlcals. The use of these models for the related calculation, radiation dose to those other than the patient, are equally valid. As to (2), the professional judgment of a qualified nuclear medicine physician is very important here. If members of CRCPD are selling therapy licenses to physicians who are in fact not qualified to educate the patient in radiation protection behavior and are not qualified to have acceptable professional judgment, then CRCPD is committing criminal negligence and has only Itself to blame. We all know that NRC's qualifications for physicians in therapy nuclear medicine are minimal to a fault. In the 1996 National Academy of Sciences-Institute of Medicine (NAS-IOM) analysis of NRC's Medical Program, the NAS-IOM recommended increasing the requirements of Authorized User physicians in nuclear medicine therapy. If, in order to remain "compatible" with NRC, an Agreement State licenses incompetent physicians, as NRC does, then it Is up to the Agreement State to adopt a higher standard and become "Incompatible" thereby. The California Policy tactfully covers this Issue. CJlCPDCOMMENT88-3-98.CSM 2

The second "whereas" states that "The current 10 CFR Part 35.75 is not an

 /nspectable rule in that it does not require verification that the actual doses received by members of the public are equal to or Jess than the licensee estimates*** *.

The notion of requiring competent physicians to behave professionally In a manner that Is "inspectable" by those not competent to practice nuclear medicine is ludicrous. Qualified nuclear medicine physicians are under no obligation to "dumb down" their professional practice to the level of a radiation inspector. Nuclear medicine physicians serve patients, not regulators, and physicians are obligated to provide efficient and effective healthcare. The fact that inspectors find that activity "uninspectable" is irrelevant. In addition, there is no valid scientific or safety reason to precisely measure an absorbed dose below 500 mrem. According to 10 CFR Part 20,

• radiation workers do not need to be badged if their exposure Is expected to be 10% or less of the maximum permissible dose, 5000 mrem/year. The cut-off is 500 mrem for workers, and we do not know if they get 5, or 50, or 499, or 520 mrem. The point is that these radiation doses are insignificant from a safety point of view. The background radiation In Denver is about 530 mrem/year, every year, for everyone, and background In Colorado gets up to 890 mrem/year in Copper City. Colorado is tied for the third LOWEST cancer death rate In the nation. Exact knowledge of Inconsequential doses has no importance or significance.

The third "whereas" states that "The current 10 CFR Part 35.75 requires the licensee to produce and maintain records that cannot be verified as accurate, and are therefore unnecessary and wasteful...... First, nuclear medicine licensees have an enormous paperwork burden exclusive of 35.75, MOST of which cannot be verified as accurate. The purpose of paperwork is to make paper for inspectors to inspect, because Inspectors are not competent enough to inspect process, as was characteristic of the more competent inspectors in years gone by. The inability to verify existing paperwork as accurate should render all of it unnecessary and wasteful, but CRCPD has never made this suggestion before. I find this idea to be exceedingly valid, and suggest that all but a very small fraction of existing paperwork, be discontinued. As far as the unnecessary and wasteful paperwork of 35. 75 is concerned, I heartily agree that it should be removed as well. The California Policy has no record-keeping requirement Unlike NRC's prescriptive regulation, California's policy is a true performance standard. CJI.CPDCO~CSM 3

The fourth "whereas" states that "The current 10 CFR Part 35.75 appears to have led to an increase in landfill alarms which require state regulating agencies to respond to the alarms with no funding reimbursement ... ". There are a number of arguments against this "whereas". First Is the word "appears". I will accept nothing but valid scientific data from a group that purports to be scientific. I suspect that valid scientific data do not exist. CRCPD will first have to demonstrate that a significant increase has occurred from outpatients containing more than 30 mCi of nuclear medicine therapy radiopharmaceuticals generally involving 1-131. We have had numerous discoveries of 1-131 at sanitary landfills from patients who have under30 mCi of 1-131 (and would have been outpatients anyway) and from hospitalized patients whose 1-131 contaminated waste was inadvertently thrown into general trash by uneducated nursing attendants. We may have an actual increase in these events only because of an increasing number of landfills putting in detectors and setting the trigger level at only a few times background. I estimate that I release approximately 40 patients a year containing more than 30 mCi of a therapy radiopharmaceutJcal, and I recently checked with Cass Kaufman of Los Angeles County Radiologic Health to see if this had caused any problems, or increase in problems, in our sanitary landfills. Kaufman has denied any problem or increase in any problem. She states that they have about an average of about 3 calls per year from the landfills. She has a portable spectrometer, and if it is 1-131, she tells them to ignore it and bury it anyway. THESE CONTAMINATION LEVELS ARE NON-HAZARDOUS AND ENTIRELY LEGAL. Which brings us to the real problem. After NRC was stopped by Congress from carrying out its "Below Regulatory Concern" (BRC) policy under Chairman Carr, it has adamantly refused to become involved with the setting of any standards for sanitary landfills. The landfills have no Intelligent, scientifically valid guidance because no other radiation regulator (e.g. CRCPD) has prepared any. CRCPD should accept the fact that NRC is useless here, and prepare national standards for sanitary landfills. Fortunately, the radionuclides presently used in nuclear medicine are not used for sealed sources and the Identification of Tc-99m, Ga-67, Tl-201, ln-111, 1-123, Sr-89, Sm-153, P-32, and 1-131 may be assumed to represent patient contamination and insignificant hazard. The technology now exists for easy identification of radionuclides, made easier by the fact that a detection event almost always involves a single radionuclide when it is due to patient contamination from a nuclear medicine procedure. Radiation detectors at sanitary landfills should find radium dumps and broken lr-192 sources, and other lost brachytherapy sources, but should easily distinguish between these and nuclear medicine contaminants. CJlCPDCOMMENTSS-,S.CSM 4

A sanitary landfill which chooses to monitor for radioactivity should be encouraged to set its detectors at ten times background. Scientific studies conducted In Los Angeles County in the early 1980's showed that such a threshold will miss virtually all nuclear medicine contaminants. In addition, a sanitary landfill which chooses to monitor for radioactivity should be expected to have a photon collection system which permits spectrometry and Identification, either at the landfill or by transmitting raw spectrometry data by modem to a nuclear professional who can do so. The way to make this happen is for state radiation regulators to require that this equipment be purchased, and refuse to undertake the responsibility to respond to an alarm unless spectrometry indicates a non-nuclear medicine contaminant. As far as reimbursement is concerned, sanitary landfills should be required to reimburse for such services, which fortunately would not be needed frequently. This should have been arranged for as soon as the detectors were installed in the sanitary landfills. This entire issue is a non-problem, which has been permitted to deteriorate into a problem because of the shortcomings of regulators, both NRC and CRCPD. If CRCPD is to be deserving of any respect at all, it should fix this situation promptly. As an interim consideration, I would also like to point out that Rita Aldrich and I published an article in the Journal of Nuclear Medicine, advising physicians as to how to counsel patients to avoid sanitary landfill contamination, even if it Is non-hazardous. This article is in the Journal of Nuclear Medicine 38(9): 26N, Sept, 1997. Send the reference to all your nuclear medicine therapy licensees. Just because NRC Is unable to act doesn't mean CRCPD needs to follow suit. The fifth "whereas" states that "When responding to these landfill alarms, agency personnel are exposed to physical and biological hazards". It is amusing to note that the CRCPD radiation regulators who composed this resolution find the "physical and biological hazards" of a sanitary (?) landfill more frightening than the radiation which they handle frequently. Considering the low level of "physical and biological hazard" of a sanitary landfill, the radiation must thereby be so innocuous as to make me wonder why we need most of our materials program regulators at all. In any case, If these CRCPD regulators followed my advice for the preceding "whereas", this "whereas" would be virtually moot The resolution states "That the Conference of Radiation Control Program Directors, Inc., and its member states recommend that the NRC revise 10 CFR Part 35.75 to remove the licensee's ability to use release factors, over which the licensee has no control, when deciding if a patient may be released". CR.CPDCOMMENT81-3-CSM

As the five "whereases" supporting this resolution have been, I believe, discredited by my arguments, one must ask what are the REAL reasons behind this resolution. I believe that there are two real reasons. The first, and it is most shameful, is that the CRCPD members who crafted this resolution do not understand the physics, the math, the radiopharmacoklnetlcs, and the scientifically valid models that apply to 10 CFR Part 35.75. Instead of quickly learning the science that one assumes, falsely, that these regulators already understand, these regulators would rather have the opportunity for scientific judgment removed. Then they wouldn't have to learn anything. This is a problem at NRC as well, and I do not believe that any NMSS staff or management, or Office of Inspection staff or management, understands the science involved and can perform these calculations. The NRC regulatory guide confirms this. The present NRC regulatory guide, by the way, was not the one reviewed by the Commissioners, the ACMUI, and the public. The present regulatory guide was substituted for the one that was reviewed and none at NRC appeared to be the wiser. Such fraud should be punished by automatic dismissal. Unfortunately at NRC, fraud involving the medical program appears to be the official agency policy. The second real reason that certain members of CRCPD oppose 35. 75 Is that it appears to set a double standard for radiation safety. Contamination levels that are scrupulously measured, quantitated, cleaned up, decayed out, recorded, and inspected are suddenly ignored In 35.75 as being insignificant in terms of safety. If such levels of contamination are In fact insignificant in terms of hazard, and I believe that there is no doubt that they are for the most part, then the regulator begins to wonder if most of what he does is not meaningless. The next worry is that if people find that out, he may be out of a job. In summary then, the real reasons for this resolution appear to be scientific inadequacy and job security. You ought to be ashamed of yourselves. CllCPDCOMMENT81-3-98.CSJd 6

                                                                        '\

llelatlna co: NuGJcecB*1let01Y Comrn;eion Rulo IOCE& P,a l5,Z$ ui*dcm udc110 stitodll WBIUABr The current lOCPll Pan 35.75 baa no provision to writ, that a relwed patient matntalnt expoaure to an Individual member ot the aeneral JNb1ic to ten ihan $00 millireml. and . WDR.EAS: The current lOCFl. Pan 35.75 ia not an inlpectablo n.de Jn that it dooa not require veriticadon tliat MNl1 do,a received by memben orthe .Public are equal to or 1en than cbo liceaaco lldmuea. and

• WBEP&A.S: The cwront lOCFA Part 35.75 require, the l1cwec to produoc and maintain records that cannot be veri:6od u ICCl.lt&tc, and 1te thenlote unneceaaary and watdW. and WJIEUAS; The GUmmt ?OCPR Pan 35,75 appura to have Jed to an lncrwe 1n landflll uarma which rcqwra state reaulatina l&endu to rapon.d to the alanna with no Alradma reimbunomtnt, and
• WIIO.EA.S: When rapondina to theae landfill a1lrma, aaency personnel are expoaed to phyaical and. bioloaical hazlrda.

NOW, BE 1T USOLWD1 n.t the Contertnco of'Radiatlon Control Pioarem Dirocton, J.nQ., and itl member atatea reco.nunond that tho NRC roviae lOCFll Pan JS. 75 to ranovo the liconlce** ability to uaa releuo Actor1, over which the licenaec hu no comrol, when docldina If a patient may be rclclued. Cl.CPD Chaitpanon Datt

STATI! OF C A l ~ IV<<> Wl\FMI! Aae<<:T PfTE Wll.SON. ~ DEPARTMENT OF HEALTH SERVICES

 'IW7,U p STlll!l!T P.O. ec<< N2'732 SACltMl&ITO. CA    ~

(916) 445-0931 July 9.1998 RADIATION SAFETY ADVISORY 98-1 TO: Group 4 & 5 Medical Licensees

SUBJECT:

Patient Discharge after Radioouclidc Therapy National Council for Radiation Protection (NCRP) Report No. 3 7 500 mil1ircm (mrem) Criterion .

• The puzpose of this advisory is to wmounce the policy of the Radiologic Health Branch (RHB) CODMroing patient discbarge after radionuclide therapy. At present, all medical liceasees engaged in radionuclide therapy aro required to implement Che n:,commendations ofNCRP No. 37 as identified in a condition on the radioactive matcria1s liccosc. These guidelines arc based on a 500 mrem limit to members of the public from patients who have had radionuclide therapy. Msny lioeMecs may also have committed to additional limits for discharge such as 30 millicurie (mCi). The purpose of committing to the 30 mCi limit, for some licensees, is to preclude perfonning calculations to verify the 500 mrem limit As of the date of this advisoiy> licensees with particular mCi limit have the option to ignore the committed 1'l1Ci limit and instead substitute the 500 mrcm lipiit However~ this option may be cxcrciscd only under the binding conditions that the Autbom.cd User Physician (1) UDdeistands how to C8lculatc radiation dose from a patient, and perfurm.s these calcalations as necessary; (2) is peoonaUy responsible fur evaluating the patient's working and living conditions., and for comnmnir:ating and explaining ncccssmy prc<:.aution6 to 1hc pa.ti.mt; and (3) is profossionally suilSficd that ti>> patient complianoc ii highly likely to assmc that no member of the public receives more than 500 mrem.

In ordato provide guidance to physicians who have not COllllSClcd patients to this extent befhre and/or who have not pafu~ 1hcsc calcu1ations,. they may aoccss the website for a tutori.a1 at www.nucgang.org undec "Newsletter' and then under "Considerations in Determining Wh.ethc2- or Not Patients May be Given Significant Quantities of Radiophannaccutioals as Outpatient". Llccasccs may choose any uunbcmatically wlid method and are not tied to this method illustrated in the website tutorial or any othel" particular method. During impecuon, licensees will be asked if thci SOO mrem limit is used for dotcrmining patient disdlarge. The, inspedor may request information pertaining to the procedores Wied to malcc this determination. A demonstration of a rational proccdurc is expected.

Radiation Safety Advisory 98-1 Page2 July 9. 1998 In following 11m advisory, medical licensees have the flcxi"bility of exmclsing the options descn"bed above for releasing therapeutic radionuclide treated patients and at the same time protecting the public from excessive exposure to radiation associated with medical therapeutic radioncl.idc treatment. Sinccrcly,

.somrnentary Ill 2 Avoiding Solid Waste Contamination

.I Ill 3: Problems fro~ lodine-131 Patients w n December 1990, a I ever, such articles are not regulated material and the physician z Petition for Rulcmak- has no obligation to label them, keep reconls or observe other ing was submitted to requirements for regulated material. Another alternative would the Nuclear Regulatory be for the physician to survey patients' waste but not ta1ce cus-Commission requesting tody ofit, and advise the patient as to when it can be discarded abandonment of the "30 The key point is for the physician to explain clearly to the mCi Rule" and its replace-

                           '-"------i            mcnt with a requirement based on an anticipated patient that body fluids will be radioactive for a period of time, and ifany articles or items with body fluid on them are discarded, they may set off a radiation alarm at the local sanitation land-limit of 500-mrem radia-fill. This can result in an expensive search for the cause of the tion absorbed dose to amember of the public. This replacement, a1ann. Such waste has been tracked back to patients who were essentially the recommendations ofNCRP no. 37 (published in then billed for the expense.

1970), was approved and became effective May 29, 1997. It is Landfills, solid waste rrocessing sites and medical waste treat-known as the "Patient Discharge Rule" and was pub-ment sites are not pennitted to accept radioactive material and shed in the Federal Register (1997;62:4120). This rule will have set detectors to find and exclude such waste. However, there enable most patients requiring high-dose sodium iodide for are locales that have developed criteria in cooperation with their th;yroid cancer to be treated as outpatients, provided that the physi-nuclear medicine community and state radiological health pro-cian can show appropriate calculations to assure public doses grams that allow disposal ofshort-lived nuclear medicine patient-within the 500-mrcm limit. This means that patient-contami-contaminated trash while protecting against handling ofillegally nated articles that were fonnerly collected and decayed out by discarded radiation sources. the nuclear medicine licensee arc now often destined dirccdy for Contact your state radiological health unit to learn what, ifany, discard in sanitary landfills by outpatients. patient waste disposal criteria are in place. If no standards The appearance of sensitive radiation detectors at sanitary exist, you may want to work with the unit to develop workable landfills and solid waste transfer and processing.sites through-solutions for waste disposal. Remember, however, that the first out the eow1try bas resulted in identification of contaminated step is ensuring that your patients are well-informed participants articles and body fluids from nuclear medicine patients. in their own treatment Iodine-131 is a special problem because it does not decay sig- -Carol S. Marr:us, PhD, MD nificantly by the next day. The problem of 131 I contamination is Harbor-UCU Medical Center, Torrance, CA pected to become more frequent with the new Patient Dis-Rule. In addition to the usual instructions for reducing -Rita A.ldric__li, MS exposure to family members and others, here are some recom- New York Slate Department ofLabor, A.lfNv1y, NY mendations for nuclear medicine physicians when counseling patients receiving 131 f therapy. Editor'* Note

1. Do not use paper plates or disposable cups or flatware. Use For those institutions that do not have written instructions for regular dishes, glasses and utensils. Wash them in the sink or radlolodine therapy patients, the SNM pamphlet "Guidelines for dishwasher. This keeps contaminated articles out of house- Patients ReceMng Radloiodlne Treatmenr may be used to meet hold trash. the NRC requirement for written instructions about general pre-

2. TlSSues and paper napkins should go in the toilet (if plumb- cautions for reducing radioactive contamination of other peo-ing allows), not the garbage. ple. Cootact the SNM Publications Department for more Infor-mation at (703) 708-9000. x 223.

3. Because saliva contains significant 131 I activity, food residues contaminated with saliva can be a problem. Apple cores, barbecue ribs, _fried chicken and com on the cob are examples of foods that contribute to radioactive residue and should be avoided the first week after therapy.

4. Articles contaminated with body fluids that cannot be washed cl~ or disposed of in the toilet should be saved in a dou-bled plastic bag and returned to the physician administering treatment after one week. The physician can decay it until it can be discarded without the risk of setting off alarms. How-26N THE JOURNAL OF NUCLEAR MEDICINE

• Vol. 3~
• No. 9
• September 1997

DOCKET ~l'UilDl :n PR . e2o 3 ;i. +35 oocKETEO UStf ~90-01-P] ( ~3 Fl<'l35lb)

                                                                              *gs ~llG - 7 p 3 '.22 U.S. NUCLEAR REGULATORY COMMISSION                              ,...

OF-f" Medical Use of Byproduct Material; Draft Policy StaterJ\eAt-AOJlH AGENCY: Nuclear Regulatory Commission. ACTION: Draft Policy Statement.

SUMMARY

The Nuclear Regulatory Commission (NRC) is proposing, for formal comment, revisions of its 1979 policy statement on the medical use of byproduct material. These proposed revisions are one component of the Commission's overall program, as previously announced in the Federal Register, for revising its regulatory framework for medical use, including its regulations that govern the medical use of byproduct material. The overall goals of this program are to focus NRC regulation of medical use on those medical procedures that pose the highest risk and to structure its regulations to be risk-informed and performance-based, where appropriate, consistent with NRC's "Strategic Plan for Fiscal Year 1997- Fiscal Year 2002."

Y1 ~ / 3 1 I 'I '1 8' DATES: Submit comments by (in&ei:t date QQ Eley& after f:n:1l:,lieatioF1 ifl the reeler:al Register). Comments received after this date will be considered if it is practical to do so, but the Commission is able only to ensure consideration of comments received on or before this date. ADDRESSES: Send comments to: Secretary, U.S. Nuclear Regulator/ Commission, Washington, DC 20555-0001 , Attention: Rulemakings and Adjudications Staff. P~. hi s/13/98 a:t I.P3F~ '/3580

You may also provide comments v,a NRC's interactive rulemaking web site through the NRC home page (http://www.nrc.gov). From the home page, select "Rulemaking>> from the tool bar. The interactive rulemaking website can then be accessed by selecting "New Rulemaking Website.* This site provides the ability to upload comments as files (any format), if your web browser supports that function. For information about the interactive rulemaking web site, contact Ms. Carol Gallagher, (301) 415-5905; E-mail: cag@nrc.gov. Deliver comments to: One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 am and 4:15 pm Federal workdays. Copies of comments received may be examined at: NRC Public Document Room, 2120 L Street, NW. (Lower Level), Washington, DC. FOR FURTHER INFORMATION CONTACT: Catherine Haney, Office of Nuclear Material Safety and Safeguards, Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-6825, E-Mail: cxh@nrc.gov, or Marjorie U. Rothschild, Office of the General Counsel, Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-1633, E-Mail: mur@nrc.gov. SUPPLEMENTARY INFORMATION: I. Background In 1979, the Nuclear Regulatory Commission published a policy statement, "Regulation of the Medical Uses of Radioisotopes" (44 FR 8242; February 9, 1979), in which it informed 2

NRC licensees, other Federal and State agencies, and the general public of the Commission's following general intention in regulating the medical use of byproduct material:

1. The NRC will continue to regulate the medical uses of radioisotopes as necessary to provide for the radiation safety of workers and the general public.

2. The NRC will regulate the radiation safety of patients where justified by the risk to patients and where voluntary standards, or compliance with these standards, are inadequate.

3. The NRC will minimize intrusion into medical judgments affecting patients and into other areas traditionally considered to be a part of the practice of medicine.

NRC activities in the medical area, such as promulgation of regulations and development of regulatory guidance, as well as cooperative relationships with other Federal agencies, have been guided by this statement. A Federal Register notice, "Medical Use of Byproduct Material: Issues and Request for Public Input" (62 FR 42219-42220; August 6, 1997), describes (as reflected below) NRC 's detailed exa~ination of the issues surrounding its medical use program during the last four years. This process started with NRC's 1993 internal senior management review; continued with the 1996 independent external review by the National Academy of Sciences (NAS), Institute of Medicine (IOM); and culminate_d in NRC's Strategic Assessment and Rebaselining Initiative (SA). In particular, medical oversight was addressed in the SA Direction-Setting Issue Paper Number 7 (OSI 7) (released September 16, 1996). In September 1997, the Commission issued its "Strategic Plan," which stated that its goal in regulating nuclear materials safety is to "prevent radiation-related deaths or illnesses due to civilian use of source, byproduct, and special nuclear materials" (NUREG-1614, Vol 1, at 9). 3

In its Staff Requirements Memorandum (SRM) - COMSECY-96-057," Materials/Medical Oversight (OSI 7)," dated March 20, 1997, the Commission stated that it supported continuation of the ongoing medical use regulatory program with improvements, decreased oversight of low-risk activities, and continued emphasis on high-risk activities. This SRM also directed the NRC staff to revise 10 CFR Part 35, associated guidance documents, and, if necessary, the Commission's 1979 "Medical Use Poli~y Statement." The Commission SRM specifically directed the restructuring of Part 35 into a risk-informed, more performance-based regulation. In addition, the Commission expressed its support for use of the Advisory Committee on the Medical Use of Isotopes (ACMUI) and professional medical organizations and societies in the revision of Part 35 and the medical policy statement. The Commission specifically directed the NRC staff to "consider a rulemaking process that provides more opportunity for input from potentially affected parties than is provided by the normal notice and comment rulemaking process, but would be less consumptive of resources and time than the process recently used in the development of NRC's rule on radiological criteria for license termination." A June 30, 1997, SRM informed the NRC staff of the Commission's approval, with comments, of the NRC staff's proposed program in SECY-97-131, Supplemental Information on SECY-97-115, "Program for Revision of 10 CFR Part 35, 'Medical Uses of Byproduct Material,'

• and Associated Federal Register notice," dated June 20, 1997. After Commission approval of the NRC staff's program to revise Part 35 and associated guidance documents, the NRC staff initiated the rulemaking process, which includes revision of the Medical Use Policy Statement, as necessary (62 FR 42219). The Commission directed the NRC staff to consider certain issues, including recommendations on revising the policy statement by focusing regulation of medical use on those procedures that are essential to patient safety and that pose the highest risk, developing regulatory oversight alternatives for diagnostic procedures that are consistent 4

with the lower overall risk of these procedures, and considering the viability of using or referencing available industry guidance and standards to the extent that they meet NRG needs (62 FR at 42219). This notice solicited informal and formal public input during the rulemaking process on the development of proposed rule language and associated documents (62 FR at 42219-4220). At various stages in this process, the Working/Steering Group placed options for a revised Medical Use Policy Statement and major issues associated with 10 CFR Part 35, and a strawman draft of the proposed rule language on the Internet. In developing a proposed revision of the policy statement, the Commission also has had the benefit of input from the Working/Steering Group, which met publicly in August, September, and December 1997 and in January, _February, and March 1998; the ACMUI, at its meetings on September 25-26, 1997, and March 1-2, 1998; ACMUI subcommittee meetings in February 1998; '"stakeholders" and members of the public at facilitated workshops in October and November 1997; professional medical organization meetings; and State regulators at a publicly noticed workshop at the October 1997, "All Agreement States" 1 Meeting. State participants have included representatives of the Organization of Agreement States and the Conference of Radiation Control Program Directors. State participation in this process is intended to further the Commission's strategy to "work with the Agreement States to assure consistent protection of public health and safety nationwide" (NUREG-1614, Vol. 1, at 11). Such State involvement also enhances development of corresponding rules in State regulations; provides an opportunity for early State input; and allows State staff to assess 1 An Agreement State is a State that has signed an agreement with NRC, pursuant to Section 274 of the Atomic Energy Act, allowing the State to regulate the use of radioactive material, other than use in reactor facilities, within the State. During the next 5 years, the total number of Agreement States may increase from 30 to 33. NRG ustrategic Plan" (Fiscal year 1997 - Fiscal year 2002), NUREG-1614, Vol. 1 (September 1997), at 9. 5

potential impacts of NRC draft language on the regulation of non-Atomic Energy Act materials used in medical diagnosis, treatment, or research in the States. At these meetings and workshops, the NRC staff presented alternatives and/or draft text for the Medical Use Policy Statement and 10 CFR Part 35. Alternatives generated by workshop participants were also discussed. To ensure that all interests were represented, to the degree possible, invited workshop participants included radiation oncologists, nuclear medicine physicians, other physici.an specialists (i.e., clinical endocrinologists and cardiologists), radiopharmacists, medical physicists, educators, patient rights advocates, oncology nurses, radiation safety officers, medical technologists, hospital administrators, State and Federal Government officials, and radiopharmaceutical manufacturers. Policy statement alternatives ranged from retaining the status quo to various modifications of the current medical policy such as statements limiting NRC's role in the regulation of medical use to ensuring that the physician's prescription is accurately delivered to the correct patient; making clear that NRC will nm intrude ir:1to medical judgments affecting patients; and providing for NRC assessment of risks to the radiation safety of patients that would reference comparable risks, standards, and modes of regulations for other types of medical practice. The normal pattern for NRC policy statement proposals is the development of a proposed policy statement by the NRC staff for Commission consideration, publication of the proposed statement for public comment, consideration of the comments by the NRC staff, and preparation of a final statement, as appropriate, for Commission approval. As directed and approved by the Commission, the NRC staff has increased participation in the early stages of this development process through meetings and workshops for affected interests and by making documents available on the Internet. 6

The meetings and workshops elicited infonned discussions of options and approaches for developing a revised Medical Use Policy Statement, and the rationale for such options and approaches. Although these meetings and workshops were not designed to seek "consensus" in the sense that there is agreement on how each issue should be resolved, they were conducted at a very early stage of proposed policy statement development to increase participation of int~rested parties and the public with the following objectives: (a) To ensure that the relevant issues have been identified; (b) To exchange information on these issues; and

• (c) To identify underlying concerns and areas of disagreement, and, where possible, approaches for resolution.

The Commission hopes that the interactions among the participants in the meetings and workshops also fostered a clearer mutual understanding of the positions and concerns of all participants. Comments made at these workshops and meetings, and related written and electronic comments (as summarized below), were considered by the NRC staff in its preparation of a staff draft proposed policy statement, as described in the paragraphs below. Comments were also used, as appropriate, in developing proposed revisions of 10 CFR Part 35. The intent of an informal comment period, in advance of publishing a proposed policy statement in the Federal Register, was to provide an opportunity for interested parties to provide input during the development of the draft proposed medical policy statement. ACMUI At the ACMUI meetings referenced above, the ACMUI recommended to the NRC staff its versions of a revised medical policy statement. At its meeting in March 1998, a four-part 7

revision of the current policy statement was recommend~d: the more technically accurate term "radionuclldes* in Statement 1 is substituted for "radioisotopes"; the order of Statements 2 and 3 is reversed; former Statement 3 (Statement 2 in the ACMUI version) is revised to make it clear that NRG "will not intrude into the medical judgments affecting patients" (rather than the current policy of minimizing such intrusions) and to drop from that statement the phrase "into other areas traditionally considered to be a part of the practice of medicine"; and to modify

• Statement 3 primarily to provide that an assessment of risks justifying NRC medical use regulations will reference comparable risks, comparable voluntary standards, and modes of regulation for other types of medical practice.

"All Agreement States* Meeting Workshop This workshop, which included State participants in the meeting as well as members of the public, also discussed the issues associated with the revision of 10 CFR Part 35 and the Medical Use Policy Statement. Some participants at the workshop stated that NRC's regulatory framework had been, and in the future could be, properly developed under the existing policy statement. Those participants who found fault with the existing medical regulatory framework did so primarily on the basis that it is too prescriptive and intrudes into the practice of medicine, which they asserted is adequately regulated by existing medical practices, including voluntary standards, within the medical community. Many comments were made about the proposal for a revised policy statement under which NRC assessment of the risks justifying its regulations would reference comparable risks and comparable modes of regulc;1tion for other types of medical practice. Some participants questioned the capability of NRC to evaluate those risks and noted that such an evaluation would require some mechanism for judging appropriate risk. 8

Participants favoring a policy statement limiting NRG's role to ensuring the accurate delivery of the physician's prescription did so mainly on the basis that the statement specified those areas NRG would regulate and that it provided a regulatory role for NRG that would not intrude into the practice of medicine. Several participants drafted an alternative option in addition to those alternatives presented by the Working Group. That alternative primarily modified Statements 2 and 3 of the current policy statement to provide that NRC's role in regulating the radiation safety of patients is to ensure that the physician's prescription is accurately delivered to the correct patient, more strongly state NRC's policy not to intrude into medical judgments affecting patients and into other areas traditionally considered to be part of the practice of medicine, and commit NRG to regulate the radiation safety of patients Q..Djy where justified by the risk to *patients and QDjy where voluntary standards or compliance with such standards are inadequate. Although no clear preference was evident, some States ' indicated their preference for certain alternatives. Facilitated Public Workshops The facilitated workshops considered alternatives for the Medical Use Policy Statement presented by the Working Group, as well as alternatives generated by the workshop participants (which were mainly modeled on the ACMUI or Agreement State recommended statements described above). Certain themes emerged in these workshop discussions, such as ensuring that NRG follows the policy statement in the future, does not interfere in the practice of medicine or medical judgments affecting patients, regulates medical use of byproduct material based on the risk posed by the medical use and only after determining that voluntary medical practice standards are inadequate, and limits its role in regulating the radiation safety of patients to ensuring that the physician's prescription is followed. At the 9

Philadelphia workshop, an alternative with this latter limitation generated the most favorable comments. Some participants expressed the view that the objectives described above could be achieved by revisions to the current statement, whereas others asserted that mechanisms such as tort law or "physician practice review procedures" could substitute for NRC regulatory control in certain areas. On the other hand, participants expressed concern that certain policy statement alternatives could so limit NRC's role that its regulation would not encompass either high-risk diagnostic or "emerging" medical use technologies. Another concern was that NRC regulation of only the administration of the byproduct material would not provide an adequate level of protection to the patient. According to certain participants, there is an absence of data supporting the necessity of NRC regulation to ensure that the correct patient receives the correct dose. In view of the perception that NRC is not qualified to assess the risks associated with medical practice, the workshop participants voted in favor of a policy statement providing that in any assessment of such risks, NRC, as a matter of policy, will rely on the determinations of the ACMUI and representatives of major professional medical organizations and Government agencies (to include stakeholder participation). Supporters of this statement pointed out that one of its advantages is that it would provide for stakeholder participation in risk assessment decisions. However, other participants expressed concern that certain professional organizations might not necessarily have the best interests of patients in mind when developing a risk assessment. Overview of Written and Electronic Comments The Commission also received written comments in response to the above notice, some of which addressed the Commission's Medical Use Policy Statement. Commenters on the

policy statement include a State, professional medical organizations, an industry trade group, universities, and members of the public. The Commission has provided an overview.of comments below. An Agreement State recommended that the Commission continue the status quo with respect to the Medical Use Policy Statement, but mo:-e strictly adhere to that policy. According to that State, any intrusion into medical judgments affecting patients should be based solely on radiation protection considerations. A number of professional societies, e.g., the American Brachytherapy Society (ABS), the Society of Nuclear rviedicine/American College of Nuclear Physicians (SNM/ACNP), and the American Association of Physicists in Medicine (AAPM) also provided comments on the Medical Use Policy Statement. ABS agrees with current Medical Use Policy Statements 1 and 3, but believes that Statement 3 needs revision to provide that NRC will regulate the radiation safety of patients Q.DJy where justified by the risk to patients and only where voluntary standards or compliance with these standards are inadequate. According to ABS, Statement 2 should also make clear that "[t]he risk threshold justifying patient safety risks will be comparable to those of other types of medical practice." ABS believes that the NRC concept of acceptable patient risk is zero. The SNM/ACNP asserts that contrary to the clear language in the current policy statement, NRC has steadily increased its involvement in the regulation of nuclear medicine despite minimal changes in this area of medicine over the years and a lack of significant problems with this medical modality. The AAPM supper.ts NRC's efforts to revise the Medical Use Policy Statement to focus on radiation safety and not on the practice of medicine or medical physics. However, the AAPM urged NRC to publish its risk data so that the regulated community can understand the NRC's actions in regulating the medical uses of radiation. 11

MPM supports the concept of risk-based regulations, although noting that the licensees' response to regulatory actions will require the expenditure of health care funds. A university of health sciences commented that NRC's current Medical Use Policy Statement is appropriate. This commenter believes that NRC should continue to regulate medical use to provide for the radiation safety of workers, patients, and the general public and that there is no need for changes to the particular statement of general policy. Another university's comments were very similar to* those of the MPM, described above. Comments were also submitted on behalf of the Council on Radionuclides and Radiopharmaceuticals, Inc., {CORAR). According to CORAR, any revision of the Medical Use Policy Statement is Mile unless NRC takes direction from that statement. As to the first statement of the medical policy, CORAR believes that 10 CFR Part 35 is unnecessary because 10 CFR Part 20 is ad~uate for regulation of all other uses of radioactive material and could be expanded to ensure the safety of medical use. CORAR commented on the second and third statements of medical policy by asserting that regulation of the radiation safety of patients is neither justified nor inadequate. In support of this contention, CORAR cited several factors, including regulation by other bodies such as the Food and Drug Administration and State Boards of Medicine, the ~sponsibility of physicians to adh'ere to standards and codes of medical practice, and the exemplary performance record of nuclear medicine. CORAR concludes that the current medical policy statement provides argument against perceived prescriptive regulation. One member of the public questioned what constitutes "other areas traditionally considered to be part of the practice of medicine," within the meaning of the policy statement. This commenter agreed that although the ACMUI should be the primary source of "risk judgments," it can't be the only source of such Judgments, and consideration should be given to 12

other groups and individuals. Another member of the public commented that the policy statement should not limit NRC's role to protection of workers and the general public. This commenter stated that the policy statement assumes there is some entity to ensure that clinical nuclear medicine physicians are qualified to protect those groups. According to the commenter, it is of considerable concern that the policy statement does not account for the fact that many private practice offices and outpatient centers are not components of hospitals. Although the Commission has considered all of the comments provided, it is specifically responding to comments that raised major issues associated with revision of the Medical Use Policy Statement. At the outset, the Commission notes that its nationwide "performance goalsD for measuring results toward meeti.ng NRC's nuclear materials safety goal include "[z]ero radiation-related deaths due to civilian use of source, byproduct, and special nuclear materials" and for "no increase in the number of misadministration events which cause significant radiation exposures" (NUREG-1614, Vol. 1, at 9-10). 2 In response to comments, the Commission is proposing revisions of its policy statement (see Section IV., below) that make clear its intent to avoid intrusion into medical judgments affecting patients, rather than the current policy of minimizing such intrusions. The Commission rejects regulation of the medical use of byproduct material on the basis of "comparable risk," as the ACMUI and ABS have proposed. The Commission doubts that such an approach would meet the statutory standard in Section 161b. of the Atomic Energy Act of 1954, as amended (AEA), to regulate all uses of byproduct material "to protect health and minimize danger to life." The Commission (as well as others, such as NAS and the ACMUI) has recognized the lack of acceptable data to compare the risks from 2 The Commission is proposing to amend its regulations to substitute the term "medical event" for "misadministration." However, in historical discussions, the term "misadministration" is still used. 13

t,. medical use of byproduct material with risks in other medical modalities. In the absence of acceptable data, regulation on the basi~ of "comparable risk* would be regulation to an inadequately understood level of risk. In addition, there is not an expressed authorization in the AEA to regulate any use of byproduct material on the basis of an insufficiently known "comparable risk." Without acceptable data or an express statutory authorization, justifying the significant departure from the Commission's established policy with respect to risk to patients would be, at a minimum, problematic.

11. Rationale NRC's principal statutory authority for regulating medical use of byproduct material rests on sections 81,161,182, and 183 of theAEA. ~ 42 U.S.C. §§ 2111, 2201, 2232, and 2233. Section 81 of the Act prohibits, without NRC authorization, the manufacture, production, transfer, receipt in interstate commerce, acquisition, ownership, possession, import, and export of byproduct material (42 U.S.C. § 2111).

Section 81 of the AEA directs that: The Commission shall not permit the distribution of any byproduct material to any licensee, and shall recall or order the recall of any distributed material from any licensee, who is not equipped to observe or who fails to observe such safety standards to protect health as may be established by the Commission or who uses such material in violation of law or regulation of the Commissio~ or in a manner other than as disclosed in the application therefor or approved by the Commission. 14

t) Id. (emphasis added). By virtue of section 161 of the Act, the Commission is authorized to undertake a variety of measures "[in] the performance of its functions" (42 U.S.C. § 2201 ). As stated in subsection b, the Commission may "establish by rule, regulation, or order, such standards and instructions to govern the possession and use of special nuclear material, source material, and byproduct material as the Commission may deem necessary or desirable ... to protect health' or to minimize danger to life or property" [42 u.s.c. § 2201 (b) (emphasis added)]. Similarly, section 161i. authorizes the Commission to "prescribe such regulations or orders as it may deem necessary" to "(3) govern any activity authorized pursuant to this Act, including standards and restrictions governing the design, location, and operation of facilities used in the conduct of such activities, in order to protect health and minimize danger to life or property" [42 U.S.C.

  § 2201 (I) (emphasis added)].

The Commission is bound by statute to regulate byproduct material (as well as source and special nuclear material) to "protect health and minimize danger to life." This statutory standard applies to the myriad of uses of byproduct material, including, not only medical use, but also, for example, radiography and irradiators. However, the Commission is not bound by the limitation in section 104a, of the AEA, which is often mistakenly cited for the proposition that, in regulating medical use of byproduct material, the AEA requires that the Commission "impose the minimum amount of regulation consistent with its obligations under this Act to promote the common defense and security and to protect health and safety of the public" [(42 U.S.C § 2134(a)]. This "minimum regulation" limitation does not apply to the medical use of byproduct material which falls within NRC's broad standard-setting authority in sections 81 and 161. Section 104a, on its face, applies only to medical therapy licenses for uutilization facilities" 15

l (e.g., reacto~) and "special nuclear material." This "minimum regulation" directive does not govern the Commission's regulation of the medical use of byproduct material. For the most part, the regulations to carry out the broad statutory scheme for byproduct materials are set forth in 10 CFR Parts 30 through 36. In addition, the public and occupational dose limits in 10 CFR Part 20, "Standards for Protection Against Radiation," apply whether the use of byproduct material is for medical or other purposes. However, the scope of Part 20 in § 20.1002 states that, "[t]he limits in this part do not apply to doses due . . . to any medical administration the individual has received or due to voluntary participation in medical research programs." The Commission has clarified that ~the medical administration of radiation or radioactive materials to any individual, even an individual not supposed to receive a medical administration, is regulated by the NRC's provisions governing the medical use of byproduct material rather than by the dose limits m the NRC's regulations concerning standards for protection against radiation" ("Medical Administration of Radiation and Radioactive Materials,* 60 FR 48623; September 20, 1995}. Thus, the Commission believes that "an administration to any individual is and should be subject to the regulations in Part 35" (60 FR 48623). The provisions of Part 30, "Rules of General Applicability to Domestic Licensing of Byproduct Material" "are in addition to ... other requirements in this chapter" (Section 30.2). This section requires that "any conflict between the general requirements in Part 30 and the specific requirements in another part" are governed by those specific requirements (Section 30.2). The regulations in Part 35 that are designed "to provide for the protection of the public health and safety" reflect the broad statutory standard in the AEA, discussed above (Section 35.1 ). The Commission has determined that, as a matter of policy, "the patient ... as 16

) well as the general public ... are all members of the public to be protected by NRC" (44 FR 8242, at 8244). (See discussion following.) The NRC and the Food and Drug Administration (FDA) have regulatory responsibilities concerning medical devices, drugs, and biological products utilizing byproduct, source, and special nuclear material. NRC has responsibility, as described above, for regulating the actual medical use of byproduct material from the standpoint of reducing unnecessary radiation exposures to the public, patients, and occupational workers. In general, the FDA is responsible for assuring the safety, effectiveness, and proper labeling of medical products, i.e., drugs, d~vices, and biologics. NRC routinely relies on prior FDA approval of medical devices as an essential component of NRC's sealed source and device safety evaluations. In a uMemorandum of Understanding" (MOU), effective August 26, 1993, NRC and FDA coordinated existing NRC and FDA regulatory programs for these devices, drugs, and products (58 FR 47300; September 8, 1993). These regulatory programs include activities for evaluating and authorizing the manufacture, sale, distribution, licensing, and labeled intended use of these products. The specific "elements of coordination" cover notification of product complaints, medical events, and emergency situations; coordination of investigations; investigation infonnation exchange; NRC and Agreement State notifications; product pre-marketing and pre-licensing infonnation exchange, and sharing of other infonnation such as special notifications to manufacturers, operators, licensees, or patients (58 FR at 47302). Ill. The Proposed Commission Policy Based on the comments and advice of all the participants in the process described previously, as well as members of the public on the "Internet" (via the NRC 's Technical 17

Conference Forum), the Commission is proposing the following as a revised Medical Use Policy Statement to guide its future regulation of the medical use of byproduct material:

1. NRC will continue to regulate the uses of radionuclides in medicine as necessary to provide for the radiation safety of workers and the general public.

2. NRC will not intrude into medical judgments affecting patients, except as necessary to provide for the radiation safety of workers and the general public.

3. NRC will, when justified by the risk to patients, regulate the radiation safety of patients primarily to assure the use of radionuclides is in accordance with the phys,cian's directions.

4. NRC, in developing a specific regulatory approach, will consider industry and professional standards that define acceptable approaches of achieving radiation safety.

Statement 1 The first portion of the proposed policy statement restates the first part of the current policy statement with the substitution of the phrase "uses of radionuclides in medicine" for the phrase "medical uses of radioisotopes." As rephrased, this is a more accurate technical statement of the scope of NRC regulation in this area. Statement 1 conveys the traditional regulatory function of NRC for all uses of byproduct, source, and special nuclear material. Protection of the radiation safety of members of the public and workers is central to fulfillment of the Commission's statutory mandate to "protect health and minimize danger to life." This protection is provided for, in part, in the public and occupational dose limits in 10 CFR Part 20 cited previously. Those limits apply whether the use of byproduct material is for medical use or other purposes. The Commission has determined to retain its long-standing regulatory 18

0 framework as necessary in the medical uses of byproduct material. As stated in the Federal Register notice initiating the Commission's request for public comment, the Commission "was not persuaded by the National Academy of Sciences (NAS), Institute of Medicine (IOM) report that recommends that the NRC should not be the Federal agency involved in the regulation of ionizing radiation in medicine" [62 FR at 42219 (quoting SRM of March 20, 1997)]. Statement 2 The second portion of the proposed policy statement is based on the third part of the current statement. The I nodifications explicitly state the Commission's proposed policy not to intrude into medical judgments affecting patients except to provide for the radiation safety of workers and the general public. Given the significance of this change, the Commission is soliciting specific public comment on whether the wording in the current statement should be revised to read "not intrude into medical judgments,* rather than "to minimize intrusion into 0 medical judgments. These comments will be especially useful in evaluating the consistency between the proposed MPS and the Commission's preliminary intent to continue to require patient notification following medical events (the proposed revision to 10 CFR Part 35 would replace the term "misadministration" with "medical event"). Specifically, some would argue that continued regulatory requirements for patient notification would be inconsistent with the proposed revision to Statement 2 of the MPS. Others would argue that notification requirements would be consistent with Statement 3 of the proposed policy statement since a medical event represents a situation where the physician's directions for the administration of byproduct material were not followed and, thus, patient notification should be made. As set forth above, providing for the radiation safety of the public and workers is essential for the Commission to carry out its statutory mandate. When this protection 19

necessitates a degree of regulation of medical judgments affecting patients, the Commission may find it necessary to intrude, to a certain extent, into medical judgments to protect the public and workers. For example, release of patients administered radioactive materials has long been considered a matter of regulatory concern to protect members of the public, not just a matter of medical judgment ("Criteria for the Release of Individuals Administered Radioactive Material,* 62 FR 4120; January 29, 1997). Thus, from a strictly medical P9int of view, it may be appropriate for a physician to release a patient administered radioactive materials from the hospital. However, patient release criteria in NRC regulations (10 CFR 35.75) may require confinement of that patient if release of that patient could result in a dose to other individuals that exceeds the dose-based limit stated in 10 CFR 35.75(a). In the current policy statement, the Commission stated its intent to "minimize intrusions into medical judgments affecting patients and into other areas traditionally considered to be part of the practice of medicine." The modifications in this part of the proposed policy statement more strongly reflect the Commission's long-standing recognition that physicians have the primary responsibility for the diagnosis and treatment of their patients. NRC regulations are predicated on the assumption that properly trained and adequately informed physicians will make decisions that are in the best interests of their patients. Therefore, in recent years, the Commission has moved away from a more rigid scheme of medical use regulation, which at one time, for example, restricted the uses of therapeutic and certain diagnostic radioactive drugs to the indicated procedures that had been approved by the FDA (44 FR 8242, at 8243). NRC regulations no longer prohibit authorized user physicians from using diagnostic or therapeutic radioactive drugs containing byproduct material for indications or methods of administration not listed in the FDA-approved package insert. Further, NRC regulations now permit medical use licensees and commercial nuclear pharmacies to depart from the 20

manufacturer's instructions for preparing radioactive drugs using radionuclide generators and reagent kits. In addition, the recent amendment of 10 CFR 35.75, cited above, substituting a dose-based limit for patient release (rather than an activity-based limit), may provide medical use licensees greater flexibility in determining when such patients may be released from their control. The Commission's proposed policy to avoid (rather than minimize) intrusion into medical judgments affecting patients is consistent wtt:h recent Federal legislation (specifically applicable to FDA), which is to be construed so as not to "limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship." (There are certain exceptions to this mandate, which do not change any existing prohibition on the promotion of unapproved uses of legally marketed devices.) "Food and Drug Administration Modernization Act of 1997," Pub. L. No. 105-115, § 906, 111 Stat. 2296 (1997). Statement 3 Neither the AEA sections cited above nor the regulations in 10 CFR Part 35 use the term "risk." The Commission's current policy statem~nt on medical use, quoted above, makes specific reference to "risk* to patients. As there stated and reaffirmed here, the Commission specifically rejects the notion that it should not regulate patient radiation safety* (44 FR at 8243). The Commission will continue to regulate radiation safety of patients where justified by the risk to patients. However, proposed Statement 3 makes clear that the focus of NRC regulation to protect the patient's health and safety is primarily to ensure that the authorized user physician's directions are followed. Th~ NRC goal in this aspect of medical use regulation is tied to the physician's directions as they pertain to the application of the radiation or radionuclide, rather 21

than to other, non-radiation related aspects of the administration. Consistent with the Commission's statutory authority, if a situation should arise in the future which identifies an additional risk to the patient's health and safety, the Commission will consider adopting an additional limitation or control on a particular radiation or radionuclide modality as necessary. "Prescription" is not being used for this purpose because it might typically include aspects of the administration that are outside NRC's purview. Either the "written directive" or "clinical procedures manual" (as those terms are defined in Part 35) would contain the physician's _directions (i.e., the procedure to be performed and the dose) . This regulatory objective is currently reflected in certain provisions of Part 35 (e.g., 10 CFR 35.32(a) (requiring "high confidence" that byproduct material or radiation therefrom will be administered as directed by an authorized user physician) and as part of the rationale of the current policy statement. In the proposed revision of 10 CFR Part 35 and as explicitly stated above, NRC is emphasizing that protection of patient radiation safety is an overall NRC goal in regulating the medical use of byproduct material. Although the Commission recognizes that physicians have primary responsibility for the protection of their patients, NRC has a secondary, but necessary, role with respect to the radiation safety of patients. The Commission is attempting to make its medical use regulatory framework more "risk-informed," based on its regulatory strategy of regulating "material uses consistent with the level of risk involved, by decreasing oversight of those materials that pose the lowest radiological risk to the public and continuing emphasis on high-risk activities" (NUREG-1614, Vol. 1, at 11 ). In addition, this portion of the proposed policy statement reflects the Commission strategy of identifying those regulations and processes that are now or can be made risk-informed (NUREG-1614, Vol. 1, at 11. SRM of March 20, 1997, at 2). 22

• Statement 4 .

According to Statement 2 of the current policy statement, NRC will regulate the radiation safety of patients where justified by the risk to patients and where voluntary standards, or compliance with these standards, are inadequate In its SRM of March 20, 1997, the Commission repeated its continued support of professional medical organizations and societies (as well as the ACMUl)*in developing regulatory guides and standards (SRM, at 1). Proposed Statement 4 commits NRC to an approach for regulation of medical use which "will consider industry .and. professional standards that define acceptable levels of achieving radiation safety." Such consideration, however, does not involve, as a prerequisite for regulation, the problematic determination of licensee compliance with a voluntary standard (as implied in current Statement 2). At a minimum, such an undertaking leaves NRC with the dilemma of how to deal with licensees that may not comply with voluntary standards. For this reason, the Commission's proposed policy statement does not retain that aspect of the current policy* statement. The Statement of Consideration for the proposed 10 CFR Part 35 rulemakings specifically addresses NRC's current policy of consideration of "voluntary standards and compliance with such standards." Affirming consideration of industry and professional standards as part of the NRC policy in achieving radiation safety in medical use conforms to the Commission's Strategic Plan. The relevant strategy there stated is to increase the involvement of licensees and others in the NRC regulatory development process, based on the concepts in the "National Technology Transfer and Advancement Act of 1995" (the NTTAA), Pub. L. No. 104-113, 110 Stat. 775 (1995). Section 12(d) of the NTTAA requires "all Federal agencies and departments to use technical standards that are developed or adopted by voluntary consensus 23

bodies . . . as a means to carry out policy objectives or activities," except when use of such standards Wis inconsistent with applicable law or otherwise impractical." It is not clear that all "medical industry and professional standards" would meet the definition of "technical standards" in Section 12(d)(4) of the NTTAA ( "perfonnance-based or design-specific technical specifications and related management systems practices)." Nevertheless, as indicated above, the Commission endorses, in regulating medical use of byproduct material, the concept in Section 12(a) of the NTTAA, of "emphasizing, where possible, the use of standards developed by private, consensus organizations.* As also stated in the Strategic Plan, the Commission encourages "industry to develop codes, standards, and guides that can be endorsed by the NRC and carried out by industry." IV. Policy Implications This proposed policy statement affinns the Commission detennination that it shall continue its role in regulating the medical use of byproduct material, but with emphasis on the goal of protecting the radiation safety of occupational workers, the public, and patients, while avoiding intrusion into medical judgments affecting patients. Ensuring that the authorized user physician's directions for the administration of byproduct material are followed is the primary means of achieving this regulatory goal. Moreover, the Commission is renewing the objective of utilizing industry and professional standards that define acceptable levels of achieving radiation safety. 24

REFERENCE INFORMATION:

1. Strategic Assessment Direction-Setting Issues Paper Number 7 is available by writing to the U.S. Nuclear Regulatory Commission, Attention: NRC Public Document Room, Washington, DC 20555-0001. telephone: (202) 634-3273; fax: (202) 634-3343.

2. The memorandum "Management Review of Existing Medical Use Regulatory Program (COMIS-92-026)" (dated June 16, 1993} is available by writing to the U.S. Nuclear Regulatory Commission, Attention: NRG Public Document Room, Washington, DC 20555-0001, telephone: (202) 634-3273; fax: (202) 634-3343.

3. "Radiation in Medicine: A Need for Regulatory Reform" (1996} is available from the National Academy Press at 2101 Constitution Avenue, NW, Box 285, Washington, DC 20555.

4. Summary minutes and transcripts of the ACMUI March 1998 meeting or transcripts of the May 8, 1997, Commission briefing are available by writing to the U.S. Nuclear Regulatory Commission. Attention: NRG Public Document Room, Washington, DC 20555-0001, telephone: (202) 634-3273; fax: (202) 634-3343. Transcripts of the May 8, 1997, briefing are also available by Internet at http://www.nrc.gov.

5. The NRC Medical Policy Act Statement of 1979 was published in the Federal Register, Volume 44, page 8242, on February 9, 1979.

6. SECY-97-115, Program for Revision of 10 CFR Part 35, "Medical Uses of Byproduct Material" and Associated i=ederal Register notice; SECY-97-131, Supplemental Information on SECY-97-131, Supplemental Information on SECY-97-115, "Program for Revision of 10 CFR Part 35, 'Medical Uses of Byproduct Material,' and Associated Federal Register notice; and the associated SRM (dated June 30, 1997) are available by writing to the U.S. Nuclear Regulatory Commission, Attention: NRC Public Document Room, Washington, DC 20555-0001, 25

telephone: (202) 634-3273; fax: (202) 634-3343.) Copies are also available on the NRC Technical Conference Forum at http://techconf.llnl.gov/noframe.html. Dated at Rockville, Maryland, this s-if day of August, 1998. For the Nuclear Regulatory Commission. C. Hoyle, ecretary of the Commission. 26

DOCKETED US HC[7590-01 -P] NUCLEAR REGULATORY COMMISSION . AUG -? p 3 :22 98 0 ~ 1,- J 10 CFR Parts 20, 32 and 35 RU' AD,.IU1 RIN 3150-AF74 Medical Use of Byproduct Material; Proposed Revision AGENCY: Nuclear Regulatory Commission. ACTION : Proposed rule.

SUMMARY

The Nuclear Regulatory Commission (NRC) is proposing a revision of its regulations governing the medical use of byproduct material. The proposed rule is one component of the Commission's overall program for revising its regulatory framework for medical use. The overall goals of this program are to focus NRC's regulations on those medical procedures that pose the highest risk to workers, patients, and the public, and to structure its regulations to be risk-informed and more performance-based, consistent with the NRC's "Strategic Plan for Fiscal Year 1997- Fiscal Year 2002." A notice in this issue of the Federal Register announcing the Commission's proposed revision of its 1979 "Medical Use Policy Statement" for public comment is published elsewhere.

                                           ~ /~ 199?

DATES: The comment period expires ~nsert date 90 days after i,uc11eation]. Comments received after this date will be considered if it is practical to do so, but the Commission is only able to ensure consideration of comments received on or before this date.

ADDRESSES : Comments may be sent to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 , Attention: Rulemakings and Adjudications Staff. Deliver comments to: One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 am and 4:15 pm on Federal workdays. Copies of comments received may be examined at: NRC Public Document Room, 2120 L Street, NW. (Lower Level), Washington, DC. You may also provide comments via the NRC's interactive rulemaking web site through the NRC home page (http://www.nrc.gov). From the home page, select "Rulemaking" from the tool bar. The interactive rulemaking website can then be accessed by selecting "New Rulemaking Website." This site provides the ability to upload comments as files (any format), if your web browser supports that function. For information about the interactive rulemaking web site, contact Ms. Carol Gallagher, (301) 415-5905; e-mail CAG@nrc.gov. FOR FURTHER INFORMATION CONTACT: Catherine Haney, Office of Nuclear Material Safety and Safeguards, Nuclear Regulatory Commission, Washington, DC 20555-0001 , (301) 415-6825, e-mail CXH@nrc.gov or Diane Flack, Office of Nuclear Material Safety and Safeguards, Nuclear Regulatory Commission, Washington, DC 02555-0001 , (301) 415-5681 , e-mail DSFl@nrc.gov. 2

SUPPLEMENTARY INFORMATION: I. Background. II. Petition for Rulemaking. Ill. Discussion and Input to Proposed Rule. IV. Discussion of Text of Proposed Rule. V. Coordination with the Advisory Committee on Medical Uses of Isotopes. VI. Coordination Wrth NRG Agreement States. V! 1* Consistency with Medical Policy Statemerrt. VIII. Implementation. IX. Issues of Compatibility for Agreement States. X. Finding of No Significant Environmental Impact: Availability. XI. Paperwork Reduction Act Statement. XII. Regulatory Analysis. XIII. Regulatory Flexibility Analysis. XIV. Backfit Analysis. I. Background Use of Byproduct Material in Medicine Since 1946, growth in the medical applications of radioisotopes has been very rapid as their usefulness has become more apparerrt in diagnosis, therapy, and medical research. Current medical procedures employ a number of radionuclides in a wide variety of chemical and 3

physical forms. Nuclear medicine procedures for diagnostic and therapeutic applications involve the internal administration of radiolabeled tracers. Administration of the radiolabeled tracers, known as radiopharmaceuticals, may be performed by intravenous injection, inhalation, or oral ingestion. Diagnostic nuclear medicine in most cases involves imaging agents used for the delineation and localization of organ -tissues by scintigraphy (e.g., technetium-99m hydroxymethylene diphosphonate used as a bone seeking radiopharmaceutical). Organ function may be determined by quantifying the accumulation of radiopharmaceuticals in organs of in~erest (e.g., iodine-131 uptake studies used to assess thyroid function). The~peutic nuclear medicine may use various radiopharmaceuticals for the treatment of disease by selective absorption or concentration (e.g., iodine-131 used to treat thyroid cancer). Other therapeutic applications may involve the use of radiopharmaceuticals in colloidal suspensions for the treatment of malignant tumors (e.g., phosphate-32 infusion for treatment of peritoneal or pleural effusions associated with malignant tumors). Since the early 1900s, radiation therapy has become one of the major modalities of treatment in the management of neoplastic disease, generally referred to as cancer. Radiation therapy may also be used as a palliative agent in the medical treatment process. The objective of conventional radiation therapy using a teletherapy sealed source is to deliver a p~sely measured dose of radiation to a defined tumor volume. This is usually accomplished by delivering a dose in daily increments over several weeks. External beam radiation therapy has evolved using innovative technology that has led to the development of the gamma stereotactic radiosurgery device used for treatment of precisely defined intracranial targets (e.g., brain tumors and arteriovenous malformations). 4

Brachytherapy uses a variety of smaller sealed sources for localized treatment of cancer. Typically the sealed sources are either inserted in a cavity (e.g., cesium-137 sources used for intracavitary treatment of cervical cancer) or implanted in tissue (e.g., iodine-125 seeds used for interstitial treatment of prostate cancer). Various remote afterloading devices have been developed for low, medium, and high dose-rate brachytherapy treatments. State and Federal Regulations Byproduct material or radiation from byproduct material is regulated by either State or Federal Laws. The NRC regulates the administration of byproduct material or radiation from byproduct material in 20 States, the District of Columbia, the Commonwealth of Puerto Rico, and various territories of the United States. There are approximately 1900 NRC licenses authorizing the medical use of byproduct material under 10 CFR Part 35, "Medical Uses of Byproduct Material." Thirty States, known as Agreement States, have entered into an agreement with the NRC to regulate the use of byproduct material (as authorized by section 274 of the Atomic Energy Act). These States issue licenses and currently regulate about 5000 institutions, e.g., hospitals, clinics, or physiqans in private practice. The use of byproduct material represents only ~ small fraction of all medical uses nationwide of radionuclides or sources of radiation, e.g. x-ray. Revision of NRC's Regulatory Program NRC's medical use program includes use of byproduct material in medical diagnosis, therapy, and research. NRC's requirements for medical licensees are described in 5

10 CFR Part 35. Approximately eleven million patients annually undergo medical procedures involving byproduct materials. The Commission examined the issues surrounding its medical use program in detail during a 1993 internal senior management review, a 1996 independent external review by the National Academy of Sciences, Institute of Medicine, and the Commission's Strategic Assessment and Rebaselining Initiative (SA). In particular, medical oversight was addressed in the SA Direction-Setting Issue Paper Number 7 (OSI 7) (released September 16, 1996). In September 1997, the Commission issued its "Strategic Plan" (NUREG-1614, Vol 1) which stated that its goal in regulating nuclear materials safety is to "prevent radiation-related deaths or illnesses due to civilian use of source, byproduct, and special nuclear materials." In its Staff Requirements Memorandum (SRM) - COMSECY-96-057, "Materials/Medical Oversight (OSI 7)," dated March 20, 1997, the Commission stated that it supported continuation of the ongoing medical use regulatory program with improvements, decreased oversight of low-risk activities, and continued emphasis on high-risk activities. This SRM also directed the NRC staff to revise Part 35, associated guidance documents, and, if necessary, the Commission's 1979 Medical Use Policy Statement (44 FR 8242; February 9, 1979). The Commission's SRM specifically directed the restructuring of Part 35 into a risk-informed, more performance-based regulation. In addition, the Commission expressed its support for the use of the Advisory Committee on the Medical Use of Isotopes (ACMUI) and professional medical organizations and societies in the revision of Part 35 and the medical policy statement. The Commission specifically directed the NRC staff to "consider a rulemaking process that provides more opportunity for input from potentially affected parties than is provided by the normal notice and 6

comment rulemaking process but would be less consumptive of resources and time than the process recently used in the development of NRC's rule on radiological criteria for license termination." During development of the rule and associated guidance, as well as during the review of the Medical Use Policy Statement, the Commission considered the following issues: (1) Focusing Part 35 on those procedures that pose the highest risk; (2) Regulatory oversight alternatives, for diagnostic procedures, that are consistent with the lower overall risk of these procedures; {3) The best way to capture not only relevant safety-significant events, but also precursor events; {4) Changing the nomendature from "misadministration" to "medical event" or comparable terminology; {5) Redesigning Part' 35 so that regulatory requirements for new treatment modalities can be incorporated in a timely manner; (6) Revising the requirement for a quality management program (10 CFR 35.32) to focus on those requirements that are essential for patient safety; and (7) The viability of using or referencing available industry guidance and standards, within Part 35 and related guidance, to the extent that they meet NRC's needs. The proposed rule that would revise Part 35 has been developed in response to these issues and concerns. 7

The Commission, in its SRM of June 30, 1997, "SECY-97-115 - "Program for Revision of 10 CFR Part 35, 'Medical Uses of Byproduct Material' and Associated Federal Register notice," approved the NRC staffs proposed plan for the revision of Part 35. The Federal Register notice, "Medical Use of Byproduct Material: Issues and Request for Public Input" (62 FR 422:19-42220; August 6, 1997), solicited early public input on the proposed rulemaking. The NRC staff implemented the approved* plan using an approach involving public Working and Steering Group meetings, with significant opportunities for input from the public, potentially affected parties, the ACMUI, and professional medical organizations. Publicly noticed Working and Steering Group meetings were held in August, September, and December 1997, and in January, February, March, and April 1998. During the Working and Steering Group meetings, the groups identified significant crosscutting issues associated with the rulemak.ing. These issues included patient notification, precursor events, Radiation Safety Committee, quality management program, and training and experience for authorized users. Rulemaking alternatives were developed for these crosscutting issues and were made available on the Internet and in the NRC's Public Document Room for comment. These alternatives were discussed with (1) the ACMUI at its September 1997 meeting, (2) the public at facilitated public work.shops held in Philadelphia, PA, in October and in Chicago, IL, in November 1997 (discussed below), (3) State regulators at a publicly noticed work.shop that was conducted during the October 1997 All Agreement States Meeting, and (4) meetings of medical professional societies. 8

In addition to the proposed revision of Part 35, the Commission is publishing for public comment, in a separate Federal Register notice, a proposed revision of its 1979 policy statement on the Medical Use of Byproduct Material *(44 FR 8242; February 9, 1979). The proposed revision of the medical policy statement is another component of the Commission's overall program for revising its regulatory framework for medical use, including its regulations in Part 35. The proposed revision of Part 35 is consistent with the proposed revision of the Medical Use Policy Statement (MPS) and is generally consistent with the current MPS (see Section VII of the Supplementary Information section of this document). Workshops The Commission believes that it is important for interests affected by the medical use rulemaking to not only have an early opportunity to comment on the rulemaking issues, but also to have an opportunity to discuss the rulemaking with one another and the agency. Accordingly, the Commission convened two public workshops in which the interests that maybe affected by the rulemaking had the opportunity to discuss the rulemaking issues. Although the workshops were intended to foster a clearer understanding of the positions and concerns of the affected interests, as well as to identify areas of agreement or disagreement, it was not the intent of the workshop process to develop a consensus agreement of the participants on rulemaking issues. In order to have a manageable discussion, the number of invited participants in the roundtable discussions at each workshop was limited. The Commission, through a facilitator for each workshop, attempted to insure participation by a broad spectrum of interests that may be 9

affected by the rulemaking. These interests included nuclear medicine physicians, physician specialists such as cardiologists and radiologists, medical physicists, medical technologists, radiation safety officers, nurses, medical education and certification organizations, radiopharmaceutical interests, hospital administrators, patients rights advocates, Agreement States, Federal agencies, and experts on risk analysis. Other members of the public were invited to attend and had the opportunity to comment on the rulemaking issues and the workshop discussions at periodic intervals during the workshops. The workshops had a comm".'"'. predefined agenda focused primarily on alternatives for major ("crosscuttingj issues, some with draft regulatory text. The workshop format was sufficiently flexible to allow for the introduction of additional related issues that participants wanted to raise. The workshop commentary was transcribed and summarized in "Summary of Discussion: Facilitated Public Workshop on Revisions to 10 CFR Part 35 Held in Philadelphia, Pennsylvania, on October 28-30, 1997D (April 17, 1998) and "Summary of Discussion: Facilitated Public Workshop on Revisions to 10 CFR Part 35 Held in Chicago, Illinois, on November 12-14, 1997" (April 17, 1998). The summary documents are available for inspection at the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. Single copies of the summary documents are available as indicated in the For Further ~nformation Contact section of this document A brief summary of the participant's positions on the major crosscutting issues associated with this rulemaking is provided in Section Ill of the Supplementary Information section of this document. 10

The Commission plans to hold three public workshops during the formal comment period to facilitate public comments on the proposed rulemaking. A notice for these workshops was published in the Federal Register on July 24, 1998 (63 FR 39763). II. Petition for Rulemaking The Commission has incorporated into this rulemaking the resolution of a Petition for Rulemaking (PRM) filed by the University of Cincinnati dated April 7, 1996 (PRM 20-24 ), c~cause of its pertinence to Part 35. On June 21, 1996 (61 FR 31874), the NRG published a notice of receipt and a request for comment on this petition for rulemaking. The petitioner requested that the NRG amend 10 CFR 20.1301, "Dose limits for individual members of the public* to: (1) Provide medical licensees the discretion to permit those visitors determined by the physician to be necessary for the emotional or physical support of the patient to receive up to 5 mSv ( 0.5 rem) (e.g., parents of very young radiation therapy patients, close family members of elderly patients, or other persons who could provide emotional support to the patient); (2) Exclude pregnant women and individuals younger than 18 years of age from receiving a dose in excess of 1 mSv (0.1 rem); and (3) Document compliance by issuing radiation dose monitoring devices (i.e., pocket dosimeter, film badge, TLD, or electronic dosimeter) to each specified visitor. In response to the request for public comments, the Commission received comments from four members of the general public. All commenters agreed with the petition. One of the 11

commenters suggested that the previous 5 mSv ( 0.5 rem) dose limit for the general public be reinstated for a "specific" public and, under unusual circumstances, also permit the authorized user to authorize even higher exposure provided the latter does not "receive more radiation than a radiation worker." Another commenter suggested permitting the authorized user to authorize even higher exposure provided it did not exceed the occupational dose limit of 50 mSv (5 rem). Although a 50 mSv (5 rem) dose limit for adult visitors exposed to radionuclide therapy patients is consistent with the recommendations of the National Council on Radiation Protection and Measurements (NCRP Commentary No. 11, Dose Limits for Individuals Who Receive Exposure From Radionuclide Therapy Patients, February 28, 1995), this suggestion is not consistent with release of patients in accordance with § ;35. 75, or with the approach to protection of the public in 10 CFR Part 20. For this reason, the NRC decided not to adopt the suggested 50 mSv (5 rem) dose limit. The NRC reviewed the petitioner's request and comments received on the petition and believes there is merit in granting the petition in part as discussed in detail later. This proposed rule responds to the petition by amending 10 CFR Part 20 to allow the licensee the :liscretion to permit visitors to receive up to 5 mSv (0.5 rem) in a year from exposure to hospitalized radiation patients. 12

Ill. Discussion and Input to Proposed Rule The program for revising Part 35 and the associated guidance documents has provided more opportunity for input from potentially affected parties (the medical community and the public) than is provided by the typical notice and comment rulemaking process. Early public input was solicited through several different mechanisms: requesting public input through Federal Register notices; holding open meetings of the government groups developing the revised rule language; meeting with medical professional societies and boards; putting background documents, options for the more significant regulatory issues associated with the rulemaking, and alternatives for revising the 1979 Medical Use Policy Statement on the Internet; and convening public workshops. The NRC received approximately 330 letters providing input to the rulemaking process. The input received from the public during the development of the proposed rulemaking is categorized and summarized below, according to the significant regulatory issues that were identified very early in the rulemaking process. A. Training and Experience.

1. Facilitated Wo:-::shops.

The issue of training and experience for authorized users generated the most discussion among workshop participants. Discussion of this topic was organized into segments that addressed "key current problems or advantages identified by participants"; certain "crosscutting" training and experience issues (including such questions as the role a professional degree, medical specialty certification, or testing should play in qualifying an 13

authorized user); and various specific alternatives (developed by the Part 35 Working Group) for training and experience necessary to qualify a physician as an authorized user. Based on specific questions posed to participants, certain issues emerged as important in detennining the necessary training and experience for qualifying as an authorized user. For instance, some participants believed that the current requirements are unrealistically stringent. Other participants maintained that training and experience can be varied, based upon the degree of risk posed by a specific modality. (However, participants did not necessarily agree on how to rank various modalities based on risk.) One question raised was whettier the training and experience requirements should be different for physicians already in practice, than for those physicians who are just starting out. Certain participants viewed Commission specification of clinical training and experience requirements as a serious intrusion into the practice of medicine and; therefore, suggested that the tenn "clinical training and experience" should be replaced with the tenn "practical training and experience." The latter would cover safe handling of radioactive materials (i.e., such topics as: safe delivery of radionuclides to patients; time, distance, and shielding; use of a dose calibrator; assessing contamination; decontaminating areas; half-lives of radionuclides; and consequences of contamination). However, some therapy ;,ractitioners supported the requirement for clinical experience as pa1 of training and experience. Another suggested approach to establishing training and experience requirements would be to have different requirements for physicians who use radionuclides for very limited purposes (i.e., cardiology and endocrinology), as opposed to physicians engaged in the general medical use of byproduct material. 14

The range of options for a physician to become an authorized user that was discussed at the workshops included - (1) Status quo (i.e., a physician who is certified in any one of a number of medical specialities, or has had a set number of hours of classroom and laboratory training and super.vised clinical experience, or has completed an approved training program that included classroom and labora~ory training, work experience, and supervised clinical experience); (2) Medical speciality certification, plus a specified number of hours of training and experience; 11 (3) Medical spP.cialty certification plus a specified number of hours of training and passing an examination; (4) Possessing an M.D. degree; (5) Passing an examination focused on radiation safety; and (6) Passing an examination focused on radiation safety and having specified clinical experience. The options were primarily analyzed in terms of therapeutic versus diagnostic uses of byproduct material. Many participants involved in therapeutic medical uses supported the status quo requirements for such uses (generally requiring either medical speciality board certification or a specified number of hours of classroom and laboratory training) because such requirements have served patients and the public well. They maintained that board certification ensures the appropriate level of training and experience and were cautiou~ about any change that could diminish assurance of competency. However, some proponents of the status quo would accept the use of medical specialty boards other than those currently listed in Part 35. Some participants also felt that clinical experience in handling radionuclides and patient cases, 15

especially across a broad range of developing therapy, is crucial. Representatives of diagnostic uses of byproduct materials asserted that the status quo effectively prohibits some medical practitioners from using byproduct materials which they could safely use if the training I requirements were decreased. They believe that an examination component of the training and experience requirements is extremely important in setting a standard for authorized users. Some diagnostic users recommended that about 150 hours of didactic training and associated clinical experience would be sufficient The discussion of training and experience requirements addressed the viewpoint that all professionals involved in handling radionuclides, including medical physicists, authorized nuclear pharm_acists, nurses, technologists, dosimetrists, and physician's assistants, should be subject to the training and experience requirements. Some participants supported degree requirements, such as a master's degree in health physics. Opposition to such a requirement was based on the concept that performance criteria, rather than a degree, should be the basis for determining competence for certain positions, such as the Radiation Safety Officer or nuclear technologist. Another viewpoint expressed was that the nuclear medicine technologist, rather than the authorized user physician, should be the focus of training and experience requi~ments, because the techno!ogist actually handles the radioactive material. Participants believed that training and experience requirements are essential for ensuring the competency of a Radiation Safety Officer. They generally expressed support for the status quo for training and experience requirements for the Radiation Safety Officer, but questioned whether an authorized user should automatically qualify as a Radiation Safety Officer. Specifically, some participants believed that an authorized user should not also be the 16

Radiation Safety Officer because of "potential conflicts of interest" (i.e., the Radiation Safety Officer should not be influenced by the "administration" of a facility). Other participants noted that an authorized user physician might be a specialist whose practice includes a limited application of the medical use of byproduct material, and who does not have sufficient training in radiation safety to address problems that might occur. Certain participants believed that it may be appropriate for an authorized user to be a Radiation Safety Officer at a small hospital, even if that authorized user did not have the breadth of training to be a Radiation Safety Officer at a large hospital. A concern of some participants is that there may not be anyone other than the authorized user to assume the responsibility as a Radiation ~afety Officer at small community hospitals. In those cases, an authorized user, who is also the Radiation Safety Officer, was seen to be preferable to not having a Radiation Safety Officer. Workshop participants generally did not question the current training and experience requirements for the Radiation Safety Officer. Some suggested changes for the Radiation Safety Officer's training and experience were discussed, such as varying the training and experience to correspond to the type of license or duties performed by an individual Radiation Safety Officer, to have a "core competency set of requirements (which could be supplemented with additional requirements for modalities posing greater risks); or to substitute a Masters of Science degree for the 200-hour training requirement. Certain participants involved in "low-dose" medical uses concluded that Part 35 should include training and experience for medical physicists. They noted that training and experience requirements should correspond to the duties and responsibilities of the physicist for different 17

modalities (i.e., instrumentation for nuclear medicine, radiation treatment planning, or administration of doses for radiation therapy). Comments by participants on this issue were favorable regarding training and experience for the authorized nuclear pharmacists. Some participants specifically stated that, based on risk, radiopharmacy training and experience should be handled similarty to other diagnostic modalities. Training and experience req*_,;--ements for ancillary personnel, such as technologists, were briefly discussed. Some participants supported training and experience requirements for technologists because the technologists, rather than the physicians, handle the radioactive materials. One participant, a nuclear medicine technologist, indicated that there are already organizations that have established voluntary training and experience requirements for technologist certification. Th_e individual did not believe that these organizations would endorse other exams. The individual also indicated that, if proposed, training for technologists should be risk-based.

2. Agreement State Workshop.

Discussions at the Agreement State Workshop focused on whether NRC's training and experience requirements should focus exclusively on the radiation safety aspects of an authorized user's training, leaving issues such as patient selection and reading scans to be part of the "practice of medicine." Workshop participants were divided on this issue. Those answering this question affirmatively believed that NRC should focus on assuring that 18

physicians are capable of safely handling and using byproduct material. One participant indicated that the level of education to demonstrate competence should be uniform regardless of the hazard posed by the material. other participants believed that, from the patient's perspective, the physician's role goes beyond safety and *into areas such as patient selection and scan interpretation. One member of the public argued that NRC and Agreement States should require physicians to master quantitative radiation protection science before permitting them to become aL1:~orized users. The individual also believed that NRC and the Agreement States should rely solely on physician practice privilege committees, State Boards of Medicine, and the Joint Commission on the Accreditation of Health Care Organizations to determine the qualifications of physicians to practice nuclear medicine. The Agreement States were concerned about the resources needed to develop and validate examinations. One participant stated that creating and validating a new exam would be costly in comparison to seeking out existing exams that were validated and acceptable to the NRC. Training and experience requirements for ancillary personnel, such as technologists, were discussed. A representative of the nuclear medicine technologist profession stated that the role of the technologist entailed more than the safe handling of radioactive materials. The role of the technologist was to provide the physician with the information needed to treat the patient. The individual went on to indicate that the success of the entire diagnostic process correlated with the education and training of the technologist and physician. The individual 19

indicated that groups currently certifying technologists support certification for technologists and State legislation mandating that tech*nologists be licensed. The individual also indicated that these certifying groups did not favor NRG setting standards for training and experience for technologists because the NRG does not have the experience necessary to determine what the training requirements for technologists should be. One workshop member confirmed that a number of States require that technologists be certified. The participant noted that the Confe,rence of Radiation Control Program Directors (CRCPD) was planning on discussing minimum training and experience qualification criteria for technologists. These requirements would be added to the Suggested State Regulations.

3. Advisory Committee on Medical Uses of Isotopes (ACMUI).

Training and experience requirements have been discussed on numerous occasions with the ACMUI. The ACMUI most recently discussed training and experience for authorized users, authorized medical physicists, authorized nuclear pharmacists, and Radiation Safety Officers at its March 1-2, 1998, meeting. The ACMUI agreed with the Commission's proposed general approach to training and experience, i.e., delete reference in the rule to the .::;peciality boards names, require preceptor forms, and require that competency be demonstrated by successful completion of an examination. Members debated whether it is possible or prudent, with respect to authorized user physician training, to separate the hours required for radiation safety training from the entire clinical training period. 20

The AGMUI unanimously recommended that the current training requirements for authorized users of sealed sources and devices for therapeutic applications (proposed §§ 35.400 and 35.600) be maintained. Specifically, they recommended retaining the 3-year clinical training in an accredited program as an alternative to medical speciality board certification. The AGMUI agreed with the views expressed by members of the radiation oncol!)QY professional societies who made formal presentations at the March 1998, meeting. Specifically, they agreed that the current requirements for authorized users of brachytherapy and therapeutic medical devices should be retained because of the risk associated with use of these modalities and because radiation safety training and clinical competence are intertwined for uses of these devices. The AGMUI unanimously recommended that the training requirements for authorized users of unsealed byproduct material for diagnostic uses (proposed §§ 35.100 and 35.200) be reduced to the levels proposed by the NRG staff (120 hours in a structured educational program). The AGMUI did not reach a consensus on the training requirements for authorized users of unsealed byproduct material for therapeutic uses. The NRG staff recommended reducing the training requirements to a 120-hour structured educational program and limited casework. Some membe, ~ of the AGMUI were concerned that training for these uses should be addressed in a manner similar to that used for the therapeutic uses of sealed sources. Finally, they unanimously agreed with NRG staff's recommendation for training requirements for authorized nuclear pharmacists (700 hours in a structured educational program) and medical physicists (Masters of Science degree and 2 years). 21

4. Written Comments.

Authorized Users Training and Experience Requirements for Unsealed Byproduct Material The Commission received numerous comments from professional societies and individual physicians on the training and experience requirements for use of unsealed byproduct material. Many professional societies, as well as individual physicians, were concerned that a reduction in training hours, as proposed in a January 20, 1998, *strawman* version of the proposed rule, would not provide adequate training and might result in approval of poorly trained practitioners. They believe that it is impossible to distinguish between safety and competence. They indicated that the current requirement for 500 hours of clinical experience is an important "patient safety regulation." Some professional organizations recommended that the Commission maintain the current training requirements in this area for authorized users, but also recommended that the training be provided only in programs accredited or approved by the American Council on G1a..!uate Medical Education. Others believed that training and experience should be developed, administered, and monitored by medical speciality organizations with experience in clinical radiation-related technologies. One professional society supported the reduction in training hours. This organization recommendec that physicians, who are not certified by an NRG-approved medical speciality board, be required to pass an examination and to obtain a written certification from a preceptor 22

that indicates that the individual is able to function independently on all aspects of radiation safety. Another society suggested that competence in radiation safety be demonstrated in a perfonnance-based manner, e.g., NRC would not specify a specific number of hours, but would assess competency through a comprehensive examination. One society urged the Commission to maintain the current training and experience requirements for use of byproduct material to treat hyperthyroidism or thyroid carcinoma. This organization opposed the proposal in the "strawman* proposed rule to increase the number of training hours needed to use material to treat hyperthyroidism or thyroid carcinoma and opposed the requirement for an examination. This organization believed that the proposed increase in training and experience requirements would have a detrimental effect for patient care, such as referral of patients to other specialists !.Ising less desirable alternative treatments. One commenter indicated that a minimum of 120 hours of classroom and laboratory training and 240 hours supervised practical experience, or a 3-month training program in nuclear medicine, was appropriate for diagnostic nuclear medicine. Training and Experience for Use of Sealed Sources in Therapy The NRC received approximately 330 letters providing input to the rulemaking process. Approximately 90 percent of these comments were from radiation oncologists who feel very strongly that the current training and experience requirements for authorized users of 23

brachytherapy and therapeutic medical devices should be retained because of the high risk associated with use of these modalities and because radiation safety training and clinical competence ar.e intertwined for uses of these devices. Commenters believed that training and experience requirements should be consistent with that required for certification by the American Board of Radiology (i.e., 3 years of therapeutic radiology and at least 6000 hours of direct clinical experience). If the Commission were to consider other medical speciality boards for certification of physicians seeking approval as authorized users to perform brachytherapy and teletherapy, the training required by those boards should be the same as that required by the American Board of Radiology for certification in therapeutic radiology. Certain comments specifically objected to either an NRG-developed or NRG-approved examination, because that would mean that the standards of the American Board of Medical Specialities and its twenty-four member boards are "too high." Most commenters believed that thorough training in radiation oncology should be required for all physicians seeking to perform applications of ionizing radiation to treat disease. According to certain comments, therapeutic treatments of the heart and brain are high-risk procedures and "relaxing" these requirements would not be in the best interest of patients or the medical profession at large. They maintained that training requirements for coronary artery brachytherapy and gamma stereotactic radiosurgery should be the same as those for other brachytherapy and teletherapy modes of treatment, respectively, and not broken into "tiny site-specific" modalities with different training requirements. 24

Other commenters noted that radiation oncologists should be involved, as part of a team with cardiologists and neurosurgeons, in brachytherapy treatment of the heart and use of gamma stereotactic radiosurgery of the brain. Other comments described the "full complement" of training for these medical uses as covering radiation biology, radiation physics, and radiation safety. A professional organization offered criteria for training and credentialling of cardiologists perfor;ming brachytherapy involving coronary and vascular interventions. This organization believes that cardiologists should perform intravascular brachyth~;-apy in collaboration with medical physicists, Radiation Safety Officers, and medical dosimetrists.

5. Resolution.

The Commission considered all of the input on training and experience that was provided di.iring the development of this rulemaking. On the basis of the public input, the Commission is proposing the following training and experience criteria for authorized users, authorized medical physicists, authorized nuclear pharmacists, and Radiation Safety Officers: (1) The requirements for training and experience should be risk-informed and focused on radiation safety; (2) Individuals should complete a structured educational program that consists of didactic training and practical experience; (3) Specific reference to speciality boards, by name, should be deleted; 25

(4) Speciality boards will be approved by the Commission or an Agreement State if the board certification process includes all the training and experience requirements associated with the equivalent training pathway; (5) Preceptors, when required, should certify that individuals have achieved a level of competency sufficient to function independently as an authorized user for the requested use, an authorized medical physicist, an authorized nuclear pharmacist, or a Radiation Safety Officer; and (6) Individuals should demonstrate sufficient knowledge in radiation safety by passing an ex2'!'lination given by an organiza+;"'n or entity approv~ by the Commission or an Agreem~nt State. The Commission believes that training and experience criteria should be risk-informed and focused on radiation safety. In addition, the Commission believes that, by requiring a combination of a structured education program, preceptorship, and examination focused on radiation safety, individuals will be able to saf~ly handle byproduct material. However, it is important to note that an individual's status as an authorized user, authorized medical physicist, authorized nuclear pharmacist, or Radiation Safety Officer means that an individual has met the requirements to handle byproduct material safely and is not an assessment of the individual's clinical or professional competency. The Commission believes that individuals should complete a structured educational program that consists of didactic training and practical experience. The number of hours and type of training were extensively d_iscussed with the medical societies and speciality boards and have been the primary issue in the public input received on the rulemaking. However, the 26

Commission recognizes that radiation safety training and clinical competency may be intertwined, especially for uses of therapeutic medical devices. Because of the high risk associated with use of sealed sources in therapeutic medical devices, the Commission has not proposed significant changes in the current training requirements for authorized users in this area, with the exception of the training required for the use of stfontium-90 eye applicators.

• Under the proposed rule, authorized users of strontium-90 eye applicators will need to meet the training requirements for authorized users of therapeutic medical devices. The Commission believes this change is warranted in light of the similarity between the use of strontium-90 eye ap;:,licators and the use of sealed byproduct material in medical devices and the recent misadministrations involving strontium-90 eye applicators. It is important that the didactic training include courses in radiation physics, dosimetry, and radiation biology so that the authorized users have a clear understanding of what a dose means in terms of radiation damage to the exposed tissue.

The Commission has focused the training requirements for use of unsealed material for diagnostic administrations when a written directive is not required on radiation safety because of the low risk posed by the radionuclides. In doing so, the didactic and practical requirements for authorized users of unsealed byproduct material for diagnostic procedures were significantly reduced. The didactic and practical requirements for use of unsealed byproduct material when a written directive is required were also reduced because of similarities between the use of unsealed material in a diagnostic setting and use in a therapeutic setting. However, the 27

Commission recognized that the use of both therapeutic unsealed sources and sealed sources involve higher risks ~nd, therefore, retained the requirement for clinical experience. The proposed rule would delete the current, specific training and experience sections that pertain to treatment of hyperthyroidism and thyroid carcinoma. Under the proposed revision of Part 35, individuals wishing to become authorized users of byproduct material for these medical uses would be required to meet the training requirements that apply to the use of unsealed material for which a written directive is required (§ 35.390). The proposed rule specifies that ( 1) the structured educational program for these individuals include an additional 40 hours of supervised practical experience; (2) these individuals have experience involving at least five cases for each procedure with radiation safety hazards similar to that use for which the individual is requesting authorized user status; and (3) these individuals pass an examination to demonstrate competency in radionuclide handling techniques applicable to th-e use of unsealed byproduct material. The Commission recognizes that this proposed rule change places additional requirements on those individuals that wish to become authorized users of byproduct material for only the treatment of hyperthyroidism and thyroid carcinoma. However, it does expect that many of the practical hours will be obtained concurrently with the casework, therefore lessening the burden on the individuals. The Commission recognizes that there have been very few misadministrations that have occurred in this area (1995 and 1997). However, it believes that thi$ change is consistent with the Commission's general intent to (1) focus training and experience criteria on radiation safety; (2) require that all authorized users have practical 28

experience in the handling of radionuclides; and (3) require that competency be demonstrated by passing an examination. The Commission believes that any reference, by name, to specialty boards should be deleted from the regulation for two reasons. First, under the current Part 35, in which speciality boards are listed by name, a rulemaking is needed to add new boards or to delete existing boards. This has been a problem with the current Part 35 because on several occasions individuals requesting authorized user or medical physicist status have been certified by a speciality board that is not listed in the regulations. in these cases, NRC has had to evaluate the training of individuals, with the help of the ACMUI, on a case-by-case basis. Secondly, the current rule does not provide for periodic review of certifying boards to determine if any changes have been made in their certifying programs. The proposed rule would require that specialty boards be approved by the NRC or an Agreement State. A specialty board will be approved by NRC if the certification process includes all of the requirements listed in the equivalent training pathway, i.e., completion of a structured educational program of specific duration that covers specific topics; obtaining a signed preceptor certificat:~m; completion of patient casework, if required; and successful completion of an examination on radiation safety. The Commission plans to discuss proposed board approvals with the ACMUI prior to approving the boards. The NRC staff also plans to conduct periodic reviews of approved speciality boards to assure that they continue to meet commitments to NRC. If a board does not meet its previous training and experience commitments, it will be removed from NRC's list of approved boards. A list of approved boards 29

will be maintained on the NRC external website. In addition, the Cor:nmission is contemplating noticing the approval of a speciality board in the Federal Register. The Commission is proposing that preceptors, when required, should certify that individuals have achieved a level of competency sufficient to independently function as an authorized user for the use that they are requesting: a medical physicist, an authorized nuclear pharmacist, or a Radiation Safety Officer. In the current Part 35, a preceptorship is only required for authorizE;!d nuclear pharmacists. The current preceptors for authorized nuclear pharmacists are only required to attest to the fact that the individual has performed a specified number of cases/treatments. Preceptor forms will be revised to add a warning that 18 U.S.C. Section 1001 Act of June 25, 1948, 62 Stat. 749, makes it a criminal offense to make a willfully false statement or representation to any department or agency of the United States as to any matter within its jurisdiction. The Commission believes that individuals should demonstrate sufficient knowledge in radiation safety commensurate with the use requested by passing an examination given by an organization or entity approved by the Commission or an Agreement State. The Commission is soliciting specific comme:t on whether the requirement for an examination to verify competer.cy is warranted, in light of current industry practice. Appendix A of the proposed rule provides the requirements for an examining organization or entity, examination programs, and written examinations. Of particular note is the requirement that procedures be established to ensure that examinations are not given to individuals who have also been instructed by the examining organization in the same subject area. This proposed requirement is consistent with current practices of medical specialty boards and was suggested for inclusion by ACMUI members. 30

The Commission is also soliciting specific public comment on whether this proposed requirement is too prescriptive. It is expected that examinations will be specific to the risk associated with the medical use of the byproduct material. For example, it is reasonable to expect that one exam could be used to address an authorized user's competency for the medical use of material pursuant to

 §§ 35.100, 35.200, and 35.300, and that another examination would be needed to assess competency for use pursuant to §§ 35.400 and 35.600. The Commission plans to discuss the

• examination process wi'h stakeholders at the facilitated public meetings scheduled to be held during the comment period of this rulemaking.

NRC expects that it will take approximately 2 years for the industry to submit required information, to NRC or an Agreement State, for approval of specialty boards or organizations providing the exam and for NRC to approve the boards or examining organizations. This 5 expectation is based on written and verbal support, received from professional organizations, for training and experience requirements that would require written examinations to assess competency and, on statements made by members of specialty boards indicating that only minor changes would need to be made to their current certification process to address the changes proposed by the Commission. The Commission anticipates that specialty boards and examining organizations will be prepared to submit requests for approval immediately following publication of the final rule. Nevertheless, the Commission is soliciting specific public comment on the amount of time that specialty boards and examining organizations will need to prepare and submit an application for approval of the Commission or an Agreement State. 31

Since NRC expects that it will take approximately 2 years to complete approval of most specialty boards and examining organizations, NRC has maintained the current training requirements in subpart J of the proposed rule. As discussed under the Supplementary Information section of this document, for a 2-year period after publication of the final rule, licensees will have the option of meeting either the requirements in subpart J or the requirements in subparts B and D-H. After the 2-year period, the requirements in subpart J will be deleted, and the licensee will need to comply with the requirements in subparts B and D-H.

8. Quality Management Program.

I. *Facilitated Workshops. Workshop participants expressed both support for the quality management program and opposition to it. Those who support it described several benefits of the program, including the requirement for licensees to have a quality management program and related requirements for "recordable events" and written directives. Opponents of the quality management program rule described it as overly prescriptive, burdensome on licensees, and ineffective in reducing the number of misadministrations. According to certain participants, the current quality management program rule interferes with quality medical care. Many believed that the current quality management rule did little to reduce the number of misadministrations. Some participants who did not support the quality management program expressed support for a performance-based rule that would not require licensees to submit the quality management program for regulatory approval. In their opinion, a performance-based rule 32

would also provide a licensee with the flexibility to custom-tailor a quality management program to meet that facility's quality management needs, including patient verification, ensuring that physician's directions are written, and verifying doses to patients. Some participants proposed that NRC work with other organizations or agencies to ensure quality assurance through other mechanisms in place. Another recommendation was that the proper way to reduce misadministrations is through better training and ensuring, during the licensing process, that personnel are qualified.

2. Agreement States Workshop.

Some Agreement States and members of the public agreed that the current quality management rule _has not addressed the problem of misadministrations. In addition, they do not believe that the quality management rule goes beyond what would typically be considered "quality management." They believe that modifying the quality management program will not solve that problem. Agreement States supported an option that would state the objectives of a quality management program (without being prescriptive), but would not require a written quality management program. Other States believed that the responsibility for quality management should lie exclusively with the medical facility, not with a regulatory agency. A member of the public advocated, in lieu of a quality management program, a training requirement for technicians and a requirement that a physician be present whenever a therapeutic dose is administered. The individual stated that the latter requirement has 33

significantly reduced the number of misadministrations in her State. Another member of the public suggested that a proposed rulemaking by the Health Care Financing Administration (HCFA) was expected to define three levels of supervision for imaging modalities. He explained that physicians would be required to be in the facility, if not in the room, when a dose was being administered in diagnostic nuclear medicine.

3. ACMUI.

Requirements for a quality m.:.-~agement program have been discussed on numerous occasions with the ACMUI. At the September 1997 meeting, the Committee ~mmended that the Commission pursue development of a rule that would state only the objectives for a quality management program. At the March 1998 meeting, the ACMUI discussed the NRC staffs proposed rev_isions to the quality management program. The ACMUI agreed with the NRC staffs proposal to delete the requirements for a quality management program. Although the ACMUI would have preferred deletion of the requirement for written directives and the reference to assuring high confidence that the patient's or human research subject's identity is verified and that each administration is in accordance with the written directive, it recognized that the Commission finds these objectives to be fundamental.

4. Written Comments.

Approximately 10 written comments were submitted to the Commission on the quality management program. The majority of the comments favored deletion of any requirements in this area. Most believed that there were industry standards in place that adequately addressed 34

administration of byproduct material; the rule intruded into medical practice; and regulation in this area was onerous. One professional society recommended that the title be changed to "Quality Assurance and Patient Safety Regulations" and believed that the regulations should be limited to requiring written prescriptions for therapy; requiring licensees to develop quality assurance programs for treatment planning and delivery devices; and requiring that independent checks be made against the written prescription before completion of a treatment. A limited number of commenters believed that the current requirements should be maintained because the quality management program provides a mechanism for reporting events and be.:ause licensees have already developed quality management plans that meet the intent of the rule.

5. Resolution.

The Commission has deleted the requirement for a quality management program. However, the Commission believes there are three elements of the current quality management program that should be addressed in the proposed rule: confirming patient identity, requiring written directives, and verifying dose. The Commission believes that some elements of the current quality management program requirements will continue to be implemented as part of the "standard of care" in medicine. In this regard, the Commission acknowledges that other factors, such as accreditation, have resulted in medical institutions adopting programs similar to those previously specified in the rule. 35

C. Reportable Events.

1. Facilitated Workshops.

The participants generally agreed that current threshold levels for reporting are too low and supported raising threshold levels. However, some participants supported the option of maintaining the current thresholds, arguing that they were familiar with the levels and reports and records of misadministrations are necessary. Participants agreed that threshold levels for recording and reporting events should be based on risk. Several participants argued that threshold levels for reportable events and Abnormal Occurrences should be the same. The NRC was commended for suggesting that the term "misadministration" be replaced with the term "reportable event."

2. Agreement State Workshop.

Discussion focused on the topic of precursor events, rather than on the threshold for reportable events. There was, however, a very brief discussion on reporting of misadministrations. Various statements made during the discussion included: regL;:atory agencies did not need to be informed of misadministrations, unless an event exceeded certain levels or occurred more than once; licensee management, rather than a regulatory agency, should be informed of misadministrations; and regulatory agencies should confirm, during periodic inspections, that licensee management is informed in cases of misadministrations, and that proper corrective actions are taken. 36

3. ACMUI.

The ACMUI discussed the threshold for reportable events at the September 1997 and March 1998 meeting. At the September 1997 meeting, the Committee reached a consensus, recommending that the current criteria for radiopharrnaceutical misadministrations be reduced from three categories to two. The two categories would be "radiopharrnaceuticals not requiring a written directive" and "radiopharmaceuticals requiring a written directive." The Committee pointed out that there is a major deficiency in the current misadministration definition, i.e., there is no thresr.old

      .         dose for wrong treatment site. They also stated
                                                              . that the reporting mechanism should be decoupled from patient notification. Finally, they agreed that an underdosage, if corrected in a clinically timely manner, should not have to be reported.

At the March 1998 ACMUI meeting, the NRC staff presented a proposed revision of the current reporting criteria. The proposed reporting requirement contained a dose threshold and modality-based criteria. The ACMUI discussed the proposed criteria and offered suggestions for minor technical corrections, but did not make a formal recommendation in this area. The Committee recognized that the NRC staff was still making changes in the proposed text to address the wrong treatrr,..:nt site and patient intervention.

4. Written Comments.

Sixteen comments were received in this area. Two of the commenters recommended raising the reporting threshold to the NRC's Abnormal Occurrence critera for misadministrations. Several commenters provided general comments on the reporting criteria, 37

including a name change from "misadministration" to "medical event." The remainder of the commenters provided specific recommendations for changes to the current reporting criteria, including recommendations for addressing patient intervention and wrong treatment site.

5. Resolution.

The Commission has a staMory responsibility to keep Congress and the public informed of incidents or events which the Commission considers significant from the standpoint of public health and safety. These criteria are specified in NRC's Abnormal OcclTSnce Policy Statement, dated April 17, 1997 (62 FR 18820). Licensees must provide NRC with information on events meeting these criteria, in order for NRC to make needed reports to Congress. The term "misadministration" has been deleted. The proposed rule would require licensees to report "medical events." The criteria for a medical event is based on the current requirements in § 35.33, Notifications, reports, and records of misadministrations. Minor changes were made to make the reporting threshold dose-based, where possible, and to address two areas that have caused problems in implementing the current requirements in § 35.33, Patient interven~::m and wrong treatment site. D. Precursor Events.

1. Facilitated Workshops.

38

Participants in the facilitated public workshops, as well as members of the public, believe that: (1) There are already adequate mechanisms in place for identifying precursor events; (2) Additional requirements for notifying NRC about precursor events could result in a significant financial burden for both NRC and licensees without an associated incremental increase in safety; (3) Because of the nature of precursor events, it will be hard to precisely define a precursor event in rule language; and (4) Inclusion of~ requirement for reporting precursor events could lead to an additional basis for enforcement action.

2. Agreement State Workshop.

The discussion on this subject focused on how to identify "precursor events." Many of the participants opposed adding additional requirements for reporting precursor events. According to some Agreement States, mechanisms are already in place to provide information to licensees about incidents which may be "precursorsD to reportable events. Most States were in favor of identifying precursors, but believe notification should be limited to facility management (especially the radiation safety organization). Some participants noted that reporting those events to a regulatory agency could actually inhibit their identification. They did, however, support internal programs for identifying precursor events. Finaliy, they stated that reporting to NRC or to the Agreement States would not be helpful unless a mechanism existed to share the information with the industry. 39

A member of the public noted that there are numerous event reporting requirements under which medical institutions document problem areas and conduct audits of potential problem areas. The individual encouraged NRC to avoid duplicating already existing programs.

3. ACMUI.

The ACMUI discussed the best way to capture precursor events at its September 1997 and March 1998 meetings. At the September 1997 meeting, most Committee members supported voluntary reporting of precursor events, provided there would be no punitive action taken by NRC against a licensee as a result of a report. One member recommended against reporting of precursors, whether mandatory or not, if it was going to have significant resource implications for NRC or the licensee. At the March 1998 meeting, the ACMUI considered three alternatives proposed by NRC staff: (1) Require reporting of conditions or incidents related to the use of radionuclides in medicine that caused or could *cause serious injury to a patient, human research subject, worker, or the public; (2) Require reporting deficiencies in equipment or procedures supplied by a manufacturer or vendor that, in the opinion of the Radiation Safety Officer, could lead to a medical event at that facility or could have detrimental health and safety implications beyond the licensee's facility; and 40

(3) Rely on current NRG reporting requirements in 10 CFR parts 20, 21, and 30 and the Memorandum of Understanding with the U.S. Food and Drug Administration and monitor/establish a system with U.S. Pharmacopeia to review its database on event reports. The ACMUI acknowledged that the Commission wanted to capture precursor events. The ACMUI believed that it was appropriate to clearly define and limit the type of events that would be required to be reported in order to minimize the resource burden on licensees and the NRG. The ACMUI recommended that the NRG staff pursue the second alternative, with minor adjustments.

4. Written Comments.

Approximately five written comments were received on capturing precursor events. One commenter indicated that NRG should develop a nonpunitive method of capturing information while minimizing the burden on licensees, citing the FDA device malfunction reporting system as a model. Three other commenters felt that precursor events were not specifically enough defined (in an earlier draft of the proposed rule) and recommended that they not be included in the proposed rule. Of the remaining two commenters, one commenter did not support reporting precursor events under any condition, while the other supported voluntary reporting.

5. Resolution.

The proposed rule does not contain a requirement for licensees to report precursor events to the NRG. Based on comments received from the public, the Commission believes 41

that there are existing regulations in place that contain sufficient requirements for licensees to identify and report events to the Commission. The Commission plans to issue an Information Notice to remind licensees of the current reporting requirements and to reinforce the need for compliance with these requirements. E. Radiation Safety Committee.

1. Facilitated Workshops.

Workshop participants expressed different opinions about the benefits of radiation safety committees. Some participants stated that although radiation safety committees may be beneficial, the time and resources that must be devoted to managing the committees are excessive and the specific requirements in the regulation are overly prescriptive and not risk-based. Many participants believed that licensees should be given more flexibility in how they administer radiation safety programs. Some participants also expressed concern that the radiation safety committee may not be necessary for effective radiation safety management at small medical institutions. _Some participants believed that a single committee, focused on radiation safety, was an important element of a radiation safety program and, therefore, recommended that the requirement for a committee be maintained. They believed that the committee enhanced 0 communication between disciplines and departments. They were concerned that, without a requirement for a radiation safety committee, administrative support for the committee would 42

decline and there would be decreased management involvement in the radiation safety program.

2. Agreement States.

Discussions at the workshop centered around two issues: (1) Whether the radiation safety committee plays a valuable role in all medical institutions, regan;iless of s~e and use of byproduct material; and (2) Whether the current radiation safety committee requirements in Part 35 are too prescriptive and should be relaxed. The majority of the participants in the workshop argued that the radiation safety committee requirements should recognize the differences between large and small institutions and between low- and high-risk procedures. Participants asserted that a radiation safety committee is unnecessary at smaller, diagnostic facilities. They generally supported the lessening of prescriptive requirements for smaller, diagnostic facilities. They argued that regulations place an unnecessary burden on facilities that conduct few procedures per year but still are required to conduct quarterly meetings. Another participant opposed a prescriptive rule, but acknowledged that it would be simpler to enforce than a performance-based rule.

3. ACMUI.

Requirements for a radiation $afety committee were discussed with the ACMUI at its September 1997 and March 1998 meetings. At the September 1997 meeting, the ACMUI 43

recommended that the NRC staff pursue developing a requirement for radiation safety committees at institutions that perform high-risk procedures. Facilities that use diagnostic, low-dose, sealed and unsealed byproduct material would not be required to have a radiation safety committee. At the March 1998 meeting, the ACMUI agreed with the Commission's proposed deletion of the requirement for a radiation safety committee. ACMUI supported the addition of requirements for licensee management to approve licensing actions and minor revisions to the radiation safety program; and for a licensee to implement procedures for interdepartmental/ interdisciplinary coordination of the licensee's radiation protection program. They believed that the proposed language would not prohibit a large organization_from utilizing a radiation safety committee, but would, at the same time, reduce regulatory burden on small rural hospitals which have small staffs and where a committee may not be needed to manage the radiation protection program.

4. Written Comments.

Approximately 10 written comments were submitted regarding the requirem-=-,,t for a radiation safety committee. The majority of the comments favored retention of the requirement for a radiation safety committee at larger facilities. These commenters believed that a committee was an effective way to ensure that management is involved in the operation of the radiation safety program. They recommended that a "graded" approach could be used in determining if a committee was needed, e.g., small facilities or facilities with limited use of material would not be required to have a committee. However, two commenters believed that 44

the requirement for a radiation safety committee should be deleted in its entirety. Two others believed that the requirements should not be revised. The Commission recognizes that medical facilities normally have a number of committees examining various areas, including safety issues, in response to accreditation requirements, etc. Specification of the objectives to be met by the radi~tion protection program (in the proposed§ 35.24), rather than the particular mechanism to be used in meeting those objectives, is an effort to provide licensees flexibility in carrying out the responsibilities for radiation safety.

5. Resolution.

The Commission is proposing deletion of the requirement for a radiation safety committee. The Commission believes that key functions of the radiation safety committee could be transferred to licensee management and that the prescriptive requirements in the current rule should be deleted. The Commission believes that many institutions will continue to use a radiation safety committee to oversee use of radioactive material. However, it ~cognizes that radiation protection prog.-... m oversight may be accomplished by other means. In particular, the Commission recognizes that medical facilities normally have a number of committees examining various areas such as environmental safety. These committees are typically formed in response to hospital accreditation requirements. In an effort to afford licensees flexibility in achieving the objectiv~s of radiation safety, the proposed rule specifies objectives that must be achieved rather than specifying the 45

mechanism to meet the objective. The proposed rule would require that the licensee approve licensing actions; individuals prior to allowing them to work as a Radiation Safety Officer, authorized user, authorized nuclear pharmacist, or authorized me,dical physicist; and radiation protection program changes that do not require a license amendn:ient. The proposed rule also contains a requirement for the licensee to develop, implement, and maintain administrative procedures for interdepartmental/interdisciplinary coordination of the licensee's radiation protection program. F. Notification Following a Misadministration or Medical Event. I. Facilitated Workshops. Many participants believed that the current requirements for licensees to notify the NRC, the referring physician, and the patient of a misadmiilistration is an intrusion into both the practice of medicine and the confidential patient-physician relationship. They stated that the decision whether to notify the patient should be left solely to the physician. Those participants . asserted that medical "standards of practice," "risk management" practices of medical institutions, and tort law aie the mechanisms that should address notification of patients. Therefore, according to these participants, Federal or State legal requirements for such notifications are unnecessary and inappropriate. Some participants believed that an authorized user would never withhold information from a referring physician because to do so would destroy the relationship between the authorized user and the referring physician. 46

Workshop participants did not believe that the requirement for a licensee to provide a written report to the individual was appropriate. They believed that a report that was submitted to NRC may greatly magnify, in the patient's mind, the significance of the event, when in fact, a medical event could be of minimal safety significance. However, other participants stated that without the NRC requirement for patient and referring physician notification, the physician's ethical obligation to make these notifications must be strong. Some commenters believed that the exchange of infonnation between physicians shou_ld extend to patients as well. The participants espousing thi$ viewpoint believe that such requirements may be necessary to protect patients and th,.,ir right to know of misadministrations.

2. Agreement State Workshop.

Some participants noted that legal requirements for protecting the privacy of patients vary from State to State and may differ from Federal requirements. Other participants stated that medical standards of practice, tort law, and medical institution risk management are mechanisms to address fundamental patient notification and, therefore, State or Federal requirements for such notification are unnecessary.

3. ACMUI.

Notification requirements have been discussed on numerous occasions with the ACMUI. The ACMUI most recently discussed the requirements in this area at its March 1998 meeting. The ACMUI continues to affinn its position that it does not support any Federal regulation requiring notification of physicians and patients. The committee strongly believes that patient 47

notification of medical events should occur as part of the patient-physician fiduciary" relationship, in which the "standard of care" for a physician is to provide the patient with complete and accurate information.

4. Written Comments.

Three written comments directly addressed notification following a medical event. Two professional organizations recommended that the requirement be deleted. One State recommended that the requirement be maintained.

5. Resolution.

The Commission believes that the current requirements for notifying individuals following a misadministration should remain unchanged with the exception of substituting the term "medical evenr for "misadministration.

• Changing terminology in this way responds to objections that the term *misadministration" has po~ible connotations of carelessness and harm, which is not always the case. Furthermore, the term "medical event" used in the proposed rule is consistent with the terms used to characterize events in other activities regulated by the NRC. The proposed rule would require that the licensee notify the NRC, referring physician, and the individual who is the subject of a medical event, unless the referring physician personally informs the licensee that he will inform the individual or that, based on medical judgment, telling the individual would be harmful. In the latter case, or if for example, the patient is a minor, or is unconscious and incapable of comprehending the information. it is expected that the licensee would report to the patient's responsible relative or guardian rather 48

than to the patient. This position reaffirms statements made by the Commission, at the time the misadministration rule was proposed and/or promulgated (and later modified), that patient notification "... recognizes the right of individuals to know information about themselves which .is contained in records both inside and outside the Federal sector." "Human Uses of Byproduct Material, Misadministration Reporting Requirements,* (43 FR 2927; May 7, 1978);

"Misadministration Reporting Requirements," (45 FR 31701-31702; May 16, 1980); and *sasic Quality Assurance Program, Records, and Reports of Misadministrations or Events Relating to the Medical Use of Byproduct Material,* (55 FR 1439-1444; January 16, 1990). The Commission also believes that patient notification enables patie, 1LS, in consultation with their personal physicians, to make timely decisions regarding any remedial and prospective medical care. This approach would also codify existing industry standards [American Medical Association Principles of Medical Ethics] obligating physicians to provide complete and accurate information to their patients_.

This approach is consistent with the U.S. Food and Drug Administration (FDA) regulation and with how Congress is addressing similar issues in the mammography area. In October 1992, Congress passed the "The Mammography Quality Standards Act" (Public Law 102-539) to establish national quality standards for mammography. In December 1993, the FDA promulgated interim regulations setting forth quality standards for mammography facilities. In October 1997, the FDA issued a final rule that becomes effective in April 1999. The final rule requires that, in cases where "FDA determines that the mammography program at a facility may present a serious risk to human health, a facility must notify the patients or their designees, their physicians or the public of action that may be taken to minimize the effects of the risk." Currently, the Senate has passed and the House is considering bills (S. 537 and H.R. 49

1289) to amend the Mammography Quality Standards Act to, inter alia, add a new section to the Act on patient notification. The bills will provide FDA with the authority to require a facility to notify patients (and their referring physicians) of, among other things, the potential harm resulting from mammograms that may have been of poor quality because of deficiencies in the mammography program at that facility. G. General Comments. In addition to the comments '", the crosscutting issues discussed above, NRC received comments on specific sections of the rule and on several general topical areas. These comments are available for review in the NRC Public Document Room, 2120 L Street, NW. (Lower Level), Washington, DC. Comments on specific sections of the rule were taken into consideration in preparing the proposed rule. General comments are summarized below.

1. Process for Developing the Risk-Informed, Performance-based Rule.

a. Comments.

Workshop participants and written commenters discussed development of a risk-informed, performance-based rule. Some commenters recommended that NRC not proceed with any revision of Part 35 until it had performed an adequate and comprehensive evaluation of the risks associated with medical use. They recommended that the assessment should be performed by an "independent scientific organization" and completed in advance of 50

any rulemaking. The risk analysis should follow the guidelines outlined by the Presidential Commission on Risk Assessment and Risk Management. Some commenters did not believe that the current regulatory system makes optimal use of either NRC or licensee resources. They believed that NRC regulations and their associated paperwork burden inevitably contribute to the cost of providing clinically necessary procedures and may compromise the availability of the benefits of medical use of byproduct material. They recommended that NRC be guided by the following basic principles: rules should emphasize training and credentialling of professional staff deemed essentiai to safe operations, quality assurance and technical regulations should be based on available practice standards, and regulations should not be promulgated in the absence of a demonstrated risk to the public or patients. Some commenters believe that Part 35 is duplicative of the Food and Drug Administration (FDA) statutes and implementing regulations and does not provide any added overall benefits to the regulatory framework. They believ~ that the FDA regulatory scheme is comprehensive, requiring documentation of adverse effects relating to the use of all drug I products, including radionuclides; regulations under 10 CFR Part 20 are adequate' to protect health and safety; high-risk medical use can be regulated on a case-by-case basis through licensing conditions; and some prescriptive license conditions can be offset by - performance-based flexibility, which is preferable to prescriptive regulations of medical users. Finally, some commenters questioned the schedule for completion of the rulemaking. They believe that sufficient time must be provided to undertake a thorough effort to change the 51

rule and for public comment on draft documents, including regulatory guides. They also believe that reorganization of Part 35 based on "similar subject areas" is appropriate, but the rule should include references to requirements in Part 20.

b. Resolution.

As a result of the NRC's Strategic Assessment and Rebaselining efforts, the NRC staff formed the Nuclear Byproduct Material Risk Review Group to develop a risk-informed, graded approach to regulating r11any material uses, including medical uses. The group's final recommendations are expected in the fall of 1998 and will be considered by the NRC staff during the Part 35 rulemaking process. The Commission considered input from a 1993 internal senior management review report; an external review report by the National Academy of Sciences, Institute of Medicine; and the information presented in the Strategic Assessment Direction-Setting Issue Paper Number 7 (DSl-7) prior to determining the role of NRC regulation in the medical use area. On the basis of these reviews, the Commission believes that Part 35 should be restructured into a risk-informed, more performance-based regulation. In developing the regulation, the Commission considered information on risk provided by members of the public and professional societies, professional medical standards of practice, and event databases maintained by NRC. The draft proposed rule reflects numerous changes from the existing requirements which reduce the regulatory burden to the average licensee.

2. Agreement State Compatibility.

a. Comments.

52

Commenters recommended that NRC follow its Strategic Plan to work with Agreement States to assure protection of the public health and safety nationwide, especially where constraints due to inconsistent regulation result in barriers to accessibility of medical use involving radionuclides. One commenter suggested that Agreement States should not be required to adopt any of the revised rule or accompanying guidance documents.

b. Resolution.

The Working Group and Steering. Group established to revise Part 35 are comprisea of NRC staff, as well as representatives of two Agreement States and a non-Agreement State. One of the Agreement State representatives on the Working Group is also a member of the Conference of Radiation Control Directors' Suggested State Regulation Committee on Medical Regulation, which is working toward parallel development of suggested state medical use regulations. The Working and Steering Groups received input from the Agreement States at several times during the rulemaking process. NRC representatives met with representatives of the Agreement States during the October 1997 All Agreement States Meeting. Agreement State representatives were invited participants at the facilitated public meetings. One Agreement State representative provided written comment during the early input stages of the proposed rule development. The Commission has reviewed the proposed rule for issues of compatibility for Agreement States. Specific designations for the proposed rule are discussed under Section IX of the Supplementary Information section of this document. 53

3. Licensing and Enforcement Actions.

a. Comments.

Some commenters believed that NRC must change to a performance-based compliance system in order to have a significant impact on the entire medical use program. They believed that no change would occur if the NRC deleted regulatory requirements but had license reviewers demand that licensees make equivalent commitments in license applications or add equivalent conditions to the license. Some commenters stated that licensees should be allowed to operate their radiation safety programs without "procedure-by-procedure" approval by NRC and that regulations should cover all necessary requirements. Commenters recommended that NRC abandon an adversarial enforcement strategy based on punishment for infractions. Commenters also believed that no change would occur if inspectors continued to apply regulatory and license requirements without regard to fault, and if inspectors continue the practice of issuing citations for minor regulatory requirements which can be attributed to normal human error and which have no safety significance. They stated that NRC must develop an enforcement system that allows for exercising dinical judgment, evaluating quality assurance policy deviations in terms of safety rather than legal significance, and accepting voluntary practice standards and measures of practice quality as the regulatory endpoints .

                                               . 54

b. Resolution.

The proposed rule provides for an overall change in regulatory philosophy. Consistent with a risk-informed, performance-based approach to medical use licensing, the amount of information needed from an applicant to possess and use byproduct material would be reduced. An applicant for an NRC medical use license would have to submit a signed application, documentation of the training and experience of the individuals named on the license, and the facility diagram and list of instrumentation. While licensees would be required to develop, implement, and maintain procedures required by the regulations, they would no longer be required to submit these proce~ures as part of the license application. Furthermore, licensees will be provided maximum flexibility in developing their procedures because most of the requirements for procedures provide performance-based objectives to be achieved, rather than a list of prescriptive details that need to be addressed in the procedures. The NRC plans to review the enforcement policy as part of its overall revision of Part 35. This review will take into account written comments as well as those comments received during the facilitated public meetings that are scheduled to occur during the formal comment period. IV. Discussion of Text of Proposed Rule 10 CFR PART 20-STANDARDS FOR PROTECTION AGAINST RADIATION Section 20.1301, Dose limits for individual members of the public, would be revised. The proposed rule responds to the petition from the University of Cincinnati by amending 55

§ 20.1301 to allow a licensee the discretion to permit visitors to receive up to 5 mSv ( 0.5 rem) in a year from exposure to individuals who are not releasable pursuant to§ 35.75. Currently, visitors are limited to 1 mSv ( 0.1 rem). The Commission has used 5 mSv (0.5 rem) as a threshold for action in multiple locations in Parts 20 and 35. This threshold is used as both a dose limit and a reporting level. For example, § 35.75 uses the 5 m_Sv (0.5 rem) as a dose limit for members of the public exposed to patients released pursuant to § 35. 75. The proposed change to § 20.1301 would also use 5 mSv (0.5 rem) as a dose limit for visitors of confined patients. In contrast, however, the proposed changes to§ 35.3047, Report of a dose to ar, embryo/fetus or a nursing child, would establish a 5 mSv (0.5 rem) reporting threshold (reference § 35.3047 for a more detailed discussion of the proposed change). In accordance with§ 35.75, patients containing radioactive material can be released from licensee control if the total dose to other individuals from exposure to the released patient is not likely to exceed 5 mSv ( 0.5 rem). The Commission recognizes that the provisions of § 35. 75 and the proposed revision to § 20.1301 (a) could result in rare instances in which certain individuals could receive a 10 mSv (1.0 rem) dose. For example, an individual could receive a 5 mSv (0.5 rem) dose while visiting a patient who can not be released pursuant to§ 35.75, and then later receive a 5 mSv (0.5 *rem) because of exposure from thE; released patient. The Commission believes that the authoriz8? user is the appropriate individual to evaluate, on a case-by-case basis, the merits of allowing a visitor to receive this potential additional dose and would do so only when it is warranted by the situation. 56

A potential consequence of this rulemaking is that pregnant visitors would not be excluded automatically from visiting individuals who could not be released pursuant to § 35. 75. The pregnant visitor is subject to the same exposure limits that are applied to any other adult member of the public. The reasons for not excluding pregnant visitors under this rulemaking are two-fold. First, as noted in NCRP Commentary No. 11, members of a radionuclide therapy patient's family are likely to perceive that visitors will benefit from providing emotional and physical support to the patient during their treatment, and these visitors are likely to be willing to bear greater risk in order to achieve that benefit. Second, declaration of pregnancy by a prospective visitor is strictly voluntary. If a prospective visitor does not voluntarily declare her pregnant status, the authorized user is not expected to demand confirmation of the visitor's nonpregnant status. As stated earlier, the proposed revision to § 20.1301 differs from the proposed revision to § 35.3047. The revision to § 20.1301 would revise the dose limit for a small population of individuals, namely visitors to individuals who can not be released pursuant to§ 35.75. In contrast, the proposed revision to§ 35.3047 would establish a reporting threshold for doses to an embryo/fetus or nursing child. For example, under the proposed § 20.1301, a pregnant visitor could receive 5 mSv (0.5 rem) as a result of a visit to a patient who has not been released. Under the proposed revision to§ 35.3047, if the dose to an embryo/fetus exceeds 5 mSv (0.5 rem), as a result of an unintended- administration to the mother, a report must be submitted to NRC. Finally, in the course of diagnosis and treatment, an authorized user may approve, in advance, an administration of byproduct material to a pregnant woman that may result in an absorbed dose to an embryo/fetus that exceeds 5 mSv (0.5 rem). 57

The Commission does not intend to require monitoring and recording of individual doses. The NRC evaluated the costs associated with monitoring individuals versus the benefits derived and determined that, at these low doses, monitoring is not justified. However, this does not preclude the licensee from monitoring and recording individual doses. 10 CFR PART 32-SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL Section 32. 72, Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under Part 35, would be revised as a result of the proposed revision of Part 35. Paragraph (b)(1) would be revised to reference the proposed § 35.27 rather than the current § 35.25 which would be deleted. This change was necessitated because of the proposed renumbering of some Part 35 sections. Paragraph (b)(2)(ii) would be revised to include both the proposed and current training and experience requirements for authorized nuclear pharmacists and to reference the proposed

§ 35.59 rather than the current § 35.972 which would be deleted. As discussed in subpart J, the current training and experience requirements would be deleted 2 years after the effective date of the final rule.

Section 32. 74, Manufacture and distribution of sources or devices containing byproduct material for medical use, would be revised as a result of the proposed revision of Part 35. Paragraphs (a) and (a)(3) would be revised to add a reference to the proposed§ 35.600. The current section does not include a reference to medical use of sealed sources in therapeutic

• devices. This oversight would be corrected by the proposed rule.

58

10 CFR PART 35-MEDICAL USE OF BYPRODUCT MATERIAL Subpart A, General Information, contains general information regarding medical use of byproduct material. Section 35.1, Purpose and scope, would be revised to specify that the requirements and provisions in Part 35 provide for the radiation safety of workers, the general public, patients, and human research subjects. Inclusion of the phrase "patients, and human research subjects" makes it clear that the provisions of this rule would apply to the radiation safety oi those individuals. This addition is consistent with the proposed revision of the Medical Use Policy Statement that wili be published separately in the Federal Register. The _section would also be revised to add a reference to Part 171, "Annual Fees for Reactor Operating Licenses, and Fuel Cycle Licenses and Materials Licensed, Including Holders of Certificates of Compliance, Registrations, and Quality Assurance Program Approvals and Government Agencies Licensed By NRC." This revision would make it clear that the provisions in Part 171 apply to medical licensees. J Section 35.2, Definitions, would be amended by deleting the definitions of "ALARA, D "dental use,D aministerial change,D "misadministration,D "pediatric use," and "recordable event' because they do not appear in the proposed rule. The definitions for authorized nuclear pharmacist and authorized user would be revised to eliminate the specific board certifications by name and to refer to the specific section containing the requirements that the individual must meet to be considered an authorized 59

nuclear pharmacist er an authorized user. Reference to the specific board certifications would be deleted because the proposed rule contains provisions for NRG to approve boards. The definition of "authorized nuclear pharmacist" would also be revised to recognize nuclear pharmacists that have been approved by a nuclear pharmacy that has been authorized by the Commission to approve authorized nuclear pharmacists. The definition of "Radiation Safety Officer" would be revised to include a reference to the specific requirements that an individual must meet in order to be authorized as a Radiation Safety Officer. This change was done to make the definition of Radiation Safety Officer consistent with the definitions of authorized nuclear pharmacist, authorized user, and authorized medical physicist. The definition of "written directive" would be revised to delete the provision for the date the directive was signed, and the signature of the authorized user before administration of any byproduct material or radiation from byproduct material to a specific patient or human research subject. These specific requirements have been moved to § 35.40. The definition of "teletherapy physicist" would be deleted and replaced with a definition for *authorized medical physicist' because it is a broader term that includes physicists that work with all types of therapeutic units .

       . The definition of "mobile nuclear medicine" would be deleted and replaced with a definition for *mobile service" because it is a broader term that would encompass all modalities that could be performed by a mobile service. A new definition would be added for "temporary

jobsite." This is needed since it is used in defining "mobile service." The definition of "temporary jobsite" is-based, in part, on the definition of "temporary jobsite" as used in 10 CFR Part 34, "Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial Radiographic Operations.* Definitions would be added for "high dose-rate remote aftertoader, * "low dose-rate remote afterloader," *pulsed dose-rate remote afterloader," and "stereotactic radiosurgery" because use of these units would be addressed in Part 35. The definitions of "high dose-rate remote afterloader" and "low dose-rate remote afterloader" contain dose rates specific to each type of afterloader. The Commission is not proposing to define the term "medium dose-rate remote afterloader" since it is not used in the proposed rule. The Commission noted that there was very little difference between the regulatory requirements for a medium dose-rate remote afterloader and high dose-rate remote afterloader and, therefore, has chosen to group the units. The Commission is soliciting public comment on whether the rule should specifically reference medium dose-rate remote afterloaders. A definition for "medical evenr would be added and refers to the criteria listed in § 35.3045{a), Reports of medical events. A new definition, "precursor event," would be added and refers to the criteria listed in§ 35.3046(a). {Reference Section 111, C, of the Supplemental Information section of this document for more detailed discussion.) A new definition, "treatment site,* would be added because it is used in§ 35.2045 of the proposed rule. A new definition, *unit dosage," was added because it is used in§§ 35.60 and 35.63 of the proposed rule. 61

Section 35.5, Maintenance of records, would be revised to insert "and" 1n the current phrase "drawings and specifications." Section 35.6, Provisions for research involving human subjects, would be unchanged. However, the Commission is soliciting comment on whether this section should be revised to require that licensees develop, implement, and maintain procedures for evaluating when a medical procedure would be considered to be a research procedure. Section 35.7, FDA, other Federal, and State requirements, would be unchanged. Section 35.8, Information collection requirements; 0MB approval, would be revised to reflect the renumbering of some sections within the rule and the additional recordkeeping and reporting sections in the proposed rule. Section 35.10, Implementation, would be a new section that discusses the proposed provisions for implementing the final rule. A detailed discussion of the implementation provisions can be found in Section VIII of the Supplementary Information section of this document This section would replace the current§ 35.999, Resolution of conflicting requirements during transition period. Section 35.11, License required, would be revi~d to reflect that the requirements for supervision in the current § 35.25 would be replaced by the prpposed requirements in § 35.27. Section 35.12, Application of license, amendment, or renewal, would be revised. 62

Paragraph (a) would be revised to state that any application for a license, amendment, or renewal must be signed by the management of the facility. The current rule indicates that any person may apply if the application is for medical use not sited in a medical institution and that only management may apply for a license if the application is for use in a medical institution. The Commission believes it is important that facility management apply for a license, regardless of where the material is used, because NRC holds the licensee responsible for any actions of its employees. Paragraphs (b) and (c) would be revised to more clearly state that separate applications must be submitted for medical uses listed in § 35.600, other than

• remote afterloaders. Separate applications must be submitted for teletherapy and gamma stereotactic radiosurgery units.because the scope and nature of information needed is much different than that needed for the other types of medical use. This requirement does not imply that the applicant has separate safety programs. Paragraphs (b) and (c) would also be revised to delete the reference to the Regulatory Guides. Guidance for completing an application may be found in draft NUREG-1556, Vol. 9, "Consolidated Guidance About Materials Licenses, Program-Specific Guidance about Medical Use Licenses." Draft NUREG-1556, Vol 9, is
• available for inspection at the NRC Public Document Room, 2120 L Street NW. (Lower Level),

Washington, DC. Single copies of the draft NUREG are available as indicated in the For Further Information Contact section of this document. Paragraph (d) would be added to address applications for medical use of byproduct material that are not specifically included in subparts D through H of the proposed rule, henceforth referred to as "emerging technologies" (e.g., intravascular brachytherapy). The current rule does not provide for efficient licensing of emerging technologies. Paragraph (d) 63

would provide a generic list of the information needed by NRC to approve a use that is not specifically addressed in subparts D through H of the proposed rule. Section 35.13, License amendments, would be revised to reflect the new numbering as a result of the overall revision of Part 35. Paragraph (b) would be revised to indicate that a licensee does not need to amend its license before allowing anyone to work as an authorized medical physicist if that individual meets the training and experience requirements in § 35.51 or § 35.961, and the requirements were met within the 7 years preceding the date of the application. Paragraph (c) would be revised to delete the requirement for licensees to amend a license if the teletherapy physicist changes provided the individual meets the requirements in §§ 35.51 (a) and 35.59 or§§ 35.961 and 35.59. This change is consistent with existing licensing requirements for authorized ~sers and authorized nuclear pharmacists. The Commission recognizes that unusual conditions may arise when the Radiation Safety Officer leaves a facility with little to no advance warning. In this event, the licensee may want to consider using an authorized user to fill the position, pending appointment of a n~ Radiation Safety Officer. Under these conditions, the licensee must move expeditiously to permanently fill the position of Radiation Safety Officer. In these situations, the licensee should contact the appropriate NRC regional office and explain the situation. In order to reduce regulatory burden, paragraph (e) would be revised to delete the requirement for a licensee to apply for a license amendment if there is a change in the areas where byproduct material is used for diagnostic purposes pursuant to §§ 35.100 and 35.200. For example, a licensee would not be required to apply for a license amendment to move a 64

sean room in a diagnostic nuclear medicine department that uses byproduct material in quantities that would not require a written directive. However, this provision does not apply to any storage or waste areas because of the pot19ntial for large quantities of materials to accumulate in these areas and the possibility of commingling of radioactive material that is used pursuant to other sections of the rule. Paragraph (f) would require an amendment if the licensee changes the address of use. For example, an amendment would be required if the licensee initiates use or storage of byproduct material at a new physical location that is under its control. Section 35.14, Notifications, would be re~sed. Paragraph (a) would be revised to include a requirement for the licensee to notify NRC no later than 30 days after the date the licensee permits an individual to work as an authorized medical physicist pursuant to § 35.13(b). Paragraph (b) would be revised to require that the licensee notify NRC when. an authorized medical physicist permanently discontinues performance of duties under the license. Paragraph (b) would also be revised to require that a licensee notify NRC when the licensee changes its name. This provision applies only if there is no change in ownership, as described in § 30.34 of this chapter. Otherwise, the licensee must take appropriate action to have its license amended prior to such change in ownership. A licensee must also notify NRC of any changes in areas where materials are used pursuant to §§ 35.100 and 35.200. These revisions were warranted because of requirements in the proposed § 35.13. Section 35:15, Exemptions regarding Type A specific licenses of broad scope, would be revised to add the term "authorized medical physicist' to paragraph (d). This revision is needed because of the requirements in the proposed § 35.13. Under this proposed section, broad 65

scope licensees would have authority to appoint authorized users, authorized nuclear pharmacists, or authorized medical physicists without notifying NRG, provided the individuals meet approved criteria in subparts 8, D-H, and J. A new paragraph (e) would be added to also exempt these licensees from § 35.49(a). This change would codify in the regulations an exemption that is currently provided to these licensees through a standard condition. NRC's medical use licensees with a Type A specific license of broad scope currently receive a standard license condition that exempts the licensee from receiving sealed sources or devices manufactured only from licensees with medical distribution licenses issued pursuant to § 32. 7 4. This change would replace the license condition. Section 35.18, License issuance, would be revised. Requirements for a mobile service license would be added as paragraph (b). The NRG will issue a license for mobile service if the applicant meets the requirements specified in paragraph (a) of the section and if the individual or human research subject to whom the applicant administers byproduct material, or radiation from byproduct material, may be released following treatment in accordance with § 35. 75. The later condition is necessary because mobile service licensees will not have the capability of controlling individuals that cannot be released pursuant to § 35. 75. Section 35.19, Specific exemptions, would be revised to delete the statement that the Commission will review requests for exemptions from training and experience requirements with the assistance of its Advisory Committee on the Medical Uses of Isotopes. This statement is a matter of Commission policy rather than a regulatory requirement. 66

Subpart B, General Administrative Requirements, contains general administrative requirements regarding medical use of byproduct material. Section 35.20, AL.ARA program, would be deleted in its entirety from Part 35. AL.ARA is discussed in 10 CFR 20.1101, "Radiation protection programs," and medical licensees must comply with the requirements of that section. That section requires, in part, that a licensee develop, document, and implement a radiation protection program and use, to the extent practicable, procedures and engineering controls to achieve occupational doses and doses to

• members of the public AL.ARA. The Commission does not believe that § 35.20 is needed in light of the requirements in § 20.1101. A medical use licensee should have flexibility in developing and implementing a radiation protection program that meets the requirements of Part 20.

Section 35.21, Radiation Safety Officer, would be deleted in its entirety from Part. 35. The requirements of paragraph (a) would be moved to the proposed § 35.24. Paragraph (b)

• would be deleted because it is overly prescriptive and in some cases overlaps with the requirements in § 20.1101. The Commission believes that the licensee should have the flexibility in developing, maintaining, and implementing its radiation protection program, including establishing tt:ie Radiation Safety Officer's duties.

Section 35.22, Radiation safety committee, would be deleted in its entirety. The issue of whether NRC should require a Radiation Safety Committee was identified as a cross-cutting issue and, therefore, was discussed at the public meetings and workshops herd in Fall 1997. Comments received on this topic are discussed in Section Ill of the Supplementary lnfonnation 67

section of this document. Based on the comments received prior to March 1, 1998, the Commission believes that key functions of the Radiation Safety Committee could be transferred to licensee management (reference proposed§ 35.24) and that the prescriptive requirements in the current § 35.22 should be deleted. The Commission believes that many institutions will continue to use a Radiation Safety Committee to oversee use of radioactive material. However, it recognizes that radiation program oversight may be accomplished by other means. In particular, medical facilities normally have a number of committees examining various areas, such as environmental safety. These committees are typically formed in response to hospital accreditation requirements. Specifying responsibilities and functions to be accomplished, rather than the particular mechanism to be used, is an effort to afford licensees flexibility in achieving the objective of radiation safety (reference § 35.24). Section 35.23, Statements of authority and responsibilities, would be deleted in its entirety and the requirements of this section, with minor modifications, would be moved to the proposed§ 35.24. Section 35.24, Authority and responsibilities for the radiation protection program, would appear as a new section. This requirement specifies objectives that must be achieved, rather than specifying how the objective is to be met, in an effort to afford licensees flexibility in achieving the objective of radiation safety. Paragraphs (a) and (b) would replace the current requirements for the Radiation Safety Committee. The licensee is responsible for approving licensing actions; individuals before allowing them to work as a Radiation Safety Officer, authorized user, authorized nuclear 68

phannacist, or authorized medical physicist; and radiation protection program-changes that do not require a license amendment. The licensee must develop, implement, and maintain administrative procedures for interdepartmental/interdisciplinary coordination of the licensee's radiation protection program. Interdepartmental/interdisciplinary coordination is believed to be a major component of an effective radiation protection program. The Commission recognizes that there are many ways to meet this objective and believes that the licensee should have flexibility in identifying and implementing the most appropriate modes of coordination at its facility. Identified alternatives include, but are not limited to, meetings, electronic transfer of infonnation, or verbal communication. This requirement applies to all medical use licensees and it is expected that the extent of the coordination will be dependent on the complexity of the licensee's program. The requirement in paragraph (c) to appoint a Radiation Safety Officer is currentty required by § 35.21. The proposed paragraph would require that the Radiation Safety Officer agree, in writing, to be responsible for implementing the radiation protection program. The requirements in paragraphs (d) and (e) are similar to the requirements in the current§ 35.23. A record of management's approval of actions in paragraph (a); written acceptance of Radiation Safety Officer duties as specified in paragraph (c); and the duties, responsibilities, and authority of the Radiation Safety Officer specified in paragraph (d) would have to be mair:itained in accordance with § 35.2024, Records of authority and responsibility for radiation protection programs. 69

The Commission is soliciting specific public comment on changes made in the rule that could impact the licensee's effectiveness in carrying out its radiation protection program, e.g., proposed deletion of the requirement for a Radiation Safety Committee and proposed requirement for the Radiation Safety Officer to acknowledge, in writing, responsibility for implementing the radiation protection program. In particular, the Commission is seeking comment in the following areas: (1) whether this combination of changes in the proposed rule may actually reduce the effectiveness of radiation protection programs; and (2) whether the radiation safety officer will be provided appropriate tools and channels through which to raise safety concerns to the highest levels of management. Finally, if the requirement for a committee, to oversee the radiation protection program, was included in the final rule, the Commission is seeking comment on whether the rule language should explicitly require that the radiation safety officer be a member of that committee. Section 35.25, s*upervision, would be deleted in its entirety and the requirements of this section, with minor modifications, would be moved to the proposed § 35.27. Section 35.26, Radiation protection program changes, would appear as a new section. The requirements in this section are similar to the requirements in the current§ 35.31, which would be deleted. The proposed section states that a licensee may revise its radiation protection progra"!I without Commission approval if the revision does not require an amendment in accordance with § 35.13; the change will not reduce radiation protection; the change has been reviewed and approved in writing by the Radiation Safety Officer and licensee management; and the affected individuals have been instructed on the revised program before the changes are implemented. This requirement provides the licensees with flexibility to 70

manage their radiation protection programs and clearly defines the situations that will not require an amendment. The Commission believes that many licensees were reluctant to make changes to their current program because the term "ministerial changes,~ as defined in the current§ 35.2 and as used in the current§ 35.31, was not clearly understood. This change is intended to provide clear guidance to a licensee on when it can revise its radiation protection program without Commission approval. The Commission believes that it is important to instruct individuals in program changes, including those permitted under§ 35.26, before they are implemented. This instruction could be provided in writing or orally and may be conducted on an informal or formal basis. It is not . necessary to document that this training has been provided to affected parties, because these changes should not reduce radiation safety. At the time of inspection, NRG inspectors may question whether this training was provided. Section 35.27, Supervision, would appear as a new section. The requirements in this section are similar to the requirements in the current § 35.25, which would be deleted. Paragraph (a)(1) and (b)(1) would be revised to delete the requirement to instruct individuals in the principles of radiation safety. This type of instruction is adequately addressed by § 19.12, Instructions to workers, of this chapter. Paragraph (a)(1) would also be revised to require that the licensee instruct supervised individuals in the written radiation protection procedures, written directives procedures, regulations of this chapter, and license conditions. Paragraph (a)(2) would require the supervised individual to follow the instructions of the supervising authorized user for medical uses of radioactive material, written radiation protection procedures, regulations, and license conditions with respect to the medical use of byproduct material. 71

Paragraphs (a)(3) and (b)(3) of the current§ 35.25 would be deleted because the licensee should have flexibility in evaluating employee performance. Paragraph (b)(2) would be revised to require supervised individuals to follow the instructions of the supervising authorized user or authorized nuclear pharmacist regarding the preparation of byproduct material for medical use, the written radiation protection procedures, and the regulations of this chapter and license conditions. Paragraph (c) would require that the licensee develop, implement, and maintain a policy for supervised individuals to request clarification, as needed, from the authorized user about instructions and requirements in a written directive prior to administering the byproduct material, or radiation from the byproduct material, and from the authorized user or authorized nuclear pharmacist about instructions and requirements provided in accordance with paragraphs (a) and (b) of the section. This change would be added so that a licensee's work environment would encourage supervised individuals to ask questions if they do not understand the instructions or requirements provided to tliem by an authorized nuclear pharmacist or an authorized user, especially when they have questions regarding administrations of byproduct material to patients or human research subjects. In the past, failure by licensee staff to ask questions has been identified as one of the key contributors to misadministrations. Section 35.29, Administrative requirements that apply to the provision of mobile service, would be deleted. The conditions for the Commission to issue a mobile service license would be moved to § 35.18. The requirements in paragraphs (b) and (d) would be moved to the proposed§ 35.80. Paragraph (c) would be deleted because this requirement was viewed as overly prescriptive. Individuals are required to comply with all provisions of the license that authorizes use, possession and transfer of material. 72

Section 35.31, Radiation safety program changes, would be deleted. The requiremen~, with minor changes, would be moved to § 35.26. This change is proposed so that all requirements that pertain to the management of the licensee's program appear in one area. Section 35.32, Quality management program, would be deleted. The issue of whether the Commission should continue to require that a licensee develop, implement, and maintain a quality management program was identified as a cross-cutting issue and was discussed at the public meetings and workshops held in Fall 1997. Comments received on this topic are discussed in Section Ill of the Supplementary Information section of this document. Based on these comments, the Commission has deleted the requirements for a quality management program. However, the Commission believes there are three elements of the current quality management program that should be addressed in the proposed rule: confirming patient identity, requiring written directives, and verifying dose. Requirements for these three elements are found in proposed §§ 35.40 and 35.41. However, the Commission believes that some elements of the current quality management program requirements will continue to be implemented as a part of the "standard of care* in medicine. In this regard, the Commission acknowledges that other factors, such as accreditation, have res~lted in medical instiMions to adopting programs similar to those previously specified in the rule. Section 35.33, Notifications, reports, and records of misadministrations, would be deleted. In this _proposed revision, recordkeeping and reporting requirements contained in Part 35 would be moved to subparts Land M, respectively. 73

Section 35.40, Written directives, would appear as a new section. This section contains requirements for preparation of written directives. These requireme~ts are similar to the requirements in the current §§ 35.2 and 35.32. Minor changes would be made in the information that must be placed in a written directive for gamma stereotactic radiosurgery, remote afterloaders, and brachytherapy. These changes were based on comments received during public meetings of the Part 35 Working Group. Section 35.41, Procedures for administrations requiring a written directive, would appear as a new section. It would require the licensee to develop, implement, and maintain written procedures to assure that, before each administration, the patient's or human research subject's identity is verified and that each administration is in accordance with the written directive, including verification of dose. It would also specify the objectives that should be addressed in the procedures. The specific details to be included in the written directives are in § 35.40. The topics identified in § 35.41 are viewed by the Commission as key elements of a program that will provide high confidence that byproduct material will be administered as directed by the authorized user. However, the regulations are not prescriptive as to how these objectives are met, allowing licensees the flexibility to develop procedures to meet their needs. There is no requirement for submittal or approval of the procedures as was previously required by the quality management rule. Section 35.49, Suppliers for sealed sources or devices for medical use, would be unchanged. 74

Requirements in the current§ 35.50, with minor modifications, would be moved to the proposed § 35.60. Section 35.50, Training for Radiation Safety Officer, would appear as a new section that would revise the current requirements of§ 35.900, Radiation Safety Officer. Section Ill of the Supplementary Information of this document contains a detailed discussion of the Commission's proposed changes to the training and experience requirements in Part 35. Note, 2 years after the final rule is published in the Federal Register, this section would replace the current requirements in § 35.900, Radiation Safety Officer. Requirements in the current § 35.51, with minor modifications, would be moved to the proposed § 35.61. Section 35.51, Training for an authorized medical physicist, would appear as a new section that would revise the training and experience requirements found in § 35.961, Training for an authorized medical physicist. Section Ill of the Supplementary Information section of this document contains a detailed discussion of the Commission's proposed changes to the training and experience requirements in Part 35. Note, 2 years after the final rule is published in the Federal Register, this section would replace the requirements in § 35.961, Training for authorized medical physicist. Section 35.52, Possession, use, calibration, and check of instruments to measure dosages of alpha- or beta-emitting radionuclides, would be deleted in its entirely and the 75

requirements of this section, with minor modifications, would be moved to the proposed § 35.63. Section 35.53, Measurements of dosages of unsealed byproduct material for medical use, would be deleted in its entirety and the requirements of this section, with minor modifications, would be moved to the proposed § 35.63. Section 35.55, Training for an authorized nuclear pharmacist, would appear as a new section that would revise the training and experience requirements found in § 35.980, Training for an authorized nuclear pharmacist. Section Ill of the Supplementary Information section of this document contains a detailed discussion of the Commission's proposed changes to the training and experience requirements in Part 35. Note, 2 years after publication in the Federal Register, this section would replace the current requirements in§ 35.980, Training for an authorized nuclear pharmacist. Requirements in the current§ 35.57, with minor modifications, would be moved to the propo~ § 35.65. Section 35.57, Training for an experienced Radiation Safety Officer, teletherapy or medical physicist, authorized user, and nuclear pharmacist, would appear as a new section that would replace the current requirements in §§ 35.901, 35.970, and 35.981, which would be deleted. Changes would be made in the regulatory text of this section to reflect the effective date of the rule. 76

Requirements in the current § 35.59; with minor modifications, would be moved to the proposed§ 35.67. Section 35.59, Recentness of training, would appear as a new section that would replace the current requirements in § 35.972. Although this is not a new requirement, questions have recently been raised regarding whether all elements of the requirements must have been obtained in the last 7 years. It is expected that either the individual has been board certified or has completed the training specified in the alternative pathway within the 7 years preceding the date of the application or must have had related continuing education and experience since completing the required training and experience requirements. Continuing education is reviewed on a case-by-case basis. The text has been revised to reference subparts B, D, E, F, G, H and J since training and experience requirements appear in multiple subparts. Subpart C, General Technical Requirements, contains general technical requirements regarding medical use of byproduct material. Requirements in the current § 35.60, with minor modifications, would be moved to the proposed§ 35.69. Section 35.60, Possession, use, calibration, and check of instruments to measure activity of photo~mitting radionuclides, would appear as a new section that would replace the current § 35.50. This section addresses calibration of all instruments used to measure the activity of photon-emitting radionuclides, rather than only dose calibrators. The change 77

recognizes that there are various types of instruments that can be used to IT)easure the activity of photon-emitting radionuclides. The proposed rule would require that licensees develop, implement, and maintain procedures for use of the instrumentation. Licensee~ would be required to calibrate all instruments used to measure the activity of photon-emitting radionuclides. Licensees would be required by the proposed § 35.63 to determine the activity of each dosage before medical use. If a licensee uses only unit dosages of radiopharmaceuticals, § 35.63 would allow the licensee to determine the dosage by a decay correction based on the measurement by a manufacturer or preparer licensed pursuant to § 32. 72 or equivalent Agreement State. If a licensee chooses to determine the dosage using this method, it would not be necessary for the licensee to possess instrumentation to measure the activity of the photon-emitter. In this case, the licensee would not be required to comply with this section. !f, however, a licensee chooses to re-assay a unit dosage to either confirm the activity or for the purpose of adjusting the dosage, the licensee must comply with this section. This requirement is appropriate because confirmation of a dosage, or adjustment of dosages, must be made based on properly-calibrated equipment. Many of the prescriptive requirements for calibration would be deleted from the current requirements in § 35.50. The requirements that would remain are viewed by the Commission as essential elements of a calibration program and are generally consistent with the recommendations of ANSI N42.13-1986 (R 1993), "Calibration and Usage of Dose Calibrator Ionization Chambers for the Assay of Radionuclides. D Licensees would be required to perform 78

accuracy, linearity, and geometry dependence tests before initial use and following repair; perform accuracy tests annually; perform linearity tests annually over the range of medical use; and check constancy and proper operation at the beginning of each day of use. Note, it would not be necessary to test for linearity for all activities that might be measured, e.g., the first elution from a fresh generator or a multidose vial, because this would subject the worker to an unnecessary radiation dose. Paragraph (c) would require that accuracy tests be performed using a source with a principle photon energy of between 100 and 500 keV whose activity is traceable to the National Institutes of Standards and Technology (NIST). The allowance for a licensee to mathematically correct dosage has been revised to raise the level for correction to 30 µCi to make the level consistent with § 35.63. The allowance for a licensee to mathematically correct dosage readings remains, but has been re-numbered§ 35.60(d). The recordkeeping requirements for this section would appear in § 35.2060, Records of instrument calibrations. Requirements in the current § 35.61, with minor modifications, would be moved to the proposed § 35.69. Section 35.61, Calibration and check of survey instruments, would appear as a new section that would replace the current § 35.51. The requirement in the current § 35.51 (a)(3) to note the apparent exposure rate from a dedicated check source, as determined at the time of calibration, and the daily check source requirement in paragraph (c) would be deleted. These changes would give the licensee greater flexibility in instrument calibrations. Paragraph (b) would require that the licensee attach a correction chart or graph to the instrument if the indicated exposure rate differs from the calculated exposure rate by more than 10 percent. 79

Paragraph (c) would require that survey instruments be removed from use if the indicated exposure rate differs from the calculated exposure rate by more than 20 percent. Previously, there was no threshold for attaching a correction chart or for removing instruments from use. The requirements in this section are generally consistent with ANSI N323-1978 (R 1993),

• Radiation Protection Instrumentation Test and Calibration." The recordkeeping requirements for this section would appear in § 35.2061, Records of radiation survey instrument calibrations.

Section 35.62, Possession, use, calibration, and check of instruments to measure dosages of alpha- or beta-emitting radionuclides, would appear as a new section that would replace the current § 35.52. This section addresses calibration of all instruments used to measure the activity of alpha- or beta-emitting radionuclides. Paragraph (a) from the current § 35.52 would be deleted. This text is no longer needed since the term "unit dosage" has been defined in§ 35.2. The new paragraph (b) would require that a licensee develop, implement, and maintain written procedures for use of the instrumentation. The Commission recognizes that it may not be possible to test linearity and geometry dependency on all instrumentation. However, the Commission believes that all instruments used to measure alpha- or beta-emitting radionuclides can be tested for accuracy or constancy. The new paragraph (c) would require that accuracy tests be performed using sources whose activity is traceable to NIST. The recordkeeping requirements for this section would appear in § 35.2060, Records of instrument calibrations. Section 35.63, Determination of dosages of unsealed byproduct material for medical use, would appear as a new section that would replace the current § 35.53. This section would require licensees to determine and record the activity of each dosage before medical use. For 80

unit dosages of an alpha-, beta-, or photon-emitting radionuclides, this determination must be made either by direct measurement or by a decay correction, based on the measurement made by a manufacturer or preparer licensed pursuant to § 32. 72 or equivalent Agreement State requirements. For other than unit doses, a licensee may determine the dosage by direct measurement or by combination of measurements and calculations. Previously, photon measurements could only be made by direct measurement This action allows licensees flexibility in determining dosages and does not distinguish between the type of the radiation (e.g., alpha, beta, or photon) and the way the determination is made. Paragraph (d) would not

• permit a licensee to use a dosage if it differed from the prescribed dosage by more than 20 percent. This change would codify requirements that are currently imposed on licensees by license conditions. This does not prevent an authorized user from revising the prescribed dosage at any time prior to the administration. The recordkeeping requirements for this section would appear in § 35.2063, Records of dosage measurements.

Section 35.65, Authorization for calibration and reference sources, would appear as a

• new section that would replace the current§ 35.57. The references in the current§ 35.57, to

 §§ 35.100 and 35.200, would be deleted because specific radionuclides were not listed in these sections. Paragraph (b) in the current§ 35.57 would be revised to extend the half-life from 100 days to 120 days to be consistent with the financial assurance regulations in 10 CFR Part 30.

The limit of 10-3 would be added to the regulation to allow receipt, possession, and use of radionuclides in quantities that do not exceed the limits requiring financial assurance. The possession limit for Tc-99m would be deleted. The Commission believes that it is not necessary to limit the possession of Tc-99m for calibration and reference sources because 81

there are no possession limits for Tc-99m associated with use of Tc-99m pursuant to§§ 35.100 or 35.200. Section 35.67, Requirements for possession of sealed sources and brachytherapy sources, would appear as a new section that would replace the current§ 35.59. Paragraph (b) would require that a source be tested for leakage before its first use, unless the licensee has a certificate from the supplier indicating that the source was tested within 6 months, and the source is tested for leakage at intervals not to exceed 6 months or at other intervals approved in the Sealed Source and Device Registry (SSDR). 1 The SSDR certificates, in most cases, will include a requirement for leak-testing. Approved intervals for testing are based on information regarding source design construction that is provided by the manufacturer. Prescriptive requirements in the current§ 35.59(c) would be deleted to reflect the risk-informed, performance-based nature of this proposed rule. Paragraph (d) would require that leak test records be maintained in accordance with § 35.2067, Records of possession of sealed sources and brachytherapy sources. Paragraph (e) would be revised to give the licensee two additional alternatives for action after a leaking source has been identified. The proposed rule would allow the licensee the added flexibility of repairing or disposing of the source, in accordance with 10 CFR parts 20 and 30, if the leakage test reveals the presence of 185 Becquerels(Bq) (0.005 microcuries) or more of removable contamination. The current rule only allows the licensee to withdraw the sealed source from use and store it in accordance with the 1 A national registry that contains all the registration certificates 3enerated by both NRC and the Agreement States. Registration certificates summarize the radiation safety information submitted by the applicant, and describe the licensing and use conditions approved for the product. 82

requirements in 10 CFR parts 20 and 30. The licensee would still be required to report to NRG if a leakage test reveals the presence of 0.005 microcuries or more of removable contamination. Reporting requirements for this section would appear in § 35.3059, Reports of leaking sources. Paragraph (g) of the current rule would be revised to change the frequency for source inventories from quarterly to semi-annually, to reduce the regulatory burden on licensees. It does not, however, preclude the licensee from conducting an inventory on a more frequent basis. Paragraph {h) of the current rule would be deleted because radiation surveys are addressed under 10 CFR Part 20. The recordkeeping requirements for this section would appear in § 35.2067, Records of possession of sealed sources and brachytherapy sources. Section 35.69, Labeling and shielding of vials and syringes, would appear as a new section that would replace the current§§ 35.60 and 35.61. It would require licensees to develop, implement, and maintain procedures for labeling and shielding radiopharmaceuticals and instruct individuals in those procedures. Procedures must ensure that a syringe, syringe shield, or vial shield is conspicuously labeled as containing radioactive material and is labeled with the radiopharmaceutical name. Toes~ requirements were needed because the Commission does not believe that the labeling and shielding requirements in Part 20 are sufficient to ensure that syringes, syringe shields, or vial shields are properly labeled to identify radioactive contents. In addition, the Commission believes that labeling helps to reduce administration errors. The proposed rule would require that licensees instruct individuals, commensurate with that individual's assigned duties, on the labeling and shielding procedures. It is expected that technologists preparing radiopharmaceuticals and nuclear pharmacists will 83

be given i_nstruction iri the licensee's procedures. Records of instructions would not be required to be maintained. Section 35. 70 would be retitled, Surveys for ambient radiation exposure rate, and revised. The proposed rule would require that licensees survey, at the end of each day of use, all areas where radiopharmaceuticals requiring a written directive were prepared for use or administered with an appropriate radiation detection survey instrument unless the material was prepared for use or administered in an area where patients or human research subjects could not be released pursuant to § 35. 75. All other requirements in this section would be deleted. Licensees are required to show compliance with the public and occupational dose limits specified in Part 20* of this chapter and specifically to develop, document, and implement a radiation protection program commensurate with the scope and extent of licensed activities (10 CFR 20.1101 ). In situations where radioactive material was used at levels that would not have required a survey pursuant to this section, the licensee should be aware that a survey may be required by § 20.1501, General. Maintaining the requirement for surveys in areas where radiopharmaceuticals requiring a written directive are used is consistent with the Commission direction for a risk-informed rule. The Commission believes that licensees will continue to perform radiation surveys as dictated by "good health physics* practices. Recordkeeping requirements for this section would appear in § 35.2070, Records of surveys for ambient radiation exposure rate. Section 35.75 would be retitled, Release of individuals containing radiopharmaceuticals or implants, and revised. The title of the section and paragraph (a) would be revised to delete the term "permanent." This was done to clarify that this section applies to all individuals 84

released from licensee control. Paragraph (b) would be revised to specrfy that licensees may provide instructions to either the released individual or to the individual's parent or guardian and to replace the term "dose" with the term total effective dose equivalent." The first change acknowledges that, in some cases, it is not appropriate to provide the individual being released with instructions (e.g., the individual is a minor or incapable of understanding the instructions). The later term was changed to clarrfy what was intended by "dose." Paragraph (b)(2) would be modified to state "potential consequences, if any," of failure to follow the guidance. The Commission recognizes that, at low doses, there may be no consequences to continued breast-feeding. A patient may be unnecessarily alarmed if he/she is provided with information on consequences. Therefore, -If consequences are not anticipated, the licensee would not be required to provide information to the individual. The Commission has recently received comments from the public Cl'} the provisions in § 35. 75 at the public workshops and in writing. Professional societies and representatives of the Agreement States have expressed concerns about the release criteria in § 35. 75. It is believed that the new criteria permit the release of patients with a body burden of as much as several hundred millicuries of 1-131. Commenters believed that the released individual is a *1eaking-source* that creates a contamination and exposure problem that extends beyond the control of the licensee. There is concern that pr8$sure from those paying for such medical procedures will undermine the Radiation Safety Officer's ability to protect the public health and safety and to control contamination within the medical facility. In addition, there is concern about the recent increase of radiation alarms going off at landfills caused by household trash from a released patient. As a result of these concerns, the Commission is specifically soliciting public comment on whether any changes need to be mad~ to the release criteria in this rule. The recordkeeping 85

requirements for this section would appear in § 35.3075, Records of the release of individuals containing radiopharmaceuticals or implants. Section 95.80 would be retitled, Provision of mobile service, and revised. The title would be changed to make it clear that the provisions in this part apply to all mobile services and not just to mobile nuclear medicine services. Current paragraphs (a), (b), and (c) would be deleted because radiopharmaceutical usage is limited by the requirements in §§ 35.100 and 35.200, and control and security of material are addressed in 10 CFR Part 20. Proposed paragraph (a) would require the mobile service provider to obtain a letter from its client, which permits the use of byproduct material at the client's address of use and that clearly delineates the authority and responsibility of each entity. Paragraph (c) would require that the mobile service provider check instruments for proper function, as described in §§ 35.60 and 35.62, before use at each address of use or on each day of use, whichever is more frequent. For example, if a mobile service licensee provides service to more than one client in a day, the instruments would need to be checked at each client's address of use. The Commission recognizes that the standard of practice is to check other types of equipment, such as gamma cameras, for proper operation at each place of use. Therefore, the Commission has not included any requirements to check this type of equipment in the proposed rule. Currently, mobile nuclear medicine services may be required by license conditions to check gamma camera operation. Based on discussions with the States, this section is designated as a Category D item of compatibility since there is no potential for medical use of byproduct material in other regulatory 86

jurisdictions under reciprocity. NRC specifically requests comment on this issue relative to whether mobile* medical licensees operate under reciprocity in other regulatory jurisdictions. Paragraph (d) would require that the licensee check survey instruments for proper operation with a dedicated check source, before use, at each address of use. The NRC staff believes this is appropriate because extensive movement in a transport vehicle may cause the instruments to become damaged or uncalibrated. Paragraph (e) would be revised to require a licensee to survey all areas of use to comply with the dose limits in 10 CFR Part 20 before leaving each client's address of use. This is necessary to assure that all radioactive material is removed from a client's facility. Recordkeeping requirements for this section would appear in § 35.2080, Records of administration and technical requirements that apply to the provision of mobile services. Section 35.90, Storage of volatiles and ga*ses, would be deleted in its entirety. Licensees are required to comply with the public and occupational public dose limits in 10 CFR Part 20 and to maintain exposures AlARA The Commission believes that licensees should have flexibility in complying with 10 CFR Part 20, and, therefore, a prescriptive requirement in Part 35 is not needed. Section 35.92, Decay-in-storage, would be revised to allow decay in storage for byproduct material with a physical half-life of less than 120 day$. If a licensee would like to decay material with a physical half life greater than 120 days, it would have to apply for and receive an amendment that would pennit the decay-in-storage. 87

I The current Part 35 only permits decay-in-storage for materials with a half-life of less than 65 days. This change provides licensees with greater flexibility in handling radioactive waste. NRC has received multiple requests to amend licenses to allow for decay-in-storage for materials greater thari 65 days, and NRC has amended licenses to allow for decay-in-storage for materials with half-lives up to 120 days. This revision to § 35.92 would codify current licensing practice. The requirement in the current paragraph (a)(1) to hold byproduct material for 10 half-lives would be deleted. This requirement is not needed in light of the requirement in paragraph (a) that precludes disposal of radioactive material as ordinary trash until radiation levels adjacent to the material do not exceed background levels. The Commission is soliciting specific public comment on whether this provision should be deleted. Concerns have been raised regarding licensees' ability to detect low levels of some beta-emitters such as sulfur-35. In this case, the requirement to hold material for 10 half-lives provides added assurance that material has decayed to background levels prior to release. The requirement in paragraph (a)(4) to separate and monitor each generator column would be deleted. This level of prescriptiveness is not warranted in light of the requirements in paragraph (a)(1 ). The recordkeeping requirements for this section would appear in § 35.2092, Records of waste disposal. Subpart D would be retitled Unsealed Byproduct Material - Low Dose. This subpart would combine the requirements in the current subpart D, Uptake, dilution, and excretion and 88

subpart E, Imaging and localization. This change is consistent with the Commission's intent to make Part 35 modality specific where appropriate. Section 35.100 would be retitled, Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required, and revised. The title would be changed to clearly state that the provisions in this subpart do not apply to the medical use of byproduct material that would require a written directive. Changes would be made to paragraph {b) to reflect the renumbering of sections in the proposed rule .

• Section 35.120, Possession of survey instruments, would be deleted because these specific requirements are not needed in Part 35. Section 20.1501 of this chapter requires that the licensee make, or cause to be made, surveys to demonstrate compliance with 10 CFR Part 20, and requires the licensee to ensure that instruments and equipment used to show compliance with Part 20 are periodically calibrated. In addition, § 30.33{a)(2) of this chapter requires licensee to have adequate instrumentation. Information on the types of instruments recommended for medical licensees is available in draft NUREG-1556, Vol. 9.

Section 35.200 would be retitled, Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required, and revised. The title would be changed to clearly state that the provisions in this part do not apply to the medical use of byproduct material that would require a written directive. Changes would be made to paragraph (b) to reflect the renumbering of sections in the proposed rule. 89

Section 35.204, Permissible molybdenum-99 concentration, would be revised. Paragraph (b) would be revised to require that a licensee measure the molybdenum-99 concentration of only the first' eluate from a generator. The Commission recognizes that the industry standard for molybdenum breakthrough is specified in the United States Pharmacopia {USP) 23 U.S. Pharmacopial Convention, Inc., 1994, page 486-487. The Commission believes that the licensee should measure the molybdenum-99 concentration in the first elution of a generator after the generator is received at the licensee's facility. Although the frequency of molybdenum breakthrough is exceedingly rare, an initial check may detect generators that have been damaged in transport. The term "extract" was deleted because the term is no longer needed. NRC is not aware of any licensees that prepare technetium-99m by the solvent extraction method. The recordkeeping requirements for this section would appear in § 35.2204, Records of molybdenum-99 concentration. Section 35.205, Control of aerosols and gases, would be deleted in its entirety. Part 35 licensees must comply with the occupational and public dose limits of 10 CFR Part 20. Additional prescriptive requirements for limiting airborne concentrations of radioactive material are not warranted in Part 35. Section 35.220, Possession of survey instruments, would be deleted in its entirety because specific requirements are not needed in Part 35. Section 20.1501 of this chapter requires that the licensee make, or cause to be made, surveys to demonstrate compliance with 10 CFR Part 20, and requires the licensee to ensure that instruments and equipment used to show compliance with 10 CFR Part 20 are periodically calibrated. In addition,§ 30.33(a)(2) of 90

this chapter requires licensees to have adequate instrumentation. Information on the types of instruments recommended for medical licensees is available in draft NUREG-1556, Vol. 9. Section 35.290, Training for uptake, dilution, and excretion studies, would appear as a new section that would revise the training and experience requirements found in § 35.910, Training for uptake, dilution, and excretion studies. Section Ill of the Supplementary Information section of this document contains a detailed discussion of the Commission's proposed changes to the training and experience requirements in Part 35. Note, 2 years after publication of the final rule, this section would replace the current requirements in § 35.920, Training for uptake, dilution, and excretion studies. Section 35.292, Training for imaging and localization studies, would appear as a new .section that would revise the training and experience requirements found in§ 35.920, Training for imaging and localization studies. Section Ill of the Supplementary Information section of this document contains a detailed discussion of the Commission's proposed changes to the training and experience requirements in Part 35. Note, 2 years after publication of the final rule, this section would replace the current requirements in§ 35.920, Training for imaging and localization studies. Subpart E would be retitled, Unsealed byproduct material - high dose. The subpart contains the requirements for any medical use of unsealed byproduct material for which a written directive is required. This subpart would replace the requirements in the current subpart F, Radiopharmaceuticals for therapy. 91

Section 35.300 would be retitled, Use of unsealed byproduct material for which a written directive is required, and revised. The title would be changed to clearly state that the provisions in this subpart apply to the medical use of unsealed byproduct material that would require a written directive. Changes would be made to paragraph (b) to reflect the renumbering of sections in the proposed rule. Section 35.310, Safety instruction, would be revised to explicitly state that the instruction requirements of this section are in addition to, and not in lieu of, the training requirements in 10 CFR 19.12. The Commission believes that it is important that personnel caring for patients or human research subjects that have received radiopharmaceutical therapy (and cannot be released in accordance with§ 35.75) receive instruction in limiting radiation exposure to the public or occupational workers and the actions to be taken in the case of a death or medical emergency. The proposed rule would require that safety instruction be provided initially and at least annually. Instruction topics are specific to medical use of unsealed radiopharmaceuticals. It is not expected that the same level of training be provided to all individuals caring for the patient. The level of training should be commensurate with the type of care that the personnel may render to the patient or human research subject. For example, the instruction provided to the registered nurse will not necessarily be the same as the instruction provided to a nursing assistant. Paragraph (a) would be revised to require that instruction on visitor control include instruction on routine visitation authorized under the provisions in § 20.1301 (a)(1 ), as well as visitation that is authorized under the proposed provisions of§ 20.1301 (a)(3). Paragraph (a) would also be revised to state that personnel should notify the authorized user and Radiation 92

Safety Officer, or his/her designee, if the patient or human research subject dies or has a medical emergency. The recordkeeping requirements for this section would appear in

  § 35.2310, Records of instruction and training.

Section 35.315, Safety precautions, would be revised. Paragraph (a) would be revised to clarify that the requirements in this section only apply if a patient has been confined pursuant to§ 35.75. Paragraph (a)(2) would be revised to require that the patient's room, rather than the door, be visibly posted to give the licensee some flexibility in determining where to place the posting. These requirements are in addition to the posting requirements in 10 CFR Part 20. The Commission believes that posting requirements in 10 CFR Part 20 are not adequate to ensure that individuals entering the room would be aware of the presence of radioactive materials in the room. The current requirements in paragraphs (a)(3), (4), (6), (7), and (8) would be deleted because they are radiation protection requirements that are covered under 10 CFR Part 20. Paragraph (b) would be revised to state that personnel should notify the authorized user and the Radiation Safety Officer, or his/her designee, as soon as possible, if the patient or human research subject dies or has a medical emergency. This change was made to recognize that the licensee's primary responsibility is the care of the patient and to provide the Radiation Safety Officer flexibility in designating who should be notified to address radiation protection issues. The Commission is soliciting specific comments on whether the requirement for a private room with a private sanitary facility in paragraph (a)(1) should be maintained in the final rule. 93

Section 35.320, Possession of survey instruments, would be deleted in its entirety because these specific requirements are not needed in Part 35. Section 20.1501 of this chapter requires that the licensee make or cause to be made surveys to demonstrate compliance with 10 CFR Part 20 and requires the licensee to ensure that instruments and equipment used to show compliance with Part 20 are periodically calibrated. In addition, 10 CFR 30.33(a)(2) requires a licensee to have adequate instrumentation. Information on the types of instruments recommended for medical licensees is available in draft NUREG-1556, Vol. 9. Section 35.390, Training for therapeutic use of unsealed byproduct material, would appear as a new section that would revise the training and experience requirements found in § 35.930, Training for therapeutic use of unsealed byproduct material, and subsumes the training requirements for treatment of hyperthyroidism and treatment of thyroid carcinoma. Section Ill of the Supplementary Information section of this document contains a detailed discussion of the Commission's proposed changes to the training and experience requirements in Part 35. Note, 2 years after publication of the final rule, this section would replace the current requirements in § 35.930, Training for therapeutic use of unsealed byproduct material, § 35.932, Training for treatment of hyperthyroidism, and § 35.934, Training for treatment of thyroid carcinoma. Subpart F would be retitled Manual brachytherapy. This subpart contains the requirements for medical use of sealed sources for manual brachytherapy and replaces the requirements in the current subpart G, Sources for brachytherapy. 94

Section 35.400 would be retitled, Use of sources for manual brachytherapy, and revised to delete the specific sources and uses listed in the current paragraphs (a) through (g). This conforms with the risk-informed, performance-based nature of this proposed rule. The licensee would have the flexibility to use sealed sources for therapeutic medical uses as approved in the Sealed Source and Device Registry. Section 35.404 would be retitled, Radiation surveys of patients or human research subjects treated with implants, and revised. Paragraph (a) would be revised to delete the requirement that a licensee may not release a patient or a human research subject treated by temporary implant until all sources have been removed and would be retitled paragraph (b}. Release of patients or human research subjects is addressed in§ 35.75. The proposed paragraph (a} contains requirements that were previously required by§ 35.406(c) with one modification. Licensees would be required to survey adjacent areas of use. This change was done to group radiation survey requirements. The recordkeeping requirements for this section would appear in § 35.2404, Records of radiation surveys of patients and human research subjects. Section 35.406, Brachytherapy sources inventory, would be revised. Paragraph (a) requires that the licensee maintain accountability for all brachytherapy sources in storage or use. The majority of the prescriptive requirements and associated recordkeeping requirements in the current section would be deleted to give the licensee flexibility in program management. The requirements in paragraph (c) would be moved to the proposed § 35.404. The Commission believes that the requirements that were maintained are essential to the radiation 95

safety program. The recordkeeping requirements for this section would appear in § 35.2406, Records of brachytherapy source inventory. Section 35.410, Safety instruction, would be revised to explicitly state that the instruction requirements in this section are in addition to, and not in lieu of, the training requirements of 10 CFR 19.12. The Commission believes that it is important that personnel caring for patients or human research subjects, that have received implant therapy and cannot be released in accordance with § 35. 75, receive instruction in limiting radiation exposure to the public and workers and the actions to be taken in the case of a death or medical emergency. The proposed rule would require that safety instruction be provided initially and at least annually. Instruction topics are specific to medical use of manual brachytherapy sources. It is not expected that the same level of training be provided to all individuals caring for the patient. The level of training should be commensurate with the type of care that the personnel may render to the patient or human research subject. Paragraph (a) would be revised to require that instruction on visitor control include instruction on routine visitation authorized under the provisions in the current § 20.1301 (a)(1 ), as well as visitation that is authorized under the provisions of revised § 20.1301 (a)(3). Paragraph (a) would also be revised to state that personnel should notify tne authorized user and Radiation Safety Officer, or designee, if the patient or human research subject dies or has a medical emergency. The record keeping requirements for this section would appear in§ 35.2310, Records of instruction and training. Section 35.415, Safety precautions, would be revised. Paragraph (a) would be revised to clarify that the requirements in this section apply only if a patient or human research subject cannot be released pursuant to§ 35.75. The current requirements in paragraphs (a)(3) and (4) 96

(, would be deleted because they are radiation protection requirements that are covered under 10 CFR Part 20. A new requirement would be added (paragraph b) to require the licensee to have equipment such as shields and remote handling tools available near each treatment room. This change codifies requirements that are currently imposed on licensees by license conditions. Current paragraph (b) would be redesignated paragraph (c) and would be revised to state that personnel should notify the authorized user and the Radiation Safety Officer, or his/her designee, as soon as possible if the patient or human research subject dies or has a medical emergency. This change was made to recognize that the licensee's primary responsibility is the care of the patient and to provide the Radiation Safety Officer flexibility in who should be notified to address radiation protection issues. The Commission is soliciting public comment on whether the requirement for a licensee to not quarter a patient in the same room as an individual who is not receiving radiation therapy be maintained in the final rule. Section 35.420, Possession of survey instruments, would be deleted in its entirety because these specific requirements are not needed in Part 35. Section 20.1501 of this chapter requires that the licensee make, or cause to be made, surveys to demonstrate, compliance with 10 CFR Part 20, and requires the licensee to ensure that instruments and equipment used to show compliance with Part 20 are periodically calibrated. In addition, 10 CFR 3-0.33(a)(2) requires licensees to have adequate equipment. Information on the types of instruments recommended for medical licensees is available in draft NUREG-1556, Vol. 9. Section 35.432, Full calibration measurements of brachytherapy sources, would appear as a new section that would require a licensee authorized to use brachytherapy sources for medical use to perform full calibration measurements on brachytherapy sources before the first 97

medical use. The requirements in this section are based on recommendations found in American Association of Physicists in Medicine (AAPM) Task Group 40- Comprehensive QA for Radiation Oncology (1994) and 56 - Code of Practice for Brachytherapy Physics (1997), and are consistent with the calibration requirements_ for sealed sources and devices for therapy. The proposed rule would allow the licensee to rely on the output measurement provided by the manufacturer or distributor. The Commission is soliciting specific comment on whether the final rule should contain a requirement for the licensee to perform full calibration measurements on brachytherapy sources before first use and on whether the final rule should allow licensees to rely on the output measurements provided by the manufacturer or distributor provided the dosimetry equipment used by the manufacturer or distributor met the calibration requirements in § 35.630. In addition, the Commission is soliciting specific public comment on calibration for sources* where there is no standard traceable to the National Institute of Standards and Technology (e.g. palladium-103). The Regulatory Analysis for this section of the proposed rule assumes that the majority of licensees using long-lived radionuclides will need to calibrate the sources to show compliance with this section. It is estimated that licensees will spend approximately $1000 to calibrate these sources resulting in a $BM burden on NRC and Agreement State licensees. The Comniission has not calculated the impact of determining the output of short-lived sealed therapy sources (e.g. iodine-125, iridium-192) because of the limited information available on the number of sources and variabil!!Y in the type of dosimeter equipment available at a licensee's facility to perform the calibration. The Commission is soliciting specific public input on the number of short and long-lived sources that will need to be calibrated on an annual 98

basis; whether licensees will need to procure additional equipment to perform the calibrations; and the time needed to calibrate the sources. Recordkeeping requirements for this section would appear in § 35.2432, Records of full calibrations on brachytherapy sources. Section 35.490, Training for use of manual brachytherapy sources, would appear as a new section that would revise the training and experience requirements found in § 35.940, Training for use of brachytherapy sources, and subsumes the requirements for training for ophthalmic use of strontium-90. Section Ill of the Supplementary Information section of this document contains a detailed discussion of the Commission's proposed changes to the training and experience requirements in Part 35. Note, 2 years after publication of the final rule, this section will replace the current requirements in§ 35.940, Training for use of brachytherapy and in§ 35.941, Training for ophthalmic use of strontium-90. Subpart G would be retitled Sealed sources for diagnosis. This subpart would contain the requirements for diagnostic medical use of sealed sources and replace the requirements in the current subpart H, Sealed Sources for Diagnosis. Section 35.500, Use of sealed sources for diagnosis, would be revised to delete the specific sources and uses listed in paragraphs (a) and (b). This conforms with the risk-informed, performance-based nature of this proposed rule. The licensee would have flexibility to use sealed sources for diagnostic medical uses as approved in the Sealed Source and Device Registry. 99

Section 35.520, Availability of survey instruments, would be deleted in its entirety because these specific requirements are not neede*d in Part 35. Section 20.1501 of this chapter requires that the licensee make or cause to be made surveys to demonstrate compliance with 10 CFR Part 20 and requires the licensee to ensure that instruments and equipment used to show compliance with 10 CFR Part 20 are periodically calibrated. In addition, § 30.33(a)(2) of this chapter requires the licensee to have adequate instrumentation. Information on the types of instruments recommended for medical licensees is available in draft NUREG-1556, Vol. 9. Section 35.590, Training for use of sealed sources for diagnosis, would appear as a new section. This section is a revision of the training and experience requirements found in § 35.950, Training for use of sealed sources for diagnosis. Section Ill of the Supplementary Information section of this document contains a detailed discussion of the Commission's proposed changes to the training and experience requirements in Part 35. Note, 2 years after publication of the final rule, this section would replace the current requirements in § 35.920, Training for use of sealed sources for diagnosis. Subpart H would be retitled, Therapeutic medical devices, and revised to address all medical uses of sealed sources and devices for therapy. Devices such as teletherapy, remote after1oaders, and gamma radiosurgery units are addressed in this subpart. This section does not contain requirements for manual brachytherapy, which are in subpart F. This subpart would replace the requirements in the current subpart I, Teletherapy, and codify requirements for

                                                                                             \

remote afterloaders and gamma stereotactic radiosurgery units currently imposed by license conditions. 100

Section 35.600 would be retitled, Use of a sealed source in a device for therapeutic medical uses, and revised to delete any references to specific radionuclides and devices. The licensee would have the flexibility to use sealed sources and devices for therapeutic medical uses as approved in the Sealed Source and Device Registry. Section 35.604, Radiation surveys of patients and human research subjects treated. with remote afterloaders, would appear as a new section. This section would require that a licensee make a radiation survey of a patient or human research subject to confirm that the sources h&ve been remov~d from the individual and returned to a shielded position before releasing the individual from licensee control. For fractionated treatments where the patient is not releasable pursuant to § 35. 75, surveys need only be performed after the last time the source is returned to the shielded position. For example, a survey of the patient is not required every time that the source is retracted into the shielded safe when nursing personnel enter the patient treatment room to provide care to patients undergoing fractionated treatments using a low- or pulsed-dose rate remote afterloader. This new requirement was previously imposed on remote afterloader licensees by license condition. Recordkeeping requirements for this section would appear in § 35.2404, Records of radiation surveys of patients and human research subjects. Section 35.605 would be retitled, Installation, maintenance and repair, and revised to clarify that only a person specifically licensed by the Commission or an Agreement State can install, maintain, adjust, or repair a device that involves work on the source shielding, source driving unit, or other electronic or mechanical mechanism that could expose the source, reduce the shielding around the source, or compromise the radiation safety of the device or the sources. It would also be revised to include additional types of devices, rather than just 101

teletherapy units. The Commission is soliciting specific comment on whether the restrictions in paragraph (a) should apply to low dose-rate remote afterloaders. Paragraph (b) would also specify that, except for low dose-rate remote afterloaders, only a person specifically licensed by the Commission or an Agreement State shall install, replace, relocate, or remove a sealed source or source contained in a device. For a low dose-rate remote afterloader, installation, replacement, relocation, or removal of a sealed source must be done by a person specifically licensed by the Commission or an Agreement State or by an

• authorized medical physicist. The exception to allow an authorized medical physicist to perform these activities for low-dose rate remote afterloaders was included in the proposed rule because the Commission believes that the i:adiation hazards associated with installation, replacement, relocation, or removal of a sealed source in these devices are similar to that of manipulation of manual brachytherapy sources. The recordkeeping requirements for this section would appear in § 35.2605, Records of installation, maintenance, and repair.

Section 35.606, License amendments, would be deleted in its entirety. The requirements in the current paragraphs (a), (b), and (d) would be addressed in the proposed revision to§ 35.13(e). Paragraph (c) would be deleted because the licensees must ..,amply with the dose limit requirements in 10 CFR Part 20 and no further limitations are warranted. The requirement in paragraph (e) to file an amendment before allowing an individual to perform the duties of the authorized medical physicist is addressed in the proposed § 35.13(b). Paragraph

-(e) would be deleted because the proposed requirements in subpart H would require that the authorized medical physicist perform specific duties. Any deviations from these .requirements would necessitate an exemption from Part 35.

102

Section 35.610 would be retitled, Safety procedures and instructions for remote afterloaders, teletherapy units, and gamma stereotactic radiosurgery units, and revised to include remote afterloaders and gamma stereotactic radiosurgery units. Paragraph (a) would require that a licensee develop, implement, and maintain safety procedures; locate safety procedures at the unit console; post safety instructions at the device console; and train operators. Par2graphs (a)(1) and (a)(3) would codify requirements that are currently imposed on licensees by license conditions related to use of remote aflerloaders. Because of the applicability of the requirements to all therapy device uses, they were added to the rule with the intent of having the requirements apply to all such device uses. Paragraph (a)(2) would be expanded to apply to all types of therapy devices. However, the Commission recognizes that there are certain design conditions that will necessitate an individual, other than the patient, being in the treatment room during the treatment. An example of this condition is use of a low energy beta or gamma source in a therapeutic medical device where the authorized user may need to be in the room with the patient. This exception does not relieve the licensees from complying with the dose l:""1its for occupationally-exposed individuals or the general public in 10 CFR Part 20. Paragraph (b) would be revised to require that a copy of the licensee's procedures be located at the unit console, and paragraph (c) would be revised to require that the location of the procedures and emergency response telephone numbers be posted Previously, all of the 103

above procedures were required to be posted. This was impractical with the addition of remote afterloaders because error conditions and responses are often several pages in length. Paragraph (d) would be revised to require that, in addition to the initial instruction required in § 35.610, the licensee must provide initial instruction, annual training, and annual practice drills, in specifically identified procedures to all individuals who operate the device. The level of instruction should be commensurate with the individual's assigned duties. For example, an individual need not be instructed in equipment inspection, unless it is expected that during the normal course of the day, the individual will be required to inspect the unit. Tre Commission believes that due to the complexity of therapeutic treatment devices, refresher training and practice drills on emergency response are warranted. The rocordkeeping requirements for this section would appear in § 35.2310, Records of instruction and training. Section 35.615 would be retitled, Safety precautions for remote afterloaders, teletherapy units, and gamma stereotactic radiosurgery units, and revised to include remote afterloaders and gamma stereotactic radiosurgery units. Many of the prescriptive requirements (e.g., beam condition indicator light and radiation monitor) were deleted from this section because they are currently addressed in 1C 8FR Part 20. The requirement in paragraph (d) for intercom systems, and the requirements in paragraphs (e), (f) and (g) would be added to codify requirements that are currently imposed on licensees by license conditions. Current license conditions were modified when they were incorporated into the proposed rule. For example, the presence of an authorized user and medical physicist during patient treatments was clarified for each type of use. As used in this 104

provision, physically present means to be within ear shot of normal voice. Immediately available means that the individual is available on an on-call basis to respond to an emergency. At a minimum, this person must be available by telephone. The Commission believes that the inherent risk of these procedures justifies the prescriptiveness of this regulation and believes that it is important that a proper1y trained physician be available at all times to respond to an emergency requiring source removal. New sources, u,. ing pure beta emitters, are being considered for use in low and high dose-rate remote afterloading brachytherapy units. Because these beta sources present lower radiation risks to medical personnel and the public, the requirements for some of the safety precautions in this section may not be appropriate. The Commission is soliciting specific public comment on whether the requirements in this section should be waved for licensees that are using remote afterloaders with beta-emitting sources. Section 35.620, Possession of survey instruments, would be deleted in its entirety because these specific requirements are not needed in Part 35. Section 20.1501 of this chapter requires that the licensee make, or cause to be made, surveys to demonstrate compliance with 10 CFR Part 20, and requires the licensee to ensure that instruments and equipment used to show compliance with 10 CFR Part 20 are periodically calibrated. In addition, § 30.33(a)(2) of this chapter requires licensees to have adequate equipment Information on the types of instruments recommended for medical licensees is available in draft NUREG-1556, Vol. 9. 105

Section 35.630, Dosimetry equipment, would be revised to provide calibration requirements for instruments used in this subpart and subpart F. Paragraph (a)(1) would require that dosimetry systems be calibrated using a source whose activity is traceable to NIST and in accordance with published protocols approved by a nationally recognized body or by a calibration laboratory approved by MPM. This change would give licensees two alternatives for direct traceability of dosimetry equipment calibration; i.e., either a source or the measurement instrument (e.g., well chamber) can be calibrated against a national standard. The Commission acknowledges that the industry standards for instrument calibration provide adequate assurance that equipment is properly calibrated. Paragraph (a)(2) would be revised to delete the reference to intercomparison meetings sanctioned by a calibration laboratory or radiologic physics centers a~edited by the AAPM. This provision is no longer necessary because the AAPM does not sanction intercomparison meetings. References to cobalt-60 and cesium-137 contained within teletherapy units were deleted from the rule text to make the section applicable to dosimetry equipment for all radionuclides and therapy units. The recordkeeping requirements for this section would appear in § 35.2630, Records of dosimetry equipment. Section 35.632 would be reti'tled, Full calibration measurements on teletherapy units, to clarify that the requirements in this section apply to teletherapy units al)d be revised. Paragraph (d) would be revised to delete the reference to the AAPM Task Group Reports and replace it with a requirement that full calibration measurements be done in accordance with published protocols approved by nationally recognized bodies. This allows the licensee more flexibility in choosing appropriate protocols. The Commission acknowledges that the industry standards for teletherapy unit calibration provide adequate assurance that equipment is 106

properly calibrated. Paragraph (f) would be revised to replace the term "teletherapy physicist" with the term "authorized medical physicist." The recordkeeping requirements for this section would appear in § 35.2632, Records of teletherapy full calibration. Section 35.633, Full calibration measurements on remote afterloaders, would appear as a new section that would contain the requirements for the calibration of remote afterloaders. This section is similar in content to§ 35.632. Requirements in this section would be based on recommendations found in AAPM Task Group Report No. 56. Recordkeeping requirements for this section would appear in § 35.2633, Records of remote after:vcider full calibrations. Section 35.634, Periodic spot-checks, would be deleted in its entirety and the requirements of this section, with minor modifications, would be moved to § 35.642. Section 35.635, Full calibration measurements for gamma stereotactic radiosurgery units, would appear as a new section. This section would contain the requirements for the

• calibration of gamma stereotactic radiosurgery units and is similar in con~ent to § 35.632.

Requirements in this section are based on recommendations found in AAPM Report No. 54 - Stereotactic Radiosurgery (Task Group 42, 1995). Recordkeeping requirements for this section would appear in§ 35.2635, Records of gamma stereotactic radiosurgery unit full calibrations. ' Section ~.636, Safety checks for teletherapy facilities, would be deleted in its entirety and the requirements in this section would be incorporated into proposed§§ 35.642, 35.643, 35.644, and 35.645. 107

Section 35.641, Radiation surveys for teletherapy facilities, would be deleted in its entirety. Radiation surveys at the surface of the main source ;;afe would be addressed under proposed § 35.652. The remaining requirements in the current § 35.641 would be deleted to allow the licensee more flexibility in managing its radiation protection program. Section 35.642 would be retitled, Periodic spot-checks for teletherapy units, and revised. The phrase teletherapy physicist" would be replaced with the term "authorized medical physicist" throughout the section. The requirement in paragraph (c) to maintain a copy of the physic;:;t's notification of the results c~ :,pot-checks to the licensee would be deleted to reduce the recordkeeping requirements for licensees. Paragraph (d) would be modified to require that the safety spot-checks be performed monthly and after each source installation. This revision would replace the safety check requirements after each source replacement in the current § 35.634, which would be deleted in the proposed rule. Paragraph (d)(3) would be modified to replace the term "beam condition indicator with "sol!rce exposure indicator" to clarify that indicators were needed to note whether the source was exposed and note to what degree the source was exposed. Paragraph (d)(4) would be revised to include a requirement for an intercom system that was previously imposed on licensees by license condition. An intercom is needed to assure that the licensee's staff and the patients have the ability to communicate verbally, in addition to the ability to communicate visually. Paragraph (e) would be revised to require that the licensee lock the control console in the off position, and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system, in case of any malfunction identified during a safety spot-check. This revision is intended to make § 35.642 consistent with the requirement in the current § 35.636 regarding immediate actions to be taken 108

when a malfunctioning system is identified. Recordkeeping requirements for this section would appear in § 35.2642, Records of periodic spot-checks for teletherapy units. The requirements in the current§ 35.643 would be deleted to allow a licensee more flexibility in designing a radiation protection program that is specific to its facility and which ensures that the dose limits in 10 CFR Part 20 are not exceeded. Section 35.643, Periodic spot-checks for high and pulsed dose-rate remote afterloaders, W.j..ild appear as a new section. This section would contain the requiiements for periodic spot-checks of high and pulsed dose-rate remote aflerloaders, and is similar in content to § 35.642. Requirements in this section are based on recommendations in AAPM Task Group Report No.

56. Recordkeeping requirements for this section would appear in § 35.2643, Records of periodic spot-checks for remote afterloaders.

Section 35 ..644, Periodic spot-checks for low-dose rate remote afterloaders, would appear as a new section. This revised section would contain the requirements for periodic spot-checks of low dose-rate remote afterloaders and would be similar in content to § 35.642. These proposed requirements are based on recommendations found in the AAPM Task Group Report No. 56. Some requirements were added to make the safety checks, and associateq corrective actions, consistent with the requirements in § 35.642. The Commission is soliciting comment on whether the requirements for electrical interlocks should apply to low-dose rate remote afterloaders. Recordkeeping requirements for this section would appear in § 35.2643, Records of periodic spot-checks for remote afterloaders. 109

The current requirements in § 35.645, would be deleted to reduce the reporting burden on medical use licensees. Survey results are maintained by a licensee to show compliance with 10 CFR Part 20 and, therefore, would be available for review. Section 35.645, Periodic spot-checks for gamma stereotactic radiosurgery units, would appear as a new section. This section would contain requirements for periodic spot-checks of gamma stereotactic radiosurgery units, and is similar in content to § 35.642. Requirements in this section are based on recommendations found in AAPM Report No. 54. Some requirements were added to make the safety checks, and associated correctiv~ actions, consistent with the requirements in § 35.642. Recordkeeping requirements for this section would appear in § 35.2645, Records of periodic spot-checks for gamma stereotactic radiosurgery units. The requirements in the current § 35.647 would be moved to the proposed § 35.655. Section 35.647, Additional technical requirements for mobile remote afterloaders, would appear as a new section. This section would contain the requirements for mobile remote afterloaders which were previously listed in an internal NRC document entitled, "Sui:;:,lement 1 to Policy and Guidance Directive FC 86-4; Revision 1, Mobile Remote Afterloading Brachytherapy Licensing Module." Recordkeeping requirements for this section would appear in§ 35.2647, Records of additional technical requirements for mobile remote afterloaders. Based on discussions with the States, this section is designated as a Category D item of compatibility since there is no potential for medical use of byproduct material in other regulatory 110

jurisdictions under reciprocity. NRC specifically requests comment on this issue relative to whether mobile medical licensees operate under reciprocity in other regulatory jurisdictions. Section 35.652, Radiation surveys, would appear as a new section. This section would replace the current§ 35.641. This section would require that, in addition to the surveys required by 10 CFR 20.1501, the licensee make surveys to assure that the maximum radiation levels and average radiation levels from the surface of the main source safe do not exceed the levels stated in the Sealed Source and Device Registry. These surveys provide added assurance i.hat a device has been manufactured and that source(s) have been installed properly. Recordkeeping requirements for this section would appear in § 35.2652, Records of surveys of therapeutic treatment units. Section 35.655, Five-year inspection for teletherapy and gamma stereotactic radiosurgery units, would appear as a new section and would contain the requirements for inspections which are in the current§ 35.647. Proposed§ 35.655 would require that teletherapy units and gamma stereotactic radiosurgery units be inspected and serviced during source replacement, or at intervals not to exceed 5 years, to assure proper functioning of the source exposure mechan1;:,m. Most gamma stereotactic radiosurgery licensees are required, by license condition, to inspect the units every 7 years; however, professionals in the medical community have indicated that the units are inspected on a more frequent bases. The Commission believes that the risk associated with using gamma stereotactic radiosurgery units justifies a change in the inspection frequency. Recordkeeping requirements for this section would appear in § 35.2655, Records of 5-year inspection for teletherapy and gamma stereotactic radiosurgery units. 111

Section 35.657, Therapy-related computer systems, would appear as a new section that would require licensees to verify that the computerized operating system and treatment planning system associated with a therapy device are operating appropriately and to perform acceptance testing on the treatment planning systems in accordance with published protocols approved by nationally recognized bodies. These changes are consistent with recommendations found in AAPM Task Group Report No. 40 - Comprehensive QA for Radiation Oncology (1994). This proposed requirement is especially important in light of recent inform-.tion on the inability of computers to correctly recognize dates beyond December 31, 1999. Therapy-related computer systems may misread the year 2000 and cause the systems to fail, generate faulty data, or act in an incorrect manner. In particular, computer software used to calculate dose or to account for radioactive decay may not recognize the tum of the century, which could lead to incorrectly calculated doses or exposure times for treatment planning. The potential for system failures, such as this, would be identified when determining compliance with this proposed section. Section 35.690, T. aining for use of therapeutic medical devices, would appear as a ncvV section. This section would revise the training and experience requirements found in § 35.960, Training for teletherapy, and would be expanded to include training for authorized uses of teletherapy, remote afterloaders, and gamma stereotactic radiosurgery units. Section Ill of the Supplementary Information section of this document contains a detailed discussion of training and experience. Note, 2 years after publication of the final rule, this section would replace the current requirements in § 35.960, Training for teletherapy. 112

Subpart J, Training and Experience Requirements, is in the current Part 35. Licensees would have the option to comply with the training and experience requirements in this subpart or in subparts B, and D-H until 2 years after the final rule is published in the Federal Register. At that time this subpart will be deleted. A more detailed discussion of the Commission's proposed changes to the training and experience requirements is in Section Ill of the Supplementary Information section of this document. The proposed schedule for implementation of the training and experience requirements is in Section VIII of the Supplementary Information section of this document. Section 35.900, Radiation Safety Officer, is in the current Part 35. Two changes would be made in this section to correspond to the revised numbering system:§ 35.57, Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized user, and nuclear pharmacist; and § 35.24, Authority and responsibilities for the radiation protection program. This section would be deleted 2 years after the final rule is published in the Federal Register at which time licensees would be required to comply with the training and experience requirements in the new § 35.50, Training for Radiation Safety Officer. Section VIII of the Supplementary Information section of this document contains a detailed discussion of the Commission's proposed implementation of the training and experience requirements. Section 35.901, Training for experienced Radiation Safety Officer, would be deleted in its entirety and the requirements of this section would be moved to the proposed § 35.57. Section 35.910, Training for uptake, dilution, and excretion studies, is in the current Part 35. One change would be made in this section to correspond to the revised numbering 113

system:§ 35.57, Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized user, and nuclear pharmacist. This section would be deleted 2 years after the final rule is published in the Federal Register, at which time licensees would be required to comply with the training and experience requirements in the new § 35.290, Training for uptake, dilution, and excretion studies. Section VIII of the Supplementary Information section of this document contains a detailed discussion of the Commission's proposed implementation of the training and experience requirements. Section 35.920, Training for imaging and localization studies, is in the current Part 35. One change would be made in this section to correspond to the revised numbering system: § 35.57, Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized user, and nuclear pharmacist. This*.section would be deleted 2 years after the final rule is published in the Federal Register, at which time licensees would be required to comply with the training and experience requirements in the new§ 35.292, Training for imaging and localization studies. Section VIII of the Supplementary Information section of this document contains a detailed discussion of the Commission's proposed implementation of the training and experience requirements. Section 35.930, Training for therapeutic use of unsealed byproduct material, is in the current Part 35. One change would be made in this section to correspond to the revised numbering system: § 35.57, Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized user, and nuclear pharmacist. This section would be deleted 2 years after the final rule is published in the Federal Register, at which time licensees would be required to comply with the training and experience requirements in the new § 35.390,. Training 114

for use of unsealed byproduct material for therapy or for use of unsealed byproduct material that requires a written directive. Section VIII of the Supplementary Information section of this document contains a detailed discussion of the Commission's proposed implementation of the training and experience requirements. Section 35.932, Training for treatment of hyperthyroidism, is in the current Part 35. One change would be made in this section to correspond to the revised numbering system: § 35.57, Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized user, and nuclear pharmacist. This section would be deleted 2 y..:.ars after the final rule is published in the Federal Register, at which time licensees would be required to comply with the training and experience requirements in the new § 35.390, Training for use of unsealed byproduct material for therapy or for use of unsealed byproduct material that requires a written directive. Section VIII of the Supplementary Information section of this document contains a detailed discussion of the Commission's proposed implementation of the training and experience requirements. Section 35.934, Training for treatment ~f thyroid carcinom~, is in the current Part 35. One change would be made in this section to correspond to the revised numbering system: § 35.57, Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized user, and nuclear pharmacist. This section would be deleted 2 years after the final rule is published in the Federal Register, at which time licensees would be required to comply with the training and experience requirements in the new § 35.390, Training for use of unsealed byproduct material for therapy or for use of unsealed byproduct material that requires a written directive. Section VIII of the Supplementary Information section of this document contains a 115

detailed discussion of the Commission's proposed implementation of the training and experience requirements. Section 35.940, Training for use of brachytherapy sources, is in the current Part 35. One change would be made in this section to correspond to the revised numbering system:

§ 35.57, Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized user, and nuclear pharmacist. This section would be deleted 2 years after the final rule is published in the Federal Register, at which time licensees would be required to comply with th..; training and experience reqL.::.Jments in the new § 35.490, Training for use of manual brachytherapy sources. Section VIII of the Supplementary Information section of this document contains a detailed discussion of the Commission's proposed implementation of the training and experience requirements.

Section 35.941, Training for ophthalmic use of strontium-90, is in the current Part 35. One change would be made in this section to correspond to the revised numbering system:

§ 35.57, Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized user, and nuclear pharmacist. This section would be deleted 2 years after the final rule is published in the Federal Register, at which time licensees would be required to comply with the training and experience requirements in the new§ 35.490, Training for use of manual brachytherapy sources. Section VIII of the Supplementary Information section of this document contains a detailed discussion of the Commission's proposed implementation of the training and experience requirements.

116

Section 35.950, Training for use of sealed sources for diagnosis, is in the current Part 35. One change would be made in this section to correspond to the revised numbering system:§ 35.57, Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized user, and nuclear pharmacist. This section would be deleted 2 years after the final rule is published in the Federal Register, at which time licensees would be required to comply with the training and experience requirements in the new § 35.590, Training for use of sealed sources for diagnosis. Section VIII of the Supplementary Information section of this document contains a detailed discussion of the Commission's proposed implementation of the trc1ining and experience requirements. Section 35.960, Training for use of therapeutic medical devices, is in the current Part 35. One change would be made in this section to correspond to*the revised numbering system:

 § 35.57, Training for*experienced Radiation Safety Officer, teletherapy or medical physicist, authorized user, and nuclear pharmacist. This section would be deleted 2 years after the final rule is published in the Federal Register, at which time licensees would be required to comply with the training and experience requirements in the new § 35.690, Training for use of therapeutic medical devices. Section VIII of the Supplementary Information section of this document contains a detailed discussion of the Commission's proposed implementation of the training and experience requirements.

Section 35.961 would be retitled, Training for an authorized medical physicist, to reflect that the training and experience requirements in this section apply to authorized medical physicists rather than just teletherapy physicists, and would be revised. In addition, the list of tasks in paragraph (c) would be changed to reflect the new numbering system. This section 117

would be deleted 2 years after the final rule is published in the Federal Register, at which time licensees would be required to comply with the training and experience requirements in the new § 35.51, Training for an authorized medical physicist. Section VIII of the Supplementary Information section of this document contains a detailed discussion of the Comr,nission's proposed implementation of the training and experience requirements. Section 35.970, Training for an authorized nuclear pharmacist, would be deleted in its entirely and the requirements would be moved to the proposed § 35.57. Section 35.971, Physicians training in a three month program, would be deleted in its entirety. Three month nuclear medicine programs are no longer available. Criteria for authorized users are now specified in other areas of the rule. Section 35.980, Training for an authorized nuclear pharmacist, would not be changed. This section would be deleted 2 years after the final rule is published in the Federal Register, at which time licensees would be required to comply with the training and experience requirements in the new § 35.55, Training for an authorized nuclear pharmacist Section VIII of the Supplementary Information section of this document contains a detailed discu&:::m of the Commission's proposed implementation of the training and experience requirements. Section 35.981, *Training for experienced nuclear pharmacists, has not been changed. This section would be deleted 2 years after the publication of the final rule in the Federal Register, at which time licensees would be required to comply with the training and experience requirements in the new § 35.55, Training for an authorized nuclear pharmacist. The 118

Commission solicits specific comment on the impact of deleting this section. Section VIII of the Supplementary Information section of this document contains a detailed discussion of the Commission's proposed implementation of the training and experience requirements. Section 35.990, Violations, would be deleted in its e~tirety, and the requirements of this section, with minor modifications, would be moved to the proposed § 35.4001 Section 35.991, Criminal penalties, would be deleted in its entirety, and the requiremer,ts of this section, with minor modifications, would be moved to the proposed

 § 35.4002.

Section 35.999, Resolution of conflicting requirements during transition period, would be deleted in its entirety, and the requirements of this section, with modifications, would be moved to the proposed § 35.10. Subpart K, Other Medical Uses of Byproduct Material or Radiation from Byproduct Material, would be a new subpart. This subpart was developed to accommodate use of radioactive material in an ..;.merging technology. Section 35.1000, Other medical uses of byproduct material or radiation from byproduct material, is new. It would be added to accommodate emerging technologies. Specific information that must be provided to the Commission in support of an application for use under

 § 35.1000 is provided in§ 35.12(d).

119

Subpart L, Records, is a new subpart. This subpart would contain all the specific recordkeeping requirements necessary to implement the proposed requirements in Part 35. General requirements for record maintenance, such as electronic storage, are provided in § 35.5. Grouping of records into one subpart was done to facilitate use by the licensees, and is consistent with the approach used in part 20. A licensee may reference this section when determining whether something must be recorded, rather than having to review the entire regulation to find out rf there is a particular recordkeeping requirement. Many of the recordkeeping requirements remain unchanged. However, some new sections have been added as a result of new requirements, especially in subpart H. The Commissior is soliciting public comment on whether all recordkeeping requirements should be grouped into one subpart or whether all recordkeeping requirements should be included in the section requiring the record. In addition, the Commission is soliciting specific public comment on which recordkeeping requirements could be deleted irt the final rule and the basis for the deletion. For example, should the recordkeeping requirements in § 35.2063 be retained for byproduct material administered pursuant to §§ 35.100 and 35.200 because of the low risk associated with this type of use? Section 35.2024, ~ecords of authority and responsibility for radiation protection programs, would require the licensee to retain a record of actions taken by the licensee's management in accordance with§ 35.24(a) for 5 years. The 5-year retention period is a reduction from current requirements to maintain records of the approval of licensing actions, individuals, and radiation protection program changes. Currently, similar records are required to be maintained for the duration of the license (reference current§ 35.22 and§ 35.31). This period would allow sufficient time for NRC to review records of licensee actions. 120

It would also require the licensee to retain the copy of the authorities, duties, and responsibilities of the Radiation Safety Officer for the duration of the license. In many cases, these records would take the place of the Radiation Safety Commrttee meeting minutes. The Commission believes that it is important to document licensees' management review and approval of licensing actions, changes to the radiation protection program, and the authorities, duties, and responsibilities of the Radiation Safety Officer. The record of licensing actions and radiation protection program changes must include a summary of actions and a signatu~ of licensee management. In addition, this section would require the licensee to retain a copy of the authorities, duties and responsibilities of the Radiation Safety Officer that includes the signatures of the radiation safety officer and licensee management for the duration of the license. This extended period is warranted in light of the importance of the functions performed by the Radiation Safety Officer.

• Section 35.2026, Records of radiation protection program safety changes, would require the licensee to retain a record of each radiation protection program change, as required by

 § 35.26 for 5 years. The record must include a copy of the old and new procedure, the effeci.ive date of the change, and the signature of the Radiation Safety Officer and licensee management that reviewed and approved the change. The Commission recognizes that t.his requirement for management's signature *is redundant to the requirement in § 35.2024.

However, it believes this approach is warranted in light of the importance of these actions and the intent to keep requirements that are closely related in one subject area. Currently, licensees must retain a record of each "radiation safety program" change until the license has 121

been renewed or terminated. Therefore, this proposed change represents a reduction in burden. This record is needed to document what radiation changes were made in the program. This record facilitates the Commission's evaluation of minor radiation safety program changes and provides licensees with a record of the changes. Section 35.2040, Records of written directives, would require the licensee to retain a copy of written directives required by § 35.40 for 3 years. These records will help to ensure that administrations were in accordance with the written directives. The 3-year recordkeeping retention period corresponds with the current retention period for written directives. Only minor changes were made to the specific items that must currently be recorded in the written directive. These changes were discussed under § 35.40. Section 35.2045, Records of medical events, would require that the licensee maintain a record of medical events reported pursuan~ to § 35.3045 for 3 years. This section, in part, is intended to replace the current recordkeeping requirements in § 35.33. The records made pursuant to § 35.3045 must contain the licensee's name; the name of the prescribing physician; the affected or potentially affected individual's social security number or other identification number if one has been assigned; a brief description of the medical event; why it occurred; the effect on the individual; and the actions taken to prevent recurrence. This record is needed to docµment medical events for licensee and Commission review. The requirement to maintain records of medical events is similar to the current requirement for maintaining records of misadministrations. This proposed requirement would provide for a reduction in licensee burden since medical events records would be required to be maintained for 3 years rather than 5 years. 122

Section 35.2060, Records of instrument calibrations, would require the licensee to maintain a record of dose calibrator calibrations performed in accordance with §§ 35.60 and 35.62 for 3 years. These records are required to document that the instruments are functioning correctly. The name, rather than the signature, of the individual who performed the calibration would be required so that licensees would have the flexibility of using paper records or computer-generated records. This requirement does not prohibit licensees from continuing to have the individual who performed the calibration sign the record. The 3-year recordkeeping retention period is consistent with the current retention period for instrument calibrations: Section 35.2061, Records of radiation survey instrument calibrations, would require the licensee to maintain a record of radiation survey instrument calibrations required by § 35.61 for 3 years. No changes have been made from the current recordkeeping requirements for radiation survey instrument calibrations. These records are required to document that the instruments are functioning correctly. The 3-year recordkeeping retention period is consistent with the current retention period for instrument calibrations .

• Section 35.2063, Records of dosage of unsealed byproduct material for medical use, would require the licensee to maintain a record of dosage determinations required by § 35.63 for 3 years. Minor changes have been made from the current recordkeeping requirements for dosage measurement to delete the requirement to record the expiration date of the radiopharmaceutical. This was done because the expiration date is primarily related to drug stability and sterility. The term "dosage measurement' has been replaced by the term "dosage determination" to be consistent with the change proposed in§ 35.63. Finally, a change would be made to require that the name of the individual who determined the dosage be documented.

123

The licensee will be required to record dosages administered to patients or human research subjects. This record is required for licensees to show that they are maintaining control of radioactive material. The 3-year recordkeeping retention period corresponds with the current retention period for dosage records. Section 35.2067, Records of possession of sealed sources and*brachytherapy sources, would require the licensee to retain records of the leak tests and inventory required by § 35.67 (b) and (g) for 3 years. The record retention period would be reduced from 5 years to 3 years to reduce regulatory burden. The c.., .. 1mission does not believe the extra period is warranted. One change has been made from the current recordkeeping requirements for leak tests and inventories. The name of the individual performing the leak test and inventory would be recorded rather than the signature of the Radiation Safety Officer. Leak test records are required to show that the leak test was done at the appropriate time interval and that sealed sources are not leaking. Inventory records are necessary to show that the possession of sealed sources did not exceed the amount authorized by the license. Section 35.2070, Records of surveys for ambient radiation exposure rate, would require the licensee to maintain records of radiation surveys for 3 years. One change has been made from the current recordkeeping requirements for radiation surveys. The name of the individual performing the survey rather than the initials of the individual would be required to be recorded. These records are needed to document that surveys were performed. The 3-year recordkeeping retention period is consistent with the current retention period for radiation surveys. 124

Section 35.2075, Records of the release of individuals containing radiopharmaceuticals or implants, would require the licensee to maintain records of patient release required by

 § 35.75 for 3 years. No changes have been made from the current recordkeeping requirements in§ 35.75. This record is needed to show compliance with the requirements in§ 35.75.

Section 35.2080, Records of administrative and technical requirements that apply to the provision of mobile services, would require the licensees to maintain a copy of the letter that permits the use of byproduct material at a client's addre.ss of use for 3 years after the last p;0vision of service; and to retain the records of the surveys for 3 years. One change has been made in these records that are required by § 35.80. The name of the individual performing the survey rather than the initials of the individuals would be required to be recorded. The records are needed to show compliance with the requirements in § 35.80. Section 35.2092, Records of waste disi;osal, would require the licensee to maintain records of the disposal of licensed materials made in accordance with § 35.92 for 3 years. Minor changes have been made jn the recordkeeping requirements in the current Part 35. The licensee would no longer be required to record the date that the material was placed in storage because the requirement to store material for 10 half-lives would be deleted in the proposed rule. The record must include the date of the disposal, the radionuclides disposed, the survey instrument used, the background dose rate, the dose rate measured at the surface of each waste container, and the name of the individual who performed the disposal. This record is needed to document that radioactive material is not disposed of as ordinary waste. The 3-year recordkeeping retention period is consistent with the current retention period for waste disposal records. 125

Section 35.2204, Records of molybdenum-99 concentration, would require the licensee to maintain a record of the molybdenum-99 concentration tests required by § 35.204(b) for 3 years. Minor changes have been made in the recordkeeping requirements from the current rule. The licensee would no longer be required to record the measured activity of the technetium expressed in millicuries, and the measured activity of the molybdenum expressed in microcuries. The record must include, for each measured elution of technetium-99m, the ratio for the measures expressed as microcuries of molybdenum per millicurie of technetium, the time and date of the measure, and the name of the individual who performed the disposal. This record is needed to document that the concentration measurement was made and that the maximum molybdenum-99 concentration level was not exceeded. The 3-year recordkeeping retention period is consistent with the current retention period for records of molybdenum-99 concentration. Section 35.2310, Records of instruction and training, would require the licensee to maintain a record of radiation safety instructions required by§§ 35.310, 35.410, and 35.610 for 3 years. The record must include a list of the topics covered, the date of the instruction or training, the name(s) of the attendee(s) and the name of the individual who gave the instruction. This record is needed to document that the instruction and training was given. The 3-year recordkeeping retention period is consistent with the current retention period for training records. Section 35.2404, Records of radiation surveys of patients and human research subjects, would require the licensee to maintain a record of the radiation surveys required by § 35.404 for 3 years. The licensee would no longer be required to record the dose rate from the patient or 126

the human research subject expressed as millirem per hour and measured at 1 meter from the patient or human research subject. Each record must include the date, location, results of the survey, an identification of the patient or the human research subject, survey instrument used, and the name of the individual who made the survey. These records are used to show that sources have not been misplaced and that all sources have been removed from the patient. The 3-year recordkeeping retention period is consistent with the current retention period for surveys. Sec.,tion 35.2406, Records of brachytherapy source inventory, would require the licensee to maintain a record of brachytherapy source accountability required by § 35.406 for 3 years. Changes have been made in the recordkeeping requirements that are in the current rule. The licensee would no longer be required to record the following items since they would be deleted from discussion in § 35.406: the names of the individuals permitted to handle the sources; name and room number of the patient or the human research subject receiving the implant; number and activity of the sources in storage after the removal; and the number and activity of sources in storage after the return .. The proposed rult.- would require that, for temporary implants, the record must include the number and activity of sources removed from and returned to storage; the time and date they were removed from and returned to storage; the location of use; and the name of the individual who removed and returned the sources to storage. For permanent implants, the record must include the number and activity of sources removed from and returned to storage; the date they were removed from and returned to storage; the number 'lnd activity of sources removed from and returned to storage; the number and activity of sources permanently 127

implanted in the patient or human research *subject; and the name of the individual who removed and returned the sources to storage. This record is required so that, if a brachytherapy source is misplaced or missing, the licensee is immediately alerted and can take appropriate action. The 3-year recordkeeping retention period is*consistent with the current retention period for inventory records. Section 35.2432, Records of full calibrations on brachytherapy sources, would require the licensee to retain a record of the results of brachytherapy source calibrations for 3 years after the last use of the source. This is a new recordkeeping section. The recorri must contain the date of the calibration; the manufacturer's name, model number, and serial number for the source and instruments used to calibrate the source; the source output; source positioning accuracy within applicators; and the name of the individual or source manufacturer who performed the calibration. These records are needed to document that the brachytherapy sources have been calibrated. Section 35.2605, Records of installation, maintenance, and repair, would require the licensee to retain a record of the installation, maintenance, and repair of therapeutic medical devices, as required by: 35.605, for 3 years. This is a new recordkeeping section. Previoucly, licensees were not required to keep records of installation, maintenance, and repair. For each installation, maintenance, and repair, the record must include the date, description of the service, and name(s) of the individual(s) who performed the work. This record is necessary to document that the devices are properly installed, maintained, and repaired; to establish trends in device performance; and to establish a service history that may be used in evaluation of generic equipment problems. 128

Section 35.2630, Records of dosimetry equipment, would require the licensee to retain a record of the calibration, intercomparison, and comparisons of its dosimetry equipment done in accordance with § 35.630 for the duration of the license. No changes have been made in the recordkeeping requirements from the current rule. These records are needed to show that calibrations of medical devices were made with properly calibrated instruments. Section 35.2632, Records of teletherapy full calibrations, would requires the licensee to maintain a record of the teletherapy full calibrations required by § 35.632 for 3 years. The record retention perioc would be decreased from the duration of the use of the teletherapy unit source to 3 years to reduce regulatory burden. The term teletherapy physicist was replaced with the term "authorized medical physicist." No other changes were made to the current recordkeeping requirements for this section. These records are needed to document that calibrations were performed in accordance with § 35.632. Section 35.2633, Records of remote afterloader full calibrations, would require the licensee to maintain a record of the remote afterloader full calibrations required by § 35.633 for 3 years. This is a new recordkeeping section. The recordkeeping requirements in this section are similar to the recordkeeping requirements for teletherapy units in § 35.2632. The record must include the date of the calibration; the manufacturer's name, model number, and serial number for the remote afterloader, source, and instruments used to calibrate the unit; the source output; an assessment of timer accuracy and linearity, source positioning accuracy, source guide tube and connector lengths, source retraction functionality; and the signature of the authorized medical physicist who performed the full calibration. These records are needed to document that calibrations were performed ih accordance with § 35.633. 129

Section 35.2635, Records of gamma stereotactic radiosurgery unit full calibrations, would require the licensee to maintain a record of the calibrations required by § 35.635 for 3 years. This is a new recordkeeping section. The recordkeeping requirements in this section are similar to the recordkeeping requirements for teletherapy units in § 35.2632. The record must include the date of the calibration; the manufacturer's name, model number, and serial number for the gamma stereotactic radiosurgery unit, source, and instruments used to calibrate the unit; the unit output; an assessment of the relative heln:,et factors, isocenter coincidence, timer accuracy and linearity, on-off error, and trunnion centricity; and the signature of the authorized medical physicist who performed the full calibration. These records are needec to document that calibrations were performed in accordance with § 35.635. This change reflects corresponding changes made in § 35.642. Section 35.2642, Records of periodic spot-checks for teletherapy units, would require the licensee to retain a record of each periodic spot-check for teletherapy units required by § 35.642 for 3 years. Minor changes have been made in the recordkeeping requirements from the current rule. The licensee would no longer be required to record the operability of the beam condition indicator light, but would be required to record the operability of the source exposure indicator light. This change reflects corresponding changes made in § 35.642. The record must include the date of the spot-check; the manufacturer's name, model number, and serial number for the teletherapy unit source, and instrument used to measure the output of the teletherapy unit; an assessment of timer linearity and constancy; the calculated on-off error, a determination of the coincidence of the radiation field and the field indicated by the light beam localizing device; the determined accuracy of each distance measuring and localization device; the difference between the anticipated output and the measured output; notations indicating the 130

operability of each entrance door electrical interlock, each electrical or mechanical stop, each source exposure indicator light, and the viewing and intercom system and doors; name of the individual who performed the test and the signature of the authorized medical physicist who reviewed the periodic spot-check. These records are needed to document that spot-checks were performed in accordance with § 35.642. The 3-year recordkeeping retention period is consistent with the current retention period for periodic spot-checks. Section 35.2643, Records of periodic spot-checks for remote afterloaders, would require the licensee to retain a record of each spot-check for remote aflcrloaders required by §§ 35.643 and 35.644 for 3 years. This is a new recordkeeping section. The record must include the date of the spot-check; the manufacturer's name, model number, and serial number for both the remote afterloader, source, and instrument used to measure the output of the remote aftertoader; the difference between the anticipated output and the measured output; notations indicating the operability of each entrance door electrical interlock, source retraction mechanism, radiation monitors, source exposure indicator lights, viewing and intercom, applicators and connectors, and source positioning accuracy; the name of the individual who performed the periodic spot-check; and signature of the authorized medical physicist who reviewed the periodic spot-check. These records are needed to document that $pot-checks were performed in accordance with §§ 35.643 and 35.644. Section 35.2645, Records of periodic spot-checks for gamma stereotactic radiosurgery units, would require the licensee to retain a record of each spot-check for gamma stereotactic radiosurgery units required by § 35.645 for 3 years. This is a new recordkeeping section. The record must include the date of the spot-check; the manufacturer's name, model number, and 131

serial number for the gamma stereotactic radiosurgery unit, and the instrument used to measure the output of the unit; the measured source output and source output against computer calculations; notations indicating the operability of radiation monitors, helmet microswitches, emergency timing circuits, emergency off buttons, electrical interlocks, source exposure indicator lights, viewing and intercom systems, timer termination systems, hydraulic cutoff mechanism, and stereotactic frames and localizing devices (trunnions); and the name of the individual who performed the periodic spot-check; and the signature of the authorized medical physicist who reviewed the periodic spot-check. This record is needed to show that spot-cnecks were performed in accu, Janee with § 35.645. Section 35.2647, Records of additional technical requirements for mobile remote afterloaders, would require the licensee to retain a record of each ch~ for mobile remote afterloaders required by § 35.647 for 3 years. This is a new recordkeeping section. The record must include the date of the check; the manufacturer's name, model number, and serial number for the remote afterloader, notations accounting for all sources before departing from a client's facility; notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom system, applicators and connectors, and source positioning accuracy; and the signature of the individual who performed the check. This record is needed to show that required spot-checks were performed in accordance with § 35.647 and that the unit is operable. The 3-year recordkeeping retention period is consistent with the current retention period for checks on mobile remote afterloaders. Section 35.2652, Records of surveys of therapeutic treatment units, would require the licensee to maintain a record of radiation surveys made in accordance with § 35.652 for the 132

duration of use of the unit. This recordkeeping section has been changed to require that the records of radiation surveys of the treatment unit must be maintained for the duration of use of the unit, rather than for the duration of the license, to reduce regulatory burden. In addition, the licensee is no longer required by this section to maintain a plan of the areas surrounding the treatment room that were surveyed, the measured dose rate at several points in each area expressed in millirem per hour, and the calculated maximum quantity of radiation over a period of 1 week for each restricted and unrestricted area. This change reflects corresponding changes made in § 35.652. The record must include the date of the measurements; the n 1anufacturer's name, model number and serial number of the treatment unit, source, and instrument used to measure radiation levels; and each dose rate measured around the source while the unit is in the off position and the average of all measurements and the signature of the individual who performed the surveys. This record is needed to document radiation levels in areas surrounding therapeutic devices. Section 35.2655, Records of 5-year inspection for teletherapy and gamma stereotactic surgery units, would require the licensee to maintain a record of the 5-year inspection for teletherapy and gamma stereotactic radiosurgery units required by § 35.655 for the duration of the unit. This recordkeeping section would be changed to require that the records of inspections of the treatment units must be maintained for the duration of use of the unit, rather than for the duration of the license, to reduce regulatory burden. A minor change was made to delete the requirement to maintain a record of the components replaced to also reduce regulatory burden. The record must contain the inspector's name; the inspector's radioactive materials license number; the date *of inspection; the manufacturer's name and model number and serial number for both the treatment unit and source; a list of components inspected and 133

serviced; the type of service; and the signature of the inspector. This record is needed to document the type of service that was performed. Subpart M, Reports, is a new subpart in Part 35. This subpart would contain all the reporting requirements necessary to implement the proposed requirements in Part 35. Grouping of reporting requirements into one subpart was done to facilitate use by the licensee. A licensee may reference this section when determining whether something must be reported, rather than having to review the entire regulation to find out if there is a particular reporting requirement. Many of the reporting requirements remain unchanged. The Commission is soliciting public comments on whether the reporting requirements should be included in the section requiring the report. Section 35.3045, Reports of medical events, would provide criteria for reporting medical events. The criteria are based on the current requirements in § 35.33. Changes would be made to make the reporting threshold dose-based where possible to add a dose threshold of 0.5 Sv (50 rem) shallow dose equivalent to the skin; and to address two areas that have caused problems in implementing the current requirements in § 35.33 - patient intervention and wrong treatment site. Wrth respect to patient intervention, the licensee is expected to act ,aasonably, in accordance with prevailing standards of care, to prevent a medical event. Generally speaking, patient intervention involves actions by the patient such as dislodging or removing treatment devices or prematurely terminating treatment. In cases where patient intervention is probable, the licensee should take reasonable actions (e.g., extra sutures, taping, or more frequent checks by the nursing staff) to avoid a medical event. Factors which may be considered in determining whether a licensee's actions are reasonable include whether the 134

licensee monitors the patient routinely and whether the licensee responds properly once it becomes aware of the disruption of treatment. The Commission is soliciting input from the public on whether the proposed changes adequately address patient intervention and wrong treatment site. The proposed rule would require that licensees notify, by telephone, the NRG Operations Center no later than the next calendar day after discovery of the medical event. The licensee would be required to submit a written report to the appropriate NRG Regional

• Office listed in 10 CFR 30.6 within 15 days after discovery of the medical event. In addition, the licensee would be required to notify the referring physician and the individual affected by the medical event, or the responsible relative or guardian, no later than 24 hours after its discovery, unless the referring physician personally informs the licensee either that he will inform the individual or that, based on medical judgment, telling the individual would be harmful. This reporting requirement is needed to ensure that NRG is aware of medical events. Section Ill of the Supplementary Information of this document contains a detailed discussion of the Commission's views on the notification requirements.

The proposed rul1:, would require that a written report be furnished to the individual within 15 days after discovery of the medical event. This requirement could be met by sending either a copy of the report that was submitted to the NRG or a brief description of both the event and the consequences as they may affect the individual. The proposed rule would delete the current requirement to include a statement that the report submitted to the NRG can be obtained from the licensee. This deletion does not preclude the license:-e from providing the 135

report to the individual but provides the licensee flexibility in transmitting pertinent information to the individual. Section 35.3047, Report of a dose to an embryo/fetus or a nursing child, would provide reporting criteria. Paragraph (a) would require that a licensee report to NRC any administration of byproduct material, or radiation from byproduct material, to a pregnant woman that results in a dose to an embryo/fetus that is greater than 5 mSv (500 mrem) absorbed dose unless specifically approved, in advance, by the authorized user. It should be emphasized that only unintended exposures would be reported to NRC. This report does not include exposure of individuals in excess of the public dose limits in Part 20. Paragraph (b) would require a licensee to report to NRC any administration of byproduct material to a breast feeding woman that results in a dose to the nursing child that is greater than 5 mSv (500 mrem) total effective dose equivalent. Oral reports must be made to the NRC Operations Center within 5 days of discovery and followed with a written report no later than 15 days. Information required by this section is needed so that ~RC can comply with Section 208 of the Energy Reorganization Act of 1974 (Public Law 93-438),*as amended, to submit an annual report to Congre.:,3 a report of unscheduled incidents or events which the Commissio11 considers significant from the standpoint of public health and safety, e.g., abnormal occurrences. NRC identifies an abnormal occurrence using the revised abnormal occurrence criteria that was puclished in the Federal Register on April 17, 1997 (62 FR 18820). Section II of the policy statement defines unintended radiation exposure as "any occupational exposure, 136

exposure to the general public or exposure as a result of a medical misadministration (as defined in § 35.2) involving the wrong individual that exceeds the reporting values ~tablished in the regulations." This section also states that "All other reported medical misadministrations will be considered for reporting as an Abnormal Occurrence under the criteria for medical licensees. In addition, unintended radiation exposures include any exposure to a nursing child, fetus, or embryo as a result of an exposure (other than an occupational exposure to an undeclared pregnant woman) to a nursing mother or pregnant woman above specified values." Appendix A, Section I. A, of the policy statement, states that NRC_will provide information on "any unintended radiation .:posure to any minor (an individual less than 18 years of age) resulting in an annual total effective dose equivalent of 50 mSv (5 rem) or more, or to an embryo/fetus resulting in a dose equivalent of 50 mSv (5 rem) or more." At the present time, NRC has no regulatory requirements that would require reporting of those types of events. The Commission considered two alternatives that could be pursued: revise the current Abnormal Occurrence Criteria to delete the requirement to inform Congress of this type of event; or develop a reporting requirement that would provide information needed by the Commission to comply with Section 208. The Commission did not pursue the first option because the Abnormal Occurrence reporting criteria were recently revised. Only two comments were received on the proposed criteria in this area. One commenter believed that the threshold for reporting a dose to any minor or embryo/fetus should be reduced to less than 0.350 rem instead of the proposed 5 rem. The second commenter recommended that the criteria related to a nursing :nfant, fetus or embryo as a result of an exposure to a nursing mother or a pregnant woman should be deleted from the criteria until the 137

issue can be resolved through consultation with the ACMUI and a separate public comment period on that issue. The Comf!!ission is not inclined to revise the criteria without public comments indicating that it is not appropriate for NRG to report this type of event to Congress and that the proposed reporting requirement in § 35.3047 is overly burdensome or unwarranted. As a result, the Commission has decided to pursue the second alternative. However, the Commission does solicit specific comments in this area regarding whether modification of the Abnormal

• Occurrence Policy Statement criteria is needed.

The proposed rule would require that licensees report to NRC any unintended exposures to an embryo/fetus or nursing child that exceeds the dose threshold, as specified in the proposed§ 35.3047. The Commission recognizes that the proposed reporting threshold is less than the Abnormal Occurrence reporting level. This was done to make the Part 35 reporting threshold consistent with the reporting thresholds in 10 CFR Part 20. The time period for reporting is similar for the reporting requirements in 10 CFR parts 20 and 35. The proposed rule would aiso require the licensee to notify the referring physician and the pregnant individual or mother within 5 days of discovery of an event that would require reporting under this section, unless the referring physician personally informs the licensee either that he or she will inform the mother or that, based on medical judgment, telling the mother would be harmful. (Note, it is recognized that in some cases, the woman may no longer be pregnant or nursing when the event is discovered. In this situation, it is expected that the individual responsible for the infant's or child's medical care would be notified.) In cases where 138

the pregnant individual or mother was not notified, the notification may be made instead to the mother's or child's responsible relative or guardian. The terminology of the notification provisions of§ 35.3047 is similar to § 35.3045. Due to uncertainties on the part of some licensees as to the scope of the term "responsible relative or guardian, Dthe Commission is soli0ing specific public comment on whether there is a better term than "responsible relative or guardianD to apply to those situations in which the mother is not notified, e.g., in the referring physician's medical judgement, telling the mother would be harmful; the mother is a minor; or the mother is not competent tu make decisions regarding medical care. The Commission is also concerned about notification in situations where the pregnant individual has purposely chosen not to tell others of her pregnancy status and notification to a responsible relative or guardian would be required by this rule, e.g., the individual is a minor and does not want others to know of the pregnancy. As a result of concerns regarding reporting and notification pursuant to this section, the NRG is soliciting specific public comment on the impacts of this reporting requirement on licensee procedures, activities, or medical practices. The Commission recognizes that the standard of practice for authorized users is to assess the pregnancy or nursing status of their patients (reference American College of Radiology "Standard for the Performance of Therapy with Unsealed Radionuclide Sources,* 1996, and *society of Nuclear Medicine General Procedure Guidelines for Imaging with Radionuclides,* 1997). As a result, NRG does not believe that it is appropriate to propose a 139

rule that would require a licensee to assess the pregnancy or nursing status of patients. It does, however, believe that it is appropriate to propose a rule that would require the licensee to inform NRC when it learns of an unintended dose to an embryo/fetus or a nursing child that exceeds the thresholds discussed above. Reporting under § 35.3047 would not necessarily be subject to enforcement action if the licensee had complied with§ 35.75. Although the regulation requires that the licensee provide information on the cause of the incident and corrective actions to prevent recurrence, NRG acknowledges that in many, and if not all, incidents, the licensee might not have been able to prevent the incident because the individual may not have been aware of the prey, 1ancy or may have opted not to disclose her pregnancy or nursing status. Section 35.3067, Reports of leaking sources, would require the licensee to file a report with the appropriate NRC Office listed in § 30.6 of this chapter, with a copy to Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, within 5 days if a leakage test required by § 35.67 reveals the presence of 185 Bq (0.005 microcurie) or more of removable contamination. This reporting requirement is similar to the current requirements for leaking sources. The report must contain the model . number and serial number if assigned, of the leaking source; Radionuclide and its estimated activity; the measured activity of each test sample expressed in microcuries; a description of the method used to measure each test sample; the date of the test; and the action taken. Subpart N, Enforcement, contains statements regarding enforcement. This subpart would replace the statements in the current Subpart K, Enforcement. 140

Section 35.4001, Violations, would appear as a new section and replace the current § 35.990 which would be deleted in the proposed rule. This section reflects the new numbering system for the revised Part 35. Section 35.4002, Criminal penalties, would appear as a new section and replace the current § 35.991 which would be deleted in the proposed rule. This section reflects the new numbering system for the revised Part 35. Appendix A to Part 35, Examining Organization or Entity, would appear as a new appendix. This appendix would provide the requirements for an examining organization or entity; examination programs; and written examinations. This appendix is needed because of the proposed revision to the training and experience criteria for an authorized user, medical physicist, authorized nuclear phannacist, and radiation safety officer that would require an individual to pass an examination given by an organization or entity approved by NRC or an Agreement State. All criteria in Appendix A are considered by the Commission as necessary to assure that an individual's competency is adequately assessed. NRC is proposing that an independent examining organization be an organization that would make its examination process available to the general public nationwide and not restrict access because of race, color, religion, sex, age, national origin or disability. The independent examining organization or entity would need to:* (1) Have adequate staff; (2) Have a viable system of financing its operations; (3) Have a policy and decision making review board; 141

(4) Be governed by written organizational by-laws and policies; (5) Provide NRC or an Agreement State*with a description of its procedures for choosing examination sites and for providing an appropriate examination environment; (6) Submit its request for approval to the Director, Office of Nuclear Materials Safety and Safeguards. An independent examining organization or entity would also need to have: (1) A committee to review and approve the examination guidelines and procedures, and to advise the organization's staff in implementing the examination program; (2) A committee to review complaints from examined individuals; (3) Written procedures describing all aspects of its examination program; (4) An agreement to exchange information about examined individuals with the Commission and the Agreement States; {5) Procedures to ensure that examinations are not given to individuals who have also been instructed by the examining organization in the same subject area; (6) Procedures to ensure that examined individuals are provided due process with respect to the administration of its examination program; (J) Procedures for proctoring examinations; and (8) Procedures to ensure that all examination questions are protected from disclosure. NRC is proposing in Section 11 of Appendix A that all examination programs must (1) require applicants for examination to receive training in the topics set forth in §§ 35.50(b)(1 ), 35.51(b)(1), 35.55(b)(3), 35.290(b)(1), 35.292(b)(1), 35.390(b)(1), 35.490{b)(1) or35.690(b)(1) 142

and satisfactorily complete a written examination covering these topics. NRC is proposing in Section Ill that: (1) The written examination must be designed to test an individual's knowledge and understanding of the topics listed in the above sections; (2) The written examination must have test items drawn from a question bank containing psychometrically valid questions based on the material in the above listed questions; and (3)*A sample examination must be submitted to the Commission for review initially and every 5 years. A 5-year review cycle is consistent with the review of residency programs by the Accreditation Council for Graduate Medical Education. Summary of Specific Issues Identified for Public Comment The Commission is soliciting specific public comment on various issues associated with this rulemaking action. These issues are discussed in detail in the noted sections.

1. Training and Ext,>erience - Is the proposed requirement for examining organizations to ensure that examinations are not given to individuals who have also been instructed by the examining organization in the same subject area too prescriptive? Is the requirement for an examination to verify competency warranted, in light of current industry practice? What is the projected amount of time needed for specialty boards and examining organizations to prepare and submit an application to NRC or Agreement States?

143

2. Section 35.2 - Should the term ~medium dose-rate remote aftertoader" be defined since it not used in the rule? (Requirements for medium dose-rate remote afterloaders have been grouped with high dose-rate remote afterloaders in this rulemaking.)

3. Section 35.6 - Should this section be revised*to require that licensees develop, implement, and maintain procedures for evaluating when a medical procedure would be considered to be a research procedure?

4. Section 35.24 - Will the deletion of the requirement for a Radiation Safety Committee and proposed new requirement for the Radiation Safety Officer to acknowledge, in writing, responsibility for implementing the radiation protection program impact th~ licensee's effectiveness in carrying out its radiation protection program? In particular, will this combination of changes actually reduce the effectiveness of radiation protection programs and will the radiation safety officer be provided appropriate tools and channels through which to raise safety concerns to the highest levels of management. If a requirement for a committee, to oversee the radiation safety program, was included in the final ru:e, should the rule language explicitly require that the radiation safety officer be a member of that committee?

5. Section 35. 75 - Should any changes be made to the release criteria specified in this section?

6. Section 35.92 -- Is it appropriate to delete the requirement to hold byproduct mater;a1 for a minimum of ten half-lives?

7. Section 35.315 - Should the requirement for a private room with a private sanitary facility be maintained in the final rule?

8. Section 35.415 - Should the requirement for a licensee to not quarter a patient in the same room as an individual who is not receiving radiation therapy be maintained in the final rule?

144

9, Section 35.432 - Should the final rule contain a requirement for the licensee to perform full calibration measurements on brachytherapy sources before first use? Should the final rule allow licensees to rely on the brachytherapy source output provided by the manufacturer or distributor if the dosimetry equipment used by the manufacturer or distributor met the calibration requirements in § 35.630? How should sources be calibrated if there is no standard traceable to the National Institute of Standards and Technology? What is the estimated number of short- and long-lived brachytherapy sources that will need to be calibrated by the licensee on an annual basis and how long will it take to perform the calibration? Will licensees need to procL r-e additional equipment to perform the calibrations?

10. Section 35.605 - Should the restrictions in paragraph (a) of the proposed rule apply to low dose-rate remote afterloaders?

11. Section 35.615 - Should the requirements in this section be waived for licensees that are using remote afterloaders with beta-emitting sources?

12. Section 35.644 - Should the restrictions for electrical interlocks and audiovisual systems apply to low dose-rate remote afterloaders?

13. Section 35.981 - What is the impact of deleting this section?

14. Subpart L - Should all recordkeeping requirements be grouped into one subpart or should they be incorporated into the section requiring the record?

15. Subpart M - Should all reporting requirements be grouped into one subpart or should they be incorporated into the section requiring the report?

16. Section 35.3045 - Do the proposed rule changes adequately address patient intervention and wrong treatment site?

17. Section 35.3047 - Should the Abnormal Occurrence Policy Statement criteria for reporting of exposures to an embryo/fetus or nursing child be modified? Is there a better term 145

than "responsible relative or guardian" that could be applied to those situations where the mother is not notified, e.g., in the referring physician's medical judgment telling the mother would be harmful; the mother is a minor; or the mother is not competent to make decisions regarding medical care? What is the impact of the proposed reporting requirement on licensee procedures, activities, or medical practices? V. Coordination With The Advisory Committee on the Medical Uses of Isotopes The Advisory Committee on the Medical Uses of Isotopes (ACMUI) is an advisory body established to advise the NRC staff on matters that involve the administration of radioactive material and radiation from radioactive material. At the public ACMUI meetings on September 25-26, 1997, and March 1-2, 1998, held in Rockville, MD., the NRC staff presented alternatives for major cross-cutting issues related to revising Part 35, recommendations for revising the NRC's Medical Use Policy Statement, and draft proposed rule text. These meetings were transcribed. The ACMUl's comments at the September 1997 meeting are summarized in "Summary of Discussion: Meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) Held in Rockville, Maryland on September 25-26, 199r (April 17, 1998). The summary document is available for inspection at the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. Single copies of the summary document are available as indicated in the For Further Information Contact section of this document. A brief summary of the ACMUI positions on the major crosscutting issues 146

associated with this rulemaking is provided in Section Ill of the Supplementary Information section of this document. Working group members also met with separate ACMUI subcommittees for diagnostic and therapeutic medical uses on February 9-10, 1998 (Rockville, MD.) and February 12-13, 1998 (Freeport, IL.), respectively. The subcommittee meetings provided the Working Group with an opportunity to discuss in depth the specific provisions of the draft proposed rule with ACMUI members. VI. Coordination With NRC Agreem~nt States NRC staff discussed the proposed revision of Part 35 with representatives of the Agreement States at a workshop on October 18, 1997. The workshop commentary was transcribed, and the participant's comments are summarized in "Summary of Discussion: Facilitated Public Workshop on NRC's Medical Rulemaking Initiative Held at All Agreement States Meeting, Los Angeles, California, October 18, 199T (April 17, 1998). The summary document is available for inspection at the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. Single copies of the summary document are available as indicated in the For Further Information Contact section of this document. A brief summary of the workshop participants' positions on the major cross-cutting issues associated with this rulemaking is provided in Section 111 of the Supplementary Information section of this document. 147

Both the Working Group and Steering Group that developed the draft proposed rule included representatives of Agreement States. The Agreement State representative on the Working Group is also a member of the Conference of Radiation Control Directors' Suggested State Regulation Committee on Medical Regulation, which is working toward parallel development of suggested state medical regulations. State participation in the process has provided an early opportunity for State input and should enhance development of corresponding rules in State regulations. In addition, it will allow the State staff to assess the potential impacts of NRC draft language on the regulation of non-Atomic Energy Act materials used in medical diagnosis*, treatment, or research in the States. VII. Consistency with Medical Policy Statement The Commission is proposing a revision to its General Policy on the Regulation of the Medical Uses of Radioisotopes that was issued on February 9, 1979 (44 FR 8424), as part of the efforts undertaken to revise 10 CFR Part 35. The proposed revision and detailed discussion on the need for the revision is being published for comment in the Federal Register concurrently with the proposed revision to Part 35. Because of the nature of the proposed revision to the policy, consistency with each policy will be discussed separately. Consistency wjth the proposed revision to the Medical Use Policy Statement The proposed revision to Part 35 is consistent with the Commission's proposed revision to the Medical Use Policy Statement. 148

The first statement of the proposed policy reads "NRC will continue to regulate the uses of radionuclides in medicine as necessary to provide for the radiation safety of workers and the general public." The proposed rule is consistent with the statement because one of its purposes is to provide for the radiation safety of workers and individual members of the public, which is central to fulfillment of the Commission's statutory mandate to "protect health and minimize danger to life." The second statement of the proposed policy reads "NRC will not intrude into medical juagments affecting patients, except as necessary to provide for the radiation safety of workers and the general public." The proposed rule would also be consistent with this statement because its focus is on protecting the public and workers from patients who have been administered byproduct material or radiation from byproduct material for medical use. The third statement of the proposed policy reads "NRC will, when justified by the risk to patients, regulate the radiation safety of patients primarily to assure the* use of radionuclides is in accordance with the physician's directions." The proposed rule is consistent with this statement because it includes provisions, where warranted by the risk, to provide high confidence that the authorized user's directions for the administration of byproduct material are followed. The fourth statement of the proposed policy reads "NRC, in developing a specific regulatory approach, will consider industry and professional standards that define acceptable approaches of achieving radiation safety." The proposed rule is consistent with this statement because the rulemaking process included examining relevant industry and professional 149

standards to determine if specific areas of concern were included in the standards, or whether regulatory requirements needed to be included in Part 35. Consistency with the 1979 Medical Use Policy Statement The proposed revision to Part 35 is generally consistent with the Commission's General Policy on the Regulation of the Medical Uses of Radioisotopes issued on February 9, 1979 (44 FR 8242). The first statement of the policy reads uThe NRC will continue to regulate the medical uses of radioisotopes as necessary to provide for the radiation safety of workers and the general public." The proposed rule is consistent with this statement because its purpose is to provide for the radiation safety of workers and individual members of the public, which is central to fulfillment of the Commission's statutory mandate to uprotect health and minimize danger to life." The second statement of the policy is "The NRC will regulate the radiation safety of patients where justified by the risk to patients and where voluntary standards, or co1. 1pliance with these standards, are inadequate." The proposed rule is generally consistent with this statement The proposed rule includes requirements to ensure the radiation safety of patients in areas where justified by the risk to patients. The rulemaking process included examining relevant industry and professional standards to determine if specific areas of concern were included in the standards, or whether additional regulatory requirements needed to be developed for inclusion in Part 35. The process did not include an assessment of licensee 150

compliance with these standards. Where appropriate, the proposed revision includes references to published protocols approved by nationally recognized bodies. Where warranted by risk, key elements of the standards were included as performance objectives. Prescriptive compliance requirements for these performance objectives were not included in the rule because it is expected that licensees will use voluntary standards to achieve the objective. This approach is consistent with a performance-based, risk-informed rule. The third statement of the policy reads, "The NRC will minimize intrusion into medical judgments affecting patients and into other areas traditionally considered to be a part of the practice of medicine." The proposed rule is consistent with this statement because it includes no requirements associated with the diagnosis and treatment of patients. VIII. Implementation The Commission intends to have different implementation dates for particular requirements of this proposed rule. Wrth one exception (discussed below), the proposed requirements would be effective 6 months after publication of the final rule in the Federal Register. Because the cu11solidated guidance document for medical use licensees is being developed in parallel with the revised regulatory requirements in Part 35, the Commission believes that a longer implementation period will not be necessary. The 6-month implementation period would allow the NRC time to train licensing and inspecting staff so that the revised Part 35 will be uniformly implemented; and provide licensees the time to understand the specific features of the revised Part 35, and to develop and implem:mt any changes in their radiation safety programs or procedures that are required to comply with the revised 151

requirements. NRC workshops might be offered for the benefit of licensees, Regional Offices, States, and others who are affected by the revision. The Commission proposes that licensees would have up to 2 years after the effective date of the final rule to comply with the proposed training requirements for authorized users, authorized medical physicists, authorized nuclear pharmacists, and Radiation Safety Officers. During this 2-year period, licensees will have the option of complying with either the existing training requirements, which will be retained in subpart J, or the training requirements in subparts B and D-H of the proposed rule. The 2-year implementation period will allow time for potential exf:lmining organizations and entities to prepare an application in accordance with Appendix A of the proposed rule; and for NRC to review and approve the applications submitted in accordance with Appendix A, and to review and approve certification of the specialty boards in §§ 35.50(a), 35.51 (a), 35.55(a), 35.290(a), 35.292(a), 35.390(a), 35.490(a), 35.590(a), and 35.690(a). The 2-year time period will also allow individuals from Agreement States time to satisfy the proposed training requirements in order to work in NRC jurisdiction. After the 2-year implementation period, the requirements in subpart ..i will be deleted. Section 35.10 of the proposed rule addresses how a licensee can determine if it must comply with the requirements of its license conditions or the requirements of the revised Part 35, when it becomes effective. 152

The Commission invites comments and suggestions on the effective date of implementation, including specific information on time and economic considerations, and on additional guidance or documents that would be needed or useful in implementing the proposed revision. IX. Issues of Compatibility for Agreement States 10 CFR PART 35-MEDICAL USE OF BYPRODUCT MATERIAL Under the "Policy Statement on Adequacy and Compatibility of Agreement State Programs" approved by the Commission on June 30, 1997 (62 FR 46517), specific requirements within this rule should be adopted by Agreement States for purposes of compatibility or because of their health and safety significance. Implementing procedures for the Policy Statement establish specific categories which have been applied to categorize the requirements in Part 35. A Category "A" designation means the requirement is a basic radiation protection standard or deals with related definitions, signs, labels or terms necessary for a common understanding of radiation protection principles. Category "A" designated Agreement State requirements should be:. essentially identical to those of the NRC. A Category "B* designation means the requirement has significant direct transboundary implications. Category "B* designated Agreement State requirements should be essentially identical to those of the NRC. A Category "C* designation means the essential objectives of the requirement should be adopted by the State to avoid conflicts, duplications or gaps. The manner in which the essential objectives are addressed in the Agreement State requirement need not be the same as NRC provided the essential objectives are met. A Category "D* designation means the requirement 153

does not need to be adopted by an Agreement State for purposes of compatibility. The Health and Safety (H&S) Category identifies requirements which are not required for compatibility, but which have particular health and safety significance. Agreement States should adopt the essential objectives of such requirements in order to maintain an adequate program. The following discussion identifies the compatibility designations for each section: Subpart A, "General Information,"§ 35.2, "Definitions,* is assigned to Compatibility Category *o,* with the exception of the terms "Agreement State", "authorized user," "medical use,* "prescribed dosage,* "prescribed dose," "sealed source,* "treatment site" and "written directive.* The terms *Agreement State" and "sealed source" are assigned to Compatibility Category "B" because they have significant direct transboundary implications. The terms "authorized user,* "medical event,* "medical use,* "precursor event,* "prescribed dosage," "prescribed dose,* "treatment site" and "written directive" have been assigned to Compatibility Category "C." Section 35.11, "License required," is assigned to Compatibility Category "C." Subpart 8, "General Administrative Requirements," is assigned to Compatibility Category "D," with the exception of nine sections. Section 35.24, "Authority and responsibilities for the radiation protection program"; § ~5.27, *supervision"; § 35.40, -Written directives"; and § 35.41 (a), "Procedures for administrations requiring a written directive" are all assigned to the Health and Safety Category. Section 35.50, "Training for radiation safety officer"; § 35.51, "Training for authorized medical physicist'; § 35.55 "Training for an authorized nuclear pharmacisr; § 35.57, "Training for experienced Radiation Safety Officer, teletherapy or medical 154

physicist, authorized user, and nuclear pharmacist;" and§ 35.59, "Recentness of training" are assigned to Compatibility Category "C." Subpart C, "General Technical Requirements," is assigned to Compatibility Category "D," with the exception of five sections. Section 35.61, "Calibration and check of survey instruments";§ 35.63(a), "Determination of dosages of unsealed byproduct material for medical use";§ 35.67, "Requirements for possession of sealed sources and brachytherapy sources"; and§ 35.70(a) and (b), "Surveys of ambient radiation exposure rate* are assigned to the Health and Safety Category. Section 35.75, "Release of individuals co,,Laining radiopharmaceuticals or implants," paragraph (a), is assigned to Compatibility Category "C: Subpart D, "Unsealed Byproduct Material - Low Dose"; and Subpart E, "Unsealed Byproduct Material - High Dose" are assigned to Compatibility Category "D,

• except for

§ 35.100, "Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required"; § 35.200, "Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required"; § 35.204, "Permissible molybdenum-99 concentration*; and § 35.300, "Use of unsealed byproduct material for which a written directive is required," which are assigned to the Health and Safety Category. Section 35.290, *Training for uptake, dilution, and excretion studies"; and§ 35.292, "Training for imaging and localization studies"; and § 35.390, "Training for use of unsealed byproduct material for therapy or for use of unsealed byproduct material that requires a written directive," are assigned to Compatibility Category "C.

• 155

Subpart F, "Manual Brachytherapy" is assigned to Compatibility Category "D,~ with the exception of five sections. Section 35.400, "Use of sources for manual brachytherapy"; § 35.404(a) and (b), "Radiation surveys of patients or human research subjects treated with implants"; § 35.406(a) and (b), "Brachytherapy sources inventory"; and § 35.432(a-e), "Full calibration measurements of brachytherapy sources* are assigned to the Health and Safety Category. Section 35.490, "Training for use of manual brachytherapy sources," is assigned to Compatibility Category "C." Subpart G, "Sealed Sources ;ur Diagnosis," is assigned to Compatibility Category "D," with the exception of Section 35.590, "Training for use of sealed sources for diagnosis" which is assigned to Compatibility Category "C." Subpart H, "Therapeutic Medical Devices," is assigned to Compatibility Category *o,* with the exception of 16 sections. The following sections are assigned to the Health and Safety Category: §§ 35.600; 35.604(a); 35.605; 35.610(a)(1), (a)(2), and (a)(4); 35.615(a), (b)(1), (b)(2), (d), and (e); 35.630; 35.632; 35.633; 35.635; 35.642; 35.643; 35.644; 35.645; 35.655; and 35.657. Section 35.690, "Training for use of therapeutic medical devices" is assigned to Compatibility Category "C.

• Subpart J,"Training and Experience Requi~ments,* Subpart K, "Other Medical Uses of Byproduct Material or Radiation from Byproduct Material,* and Subpart L, "Records,* are assigned to Compatibility Category "D."

Subpart M, "Reports,* is assigned to Compatibility Category "C." 156

Subpart N, "Enforcement," is assigned to Compatibility Category "D." Appendix A, "Examining Organization or Entity," is assigned to Compatibility Category "B." PART 20-STANDARDS FOR PROTECTION AGAINST RADIATION Section 20.1301(a)(3) is assigned to Compatibility Category "A." PART 32-SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL Section 32.72 (b)(1) and (b)(2)(ii) and§ 32.74 (a) and (a)(3) are assigned to Compatibility Category "B." As discussed under Section VIII of this document, the Commission proposes that licensees would have up to 2 years after the effective date of the final rule to comply with the proposed training requirements ~or authorized users, authorized medical physicists, authorized nuclear pharmacists, and Radiation Safety Officers. During this 2-year period, licensees would have the option of complying with either the existing training requirements in subpart J, or the proposed training requirements in subparts B and D through H. At the end of the 2 years, subpart J would be deleted and licensees would have to comply with the proposed training and experience criteria. The training and experience requirements in the proposed subpart J are assigned to Compatibility Category "D, n as they are in the current rule. Subparts B and D 157

through H of the proposed rule have been assigned to Compatibility Category "C" for Agreement States. Under the "Policy Statement on Adequacy and Compatibility of Agreement State Programs/ approved by the Commission on June 30, 1997, the Agreement States are required to adopt NRC program elements (or promulgate regulations) required for compatibility within 3 years of the effective date of the NRC rulemaking. Therefore, the Commission recognizes that if an Agreement State does not revise its regulations until 2 years after the effective date of the NRC rule, it may choose not to include subpart J training and experience requirements in the newly promulgated rules, since the subpart J requirements are assigned to Compatibility Category "D" (not required for compatibility). In this case, the Agreement States would only be expected to adopt the proposed training and experience requirements in subparts B and D through H. X. Finding of No Si9niflcant Environmental Impact Availability The Commission has determined under the National Environmental Policy Act of 1969, as amended, and the Commission's regulations in subpart A of 10 CFR Part 51, that the proposed amendments, if adopted, would be a major Federal action but would not significantly affect the quality of the human environment, and therefore an environmental impac~ statement is not required. The proposed amendments would relax certain requirements and eliminate other procedural restrictions associated with the medical use of byproduct material. The Commission believes these proposed amendments would provide greater flexibility in the medical use of byproduct material while continuing to adequately protect public health and safety. The proposed amendments to Part 35, if adopted, would not cause any significant increase in radiation exposure to the public or radiation release to the environment beyond the 158

exposures or releases currently resulting from the medical use of byproduct material. The proposed amendment to 10 CFR 20.1301 is expected to result in an increase in radiation exposure to the public. However, this alternative is consistent with generally accepted radiation protection principles, such as those expressed by the International Commission on Radiation Protection (ICRP), the National Council on Radiation Protection and Measurements (NCRP), and the International Atomic Energy Agency (IAEA). The draft environmental assessment on which this determination is based is available for inspedon at the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. Single copies of the environmental assessment are available as indicated in the For Further Information Contact section of this document. XI. Paperwork Reduction Act Statement This proposed rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This rule has been submitted to the Office of Management and Budget for review and approval of the paperwork requirements. Because the rule will reduce existing information collection requirements, the public burden for this information collection is expected to be decreased by approximately 74 hours per licensee. This reduction includes the time required for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the information collection. The U.S. Nuclear Regulatory Corimission is seeking 159

public comment on the potential impact of the information collection in the proposed rule and on the following issues:

1. Is the proposed information collection necessary for the proper performance of the functions of the NRC, including whether the information will have practical utility?

2. Is the estimate of burden accurate?

3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?

4. How can the burden of the information collection be minimized, including the use of automated collection techniques?

Send comments on any aspect of this proposed information collection, including suggestions for further reducing the burden, to the Records Management Branch (T-6 F33), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by Internet electronic mail at BJS1@nrc.gov; and to the Desk Officer, Office of Information and Regulatory Affairs, NEOB-10202, (3150-0010 and 3150-0120), Office of Management and Budget, Washington, DC, 20503. Comments to or.~B on the information collections or on the above issues should be submitted by (insert date 30 days after publication in the Federal Register). Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given to comments received after this date. 160

Public Protection Notification If an information collection does not display a currently valid 0MB control number, the NRC may not conduct or sponsor, and a person is not required to respond to, the information collection. XII. Regulatory Analysis The Commissi~n has prepared a draft regulatory analysis for the proposed rule. The analysis examines the costs and benefits of the alternatives considered by the Commission. The draft analysis is available for inspection at the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. Single copies of the regulatory analysis are available as indicated in the For Further Information Contact section of this document. The Commission requests public comment on the draft regulatory analysis. Comments on the draft regulatory analysis may be submitted to the NRC as indicated under the Addresses section of this document. XIII. Regulatory Flexibility Analysis The NRC has prepared an initial regulatory flexibility analysis of the impact of this proposed rule on small entities. The preliminary regulatory flexibility analysis indicates that the proposed rule will have an economic impact of approximately $8,000 annually on medical licensees, of which 36 percent are small entities. However, the NRC notes that this would be a 161

substantial reduction in the cost to the average licensee under the current regulations. The NRC estimates that the proposed requirements would reduce the annual cost to an average medical licensee by approximately $1500. The NRC believes that the proposed alternative is the least costly alternative that provides adequate protection from radiation exposure for patients and workers. The regulatory flexibility analysis appears as Appendix A to this document. Because of the widely differing conditions under which small medical licensees operate, the NRC is seeking comments on the impact of the rule and any suggested modifications ~hat may affect its economic impact. Any small medical licensee that would be subject to this regulation that determines, because of its size, that it is likely to bear a disproportionate adverse economic impact, should notify the Commission of this in a comment that indicates-(a) The licensee's size and how this proposed regulation would result in a significant economic burden upon the licensee as compared to the economic burden on a larger licensee; (b) How the proposed regulations could be modified to take into account the licensee's differing needs or capabilities; (c) The benefits that would accrue, or the detriments that would be avoided, if the proposed regulations were modified as suggested under paragraph (b) above; (d) How the proposed regulation, as modified, would more closely equalize its impact as opposed to providing special advantages to any individual licensee or groups of licenses; and (e) How the proposed regulations, as modified, would still adequately protect the public health and safety. 162

The comments should be sent to the NRG as indicated under the Addresses section of this document. XIV. Backfit Analysis The NRG has determined that the backfit rule does not apply to this proposed rule and, therefore, that a backfit analysis is not required for this proposed rule because these amendments would not involve any provision that would impose backfits as defined in 10 CFR

• Chapter I.

List of Subjects 10 CFR Part 20 Byproduct material, Criminal penalties, Licensed material, Nuclear mate~als, Nuclear power plants and reactors, Occupational safety and health, Packaging and containers, Radiation protection, *Reporting and recordkeeping requirements, Special nuclear material, Source material, Waste treatment and disposal. 10 CFR Part 32 Byproduct material, Criminal penalties, Labeling, Nuclear materials, Radiation Protection, Reporting and recordkeeping requirements. 163

10 CFR Part 35 Byproduct material, Criminal penalties, Drugs, Health facilities, Health professions, Medical devices, Nuclear materials, Occupational safety and health, Radiation protection, Reporting and recordkeeping requirements. For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 553, the NRG is proposing to adopt the following amendments to 10 CFR parts 20, 32 and 35. PART 20-STANDARDS FOR PROTECTION AGAINST RADIATION

1. The authority citation for Part 20 continues to read as follows:

AUTHORITY: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68 Stat. 930, 933, 935, 936,937,948,953,955, as amended, sec. 1701, ~06 Stat. 2951, 2952, 2953 (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236, 2297f), secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).

2. In§ 20.1301, paragraph (a)(3) is added to read as follows:

§ 20.1301 Dose limits tot individual members of the public. (a) * * * (3) Notwithstanding paragraph (a)(1) of this section, a licensee may permit visitors to individuals who are not released in accordance with§ 35.75 to receive a radiation dose greater 164

than (1 mSv) 0.1 rem, but not to exceed (5 mSv) 0.5 rem, if the authorized user, as defined in 10 CFR Part 35, determines that it is appropriate. PART 32-SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL

3. The authority citation for Part 32 continues to read as follows:

AUTHORITY: Secs. 81, 82, 161, 182, 183, 68 Stat. 935,943,953,954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).

     § 32,72 [Amended]

4. In§ 32.72, in paragraph (b)(1), the reference to a10 CFR 35.25" is revised to read a10 CFR 35.27" and in paragraph (b)(2)(ii), the reference to *10 CFR 35.980(b) and 35.972" is revised to read "10 CFR 35.55(b) and 35.59 or 10 CFR 35.980(b) and 35.972."

     § 32. 74 [Amended]

5. In§ 32.74, in paragraph (a), the reference to"§§ 35.400 and 35.500" is revised to read "§§ 35.400, 35.500, and 35.600" and in paragraph (a)(3), the reference to "§§ 35.58, 35.400, or 35.500" is revised to read a§§ 35.400, 35.500, and 35.600."

6. 10 CFR Part 35 is revised to read as follows:

165

PART 35-MEDICAL USE OF BYPRODUCT MATERIAL Subpart A--General Information Sec. 35.1 Purpose and scope. 35.2 Definitions. 35.5 Maintenance of records. 35.6 Provisions for research involving human subjects.

35. 7 FDA, other Federal, and State requirements.

35.8 Information collection requirements: 0MB approval. 35.10 Implementation. 35.11 License required. 35.12 Application for license, amendment, or renewal. 35.13 License amendments. 35.14 Notifications. 35.15 Exemptions regarding Type A specific licenses of broad scope. 35.18 License issuance.

35. 19 Specific exemptions.

Subpart B-General Administrative Requirements 35.24 Authority and responsibilities for the radiation protection program. 35.26 Radiation protection program changes. 35.27 Supervision. 166

35.40 Written directives. 35.41 Procedures for administrations requiring a written directive. 35.49 Suppliers for sealed sources or devices for medical use. 35.50 Training for Radiation Safety Officer. 35.51 Training for an authorized medical physicist. 35.55 Training for an authorized nuclear pharmacist. 35.57 Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized user, and nuclear pharmacist. 35.59 Recantness of training. Subpart C-General Technical Requirements 35.60 Possession, use, calibration, and check of instruments to measure the activity of photon-emitting radionuclides. 35.61 Calibraµon and check of survey instruments. 35.62 Possession, use, calibration, and check of instruments to measure dosages of alpha- or beta-emitting radionuclides. 35.63 Determination of dosages of unsealed byproduct material for medical use. 35.65 Authorization for c.::libration and reference sources. 35.67 Requirements for possession of sealed sources and brachytherapy sources. 35.69 Labeling and shielding of vials and syringes.

35. 70 Surveys for ambient radiation exposure rate.

35. 75 Release of individuals containing radiopharmaceuticals or implants.

35.80 Provision of mobile service. 35.92 Decay-in-storage. 167

Subpart D-Unsealed Byproduct Material - Low Dose 35.100 Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required. 35.200 Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required. 35.204 Permissible molybdenum-99 concentration. 35.290 Training for uptake, dilution, and excretion studies. 35.292 Training for imaging and localization studies. Subpart E - UnseaJed Byproduct Material - High Dose 35.300 Use of unsealed byproduct material for which a written directive !s required. 35.310 Safety instruction. 35.315 Safety precautions. 35.390 Training for use of unsealed byproduct material for therapy or for use of _unsealed byproduct material that requires a written directive. Subpart F-Manual Brachytherapy 35.400 Use of sources f::- manual brachytherapy. 35.404 Radiation surveys of patients or human research subjects treated with implants. 35.406 Brachytherapy sources inventory. 35.410 Safety instruction. 35.415 Safety precautions. 35.432 Full calibration measurements of brachytherapy sources. 35.490 Training for use of manual brachytherapy sources. 168

Subpart G -Sealed Sources for Diagnosis 35.500 Use of sealed source$ for diagnosis. 35.590 Training for use of sealed sources for diagnosis. Subpart H-Therapeutic Medical Devices 35.600 Use of a sealed source in a device for therapeutic medical uses. 35.604 Radiation surveys of patients and human research subjects treated with remote afterloaders . 35.605 Installation, m2'ntenance, and repair. 35.610 Safety procedures and instructions for remote afterloaders, teletherapy units, and gamma stereotactic radiosurgery units. 35.615 Safety precautions for remote afterloaders, teletherapy units, and gamma stereotactic radiosurgery units. 35.630 Dosimetry equipment. 35.632 Full calibration measurements on teletherapy units. 35.633 Full calibration measurements on remote afterloaders. 35.635 Full calibration measurements on gamma stereotactic radiosurgery units. 35.642 Periodic spot-checks for teletherapy units. 35.643 Periodic spot-checks for high dose-rate and pulsed dose-rate remote afterloaders. 35.644 Periodic spot-checks for low dose-rate remote afterloaders. 35.645 Periodic spot-checks for gamma stereotactic radiosurgery units. 35.647 Additional technical requirements for mobile remote afterloaders. 35.652 Radiation surveys. 35.655 Five-year inspection for teletherapy and gamma stereotactic radiosurgery units. 169

35.657 Therapy-related computer systems. 35.690 Training for use of therapeutic medical devices . Subpart I - Reserved Subpart J-Training and Experience Requirements 35.900 Radiation Safety Officer. 35.910 Training for uptake, dilution, and excretion studies. 35.920 Training for i~aging and localization studies. 35.930 Training for therapeutic use of unsealed byproduct material. 35.932 Training for treatment of hyperthyroidism. 35.934 Training for treatment of thyroid carcinoma. 35.940 Training for use of brachytherapy sources. 35.941 Training for ophthalmic use of strontium-90. 35.950 Training for use of sealed sources for diagnosis. 35.960 Training for use of therapeutic medical devices. 35.961 Training for an authorized medical physicist. 35.980 Training for an authorized r.uclear pharmacist. 35.981 Training for experienced nuclear pharmacists. 170

Subpart K-Other Medical Uses of Byproduct Material or Radiation from Byproduct Material 35.1000 Other medical uses of byproduct material or radiation from byproduct material. Subpart L - Records 35.2024 Records of authority and responsibilities for radiation protection programs. 35.2026 Records of radiation program safety changes. 35.2040 Records of written directives. 35.2045 Records of medical events. 35.2060 Records of instrument calibrations. 35.2061 Records of radiation survey instrument calibrations. 35.2063 Records of dosages of unsealed byproduct material for medical use. 35.2067 Records for possession of sealed sources and brachytherapy sources. 35.2070 Records of surveys for ambient radiation exposure rate. 35.2075 Records of the release of individuals containing radiopharmaceuticals or implants. 35.2080 Records of administrative and technical requirements that apply to the provision of mobile services. 35.2092 Records of waste disposal. 35.2204 Records of molybdenum-99 concentration. 35.2310 Records of instruction and training. 35.2404 Recoras of radiation surveys of patients and human research subjects. 35.2406 Records of brachytherapy source inventory. 35.2432 Records of full calibrations on brachytherapy sources. 35.2605 Records of installation, maintenance, and repair. 171

35.2630 Records of dosimetry equipment. 35.2632 Record~ of teletherapy full calibrations. 35.2633 Records of remote afterloader full calibrations. 35.2635 Records of gamma stereotactic radiosurgery unit full calibrations. 35.2642 Records of periodic spot-checks for teletherapy units. 35.2643 Records of periodic spot-ch~cks for remote afterloaders. 35.2645 Records of periodic spot-checks for gamma stereotactic radiosurgery units. 35.2647 Records of additional technical requirements for mobile remote afterloaders. 35.26:2 Records of surveys of ther::;:3utic treatment units. 35.2655 Records of 5-year inspection for teletherapy and gamma stereotactic radiosurgery units. Subpart M -Reports 35.3045 Reports of medical events. 35.3047 Report of a dose to an embryo/fetus or a nursing child. 35.3067 Reports of leaking sources. Subpart N - Enforcement 35.4001 Violations. 35.4002 Criminal penalties. Appendix A to 10 CFR Part 35 - Examining Organization or Entity 172

AUTHORITY: Secs. 81, 161, 182, 183, 68 Stat. 935,948,953,954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841). Subpart A-General Information § 35.1 Purpose and scope. This part prescribes requirements and provisions for the medical use of byproduct material and for issuance of specific licenses authorizing the medical use of this material. These re4uirements and provisions provide for the radiation safety of worke,-s, the general public, patients, and human research subjects. The requirements and provisions of this part are in addition to, and not in substitution for, others in this chapter. The requirements and provisions of parts 19, 20, 21, 30, 71, 170, and 171 of this chapter apply to applicants and licensees subject to this part unless specifically exempted. § 35.2 Definitions. Address of use means the building or buildings that are identified on the license and where byproduct material may be received, used, or stored. Agreement State means any State with which the Commission or the Atomic Energy Commission has entered into an effective agreement under subsection 274b of the Atomic Energy Act of 1954, as amended. Area of use means a portion of an address of use that has been set aside for the purpose of receiving, using, or storing byproduct material. Authorized medical physicist means a physicist who - (1) Meets the requirements in §§ 35.51 (a) and 35.59 or §§ 35.961 and 35.59; or 173

(2) Is identified as a medical physicist on a Commission or Agreement State license; or (3) Is identified as a medical physicist on a permit issued by a Commission or Agreement State specific licensee of broad scope that is authorized to permit the use of byproduct material. Authorized nuclear pharmacist means a pharmacist who - (1) Meets the requirements in §§ 35.55(a) and 35 59 or§§ 35.980(a) and 35.59; or (2) Is identified as an authorized nuclear pharmacist on a Commission or Agreement State license that authorizes the use of byproduct material in the practice of nuclear pharmacy; or (3) Is identified as an authorized nuclear pharmacist on a permit issued by a Commission or Agreement State specific licensee of broad scope that is authorized to permit the use of byproduct material in the practice of nuclear pharmacy; or (4) Is approved as an authorized nuclear pharmacist by a nuclear pharmacy authorized by the Commission to approve authorized nuclear pharmacists. Authorized user means a physician, dentist, or podiatrist who - (1) Meets the requirements in §§ 35.290(a), 35.292(a}, 35.390(a), 35.490(a), 35.590(a), or 35.690(a) and§ 35.59, or§§ 35.910, 35.920, 35.930, 35.932, 35.934, 35.940, 35.941,

• 35.950, 35.960 and § 35.59; or (2) Is identified as an authorized user on a Commission or Agreement State li~nse that authorizes the medical use of byproduct material; or (3) Is identified as an authorized user on a permit issued by a Commission or Agreement State specific licensee of broad scope that is authorized to permit the medical use of byproduct material.

174

Brachytherapy source means a radioactive sealed source or a manufacturer-assembled source train or a combination of these sources that is designed to deliver a therapeutic dose within a distance of a few centimeters. Dedicated check source means a radioactive source that is used to assure the constant operation of a radiation detection or measurement device over several months or years. Dentist means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice dentistry. Diagnostic clinical procedures manual means a collection of written procedures that describes &ach method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration. High dose-rate *remote afterloader, as used in this part, means a device that remotely delivers a dose rate in excess of 2 gray (200 rads) per hour at the point or surface where the dose is prescribed. Low dose-rate remote afterloader as used in this part, means a device that remotely delivers a dose rate of less than 2 gray (200 rads) per hour at the point or surface where the dose is prescribed. Management mer:,, ,s the chief executive officer or that person's delegate or delegates. Medical event means an event that meets the criteria in § 35.3045(a). Medical institution means an organization in which several medical disciplines are practiced. Medical use means the intentional internal or external administration of byproduct material or the radiation from byproduct material to patients or human IT'..Search subjects under the supervision of an authorized user. 175

Mobile service means the transportation and medical use of byproduct material by the same licensee at temporary jobsites. Output means the exposure rate, dose rate, or a quantity related in a known manner to these rates from a teletherapy unit for a specified set of exposure conditions. Pharmacist means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice pham,acy. Physician means a medical doctor or doctor of osteopathy licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine. Podiatrist means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice podiatry. Prescribed dosage means the quantity of radiopham,aceutical activity as documented - (1) In a written directive; or (2) Either in the diagnostic clinical procedures manual or in any appropriate record in accordance with the directions of the authorized user for diagnostic procedures. Prescribed dose means - (1) For gamma stereotactic radiosurgery, the total dose as documented in the written directive; (2) For teletherapy, the total dose and dose per fraction as documented in the written directive; (3) For brachytherapy, either the total source strength and exposure time or the total dose, as documented in the written directive; or (4) FClr remote afterloaders, the total dose as documented in the written directive. 176

Pulsed dose-rate remote afterfoader means a special type of remote afterloading device that uses a single source capable of delivering dose rates in the "high dose rate" range, but is used to simulate the radiobiology of a low dose rate treatment by inserting the source for a given fraction of each hour. Radiation Safety Officer means the individual identified as the Radiation Safety Officer on a Commission license who - (1) Meets the requirements in§§ 35.50 and 35.59 or§§ 35.900 and 35.59; or (2) Is identified as a Radiation Safety Officer on a Commission or: Agreement State license. Sealed source means any byproduct material that is encased in a capsule designed to prevent leakage or escape of the byproduct material. Sealed Source and Device Registry means the national registry that contains all the registration certificates, generated by both NRC and the Agreement States, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product. Stereotactic radiosurgery means the use of external radiation in conjunction with a stereotactic guidance device to very precisely deliver a dose to a tissue volume. Structured educational program means an educational program designed to impart particular knowledge and practical education through interrelated studies and supervised training. Temporary jobsite means a location where mobile services are conducted other than those location(s) of use authorized on the license. Treatment site means the anatomical description of the tissue intended to receive a radiation dose, as described in a written directive. 177

Unit dosage means a dosage intended for medical use in a single patient or human research subject that has been obtained from a manufacturer or preparer licensed pursuant to § 32. 72 of this chapter or equivalent Agreement State requirements. Written directive means an authorized user's written order for the administration of byproduct material or radiation from byproduct material to a specific patient or human research subject, as specified in § 35.40. § 35.5 Maintenance of records. Each record required by this part must be legible throughout the retention period specified by each Commission regulation. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable bf producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete*r:ecords during the required retention period. Records such as letters, drawings, and specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records. § 35.6 Provisions for research involving human subjects. A licensee may conduct research involving human subjects using byproduct material provided that the research is conducted, funded, supported, or regulated by another Federal Agency which has implemented the Federal Policy for the Protection of Human Subjects. Otherwise, a licensee shall apply for and receive approval of a specific ame~ment to its NRC license before conducting such research. Both types of licensees shall, at a minimum, obtain 178

informed consent from the human subjects and obtain prior review and approval of the research activities by an "Institutional Review Board" in accordance With the meaning of these terms as defined and described in the Federal Policy for the Protection of Human Subjects.

 § 35.7 FDA, other Federal, and State requirements.

Nothing in this part relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs or devices .

• § 35.8 lnfonnation collection requirements: 0MB approval.

(a) The Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (0MB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid 0MB control number. 0MB has approved the information collection requirements in this part under control number 3150-0010. (b) The approved information collection requirements contained in this part appear in

 §§ 35.6, 35.12, 35.13, 35.14, 35.24, 35.26, 35.27, 35.40, 35.41, 35.50, 35.51, 35.55, 35.60, 35.61, 35.62, 35.63, 35.67, 35.69, 35.70, 35.75, 35.80, 35.92, 35.204, 35.290, 35.292, 35.310, 35.315, 35.390, 35.404, 35.406, 35.410, 35.415, 35.432, 35.490, 35.590, 35.604, 35.605, 35.610, 35.630, 35.632, 35.633, 35.635, 35.642, 35.643, 35.644, 35.645, 35.647, 35.652, 35.655, 35.690, 35.900, 35.910, ~.920, 35.930, 35.940, 35.950, 35.960, 35.961, 35.980, 35.981, 35.2024, 35.2026, 35.2040, 35.2045, 35.2060, 35.2061, 35.2063, 35.2067, 35.2070, 35.2075, 35.2080, 35.2092, 35.2204, 35.2310, 35.2404, 35.2406, 35.2432, 35.2605, 35.2630, 179

35.2632, 35.2633, 35.2635, 35.2642, 35.2643, 35.2645, 35.2647, 35.2652, 35.2655, 35.3045, 35.3047, 35,3067, and Appendix A. (c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and the con.trol numbers under which they are approved as follows: (1) In§ 35.12, NRC Form 313, including NRC Forms 313A, and 3138 which licensees may use to provide supplemental information, is approved under control number 3150-0120. (2) [Reserved] § 35.1 O Implementation. (a) A licensee shall implement the provisions in this part on or before [insert date 6 months from publication of the Final Rule], with the exception of the requirements listed in paragraph (b) of this section. (b) A licensee shall implement the training requirements in §§ 35.50(a), 35.51 (a), 35.55(a), 35.59, 35.290(a), 35.292(a), 35.390(a), 35.490(a), 35.590(a), and 35.690(a) on or before [insert date- 2 years from publication of the Final Rule]. (c) Prior to ~nsert date- 2 years from publication of the Pinal Rule], a licensee shall satisfy the training requirements of this part for a Radiation Safety Officer, an authorized medical physicist, an authorized nuclear pharmacist, or an authorized user by complying with either: (1) The appropriate training requirements in sub~rt J; or (2) The appropriate training requirements in subpart B or subparts D-H. 180

(d) If the requirements of this part are more restrictive than the existing license condition, the licensee shall comply with this part unless exempted by paragraph (f) of this section. (e) Any existing license condition that is more restrictive than a requirement in this part remains in effect until there is a license amendment or license renewal. (f) If a license condition exempted a licensee from a provision of Part 35 on [insert date- 6 months from publication of the Final Rule], it will continue to exempt a licensee from the corresponding provision in this part. (g) If a license condition cites provisions in Part ~5 that will ba deleted on [insert date-6 months from publication of the Final Rule], then the license condition remains in effect until there is a license arnendment or license renewal that modifies or removes this condition.

  § 35.11 License required.

(a) A person may not manufacture, produce, acquire, receive, possess, use, or transfer byproduct material for medical use except in accordance with a specific license issued by the

• • Commission or an Agreement State, or as allowed in paragraph (b) or (c) of this section.

(b) An individual may receive, possess, use, or transfer byproduct material in accordance with the regulations in this chapter under the supervision of an authorized user as provided in§ 35.27, unless prohibited by license condition. (c) An individual may prepare unsealed byproduct material for medical use in accordance with the regulations in this chapter under the supervision of an authorized nuclear pharmacist or authorized user as provided in§ 35.27, unless prohibited by license condition. 181

§ 35.12 Appllcatio'! for license, amendment, or renewal. (a) An application must be signed by the management of the facility. (b) An application for a license for medical use of byproduct material as described in §§ 35.100, 35.200, 35.300, 35.400, and 35.500, and for medical use of remote afterloaders in § 35.600, must be made by filing an original and one copy of NRG Form 313, "Application for Material License." A request for a license amendment or renewal may be submitted as an original and one copy in letter format. (c) Except for medical use of remote afterloaders, a separate license application must be filed for each medical use of byproduct material as described in § 35.600 by filing an original and one copy of NRG Form 313. A request for a license amendment or renewal may be submitted as an original and one copy in letter format. (d) An application for a license for medical use of byproduct material as described in § 35.1000 must be made by filing an original and one copy of NRG Form 313. (1) In addition to the information required in NRG Form 313, the application must also include information regarding any radiation safety aspects of the medical use of the material that is not addressed in Subparts A through C of this part, as well as any specific information necessary for - (i) Radiation safety precautions and instructions; (ii) Training and experience of proposed users; (iii) Methodology for measurement of dosages or doses to be administered to patients or human research subjects; and (iv) Calibration, maintenance, and repair of instruments and equipment necessary for radiation safety. 182

(2) The applicant or licensee shall also provide any other information requested by the Commission in its review of the application. (e) An applicant that satisfies the requirements specified in § 33.13 may apply for a Type A specific license of broad scope.

 § 35.13 License amendments.

A licensee shall apply for and must receive a license amendment - (a) Before it receives or uses byproduct material for a type of use that is pennitted under this .:>art, but that is not authorized on the licensee's current license issued pursuant to this part; (b) Before it permits anyone to work as an authorized user, authorized nuclear pharmacist, or authorized medical physicist under the license, except an individual who is - (1) An authorized user who meets the requirements§§ 35.290(a), 35.292(a), 35.390(a), 35.490(a), 35.590(a), or 35.690(a) and § 35.59, or§§ 35.910, 35.920, 35.930, 35.932, 35.934, 35.940, 35.941, 35.950, 35.960 and§ 35.59;

• (2) An authorized nuclear phannacist who meets the requirements in § 35.55(a) and

 § 35.59; or §§ 35.980 and 35.59; (3) An authorizet.: medical physicist who meets the requirements in § 35.51 (a) and
 § 35.59; or§§ 35.961 and 35.59; (4) Identified as an authorized user, an authorized nuclear pharmacist, or authorized medical physicist on a Commission or Agreement State license that authorizes the use of byproduct material in medical use or in the practice of nuclear pharmacy, respectively; or (5) Identified as an authorized user, an authorized nuclear phaM1acist, or authorized medical physicist on a permit issued by a Commission or Agreement State specific licensee of 183

broad scope that is authorized to permit the use of byproduct material in medical use or in the practice of nuclear pharmacy, respectively. (c) Before it changes Radiation Safety Officers; (d) Before it orders byproduct material in excess of the amount, or radionuclide or form that is different than the radionuclide or form authorized on the license; (e) Before it adds to or changes the areas identified in the application or on the license, except for areas where byproduct material is used in accordance with §§ 35.100 and 35.200; and (f) Before it changes the address(es) of use identified in the application ('r on the license. § 35.14 Notifications. (a) A licensee shall provide to the Commission a copy of the board certification, the Commission or Agreement State license, or the permit issued by a licensee of broad scope for each individual no later than 30 days after the date that the licensee permits the individual to work as an authorized user, an authorized nuclear pharmacist, an authorized medical physicist, pursuant to§ 35.13 (b)(1) through (b)(5). (b) A licensee st..:111 notify the Commission by letter no later than 30 days after: (1) An authorized user, an authorized nuclear pharmacist, a Radiation Safety Officer, or an authorized medical physicist permanently discontinues performance of duties under the license or has a name change; (2) The licensee's mailing address changes; (3) The licensee's name changes, but the name change does not constitute a transfer of control of the license as described in § 30.34(b) of this chapter; or 184

(4) The licensee has added to or changed the areas where byproduct material is used in accordance with §§ 35.100 and 35.200. (c) The licensee shall mail the documents required in this section to the appropriate address identified in § 30.6 of this chapter. § 35.15 Exemptions regarding Type A specific licenses of broad scope. A licensee possessing a Type A specific license of broad scope for medical use is exempt from - (a) The provisi'1ns of§ 35.13(b); (b) The provisions of § 35.13(e) regarding additions to or changes in the areas of use only at the addresses specified in the license; (c) The provisions of§ 35.14(a); (d) The provisions of§ 35.14(b)(1) for an authorized user, an authorized nuclear pharmacist, or an authorized medical physicist; and (e) The provisions of§ 35.49(a). § 35.18 License issuance. (a) The Commission shall issue a license for the medical use of byproduct material r. - (1) The applicant has filed Form NRC-313 "Application for Materials License" in accordance with the instructions in§ 35.12; (2) The applicant has paid a~y applicable fee as provided in Part '1 70 of this chapter, (3) The Commission finds the applicant equipped and committed to observe the safety standards established by the Commission in this Chapter for the protection of the public health and safety; and 185

(4) The applicant meets the requirements of Part 30 of this chapter. (b) The Commission shall issue a license for mobile services if the applicant: (1) Meets the requirements in paragraph (a) of this section; and (2) Assures that individuals or human research subjects to whom radiopharmaceuticals or radiation from implants will be administered may be released following treatment in accordance with§ 35.75. § 35.19 Specific exemptions. The Commission may, upon application of any interested person or upon its own initiative, grant such exemptions from the regulations iri this part as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest. Subpart 8-General Administrative Requirements § 35.24 Authority and responsibilities for the radiation protection program. (a) In addition to the radiation protection program requirements of§ 20.1101 of this chapter, a licensee's management must approve in writing - (1) Requests for license application, renewal, or amendments before submittal to the Commission; (2) Any individual before allowing that individual to work as an authorized user, authorized nuclear pharmacist, authorized medical physicist; and (3) Radiation protection program changes that do not require a license amendment and are permitted under § 35.26; 186

(b) A licensee with multiple modalities or multiple users shall also develop, implement, and maintair, written administrative procedures for interdepartmental/interdisciplinary coordination of the licensee's radiation protection program. (c) A licensee's management shall appoint a Radiation Safety Officer, who agrees in writing to be responsible for implementing the radiation protection program. The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements in the daily operation of the licensee's radiation protection program (d) A licensee shall establish in writing the authority, du!:~s. and responsibilities of the Radiation Safety Officer. (e) A licensee shall provide the Radiation Safety Officer sufficient authority, organizational freedom, time, resources, and management prerogative, to - (1) Identify radiation safety problems; (2) Initiate, reco~mend, or provide corrective actions; (3) Stop unsafe operations; and, (4) Verify implementation of corrective actions. (f) A licensee shall retain a record of actions taken pursuant to paragraphs (a), (c), and (d) of this section in accordance with § 35.2024. § 35.26 Radiation protection program changes. (a) A licensee may revise its radiation protection program without Commission approval if-(1) The revisions do not require an amendment under§ 35.13; (2) The revisions do not reduce radiation safety; 187

(3) The revisions have been reviewed and approved by the Radiation Safety Officer and licensee management; and (4) The affected individuals are instructed on the revised program before the changes are implemented. (b) A licensee shall retain a record of each change in accordance with§ 35.2026. § 35.27 Supervision. (a) A licensee that permits the receipt, possession, use, or transfer of byproduct mate:-:al by an individual under the t:.:~rvision of an authorized user or as allowed by § 35.11 (b) of this part shall - (1) Instruct the supervised individual in the licensee's written radiation protection procedures, written directive procedures, regulations of this chapter, and license conditions with respect to the use of byproduct material; and (2) Require the supervised individual to follow the instructions of the supervising authorized user for medical uses of radioactive material, written radiation protection procedures established by the licensee, regulations of this chapter; and license conditions with respect to the medical use of byproduct material. (b) A licensee that permits the preparation of byproduct material for.medical use by an individual under the supervision of an authorized nuclear pharmacist or physician who is an authorized user, as allowed by § 35.11 (c), shall - (1) Instruct the supervised individual in the *preparation of byproduct material for medical use, as appropriate to that individual's use of byproduct material; and (2) Require the supervised individual to follow the instructions of the supervising authorized user or authorized nuclear pharmacist regarding the preparation of byproduct 188

material for medical use, the written radiation protection procedures established by the licensee and the regulations of this chapter, and license conditions. (c) A licensee shall establish, implement, and maintain a policy for all supervised individuals to request clarification, as needed, from - (1) The authorized user, before initiating or continuing any procedure that requires a written directive, if the supervised individual has any question about what should be done or how it should be done; and (2) The authorized user or authorized nuclear pharmacist about the instructions and ra.:juirements provided to the supervised individual in accordance wit, paragraphs (a) and (b) of this section. (d) A licensee that permits supervised activities under paragraph (a) and (b) of this section is responsible for the acts and omissions of the supervised individual. § 35.40 Written directives. (a) A written directive must be prepared, dated, and signed by an authorized user prior to administration of 1-131 sodium iodide greater than 1.11 Megabequerels (Mbq) (30 microcuries (µCi) ), any therapeutic dosage of a radiopharmaceutical, or any therapeutic dose of radiation from byproduct material. 1 1 If, because of the emergent nature of the patient's condition, a delay In order to provide a written dfrective would jeopardize the patient's health, an oral dlrecbve will be acceptable, provided that the infonnatlon contained in the oral directive is documented immediately In writing In the patient's record and a written directive is prepared within 48 hours of the oral directive. If, because of the patient's condition, a delay in order to provide a wntten revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive will be acceptable, provided that the oral revision Is documented lmmedlately in the patient's record and a revised written directive is signed by the authorized user within 48 hours of the oral revision. Also, a written revision to an existing written directive may be made for any diagnostic or therapeutic procedure provided that the revision is dated and signed by an authorized user prtor to the administration of the racf10pharmaceutlcal dosage, the brachytherapy dose, the gamma stereotactJc radiosurgery dose, the teletharapy dose, or the next teletherapy fractional dose. 189

(b) The written directive must contain the patient or human research subject's name and the following: (1) For any administration of quantities greater than 1.11 MBq (30 µCi) of sodium iodide 1-131: the dosage; (2) For a therapeutic administration of a radiopharmaceutical other than sodium iodide 1-131: the radiopharmaceutical, dosage, and route of administration; (3) For gamma stereotactic radiosurgery: target coordinates (including gamma angle), collimator size, plug pattern, total dose for the treatment, and the total treatment volume; (4) For teletherapy: the total dose, dose per fraction, number of fractions, treatment site, and overall treatment period; (5) For remote afterloading brachytherapy: the radionuclide, treatment site, dose per fraction, number of fractions, and total dose; or (6) For all other brachytherapy: (i) Prior to implantation: treatment site, the radionuclide, number of sources and source strengths or dose; and (ii) After implantation but prior to completion of the procedure: the radionuclide, treatment site, and total source strength and exposure time (or, equivalently, the total dose). (c) The licensee shall retain the written directive in accordance with § 35.2C 10. § 35.41 Procedures for administrations requiring a written directive. (a) For any administration requiring a written directive, the licensee shall develop, implement, and maintain written procedures to provide high confidence that: (1) The patient's or human research subject's identity is verified before each administration; and 190

(2) Each administration is in accordance with the written directive. (b) The procedures required by paragraph (a) of this section must, at a minimum, address - (1) Verifying the identity of the patient or human research subject; (2) Verifying that the specific details of the administration are in accordance with the written directive and treatment plan; (3) Checking both manual and computer-generated dose calculations; and (4) Verifying that any computer-generated dose *calculations are correctly transfe~ into the co,1soles of therapeutic medical devices authorized by § 35.600.

 § 35.49 Suppliers for sealed sources or devices for medical use.

A licensee may use for medical use only - (a) Sealed sources or devices manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant to 10 CFR Part 30 and § 32. 7 4 of this chapter or the equivalent requirements of an Agreement State; or

• (b) Teletherapy sources manufactured and distributed in accordance with a license issued pursuant to 10 CFR Part 30 or the equivalent requirements of an Agreement State.

 § 35.50 Training for Radiation Safety Officer Except as provided in§ 35.57, the licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer (RSO) as provided in § 35.24 to be an individual who-191

(a) Is certified by a speciality board whose certification process includes all of the requirements in paragraph (b) of this section and whose certification has been approved by the Commission or; (b)(1) Has completed a structured educational program consisting of both: (i) 200 hours of didactic training in the following areas-(A) Radiation physics and instrumentation; (B) Radiation protection; (C) Mathematics pertaining to the use and measurement of radioactivity; (D) Radiation biology; and (E) Radiation dosimetry; and (ii) One year of full-time radiation safety experience under the supervision of the individual identified as the RSO on a Commission or Agreement State license that authorizes similar type(s) of use(s) of byproduct material involving the following; (A) Shipping, receiving, and performing related radiation surveys; (B) Using and performing checks for proper operation of dose calibrators, survey meters, and instruments used to measure radionuclides; (C) Securing and controlling byproduct material; (D) Using admi1 ,:3trative controls to avoid mistakes in the administration of byproduc~ material; (E) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures; and (F) Disposing of byproduct material; and (2) ~as obtained written certification, signed by a preceptor RSO, that the requirements in paragraph (b)(1) of this section have been satisfactorily completed and that the individual has 192

achieved a level of competency sufficient to independently function as an RSO for medical uses of byproduct material; and (3) Following completion of the requirements in paragraph (b) of this section, has demonstrated sufficient knowledge in radiation safety commensurate with the use requested by passing an examination given by an organization or entity approved by the Commission in accordance with Appendix A of this part; or (c) Is an authorized user, authorized medical physicist, or authorized nuclear pharmacist identified on the licensee's license and has experience with the radiation safety aspects of similar type 3 of use of byproduct material for which the individual has RSO responsibilities. § 35.51 Training for authorized medical physicist The licensee shall require the authorized medical physicist to be an individual who - (a) Is certified by a speciality board whose certification process includes all of the training and experience requirements in paragraph (b) of this section and whose certification has been approved by the Commission; or (b)(1) Holds a master's or doctor's degree in physics, biophysics, radiological physics, medical physics, or health physics, or an equivalent training program approved by the NRC, I and has completed one year of full-time training in therapeutic radiological physics and an additional year of full-time practical experience under the supervision of a medical physicist at a medical instiMion that includes the tasks listed in §§ 35.67, 35.632, 35.633, 35.635, 35.642, 35.643, 35.644, 35.645 and 35.652, as applicable; and (2) Has obtained written certification, signed by a preceptor authorized medical physicist, that the requirements in paragraph (b)(1) in this section have been satisfactorily 193

completed and that the individual has achieved a level of competency sufficient to independently function as an authorized medical physicist; and, (3) Following completion of the requirements in paragraph (b)(1) of this section, has demonstrated sufficient knowledge in radiation safety commensurate with the use requested by passing an examination given by an organization or entity approved by the Commission in accordance with Appendix A of this part. § 35.55 Training for an authorized nuclear pharmacist The licensee shall require the authorized nuclear pharmacist to be a pharmacist who - (a) Is certified as a nuclear pharmacist by a speciality board whose certification process includes all of the requirements in paragraph (b) of this section and whose certification has been approved by the Commission, or (b)(1) Has completed 700 hours in a structured educational program consisting of both: (i) Didactic training in the following areas - (A) Radiation physics and instrumentation; (B) Radiation protection; (C) Mathematics pertaining to the use and measurement of radioactivity; (D) Chemistry of byproduct material for medical use; and (E) Radiation biology; and Oi) Supervised practical experience in a nuclear pharmacy involving - (A) Shipping, receiving, and performing related radiation surveys; (B) Using and performing checks for proper operation of dose calibrators, survey meters, and, if appropriate, instruments used to measure alpha- or beta-emitting radionuclides; 194

(C) Calculating, assaying, and safely preparing dosages for patients or human research subjects; (D) Using administrative controls to avoid medical events in the administration of byproduct material; and (E) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures; and (2) Has obtained written certification, signed by a preceptor authorized nuclear ph~rmacist, that the requirements in paragraph (b)(1) have been satisfactorily completed and that the individual has achieved a level of competency sufficien! ~o independently operate a nuclear pharmacy; and (3) Following completion of the requirements in paragraph (b)(1) of this section, has demonstrated sufficient knowledge in radiation safety commensurate with the use requested by passing an examination given by an organization or entity approved by the Commission in accordance with Appendix A of this part. § 35.57 Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized user, and nuclear pharmacist (a) An individual identified as a Radiation Safety Officer, a teletherapy or medical physicist, or a nuclear pharmacist on a Commission or Agreement State license before [insert date-6 months from publication of the Final Rule] need not comply_with the training requirements of§§ 35.50 and 35.51, respectively. (b) Physicians, dentists, or podiatrists identified as authorized users for the medical, dental, or pediatric use of byproduct material on a Commission or Agreement State license issued before [insert date-6 months from publication of the Final Rule] who perform only those 195

medical uses for which they were authorized on that date need not comply with the training requirements of Subparts C-H. § 35.59 Recentness of training. The training and experience specified in subparts B, D, E, F, G, H, and J must have been obtained within the 7 years preceding the date of application or the individual must have had related continuing education and experience since the required training and experience was completed. Subpart C--::eneral Technical Requirements § 35.60 Possession, use, calibration, and check of instruments to measure the activity of photon-emitting radionuclides. (a) For other than unit dosages, a licensee shall possess and use instrumentation to measure the activity of photon-emitting radionuclides prior to administration to each patient or human research subject. (b) If a licensee uses instrumentation to measure the activity of dosages of photon-emitting radionuclides, including unit dosages, it shall develop, implement, and maintain written procedures for proper operation of the instrumentation. At a minimum, a licensee shall - (1) Perfonn tests, before initial use and following repair, on each instrument for accuracy, linearity, and geometry dependence; (2) Perfonn an accuracy test annually; (3) Perfonn a linearity test annually over the range of medical use; and (4) Check each instrument for constancy and proper operation at the beginning of each day of use. 196

(c) Accuracy tests must be performed with source(s) with a principal photon energy of between 100 and 500 keV whose ~ctivity is traceable to the National Institute of Standards and Technology (NIST) or by a supplier who has compared the source to a source that was calibrated by NIST. (d) A licensee shall mathematically correct dosage readings for any geometry or linearity error that exceeds 10 percent if the dosage is greater than 1.11 MBq (30 µCi) and shall repair or replace the instrumentation if the accuracy or constancy error exceeds 10 percent. (e) A licensee shall retain a record of each check and test required by this section in aCM>rdance with § 35.2060. § 35.61 Calibration and check of survey instruments. (a) A licensee shall calibrate the survey instruments used to show compliance with this part and 10 CFR Part 20 before first use, annually, and following repair. A licensee shall - (1) Calibrate all scales with readings up to 10 mSv (1000 mrem) per hour with a radiation source; (2) Calibrate two separated readings on each scale that will be used to show compliance with this part; and (3) Conspicuously note on the instrument the date of calibration. (b) A licensee shall consider a point as calibrated if the indicated exposure rate differs from the calculated exposure rate by not more than 20 percent, and conspicuously attach a correction chart or graph to the instrument if the indicated exposure rate differs from the calculated exposure rate by more than 10 percent. (c) Survey instruments must be removed from use if the indicated exposure rate differs from the calculated exposure rate by more than 20 percent. 197

(d) A licensee shall retain a record of each survey instrument calibration in accordance with § 35.2061. § 35.62 Possession, use, calibration, and check of instruments to measure dosages of alpha- or beta-emitting radionuclides. (a) For other than unit dosages, a licensee shall possess and use instrumentation to measure the radioactivity of alpha- or beta-emitting radionuclides. A licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha- or beta-emitting radionuclides prior to administration to each patient or human research subject. (b) A licensee shall develop, implement, and maintain written procedures for use of the instrumentation. At a minimum, a licensee shall - (1) Perform tests before initial use, and following repair, on each instrument for accuracy, linearity, and geometry dependence, unless it is not appropriate for the use of the instrument; and make adjustments when necessary; (2) Perform accuracy annually; (3) Perform linearity tests annually over the range of medical use; and (4) Check each instrument for constancy and proper operation at the beginr.;:,g of each day of use. (c) Accuracy tests must be performed with source(s) that are traceable to NIST or by a supplier who has compared the source to a source that was calibrated by NIST. (d) A licensee shall retain a record of each check and test required by this section in accordance with § 35.2060. 198

§ 35.63 Determination of dosages of unsealed byproduct material for medical use. (a) A licensee shall detennine and record the activity of each dosage prior to medical use. (b) For a unit dosage of an alpha-, beta-, or photon-emitting radionuclide, this detennination must be made either by direct measurement or by a decay correction, based on the measurement made by a manufacturer or preparer licensed pursuant to § 32. 72 of this chapter or equivalent Agreement State requirements. (c) For a dosage of a alpha-, beta-, or photon-emitting radionuclide prepared by the licensee, th;s detennination must be made by direct measurement or by combination of measurements and calculations. {d) A licensee shall not use a dosage if the dosage differs from the prescribed dosage by more than 20 percent. (e) A licensee shall retain a record of the dosage detennination required by this section in accordance with § 35.2063. § 35.65 Authorization for calibration and reference sources. Any person authorized by § 35.11 for medical use of byproduct material may receive, possess, and use the folk,.ving byproduct material for check. calibration, and reference use: (a) Sealed sources manufactured and distributed by a person licensed pursuant to § 32. 74 of this chapter or equivalent Agreement State regulations and that do not exceed 1. 11 kBq (30 mCi) each; (b) Any byproduct material with a half-life not longer than 120 days in indMdual amounts not to exceed 0.555 MBq (15 mCi); 199

(c)

• Any byproduct material with a half-life longer than 120 days in individual amounts not to exceed 7.4 MBq ( 200 µCi) each and not to exceed 1000 times the quantities in Appendix B of Part 30 whichever is more limiting; and (d) Technetium-99m in amounts as needed.

§ 35.67 Requirements for possession of sealed sources and brachytherapy sources. (a) A licensee in possession of any sealed source or brachytherapy source shall follow the radiation safety and handling instructions supplied by the manufacturer, and shall maintain the instructions for the duration of source use in a legible form convenient to use~. (b) A licensee in possession of a sealed source shall - (1) Test the source for leakage before its first use unless the licensee has a certificate from the supplier indicating that the source was tested within 6 months before transfer to the licensee;and

    .  (2) Test the source for leakage at intervals not to exceed 6 months or at other intervals approved by the Commission or an Agreement State in the Sealed Source and Device Registry.

(c) To satisfy the leak test requirements of this section, the licensee shall measure the sample so that the leakage test can detect the presence of 185 Bq (0.005 µCi) of radioactive material on the sample. (d) A licensee shall retain leakage test records in accordance with§ 35.2067. (e) If the leakage test reveals the presence of 185 Bq (0.005 µCi) or more of removable contamination, the licensee shall - (1) Immediately withdraw the sealed source from use and store, dispose, or cause it to be repaired in accordance with the requirements in parts 20 and 30 of this chapter; and (2) File a report within 5 days of the leakage test in accordance with § 35.3067. 200

(f) A licensee need not perform a leakage test on the following sources: (1) Sources containing only byproduct material with a half-life of less than 30 days; (2) Sources containing only byproduct material as a gas; (3) Sources containing 3.7 MBq (100 µCi) or less of beta or gamma-emitting material or 0.37 MBq (10 µCi) or less of alpha-emitting material; (4) Sources stored for less than a 10-year period and not being used. The licensee shall, however, test each such source for leakage before any use or transfer unless it has been leakage-tested within 6 months before the date of use or transfer; and (5) Seeds of iridium-192 encased in nylon ribbon. (g) A licensee in possession of sealed sources or brachytherapy sources, except for gamma stereotactic radiosurgery sources, shall conduct a semi-annual physical inventory of all such sources in its possession. The licensee shall ~tain each inventory record in accordance with § 35.2067. § 35.69 Labeling and shielding of vials and syringes. (a) A licensee shall develop, implement, and maintain written procedures for - (1) Labeling each syringe, syringe shield, or vial shield that contains a radiopharmaceutical to identify the radiopharmaceutical name, or its abbreviation, c&,,d to ensure that the contents are conspicuously identified as containing radioactive material; and (2) Shielding vials and syringes containing radiopharmaceuticals. (b) A licensee shall instruct individuals, commensurate with the individual's assigned duties, in the procedures required by paragraph (a) of this section. 201

§ 35. 70 Surveys for ambient radiation exposure rate. (a) Except as provided in paragraph (b) of this section, a licensee shall survey with a radiation detection survey instrument at the end of each day of use all areas where radiopharmaceuticals requiring a written directive were prepared for use or administered. (b} A licensee does not need to perform the surveys required by paragraph (a) of this section in an area(s} where patients or human research subjects can not be released pursuant to§ 35.75. {c) A licensee shall retain a record of each survey in accordance with§ 35.2070. § 35.75 Release of individuals containing radiopharmaceuticals or implants. . (a) A licensee may authorize the release from its control of any individual who has been administered radiopharmaceuticals or implants containing radioactive material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 5 mSv (0.5 rem). 2 {b) A licensee shall provide the released individual, or the individual's parent or guardian, with instructions, including written instructions, on actions recommended to maintain doses to other individuals as low as is reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed 1 mSv (0.1 rem). If the total effective dose equivalent to a breast-feeding infant or child could exceed 1 mSv {0.1 rem) assuming there were no interruption of breast-feeding, the instructions shall also include - (1) Guidance on the interruption or discontinuation of breast-feeding; and (2) Information on the potential consequences, if any, of failure to follow the guidance. 2 Regulatory Guide 8.39, "Release of Patients Administered Radioactive Materials," describes methods for calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding 0.5 rem (5 mSv). 202

(c) A licensee shall maintain a record of the basis for authorizing the release of an individual, in accordance with§ 35.2075(a). (d) The licensee shall maintain a record of instructions provided to breast-feeding women in accordance with § 35.2075(c). § 35.80 Provision of mobile service.- (a) A licensee providing mobile service shall - (1) Obtain a letter signed by the management of each client for which services are rendered tr.at permits the use of byproduct material at the client's address of use and clearly delineates the authority and responsibility of each entity; (2) Check instruments as described in §§ 35.60 and 35.62 for proper function before medical use at each address of use or on each day of use, whichever is more frequent; (3) Check survey instruments for proper operation with a dedicated check source before use at each address of use; (4) Before leaving a client's address of use, survey all areas of use to ensure compliance with the requirements in Part 20 of this chapter; and (b) A mobile nuclear medicine service may not have byproduct material delivered from the manufacturer or the C::3tributor to the client's address of use, unless the dient has a license allowing possession of the byproduct material. Radioactive material delivered to the client's address of use must be received and handled in conformance with the client's license. (c) A licensee providing mobile nuclear services shall retain the letter required in paragraph (a)(1) and the record of each survey required in paragraph (a)(4) of this section in accordance with § 35.2080. 203

§ 35.92 Decay-in-storage. (a) A licensee may hold byproduct material with a physical half-life of less than 120 days for decay-in-storage before disposal in ordinary trash if it - (1) Monitors byproduct material at the surface before disposal as ordinary trash and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding; and ( 2) Removes or obliterates all radiation labels; (b) A licensee shall retain a record of each disposal permitted under parc:igraph (a) of this section in accordance with § 35.2092. Subpart D-Unsealed Byproduct Material - Low Dose § 35.100 Use of unsealed byproduct material for uptake, dllution, and excretion studies for which a written directive Is not required. A licensee may use for uptake, dilution, ~r excretion studies any unsealed byproduct material, except in quantities that require a written directive pursuant to§ 35.40, prepared for medical use that is eithe:- - (a) Obtained from a manufacturer or preparer licensed pursuant to § 32.72 of this chapter or equivalent Agreement State requirements; or (b) Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in § 35.292, or an individual under the supervision of either as specified in § 35.27. 204

§ 35.200 Use of unsealed byproduct material for imaging and localization studies for which a written directive Is not required.

A licensee may use for imaging and localization studies any unsealed byproduct material, except in quantities that require a written directive pursuant to § 35.40, prepared for medical use that is either - (a) Obtained from a manufacturer or preparer licensed pursuant to§ 32.72 of this chapter or equivalent Agreement State requirements; or (b) Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets tJ,<3 requirements specified in § 35.292, or an individual under the supervision of either as specified in § 35.27. § 35.204 Permissible molybdenum-99 concentration. (a) A licensee may not administer to humans a radiopharmaceutical containing more than 5.55 kBq (0.15 µCO of molybdenum-99 per millicurie of technetium-99m. (b) A licensee that uses molybdenum-99/technetium-99m generators for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99 concentration of the first eluate after receipt of a generator to demonstrate compliance with paragraph (a) of this section. (c) A licensee that must measure molybdenum concentration shall retain a record of each measurement in accordance with § 35.2204. § 35.290 Training for uptake, dilution, and excretion studies. Except as provided in §§ 35.57, the licensee shall require the authorized user of a radiopharmaceutical for uses authorized under § 35.100 to be a physician who - 205

(a) Is certified by a medical specialty board whose certification process includes all of the requirements in paragraph (b) of this section and whose certification has been approved by the Commission or - (b)(1) Has completed a structured educational program in basic radionuclide handling techniques applicable to the use of diagnostic radiopharmaceuticals, consisting of both - (i) 40 hours of didactic training in the following areas - (A) Radiation physics and instrumentation; (B) Radiation protection; (C) Mathematics pertaining to the use and measurement of radioactivity; (D) Chemistry of byproduct material for medical use; and (E) Radiation biology; and (ii) 20 hours of supervised practical experience under the supervision of an authorized user involving - (A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (8) Calibrating dose calibrators and diagnostic instruments and performing checks for proper operation of survey meters; (C) Calculating, measurins, and safely preparing patient or human research subject dosages; (D) Using administrative controls to prevent a medical event involving the use of byproduct mate1ial; (E) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and (F) Administering dosages to patients or human research subjects; and 206

(2) Has obtained written certification, signed by a preceptor authorized user, that the requirements in paragraph (b)(1) of this section have been satisfactorily completed and that the individual has achieved a level of competency sufficient to independently function as an authorized user of a diagnostic radiopharmaceutical for the uses listed in § 35.100; and (3) Following completion of the requirements in paragraph (b)(1) of this section, has demonstrated sufficient knowledge in radiation safety commensurate with the use requested by passing an examination given by an organization or entity approved by the Commission in accordance with Appendix A of this part .

• § 35.292 Training for imaging and localization studies.

Except as provided in §§ 35.57, the licensee shall require the authorized user of radiopharmaceuticals and generators for the uses authorized under § 35.200 to be a physician who-(a) Is certified by a medical specialty board whose certification process includes all of the requirements in paragraph (b) of this section and whose certification has been approved by the Commission; or (b)(1) Has completed a structured educational program in basic radionuclide handling techniques applicable to the use of diagnostic radiopharmaceuticals and generators, consisting of both - (i) 80 hours of didactic training in the following areas - (A) Radiation physics and instrumentation; (B) Radiation protection; (C) Mathematics pertaining to the use and measurement of radioactivity; (D) Chemistry of byproduct material for medical use; and 207

(E) Radiation biology; and (ii) 40 hours of supervised practical experience under the supervision of an authorized user involving - (A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (8) Calibrating dose calibrators and diagnostic instruments and performing checks for proper operation of survey meters; (C) Calculating, measuring, and safely preparing patient or human research subject dosa!;;::s; (D) Using administrative controls to prevent a medical event involving the use of byproduct material; (E) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; (F) Eluting technetium-99m from generator systems, measuring and testing the eluate for molybdenum-99, and processing the eluate with reagent kits to prepare technetium-99m labeled radiopharmaceuticals; and (G) Administering dosages to patients or human research subjects; and (2) Has obtained written certification, signed by a preceptor authorized user, that the requirements in paragraph (b)(1) of this section have been satisfactorily completed and that the individual has achieved a level of competency sufficient to independently function* as an authorized user of diagnostic radiopharmaceuticals and generators for the uses listed in § 35.200; and (3) Following completion of the requirements in paragraph (b)(1) of this section, has demonstrated sufficient knowledge in radiation safety commensurate with the use requested by 208

passing an examination given by an organization or entity approved by the Commission in accordance with Appendix A of this part. Subpart E-Unsealed Byproduct Material - High Dose

 § 35.300 Use of unsealed byproduct material for which a written directive is required.

A licensee may use any unsealed byproduct material prepared for medical use and for which a written directive is required that is either -

• (a) Obtained from a manufacturer or preparer licensed pursi..ant to§ 32.72 of this chapter or equivalent Agreement State requirements; or (b) Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in § 35.292, or an individual under the supervision of either as specified in§ 35.27.

 § 35.310 Safety instruction.

In addition to the requirements of§ 19.12 of this chapter, (a) A licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects that have received radiopharmaceutical therapy and can not be released in.. accordance with § 35. 75. To satisfy this requirement, the instruction must be commensurate with the duties of the personnel and include - (1) Patient or human research subject control; (2) Visitor control, including - (i) Routine visitation to hospitalized individuals in accordance with § 20.1301 (a)(1 ); and 209

(ii) Visitation authorized in accordance with§ 20.1301(a)(3); (3) Contamination control; (4) Waste control; and (5) Notification of the authorized user and the Radiation Safety Officer, or his designee, if the patient or the human research subject dies or has a medical emergency. (b) A licensee shall retain a record of individuals receiving instruction in accordance with§ 35.2310. § 35.315 Safety precautions. (a) For each patient or human research subject that cannot be released in accordance with § 35. 75, a licensee shall - (1) Provide a private room with a private sanitary facility; (2) Visibly post the patient's or the human research subject's room with a "Radioactive Materials" sign and note on the door or in the patient's or human research subject's chart where and how long visitors may stay in the patient's or the human research subject's room; and (3) Either monitor material and items removed from the patient's or the human research subject's room to determine that their radioactivity cannot be distinguished from the natural background radiation level with a radiation detection survey instrument set on its rr~st sensitive scale and with no interposed shielding, or handle such material and items as radioactive waste. {b) A licensee shall notify the authorized user and the Radiation Safety Officer, or his or her designee, as soon as possible, if the patient or human research subject has a medical emergency and, immediately, if the patient dies. 210

§ 35.390 Training for use of unsealed byproduct material for therapy or for use of unsealed byproduct material that requires a written directive. Except as provided in§ 35.57, the licensee shall require the authorized user of a radiopharmaceutical for the uses authorized under § 35.300 to be a physician who - (a) Is certified by a medical specialty board whose certification process includes all of the requirements in paragraph (b) of this section and whose certification has been approved by the Commission; or (b)(1) Has completed a structured educational program in basic radionuclide handling technique~ applicable to the use of unsealed byproduct material consisting of both - (i) 80 hours of didactic training in the following areas - (A) Radiation physics and instrumentation; (8) Radiation protection; (C) Mathematics pertaining to the use and measurement of radioactivity; and (D) Radiation biology; and (ii) 40 hours of supervised practical experience under the supervision of an authorized user at a medical institution involving - (A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (8) Calibrating dose calibrators, as appropriate, and performing checks for proper operation of survey meters; (C) Calculating, measuring, and safely preparing patient or human research subject dosages; (D) Using administrative controls to prevent a medical event involving the use of byproduct material; 211

(E) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and (2) Has had experience, obtained under the direct supervision of an authorized user, involving at least five cases for each procedure with radiation safety hazards similar to that use for which the indMdual is requesting authorized user status. This experience may be obtained concurrently with the supervised practical experience required by paragraph (b)(1 )(ii) of this section; (3) Has obtained written certification, signed by a preceptor authorized user, that the requirements in paragraphs (b)(1) and (2) of this section have been satisfactorily completed and that the individual has achieved a level of competency sufficient to independently function as an authorized user of unsealed byproduct material for the uses listed in § 35.300; and (4) Following completion of the requirements in paragraph (b)(1) and (2) of this section, has demonstrated sufficient knowledge in radiation safety commensurate with the use requested by passing an examination given by an organization or entity approved by the Commission in accordance with Appendix A of this part. Subpart F- Manual Brachytherapy § 35.400 Use of sources for manual brachytherapy. A licensee shall use only brachytherapy sources for therapeutic medical uses as approved in the Sealed Source and Device Registry. § 35.404 Radiation surveys of patients or human research subjects treated with implants. 212

(a) Immediately after implanting sources in a patient or a human research subject, the licensee sha" make a radiation survey of the patient or the human research subject and the adjacent area of use to confirm_ that no sources have been misplaced. (b) Immediately after removing the last temporary implant source from a patient or a human research subject, the licensee shall make a radiation survey of the patient or the human research subject with a radiation detection survey instrument to confirm that all sources have been removed. (c) A licensee shall retain a record of patient or human research subject surveys in accordance with § 35. ?.404.

 § 35.406 Brachytherapy sources inventory.

(a) A licensee shall maintain accountability at all times for all brachytherapy sources in storage or use. (b) Promptly after removing sources from a patient or a human research subject, a licensee shall return brachytherapy sources to a secure storage area .

• (c) A licensee shall maintain a record of the brachytherapy source accountability in accordance with § 35.2406.

 § 35.410 Safety Instruction.

In addition to the requirements of § 19.12 of this chapter, (a) The licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects that are undergoing implant therapy and cannot be released in accordance with§ 35.75. To satisfy this requirement, the instruction must be commensurate with the duties of the personnel and include the - 213

(1) Size and appearance of the brachytherapy sources; (2) Safe handling and shielding instructions; (3) Patient or human research subject control; (4) Visitor control, including both - (i) Routine visitation of hospitalized individuals in accordance with § 20.1301 (a)(1 ); and (ii) Visitation authorized in accordance with § 20.1301 (a)(3); and (5) Notification of the authorized user and Radiation Safety Officer, or his or her designee, if the patient or the human research subject dies or has a medical emergency. (b) A licensee shall retain a record of individuals receiving instruction in accordance with§ 35.2310. § 35.415 Safety precautions. (a) For each patient or human research subject receiving brachytherapy and confined pursuant to§ 35.75, a licensee shall - (1) Not quarter the patient or the human research subject in the same room as an individual who is not receiving radiation therapy; and (2) Visibly post the patient's or human research subject's room with a "Radioactive Materials" sign and note on the dcor or in the patient's or human research subject's chart where and how long visitors may stay in the patient's or human research subject's room. (b) A licensee shall have available, near each treatment room, emergency response equipment The emergency response equipment must include, as applicable - (1) A device to assist in placing the source(s) in the shielded position; (2) A shielded source/applicator storage container; (3) Remote handling tools; and 214

(4) Supplies necessary to surgically remove applicators or sources from a patient or human research subject treated internally with sealed sources. (c) A licensee shall notify the authorized user and the Radiation Safety Officer, or his designee, as soon as possible, if the patient or human research subject has a medical emergency and, immediately, if the patient dies.

 § 35.432 Full calibration measurements of brachytherapy sources.

(a) A licensee authorized to use brachytherapy sources for medical use shall perform full calibration measurements on brachytherapy sources before ~~e first medical use of the ( source or source/applicator configuration. (b) A licensee may use calibration measurements provided by the source manufacturer that are made in accordance with the requirements of this section. (c) To satisfy the requirements of paragraphs (a) and (b) of this section, full calibration measurements must include determination of - (1) The output or activity within+/- 5 percent; and (2) Source positioning accuracy within applicators. (d) A licensee shall use the dosimetry system described in§ 35.630(a) to measure the output or activity of the brachytherapy source. (e) A licensee shall make full calibration measurements required by paragraph (a) of this section in accordance with published protocols by nationally recognized bodies. (f) A liCGnsee shall mathematically correqt the outputs or activities determined in paragraph (c) of this section for physical decay at intervals consistent with 1 percent physical decay. (g) A licensee shall retain a record of each calibration in accordance with § 35.2432. 215

§ 35.490 Training for use of manual brachytherapy sources. Except as provided in§ 35.57, the licensee shall require the authorized user of a manual brachytherapy source for the uses authorized under § 35.400 to be a physician who - (a) Is certified by a medical specialty board whose certification process includes all of the requirements in paragraph (b) of this section and whose certification has been approved by the Commissi,;m; or (b)(1) Has completed a structured educational program in basic radionuclide handling techniques applicable to the use of manual brachytherapy sources consisting of both - (i) 200 hours of didactic tra;""19 in the following areas - (A) Radiation physics and instrumentation; (8) Radiation protection; (C) Mathematics pertaining to the use and measurement of radioactivity; and (D) Radiation biology; (ii) 500 hours of supervised practical experience, under the supervision of an authorized user at a medical institution, involving - (A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (B) Checking survey meters for proper operation; (C) Preparing, implanting, and removing sealed sources; (D) Maintaining running inventories of material on hand; (E) Using administrative controls to prevent a medical event involving the use of byproduct material: (F) Using emergency procedures to control byproduct material; and 216

(2) Three years of supervised clinical experience that includes one year in a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association or equivalent program approved by the NRC, and an additional two years of clinical experience under the supervision of an authorized user; and (3) Has obtained written certification, signed by a preceptor authorized user, that the requirements in paragraphs (b)(1) and (2) of this section*have been satisfactorily completed and th.::t th~ individual has achieved a level of competency sufficient to independently function as an authorized user of manual brachytherapy sources for the uses listed in § 35.400; and, (4) Following completion of the requirements in paragraph (b)(1) and (2) of this section, has demonstrated sufficient knowledge in radiation safety commensurate with the use requested by P,assing an examination given by an organization or entity approved by the Commission in accordance with Appendix A of this part. Subpart G-Sealed Sources for Diagnosis § 35.500 Use of sealed sou~ for diagnosis. A licensee shall use only sealed sources for diagnostic medical uses as approved in the Sealed Source and Device Registry. § 35.590 Training for use of sealed sources for diagnosis. Except as provided in§ 35.57, the licensee shall*require the authorized user of a diagnostic sealed source for the use in a device authorized under § 35.500 to be a p~ysician, dentist, or podiatrist who - 217

(a) Is certified by a speciality board whose certification process includes all of the requirements in paragraph (b) of this section and whose certification has been approved by the Commission; or (b) Has had 8 hours of classroom and laboratory training in basic radionuclide handling techniques specifically applicable to the use of the device that includes - (1) Radiation physics and instrumentation; (2) Radiation protection; (3) Mathematics pertaining to the use and measurement of radioactivity; (4) Radiation biology; and (5) Training in the use of the device for the uses requested. Subpart H-Therapeutic Medical Devices § 35.600 Use of a sealed source in a device for therapeutic medical uses. A licensee shall use sealed sources and devices for therapy as approved in the Sealed Source and Device Registry for medical use. § 35.604 Radiation surveys of patients and human research subjects treated '.. .'ith remote 0 afterloaders. (a) Before releasing a patient or a human research subject from licensee control, a licensee shall make a survey of the patient or the human research subject and the afterloader device with a portable radiation detection survey instrument to confirm that the source(s) has been removed from the patient or human research subject and returned to the safe shielded position. 218

(b) A licensee shall retain a record of patient or human research subject surveys in accordance with § 35.2404.

§ 35.605 Installation, maintenance, and repair.

(a) Only a person specifically licensed by the Commission or an Agreement State shall install, maintain, adjust, or repair a device that involves work on the source(s) shielding, the -source(s) driving unit, or other electronic or mechanical component that could expose the source, reduce the shielding around the source(s), or compromise the radiation safety of the device or tr.a source(s). (b) Except for low dose-rate remote afterloader devices, only a person specifically licensed by the Commission or an Agreement State shall install, replace, relocate, _or remove a sealed source or source contained in a device, (c) For a low dose-rate remote afterloader device, only a person specifically licensed by the Commission or an Agreement State or an authorized medical physicist shall perform the functions listed in paragraph (b) of this section. (d) A licensee shall retain a record of the installation, maintenance, and repair done on therapeutic medical devices in accordance with § 35.2605. § 35.610 Safety procedures and instructions for remote afterloaders, teletherapy units, and gamma stereotactic radiosurgery units. (a) A licensee shall develop, implement, and maintain written procedures for - (1) Securing the device, the console, the console keys, and the treatment room when not in use or unattended; 219

(2) Except for low dose-rate remote afterloaders, ensuring that only the patient or the human research subject is in the treatment room before initiating treatment with the source(s), unless contraindicated, or after a door interlock interruption; (3) Preventing dual operation of more than one radiation producing device in a treatment room if applicable; and (4) Responding to an abnormal situation when the operator is unable to place the source(s) in the shielded position, or remove the patient or human research subject from the radiation field with controls from outside the treatment room. This procedure must include - (i) Instructions .for responding to equipment failures and the names of the individuals responsible for implementing corrective actions; (ii) The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure; and (iii) The names and telephone numbers of the authorized users, the authorized medical physicist, and the Radiation Safety Officer to be contacted if the device or console operates abnormally. (b) A copy of the procedures required by § 35.610(a) must be physically located at the unit console. (c) A licensee sh.:~I post instructions at the device console to inform the operator of-(1) The location of the procedures required by § 35.61 O(a); and (2) The names and telephone numbers of the authorized users, the authorized medical physicist, and the Radiation Safety Officer to be contacted if the device or console unit or console operates abnormally. (d) A licensee shall provide instruction and practice drills, initially and at least annually, in the procedures identified in paragraph (a) of this section and the operating procedures to all 220

individuals who operate the device, as appropriate to the individual's assigned duties. A licensee shall ensure that operators receive refresher training in the operation of the unit and procedures for periodic spot-checks and full calibrations; and that operators, authorized medical physicists, and authorized users participate in drills of the emergency procedures. (e) A licensee shall retain a record of individuals receiving instruction required by paragraph (d) of this section, in accordance with§ 35.2310.

 § 35.615 Safety precautions for remote afterloaders, teletherapy units, and gamma

• stereotactic radiosurrery units.

(a) A licensee shall control access to the treatment room by a door at each entrance. (b) A licensee shall equip each entrance to the treatment room with an electrical interlock system that will - (1) Prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed; (2) Cause the sources to be shielded immediately when an entrance door is opened; and (3) Prevent the primary beam of radiation from being turned on following an interlock interruption until all treatment room entrance doors are closed and the beam on-off control is reset at the console. (c) A licensee shall require any individual entering the treatment room to assure, through the use of appropriate radiation monitors, that radiation levels havt:: returned to ambient levels. 221

(d) Except for low-dose remote afterloaders, a licensee shall construct or equip each treatment room with viewing and intercom systems to permit continuous observation of the patient or the human research subject from the treatment console during irradiation. (e) For licensed activities where sources are placed within the patient's or human research subject's body, a licensee shall only conduct treatments which allow for expeditious removal of a decoupled or jammed source. (f) In addition to the requirements specified in paragraphs (a) through (e) of this section, a licensee shall - (1) For low dose-rate remote afterloader devices, require - (i) An authorized user or an authorized medical physicist to be physically present during the initiation of all patient treatments involving the device; and (ii) An authorized medical physicist and an authorized user or a physician, who has been designated by the authorized user and who is a radiation oncology physician trained in emergency response for the device, to be immediately available during continuation of all patient treatments involving the device. (2) For high dose-rate remote afterloader devices, require - (i) An authorized user and an authorized medical physicist to be physically present during the initiation of all patient treatments involving the device; and (ii) An authorized medical physicist and an authorized user or a physician, who has been designated by the authorized user and who is a radiation oncology physician that has been trained in emergency response for the device, to be physically present during continuation of all patient treatments invoMng the device. (3) For pulsed dose-rate remote afterloader devices, require - 222

). (i) An authorized user and an authorized medical physicist to be physically present during the initiation of all patient treatments involving the device; and (ii) An authorized medical physicist and an authorized user or a physician, who has been designated by the authorized user and who is a radiation oncology physician that has been trained in emergency response for the device, to be immediately available during continuation of all patient treatments involving the device. (4) For gamma stereotactic radiosurgery units, require an authorized user and an authorized medical physicist to be physically present throughout all patient treatments involving the unit. (g) The licensee shall have emergency response equipment available near each treatment room. The emergency response equipment must include, as applicable - (1) A device to assist in placing the source(s) in the shielded position; (2) A shielded source/applicator storage container; (3) Remote handling tools; and (4) Supplies necessary to surgically remove applicators or sources from a patient or human research subject treated internally with sealed sources.

  § 35.630 Dosimetry equipment (a) A licensee shall have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two conditions must be met.

(1) The ~ystem must have been calibrated using a source traceable to the National Institute of Standards and Technology and published protocols approved by nationally recognized bodies or by a calibration laboratory accredited by the American Association of 223

Physicists in Medicine (AAPM). The calibration must have been performed within the previous 2 years and after any servicing that may have affected system calibration; or (2) The system must have been calibrated within the previous 4 years; 18 to 30 months after that calibration, the system must have been intercompared with another dosimetry system that was calibrated within the past 24 months by the National Institute of Standards and Technology or by a calibration laboratory accredited by the AAPM. The results of the intercomparison must have indicated that the calibration factor of the licensee's system had not changed by more than 2 percent. The licensee may not use the intercomparison result to chang"" the calibration factor. When in+ercomparing dosimetry systems to be used for calibrating sealed sources for therapeutic devices, the licensee shall use a comparable device with beam attenuators or collimators, as applicable, and sources of the same radionuclide as the source used at the licensee's facility. (b) The licensee shall have available for use a dosimetry system for spot-check measurements. To satisfy this requirement, the system may be compared with a system that* has been calibrated in accordance with paragraph (a) of this section. This comparison must have been performed within the previous year and after each servicing that may have affected system calibration. The spot-check system may be the same system used to meet the requirement in paragraph (a) of this section. (c) The licensee shall retain a record of each calibration, intercomparison, and comparison in accordance with § 35.2630. § 35.632 Full calibration measurements on teletherapy units. (a) A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit - 224

(1) Before the first medical use of the unit; and (2) Before medical use under the following conditions:. (i) Whenever spot--check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay; {ii) Following replacement of the source or following reinstallation of the teletherapy unit in a new location; (iii) Following any repair of the teletherapy unit that includes removal of the source or IT':::>jor repair of the components associated with the source exposure assembly; and (3) At intervals not exceeding 1 year. (b) To satisfy the require~ent of paragraph {a) of this section, full calibration measurements must include determination of - (1) The output within +/-3 percent for the range of field sizes and for the distance or range of distances used for medical use; (2) The coincidence of the radiation field and the field indicated by the light beam localizing device; (3) The uniformity of the radiation field and its dependence on the orientation of the useful beam; (4) Timer accuracy and linearity over the range of use; {5) On-off error; and (6) The accuracy of all distance measuring and localization devices in medical use. (c) A licensee shall use the dosimetry system described in§ 35.630(a) to measure the output for one set of exposure conditions. The remaining radiation measurements required in 225

paragraph (b)(1) of this section may be made using a dosimetry system that indicates relative dose rates. (d) A licensee shall make full calibration measurements required by paragraph (a) of this section in accordance with published protocols approved by nationally recognized bodies. (e) A licensee shall mathematically correct the outputs determined in paragraph (b)(1) of this section for physical decay for intervals not exceeding 1 month for cobalt-SO, 6 months for cesium-137, or at intervals consistent with 1 percent decay for all other nuclides. (f) Full calibration measurements required by paragraph (a) of this section and physical decay corrections required by paragraph (e) of this section must be performed by the authorized medical physicist. {g) A licensee shall retain a record of each calibration in accordance with § 35.2632. § 35.633 Full calibration measurements on remote afterloaders. (a) A licensee authorized to use a remote afterloader for medical use shall perform full calibration measurements on each unit - ( 1} Before the first medical use of the unit; (2) Before medical use under the following conditions: (i) Whenever spot-check measurements indicate that the output differs by l'T'nre than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay; (ii) Following replacement of the source or following reinstallation of the unit in a new location outside the facility; and (iii} Following any repair of the unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and 226

(3) At intervals not exceeding 120 days for high dose-rate and pulsed dose-rate remote afterloaders; and (4) At intervals not exceeding 1 year for low dose-rate remote afterloaders. (b) To satisfy the requirement of paragraph (a) of this section, full calibration measurements must include determination of: (1) The output within+/- 5 percent; (2) Source positioning accuracy to within +/- 1 millimeter; (3) Source retraction with backup battery upon power failure; and (4) The operability of the electrically assisted treatment room doors with the high-dose rate remote afterloader unit electrical power turned off. (c} In addition to the requirements for full calibrations for all remote afterloaders in paragraph {b) of this section, a licensee shall: (1) For high dose-rate and pulsed dose-rate remote afterloaders, calibrate - (i) At intervals not exceeding one quarter: (A) The source guide tubes; (B) Timer accuracy and linearity over the typical range of use; and (C) Length of the connectors; and (ii) Annually, the f'..:nction of the source tube guides and connectors. (2) For low dose-rate remote afterloaders, perform an autoradiograph of the source(s) to verify inventory and source(s) arrangement and a spot check of the absolute timer accuracy at intervals not exceeding one quarter. (d) A licensee shall use the dosimetry system described in§ 35.630(a} to measure the output. 227

(e) A licensee shall make full calibration measurements required by paragraph (a) of this section in accordance with published protocols approved by nationally recognized bodies. (f) A licensee shall mathematically correct the outputs determined in paragraph (b)(1) of this section for physical decay at intervals consistent with 1 percent physical decay. (g) Full calibration measurements required by paragraph (a)*of this section and physical decay corrections required by paragraph {f) of this section must be performed by the authorized medical physicist. (h) A licensee shall retain a record of each calibration in accordance with§ 35.2633. § 35.635 Full calibration measurements on gamma steraotactic radiosurgery units. (a) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform full calibration measurements on each unit - ( 1) Before the first medical use of the unit; (2) Before medical use under the following conditions - {i) Whenever spot-check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay; Oi) Following rep'.:Jcement of the sources or following reinstallation of the gamma stereotactic radiosurgery unit in a new location; and {iii) Following any repair of the gamma stereotactic radiosurgery unit that includes removal of the sources or major repair of the components associated with the source assembly; and {3) At intervals not exceeding 1 year. 228

.l ,_ (b) To satisfy the requirement of paragraph (a) of this section, full calibration measurements must include determination of - (1) The output within +/-3 percent; (2) Relative helmet factors; (3) lsocenter coincidence; (4) Timer accuracy and linearity over the range of use; (5) On-off error; and (6) Trunnion centricity. (c) A licensee ~hall use the dosimetry system described in § 35.630(a) to measure the output for one set of exposure conditions. The remaining radiation measurements required in paragraph (b)(1) of this section may be made using a dosimetry system that indicates relative dose rates. (d) A licensee shall make full calibration measurements required by paragraph (a) of this section in accordance with published protocols approved by nationally recognized bodies. (e) A licensee shall mathematically correct the outputs determined in paragraph (b)(1) of this section at intervals not exceeding 1 month for cobalt-60 and at intervals consistent with 1 percent physical decay for all other radionuclides. (f) Full calibration measurements required by paragraph (a) of this section and physi:al decay corrections required by paragraph (e) of this section must be performed by the authorized medical physicist. (g) A licensee shall retain a record of each calibration in accordanve with § 35.2635. 229

J. § 35.642 Periodic spot-checks for teletherapy units. (a) A licensee authorized to use teletherapy units for medical use shall perform output spot-checks on each teletherapy unit once in each calendar month that include determination of-(1) Timer constancy, and timer linearity over the range of use; (2) On-off error, (3) The coincidence of the radiation field and ~he field indicated by the light beam localizing device; (4) The accuracy of all distance measuring and localization devices used for medical use; (5) The output for one typical set of operating conditions measured with the dosimetry system described in § 35.630(b) and (6) The difference between the measurement made in paragraph (b)(5) of this section and the anticipated output, expressed as a percentage of the anticipated output (i.e., the. value obtained at last full calibration corrected mathematically for physical decay). (b) A licensee shall perform measurements required by paragraph (a) of this section in accordance with written procedures established by the authorized medical physicist. That individual need not actually perforr:, the spot check measurements. (c) A licensee shall have the authorized medical physicist review the results of each spot-check within 15 days. The authorized medical physicist shall promptly notify the licensee in writing of the ,-esults of each spot-check.. (d} A licensee authorized to use a teletherapy unit for medical use shall perform safety spot-checks of each teletherapy facility once in each calendar month and after each source installation to assure proper operation of - 230

(1) Electrical interlocks at each teletherapy room entrance; (2) Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation (restriction of source housing angulation or elevation, carriage or stand travel and operation of the beam on-off mechanism); (3) Source exposure indicator lights on the teletherapy unit, on the control console, and in the facility; (4) Viewing and intercom systems; (5) Treatment room doors from inside and outside the treatment room; and (6) Electrically assisted treatment room doors with the tc~~therapy unit electrical power turned off. (e) If the results of the checks required in paragraph (d) of this section indicate the.. malfunction of any S\YStem, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system. (f) A licensee shall retain a record of each spot-check required by paragraphs (a) and (d), in accordance with§ 35.2642 § 35.643 Periodic spot-checks for high dose-rate and pulsed dose-rate remote afterloaders. (a) A licensee authorized to use high dose-rate or pulsed dose-rate remote afterloaders for medical use ~hall perform spot-checks on each unit: (1) At the beginning of each week of use; (2) At the beginning of each day of use; and (3) After each source installation. 231

(b) The licensee shall have the authorized medical physicist: (1) Establish written procedures for performing the spot-checks required in paragraph (a) of this section; and (2) Review the results of each spot-check required by paragraph (a)(1) of this section within 15 days of the check. The authorized medical physicist need not actually perform the spot-check measurements. (c} To satisfy the requirements of paragraphs (a)(1) of this section, spot-checks must, at a minimum - {1) Verify source positionin~ ::curacy; (2) Determine output with the dosimetry system described in§ 35.630(b); and (3) Calculate the difference between the measurement made in paragraph (c)(2) of this section and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration mathemavcally corrected for physical decay). (d) To satisfy the requirements of paragraphs (a)(2) and (a)(3) of this section, spot-checks must, at a minimum, assure proper operation of - (1) Electrical interlocks at each remote afterloader room entrance; (2) Source exposure indicator lights on the remote after1oader unit, on the control console, and in the facility; (3) Viewing and intercom systems; (4) Emergency response equipment; (5) Radiation monitors used to indicate the source position; (6) Timer constancy; and (7) Clock {date and time) in the unit's computer. 232

(e) In addition to the requirements for spot checks in paragraph (d} of this section, a licensee shall ensure overall proper operation of the unit by conducting a simulated cycle of treatment as part of the spot-checks. (f) A licensee shall arrange for prompt repair of any system identified in paragraph (c) of this section that is not operating. (g) If the results of the checks required in paragraph (d) of this section indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning sy.:.tem. {h) A licensee shall retain a record of each check required by paragraphs (c) and (d) of this section in accordance with§ 35.2643. § 35.644 Periodic spot-checks for low dose-rate remote afterloaders. {a) A licensee authorized to use low dose-rate remote afterfoaders for medical use shall perform spot-checks on each unit prior to each patient treatment and after each source installation that include proper operation of - (1) Electrical interlocks at each remote afterfoader room entrance; (2) Source exposure indicator lights on the remote afterfoader unit, on the control console, and in the facility; (3) Emergency response equipment; (4) Radiation monitors used to indicate the source position; (5) Timer constancy; and (6) Clock (date and time) in the unit's computer. 233

(b) In addition to the requirements for spot checks in paragraph (a) of this section, a licensee shall ensure overall proper operation of the unit by conducting a simulated cycle of treatment as part of the spot-checks. (c) The licensee shall have the authorized medical physicist - (1) Establish written procedures for performing the spot-checks required in paragraph (a) of this section; and (2) Review the results of each spot-check required by paragraph (a) of this section within 15 days of the check. The authorized medical physicist need not actually perform the spot-check measurements. (d) If the results of the checks required in paragraph (a) of this section indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system. {e) A licensee shall retain a record of each check required by paragraph (a) of this section in accordance with § 35.2643. § 35.645 Periodic spot-checks for gamma stereotactic radlosurgery units. (a) A licensee authorized to use gamma stereotactic radiosurgery units for ;;1edical use shall perform spot-checks on each unit - (1) Monthly, (2) At the beginning of each day of use, and (3) After each source installation. (b) The licensee shall have the authorized medical physicist-234

(1) Establish written procedures for performing the spot-checks required in paragraph (a) of this section; and (2) Review the results of each spot-check required by paragraph (a)(1) of this section within 15 days of the check. The authorized medical physicist need not actually perform the spot-check measurements. (c) To satisfy the requirements of paragraph (a)(1) of this section, spot-checks must, at a minimum-(1) Assure proper operation of - (Q Treatment table retraction mechanism, using backup battery power or hydraulic/electrical backups with the unit off; (ii) Helmet microswitchs; (iii) Emergency timing circuits; (iv) Emergency off buttons; and (v) Stereotactic frames and localizing devices (trunnions). (2) Determine - (i) The output for one typical set of operating conditions measured with the dosimetry system described in§ 35.630(b); (ii) The differenCk between the measurement made in paragraph (c)(2)(i) of this section and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay); (iii) Source output against computer calculation; (iv) Timer accuracy and linearity over the range of use; (v) On-off error; and (vi) Trunnion centricity. 235

(d) To satisfy the requirements of paragraphs (a)(2) and (a)(3) of this section, spot-checks must assure proper operation of - (1) Electrical interlocks at each gamma stereotactic radiosurgery room entrance; (2) Source exposure indicator lights on the gamma stereotactic radiosurgery unit, on the control console, and in the facility; (3) Viewing and intercom systems; (4) Timer termination; (5) Radiation monitors used to indicate room exposures; and (6) Hydraulic cutoff mechanism (if applicable). (e) A licensee shall arrange for prompt repair of any system identified in paragraph (c) of this section that is not operating properly. (f) If the results of the checks required in paragraph (d) of this section indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system. (g) A licensee shall retain a record of each check required by paragraphs (c) and (d) of this section in accordance with § 35.2645. § 35.647 Additional technical requirements for mobile remote afterloaders. (a) A licensee providing mobile remote afterloader service shall - (1) Check survey instruments before medical use at each address of use or on each day of use, which ever is more frequent; and (2) A~unt for all sources before departure from a client's address of use. 236

(b) In addition to the periodic spot-checks required by§ 35.643, a licensee authorized to use mobile afterloaders for medical use shall perform checks on each remote afterloader before each address of use. At a minimum, checks must be made to verify the operation of - (1) Electrical interlocks on treatment area access points; (2) Source exposure indicator lights on the remote afterloader, on the control console, and in the facility; (3) Viewing and intercom systems; (4) Applicators and connectors;

• (5) Radiation ~onitors used to indicate room exposures; (6) Source positioning (accuracy); and (7) Radiation monitors used to indicate whether the source has returned to a safe shielded position.

(c) In addition to the requirements for checks in paragraph (b) of this section, a licensee shall ensure overall proper operation of the remote afterloader unit by conducting a simulated cycle of treatment before use at each address of use. (d) A licensee shall arrange for prompt repair of any system identified in paragraph (b) of this section that is not operating properly. (e) A licensee shall retain a record of each check required by paragraph (b) of this section in accordance with§ 35.2647.

 § 35.652 Radiation surveys.

{a) In addition to the survey requirement in§ 20.1501 of this chapter, a licensee shall make such surveys as defined in the Sealed Source and Device Registry to assure that the 237

maximum radiation levels and average radiation levels from the surface of the main source safe with the source(s) in the shielded position does not exceed the levels stated in the Registry. (b) The licensee shall make the survey required by paragraph (a) of this section at installation of a new source and following repairs to the source(s) shielding, the source(s) driving unit, or other electronic or mechanical component that could expose the source, reduce the shielding around the source(s), or compromise the radiation safety of the device or the source(s). (c) A licensee shall retain a record of the radiation surveys required by paragraph (a) of this section in accordance with § 35.2652. § 35.655 Five-year inspection for teletherapy and gamma stereotactic radiosurgery units. (a) A licensee shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during source replacement or at intervals not to exceed 5 years, whichever comes first, to assure proper functioning of the source exposure mechanism. (b) This inspection and servicing may only be performed by persons specifically licensed to do so by the Commissl;:m or an Agreement State. (c) A licensee shall keep a record of the inspection and servicing in accordance with § 35.2655. § 35.657 Therapy-related computer systems. The licensee shall: 238

(a) Verify that the computerized operating system and treatment planning system associated with the therapy device are operating appropriately; and (b) Perform acceptance testing on the treatment planning system in accordance with published protocols approved by nationally recognized bodies. § 35.690 Training for use of therapeutic medical devices. Except as provided in § 35.57, the licensee shall require the authorized user of a sealed source for a use authorized under§ 35.600 to be a physician who - (a) Is certified by a specialty board whose certification p:-:cess includes all of the requirements in paragraph (b) of this section and whose certification has been approved by the Commission; or; (b)(1) Has completed a structured educational program in basic radionuclide techniques applicable to the use of a sealed source in a therapeutic medical device consisting of both-(i) 200 hours of didactic training in the following areas - (A) Radiation physics and instrumentation; (8) Radiation protection; (C) Mathematics pertaining to the use and measurement of radioactivity; and (D) Radiation biology; and (ii) 500 hours of supervised practical experience, under the supervision of an authorized user at a medical instiMion, involving - (A) Review of the full calibration measurements and periodic spot checks; (8) Preparing treatment plans and calculating treatment doses and times; 239

(C) Using administrative controls to prevent a medical event involving the use of byproduct material; (D) Implementing emergency procedures to be followed in the event of the abnormal operation of the medical device or console; (E) Checking and using survey meters; and (F) Selecting the proper dose and how it is to be administered; and (2) Three years of supervised clinical experience that includes one year in a formal trainir.d program approved by the Rc:;dency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association or equivalent program approved by the NRC and an additional two years of clinical experience under the supervision of an authorized user; and (3) Has obtained written certification, signed by a preceptor authorized user, that the above training has been satisfactorily completed and that the individual has achieved a level of competency sufficient to independently function as an authorized user of the therapeutic medical device for which the individual is requesting authorized user status; and (4) Following completion of the ~uirements in paragraph (b)(1) and (2) of this section, has demonstrated sufficient knowledge in radiation safety commensurate with the use requested by passing an examination given by an organization or entity approved by the Commission in accordance with Appendix A of this part. 240

Subpart 1- -Reserved Subpart J-Training and Experience Requirements § 35.900 Radiation Safety Officer. Except as provided in§ 35.57, the licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer as provided in § 35.24 to be an individual who - (a) Is certified by the -- (1) American Board of Health Physics in Comprehensive Health Physics; (2) American Board of Radiology; (3) American Board of Nuclear Medicine; (4) American Board of Science in Nuclear Medicine; (5) Board of Pharmaceutical Specialties in Nuclear Pharmacy; (6) American Board of Medical Physics in radiation oncology physics; (7) Royal College of Physicians and Surgeons of Canada in nuclear medicine; (8) American Osteopathic Board of Radiology; or (9) American Osteopathic Board of Nuclear Medicine; or (b) Has had classroom and laboratory training and experience as follows - (1) 200 hours of classroom and laboratory training that includes - (i) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pef!aining to the use and measurement of radioactivity; (iv) Radiation biology; and (v) Radiopharmaceutical chemistry; and 241

(2) One year of full time experience as a radiation safety technologist at a medical institution under the supervision of the individual identified as the Radiation Safety Officer on a Commission or Agreement State license that authorizes the medical use of byproduct material; or (c) Be an authorized user identified on the licensee's license. § 35.910 Training for uptake, dilution, and excretion studies. Except as provided in § 35.57, the licensee shall require the authorized user of a radiopharmaceutical in § 35.1 OO(a) to be a physician who - (a) Is certified in - (1) Nuclear medicine by the American Board of Nuclear Medicine; (2) Diagnostic radiology by the American Board of Radiology; (3) Diagnostic radiology or radiology by the American Osteopathic Board of Radiology; (4) Nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or (5) American Osteopathic Board of Nuclear Medicine in nuclear medicine; or (b) Has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of prepared radiopharmaceuticals, and supervised clinical experience as follows-(1) 40 hours of classroom and laboratory training that includes - (i) Radiation physics and instrumentation; M Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; (iv) Radiation biology; and (v) Radiopharmaceutical chemistry; and 242

(2) 20 hours of supervised clinical experience under the supervision of an authorized user and that includes - (i) Examining patients or human research subjects and reviewing their case histories to determine their suitability for radioisotope diagnosis, limitations, or contraindications; (ii) Selecting the suitable radiopharmaceuticaI$ and calculating and measuring the dosages; (iii) Administering dosages to patients or human research subjects and using syringe radiation shields; (iv) Collaborating with the authorized user in the interpretation of radioisotope test results; and (v) Patient or human research subject follow up; or (c) Has successfully completed a 6-month training program in nuclear medicine as part of a training program that has been approved by the Accreditation Council for Graduate Medical Education and that included classroom and laboratory training, work experience, and supervised clinical experience in all the topics identified in paragraph (b) of this section. § 35.920 Training for imaging and localization studies. Except as provide! in § 35.57, the licensee shall require the authorized user of a radiopharmaceutical, generator, or reagent kit in§ 35.200(a) to be a physician who - (a) Is certified in - (1) Nuclear medicine by the American Board of Nuclear Medicine; (2) Diagnostic radiology by the American Board of Radiology; (3) Diagnostic radiology or radiology by the American Osteopatliic Board of Radiology; (4) Nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or 243

(5) American Osteopathic Board of Nuclear Medicine in nuclear medicine; or (b) Has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of prepared radiopharmaceuticals, generators, and reagent kits, supervised work experience, and supervised clinical experience as follows - ( 1) 200 hours of classroom and laboratory training that includes - (i) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; (iy) Radiopharmaceutical chemistry; and (v) Radiatio11 biology; and (2) 500 hours of supervised work experience under the supervision of an authorized user that includes - (i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (ii) Calibrating dose calibrators and diagnostic instruments and performing checks for proper operation of survey meters; (iii) Calculating and lx3fely preparing patient or human research subject dosages; (iv) Using admir.'3trative controls to prevent the medical event of byproduct material; (v) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and (vi) Eluting technetium-99m from generator systems, measuring and testing the eluate for molybdenum-99 and alumina contamination, and processing the eluate with reagent kits to prepare tech11etium-99m labeled radiopharmaceuticals; and 244

(3) 500 hours of supervised clinical experience under the supervision of an authorized user that includes - (i) Examining patients or human research subjects and reviewing their case histories to determine their suitability for radioisotope diagnosis, limitations, or contraindications; (ii) Selecting the suitable radiopharmaceuticals and calculating and measuring the dosages; (iii) Administering dosages to patients or human research subjects and using syringe radiation shields; (iv) Collaborati,g with the authorized user in the interpretation of radioisotope test results; and (v) Patient or human research subject follouv up; or (c) Has successfully completed a 6-month training program in nuclear medicine that has been approved by the Accreditation Council for Graduate Medical Education and that included cJassroom and laboratory training, work experience, and supervised clinical experience in all the topics identified in paragraph (b) of this section. § 35.930 Training for therapeutic use of unsealed byproduct material. Except as provided in§ 35.57, the licensee shall require the authorized user of radiopharmaceuticals in § 35.300 to be a physician who - (a) Is certified by - (1) The American Board of Nuclear Medicine; (2) The American Board of Radiology in radiology, therapeutic radiology, or radiation oncology; (3) The Royal College of Physicians and Surgeons of Canada in nuclear medicine; or 245

(4) The American Osteopathic Board of Radiology after 1984; or (b) Has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of therapeutic radiopharmaceuticals, and supervised clinical experience as follows-(1) 80 hours of classroom and laboratory training that includes - (i) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; and (iv) Radiation biology; and (2) Supervised clinical experience under the supervision of an authorized user at a medical institution that includes - (i) Use of iodine-131 for diagnosis of thyroid function and the treatment of hyperthyroidism or cardiac dysfunction in 10 individuals; and (ii) Use of iodine-131 for treatment of thyroid carcinoma in 3 individuals. § 35.932 Training for treatment of hyperthyroidism. Except as provided in § 35.57, the licensee shall require the authorized user of only iodine-131 for the treatment of hyperthyroidism to be a physician with special experience in thyroid disease who has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of iodine-131 for treating hyperthyroidism, and supervised clinical experier1ce as follows - (a) 80 hours of classroom and laboratory training that includes - (1) Radiation physics and instrumentation; (2) Radiation protection, 246

(3) Mathematics pertaining to the use and measurement of radioactivity; and (4) Radiation biology; and (b) Supervised clinical experience under the supervision of an authorized user that includes the use of iodine-131 for diagnosis of thyroid function, and the treatment of hyperthyroidism in 10 individuals. § 35.934 Training for treatment of thyroid. carcinoma. Except as provided in § 35.57, the licensee shall require the authorized user of only iodine-131 for the treatment of thyroid carcinoma to be a physic:.:n with special experience in thyroid disease who has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of iodine-131 for treating thyroid carcinoma, and supervised clinical experience as follows - (a) 80 hours of classroom and laboratory training that includes - (1) Radiation physics and instrumentation; (2) Radiation protection; (3) Mathematics pertaining to the use and measurement of radioactivity; and (4) Radiation biology; and (b)' Supervised clinical experience under the supervision of an authorized user that includes the use of iodine-131 for the treatment of thyroid carcinoma in 3 individuals. § 35.940 Training for use of brachytherapy sources. Except as provided in§ 35.57, the licensee shall require the authorized user of a brachytherapy source listed in § 35.400 for therapy to be a physician who - (a) Is certified in - 247

(1) Radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology; (2) Radiation oncology by the American Osteopathic Board of Radiology; {3) Radiology, with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or (4} Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or (b) Is in the active practice of therapeutic radiology, has had classroom and laboratory traini:-:~ in radioisotope handling tec~-iques applicable to the therapeutic use of brachytherapy sources, supervised work experience, and supervised clinical experience as follows - (1) 200 hours of classroom and laboratory training that includes - (i) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; and (iv) Radiation biology; (2) 500 hours of supervised work experience under the supervision of an authorized user at a medical institution that includes -

0) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (ii) Checking survey meters for proper operation; Oii) Preparing, implanting, and removing sealed sources; (iv) Maintaining running inventories of material on hand; (v) Using administrative controls to prevent a medical event invoMng byproduct material; and 248

(vi) Using emergency procedures to control byproduct material; and (3} Three years of supervised clinical experience that includes one year in a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association, and an additional two years of clinical experience in therapeutic radiology under the supervision of an authorized user at a medical institution that includes - (i) Examining individuals and reviewing their case histories to determine their suitability fa:- ~rachytherapy treatment, and any limitations or contraindications; (ii) Selecting the proper brachytherapy sources and dose and method of administration; (iii) Calculating the dose; and (iv) Post-administration follow up and review of case histories in collaboration with the authorized user. § 35.941 Training for ophthalmic use of strontium-90. Except as provided in§ 35.57, the licensee shall require the authorized user of only strontium-90 for ophthalmic radiotherapy to be a physician who is in the active practice of therapeutic radiology or ophthalmology, and has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of strontium-90 for ophthalmic radiotherapy, and a period of supervised clinical training in ophthalmic radiotherapy as follows - (a) 24 hours of classroom and laboratory training that includes - (1) Radiation physics and instrumentation; (2} Radiation protection; (3) Mathematics pertaining to the use and measurement of radioactivity; and 249

(4) Radiation biology; (b) Supervised clinical training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution that ("eludes the use of strontium-90 for the ophthalmic treatment of five individuals that includes - (1) Examination of each individual to be treated; (2) Calculation of the dose to be administered; (3) Administration of the dose; and (4) Follow up and review of each individual's case history. § 35.950 Training for use of sealed sources for diagnosis. Except as provided in§ 35.57, the licensee shall require the authorized user of a sealed source in a device listed in § 35.500 to be a physician, dentist, or podiatrist who - (a) Is certified in - (1} Radiology, diagnostic radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology; (2) Nuclear medicine by the American Board of Nuclear Medicine; (3) Diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or (4) Nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or {b) Has had 8 hours of classroom and laboratory training in basic radioisotope handling techniques specifically applicable to the use of the device that includes - (1) Radiation physics, mathematics pertaining to the use and measurement of radioactivity, and instrumentation; {2) Radiation biology; 250

(3) Radiation protection; and (4) Training in the use of the device for the uses requested.

§ 35.960 Training for use of therapeutic medical devices.

Except as provided in§ 35.57, the licensee shall require the authorized user of a sealed source listed in § 35.600 to be a physician who - (a) Is certified in - (1) Radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology; (2) Radiation oncology by the American Osteopathic Board of Radiology; (3) Radiology, with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology or "Fellow of the Royal College of Radiology"; or (4) Therapeutic radiology by the Canadian Royal College of Physicians.and Surgeons; or (b) Is in the active practice of therapeutic radiology, and has had classroom and laboratory training in basic radioisotope techniques applicable to the use of a sealed source in a therapeutic medical device, supervised work experience, and supervised clinical experience as follows-(1) 200 hours of classroom and laboratory training that includes - (i) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; and (iv) Radiation biology; 251

(2) 500 hours of supervised work experience under the supervision of an authorized user at a medical institution that includes - (i) Review of the full calibration measurements and periodic spot-checks; (ii) Preparing treatment plans and calculating treatment times; (iii) Using administrative controls to prevent medical events; (iv) Implementing emergency procedures to be followed in the event of the abnormal operation of the medical device or console; and (v) Checking and using survey meters; and (3) Three years of supervised clinical experience that includes one year in a forma1 training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association and an additional two years of clinical experience in therapeutic radiology under the supervision of an authorized user at a medical institution that includes - (i) Examining individuals and reviewing their case histories to determine their suitability for teletherapy, remote afterloader, or gamma stereotactic radiosurgery treatment, and any limitations or contraindications; 0i) Selecting the proper dose and how it is to be administered; (iii) Calculating the doses and collaborating with the authorized user in the review of patients' or human research subjects' progress and consideration of the need to modify originally prescribed doses as warranted by patients' or human research subjects' reaction to radiation; and (iv) Post-administration follow up and review of case histories. 252

§ 35.961 Training for authorized medical physicist The licensee shall require the authorized medical physicist to be an individual who - (a) Is certified by the American Board of Radiology in - (1) Therapeutic radiological physics; (2) Roentgen ray and gamma ray physics; (3) X-ray and radium physics; or (4) Radiological physiC?; or (b) Is certified by the American Board of Medical Physics in radiation oncology physics; or (c) Holds a master's or doctor's degree in physics, biophysics, radiological physics, or health physics, and has completed 1 year of full time training in therapeutic radiological physics and an additional year of full time work experience under the supervision of a medical physicist at a medical institution that includes the tasks listed in§§ 35.67, 35.632, 35.633, 35.635, 35.642, 35.643, 35.644, 35.645 and 35.652, as applicable. § 35.980 Training for an authoriz~d nuclear pharmacist. The licensee shall require the authorized nuclear pharmacist to be a pharmacist who - - (a) Has current board certification as a nuclear pharmacist by the Board of Pharmaceutical Specialties; or (b)( 1) Has .completed 700 hours in a structured educational program consisting of both-(i) Didactic training in the following areas: (A) Radiation physics and instrumentation; (B) Radiation protection; 253

(C) Mathematics pertaining to the use and measurement of radioactivity; (D) Chemistry of byproduct material for medical use; and (E) Radiation biology; and (ii) Supervised experience in a nuclear pharmacy involving the following - (A) Shipping, receiving, and performing related radiation surveys; (B) Using and performing checks for proper operation of dose calibrators, survey meters, and, if appropriate, instruments used to measure alpha- or beta-emitting radionuclides; (C) Calculating, assaying, and safely preparing dosages for patients or human research subjects; (D) Using administrative controls to avoid mistakes in the administration of byproduct material; (E) Using procedures to prevent or minimize contamination and using proper decontamination procedures; and (2) Has obtained written certification, signed by a preceptor authorized nuclear pharmacist, that the above training has been satisfactorily completed and that the individual has achieved a level of competency sufficient to independently operate a nuclear pharmacy. § 35.981 Training for experienced nuclear phannaclsts. A licensee may apply for and must receive a license amendment identifying an experienced nuclear pharmacist as an authorized nuclear pharmacist before it allows this individual to work as an authorized nuclear pharmacist. A pharmacist who has completed a structured educational program as specified in§ 35.980(b)(1) before December 2, 1994, and who is working in a nuclear pharmacy would qualify as an experienced nuclear pharmacist. An experienced nuclear pharmacist need not comply with the requirements for a preceptor 254

statement (§ 35.980(b)(2)) and recentness of training (§ 35.59) to qualify as an authorized nuclear pharmacist. Subpart K-Other Medical Uses of Byproduct Material or Radiation from Byproduct Material § 35.1000 Other medical uses of byproduct material or radiation from byproduct material. A licensee may use byproduct material or a radiation source approved for medical use which is not specifically addressed in subparts D through H of this part if -- (a) The applicant or licensee has submitted the information required by§ 35.12(d); and (b) The applicant or licensee has received written approval from the Commission in a license and uses the material in accordance with the regulations and specific conditions the Commission considers necessary for the medical use of the material. Subpart L-Records § 35.2024 Records of authority and responsibilities for radiation protection programs. (a) A licensee shall retain a record of actions taken by the licensee's management in accordance with § 35.24(a) for 5 years. The record must include a summary of the actions taken and a signature of licensee management (b) The licensee shall retain a current copy of the authorities, duties and responsibilities of the radiation safety officer, as required by § 35.24(d), and a signed copy of the radiation safety officer's willingness to be responsible for implementing the radiation safety program, as 255

required by § 35.24(b). The records must include the signature of the radiation safety officer and licensee management. § 35.2026 Records of radiation protection program safety changes. A licensee shall retain a record of each radiation protection program change made in. accordance with § 35.26(a) for 5 years. The record must include a copy of the old and new procedures; the effective date of the change; and the signature of the radiation safety officer and the licensee management that reviewed and approved the change.

§ 35.2040 Records of written directive$.

A licensee shall retain a copy of each written directive as required by§ 35.40 for 3 years. § 35.2045 Records of medical events. A licensee shall retain a record of medical events reported pursuant to § 35.3045 for 3 years. The record must contain the licensee's name, names of all the individuals involved, the affected or potentially affected individual's social security number or other identification number if one has been assigned, a brief description of the medical event, why it occurred, tne effect on the individual, and the actions taken to prevent recurrence. § 35.2060 Records of instrument calibrations. A licensee shall maintain a record of instrument calibrations required by §§ 35.60 and 35.62 for 3 years. The records must include - 256

(a) For constancy, the model and serial number of the instrument, the identity of the radionuclide contained in the check source, the date of the check, and the activity measured, and the name of the individual who performed the check; (b) For accuracy, the model and serial number of the instrument, the model and serial number of each source used, the identity of the radionuclide contained in the source and its activity, the date of the test, and the results of the test, and the name of the individual who performed the test - (c) For linearity, the model and serial number of the instrument, the calculated activities, the measured activities, and the date of the test, and the name of the individual who performed the test; and (d) For geometric dependence, the model and serial number of the instrument, the configuration of the source measured, the activity measured for each volume measured, and the date of the test, and the name of the individual who performed the test. § 35.2061 Records of radiation survey instrument calibrations. A licensee shall maintain a record of radiation survey instrument calibrations required by § 35.61 for 3 years. The record must include - (a) A description of the calibration procedure; and (b) The date of the calibration, a description of the source used and the certified exposure rates from the source, and the rates indicated by the instrument being calibrated, the correction factors deduced from the calibration data, and the name of the individual who performed the calibration. 257

§ 35.2063 Records of dosages of unsealed byproduct material for medical use. (a) A licensee shall maintain a record of dosage determinations required by§ 35.63 for 3 years. (b) To satisfy this requirement, the record must contain the - (1) Radionuclide, generic name, trade name, or abbreviation of the radiopharmaceutical, and its lot number; (2) Patient's or human research subject's name, or identification number if one has been assigned; (3) Prescribed dosage and activity of the dosage at the time of determination, or a notation that the total activity is less than 1.1 MBq (30 µCi); * (4) Date a:id time of the dosage determination; and (5) Name of the individual who determined the dosage. § 35.2067 Records of possession of sealed sources and brachytherapy sources. (a) A licensee shall retain records of leak tests required by§ 35.67(b) for 3 years. The records must contain the model number, and serial number if one has been assigned, of each source tested, the identity of each source radionuclide and its estimated activity, the measured activity of each test sample, a description of the method used to measure each test sample, tne date of the test, and the name of the individual who performed the test. (b) A licensee shall retain records of the semi-annual physical inventory of sealed sources and brachytherapy sources required by§ 35.67(g) for 3 years. The inventory records must contain the model number of each source, and serial number if one has been assigned, the identity of each source radionuclide and its nominal activity, the location of each source, and the name of the individual who performed the inventory. 258

§ 35.2070 Records of surveys for ambient radiation exposure rate. A licensee shall retain a record of each survey required by § 35. 70 for 3 years. The record must include the date of the survey, a plan of each area surveyed, the trigger level established for each area, the detected dose rate at several points in each area expressed in millirem per hour or the removable contamination in each area expressed in disintegrations per minute per 100 square centimeters, the instrument used to make the survey or analyze the samples, and the name of the individual who performed the survey. § 35.2075 Records 01 the release of individuals containing radiophannaceutlcals or implants. (a) A licensee shall retain records of the release of individuals containing pharmaceuticals or implants in accordance wtth § 35.75 for 3 years after the date of release. (b) A licensee shall retain a record in accordance with§ 35.2075(a) that describes the basis for authorizing the release of individuals if the total effective dose equivalent is calculated by-(1) Using the retained activity rather than the activity administered; (2) Using an occupancy factor less than 0.25 at 1 meter; (3) Using the biological or effective half-life; or (4) Considering the shielding by tissue. (c) A licensee shall retain a record that the instructions required by§ 35.75(b) were provided to a breast-feeding woman if the radiation dose to the infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding 5 mSv (0.5 rem). 259

§ 35.2080 Records of administrative and technical requirements that apply to the provision of mobile services. (a) A licensee shall retain a copy of the letter(s) that permits the use of byproduct material at a client's address of use, in accordance with§ 35.80(a)(1). This letter must clearly delineate the authority and responsibility of each entity and must be retained for 3 years after the last provision of service. (b) A licensee shall retain the record of each survey required by§ 35.80(a)(4) for 3 years. The record must include the date of the survey, a plan of each area that was surveyed, the measured dose rate at several points in each area of use expressed in millirem per hour, the instrument used to make the survey, and the name of the individual who performed the survey. § 35.2092 Records of waste disposal. A licensee shall maintain records of the disposal of licensed materials made in accordance with § 35.92 for 3 years. The record must include the date of the disposal, the radionuclides disposed, the survey instrument used, the background dose rate, the dose rate measured at the surface of each waste container, and the name of the individual who performed the disposal. § 35.2204 Records of molybdenum-99 concentrations. A licensee shall maintain a record of the molybdenum-99 concentration tests required by § 35.204(b) for 3 years. The record must include, for each measured elution of technetium-99m, the ratio of the measures expressed as microcuries of molybdenum per 260

millicurie of technetium, the time and date of the measurement, and the name of the individual who made the measurement. § 35.2310 Records of instruction and training. A licensee shall maintain a record of instructions and training required by §§ 35.310, 35.410, and 35.610 for 3 years. The record must include a list of the topics covered, the date of the instruction or training, the name(s) of the attendee(s), and the name(s) of the individual(s) who provided the instruction. § 35.2404 Records of radiation surveys of patients and human research subjects. A licensee shall maintain a record of the radiation surveys of patients and human research subjects required by §§ 35.404 and 35.604 for 3 years. Each record must include the date, location, and results of the survey, an identifier for the patient or the human research subject, the survey instrument used, and the name of the individual who made the survey. § 35.2406 Records of brachytherapy source inventory. (a) A licensee shall maintain a record of brachytherapy source accountability required by § 35.406 for 3 years. (b) For temporary implants, the record must include - (1) The number and activity of sources removed from storage, the time and date they were removed from storage, the name of the individual who removed them from storage, and the location of use; and (2) The number and activity of sources returned to storage, the time and date they were returned to storage, and the name of the individual who returned them from storage. 261

(c) For permanent implants, the record must include - (1) The number and activity of sources removed from storage, the date they were removed from storage, and the name of the individual who removed them from storage; (2) The number and activity of sources returned to storage, the date they were returned to storage, and the name of the individual who returned them to storage; and (3) The number and activity of sources permanently implanted in the patient or human - research subject. § 35.2432 Records of full calibrations on brachytherapy sources. A licensee shall maintain a record of the full calibrations on brachytherapy sources required by § 35.432 for 3 years after the last use of the source. The record must include the date of the calibration; the manufacturer's name, model number, and serial number for the source and instruments used to calibrate the source; the source output; source positioning accuracy within applicators; and the name of the individual or the source manufacturer who performed the calibration. § 35.2605 Records of installation, maintenance, and repair. A licensee shall retain a record of the installation, maintenance, and repair of therapeutic medical devices as required by § 35.605 for 3 years. For each installation, maintenance, and repair, the record must include the date, description of the service, and name(s) of the individual(s) who performed the work. 262

§ 35.2630 Records of dosimetry equipment (a) A licensee shall retain a record of the calibration, intercomparison, and comparisons of its dosimetry equipment done in accordance with § 35.630 for the duration of the license.

(b) For each calibration, intercomparison, or comparison, the record must include - (1) The date; (2) The model numbers and serial numbers of the instruments that were calibrated, intercompared, or compared as required by paragraphs (a) and (b) of§ 35.630; (3) The correction factor that was determined from the calibration or comparison or the apparent correction factor that was determined from an intercomparison; and (4) The name(s) of the individual(s) who performed the calibration, intercomparison, or comparison. § 35.2632 Records of teletherapy full calibrations. (a) A licensee shall maintain a record of the teletherapy full calibrations required by § 35.632 for 3 years. (b) The record must include - (1) The date of the calibration; (2) The manufacturer's name, model number, and serial number for the teletherapy unit, source, and instruments used to calibrate the teletherapy unit; (3) Tables that describe the output of the unit over the range of field sizes and for the range of distances used in radiation therapy; (4) A determination of the coincidence of the radiation field and the field indicated by the light beam localizing device; (5) An assessment of timer accuracy and linearity; 263

(6) The calculated on-off error; (7} The estimated accuracy of each distance measuring and localization device; and (8) The signature of the authorized medical physicist who performed the full calibration. § 35.2633 Records of remote afterloader full calibrations. (a) A licensee shall maintain a record of the remote afterloader full calibrations required by § 35.633 for 3 years. (b) The record must include-(1) The date of the calibration; (2) The manufacturer's name, model number, and serial number for the remote afterloader, source, and instruments used to calibrate the unit; the source output; (3) An assessment of timer accuracy and linearity, source positioning accuracy, source guide tube and connector lengths, and source retraction functionality; and (4) The signature of the authorized medical physicist who performed the full calibration. § 35.2635 Records of gamma stereotactic radiosurgery unit full calibrations. (a) A licensee shall maintain a record of the gamma stereotactic radiosurgery full calibrations required by § 35.635 for 3 years. (b) The record must include - (1) The date of the calibration; (2) The manufacturer's name, model number, and serial number for the gamma stereotactic radiosurgery unit, source, and instruments used to calibrate the unit; (3) The unit output; 264

(4) An assessment of the relative helmet factors, isocenter coincidence, timer accuracy an,d linear;ify, on-off error, and trunnion centricity; and {5) The signature of the authorized medical physicist who performed the full calibration. § 35.2642 Records of periodic spot-checks for teletherapy units. (a) A liqensee shall retain a record of each periodic spot-check for teletherapy units required by§ 35.642 for 3 years. (b) The record must include - (1) The date of the spot-check; (2) The manufacturer's name, model number, and serial number for the teletherapy unit, source and instrument used to measure the output of the teletherapy unit; (3) An assessment of timer linearity and constancy; (4) The calculated on-off error; (5) A determination of the coincidence of the radiation field and the field indicated by the light beam localizing device; {6) The determined accuracy of each distance measuring and localization device; (7) The difference between the anticipated output and the measured output; (8) Notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each source exposure indicator light, and the viewing and intercom system and doors; and (9) The name of the individual who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check. 265

§ 35.2643 Records of periodic spot-checks for remote afterloaders. (a) A licensee shall retain a record of each spot-check for remote afterloaders required by §§ 35.643 and 35.644 for 3 years. (b) The record must include - (1) The date of the spot-check; (2) The manufacturer's name, model number, and serial number for the remote afterloader, source, and instrument used to measure the output of the remote afterloader; (3) The difference between the anticipated output and the measured output; (4) Notations indicating the operability of each entrance door electrical interlock, source retraction mechanism, radiation monitors, source exposure indicator lights, viewing and intercom systems if applicable, applicators and connectors, and source positioning accuracy; and (5) The name of the individual who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check. § 35.2645 Records of periodic spot-checks for gamma stereotactic radiosurgery units. (a) A licensee shall retain a record of each spot-check for gamma stereotactic radiosurgery units required by § 35.645 for 3 years. (b) The record must include - (1) The date of the spot-check; (2) The manufacturer's name, model number, and serial number for the gamma stereotactic radiosurgery unit and the instrument used to measure the output of the unit; (3) Tne measured source output and source output against computer calculations; 266

t .. (4) Notations indicating the operability of !"c3diation monitors, helmet microswitchs, emergency timing circuits, emergency off buttons, electrical interlocks, source exposure indicator lights, viewing and intercom systems, timer termination systems, hydraulic cutoff switch and stereotactic frames and localizing devices (trunnions); and (5) The name of the individual who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.

    § 35.2647 Records of additional technical requirements for mobile remote afterloaders.

(a) A licensee shall retain a record of each check for mobile remote afterloaders required by§ 35.647 for 3 years. (b) The record must include - (1) The date of the check; (2) The manufacturer's name, model number, and serial number of the remote afterloader; (3) Notations accounting for all sources before the licensee departs from a facility; (4) Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom system, applicators and connectors, and source positioning accuracy; and (5) The signature of the individual who performed the check.

    § 35.2652 Records of surveys of therapeutic treatment units.

(a) A licensee shall maintain a record of radiation surveys of treatment units made in accort:!ance with § 35.652 for the duration of use of the unit. (b) The record must include - 267

                                                                                                .. t (1) The date of the measurements; (2) The manufacturer's name, model number and serial number of the treatment unit, source, and instrument used to measure radiation levels; (3) Each dose rate measured around the source while the unit is in the off position and the average of all measurements; and (4) The signature of the individual who performed the test.

§ 35.2655 Records of 5-year inspection for teletherapy and gamma stereotactlc surgery units. (a) A licensee shall maintain a record of the 5-year inspections for teletherapy and gamma stereotactic radiosurgery units required by § 35.655 for the duration of use of the unit. (b) The record must contain - (1) The inspector's radioactive materials license number; (2) The date of inspection; (3) The manufacturer's name and model number and serial number of both the treatment unit and source; (4) A list of components inspected and serviced, and the type of service; and (5) The signature of the inspector. 268

Subpart M-Reports

 § 35.3045 Reports of medical events.

(a) A licensee shall report any administration, except for administrations resulting from a direct intervention of a patient or human research subject that could not have been reasonably prevented by the licensee, that results in either - {1) A dose that differs from the prescribed dose by more than 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem} to an organ or tissue, or 0.5 Sv {50 rem) shallow dose equivalent to the skin; and (i) The total dose or dosage delivered differs from the prescribed d9se or dosage by 20 percent or more; or (ii) The fractionated dose delivered differs from the prescribed dose, for a single fraction, by 50 percent or more. (2) A dose that exceeds 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin from any of the following - (i) An administration of a wrong pharmaceutical; (ii) An administration of a radiopharmaceutical by the wrong route of administration; (iii) An administration of a dose or dosage to the wrong individual or human research subject; (iv) An administration of a dose or dosage delivered by the wrong treatment mode; or (v) A leaking sealed source. 269

(3) A dose to the skin or an organ or tissue other than the treatment site that exceeds by 0.5 Sv (50 rem) to an organ or tissue and 20 percent the dose expected from the administration defined in the written directive. (b) The licensee shall notify by telephone the NRC Operations Center (301-951-0550) no later than the next calendar day after discovery of the medical event . (c) The licensee shall submit a written report to the appropriate NRC Regional Office listed in § 30.6 of this chapter within 15 days after discovery of the medical event. (1) The written report must include - (i) The licensee's name; (ii) The name of the prescribing physician; (iii) A brief description of the event; (iv) Why the event occurred; {v) The effect on the individual(s) who received the administration; (vi) What improvements are needed to prevent recurrence; (vii) Actions taken to prevent recurrence; (viii) Whether the licensee notified the individual (or the individual's responsible relative or guardian), and if not, why not; and (ix) If there was notification, what information was provided. (2) The report must not contain the individual's name or any other information that could lead to identification of the individual. (d) The licensee shall notify the referring physician and also notify the individual affected by the medical event no later than 24 hours after its discovery, unless the referring physician personally informs the licensee either that he or she will inform the individual or that, based on medical judgement, telling the individual would be harmful. The licensee is not 270

required to notify the individual without first consulting the referring physician. If the referring physician or the affected individual cannot be reached within 24 hours, the licensee shall notify the individual as soon as possible thereafter. The licensee may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the medical event, because of any delay in notification. To meet the requirements of this section, the notification of the individual receiving the medical event may be made instead to that individual's responsible relative or guardian, when appropriate. (e) If the individual was notified pursuant to paragraph (d) of this section, the licensee shall also furnish, within 15 days after discovery of the medical event, a written report to the individual by sending either - (1) A copy of the report that was submitted to the NRC; or (2) A brief description of both the event and the consequences as they may affect the individual. (f) Aside from the notification requirement, nothing in this section affects any rights or duties of licensees and physicians in relation to each other, to individuals affected by the medical event, or to that individual's responsible relatives or guardians. § 35.3047 Report of a dose to an embryo/fetus or a nursing child. (a) A licensee shall report any dose to an embryo/fetus that is greater than 5 mSv (500 mrem) absorbed dose that is a result of an administration of byproduct material or radiation

                                                                                               /

from byproduct material to a pregnant individual unless the dose to the embryo/fetus was specifically approved, in advance, by the authorized user. 271

(b) A licensee shall report any dose to a nursing child that is greater than 5 mSv (500 mrem) total effective dose equivalent that is a result of an administration of byproduct material to a breast feeding individual. (c) The licensee shall notify by telephone the NRC Operations Center within 5 days after discovery of a dose to the embryo/fetus or nursing child that requires a report in paragraphs (a) or (b) in this section. (d) The licensee shall submit a written report to the appropriate NRC Regional Office listed in § 30.6 no later than 15 days after discovery of a dose to the embryo/fetus or mirsing child that requires a report in paragraphs (a) or (b) in this section. (1) The written report must include - (i) The licensee's name; (ii) The name of the prescribing physician ; (iii) A brief description of the event; (iv) Why the event occurred; (v) The effect on the embryo/fetus or the nursing child; (vi) What improvements are needed to prevent recurrence; and (vii) Actions taken to prevent recurrence. (2) The report must not contain the individual's or child's name or any other information that could lead to identification of the individual or child. (e) The licensee shall notify the referring physician and also notify the pregnant individual or mother, hereafter referred to as the mother, within 5 days of discovery of an event that would require reporting under paragraph (a) or (b) of this section, unless the referring physician personally informs the licensee either that he or she will inform the mother or that, based on medical judgment, telling the mother would be harmful; 272

(f) To meet the requirements of this section, the notification of the mother may be made instead to the mother's or child's responsible relative or guardian, when appropriate. (g) The licensee is not required to notify the mother without first consulting the referring physician. If the referring physician or mother cannot be reached within 5 days, the licensee shall make the appropriate notifications as soon as possible thereafter. The licensee may not delay any appropriate medical care for the embryo/fetus or for the nursing child, including any necessary remedial care as a result of the event, because of any delay in notification. (h) If notification was made pursuant to paragraphs (e) and (f) of this section, the licensee shall also furnish, within 15 days after discovery of the event, a written report to the mother or responsible relative or guardian, by sending either - (1) A copy of the report that was submitted to the NRC; or (2) A brief description of both the event and the consequences as they may affect the embryo/fetus or nursing child. § 35.3067 Reports of leaking sources . A licensee shall file a report within 5 days if a leakage t8$t required by § 35.67 reveals the presence of 185 Bq ( 0.005 µCi) or more of removable contamination. The report must be filed with the appropriate NRC Regional Office listed in § 30.6 of this chapter, with a copy to the Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. The written report must include the model number and serial number if assigned, of the leaking source; the radionuclide and its estimated activity; the measured activity of each test sample expressed in microcuries; a description of the method used to measure each test sample; the date of the test; and the action taken. 273

Subpart N--Enforcement § 35.4001 Violations. (a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of-(1) The Atomic Energy Act of 1954, as amended; (2) Trtle 11 of the Energy Reorganization Act of 1974, as amended; or (3) A regulation or order issued pursuant to those Acts. (b) The Commission may obtain a court order for the payment of a civil pt:,nalty imposed under Section 234 of the Atomic Energy Act: (1) For violations of-(i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended; (ii) Section 206 of the Energy Reorganization Act; (iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1 )(I) of this section; (iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(I) of this section. (2) For any violation for which a license may be revoked under Section 186 of the Atomic Energy Act of 1954, as amended. § 35.4002 Criminal penalties. (a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation 274

issued under sections 161 b, 161 i, or 161 o of the Act. For purposes of Section 223, all the regulations in 10 CFR Part 35 are issued under one or more of sections 161 b, 161 i, or 161 o, except for the sections listed in paragraph (b) of this section. (b) The regulations in 10 CFR Part 35 that are not issued under subsections 161b, 161i, or 1610 for the purposes of Section 223 are as follows: §§ 35.1, 35.2, 35.7, 35.8, 35.12, 35.15, 35.18, 35.19, 35.65, 35.100, 35.200, 35.300, 35.600, 35.4001, and 35.4002. Appendix A to 10 CFR Part 35-Examining Organization or Entity I. Requirements for an examining organization or entity. An independent organization or entity that submits an application for approval of the Commission to examine individuals pursuant to §§ 35.50(b)(3), 35.51 (b)(3), 35.55(b)(3), 35.290(b)(3), 35.292(b)(3), 35.390(b)(4), 35.490(b)(4), or 35.690(b)(4) shall:

1. Make its examination process available to the general public nationwide and ensure that it is not restricted because of race, color, religion, sex, age, national origin, or disability;

2. Have an adequate staff, a viable system for financing its operations, and a policy-and decision-making review board;

3. Have a set of written organizational by-laws and policies that provide adequate assurance of lack of conflict of interest and a system for monitoring and enforcing those by-laws and policies;

4. Have a committee, whose members can carry out their responsibilities impartially, to review and approve the examination guidelines and procedures, and to advise the organization's staff in implementing the examination program; 275

                                                                                                       ,r

5. Have a committee, whose members can carry out their responsibilities impartially, to review complaints by examined individuals;

6. Have written procedures describing all aspects of its examination program, maintain records of the current status of each individual's examination and the administration of its examination program;

7. Have procedures to ensure that examinations are not given to individuals who have also been instructed by the examining organization in the same subject area;

8. Have procedures to ensure that examined individuals are provided due process with respect to the administration of its examination program, including the process of being examined;

9. Have procedures for proctoring examinations, including qualifications for proctors.

10. Exchange information about examined individuals with the Commission and other independent examining organizations and/or Agreement States and allow periodic review of its examination program and related records;

11. Provide a description to the Commission of its procedures for choosing examination sites and for providing an appropriate examination environment; and

12. Submit its request to the Director, Office of Nuclear Materials Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

II. Requirements for Examination Programs. All examination programs must -

1. Require applicants for examination to receive training in the topics set forth in

§§ 35.50(b)(1), 35.51(b)(1), 35.55(b)(1), 35.290(b)(1), 35.292(b)(1), 35.390(b)(1), 35.490(b)(1) 276

or 35.690(b)(1), or equivalent Agreement State regulations, and satisfactorily complete a written examination covering these topics; and

2. Include procedures to ensure that all examination questions are protected from improper disclosure.

Ill. Requirements for Written Examinations.

1. All examinations must be designed to test an:individual's knowledge and understanding of the topics listed in §§ 35.50(b)(1 ), 35.51 (b)(1 ), 35.55(b)(1 ), 35.290(b)(1 ),

35.292(b)(1 ), 35.390(b)(1 ), 35.490(b)(1) or 35.690(b)(1 ), or equivalent Agreement State regulations;

2. Test questions must be drawn from a question bank containing psychometrically valid questions based on the material in§§ 35.50(b)(1), 35.51(b)(1), 35.55(b)(1), 35.290{b)(1),

1 35.292(b)(1), 35.390(b)(1), 35.490(b)(1) or 35.690(b)(1), or equivalent Agreement State regulations; and 277

3. Sample examinations must be submitted to the Commission for review initially and every 5 years.

ti. Dated at Rockville, Maryland, this ;(' - day of August, 1998. For the Nuclear Regulatory Commission. Jovr,J C. Hoyle, Secretary of the Commission. 278

APPENDIX A Preliminary Regulatory Flexibility Analysis The NRC is required by the Regulatory Flexibility Act (RFA)-(5 U.S.C. 601 et seq.) as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) to consider the impact of their rulemakings on small entities and evaluate alternatives that would accomplish regulatory objectives without unduly burdening small entities or erecting barriers to competition. This analysis describes the assessment of the small entity impacts expected to be incurred by 10 CFR Part 35 licensees as a result of the comprehensive revisions to Part 35 being proposed. An assessment of small entity impacts involves three major tasks: (1) defining "small entities" for the rule being analyzed, including "small businesses," "small governments," anq "small organizations;" {2) determining what number constitutes a "substantial number" of these entities; and {3) determining if "significant impacts" will be incurred by licensees under the proposed rule. 1.1 Defining "Small Entities" Affected by the Rule The NRC has established size standards that it uses to determine which NRC licensees qualify as small entities (60 FR 18344; April 11, 1995). These size standards are codified in 10 CFR 2.810. The size standards pertinent to Part 35 licensees include the following: 279

Jt' Untjer 10 CFR 2.810(a)(1), a small business is a for-profit concern and is a concern that provides a service or a concern not engaged in manufacturing with average gross receipts of $5 million or less over its last 3 completed fiscal years. (The Small Business Administration size standards for the "health services" category, including "offices and clinics of doctors of medicin'e" and all other health services subcategories also establish $5 million as the cut off point for "small entities."} Under 10 CFR 2.810 (b) a small organization is a not-for-profit organization which is independently owned and operated and has annual gross receipts of $5 million or less. For purposes of this analysis, therefore, "small entity" refers to any specific licensee under 10 CFR Part 35 with annual gross receipts of $5 million or less. The proposed rule would affect 1902 NRC licensees. These licenses are issued principally to medical institutions, with at least 1216 of the Part 35 licensees classified as medical institutions (codes 2110, 2120, and 2121 in NRC's licensee tracking system). Review of available data indicates that at most 8 of these medical institutions had operating revenues of less than $5 million in 1996. First, all hospitals in States in which Part 35 licensees are regulated by NRC were screened for revenues, using data obtained from Profiles of U.S. Hospitals, 1996, HCIA Inc. HCIA collects, analyzes, and publishes data on hospitals, based on financial submissions to the Health Care Financing Administration (HCFA). Revenues were measured as operating revenue, which is the sum of llitl patient revenue and other operating revenue, such as revenue 280

from sources such as cafeterias and parking facilities, but which does not include revenue from non-operating sources such as investment income or donations. Operating revenue therefore is a less inclusive measure of revenues than gross revenues. All hospitals identified as having operating revenues less than $5 million then were checked against the NRC License Tracking System to identify those medical institutions that both had revenu':ls less than $5 million and were regulated by NRC under Part 35. Of the eight institutions that were identified as meeting both criteria, three had operating revenues above $4.4 million, and therefore may have gross revef')ues above $5 million. They have, however, been included in the group of institutions with less than $5 million in revenues for this analysis. The balance of the licenses, approximately 686 licenses, are issued principally to physicians in private practice. Information on gross revenues for such physicians suggests that all may be "small entities." First, data from the Af.AA's Socioeconomic Monitoring System, provided in Physician Marketplace Statistics 1996: Profiles for Detailed Specialties, Selected States and Practice Arrangements. Center for Health Policy Research, American Medical Association, were reviewed for physicians' revenues or income. Table 89 of that source, which reports 1'Total Practice Revenue per Self-Employed Nonfederal Physician (in thousands of dollars), 1995" indicates that even at the 75th percentile no physician specialty, geographic area, or practice arrangement exceeded even $1 million in revenues. Similar data from the Physician Compensation and Production Survey: 1996 Report Based on 1995 Data, Medical Group Management Association, indicate that the median for "production," defined as gross charges, for all physicians was $422,937 in 1995 (p. 10). Although "production" generally is larger for 281

specialists than all physicians, the difference is too small to place specialists above the $5 million criterion. In total, therefore, an upper bound estimate of 36 percent of Part 35 licensees, or approximately 686 licensees, may be "small entities." 1.2 Determining What Number Constitutes a Substantial Number This analysis applied a figure corresponding to 20 percent of small entities in determining whether a "substantial number" of small entities are likely to be impacted by the rule. Therefore, based on the analysis in section 1.1, the proposed rule would affect a substantial numbei of small entities. 1.3 Measuring "Significant Impacts" To evaluate the impact that a small entity is expected to incur as a result of the rule, the analysis should calculate the entity's ratio of annualized compliance costs as a percentage of gross receipts. Entities are classified as facing potentially "significant" impacts if this ratio exceeds one percent. Determining annual compliance costs for the revisions to Part 35, however, is complicated by the fact that the proposed rule would comprehensively address a wide variety of uses of byproduct materials in medicine. The entities likely to be most *affected by the rule are broad scope medical institutions with a large number of different modalities and conducting a large number of medical procedures involving byproduct material or radiation from byproduct material. However, the preceding analysis indicated that such broad scope licensees are not 282

small entities. The costs attributable to Part 35 compliance for such broad scope licensees will be substantially greater than the annual compliance costs likely to be incurred by those licensees most likely to be small entities (i.e., single private practice physicians performing diagnostic procedures). The Part 35 rule addresses contingent actions as well as actions that must be carried out by all licensees. In particular, the lower risk posed by diagnostic procedures reduces the likelihood that private practice physicians performing diagnostic procedures will experience medical events involving costs of reporting and follow up. All licensees will incur annual compliance costs for general administrative and technical requirements established by Part 35, although the level of such compliance costs will vary significantly depending on certain contingencies and on the activities being performed by the licensee. Annual compliance costs for licensees are expected, in all cases, to involve compliance with requirements to establish and maintain a radiation protection program; possess, use, calibrate, and check survey instruments, and satisfy the requirements pertinent to the modality or modalities used by the licensee. NRC estimates that annual compliance costs for a licensee carrying out any level of activities under Part 35 will in all cases exceed 80 hours annually at $100 per hour, or $8,000. Assuming annual revenues of $244,000 for a single private practitioner subject to Part 35, as estimated in Socioeconomic Characteristics of Medical Practice, 1997, American Medical Association, Center for Health Policy Research, Table 43. "Mean Physician Net Income (in thousands of dollars) after Expenses before Taxes, 1995," for the net income for "all 283

physicians-rad," a very conservative surrogate for gross revenues, these annual compliance costs exceed both the one percent cutoff level and the three percent cutoff level under SBREFA for "significant impacts." Assuming an average "production" of $423,000, (Section 1.1 of this analysis), however, the 1 percent but not the 3 percent cutoff is exceeded. Therefore, the proposed rule appears to have *significant impacts on a significant number of licensees. NRC has taken a number of actions in this proposed rule to ensure that the proposed alternative is the least costly alternative that adequately protects workers and patients from radiation exposure. As the Regulatory Analysis prepared for the proposed rule demonstrates, / the total annual cost to licensees of compliance with the proposed rule would be approximately $9.87 million less than the cost of compliance with the current rule (See XII. Regulatory Analysis of the Supplementary Information section of this document). This is equivalent to savings of approximately $1500 per licensee. Although savings to small licensees can be expected to be proportionately less than savings to licensees with more extensive operations, smaller licensees also can be expected to incur smaller compliance costs. In order to assist small licensees, the NRC has sought in the proposed rule to eliminate prescriptive requirements wherever possible, and to allow for much greater flexibility in . compliance. Such flexibility is particularly helpful to small licensees in reducing their cost of compliance, because it will enable them to avoid the costs of radiation safety measures, such as the detailed requirements for Radiation Safety Committees, that were especially oriented toward larger licensees with numerous modalities and activities in the same institution. NRC has reduced the training and experience requirements applicable to the diagnostic use of byproduct material by focusing those requirements on radiation safety and by reducing the 284 I

number of hours of training required. NRC has also sought to reduce the prescriptive nature of requirements for testing and calibration, and to reduce reporting and recordkeeping burdens, which can have an especially strong impact on small entities. Finally, the program for revising Part 35 and the associated guidance documents has involved more interactions and consultations with potentially affected parties (the medical community and the public, including representatives of small licensees) than is provided by the typical notice and comment rulemaking process. Early public input was solicited through several different mechanisms: requesting public input through Federal Register notices; holding open meetings of the government groups developing the revised rule language; meeting with medical professional societies and boards; putting background documents, options for the more significant regulatory issues associated with the rulemaking, and a "strawman" draft proposed rule on the Internet; and convening public workshops. Participants from the broad spectrum of interests that may be affected by the rulemaking were invited to attend the public workshops in Philadelphia, PA., and Chicago, IL., held in October and November 1997. The public was also welcome to attend these workshops, as well as the Part 35 Workshop that was held in conjunction with the All Agreement States Meeting in October 1997, and the NRC's Advisory Committee on the Medical Uses of Isotopes meetings in September 1997 and March 1998. As indicated in the Regulatory Flexibility Analysis statement included 'in the proposed rule, the NRC requests comments from small medical licensees concerning the impacts of the proposed rule and any suggested modifications that may affect the economic impact of the proposed requirements. 285

              ,I P'rom:         Michael Lesar To:            WND1.WNP2(CJS)

Date: 8/14/98 12:31pm

Subject:

Part 35 Policy Statement and Proposed Rule -Reply

Jeanne, I noticed this yesterday and called the NMSS staff. They don't believe its a concern so we need not do anything.

Mike

From: Jeanne Shoemaker To: TWD2.TWP6.DLM1, 1WD2.1WP6.MfL, TWD2.1WP6.AWS1 Date: 8/14/98 10:58am

Subject:

Part 35 Policy Statement and Proposed Rule Adria Byrdsong, who will be collecting comments on the subject documents, pointed out that the Federal Register put two different dates for expiration of the comment periods. The expiration date for comments on the Policy Statement is November 13 and the date for comments on the Proposed Rule is November 12. They were both published yesterday, August 13, and both indicated that a date 90 days from publication should be inserted. Do we need to do anything? Thanks, Jeanne CC: ATBl

October 30, 1998 NOTE TO: Emile Julian Chief: Docketing and Services Branch FROM: Carol Gallagher ADM,DAS

SUBJECT:

DOCKETING OF COMMENT ON PROPOSED RULE, MEDICAL USE OF BYPRODUCT MATERIAL (PART 3 5)" Attached for docketing is a comment letter related to the subject proposed rule. This comment was received via the rulemaking forum website on October 26, 1998. The submitter's name is Thomas Hill, Department ofNatural Resources, 4244 International Parkway, Suite 114, Atlanta, Georgia 30354. Please send a copy of the docketed comment to Cathy Haney (mail stop T9-F-31) for her records.

Attachment:

As stated cc w/o attachment: C. Haney

MEMORANDUM TO: Emile Julian FROM:

SUBJECT:

Theresa Lee K e n d a l l ~ MATERIAL TO BE DOCKETED L ~ DATE: October 26, 1998 I am forwarding the attached correspondence, which I received today, for docketing in response to the August 8, 1997, FRN (62 FR 42219) on the request for public input on the revision of Part 35, Medical Uses of Byproduct Material. If there are any questions, please call Diane Flack on 415-5681 or Cathy Haney on 415-6825.

MEMORANDUM TO: Emile Julian _ O ,O Jj , ~ fl I} FROM: Theresa Lee Kendall ~ ~-/~

SUBJECT:

MATERIAL TO BE DOCKETED DATE: October 6, 1998 I am forwarding the attached correspondence, which I received today, for docketing in response to the August 8, 1997, FRN (62 FR 42219) on the request for public input on the revision of Part 35, Medical Uses of Byproduct Material. If there are any questions, please call Diane Flack on 415-5681 or Cathy Haney on 415-6825. cc: C. Haney (per DSFlack)

October 26, 1998 NOTE TO: Emile Julian Chief: Docketing and Services Branch FROM: Carol Gallagher ADM,DAS

SUBJECT:

DOCKETING OF COMMENT ON PROPOSED RULE, "MEDICAL USE OF BYPRODUCT MATERIAL (PART 35)" Attached for docketing is a comment letter related to the subject proposed rule. This comment was received via the rulemaking forum website on October 23, 1998. The submitter's name is Mack L. Richard, M.S., Indiana University Medical Center, 541 Clinical Dr., Indianapolis IN 46202-5111, Please send a copy of the do~keted comment to Cathy Haney (mail stop T9-F-

31) for her records.

Attachment:

As stated cc w/o attachment: C. Haney

D- \Cc, - C.. l MEMORANDUM TO: Emile Julian FROM: Theresa Lee Kendall ~ L~

SUBJECT:

MATERIAL TO BE DOCKETED DATE: October 5, 1998 I am forwarding the attached correspondence, which I received today, for docketing in response to the August 8, 1997, FRN (62 FR 42219) on the request for public input on the revision of Part 35, Medical Uses of Byproduct Material. If there are any questions, please call Diane Flack on 415-5681 or Cathy Haney on 415-6825.

MEMORANDUM TO: Emile Julian FROM: Theresa Lee Kendall ~ L ~

SUBJECT:

MATERIAL TO BE DOCKETED DATE: September 28, 1998 I am forwarding the attached correspondence, which I received today, for docketing in response* to the August 8, 1997, FRN (62 FR 42219) on the request for public input on the revision of Part 35, Medical Uses of Byproduct Material. If there are any questions, please call Diane Flack on 415-5681 or Cathy Haney on 415-6825.

MEMORANDUM TO: Emile Julian /) FROM: Theresa Lee Kendall ~ ';(_

SUBJECT:

MATE RIAL TO BE DOCKETED DATE: September 2, 1998 (second submittal of the day) I am forwarding the attached correspondence, which I received today, for docketing in response to the August 8, 1997, FRN (62 FR 42219) on the request for public input on the revision of Part 35, Medical Uses of Byproduct Material. If there are any questions, please call Diane Flack on 415-5681 or Cathy Haney on 415-6825.

MEMORANDUM TO: Emile Julian FROM: Theresa Lee Kendall ~ ';/!__,_ ~

SUBJECT:

MATE RIAL TO BE DOCKETED DATE: September 2, 1998 I am forwarding the attached correspondence, which I received tdday, for docketing in response to the August 8, 1997, FRN (62 FR 42219) on the request for public input on the revision of Part 35, Medical Uses of Byproduct Material. If there are any questions, please call Diane Flack on 415-5681 or Cathy Haney on 415-6825 .

[7590-01-P] NUCLEAR REGULATORY COMMISSION 10 CFR Part 35 Medical Use of Byproduct Material; Workshop AGENCY: U.S. Nuclear Regulatory Commission. ACTION: Notice of workshop ..

SUMMARY

The Nuclear Regulatory Commission has developed a proposed rulemaking for a comprehensive revision of its regulations governing the medical use of byproduct material in

• 10 CFR Part 35, "Medical Use of Byproduct Material," and a proposed revision of its 1979 Medical Use Policy Statement (MPS). Throughout the development of the proposed rule and MPS, the Commission solicited input from the various interests that may be affected by these proposed revisions. The Commission is now soliciting comments on the proposed rule and MPS through two mechanisms - publishing the documents in the Federal Register for a 90-day public comment period (63 FR 43516 and 63 FR 43580, August 13, 1998); and convening facilitated public meetings and a workshop, during the public comment period, to discuss the Commission's proposed resolution of the major issues. The workshop on NRC's medical rulemaking initiative will be held during the Organization of Agreement States' (OAS) 1998 All Agreement States Meeting, in Bedford, New Hampshire.

DATE: The workshop will be held on October 31, 1998, from 9:00 a.m. to 12 noon. ADDRESS: The Wayfarer Inn, 121 South River Road, Bedford, NH 03110, telephone 603-622-3766. FOR FURTHER INFORMATION CONTACT: Cathy Haney, U.S. Nuclear Regulatory Commission, Office of Nuclear Material Safety and Safeguards, telephone 301-415-6825, e-mail cxh@nrc.gov.

SUPPLEMENTARY INFORMATION: After a comprehensive review of its medical use program, the Commission directed the staff to revise 10 CFR Part 35, associated guidance documents, and, if necessary, the Commission's 1979 MPS [Staff Requirements Memorandum (SRM)- COMSECY-96-057, "Materials/Medical Oversight" (DSI 7), dated March 20, 1997]. The Commission's SRM specifically directed the restructuring of Part 35 into a risk-informed, more performance-based regulation. In its SRM dated June 30, 1997, "SECY-97-115, Program for Revision of 10 CFR Part 35, 'Medical Uses of Byproduct Material' and Associated Federal Register Notice," the Commission approved the staffs proposed plan for the revision of Part 35 and the Commission's 1979 MPS. The schedule the Commission approved in SRM-SECY-97-115 provides for the rulemaking to be completed by June 1999. After Commission approval of the staffs program to revise Part 35 and associated guidance documents, the staff initiated the rulemaking process, as announced in 62 FR 42219 (August 6, 1997). The proposed rule and MPS were developed using a group approach. A Working Group and Steering Group, consisting of representatives from NRC, OAS, and the Conference of Radiation Control Program Directors, Inc., were established to develop rule text alternatives, rule language, and associated guidance documents. State participation in the process was intended to enhance development of corresponding rules in State regulations, to provide an opportunity for early State input, and to allow State staff to assess potential impacts of NRG draft language on the regulation of non-Atomic Energy Act materials used in medical diagnosis, treatment, or research, in the States. The proposed revision of Part 35 is based on the Commission's directions in the SRMs of 2

March 20, 1997, and June 30, 1997. The revision is intended to make Part 35 a more risk-informed, performance-based regulation that will: (1) focus the regulations on those medical procedures that pose the highest risk, from a radiation safety aspect, with a subsequent decrease in the oversight of low-risk activities; (2) focus on those requirements that are essential for patient safety; (3) initiate improvements in NRC's medical program, by implementing recommendations from internal staff audits, other rulemaking activities, and results of analyses in medical issues papers; (4) incorporate regulatory requirements for new treatment modalities; (5) reference, as appropriate, available industry guidance and standards; and (6) provide for capturing relevant safety-significant events. The program for revising Part 35, associated guidance document, and MPS has provided more opportunity for input from potentially affected parties (the medical community and the public) than is provided by the typical notice and comment rulemaking process. Based on the worthwhile public input received during the early rulemaking process, the Commission believes that it is important for interests affected by the proposed revisions not only to have an opportunity to comment on the proposed rulemaking and MPS, but also to have an opportunity to discuss the proposed revisions with one another and the Commission. Accordingly, the Commission is convening three public meetings (63 FR 39763, July 24, 1998) and a workshop, during the public comment period, where representatives of the interests that may be affected by the proposed rulemaking and MPS will have an opportunity to discuss the proposed revisions. The workshop will be open to the public, on a space available basis. The agenda for the workshop will focus on discussion of: (1) the proposed revision of Part 35 and the MPS; 3

(2) proposed changes in licensing, inspection and enforcement philosophy; (3) implementation costs; (4) resolution of cross-cutting issues; and (5) Agreement State issues. However, the workshop will also provide enough flexibility for the public to have an opportunity to comment on related rulemaking issues. Members of the public who are unable to attend the workshop can send comments to Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff, or provide comments via NRC's interactive rulemaking website through the NRG home page (http://www.nrc.gov). The comment periods for the proposed rule and the MPS end on November 12 and November 13, 1998, respectively. Comments received after these dates will be considered if it is practical to do so, but the Commission is only able to ensure consideration of comments received on or before these dates. Dated at Rockville, ly1aryland this ind day of dct ,1998. Fo 1 I 1N~1/4ea,:,

                                                /

Rfgulatory Commission. Fred'inck-C. C o ~ r : ~ o r , Division of Industrial and Medical Nuclear Safety, Office of Nuclear Material Safety and Safeguards. 4

[7590-01-P] NUCLEAR REGULA TORY COMMISSION 10 CFR Part 35 Medical Use of Byproduct Material; Public Meetings AGENCY: U.S. Nuclear Regulatory Commission. ACTION: Notice of public meetings.

SUMMARY

The Nuclear Regulatory Commission has developed a proposed rulemaking for a comprehensive revision of its regulations governing the medical use of byproduct material in 10 CFR Part 35, "Medical Use of Byproduct Material," and a proposed revision of its 1979 Medical Use Policy Statement (MPS). Throughout the development of the proposed rule and MPS, the Commission solicited input from the various interests that may be affected by these proposed revisions. The Commission now plans to solicit comme_nts on the proposed rule and MPS through two mechanisms - publishing the documents in the Federal Register for public comment (scheduled for August 1998); and convening three facilitated public meetings, during the public comment period, to discuss the Commission's proposed resolution of the major issues. The public meetings will be held in San Francisco, California, on August 19-20, 1998; in Kansas City, Missouri, on September 16-17, 1998; and in Rockville, Maryland, on October 21-22, 1998. All meetings will be open to the public. Francis X. Cameron, Special Counsel for Public Liaison, in the Commission's Office of the General Counsel, will be the convener and facilitator for the meetings.

DATES: The first public meeting will be In San Francisco on August 19-20, 1998, from 8:30 a.m. to 5:00 p.m. each day; the second public meeting will be in Kansas City on September 16-17, 1998, from 8:30 a.m. to 5:00 p.m. each day; and the third public meeting will be in Rockville on bctober21-22,1998, from 8:30 a.m. to 5:00 p.m. each day.

ADDRESSES: The San Francisco meeting will be held at the ANA Hotel San Francisco, 50 Third Street, San Francisco, California 94103, 415-97 4-6400. The Kansas City meeting will be held at the Radisson Suite Hotel Kansas City, Kansas Cify', 106 West 12th Street, Kansas City, MO 64105, 800-333-3333. The Rockville meeting will be held in the auditorium at the U.S. Nuclear Regulatory Commission, 11545 Rockville Pike, Rockville, MD 20852-2738. FOR FURTHER INFORMATION CONTACT: Francis X. Cameron, Special Counsel for Public Liaison, Office of the General Counsel, Nuclear Regulatory Commission, Washington D.C. 20555-0001, Telephone: 301-415-1642. SUPPLEMENTARY INFORMATION:

Background

Following a comprehensive review of its medical use program, the Commission directed the NRC staff to revise 10 CFR Part 35, associated guidance documents, and, if necessary, the Commission's 1979 Medical Policy Statement [Staff Requirements Memorandum (SRM) - COMSECY-96-057, Materials/Medical Oversight (OSI 7), dated March 20, 1997]. The Commission's SRM specifically directed the restructuring of Part 35 into a risk-informed, more performance-based regulation. In its SRM dated June 30, 1997, "SECY-97-115, Program for Revision of 10 CFR Part 35, 'Medical Uses of Byproduct Material' and Associated Federal Register Notice," the Commission approved the NRC staff's proposed plan for the revision of Part 35 and the Commission's 1979 Medical Use Policy Statement (MPS). The schedule approved by the Commission in SRM-SECY-97-115 provides for the rulemaking to be completed by June 1999.

After Commission approval of the NRC staff's program to revise Part 35 and associated guidance documents, the NRC staff initiated the rulemaking process, as announced in 62 FR 42219 (August 6, 1997). The proposed rule and MPS were developed using a group approach. A Working Group and Steering Group, consisting of representatives of NRC, the Organization of Agreement States, and the Conference of Radiation Control Program Directors, were established to develop rule text alternatives, rule language, and associated guidance documents. State participation in the process was intended to enhance development of corresponding rules in State regulations, to provide an opportunity for early State input, and to allow State staff to assess potential impacts of NRC draft language on the regulation of non-Atomic Energy Act materials used in medical diagnosis, treatment, or research, in the States. The proposed revision of Part 35 is based on the Commission's directions in the SRMs l of March 20, 1997, and June 30, 1997. The revision is intended to make Part 35 a more risk-informed, performance-based regulation that will focus the regulations on those medical procedures that pose the highest risk, from a radiation safety aspect, with a subsequent decrease in the oversight of low-risk activities; focus on those requirements that are essential for patient safety; initiate improvements in NRC's medical program, by implementing recommendations from internal staff audits, other rulemaklng activities, and results of analyses in medical issues papers; incorporate regulatory requirements for new treatment modalities; and reference, as appropriate, available industry guidance and standards.

.F \. As part of the rulemaking process, significant issues associated with the regulation of the medical use of byproduct material and the revision of the MPS were identified, alternatives were developed for them.and public input on them was specifically sought. These alternatives

                                                                                   ""('

were developed to stimulate input from members of the public in an effort to.encourage all interested parties to contribute to the development of the revised regulation and were discussed during facilitated public workshops and meetings throughout the development of the proposed rule and MPS. The program for revising Part 35, associated guidance document, and MPS has provided more opportunity for input from potentially affected parties (the medical community and the public) than is provided by the typical notice and comment rulemaking process. Early public input was solicited by requesting input through Federal Register notices; holding public meetings of the Working and Steering Groups; meeting with medical professional societies and boards; putting background documents, rulemaking alternatives, and a "strawman" draft proposed rule on the Internet and in NRC's Public Document Room; and convening two facilitated public workshops. Significant regulatory issues were also discussed at the Part 35 Workshop that was held in conjunction with the All Agreement States Meeting in October 1997, the Advisory Committee on the Medical Uses of Isotopes (ACMUI) meetings in September 1997 and March 1998, and the ACMUI subcommittee meetings in February 1998. Input received during these interactions and in writing were beneficial to the staff in developing the proposed rule and MPS. Workshops Based on the substantive public input received *during the early rulemaking process, the Commission believes that it is important for interests affected by the proposed revisions to have

\. an opportunity to comment on the proposed rulemaking and MPS, as well as have an opportunity to discuss the proposed revisions with one another and the Commission. 2 Accordingly, the Commission is convening three public meetings, during the public comment period, where representatives of the interests that may be affected by the proposed rulemaking and MPS will have an opportunity to discuss the proposed revisions. Although the meetings are intended to foster a clearer understanding of the positions and concerns of the affected interests, as well as to identify areas of agreement or disagreement, it is not the intent of the meetings to develop a consensus agreem~nt of the participants on the rulemaking issues.

                         )

To have a manageable discussion, the number of participants in each meeting will be limited. The Commission, through the facilitator for the meeting, will attempt to ensure participation by the broad spectrum of interests that may be affected by the proposed . rulemaking and MPS. These interests include: nuclear medicine physicians; physician specialists, such as cardiologists and radiologists; medical physicists; medical technologists; nurses; medical education and certification organizations; radiopharmaceutical interests; hospital administrators; radiation safety officers; patients' rights advocates; Agreement States; Federal agencies; and experts in risk analysis. Other members of the public are welcome to attend, and the public will have the opportunity to comment on the proposed rulemaking and MPS and to participate in the meeting discussions at periodic intervals. Questions about participation may be directed to the facilitator, Francis X. Cameron. The meetings will have a pre-defined scope and agenda focused on the Commission's resolution of the major issues addressed during the development of the proposed rule and MPS. However, the meeting format will be sufficiently flexible to allow for the introduction of additional

related issues that the participants may want to raise. The meeting commentary will be transcribed and made available to the participants and the public. Copies of the proposed revision of Part 35 and the MPS will be provided to the meeting participants. Also, copies will be available for members of the public in attendance at the meetings. The availability of the proposed rule, and associated documents, and the MPS for individuals who are unable to attend any of the public meetings will be noted in the Federal Register notices for these documents. Public comments on the proposed rule and MPS are solicited but, to be most helpful, i:,hould be received by the date that will be announced in the Federal Register notices on the proposed rule and MPS. Comments received after this date will be considered if it is practical to do so, but the Commission only is able to ensure consideration of comments received on or before this date. Written input and suggestions can be sent to Secretary, Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff. Hand-deliver comments to 11555 Rockville Pike, Rockville, MD, between 7:30 a.m. and 4:15 p.m. on Federal workdays. Dated at Rockville, Maryland this 11 ~ day o f ~ . 1998. Fort clerlal\~ Commission.

                                     \                         \   I Fre , rick C. Combs, A~tihg Director, Division of Industrial and* Medical Nuclear Safety, Office of Nuclear Material Safety and Safeguards.

DEPARTMENT OF HEALTH&.. HUMAN SERVICES Public Health Service DQC:KFTFD US~IRC National Institutes of Health Bethesda, Maryland 20892 "98 NOV 13 All :27 OF+*,- RL November 12, 1998 ADJL.h.-"( Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 DOCKET NUllllt,t:N ~ 3-;._J--35 Attention: Rulemakings and Adjudications Staff (61 i-fL43f 16) Dear Madam/Sir; The Radiation Safety Branch of the National Institutes of Health (NIH) wishes to provide comments regarding the Proposed Rulemaking for "10 CFR 35- Medical Use of Byproduct Material" dated August 13, 1998. Due to the fact that the NIH Radiation Safety Program operations are governed by a significant portion of the current 10 CFR 35, we feel qualified to address the questions presented by the NRC. We have addressed the questions as well as provided general comments outlining our concerns on specific details noted during a review of the proposed regulations. Please note that the National Institutes of Health, in concert with all other stakeholders in this regulatory revision, requests that the NRC revise its schedule for this rulemaking to slow the process down and to do it right by beginning with a technically competent and comprehensive risk analysis of the activities to be regulated. Furthermore, "the scope, significance and potential cost of this regulation is so vast that it is essential for the Commission to provide sufficient time for stakeholders to comment on the proposed rule, once set to text. This has NOT been the case for the August 13, 1998 PR. Thus the recommendations below are submitted within the allowed schedule but the NIH would have provided much more input had additional time been permitted. Our comments are below: I. Training and Experience - Is the proposed requirement for examining organizations to ensure that examinations are not given to individuals who have also been instructed by the examining organization in the same subject too prescriptive? Is the requirement for an examination to verify competency warranted, in light of current industry practice? What is the projected amount of time needed for specialty boards and examining organizations to prepare and submit an application to the NRC or Agreement States? The proposed requirement for examining organizations as outlined in Appendix A is much too prescriptive. The NRC is overstepping their bounds in trying to regulate the current specialty boards and examining organizations. Those organizations are already established and accepted within the medical community in order for physicians to be certified. The NRC wants each 1 8 1998

Uc:- .,, ,,..., c110 oe,-, 1111Tf"nv ~OMMISSION

                                      ,..,NS STAFF HE SEC        ARY f      I: COMMISSION
                  .:ucument Statistics Postmark Date          1-/~e)      µ        t..J ~~

Copies Received---"-.,,-- - - - - Add'I Copies Repro Special Distribution,~ ~ ~ ~.....'.!.:~ ~ ~

!J.i'~c.~*tiJ                                     7

Secretary, U.S. Nuclear Regulatory Commission Page 2 specialty board and examining organization to prepare an application to the NRC or Agreement States. The NRC should devise their own set of exams instead of trying to regulate each separate board/organization who conducts an exam. An examination is not necessarily the best method of approach to determine competency. Consideration should be given to experience and to the size of the program. Clearly, a licensee with one nuclear medicine camera using unit doses may not require a full time RSO to pass an extensive examination. The NRC acknowledged the comments from the workshop participants, but did they really consider the opinions and address the concerns as outlined below?

                 "Workshop participants generally did not question the current training and experience requirements for the Radiation Safety Officer. Some suggested changes for the Radiation Safety Officer's training and experience were discussed, such as varying the training and experience to correspond to the type of license or duties performed by an individual Radiation Safety Officer; to have a "core competency" set of requirements (which could be supplemented with additional requirements for modalities posing greater risks); or to substitute a Master of Science degree for the 200 hour training requirement

2. Section 35.2: Should the term 'medium dose rate remote afterloader' be defined since it ls not used in the rule?,

Since the industry current markets low, medium and high dose rate afterloaders, it may be beneficial to define the medium dose rate afterloader and include the statement that from a regulatory perspective they are grouped with high dose rate afterloaders.

3. Section 35.6 Should this section be revised to require that licensees develop, implement, and maintain procedures for evaluating when a medical procedure would be considered to be a research procedure?

The NRC should not have any influence over the criteria or even the ,decision to consider a procedure medical or research oriented. This implies that the NRC will be in a position to evaluate proposals that involve human research subjects. Is the NRC willing to take responsibility for adverse consequences to their decisions regarding human research subjects? This should be left to the individual licensee and the licensee's Institutional Review Boards which must follow the Federal Policy for the Protection of Human Subjects. There is already adequate oversight for these issues and the NRC need not be involved.

4. Section 35.24 Will the deletion of the requirement for a Radiation Safety Committee and proposed new requirement for the Radiation Safety Officer to acknowledge, in writing, responsibility for implementing the radiation protection program impact the licensee's effectiveness in carrying out its radiation protection program? In particular, will this combination of changes actually reduce the effectiveness of radiation protection programs and will the radiation safety officer be provided appropriate tools and channels through which to raise safety concerns to the highest levels of management. If a requirement for a committee to oversee the radiation safety program, was included in the final rule, should the rule language explicitly require that the radiation safety officer be a member of that committee?

The proposed changes would not have an impact the licensee's effectiveness in implementing its radiation protection program. The proposed changes would not reduce the effectiveness of the program. The NRC has adequately covered the concerns regarding management oversight

Secretary, U.S. Nuclear Regulatory Commission Page 3 through means of the written administrative procedures for interdepartmental/interdisciplinary coordination of the program. We are in favor of eliminating the requirement for a radiation safety committee, especially for smaller institutions where staffing is limited. However, it is of great concern that the NRC wants the RSO to acknowledge in writing his or her responsibility for implementing the program. If the RSO's name is already on the license, why does the NRC require a written statement from the RSO? What is driving the need for a written statement of commitment? It would appear that the NRC is demanding a name along with a binding statement of commitment from which to take legal action if the program fails to meet the NRC expectations. The NRC is directing the licensee to establish a condition of employment on the RSO beyond the normal hiring practices of the licensee. For example, the licensee could sue for "breach of contract because the RSO did not fulfill the commitments in the letter after violations were noted during an inspection. What else is the NRC trying to accomplish by eliminating one body of oversight (Le., Radiation Safety Committee) and adding the requirement for a written statement from one individual, the RSO? If the requirement for a committee to oversee the radiation safety program was included in the final rule, the language should require that an RSO definitely be a member of the committee. In the written discussion, the NRC states that in the event that an RSO leaves a licensee, an Authorized User could fill in until an RSO was officially approved. Has the Commission considered the concept of Deputy RSO on the license particularly for a large facility?

5. Section 35.75: Should any changes be made to the release criteria specified in this section?

Nothing should be changed in this section. The revised patient release criteria provides greater flexibility within a medical institution to manage these radioactive patients. Numerous papers have been written citing that the majority of radioactive contamination from these patients occurs within the first 24 hours and decreases rapidly thereafter. Consequently, releasing these individuals to the general public would have little impact on the dose to the general public provided the individual is educated on ways to minimize the spread of contamination. Most of these medical procedures involve the release of a radioactive patient from the hospital to their home. Rarely is the individual confined to the hospital for additional procedures. If there is a need to keep the patient in the hospital, the RSO can develop internal procedures to minimizing contamination within the hospital. U.S. NRC Regulatory Guide 8.39 "Release of Patients Administered Radioactive Materials" provides ample guidance to the RSO on the conditions under which a patient shoulcl be released to maintain compliance with current regulations. Consequently, it does not seem likely that the authority of the RSO will be undermined What risk analysis has been completed by the NRC to substantiate the placement of further restrictions on patients because an alarm is triggered at a landfill from patient waste materials? Perhaps the trigger for the alarms at the landfills need to be adjusted because there is no documented risk to others from this release of radioactive material, especially based on the fact that the types and amounts used in patient treatment is relatively short-lived.

6. Section 35.92 Is it appropriate to delete the requirement to hold byproduct material for a minimum of 10 half-lives?

Since 10 CFR 35 covers the medical ,use of radioactive material, it is unclear why the NRC feels compelled to address decay in storage in this part of the regulations. It would make more sense to

Secretary, U.S. Nuclear Regulatory Commission Page4 address this in 10 CFR 20 under Subpart K "Waste Disposal". It is a tremendous improvement to delete the requirement to hold byproduct material for a minimum of 10 half-lives. This significantly decreases the cost to the licensee from holding large amounts of waste for decay or paying for disposal. Permitting decay in storage for nuclides with half-lives less than 120 days is a significant improvement. The NRC states that "there is concern over the licensee's ability to detect low levels ofbeta-emitters such as sulfur-35". "In this case, the requirement to hold material for 10 half-lives provides added assurance that material has decayed to background levels prior to release." This statement is not true. Holding material for 10 half-lives does not guarantee that the activity has decayed to below background levels. The decay is dependent upon the initial activity. Consequently, permitting the licensee to do decay in storage for half-lives less than 120 days plus ensuring that radiation levels are below background prior to release would be a much more practical approach. Furthermore, the example of sulfur-35 is inappropriate. We are unaware of any medical use for sulfur-35.

7. Section 35.315 Should the requirement for a private room with a private sanitary facility be maintained in the final rule?

The requirement for a private room with a private sanitary facility should be deleted from the final rule. The sharing of these facilities with other patients undergoing similar procedures could significantly reduce the cost to the hospital. For example, the number ofrooms restricted for radiation use only would be minimized as well as the staff-hours required to decontaminate multiple rooms. Cross contamination from iodine is not a health issue for those patients in isolation.

8. Section 35.415 Should the requirement for a licensee to not quarter a patient in the same room as an individual who is not receiving radiation therapy be maintained in the final rule?

The requirement to not quarter a patient in the same room as a individual who is not receiving radiation therapy should be eliminated in the final rule. By continuing with the regulation as it is currently written eliminates unnecessary concern for non-radiation patients and maintains radiation exposures to others at a minimum. However, it limits the licensee in the ability to operate their program by requiring the use of additional hospital rooms. If another patient were in the room with a radiation therapy patient undergoing brachytherapy, that individual would still be considered a member of the general public whose exposure must be maintained at 100 mrem/year. The licensee would have the flexibility to use portable radiation shields and could demonstrate via radiation levels that the radiation exposure to the non-radiation patient would be below 100 mrem/year.

9. Section 35.432 Should the final rule contain a requirement for the licensee to perform full calibration measurements on brachytherapy sources before first use? Should the final rule allow licensees to rely on the brachytherapy source output provided by the manufacturer or distributor if the dosimetry equipment used by the manufacturer or distributor met the calibration requirements in Section 35.630? How should sources be calibrated if there is no standard traceable to the NIST? What is the estimated number of short- and long- lived brachytherapy sources that will be to be calibrated by the licensee on an annual basis and how long will it take to perform the calibration? Will licensees need to procure additional equipment to perform the calibrations?

Secretary, U.S. Nuclear Regulatory Commission Page 5 If the sources are calibrated by the manufacturer or distnbutor prior to shipment to the licensee in accordance with Section 35.630, the licensee should not have to recalibrate the source prior to first use. If there is no soqrce traceable to NIST, the licensee should ge permitted to use a source of similar energy and characteristics. No further comments on this set of questions.

10. Section 35.605 Should the restrictions in paragraph (a) of the proposed rule apply to low dose-rate remote afterloaders?

Paragraph A should not apply to low dose-rate remote afterloaders. The risk from these low dose units is minimal enough that a trained individual knowledgeable of the unit's operation could install, perform maintenance, adjust or repair the device. The NRC should not over-regulate these units.

11. Section 35.615 Should the requirements in this section be waived for licensees that are using remote afterloaders with beta-emitting sources?

The regulations in Section 35.615 should be waived for beta-emitting sources because they are extremely over prescriptive. The risk from these devices is minimal. The only parts of the regulation that should apply are Section 35.615 (a), (c), (e), (f)(l)(i), and (f)(l)(ii).

12. Section 35.644 Should the restrictions for electrical interlocks and audiovisual systems apply to low dose-rate remote afterloaders?

The requirement for electrical interlocks and audiovisual systems should not apply to low-dose rate remote afterloaders. There is no need for such additional burden to the licensee in order to operate the afterloader. In this section, the NRC is extremely prescriptive. The risks associated with these units doe not warrant this excessive regulation. Let the licensee develop and implement their own procedures for periodic spot checks.

13. Section 35.981 What is the impact of deleting this section?

This section should be deleted. There would be minimal impact because the requirements for an experienced nuclear pharmacist are adequately covered in Section 35.55.

14. Subpart L Should all record keeping requirements be grouped into one subpart or should they be incorporated into the section requiring the record?

Record keeping requirements should be incorporated into the section requiring the actual record so all the requirements pertaining to a particular area of interest are complete. In addition, the NRC could summarize the requirements into one subpart and provide a cross reference to the individual section.

15. Subpart M Should all reporting requirements be grouped into one subpart or should they be incorporated into the section requiring the report?

Since failure to report certain incidents to the NRC can carry a significant penalty, the requirements for reporting should be grouped into one subpart so that there is no misunderstanding of the expectations of the NRC. However, to make the expectations very clear to the licensee, each individual section within 10 CFR 35 that requires a report should cross reference the subpart.

Secretary, U.S. Nuclear Regulatory Commission Page 6

16. Section 35.3045 Do the proposed rule changes adequately addr~ patient intervention and wrong treatment site?

The proposed rule change adequately addresses patient intervention and wrong treatment site.

17. Section 35.3047 Should the Abnormal Occurrence Polley statement criteria for reporting of exposures to an embryo/fetus or nursing child be modified? Is there a better term than "responsible relative or guardian" that could be applied to those situations where the mother is not notified, e.g., in the referring physician's medical judgement telling the mother would be harmful; the mother is a minor; or the mother is not competent to make decisions regarding medical care? What is the impact of the proposed reporting requirement on licensee procedures, activities, or medical practices?

It is difficult to believe that the NRC is reluctant to further revise the Abnormal Occurrence Criteria simply because it recently underwent revision. And yet the NRC would require the licensees to report exposure to an embryo-fetus or a nursing child (when the proposed reporting requirements are more restrictive than those outlined in the Abnormal Occurrence Criteria) just because the NRC wants to be consistent with the recently revised 10 CFR 20. This is unnecessary over-regulation. The NRC should modify the Abnormal Occurrence Criteria to eliminate this reporting requirement The licensee should not have to report a dose to a nursing child because the licensee might not be able to control the actions of the mother once she has been educated on the steps to prevent radiation dose to the nursing child. In addition, the physician should be permitted to complete a Nuclear Medicine scan on a pregnant patient if the physician believes that the medical benefit from the procedure outweighs the risk to the fetus. While providing comments to the revisions made to 10 CFR 20 and 35, licensees argued that the criteria for reporting should be risk-informed and performance-based. It is evident that the NRC has not listened to the licensees and just because ofone incident involving the ablation ofa child's thyroid because of a failure to follow an established procedure (which would have prevented such an occurrence), the NRC has over-reacted yet again. The term responsible relative or guardian is sufficient The NRC could minimize their interference with the practice of medicine by not requiring the notification under NRC regulations and permitting the physician to consult with the patient. By requiring that the licensee notify the responsible relative or guardian" of a reportable event, the NRC has interfered with the patient/physician relationship. The physician should be given the authority to judge the siru.ation accordingly. Just because the NRC feels compelled to report these issues to Congress should not give them the right to dictate how a physician should practice medicine by forcing the physician to notify the "responsible relative or guardian". It is discouraging to see that even though the ACMUI and many other commentors did not feel that the regulations should require a physician to notify a patient of a medical event, the NRC continues to insist on such a regulation. It is evident that the NRC had their minds made up prior to considering comments from those in the field. General Comments The commission clearly stated that the revision of 10 CFR 35 would be established on risk-informed and performance based issues. If this is the case, then why require additional requirements for those individuals who wish to become authorized users of byproduct material for the treatment of hyperthyroidism and thyroid carcinoma when in the same paragraph, the NRC

Secretary, U.S. Nuclear Regulatory Commission Page 7 states" there have been very few misadministrations that have occurred in this area"? Why make a regulation more restrictive when there is no proof that there was a need to do so? It is evident that the NRC has not met its obligation to revise the regulation based on performance issues. In the NRC write-up, they reference the Sealed Source and Device Registry relative to Section 35.67 "requirements for possession of sealed source and brachytherapy sources". Based on past experience with the registry, the NRC does not provide their licensing staff with current source registries and this has led to difficulty in licensing a relatively new sealed source. How often is the Sealed Source Registry updated and made available to the public and the NRC staff? Section 3 5 .5 Maintenance of records: The NRC indicates that the record may be the original or a reproduced copy or a microform provided the copy or microform is authenticated by authorized personnel... It is unclear how the copy or microform is authenticated by authorized personnel. There is not requirement to authenticate records stored in electronic media. All records should be required to be authenticated in writing when provided for legal purposes or verbally when being reviewed during an inspection. Section 35.l0(e) and (g): As part of the implementation pmcess, we question whether or not the NRC will seriously consider license amendments which make the license less restrictive than the regulations. Section 35.14 Notifications: It is understanding the need to list the RSO on a license; however, is there a pressing need to list the names of medical physicists? It is our understatlding that the NRC agreed to reduce the regulatory burden on licensees to list exact names of approved users, i.e., medical physicists. Perhaps the NRC would permit a blanket statement that only approved medical physicists who meet the training and experience criteria of35 CFR. ... will be permitted to perform duties related to Part 3 5 under this license". Section 35.65 Authorization for callbration and reference sources: The permissible values in Bq and mCi for the calibration sources were not calculated properly. For example, "1.11 kBq (30 mCi)" should be 1.11 kBq (30 nCi), or 1.11 Gbq (30 mCi). Subpart H of 10 CFR 35 should be re-written to eliminate the redundancy and over prescriptive procedures that the NRC expects these licensees to follow. Let the licensees develop their own procedures to implement instead of dictating each step and each procedure. This leaves the licensee open to violations if each portion is not carried out as specified in the regulation.

Secretary, U.S. Nuclear Regulatory Commission Page 8 Thank you for the opportunity to provide comments regarding this proposed regulation. In addition to our input on the proposed revision to Part 35, enclosed is a critique ofNUREG-1556, Vol. 9, "Program-Specific Guidance About Medical Use Licenses. In our opinion this NUREG was developed prematurely, since the Regulation had not yet been finalized. The content of the NUREG does not track with the proposed regulation and, in numerous areas, is not technically competent. The Commission should strongly consider withdrawing the NUREG until a proper job ofRulemaking is accomplished. The NUREG should then be developed with the assistance of stakeholders who have the expertise to advise the NRC how to develop appropriate risk based procedure recommendations. If you have any questions or need clarification, please contact me at (301) 496-2254.

?~n,~~

• Enclosure Radiation Safety Officer, NIH

Comments on Draft NUREG-1556, Vol. 9 The National Institutes of Health Preface: We request that the comment period for NUREG - 1556 be extended. The changes in 10 CFR 35 and NUREG-1556 are extensive, and licensees should be given ample opportunity to ensure the accuracy and applicability of the recommendations presented in this NUREG. In addition, the changes to 10 CFR 35 have not been approved; therefore, NUREG-1556 Vol. 9 may have to be revised and re-reviewed in accordance with changes in Part 35. Comment/Edit Notations Guide: Information recommended to be deleted are shown in strike outs; information suggested as replacements and/or additions are shown in bold italics .

• SECTION 8 CONTENTS OF AN APPLICATION COMMENTS:

Page 8-1, second to last paragraph, change order: ...."Short sentence responses, NA" or N responses to Items 5 through 10..*. should be changed to "NA, N, or short sentence responses to Items 5 through 10... " 8.1 ITEM 1 through 8.5 ITEM 5: Comments forthcoming. 8.6 ITEM 5: FINANCIAL ASSURANCE AND RECORD KEEPING FOR DECOMMISSIONING Page 8-8, last paragraph:

 "Even if no financial assurance is required, licensees are required to maintain, pursuant to 10 CFR 30.35(g), in an identified location, decommissioning records related to structures and equipment were licensed material is was used or stored, spills or spread of oontamination any information relevant to spills (e.g., where contamination remains after cleanup procedures or when there is reasonable likelihood that contaminants may have spread) and leaking sealed sources (see Figure 8.2).

Comment: Also, please delete reference to/and Figure 8.2. Figure 8.2 has no relevancy. 1

Page 8-9: The regulations given in 10 CFR 30.35 are very clear; much more so than the paraphrased comments on page 8-9. The requirements for financial assurance for unsealed vs sealed sources should be more clearly identified in this guide. Suggestion to add the following: "., .Most medical use applicants and licensees do not need to take action to comply with the

financial assurance requirements because:

a. either their total inventory of unsealed licensed material does not exceed the limits in 10 CFR 30.35 (lfJ5 times the applicable quantities set forth in appendix B), or the half life of the unsealed byproduct material used does not exceed 120 days.

b. If the total inventory of sealed sources does not exceed the limits in 10 CFR 30.35 (ln1° times the applicable quantities of appendix B). Examples are shown in Table 8.2.

Additional comments: Tables headings in 10 CFR 30 Appendix B are incorrect. Page 8-10, second paragraph: Table 8.2 is not all-inclusive without the changes indicated below; the licensee may be led to believe that the authorization is only for the three radionuclides listed in table 8.2. Recommended change: NRC will authorize sealed source possession exceeding the limits given in 10 Part 30.35 (d) shown in Table 8.2 without requiring decommissioning financial assurance, for the purpose of normal sealed source exchange for no more than 30 days. Examples are shown in Table 8.2." Pages 8-14 to 8-19: These pages desen'be methods of therapy treatments, in unnecessarily excessive detail. These descriptions are available in the literature and in textbooks, and need not be included in this Regulatory Guide. 8.10 ITEM 7: RADIATION SAFETY OFFICER <RSO) The training requirements are subject to change based on changes in Part 35, and a radiation safety exam is not necessary for the RSO; a description of training and experience is sufficient Other comments are forthcoming. Page 8-23 Yd bullet: " ...AND ... Written certification, signed by a preceptor RSO, that the above training and experience has been satisfactorily completed." Comment: This is unnecessary given the professional and experience qualifications of health physicists. This is also asking for a contract between a preceptor RSO and the NRC, which may put a preceptor at potential risk should unforseen circumstances arise. Page 8-23, <;th bullet: "Descriptions of training and experience will be reviewed using the criteria listed above. This documentation will be reviewed on a case-by-case basis to determine whether the applicable criteria in Subparts B or J are met" Comment: Review on a "case-by-case" basis is not only too discretionary, but it will be extremely time consuming for the NRC to review each case, and then to defer to ACMUI if necessary. This may cause unacceptable delays in the assignment of AU's. The NRC should rely on the licensee's internal review system, which is 2

always available for NRC review. ( 8.11 ITEM 7: AUTHORIZED USERS Pages 8-23 through 8-25: The training requirements are subject to change based on changes in Part 35, and a radiation safety exam is not necessary. The NRC's views on the duties of an AU are unclear; the training requirements are not always going to be commensurate with these duties, i.e., for in vitro and animal research, calibration of survey instruments, and other uses that do not involve the intentional exposure of humans. Must the licensee "notify the NRC within 30 days if an AU permanently discontinues his/her duties ... ," for AU's who do not use byproduct material for human use? Would it not be sufficient for the licensee to keep an updated file which is subject to NRC review? Page 8-25, ~ bullet of page: "Descriptions of training and experience will be reviewed using the criteria listed above. This documentation will be reviewed on a case-by-case basis to determine whether the applicable criteria in 10 CFR Part 3 5 are met. If the training and experience do not appear to meet.. .. the NRC may request the assistance of its ACMUI." Comment: Review on a "case-by-case" basis is not only too discretionary, but it will be extremely time consuming for the NRC to review each case, and then to defer to ACMUI if necessary. This may cause unacceptable delays in the assignment of AU's. The NRC should rely on the licensee's internal review system, which is always available to the NRC for review. 8.12 ITEM 7: AUTHORIZED NUCLEAR PHARMACIST Training requirements are subject to change based on changes in Part 35. Radiation safety exam is not neces~. 8.13 ITEM 7: AUTHORIZED MEDICAL PHYSICIST Training requirements are subject to change based on changes in Part 35. Radiation safety exam is not necessary. 8.14 ITEM 8: TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS Training requirements are subject to change based on changes in Part 35. 8.15 - 8.17 Comments forthcoming. 3

8.18 ITEM 9: DOSE CALIBRATOR AND OTHER DOSAGE MEASURING EQUIPMENT Page 8-40, second paragraph ... "Currently no alpha emitting nuclides are used in unsealed form in medicine. Therefore guidance is not provided in this document o the measurement of these radionuclides." Comment: Research involving alpha-labeled monoclonal antibodies for cancer therapy is rapidly progressing, and it is likely that use of this technique will occur in the near future. The authors of this guide should consider addressing model procedures for alpha measurement, i.e., emerging technology. Page 8-40, 3rd paragraph: "Equipment used to measure dosages that emit gamma, alpha, or and beta _radiation must be calibrated for the applicable radionuclide being measured (per the above NUREG discussion regarding alpha emitters). 8.19 ITEM 9: DOSIMETRY EQUIPMENT - CALIBRATION AND'USE Page 8-41, 3rd paragraph, Discussion: "The applicant must possess a calibrated dosimetry system... to perform calibration measurements of sealed sources to be used for patient therapy." (Sealed sources are used for many procedures--as markers, irradiators, etc. This guide must indicate that this ITEM 9 refers to sealed sources used for therapy.) 8.20 ITEM 9: OTHER EQUIPMENT AND FACil,ITIES Comments forthcoming. 8.21 ITEM 10: RADIATION PROTECTION PROGRAM Page 8-46 "Additionally, any calculations or measurements used to demonstrate compliance with NRC regulation must be representative of typical quantities in use or maximum patient doses."

• Comment: Unclear as to which this sentence requires. Which does the NRC really want, representative of typical quantities in use or maximum patient doses - 'is it one or the other at the licensee's d'iscretion?

Page 8-46, under bulleted item "Material Receipt and Accountability" - should include only "Ordering and Receiving" through "Use" records bullets. The remaining items: Patient or Human Research Subject Release, Safety Procedures for Therapy Treatments .. , and Safety and Device Calibration Procedures, Administration Requiring a Written Directive, Safe Use of Unsealed Licensed Material, Maintenance of Therapy Devices Containing Sealed Sources, Spill Procedures, Emergency Response for Sealed Sources.. , should be placed under different headings. For example: Change "Minimization of Contamination" to Minimization of Exposure and Contamination, and should include: Area Surveys, Spill procedures, Leak Tests, and Safe 4

Use of Unsealed Licensed Material. Emergency response for Sealed Sources or Devices... should be included under "Operating and Emergency Procedures" Add a heading: "Patient Use," under which the following should be included: Administrations Requiring a written directive, Patient or Human Research Subject Release, and Safety Procedures for Therapy Treatments Where Patients are Hospitalized. Add heading "Equipment Performance," under which Maintenance of Therapy Devices Containing Sealed Sources and Safety and Device Calibration Procedures 8.22 ITEM 10: AUDIT PROGRAM Comments forthcoming .

• 8.23 ITEM 10: OCCUPATIONAL DOSE Page 8-50, 1st paragraph: If external dose monitoring is necessary, the applicant should describe the type of personnel dosimetry, i.e., film badges or thermoluminesoent dosimeters (TLDs), that will be used by personnel. Whole body dosimeters may be composed offdm, thermoluminescent (TLD), or opticaIJy stimulated luminescence (OSL) detectors. Extremity (ring) dosimeters may be composed of TLD or OSL detectors. Comment: The second half of this paragraph is redundant and therefore should be omitted: If oooupational workers handle lioensed material, the lieeru,ee should evaluate the need to provide eKtremity m-0nitors [ie.,

required if likely to receive a dose in .....] in addition to *.vhole body badges. 8.24: ITEM 10: PUBLIC DOSE Comment: Perhaps NUREG-1556 could provide more guidance on "security" of radioactive material; reference EGM 98-004" Page 8-52, under "Discussion": " ... Public dose is controlled, in part, by ensuring that licensed material is secured (e.g., loeated in a looked area) to prevent unauthorized access or use. Comment: Licensees should be able to use their own discretion as to how they will secure from unauthorized access. Page 8-53, 2nd paragraph: Licensees can determine the radiation levels adjacent to licensed material either by direct measurement, calculations, or a combination of direct measurements and calculations using some or all of the following ... " Page 8-53, 4th paragraph:" .... During NRC inspections, licensees must be able to provide documentation demonstrating, by measurement or calculatio~ or both, that the total effective 5

dose equivalent to the individual likely to receive the ... " 8.25 ITEM 10: MINIMIZATION OF CONTAMJNATION Comment: Reference Nureg Guide 8.23 "Radiation Safety Surveys at Medical Institutions, " which provides comments on acceptable fixed and loose contamination limits. 8.26 ITEM 10: OPERATING AND EMERGENCY PROCEDURES Comment: References to 10 CFR 35 are not consistent with the numbering in Part 35 Page 8-54, 3n1 bullet: Add the words written directive." "Instructions for administering licensed material in accordance with the wrltJen directive (WD). Page 8-55, under "Discussion:" Applicants shall develop operating and emergency procedures* that minimize radiation safety risks, while keeping radiatioB: exposures ALAR.t\. exposure

• consistent with the ALARA principle.

Page 8-55, 3n:1 sentence in 3rd paragraph under "Discussion:" " ...The change in emphasis when and operation or autopsy is to be performed is due to the possible exposure of the hands and face to relatively intense beta radiation (if present) in addition to the gamma component. Page 8-56, 1st paragraph: "The NRC must be notified when licensed material in excess of 10 times the quantity specified in Appendix C to part 20 is discovered to be lost or stolen." 8.27 ITEM 10: MA1ERIAL RECEIPT AND ACCOUNTABILITY References to Part 35 are incorrect. Comments forthcoming. 8.28 ITEM 10 ORDERING AND RECEIVING No Comments, except that the NUREG-1556 should include a statement that if the licensee ships radioactive material from their facility, that the licensee must ensure that the receiver has a license to receive the material. 8.29 ITEM 10: OPENING PACKAGES No Comments, but see Appendix P comments. 8.30 ITEM 10: SEALED SOURCE INVENTORY References to Part 35 are incorrect. Comments forthcoming. 8.31- 8.32: References to Part 35 are incorrect. Comments forthcoming 6

8.33 ITEM 10: AREA SURVEYS References to Part 3 5 are incorrect Page 8.62: A survey of the patient's bed linens is suggested. The NRC should also suggest that a survey of all trash exiting the patient's room be surveyed. If the new proposed Part 35 is only going to require a semi-annual inventory of sealed sources, then this guide should be revised to only require a semi-annual survey of sealed source storage areas instead of quarterly surveys. The section regarding Contamination Surveys should reference Regulatory Guide 8.23 "Radiation Surveys at Medical Institutions". 8.34 ITEM 10: PROCEDURES FOR ADMINISTRATIONS REQUIRING A WRITTEN DIRECTIVE References to Part 3 5 incorrect. Comments forthcoming. 8.35-8.42: Comments forthcoming. 8.43 ITEM 10: TRANSPORTATION Comments forthcoming. 8.44 ITEM 11: WASTE MANAGEMENT Page 8-81: 49CFR should be included in the list of referenced regulations at the beginning of this section. Page 8.82, 2nd bullet, 1st item: It should be clarified the only excreta from patients is exempt, not fluids. Blood is not exempt. 8.45 - 8.46. 9 and 10: Comments forthcoming. 7

APPENDICES APPENDICES A-E: Comments forthcoming. APPENDIX F - TYPICAL DUTIES AND RESPONSIBILITIES OF THE RADIATION SAFETY OFFICER AND SAMPLE DELEGATION AUTHORITY Page F-2: Model Delegation of Authority: The requirement for signatures of the Management Representative and the RSO should be deleted. The position ofRSO is a professional one, and the duties and responsibilities of ensuring the safe use of radiation is inherent in this occupation. The successful performance of the Radiation Safety Program and of the RSO is constantly reviewed by the NRC via inspections, license applications, and informal communications; the request for a contractual signature is

• unwarranted.

In addition, the following: "It is estimated that you will spend_ hours per week conducting radiation protection activities" must be removed. What is the purpose of contracting a time commitment? Successful completion of 10 CFR 35 requirements should be the criteria used for judging a successful radiation safety program; the amount of time spent doing so is irrelevant. APPENDIX G - DOCUMENTATION OF TRAINING AND EXPERIENCE Subject to change in accordance with final 10 CFR 35 document. Comments forthcoming. APPENDIX B - MODEL TRAINING PROGRAM Subject to change in accordance with final 10 CFR 35 document Comments forthcoming .

• APPENDIX I - RADIATION MONITORING INSTRUMENT SPECIFICATIONS AND MODEL SURVEY INSTRUMENT CALIBRATION PROGRAM Comments forthcoming.

APPENDIX J - MODEL PROCEDURES FOR DOSE CALIBRATOR CALIBRATION Page J-1, 1st paragraph: ..."We will consider repair, replacement, or arithmetic correction, as applicable, if the dose calibrator falls outside the suggested tolerances."

 "After repair, adjustment, or a relocation to a.nether building which is likely to affect performance of the dose calibrator, we will repeat the above tests before use" Page J-1, middle of the page: 'We will assay at least one relatively long-lived source such as Cs-137, Co-60, oobalt 57 (Co-57, or radimn 226 (Ra-226)."                                        1,,

8

Page J-2: Add to list and to list on J-6 under accuracy: "A sticker wUl be affixed to the dose calibrator to indicate the dates of the linearity (and accuracy) checks. Page J-5: Delete from NUREG-1556 all references that say "Subtract background from the indicated activity to obtain the net activity," and simply state to "measure background and record the net activity." APPENDIX K - SUGGESTED MEDICAL LICENSEE AUDIT Comments forthcoming. APPENDIX L-MODEL PROCEDURES FOR AND OCCUPATIONAL DOSE PROGRAM Page L-1: Edit the first paragraph by placing the first sentence under "External dose Exposure" to the first sentence of the first paragraph, i.e., "The mechanism by which doses to individuals from exposure to radiation is evaluated is called dosimetry. Dosimetry is required for individuals likely to receive in 1 year a dose in excess of 10% of the applicable ..." Page L-1: Comment: Add a paragraph before ALARA, entitled, Occupational Dose Limits, and add some definitions and explanations. For example: The occupational dose limits/or adults is given in 10 CFR 20.1201: (1) Annual limit, which is the more limiting of: (i) The total effective dose equivalent (I'EDE or Hd being equal to 5 rem (0.05 Sv). The TEDE is the sum of the deep dose equivalent (DDE or H) from penetrating external radiation, and the committed effective dose equivalent (CEDE, or HE, 5J from internal radiation exposure. Or, (ii) the sum of the deep dose equivalent and the committed dose equivalent (CDE or H r,so>

• to any individual organ or tissue other than the lens of the eye being equal to 50 rem (0.05 Sv).

And (2) The annual limits to the lens of the eye, to the skin, and to the extremities, which are: (i) An eye dose equivalent of 15 rems (0.15 Sv), and (ii) A shallow-dose equivalent (H)of 50 rems (0.50 Sv) to the skin or to any extremity.

• The deep dose equivalent is the dose received from external penetrating radiation at a point on the whole body located at a tissue depth 1000 mg/cm2 (1 cm) below the skin surface.
• The shallow dose equivalent is the dose received averaged over a 1 cm2 area.

located 7 mgicm2 (0.007 cm) below the skin surface.

• The CDE (Hr, 5cJ is the cumulative dose received by an organ that will be received from an intake of radioactive material during the 50-year period following the 9

intake.

• The CEDE is the sum of the CDE to each individual organ multiplied by the organ weightingfactor. CEDE = I:[HT. 50 w 11 Page L-1, Third paragraph under "External Dose exposure":

Add: "There are three occupational dose limits included in .. " Page L-2, First paragraph, 3n:1 sentence, add: " ... (i.e., adult, minor, or the fetus of a declared pregnant woman)." Page L-2, First bullet: add: "For adults occupational workers who are likely to receive an annual dose in excess of any of the following ... " Delete the bulleted information on Page L-2 which enumerates 10% of each limit. It is sufficient to say that "monitoring devices for extemal dose is required when an occupational worker or minors are to receive 10% of the applicable limits. " The individual numbers representing I/10th of these values need not be listed. Page L-3: 1st paragraph: "External dose is determined by using individual monitoring devices such as film badges or optically stimulated luminescence (OSL) badges, or thermoluminescent dosimeters (+/-IDB) TLD's." Delete Page L-3, 6th paragraph: "If the lioensee determines that extremity monitoring is required, it may be appropriate to use an extremity dosimeter for some, but not all, radiation exposure. Tue licensee eould supply an e:xtremity dosimeter when exposure is non uniform. When exposure is unifoffil; the shallow dose equPraleBt measured by a. torso dosimeter would be representative of the shallow dose equivalent to the extremities, and separate extremity monitoring \You.Id not be needed." Add: Extremity dosimeters are required when the extremities are likely to receive 10% of the applicable limit. Comments: This (i1h paragraph is very confusing. If the exposure is uniform, then the 5 rem to the whole body is the limiting dose; extremity monitoring is therefore of no concern because the extremity limit is 10 times the whole body dose. Radiation fields are never static or uniform over the entire body when radioactive material is handled; exposure to the hands is always higher because of distance and/or torso shielding (i.e., beta shields or leaded shields) factors. NUREG-1556 should simply state that extremity dosimeters are required when the extremities are likely to receive 10% of the applicable limit. This information can determined by using historical extremity dosimetry data, or by considering the radionuclide used and expected amount of time it will be handled yearly.

Page L-4 Investigation Levels - External Dose Monitoring: The presentation of investigation levels does not reflect updated version of yearly dose limits in 10 CFR 20. Why are the Investigation Levels in terms of dose per quarter; this is inconsistent with the updated dose limits which are based on a yearly, not quarterly period. Why are the lens of eyes combined with the whole body, head and trunk, active blood forming organs, or gonads, and why are the extremity and skin of the whole body investigational levels different when their dose limits are the same? Why is there not a separate investigation for lens of the eyes? Also, why not just state "whole body," the head and trunk, active blood forming organs, or gonads" are implied by this definition; similarly for the "hands and forearms, feet and ankles which are defined as "extremities." The dose thresholds per quarter which would require investigation, according to this section, are much too conservative. The Investigation Level 1 per quarter for the whole body (etc.) is only 2% of the annual limit, the "hands and forearms, feet and ankles" is 3.7%, and the

• skin of the whole body" is 1.5% of the annual limits. For the whole body, this means that an investigation must be performed for an average dose of 42 mrem per month! Additionally, personnel who will not receive 500 mrem in a year, and who are therefore not monitored, may reach 125 mrem in a quarter.

The preferred investigation action guideline would be a threshold of a certain reasonable percentage of the yearly annual dose. For example, "Investigation Level 1 when occupational dose reaches 10% of the annual limit, and lnvestigational Level 2 at 30%." Page L-6 Internal Dose exposure: This section is poorly constructed, and does not include clear and concise information regarding the definitions and use of ALis and DACs. 1st paragraph: With respect to internal exposure, you are required to monitor-yel+/-f-Occupational intake of radioactive material and assess the resulting dose if it appears likely that you will to receive greater than 10% of the ALI from intakes in 1 year .................. " Suggested changes to page L-6: Switch paragraphs 2 and 3, and other additions/deletions throughout the page:

 "For each class of each radionuclide, there are two Annual Limit on Intakes (ALis), one for ingestion and one for inhalation. The ALI (uCi) is that quantity of radioactive material that, if taken into the body of an adult worker over the course of a year by the corresponding route would result in a committed effective dose equivalent (CEDE) of 5 rems (0.05 Sv) (known as the "SALi" - "S" for stochastic), or a committed dose equivalent of 50 rems (known as the "NALi"
 - "N"for non-stochastic) ..."

fu.posure to airborne radioaoti1t'ity at a level of 1 D,'\..C for 1 year......)The Derived Air Concentration (DA CJ for each class of radionuclide is the concentration of airborne 11

radioactivity (uCilml) that, if an occupational worker were to be continuously exposed for 2000 hours (1 year), would result in a committed effective dose equivalent of 5 rems (0.05 Sv), or a committed dose equivalent of 50 rems (0.5 Sv) to any individual organ or tissue, again, with no ... " The ALI and DA C for each radionuclide in a specific chemical form is listed in 10 CFR Part 20, Appendix B. The total effective dose equivalent (TEDE) concept described above makes it possible to combine both the internal and external doses in assessing the overall risk to the health of an individual. The 10 CFR 20 dose methodology evaluates the doses to all major body organs ALI and DA C numbers reflect the doses to all principal organs that are i"adiated, and will indicate the committed effective dose equivalent (via the SALI) or the committed dose equivalent to an individual organ (via the NALi) due to an intake of a particular radionuclide compound. The ALI and DA C were derived by multiplying a unit intake by the appropriate organ weighting factors WP for the organs specifically targeted by the radionuclide compound, and then summing the organ-weighted doses to obtain a whole body risk-weighted "effective dose. "Per 10 CFR 20 Appendix B, when an ALI is defined by the stochastic dose limit, this value alone, is given. When the AU is determined by the non-stochastic dose limit to an organ, the organ or tissue to which t the limit applies is shown, and the ALI for the stochastic limit is shown in parentheses. If the intake consists of a mixture of radionuclides, then: Z{ALI/JntakeJ <1 Suggestion: Give examples: Total effective dose equivalent:

• If the dose is external only, then TEDE = deep dose equivalent for whole body.
• If the doses are internal only, then:

J. Ingestion: TEDE = (Intake/ALI) x 5 rem

2. Inhalation: TEDE = (Concentration/DAC)(Number of hours exposed)/2000 hours) x 5 rem

• If the doses are internal and external:

TEDE = {deep dose equivalent]+ [(Intake/ALI) x 5 rem}+ {(Concentration/DAC)(Number of hours exposed)/2000 hours) x 5 rem] 12

APPENDIX M- GUIDANCE FOR DEMONSTRATING THAT INDIVIDUAL M:EMBERS OF THE PUBLIC WILL NOT RECEIVE DOSES EXCEEDING THE ALLOWABLE LIMITS Comments: The step-by-step tabulated example of calculation method for determining that allowable limits are met, Pages M M-7 are excessive, and quite confusing Table M.2 can be replaced by simplifying the example. An abbreviated (prototype) suggestion is given below: Step I: Consider distance from unshielded source only: Using the inverse square law: (Define terms ..... )

• 11 = 5000 mrem/hr (3.28 ft) 2 / (15 ft)2 =239 mrem/hr Yearly dose= 239 mrem/hr x 24 hrs/day x 365 days/year= 2.09xl06 mrem/year Step 2: Include Occupancy Factor:

Jee Reviews his assumptions and make a realistic estimate reeognizes by considering that the secretary is not at the desk chair and desk are not occupied 24 hours/day; recalculate the annual dose using an occupancy factor, He decides to make a realistie estimate of the number of hours the seeretary sits in the chair at the desk, keeping his other assumptions constant.. ..

• Yearly dose= [Dose rate at the location] x [occupancy factor]

Yearly dose= [239 mrem/hr]x[(5 hours/day)(3 days/week)(52 weeks/year)]=l.86xl05 mrem/year Step 3: Include Source Use Factor Yearly dose =[Dose rate at the location] x [occupancy factor] x [Fraction oftime the source is exposed] [Fraction of time source exposed]= Max exposure time per patient x number of patients per day] [Fraction of time source exposed]= {l minute x 16 patients per day}/1440 minutes per day [Fraction of time source exposed]= 0.011 Yearly dose =[Dose rate at the location] x [occupancy factor] x [Fraction of time the source is exposed] Yearly dose = 1. 86x 105 mrem/year x 0.011 = 2046 mrem/yr 13

Step 4 Include shielding: I=I e-ux (Define terms) 0 etc. A more detailed example can be provided in the future comment period. APPENDIX N - EMERGENCY PROCEDURES: Comment: This section, Appendix N, should distinguish between spills in restricted and unrestricted areas. This guide should also reference Regulatory Guide 8.23 "Radiation Safety Surveys at Medical Institutions." Minor spills of Liquids and Solids.

• 1.

2. 3. No comment Prevent the spread of contamination by covering the spill with "cram"- labeled absorbent paper. Carefully identify the label the boundaries of the spill. Wearing gloves and protective clothing such as a lab coat and booties, clean up the spill using disposable gloYes and absorbent paper. Carefully fold the absorbent paper with the clean side out and place in a "cram"- labeled bag for transfer ....

4. Survey the area with a low range radiation deteotor survey meter sufficiently sensitive to detect the radionuclide.

5. Smear the area to ensure contamination is below limits.

6. Additional decontamination efforts may be required to achieve acceptable levels listed in Regulatory Guide 8.23 "Radiation Safety Surveys at Medical Institutions.

6. Report the inoident to the RSO.

Comment: The RSO does not need to be informed of minor spills, unless it involves skin contamination or the spill occurred in an unrestricted area. This requirement as to whether or not to involve the RSO for a minor spill should be at the discretion of the RSO whom should also be permitted to delegate responsibility to staff. Major Spills of Liquids and Solids

1. Clear the area. Notify all persons not involved in the spill to vacate the room after they have monitored their shoes.

2. Prevent the spread of contamination by covering the spill with cram-labeled absorbent paper, but do not attempt to clean it up. To prevent the spread of contamination, clearly indicate the boundaries of the spill, and limit the movement of all personnel who may be contaminated.

3. Shield the sow=oe if possible. Do this only if it can be done without further contamination 14

or a significant inerease in radiation exposure. Comment: Shielding the source is extremely impractical, and most probably unnecessary.

4. Close the room and look or otherwise Secure the area to prevent entry.

5. Notify the RSO immediately.

6. " .. .if contamination remains, induce perspiration by eoy.zering the area r.,vith plastic ..... "

Comment: For skin contamination it is not good to induce perspiration by covering the area. This could lead to absorption through the pores and an internal intake. It is better to decontaminate the area until no more contamination can be removed, or until skin becomes irritated. Take measurements with meter and calculate the skin dose in the worst case scenario; if the dose is less than 10% of the annual limit, then it is best to leave it alone. Page N-2, 1st paragraph: Regarding: "For some spills of short-lived radionuclides, the best spill procedure may be restricted access pending complete decay."Comment: This advice is very misleading as written. Per 10 CFR 30.50 (b): Twenty four hour report to the NRC is required

• for ...

(1) (i) (ii) an unplanned contamination that: Requires access to the contaminated are ... to be restricted for more than 24 hours by imposing .... or by prohibiting entry into the area; Involves a quantity of material greater than five times the lowest annual limit on intake specified in Appendix B .... (iii) Has access to the area restricted for a reason other than to allow isotopes with a half-life ofless than 24 hours to decay prior to decontamination ... " Recommendation: change this sentence to- "For some spills ofradionuc/ides with half-lives shorter than 24 hours, in amounts less than jive times the lowest ALI, an alternative spill procedure may be to restricted access pending complete decay." Page N-2, Table N-1 Relative Hazards of Common Radionuclides Comment: What is the basis upon which the quantities in this table were determined to distinguish between major vs. minor spills? Page N-2 Spill Kit This type of detail is unnecessary. Comments:

1. Enumeration of number of items is unnecessary. If the licensee states in their application that they will adopt the precautions outlined in Appendix N, Spill Kit, the licensee should not be held to requiring exactly 6 pairs of gloves, 2 lab coats, etc.

2. The list is incomplete; urine bioassay cups, for example, are also important to have.

Page N-3, Item 2 and N-4 Item 3: NRC does not need to give guidance to prevent possible splashing of"foreign materials." Recommended change: "The surgeon and the personnel involved in the surgical procedures will wear protective gear for the eye protection of the eye 15

from possible splashing of foreign materials, as well as from bet radiation radioactive material." Item #4 under "Autopsy of Patients Who Have Received Therapeutic Amounts of Radionuclides" should not be so specific. The NRC has no right to dictate how a pathologist performs an autopsy. Certainly removing an entire block of tissue containing the nuclide would limit the radiation exposure, but the NRC does not have to be that detailed. The RSO should not have to be informed of any hazard associated with Emergency Surgery or an Autopsy. The RSO should determine the criteria in which he/she is to be notified and the NRC should not dictate when the RSO be notified of a situation. Let the RSO manage the program as he/she deems appropriate. APPENDIX O- MODEL PROCEDURES FOR ORDERING AND RECEIVING PACKAGES Page 0-1: Under Model Guidance, the NRC references "written records/' This should be changed to permit electronic records as well as written records. APPENDIX P - MODEL PROCEDURE FOR SAFELY OPENING PACKAGES CONTAINING RADIOACTIVE MATERIAL There are references in Appendix P that require immediate notification of the RSO (e.g., damaged package received, etc.). This should be less restrictive and permit notification of the RSO or DESIGNEE. Page P-1, Item 4: "Monitor the external surfaces and at 1 meter for radiation levels ..... " APPENDIX O - MODEL LEAK TEST PROGRAM References to Part 35 are incorrect Comments forthcoming. APPENDIX R - MODEL PROCEDURE FOR AREA SURVEYS Page R-1: Relocate the first paragraph (bullets under "Facilities and Equipment) to Page R-2 under "Contamination Surveys" Page R-2, table R.1: Why is the trigger ambient dose rate for unrestricted areas 0.05 mR/hr (50 uR/hr); this is about the ambient background radiation level!? And assuming that this was indeed the NUREG intended level, there is then an inconsistency between: page R-1 Radiation level surveys will consist of measurements with a survey meter sufficiently sensitive to detect 0.1 mR/hr." How then would one measure the trigger level of 0.05 mR/hr? Also, the trigger levels outlined in Table R 1 "Ambient Dose Rate Trigger Levels" do not specify 16

at what distance these readings should be obtained. Page R-3: indicates that "The area will be either decontaminated, shielded, or posted and restricted from use if unable to decontaminate". This is misleading because in 10 CFR 30.50(b)(i) requires 24 hours notification, as applicable, if an area is restricted to allow for decay. Page R-4: The sample nuclides given in Table R2 are not comprehensive enough compared to what is used in the medical field today. For example, Y-90, Lu-177, and Sm-153 are not included. The limits in this table are more restrictive than those outlined in Table 2 "Recommended Action Levels For Removable Surface Contamination in Medical Institutions" and there is no justification for making these limits more restrictive. Why the change? Table R3 can be used for unrestricted areas and equipment. The NRC does not need to make the decontamination limits so restrictive for I-125. The material (I-125) is more benign than I-131 and the only reason it appears in the more restrictive category is that it has a longer half-life. This is unnecessary and should be taken into consideration before this guide is finalized. Page R-5: The section on Alternate Survey Frequency is confusing and not user friendly. In the NRC 's attempt to simplify the criteria for alternate survey frequencies, they have made it more complicated and unnecessarily so. What is the NRC's criteria for placing certain nuclides in the specific groups as outlined on page R-6? Other comments forthcoming. APPENDIX S - PROCEDURES FOR DEVELOPING, MAINTAINING, AND IMPLEMENTING WRITTEN DIRECTIVES A great deal of detail specified in Appendix Sis not necessary if the NRC changes 10 CPR 35. The NUREG should not be finalized until the revision to Part 35 is complete so that the required information is accurately reflected. Page S-5: The section on Review of Administrations Requiring a Written Directive is confusing as written. The NRC should be less prescriptive. Other comments forthcoming APPENDIX T - MODEL PROCEDURES FOR SAFE USE OF LICENSED MATERIAL Page T-1: 1st bullet: "wear lab coats or other protective clothing at all times in areas where radioactive materials are used." This is too restrictive. This would require anyone entering a laboratory where RAM is used to wear a lab coat. A lab coat only needs to be worn when working with 17

RAM not when in RAM use area. Suggest: "Wear lab coats or other protective clothing whenever working with radioactive material. " sth bullet: "do not store food ... in any area where licensed material is stored or used". This is too general, please define "area." Does it refer to an area that is used only to store RAM or does it refer to RAM stored in refrigerator located in a lab wherein RAM work is performed? Th bullet: Please delete this entire bullet, and replace with a general statement such as: "Wear extremity dosimeters, if required, when handling radioactive material." All the examples of such instances is unnecessary. 10th bullet: The decay method is not always applicable, Per 10 CFR 30.50 (b). APPENDICES U AND V Comments forthcoming .

• APPENDIX W TRANSPORTATION Comments forthcoming.

APPENDIX X: MODEL PROCEDURE FOR WASTE DISPOSAL BY DECAY-IN-STORAGE, GENERATOR RETURN, AND LICENSED MATERIAL RETURN Page X-1: 1st bullet: It is not within this NUREG guide's authority to prescribe how biomedical waste will be segregated for disposal, other than to ensure that radioactive waste is properly disposed. Segregation of biomedical waste is under the auspice of the licensee's Occupational Safety program. Yd bullet, ind item:

 "Check the radiation detection survey meter for proper operation and cu"ent calibration status."

3 rd bullet, 4 th and 5th items:

 "Remove any shielding from around the container or generator column.," ... Monitor, at contact all surfaces of each individual container." Comment: What is the logic behind removing shielding and monitoring each individual container? - doing so may present a significant biological hazard.

All containers, i.e., MPW boxes, syringe boxes, will provide some measure of shielding. Why is it inappropriate for this shielding to be advantageously used as an exposure reduction method, especially for short-lived biomedical radioactive material? 18

3rd bullet, Th item: "Discard as in-house waste only those containers that cannot be distinguished from background" Comment: What are considered to be the "containers"? - MPW boxes, syringe boxes? Does this conflict with items 4 and 5 above? Also, " ... Record the disposal date, the radionuolides disposed, the survey instrument used, the background dose rate, the dose rate measured at the smfaee of eooh waste eontainer, and the name .... " Comment: There is no need to include the radionuclide because it has decayed and no longer exists. There is also no need to document the background and surface dose rates, which will be at background radiation levels. The surveyor is responsible for ensuring that the proper disposal criteria are met; maintaining additional superfluous documentation is burdensome. 19

R TOH TEXAS DEPARTMENT OF HEALTH DOCKETED US N~C Ae> 13 r1:33 Texas Department of Heal1h NO ' ~ ~ William R. Archer ill, M.D. 1100 West 49th Street Patti J_. PatterSOIJ, M.D., M.P.H. Commissioner Austin, Texas 78756-3189 Executive Deputy Commissioner (512) 458-7111 Radiation Control (512) 834-6688 November 10, 1998 ~o 5:i-1 ~ ( e,3 Fij'I 3511:,) Secretary U.S. Nuclear Regulatory Commission

                                                                                                                                          @)

Washington, D.C. 20555-0001 Re: Medical Use of Byproduct Material; Proposed Revision to 10 CFR Part 35 ear Secretary: We appreciate the opportunity to comment on the Nuclear Regulatory Commission's proposed changes to 10 CFR Part 35. The comments on the referenced subject, from the Texas Department of Health's Bureau of Radiation Control, are contained within the following paragraphs: A. Training and Experience:

1. Authorized Physician Users

a. Once the Nuclear Regulatory Commission (Commission) has determined which medical boards have certification processes which include the radiation safety training and experience required to qualify a physician as an authorized user, §35.290, §35.292, §35.390, §35.490, §35.590 and

                    §35.690 should be changed to include those specific medical boards. These boards rarely change (the last change of consequence was in 1979).

b. A definition for preceptor should be included in §35.2 to the effect that:

(1) Preceptors for low-dose radiopharmaceuticals (diagnostic) training can be persons designated as authorized physician users of low-dose radiopharmaceuticals; and (2) Preceptors for high-dose radiopharmaceuticals (therapeutic) training must be Program Directors of structured educational programs in medical teaching institutions that consist of didactic training and practical experience (accredited by either the American Medical Association's Accreditation Committee on Graduate Medical Education or the Committee on Postgraduate Training of the American Osteopathic Association). [Qualification and subsequent authorization could be affected by the type of radiation emitted (e.g., gamma, beta, alpha).]

c. A definition for authorized user should be included in §35.2 to include responsibilities (e.g.,

ordering, delegating, supervising). l 8 1998 r.kri edqedbycard----- http://www.tdh.state.tx.us/ech/rad/pages/brc.htm An Equal Employment Opportunity Employer

    . UCLEAR REGULATORY COMM! *

.EMAKINGS & ADJUDICATIONS SI F OFFICE OF THE SECRETARY OF THE COMMISfrlON Document Statistics Postmark Date _ _ _ _ _ __

Copies Received _ _ _ _ _ _ __ Add'I Copies Reproduced _ _ _ _ __ Special Distribution_ _ _ _ _ __

Secretary, NRC Page two of seven November 10, 1998

2. Nuclear Medicine Technologists With the proposed reduction in the amount of radiation safety training required for authorized physician users, it is appropriate to codify the training and experience requirements for those who actually handle the radioactive material in day-to-day clinical settings. Enclosed is our proposal, excised from our latest Regulatory Guide. With the exception of our having a separate state-run technologist certification board, our "minimum training" section could be adopted with only a few minor changes. Our suggestions for a licensee-conducted training program, however, should remain in a regulatory guide to allow licensees some performance-based flexibility.

B. Radiation Safety Committee (RSC):

1. §35.24(b) should be changed to read" A licensee with multiple modalities or multiple users shall also develop, implement, and maintain written administrative procedures for interdepartmental/

interdisciplinary coordination of the licensee's radiation protection program throu2h a radiation safety commitee which meets at least annually."

2. §35.22(b) of the current rule should be retained as part of the proposed §35.24(b) to provide a reasonable degree of structure to the committee's activities.

C. General

1. §35.12(b) should be changed to include the requirement for applicants to either (1) commit to adopting the model procedures contained within the current version of NUREG 1556, Volume 9, or (2) submit with the application, the procedures they wish to use for review and approval by the Commission. Inspectors do not have the time or resources at hand at the inspection site to be able to determine the appropriateness of procedures which have been developed by each licensee and

• then conduct their typical inspection aimed at determining conformance with appropriate procedures.

2. The title for §35.14 should be changed to "Thirty-day Notifications for Amendments." A first sentence should be added to the effect that: "In addition to the amendments required by §35 .13, the following notifications should be made to initiate amendments to licenses - " Without this sentence, it is not clear that the purpose of the notification is to initiate an amendment.

D. 10 CFR Part 20 - Standards for Protection Against Radiation: Reg~ing §20.1301, the RSO, not the authorized user, should be the appropriate individual to approve, on a case-by-case basis, the merits of allowing a visitor to receive up to 5 mSv in a year. E. 10 CFR Part 35 - Medical Use of Byproduct Material:

1. It is agreed that the purpose and scope of 10 CFR Part 35 should be revised to include patients and-human research subjects.

2. Nuclear pharmacies should not be authorized to approve authorized nu.clear pharmacists. Criteria for designation of authorized nuclear pharmacists are not codified.

Secretary, NRC Page three of seven November 10, 1998 F. Summary of Specific Issues Identified for Public Comment: QlA: Training and Experience - Is the proposed requirement for examining organizations to ensure that examinations are not given to individuals who have also been instructed by the examining organization in the same subjects area too prescriptive? AlA: No. QlB: Is the requirement for an examination to verify competency warranted, in light of current industry practice? AlB: Yes, because this option is offered in lieu of related testing by a certifying medical board. Q2: Section 35.2 - Should the term "medium dose-rate remote afterloader" be defined since it is not used in this rule? [Requirements for medium dose-rate remote a:fterloaders have been grouped with high dose-rate remote afterloaders (HDR) in this rulemaking.] A2: No. HDR requirements are sufficient standards for this limited modality. Q3: Sec 35.6 - Should this section be revised to require that licensees develop, implement, and maintain procedures for evaluating when a medical procedure would be considered to be a research procedure? A3: No. The Commission should, however, continue to provide guidance in appropriate regulatory guides on when requests for amendments authorizing research should be submitted. Q4A: Section 35.24 - Will the deletion of the requirement for a Radiation Safety Committee and proposed new requirement for the Radiation Safety Officer to acknowledge, in writing, responsibility for implementing the radiation protection program impact the licensee's effectiveness in carrying out its radiation protection program? A4A: Yes, deletion of the requirement for a RSC will adversely impact the licensee's effectiveness in carrying out its radiation protection program at multi-disciplinary institutions. Management may not be as active and knowledgeable about the program needs and resources. No, the proposed new requirement for the RSO to acknowledge, in writing, responsibility for implementing the radiation protection program will not positively impact the licensee's effectiveness in carrying out its radiation protection program. Q4B: In particular, will this combination of changes actually reduce the effectiveness of radiation protection programs ...

• Secretary, NRC Page four of seven November 9, 1998 A4B: Yes, for multi-disciplinary or multi-departmental programs, a high probability exists that the combination of changes will actually reduce the effectiveness of radiation protection programs by focusing responsibility solely upon the RSO instead of extending this throughout the institution as espoused thru NUREG 1516. No, for small programs, with single disciplines or single departments.

Q4C: ... and will the radiation safety officer be provided appropriate tools and channels through which to raise safety concerns to the highest levels of ~gement? A4C: No, for multi-disciplinary or multi-departmental programs, the RSO will not, necessarily, be provided appropriate tools and chamiels through which to raise safety concerns to the highest levels of management. For small programs, with single disciplines or single departments, the RSO should be able to have the tools and channels for raising radiation safety concerns to management without the backing of an RSC. Q4D: If a requirement for a committee, to oversee the radiation safety program, was included in the final rule, should the rule language explicitly require that the radiation safety officer be a member of the committee? A4D: Yes, as well as licensee management. A requirement for a quorum should also be codified as it is in the current rule. Q5: Section 35.75 - Should any changes be made to the release criteria specified in this section? AS: No, except that the radiation safety officer, in conjunction with the authorized user, should make the final dete~on for the licensee regarding patient release. Q6: Section 35.92 -- Is it appropriate to delete the requirement to hold byproduct matenal for a minimum of ten half-lives? A6: No. Q7: Section 35.315 - Should the requirement for a private room with a private sanitary facility be maintained in the final rule? A 7: Yes. Significant radiation contamination or exposure considerations could result as a consequence of removing this rule. Q8: Section 35.415 - Should the requirement for a licensee to not quarter a patient in.the same room as an individual who is not receiving radiation therapy be maintained in the final rule? A8: Yes (low-energy photon-emitting seed implants may be an exception). Q9A: Section 35.432 - Should the final rule contain a requirement for the licensee to perform full cahbration measurements on brachytherapy sources before first use?

Secretary, NRC Page five of seven November 10, 1998 A9A: No. This has not been shown to be a radiation safety hazard, therefore is not ALARA (to require more frequent handling of radioactive sources). Q9B: Should the final rule allow licensees to rely on the brachytherapy source output provided by the manufacturer or distnbutor if the dosimetry equipment used by the manufacturer or distributor met the calibration requirements in §35.630? A9B: Yes (see A9A). Q9C: How should sources be cahbrated if there is no standard traceable to the National Institute of Standards and Technology?

   , A9C:     The rule, as proposed, provides an appropriate degree of flexibility to use,protocols approved by national professional organiz.ations.

Q9D: What is the estimated number of short- and long-lived brachytherapy sources that will need to be cahbrated by the lice~ QP. an annual ba,sis and how long will it take to-perform the calibration? * ' , A9D: No precise information is available, but it is expected that the number would be significant. Not able to provide the requested information (i.e., time to perform calibration). Q9E: Will licensees need to procure additional equipment to perfo~ the calibrations? A9E: Yes. QlO: Section 35 .605 - Should the restrictions in paragraph (a) of the proposed rule apply to low dose-rate remote afterloaders? AlO: Yes (only for automatic low dose-rate remote afterloaders). Qll: Section 35.615 - Should the requirements in this section be waived for licensees that are using remote afterloaders with beta-emitting sources? , Al 1: Yes. It is essential for medical reasons for personnel to occupy the treatment room (see comment on A3) Q12: Section 35.644 - Should the restrictio;nsfor electrical interlocks and audiovisual systems apply to low dose-rate remote afterloaders? A12: Yes, except when direct visual contact is available; and audio surveillance should always be provided. Q 14: Subpart L - Should all recordkeeping requirements be grouped into one subpart or should they be incorporated into the section requiring the record?

Secretary, NRC Page six of seven November 10, 1998 A14: Recordkeeping requirements should be located both in (1) the section requiring the record and (2) in a separate section summarizing all the requirements for records, including the timeframes for retention of records. If this is not possible, it is preferred to locate the record.keeping requirements in the sections requiring the records. Q15: Subpart M - Should all reporting requirements be grouped into one subpart or should they be incorporated into the section requiring the record? A15: Reporting requirements should be located both in (1) the section requiring the report and (2) in a separate section summarizing all the requirements for reports. If this is not possible, it is preferred to locate the reporting requirements in the sections requiring the reports. Q16: Section 35.3045 - Do the proposed rule changes adequately address patient intervention and wrong treatment site? ,. A16: Yes. Q17B: Is there a better term than "responsible relative or guardian" that could be applied to those situations where the mother is not notified, e.g., in the referring physician's medical judgment telling the mother would be harmful; the mother is a minor; or the mother is not competent to make decisions regarding medical care? A17B: No. (fwo additional solititations for public comment, not listed in "Summary of Specific Issues Identified for Public Comment" Federal Register Volume 63, No. 156, Thursday, August 13, 1998, page 43549) Q 1: (Should) mobile medical licensees operate under reciprocity in other regulatory jurisdictions? Al: No. Q2: Which recordkeeping requirements could be deleted in the final rule? A2: None were immediately evident. G. Compatibility -- Health & Safety (H&S) designation should be deleted. H&S designation only confuses the issue of compatibility. Perhaps a solution would be to increase a compatibility designation one level whenever Commission staff decided that an H&S issue was related to a particular part of a rule (e.g., "D H&S" would be increased to "C").

Secretary, NRC Page seven of seven November 10, 1998 Thank you for the opportunity to provide our comments on this important rule. If you have any questions concerning these comments, do not hesitate to contact us. Sincerely,

~~ 1tlc_~

Richard A. Ratliff, P.E., Chief t~ Bureau of Radiation Control Enclosure

Technologists - All personnel who will be authorized to handle radioactive material must be qualified through training and experience to use the material in question for the purpose requested, and in such a manner as to mioimire danger to public health and safety or the environment. Multi-modality operations authorized under a single license may require several descriptions, each unique to the delegated specialty tasks (therapy, diagnostic imaging, in vitro). [Note that the word technologist, as someone delegated to by a medical doctor, will be used synonymously with any delegation within the following career fields: physicist, dosimetrist, nurse, or physician's assistant. Note that in addition to meeting commitments to the Agency for training criteria, final technologist approval should always rest with the physician who is obligated to supervise and is ultimately responsible for the performance of all clinical tasks he/she has delegated.] Mioiroum Training for Individuals Handlin~ Medical Group Radiopharmaceuticals Submit documentation of the following: Individuals must be certified as a general certificate Medical Radiologic Technologist (MRT) under Texas Civil Statutes, Article 4512m. In 'addition each individual must:

1. be certified by the Nuclear Medicine Technologist Certificatjon Board (CNMT); or

2. be certified in nuclear medicine by the American Registry of Radiologic Technologists [ARRT (N)];

or

3. be board eligible to take the CNMT or ARRT(N) examinations; or

4. have graduated from an approved Joint Review Committee on Educational Programs in Nuclear Medicine Technology (JRCNMT) program or be a student who is supervised and operating within such a program. (Contact JRCNMT at 801-364-4310 to verify approved programs); or

5. demonstrate grand-fathering based on full-time nuclear medicine experience; or

6. have performed full-time nuclear medicine for a minimum of two years during the past five year period. This experience must be certified in writing by an authorized physician user; or

7. have completed training in accordance with the outline in Appendix H, "Sample of a Minimum Radiation Safety Training Outline for Radiation Handlers." Note: If hiring an individual with this type of documentation, the prior training could be considered acceptable without need for additional training, if the scope of practice was equivalent to the original training site.

APPENDIXH SAMPLE OF A MINIMUM RADIATION SAFETY OUTLINE FOR-RADIATION HANDLERS (TECHNOLOGISTS) IN THE NUCLEAR l\ffiDICINE DEPARTMENT

1. Outline should include the following:

a. Instructor(s) qualifications;

b. Course Syllabus;

c. Lesson plan (e.g. how the material is provided to the student;

d. Minimum supervisory requirements of the trainee at each phase of the on-the-job-training (OJT);

e. Reference supplied texts and workbooks;

f. Testing criteria (quizzes, final exam, and passing score) determining successful completion of each step of the training and tasks mastered. Quizzes following each didactic section and a final examination committed to, but not submitted. If didactic training is sub-contracted and not structured to your program's specifications, supplemental training and independent creation of quizzes and a final examination will likely be necessary.

2. Classroom Training - Format may include lecture and audio/videos. If audio/video training is utilized, it should be less than 50 % of the total hours.

Subjects ~ Radiation physics (atomic structure, modes of decay, interaction with matter, 6 units of dose and activity, conversion of units) Principles of radiation detection and detectors 6 Principles of electronic instruments(Pulse-height analyzers, scalers, count-rate 2 meters and computers) Mathematics pertaining to use and measurement of radioactivity (statistics, 4 logarithms, exponentials, decay formula, dilution/concentration, inverse square law) Radiation protection (time, distance, shielding, routes of intake, techniques for 4 radioactive storage and disposal) Radiation biology and measurement techniques (TLD's, film badges, bioassays) 2 Radiopharmaceuticals (preparation, quality control testing, and biodistnlmtion) 4 Radiation worker rights and responsibilities (orientation with regulatory and 4 record keeping requirements in the following: Texas Regulations for Control of Radiation, United States Department of Transportation rules, Code of Fed-eral Regulations (CFR) Parts 171 - 178, documented Radiation Protection Program, Agency approved Operating, Safety, and Emergency Procedures Manual, Clinical Procedures Manual, Standing Delegation Orders

APPENDIX H CONTINUED Clinical Procedures Manual and Standing Delegation Orders are typical names for documents approved by authorized physician users delineating the radiophannaceutical, activity, imaging protocol, exam sequence,contra-indications, and under what conditions radiation shall be delivered to a patient.

3. Laboratoi:y Trainin2 Instrumentation testing (cameras, dose calibrators, scalers and survey 4 instruments)

Surveying packages and department, performing decontamination and 4 monitoring procedures. Total Classroom and Laboratory Training 40HRS

4. On--The-Job-Traioin2 (OJT)

OJT should consist of a minimum of three months training and should be a full-time commitment, averaging a minimum of four exams per day. The OT period may extend up to six months or longer depending on the scope of the program and the abilities of the trainee. During the OJT, the trainer should document and sign-off on the trainee's mastery of all procedures (detection equipment, clinical testing, radiation protection, surveys, and packaging.) The following minimum OJT should be followed unless extended periods are deemed necessary by the trainer:

a. Observation of procedures - two weeks.

b. Performance of procedures with trainer in room - two weeks.

c. Performance of procedures with trainer accessible within the building - two months.

5. Trainer Credwtials

a. Didactic Trainer. The following individuals or combination of individuals are suggested as didactic trainers:

(i) Authorized physician user. (ii) Board certified nuclear pharmacist. (iii) Certified Health Physicist (CHP). (iv) Licensed medical physicist with specialty in health physics or nuclear medicine. (v) Nuclear medicine technologist, CNMT or ARRT(N), with 5 years experience.

b. On-The-Job-Trainer. The following individuals or combination of individuals are suggested as on-the-job-trainers:

(i) Authorized physician user. (ii) Licensed medical physicist with specialty in medical health physics or nuclear medicine. (iii) Nuclear medicine technologist, CNMT or ARRT(N), with 1 year experience. (iv) RSO. (v) Board certified nuclear pharmacist could supervise some aspects of training as appropriate.

APPENDIX H CONTINUED

6. OJT PERIOD - The training period should be a full-time commitment if the work-load supports such (e.g., averaging at least 4 exams/day). In addition to the number of procedures, considerations should include the complexity of program, and scope of practices and delegated tasks. Assuming a simple unit-dose, diagnostic only practice performing only the most common procedures, 3 months (equivalent to 480 hours) of laboratory practices would be expected. No licensed program averaging less than 10 exams a week should consider an in-house training program. The OJT period may run as long as 6 or even 12 months depending of the scope of program and/or infrequency of exams due to low referral numbers.

7. TRAINEE EVALUATION - Multiple quizzes (one with each didactic section), a final exam (minimum 50 questions), and trainer signed-off recognition of successful mastery for the various tasks expectations, will demonstrate successful trainee comprehension. Any trainee testing yielding unacceptable scores, must include documentation of remedial training and successful retesting.

8. RECORD KREPJNG REQUIREMENTS -The following records shall be maintained:

a. Classroom attendance sheets identifying trainee, dates, time, and signature of trainer.

b. Credentials of didactic and on-the job trainers.

c. All graded quizzes and final exam.

d. Copy of certificate and/or document indicating successful completion of training with original going to the trainee.

fs'E"CY - dose calibrators From: Tom Defranco" <pharmalogic@worldnet.att.net> To: OWFN_DO.owf5_po(SECY) Date: Fri, Nov 13, 1998 8:08 AM

Subject:

dose calibrators This message regards the changing of 10CFR part 35. The change is to allow hospitals to use radiopharmaceuticals without measuring them in a dose calibrator. I am a Nuclear pharmacist. I strongly oppose this change. I think all doses should be measured for activity before injection. Thank you, Tom DeFranco, RPh.

                                                                                                )> 0 0:JJ"Tl c.._c =-i  \0 c~         C0 c:-                      0 z

c.:::> co r < (/)("") __. rr, w  ;:.::;-i

• f'T1

                                                                                                           -0             n N

w f -i1AIL 8 9

u.~ ~** lr"'I r-' 0 or:r-, II I\Tf"lRY rf)MM!SSIU w ~S STAFF Of-t-I(,1: r- f11 .::,tGRETARY OF Tt- C .;M\1ISSION Do" . nt Statistics Posti-,ark Date £-jt1~u}u 11/ 3/'fr 1 Copies Received _ / _ _ _ _ _ __ Add'! Copies ReprccLt;er ---' J -- - - - r - - , - -- Special Distributio,1 ~~ F ac.,~ ~O~b[Chi tJ..~ ll'o/~ _plJ Tl--1-- )z:IVJf__ - - - -

ISECY - Part.obi Page 11 This message regards the changing of I OCFR part 35. The change is to allow hospitals to use radiopharmaceuticals without measuring them in a dose calibrator. I am a Nuclear pharmacist. I strongly oppose this change. I think all doses should be measured for activity before injection. Thank you, Tom Defranco, RPh .

MEDICAL COLLEGE DOCKETED llSNPC "98 NOV 13 A1 1 :30 November 3, I 998 OF WISCONSIN

                                                                                                       ,-r  I                   Radiation Oncology J. Frank Wilson , M.D., FACR                                                                         0 1*'. -

Chairman (414) 805-4450 R. . . I AfJ ,l,., l I Roger W. Byhardt, M.D. Secretary, U.S. uclear Regulatory Commission (414) 384-2000, Ext. 2585 Beth A. Erickson , M.D. (414) 805-4460 Washington, DC 20555-0001 DOCKET NUMBER

                                                                                         ;:s ,r'lSED RULE p    )._O          '7 ,__

7 J-- 3S Colleen A. Lawton, M.D. (414) 805-4470 Attn : Rule Makings and Adjudications Staff Medical Use of Byproduct Material, Proposed Revision L 6 3 f fl L-/ 3_5_/ iJ Kevin J. Murray, M.D. (414) 805-4475

Dear Sir:

Elizabeth M. Gore, M.D. (414) 805-4465 Please consider the following comments on either your proposed revision of Part 35: her J. Schultz, M.D. 5-4480

1. Paragraph 35.50 and 35.51 contains the following statement "and whose certification Julia R. White, M.D.

(414) 805-4485 has been approved by the commission". To the best of my knowledge, the NRC has not published the criteria upon which such approval would be based. It is my opinion Medical Radiation Physics Michael T. Gillin, Ph.D. that it is both unwise and unfair to include such a blanket statement in the regulations Ron Zhu, Ph.D. without having first defined the criteria and had them available for public comment. Daniel F. Grimm, M.S. William R. Hendee, Ph.D. Francisco Lopez, M.S. Jason Rownd, M.S. 2. Thank you for referring to medical physicists as medical physicists and not (414) 805-4460 teletherapy physicists. Radiation Biology John E. Moulder, Ph.D. (414) 456-4670 3. It is my opinion that except for the simplest and smallest programs the requirement for a radiation safety committee should be retained. This is based on my experience Clinic (Patient Scheduling) . (414) 805-4400 both working in community hospitals and economic medical centers. The Radiation nagement Safety Committee provides a vehicle to bring to the attention of the hospital 5-4375 administration safety issues. This vehicle is available to a variety of different types of

           /ration                  medical specialists, including nurses, pathologists, and medical physicists.

Timothy Longden , FHFMA - (414) 805-4495

4. It is my opinion that it is a marvelous idea to have the radiation safety officer Quality Management Cheryl Glisch , M.S. acknowledge in writing that they are the radiation safety officers. It has been my (414) 805-4484 experience at the community hospital level that the radiation safety officer may go to great extent to avoid any responsibilities for this position.

5. It is my opinion that any patient intervention should not result in a medical event. The current draft regulation will result in arguments between lawyers as to whether a specific action was reasonable or whether other actions should have been undertaken .

It is my opinion that the NRC should trust the judgement of the healthcare providers on this issue.

6. It is my opinion that the RC has by adopting a uniform standard for all therapies relative to a medical event has not met the criteria of risk based regulations. I am unaware of any data for brachytherapy or for gamma knife therapy, which states that a 20% difference between the prescribed dose and the liver dose would result in harm l 8 1998 8701 Watertown Plank Rd.

Milwaukee, Wisconsin 53226 rim p(1 d card -**** &1111 if . . . . FAX: (414) 805-4369

U" "' ,,., c ttD cu::*,-, 11 /JT""" r)MMISSION

                                  . ..... :1Ji~S S14\ff
          '..,J r- 1Ct 1.*- q,iE SECRETA~

C r

• COMMISSIO J Lx-cur,.1nt Statistics Postmark Date _ 1..;__1_l.. .,t.1_ l~ 1. r.; . ____

Copies Received _ __.__ _ _ _ _ __ Add'I Copies Reproduced -= 6___ ..,.__ ~at Distribution,_._,j.,_,~,;,:.c.~..,,_,,-..~ .....:;:;:;.... _:..;:~ :t:~ ~ ~~;z-,-...£1.-~ ~ ~~

to the patient. In brachytherapy therapy, there is a 20% difference in dose over a span of several mm. It would be my recommendation that these criteria be changed to I 00% criteria.

7. It is my opinion that with respect to the writtent directive the NRC should require only that the licensee have a written dose prescription, which specifies the essential elements of the procedure. I have wasted a substantial amount of time in discussions with various inspectors and other members of the NRC as to whether or not our good faith efforts met the NRC specific requirements. We have debated issues ranging from what is a source to what dose is required. It is my opinion that ifwe followed some of the recommendations of various NRC inspectors we would increase the probability of a misadministration in that new vocabulary and non-standard approach was being forced upon us. That is certainly not the intent of the regulation. The intent of the regulation is to ensure adequate communication between the authorized user and their support staff. It is a mistake to have the regulators define each element in that communication process.

8. My institution has had established calibration procedures for low dose rate brachytherapy sources for well over a decade. I believe that it is our responsibility to confirm the calibration provided to us by the vendors. I am unaware of various quality control efforts that the vendor makes in their establishment of the statement of activity. I am also troubled by the fact that there is at least one commonly used brachytherapy source, namely Pd-103 , for which there has been no NIST traceable standard developed. Significant changes in the calibration of these sources have been rumored within the physics community. Thus, it is my personal opinion that institutions should calibrate brachytherapy sources and every source used for therapeutic purposes should have a NIST traceable calibration associated with it.

9. I appreciate the efforts on the part of the drafters of this proposed revision to include all record keeping requirements in one subgroup and all reporting requirements in another subgroup. I also appreciate the modernization of the regulations, which provides a single source for consultation.

Thank you very much for considering these comments. Michael T. Gillin, Ph. D. Professor MTG:bb

(

        ~oo          --Vereran.A venue Secretary Attention: Rulemaking and Adjudications Staff U.S. Nuclear Regulatory Commission

• I -

Washington D.C. 20555-0001 Re: Proposed Revision of 10 C.F.R. Part 35; DOCKETN BER 63 Fed. Reg. 43549 (Aug. 13, 1998) PROPOSED RULE p ~o 3 :2. .f 35" (<,'3F 435/to)

Dear Sir or Madam:

I previously testified at the NRC regarding the extent of American Board of Nuclear Medicine training (3 years) and the fact that our examination fully covers issues of radiation safety and nuclear medicine science. William H. Blahd, M.D. our president, has affirmed this in a recent letter. With this letter, I include our fundamental components of competence of a nuclear medicine physician which details the extensive training a nuclear medicine physician receives. Thus, we are confident that a physician who has successfully passed the American Board of Nuclear Medicine (ABNM) written examination and completed the training requirements in an ACGME approved nuclear medicine program should be fully qualified to be an authorized user as defined by the Nuclear Regulatory Commission. Thus, we request that the current "deemed" NRC status for such ABNM diplomates continue. ABNM training is much more extensive than proposed in the NRC proposed revision of 10 C.F.R. Part 35, it is obviously reasonable that this deemed status should continue. Indeed our board is concerned that the significant reductions in training in the proposed revision to 10 C.F.R. Part 35 may result in a lowering of the quality of practice of nuclear medicine in the United States. We also wish to advise the NRC that we at the ABNM have extensive experience in administering a written examination assessing a broad array of aspects of nuclear medicine science including radiation safety. Specifically, we have an adequate staff, have a viable system of financing our operation at its current level, have a policy and decision making review board, are governed by written organizational bylaws and policies, have a committee to examine and approve the examination and guidelines, have written procedures describing all aspects of our examination, and have appropriate safeguards for proctoring our examination including examination security. In addition, our exam has been extensively validated from a psychometric standpoint. As I stated at the NRC hearing in Washington DC, we would be willing to explore with the NRC whether our ABNM testing organization could be expanded, with appropriate funding, to develop an examination exclusively assessing radiation safety and basic sciences proposed in the new 10 C.F.R. Part 35. In summary, the extensive training clinical experience and testing performed to achieve ABNM board certification should easily be sufficient for ABNM diplomates to maintain deemed status as authorized users of radioactivity under the proposed revised 10 C.F.R. Part 35. Secondly, if the proposed regulations are implemented, we as a board would be pleased to discuss with the NRC the possibility of developing and administering a separate examination assessing the non-clinical aspects of radiation safety competence which could then be administered to authorized users. Please do not hesitate to contact my office if additional information is required. NOV 1 8 19.98 [;:tv1~ Richard L. Wahl, M.D. ArfmnwfMr,~rf bv eard .........._ _ Chairman, American Board of Nuclear Medicine CHAIRMAN PHE510~NT 'VICf PAfSIDENT VI Cf CHAIRMAN SfCIUTA I\Y TIU.A.SUR.t:A.. J11mr.s w.7/trchrr..Al.0. Jt1stph F .AMs,.,t.'-'1 -,,,.,iJluim 1-1. ~lal,J ~ta 1'fl(Y r.-x.,rrlm,r.M -0. J1m1tS.A,,LWHlfmJ111 ,..A.f..D $tAnUyJ- oi!ldsmtlh,.,44..0. PJ,,llp <t.A.ldt!Yhl,.M.a j( .l.4'lliJ, .Ml,SCUrt L"1All!JflN, CMl{"mllt 1"J.Nljtlts, (."Al1{,,n1111 1on11, c-,,y, lh-nz Tur,son,.Art.Urllf. -Nr-,.,yrrlf.,..Nov!f,,,.,,,_, .NrtvY,r/c,NrW!Jrrlt,., JAm(jJ. et,11w,1,y. ....,.o. E"111- "V DubDYSk!f, A4..C. A411trt.A.'Xrafr,M .O. 2tlw11r'- A..7'nvslltr...Af.a "Httiry D. A#!J'U, ..M..a H~mncli A. Sthdbrrt'..A-~.D. 7t4,#uu'd L. WAhi,..M.a ClrUAS(I, lllmou l!hrmmJh*m.AIMt1-mt1- 1Jurl1n9Rmt,C1tll{ort1ut- 'DrtrP1r,::\-cuh1.111.n .sr Louu,.1U11111un L'1SA.n_Jtlts, CRl1fttrt1µ;i .AnnArl:l"1', Mi.ch1.111n

U.S ~UCLEAR REGULATORY COMMISSIO RULEMAKINGS & ADJUDICATIONS STAF OFFICE OF THE SECRETARY OF THE COMMISSIO ant Sta~ Postmarl< Date / :J. I I 1;;.f-qg 4-IA(d-Cop es ed I Ariri'I f":. ep 1AI Distributio _ 7---M.- 1

  ?PR. J                 "ii- -               i

POSITION STATEMENT Components of Professional Competence of Nuclear Medicine Physicians American Board of Nuclear Medicine

d. Interaction of radiation with matter and its biolog-J Nucl Med 1994; 35:1234-1235 ical implications.

e. Basic principles of imaging procedures, including x-ray computed tomography, magnetic resonance imaging, magnetic resonance spectroscopy, ultra-The nuclear medicine physician must have broad knowl- sonography and Doppler ultrasound.

edge and experience in medicine. As the specialty ad- II. Instrumentation vances, the nuclear medicine physician must be prepared a. Principles of radiation detection and detectors. to participate by extending the scope of nuclear medicine b. Imaging instrumentation such as the gamma scin-practice beyond that available at the time of training. Upon tillation camera, scanners, single photon emission referral of a patient for consultation, a nuclear medicine computed tomography (SPECI), positron emission physician must be prepared to: tomography (PET), single- and dual-photon absorp-

a. Obtain a pertinent history. tiometry and nonimaging instrumentation such as

b. Perfonn a physical examination appropriate to the the whole-body counter, gamma well counter, consultation. scintillation probe, liquid scintillation counter, ra-

c. Select and carry out diagnostic and therapeutic pro- diation monitoring devices and dose calibrator.

cedures in a manner that is safe both to the patient c. Collimation for the various types of radiation detec-and the staff. tors with special emphasis on the characteristics of

d. Interpret the results, arrive at a reasonable diagnosis parallel-hole. diverging, converging, slant-hole, pin-on the basis of correlation of all available clinical and hole, fan-beam, and cone-beam collimators and laboratory infonnation, and issue a timely report. their response to point, line and plane sources.

e. Recommend further study or treatment as appropriate. d. Electronic instruments such as pulse amplifiers,

f. Assume responsibility for patient management if nu- pulse-height analyzers, scalers and count rate clear medicine therapy is indicated. meters.

g. Communicate effectively with patients and referring e. Image production and display technology, including physicians. photographic principles, sensitivity, resolution.

h. Develop and supervise programs for quality assur- contrast, latitude and film processing.

ance and quality control. m. Mathematics and Statistics

i. Provide expert consultation regarding the most appro- a. Fundamental concepts of mathematics, includ-priate and cost effective examinations. ing algebra, geometry and calculus.

The practice of nuclear medicine requires special knowl- b. Fundamental concepts of statistics, including edge in the following areas: probability distributions, parametric and nonpa-rametric statistics. I. Physical Science c. Principles of medical decision making, including

a. The structure of matter. Bayes' theorem, comparative accuracy of diag-

b. Modes of radioactive decay and the accompanying nostic tests and effectiveness of therapeutic pro-emissions. cedures and principles of clinical study design

c. Emissions accompanying radioactive decay and and analysis.

theµ- biological implications. d. Mathematical models of physiologic systems.

e. Principles of data transport and storage, picture Previous versions of the Components of Professional Competence of Nuclear archiving and communication systems.

Medicine Physicians have been published in Tl!s Jouma/ of Nuclear MedicinB, Vol. 12, December 1971; va. 22. December 1981; anct va. 21. June 1986. This IV. Computer Science revision was prepared by the American Board of Nuclear Medicine, May 1994. a. Basic aspects of computer structure, function For reprin1S contact The American Board of Nuclear Medicine, 900 Veteran Avenue, Los Angeles. CA 90024. and programming. 1234 The Journal of Nuclear Medicine

• Vol. 35
• No. 7
• July 1994

b. Principles of computer applications with emphasis trocardiographic interpretation, and cardiopulmo-on digital imaging acquisition, image filters, analy- nary resuscitation during interventional tests such sis, processing and enhancement, tomographic re- as exercise and pharmacological stress.

construction, display and recording of findings. g. Pharmacology of drugs used in nuclear medicine. V. Radiation Biology and Protection h. Preparation and use of labeled antibodies, pep-

a. Biological effects of radiation exposure, with em- tides and cells and related areas of immunology.

phasis on the effects of low-level exposure. VIII. In Vitro Studies Including Nonradioactive Isotopic

b. Administrative and technical means of reducing Tracers unnecessary radiation exposure to patients, per- a. Methodology, quality control and biological ba-sonnel and the environment. sis of radioligand assay.

c. Calculation of radiation dose from internally ad- b. Principles of activation analysis and autora-ministered radionuclides. diography.

d. Diagnosis, evaluation, clinical management and IX. Therapeutic Uses of Radionuclides treatment of patients experiencing radiation over- a. Patient selection, including the diagnostic proce-exposure in any form. dures necessary to establish the need for radio-

e. Management of radiation accidents, including mon- nuclide therapy, the indications and contraindi-itoring, decontamination and subsequent control. cations for the use of radionuclide therapeutic

f. Governmental regulations regarding limits of radia- procedures and their effectiveness in relation to tion exposure, handling of radioactive patients and other therapeutic approaches.

disposal of radioactive wastes. b. Understanding and calculation of absorbed radi-VI. Radiopharmaceutical Production, Biochemistry and ation dose, including calculation of absorbed ra-Clinical Physiology diation dose to the target area, to the surrounding

a. Production of radionuclides by reactors, cyclo- tissue, other organ systems and total body.

trons, other particle accelerators and the use of c. Patient care during radionuclide therapy, includin radionuclide generators. understanding of potential early and late adverse

b. Formulation of radiopharmaceuticals consider- reactions, additive toxicity when combined with ing chemical properties and quality control in- other therapy, the timing and parameters of antic-cluding sterility and pyrogenicity testing. ipated response and follow-up care and evaluation.

c. Biochemistry, physiology, pharmacokinetics of d. Potential adverse effects of radiation (e.g., onco-radiopharmaceuticals and mechanisms of localiza- genesis and genetic effects). Effect on family mem-tion in normal and abnormal physiologic states. bers, the public. Maximum body dose on discharge

d. Role of regulatory bodies applicable to the use of from the hospital.

radiopharmaceuticals in nuclear medicine practice e. Application to children, e.g., cancer incidence, tis-and research. sue sensitivity. VII. In Vivo Diagnostic Use of Radiopharmaceuticals f. Specific applications: e.g., radioiodine in hyperthy-

a. In vivo imaging and/or body function measure- roidism and thyroid carcinoma; radiophosphorus ments, including the central nervous system, (soluble) in polycythernia ruba vera and other my-endocrine system, salivary glands, bone marrow eloproliferative disorders, radiocolloids for ther and hematologic system, respiratory system, apy, radionuclides for metastatic bone disease a

• cardiovascular system, gastrointestinal tract, radiolabeled antibody therapy.

hepatobiliary system and spleen, the musculo-skeletal system and the genitourinary system.

b. Use of imaging devices and detectors for body ABNM BOARD organ, time-dependent and differential function studies and quantification of function.

c. Cellular kinetics, absorption, excretion and di- Philip 0. Alderson, MD Robert A. Kraft, MD New York Hillsborough lution analyses and balance studies using radio- Edward R. Powsner, !>ID William H. Blahd. MD tracers. Los Angeles Detroit

d. Body composition tests, including compartmen- R. Edward Coleman, MD Joseph F. Ross, MD tal analysis. Durham Los Angeles

e. Relationship between and correlation of nuclear James J. Conway, MD Heinrich R. Schelbert, .\,ID Chicago Los Angeles medicine procedures and other pertinent imag- James W. Fletcher, MD H. William Strauss, MD ing modalities such as diagnostic radiographic St. Louis Princeton techniques, ultrasound, x-ray computed tomog- Stanley J. Goldsmith, MD &chard L Wahl, MD raphy, magnetic resonance imaging and mag- New York Ann Arbor netic resonance spectroscopy. Peter T. Kirchner, MD James M. Woolfenden, MD Iowa City Tucson

f. Patient monitoring with special emphasis on elec-Components of Professional Competence

• ABNM 1235

POSITION STATEMENT Components of Professional Competence of Nuclear Medicine Physicians American Board of Nuclear Medicine

d. Interaction of radiation with matter and its biolog-J Nucl Med 1994; 35:1234-1235 ical implications.

e. Basic principles of imaging procedures, including x-ray computed tomography, magnetic resonance imaging, magnetic resonance spectroscopy, ultra-The nuclear medicine physician must have broad knowl- sonography and Doppler ultrasound.

edge and experience in medicine. As the specialty ad- II. Instrumentation vances, the nuclear medicine physician must be prepared a. Principles of radiation detection and detectors. to participate by extending the scope of nuclear medicine b. Imaging instrumentation such as the gamma scin-practice beyond that available at the time of training. Upon tillation camera, scanners, single photon emission referral of a patient for consultation, a nuclear medicine computed tomography (SPECf), positron emission physician must be prepared to: tomography (PET), single- and dual-photon absorp-

a. Obtain a pertinent history. tiometry and nonimaging instrumentation such as

b. Perform a physical examination appropriate to the the whole-body counter, gamma well counter, consultation. scintillation probe, liquid scintillation counter, ra-

c. Select and carry out diagnostic and therapeutic pro- diation monitoring devices and dose calibrator.

cedures in a manner that is safe both to the patient c. Collimation for the various types of radiation detec-and the staff. tors with special emphasis on the characteristics of

d. Interpret the results, arrive at a reasonable diagnosis parallel-hole, diverging, converging, slant-hole, pin-on the basis of correlation of all available clinical and hole, fan-beam, and cone-beam collimators and laboratory information, and issue a timely report. their response to point, line and plane sources.

e. Recommend further study or treatment as appropriate. d. Electronic instruments such as pulse amplifiers,

f. Assume responsibility for patient management if nu- pulse-height analyzers, scalers and count rate clear medicine therapy is indicated. meters.

g. Communicate effectively with patients and referring e. Image production and display technology, including physicians. photographic principles, sensitivity, resolution,

h. Develop and supervise programs for quality assur- contrast, latitude and film processing.

ance and quality control. III. Mathematics and Statistics

i. Provide expert consultation regarding the most appro- a. Fundamental concepts of mathematics, includ-priate and cost effective examinations. ing algebra, geometry and calculus.

The practice of nuclear medicine requires special knowl- b. Fundamental concepts of statistics, including edge in the following areas: probability distributions, parametric and nonpa-rametric statistics. I. Physical Science c. Principles of medical decision making, including

a. The structure of matter. Bayes' theorem, comparative accuracy of diag-

b. Modes of radioactive decay and the accompanying nostic tests and effectiveness of therapeutic pro-emissions. cedures and principles of clinical study design

c. Emissions accompanying radioactive decay and and analysis.

their biological implications. d. Mathematical models of physiologic systems.

e. Principles of data transport and storage, picture Previous V81Sions of the Components of Professional Competence of Nuclear archiving and communication systems.

Medicine Physicians have been published in The Joumsl of /\luclsar MecJicm, Vol. 12, December 1971; Vol. 22, December 1981; and Vol. 27, June 1986. This IV. Computer Science AMSion was prepared by the American Board ol Nuclear Medicine, May 1994. a. Basic aspects of computer structure, function For reprints contact The American Board of Nuclear Medicine, 900 Veteran Avenue, Los Angeles, CA 90024. and programming. 1234 The Journal of Nudear Medicine

• Vol. 35
• No. 7
• July 1994

b. Principles of computer applications with emphasis trocardiographic interpretation, and cardiopulmo-on digital imaging acquisition, image filters, analy- nary resuscitation during interventional tests such sis, processing and enhancement, tomographic re- as exercise and pharmacological stress.

construction, display and recording of findings. g. Pharmacology of drugs used in nuclear medicine. V. Radiation Biology and Protection h. Preparation and use of labeled antibodies, pep-

a. Biological effects of radiation exposure, with em- tides and cells and related areas of immunology.

phasis on the effects of low-level exposure. VIII. In Vitro Studies Including Nonradioactive Isotopic

b. Administrative and technical means of reducing Tracers unnecessary radiation exposure to patients, per- a. Methodology, quality control and biological ba-sonnel and the environment. sis of radioligand assay.

c. Calculation of radiation dose from internally ad- b. Principles of activation analysis and autora-ministered radionuclides. diography.

d. Diagnosis, evaluation, clinical management and IX. Therapeutic Uses of Radionuclides treatment of patients experiencing radiation over- a. Patient selection, including the diagnostic proce-exposure in any form. dures necessary to establish the need for radio-

e. Management of radiation accidents, including mon- nuclide therapy, the indications and contraindi-itoring, decontamination and subsequent control. cations for the use of radionuclide therapeutic

f. Governmental regulations regarding limits of radia- procedures and their effectiveness in relation to tion exposure, handling of radioactive patients and other therapeutic approaches.

disposal of radioactive wastes. b. Understanding and calculation of absorbed radi-VI. Radiopharmaceutical Production, Biochemistry and ation dose, including calculation of absorbed ra-Clinical Physiology diation dose to the target area, to the surrounding

a. Production of radionuclides by reactors, cyclo- tissue, other organ systems and total body.

trons, other particle accelerators and the use of c. Patient care during radionuclide therapy, including radionuclide generators. understanding of potential early and late adverse

b. Formulation of radiopharmaceuticals consider- reactions, additive toxicity when combined with ing chemical properties and quality control in- other therapy, the timing and parameters of antic-cluding sterility and pyrogenicity testing. ipated response and follow-up care and evaluation.

c. Biochemistry, physiology, pharmacokinetics of d. Potential adverse effects of radiation (e.g., onco-radiopharmaceuticals and mechanisms of localiza- genesis and genetic effects). Effect on family mem-tion in normal and abnormal physiologic states. bers, the public. Maximum body dose on discharge

d. Role of regulatory bodies applicable to the use of from the hospital.

radiopharmaceuticals in nuclear medicine practice e. Application to children, e.g., cancer incidence, tis-and research. sue sensitivity. VII. In Vivo Diagnostic Use of Radiopharmaceuticals f. Specific applications: e.g., radioiodine in hyperthy-

a. In vivo imaging and/or qody function measure- roidism and thyroid carcinoma; radiophosphorus ments, including the central nervous system, (soluble) in polycythemia ruba vera and other my-endocrine system, salivary glands, bone marrow eloproliferative disorders, radiocolloids for ther-and hematologic system, respiratory system, apy, radionuclides for metastatic bone disease and cardiovascular system, gastrointestinal tract, radiolabeled antibody therapy.

hepatobiliary system and spleen, the musculo-skeletal system and the genitourinary system.

b. Use of imaging devices and detectors for body ABNM BOARD organ, time-dependent and differential function studies and quantification of function.

c. Cellular kinetics, absorption, excretion and di- Philip 0. Alderson, MD Robert A. Kraft, MD New York Hillsborough lution analyses and balance studies using radio-William H. Blahd, MD Edward R. Powsner, MD tracers. Los Angeles Detroit

d. Body composition tests, including compartmen- R. Edward Coleman, MD Joseph F. Ross, MD tal analysis. Durham Los Angeles

e. Relationship between and correlation of nuclear James J. Conway, MD Heinrich R. Schelbert, MD Chicago Los Angeles medicine procedures and other pertinent imag-James W. Fletcher, MD H. William Strauss, MD ing modalities such as diagnostic radiographic St. Louis Princeton techniques, ultrasound, x-ray computed tomog- Stanley J. Goldsmith, MD Richard L Wahl, MD raphy, magnetic resonance imaging and mag- New York Ann Arbor netic resonance spectroscopy. Peter T. Kirchner, MD James M. Woolfenden, MD Iowa City Tucson

f. Patient monitoring with special emphasis on elec-Components of Professional Competence

• ABNM 1235

                                                                                                     ~() 3:l J- '5

( '13 F1? 'i-3Slfo) DEPARTME 6::ih ~l--l

                                                         ~; :                          R SAFETY 1O,:;};Zrf!~'"'" '-'-:"-.:   ....,_,v..- E Jim Edgar Governor SPRI            ~~=:l:~         * ,~             704   Thomas W. Ortciger Director November 4, 1998 Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 Attention: Rulemakings and Adjudications Staff To Whom it May Concern:

The Illinois Department of Nuclear Safety (Department) hereby requests the NRC to extend the comment period on the proposed revisions to the medical rules (10 CFR Part 35) and the associated guidance document (NUREG- 1556, Vol. 9). This extension is warranted because of the sweeping changes to the medical rules and the possible ramifications for licensees and Agreement States. The Department would appreciate additional time to thoroughly review and comment on the proposals. Many of the proposed changes, such as the proposal to no longer review licensee's procedures during the licensing phase, could have a profound impact on the way the Department functions. We would appreciate additional time to fully analyze comments made at the public meetings in October, and additional details concerning the "Health and Safety" compatibility designations to be forwarded to us soon. We realize this request also would necessitate extending the implementation date for this rule. Such an extension would be welcome if it allows us the opportunity to conduct a more comprehensive review of your proposals. Thank you for considering this request. Should you have any questions, please contact me at 217-785-9931. I, tV' Kathy Allen fJ Senior Project Manager cc: Catherine Haney Office of Nuclear Material Safety and Safeguards @ recyclable

LEAR REGULATOR COMMISSION AKINGS & ADJUOICATI SSTAFF FF'CE OF THE SECRETAR OF THE COMMISSI

                                                            ~()1 '3!2. ..J 3S-( ~:3 F1? t/ 351 <,)

HEAL ICS SOCIETY KEITH H. DINGER, CDP President 1998 - 1999 November 6, 1998 Executive Offices, Suite 402 1313 Dolley Madison Blvd. The Honorable Shirley Jackson McLean, Virginia 22101 Chairman Tel: (703) 790-1745 U. S. Nuclear Regulatory Commission Fax: (703) 790-2672 E-Mail: hps@burkinc.com Washington, DC 20555 RE: Request for Extension of Comment Period; 63 Fed. Reg. 43516 (August 13, 1998); RIN 3150-AF74

Dear Chairman Jackson:

On behalf of the members of the Heaith Physics Society, I request the Commission extend the comment period for the referenced proposed revision of its regulations governing the medical use of byproduct material. I request this extension be for a minimum of sixty (60) days beyond the currently established expiration date of November 12, 1998. The Health Physics Society views 10 CFR Part 35 as an extremely important regulation providing the standards of safety to be used in the beneficial application of radiation and radioactive materials in medicine. Accordingly, the Society has established an Ad Hoc Committee specifically tasked with being involved in the development of revisions to this regulation. The Committee is actively developing comments on the proposed revision. However, due to the extensive nature of the proposed changes it is impossible to develop consensus comments in the time frame of the current comment period. The Health Physics Society's interest in these regulations is somewhat unique in that we can not simply review and comment on a specialized or selected area of the regulations, but rather we must view it from a holistic standpoint. As radiation safety professionals providing the safety program implementation and oversight in medical facilities, our interest and responsibilities span the entire construct of the rule. This broad area of interest results in the need for considerable time and effort to develop responsible, and useful comments. Our desire is to provide constructive comments in line with the stated intent for this revision to be risk-informed and more performance-based, something we feel is not reflected in the current proposal. We are interested in assisting the Commission in improving the proposed rule, not in simply identifying items or areas we consider unacceptable. However, the development of constructive comments takes time not available in the current comment period.

tJ.S. NUCLEAR REGULATORY COM I ~ RULEMAKINGS &ADJUDICATIONS ST OFRCE OF THE SECRETARY OF THE COMMISSION

I look forward to a favorable decision on this request, reflecting the Commission's commitment to develop a quality regulation that provides appropriate protection for the safety and health of the public rather than one that meets an arbitrary scheduled issue date. Please feel free to contact me if I can be of further help in this important matter. Sincerely, Keith H. Dinger, CHP President cc: The Honorable Greta Joy Dicus, Commissioner The Honorable Nils J. Diaz, Commissioner The Honorable Edward McGaffigan, Jr., Commissioner The Honorable Jeffrey Merrifield, Commissioner Dr. William D. Travers, Executive Director for Operations Hugh L. Thompson, Jr. , Deputy Executive Director Dr. Carl J. Paperiello, Director - NMSS

547 4658 C E NU BER 'jl.J-35 raioo2

                                                                           ,      0'/ \ 2 p 2 :3~11 Campolindo Dtivo:

98

• Moraga, CA 94556- 1551 510/283-1850 Fax: 510/283-1850 Of , ,

Hen.-y H. Kr.uner, Ph.D., FACNP RJ _t FF E:.:~cwti,*~ Orr,rn,,,. AOJL;:,'t.,r November 12, 1998 Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 RE: Request for comments on changes to 10 C.F.R. Part 35.75 The following comments are submitted on behalf of the Council of Radionuclides and Radiopharmaceuticals, Inc. (CORAR) . CORAR is an industry association of manufacturers of radiopharmaceuticals, radionuclides, radiochemicals and other radioactive products primarily used in medicine and life science research. The member companies of CORAR supply vitally important radiopharmaceuticals and radioactive material to physicians and research facilities throughout the world. These comments address the Commission's request for comment on changes to Part 35.75 the patient release criteria. CORAR will be submitting a complete set of comments to the Commission on the entire Part 35 revision under a separate cover. As an organization that represents manufacturers of radiopharmaceuticals, CORAR members share a strong interest in promoting policies that we believe benefit the patient, afford greater access to new and promising life-saving treatments, while still ensuring broad protection to the public. In response to the Commission's query about changes to the release criteria, CORAR sees no scientific, policy, or public health concern that would justify making any substantive changes to the current release criteria . The current regulations {Part 35.75) as described in Regulatory Guide 8.39 are an excellent and safe guide for physicians and other personnel involved in the care of patients receiving therapy with radioactive substances. The Commission should be applauded for adopting the revised patient release criteria, which avoids unnecessary hospitalization that can have an adverse impact on patient recovery. Unnecessary hospitalization also punishes patients financially without providing any improved standard of care. Co-pays associated with hospitalization add costs that patients must bear. These costs may prevent patients from receiving the most appropriate treatment.

U.S. NlJrl i:~o J:tf::GULATORY COMMISSI RUL t11 " - - DJUDICATIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSION Postmark Date Document Statistics

               ~e,)._

L Copies Received ----;;------ JJ /J:f qg 6.__--:=:"T"- - Add'I Copies Reproduced ..... ~"ecial Dis~ ~ YA F~ llA+/-b sc.b,~ _ r_:;4,11%t.LG P/J ~~ I

{aJ003 ALPINE GROUP 11/12/ 98 THU 12 : 13 FAX 202 547 4858 The Commission noted that concerns have been raised about a recent increase of radiation alarms going off at landfills caused by household trash from released patients treated with radioactivity. It is unlikely that the new patient release criteria are causing these landfill monitors to alarm since most Agreement States have not adopted these new criteria yet. While CORAR questions the basis for this concern, we would argue that landfill monitors are alarming as a result of the lower level of detection for the radiation monitors used at landfills are not uniformly regulated at any level. Therefore, CORAR believes that this "concern" is both unsupported and not a convincing reason for the Commission to revise the rule. In conclusion, the public is well protected by the Nuclear Regulatory Commission's (NRC) current 500 millirem rule. The revised NRC rule more appropriately focuses on potential exposure to the general public rather than on the amount of activity administered to the patient. CORAR would strongly urge the Commission to maintain the current criteria as it considers revisions to its regulations governing the medical use of by-product material (10 C.F.R. Part 35) . Sincerely yours, oy Brown Council on Radlonuclides and Radiopharmaceuticals

[4]0 01 11/12/98 THU 12 : 12 FAX 202 547 4858 ALPINE GROUP ALPI NE ,/ i. 6 ROU P Government Relations Consultants FAX TO: FROM: DATE: PAGE(S): COMMENI':

                  '1"\,u,c:- C-o~e,~l,. ~ d l ~ ~...                                    £..oMl\~t~to.-t 1

S ttf,.._<<-bi .!'...r <..c.WIM°"'+ o--... C-~&6 ~ ';>__,:\- ,3(. 75"

          -n-. ._ ~.\-~c.,,s.\. n ~eA.M..- <-n'.v, .__ . LC.12¥1-12. .... ;ll
           ~       5~'M. ,\\-\~ -- ~~l')\la-~                         ~ ~~ ~~
           -k>     ~            C-oM~LY=,.l6~             o~    1l,..__   ~+~~~~as f' L\:, L~le,~        ~L.,--       ~ et , P ~                    C..0\J'<J ..

66 6 rE NN SYLYANIA AV£ ., 5E SUI TE 201 WAS HI NGTON , DC 20003 TH Z02 . S47 . 18ll FAX 202 . 547 . 465 8 ALP IN E@AL PI NEG RO UP . COM

IcAAIRMAN -AsLTRXTNsN1 .Rdsiv.doc Page 11 DOC ETED US .C NOV -9 P2 :39 OF+ I RL I' AD L'l, ~- Organization of A&reement States Roland G. Fletcher, Chair Stan Marshall, Chair-Elect Robert Qulllln, Past Chair Richard Ratliff, Secretary November 6, 1998 The Honorable Shirley Jackson Chairman U.S. Nuclear Regulatory Commission Washington, DC l0SSS Re: Urgent Request for Extension of Comment Period: 63 Fed. Reg. 43516 (Aug. 13, 1998); RIN 31SO-AF74

Dear Chairman Jackson:

At the 1998 Annual Agreement States meeting held in Bedford, NH October 29-31, 1998, the majority of attendees present voted to forward this request to the Commission. OAS asks that this request be given your most favorable consideration. The Organization of Agreement States urgently requests the extension of the comment period for the ongoing revision of 10 CFR Part JS to allow for the development of the risk analysis and the rule accordingly. This request supports and concurs with a similar request submitted October 30, 1998 jointly by the following organizations. American College of Nuclear Physicians Society of Nuclear Medicine American College of Radiology Council on Radionuclides and Radiopharmaceuticals Nuclear Energy Institute National Electrical Manufacturers Association American College of Nuclear Medicine American Association of Physicists in Medicine

U.S. Nll('t J=AA AEGULATORY COMMISSION RULE~ 1 - r,.1 .;...; & ADJUDICATIONS STAFF OFFICE OF THf SECRETARY OF THE COMMISSION Document Statistics Postmark Date J:- A.; I 11 / 6 /q. Copies Received_/_ _ _ _ _ _ __ Add'I Copies Reproduced _6_~-:--~- 1P[:b.:A,I~ pecial Distributio "--'-- ...,.,_,,~_,__,-=~-

IcAAIRMAN -AsLTRXTNsNi .RasN.doc Page 21 Sincerely, ORIGINAL SIGNED Roland G. Fletcher, Chair Organization of Agreement States cc: The Honorable Edward McGafragan, Jr.t Commissioner The Honorable Nils J. Diaz. Commissioner The Honorable Jeffrey Merrifield, Commissioner The Honorable Greta Joy Dicust Commissioner Hugh L. Thompsont Jr.t Deputy Executive Director Carl ,. Paperiellot Ph.D., Director - NMSS

MDE-RHP Fax:410-631-3198 Nov 9 '98 P.02 Roland G. Fletcher, Chair Stan Marshall, Chair-Elect Robert Quillin, Past Chair ~ichard Ratliff, Secretary Organiution of Agreement States November 6, 1998 The Honorable SWrley Jackson Chairman U.S. Nuclear Regulatory Commission Washington, DC 20555 Re: Urgent Request for Extension of Comment Period: 63 Fed. Reg. 43516 (Aug. 13, 1998); RIN 3150-AF74

Dear Cuirnun Jackson:

At the 1998 Annul Agreement S~tes meeting held in Bedford, NH October 29-31, 1998, lhe majority of attendees present voted to forward this request to the Commission. OAS asks that this request be given your most favorable consideration. The Organlution of Agreement St.ates urgently requests the extension of the comment period for the ongoing revision of 10 Cl<~ Part 35 to allow for the development of the risk analysis and the rule accordingly. This reque~-t supports and concurs with a simiiar request submitted October 30, 1998 jointly by the following orgaDizatious. American College of Nuclear Physicians Society of Nuclear Medicine American College or Radiology Council on Radionuclides and Radiopbannaceuticals Nuclear Energy Institute Nlltiooal Electrical Manufacturers Association American College of Nuclear Medicine American Association of Physicists in Medicine r?liii&}f!!~~ Organization of Agreement States cc: The Honorable Edward McGllffigan, Jr., Commissionea* The Honorable Nils J. Diaz, Commissioner The Honorable Jeffrey Merrifield, Commissioner The Honorable Greta Joy Dicus, Commissioner Hugh L. Thompson, Jr., Deputy Executive Director Carl J. Paperiello, Ph.D., Director - NMSS 11/9 *** To EDO to Prepare Response for Chairman's Si gna t ure *** Date due Comm: Nov 12 *** Cpy to: Chairman, Comrs, SECY/RAS ** 98-1033 Coord response with OGC ***** (Commission Correspondence) s... 0  :..'"\ (:.J

                                                                                                    ~

0

                                                                                                   ~
                                                                                                   ~
                                                                                                           ~

0

                                                                                                   ~      :l!I,,

5i CrJ a:

                                                                                                          °'

ICHAIRMAN - Urgent Request for Part 35 Comment Period Extension Page 11 DOCKE TED From: "Roland Fletcher <rfletcher@mde.state.md.us> US , 'RC To: OWFN_DO.owf5_po(CHAIRMAN) Date: Fri, Nov 6, 1998 4:28 PM

Subject:

Urgent Request for Part 35 Comment Period Extension '98 NOV -9 P 2 :39 Chairman Jackson Commission Dicus Orr I Commissioner Diaz RlJ AD .i Commissioner McGaffigan Commissioner Merrifield Subject letter is attached. The OAS appreciates any consideration you can give to this request so near the scheduled end of the period. We await your decision . CC: TWFN_DO.twf1_po(ROV,RLB2),CH_DO.ch_po(JLL2),0WFN_D...

11 / 12 / 98 THU 13: 19 FAX 415 849 75.! ~ COULTER PHARMACEUTICAL 14!002

                                                                                                               ~

DOCKET N\NBER 2-0 3 1.._cJ- 3 ~ DOCKE TED\::!.!!_/ PROPOSED RULE ' us~m, C63Fflt-JJ516.J Coulter PH ARM ACEU T I CA L

                                                                                                  '98 NOV 12 P4 :28 Novemher 12, 1998 Of r-RL ADJ IL, BY TELECOPIER Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 Attention: Rulemakings and Adjudications Staff Re:     Proposed Revision of 10 C.F.R. Part 35; 63 FED. REG. 43516 (Aug. 13, 1998); RIN 3150-AF74 I.      JNTRODlJCTION AND 

SUMMARY

OF COMMENTS These commenrs are submitted by Coulter Pham,aceurical, Inc. ("Coulter) in response to the Nuclear Regulatory Commission' s ("'NRC"s or "the Commission ' s") proposal to revise its regulations governing the medical use of byproduct material. As published in the FEDERAL REGISTER of August 13, l 998, 63 Fr.D. REG . 43516, the proposal envisions a broad revision of . NRC' s existing regulations. Comments were requested to be submitted by N()vember 12, 1998. Coulter, located in Palo Alto, California, is engaged in the development and commercializati<>n of novel drugs and thcrap.ies for the treatment of people with cancer. It is currently preparing to file a biologics license application with the U.S . Food and Drug Administration for fodinc-131 Anti-Bl Antibody (tositumomab), a radiolabelcd monoclonal antibody for the treatment of non-Hodgkin ' s lymphoma ("NHL"). 11 During the on-going clinical investigations and after approval , the use of lodine-131 Anci-B 1 Antibody is subject to NRC regulations governing medical use of radioisotopes in NRC Srntes. These comments ex.elusively address one issue: the release from licensee control of patients who have been administered radiopharmaceuticals or radioactive implants. The NRC's current patient release rule is codified at 10 C.F.R. § 35.75. Only minor revisions arc proposed 11 Iodine-131 Anti-Bl Antibody is being investigated for the treatment of low-grade and transformed low-grade non-Hodgkin's lymphoma. In the U.S ., NHL is the sixth leading (and second fastest growing) cause of cancer mortality. Iodine-131 Anti-B 1 Antibody therapy consists of Iodine-131 combined with a monoclonal antibody that selectively targets the CD20 antigen, an anLigen which serves a.,;; a target for NHL cells. Iodinc-131 Anti-BI Antibody delivers cancer-killing radiation to the tumor site while generaHy sparing normal tissue.

                                                       , .i 1*., ",,.., ,... , n orf"r II I\T'1PY r,n     ~MISS!
                                           ,,~_, STAFF
                                  .. RETAR T
                                ", SSION
                    "":..,., n+ St1tistics rtv--cJ pr

_il,a~h~-='-=~=~':C4-I-~ _ Pf.JP-I

11/12/98 THU 13:20 FAI..415 849 7348 COULTER PII.ARKACEUTICAL liJ 003 Secretary . U.S. Nuclear Regulalory Commission November 12, 1998 Page2 to seclion 35.75, a regulation which was adopted just a year ago. Nonetheless, in the preamble to the proposed rule. the NRC said lhat it "is specifically soliciting public comment on whether any changes need to be made to Lhe relea.,:;e criteria in this rule. 63 FED. REG. at 43535. For the reasons discussed below, Coulter believes that the scientific, factual and policy determinations made by the Commission when it adopted section 35.75 in 1997 remain valid today. Coulter believes that lhc only change which should be made to 35.75 is to change it~ Agreement Slate Compatibility category from Category C to Category B to mitigate Lransboundary implications and so that patients, their families, and hospitals and their personnel will benefit from the rule, regardless of the state in which they reside .

• n. BACKGROUND A patient who receives radioactive material For a medical procedure emits a certain level of rd.dioactivity and transfers radioactivity lo objects (such as tissues) for some period after the radioactive material is administered. When a short-lived radioisolopc is used. its rapid decay generally means that there is no significant exposu~ to other persons. Admini~tration of longer-lived isotopes. such as Iodine-I 31. require that thought be given to the potential exposure of third parties. Accordingly, the NRC has historically mandated that patients administered certain levels of radioactivity be confined until such time as the radioactivity in the patient decayed lo levels considered safe for third parties.

In thc.FEDERALREG1S1'ER of January 29, 1997. 62 FED. REG. 4120. the NRC amended its criteria for the release of patients administered radioactive mo.terial to focus on the exposure of

• third parties by the released patient. ralher than on the amount of radioactivity administered to the patient. The original rule stated that a licensee could not release from confmement a patient or research subject administered a radiopb.anrutccutical until either ( 1) the measured dose rate from the patient was less than 5 millircrns per hour at a distance of I meler, or (2) the activity in the patient was less than 30 rnillicuries. In the new rule, the NRC set the release criteria based on the likely dose to third panies:

The licensee may authorize the release from its control of any individual who bas been administered radiopharmaceuticals or permanent implants containing radioactive mpJ:.erial if the total cffeclive dose equivalent to any other individual from the released individual is not likely to exceed 5 m.illisievens (0.5 rem). 21 11 The rule also requires the licensee to provide the released individual with instructions on recommended actions to maintain doses to others as Jow as reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed I miHisicvert (0.1 rem). The rule also contains guidance for breast-feeiling mothers and cettain record keeping requirements.

11/12/98 THU 13:20 FAX 4~5 849 7548 COULTER PHARllACEUTICAL 141004 Secretary U.S. Nuclear Regulatory Commission November 12, 1998 Pagc3 The rule notes (in footnote 1) that Regulatory Guide 8.39 describes methods for calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding S millisieverts {0.5 rem)." The new patient rclea,;;e criteria were adopted in response to three petitions received by the NRC going back to 199 L The NRC issued 11 proposed rule on June 15. I 994, 59 FED. REG. 30724, explaining that it was proposing to adopt a dose limit rather than an activity limit because: The NRC's primary concern is Lhe public hcaJth and safety. Doses are a measure of degree of protection, whereas activity of different radionuclides is not related in any consjs1cnt way to the level of protection. For this rea"ion, the NRC proposes to establish a dose limit as the only patient release criterion jn 10 CFR 35.75. The proposed dose limit is 5 millisievcrts (0.5 rem) total effective dose equivalent in a year. This dose limit is consistent with the underlying risk basis of lhe current 10 CFR 35.75 (50 FED. REG. 30627), the recommendations of the ICRP, and the provisions in 10 CFR 20.1301(c), pertaining to situations in which there is requisite justification for a dose limit higher than 1 milli.sievert (0.1 rem). Unlike the current 10 CFR 35.75. the proposed 10 CFR 35.75 does not l->-pecify an activity or dose r:ite for authorizing patient release. The l,110-rncgabecqucrel (30-millicuric) requirement was not rerained because the doses from a released patient are different for different radionuclide~ that ha.ve uie same activily. Likewise, a release criterion based on dose rate from the patient is.not a uniform indicator of dose because

• the total dose depend<. on the effective half-life of the radioactive material in the body of the patient and other factors, which will differ for different materials.

59 FED. REG. at 30728. NRC's proposal received widespread support from the medical community. Among those organizations which urged the NRC Lo adopt lhc new patient release rule were lhc American College of Nuclear Physicians, Society of Nuclear Medicine, American Medical Association, American College of Radiology, National Institutes of Health of the Department of Health and Human Services, American Association of Clinical Endocrinologists, Council on Radionuclide.~ and Radiopharrnaceuticals, Inc., Nuclear Energy Institute, American Society of Hospital Pharmacists, American College of Nuclear Medicine, Nuclear Management and Resoorces Council, the Chair of the Department of Veterans Affair& National Advisory Group on Radiation Safety, and American Association of Physicists in Medicine. In addition, numerous physicians and medical institutions expressed their support for the new rule to the NRC. Not all commenters supported the proposed rule. However, the Commission effectively responded to opposing comments.

11/12/98 ~ ;.~.: 21 F~. 415 849 7548 COULTER PHARllACEUTICAL 141005 Sccretn.ry U.S. Nuclear Regulatory Commission November 12, 1998 Pagc4 As demonstrated in the following sectjons, there is no scientific evidence or legal basis which justifie.-. a revision of section 35.75. To the contrary, there is ample, indeed compelling, scjentific evidence that the NRC acted in the best interests of the public when it adopted the current patient release rule. No new evidence to the cont.racy ha,; emerged since the rule was adopted. In fuel, new evidence demonstrates that the rule i!i conservative and amply protects public health nnd safety. ID. THE CURRENT PROVISIONS OF 10 C.F.R. § 35.75 SHotJl,D BE MAINTAINED The NRC engaged in a careful, lengthy and methodical rulemak.ing proceeding before adopting the current patient release criteria in section 35.75. Nothing in the record serves to undcnnine the conclusions reached in that proceeding. A. THE PuBUC IS WELL-PROTECTED BY THE 500 MILLJREM Ruu.:

1. 500 MREM IN PERSPECTIVE In 1996, the Health Physics Society recommended against quantitative estimation of health risk below an individual dose of 5,000 mrem (1.en-fold higher Lhan the 500 rnrem rule) in one year since the risk of heallh effects are either too small to be observed or are none:xisrent. A review by the National Institutes of Heallh in 1998 also concluded that the health risks from low-level radiation cannot be observed above the "noise" of ad.verse evenLS of everyday life. This conclusion was ba.:;ed on studies of h~alth haza:rds after exposures to background radiation, radon

• in homes. medical procedures and occupational radiation in large population samples.

2. THE NRC DEFAULT TABLES AND 'fffR CAsE-SPECIFIC CALCULATlONS ARE CONSERVATIVE IN EmMATING THmD PARTIES' ExPosuRE To nssist licensees in implementing the dose-based rule, the NRC issued Regulatory Guide 8.39. This guide allows licensees to dctennine a releasable dose using two different approaches: 1) use the default tables provided by the NRC, or 2) perform a case-specific dose calculation for each patient or class of patients taking into account biological elimination.

Both the default Lab1es and the case-specific dose calculations are conservative in their estimation of third party exposure. The default tables arc extremely conservaLivc in estimating exposure(j.e., they over-estimate exposure) because they were developed usjng the physical half-life of the radionuclide. but noL the biological half-life of the radiopharmaceutical. The tables were developed assuming that the radionuclide remains in the body until fully decayed and that none of it is cleared through biological processes. Clearly, biological processes accelerate the clearance of radionuclides. The case-specific

11/12/98 THI.:. 13: 21 FAX 415 849 7548 COULTER PHARKACEUTICAL laJ006 Secretary U.S. Nuclear Rcgularory Commission November 12, 1998 PageS calculaLions use the physical and biological half-life of the radjonuclide and therefore are more nppropriate rhan the default tables. A study that was recenlly conducted ar the University of California, San Francisco, measured radiation exposure at various locations in the hospita1 room of 15 thyroid cancer patients who received lodine-13 l.JJ Administered activity doses ranged from 74.8 to 200 mCi. The mean effective half"life oflodine-131 in these individuals was 12 to l 3 houl"S, a fraction of the physical half-life of Iodine-131 (which is 8 days). The patients were confined to their rooIIlS until the dose rate at one meter was at or below 2 mrem/hour. The mean dose measured one meter from the center of the patienL<.' beds was 393 mrem (range 170 to 670 mrem). As patients are unlikely to remain in the same room with an individual 24 hours per day, particularly at such close proximity. these doses arc 1ikely substantially higher than the dose which a Lhird party would receive. In addition, this data demonstrates that exclusion of the biological half-life will resull in a gross overestimation of the dose to an individual who is exposed to a po.dent being created with Iodine-] 31. B. SOCIETY BENEFITS FROM Tim N:KW RUL£

1. BF..NEFITS TO PA TJENTS AND T.HF.JR FAMILIES Early release following treatment improves a patienf s quality of life. The hospital environment reminds the patient and the patient's family of the patient's illness and isolates the patient in an uncomfortable and foreign environment. Early patient release allows earlier reunion and support of families, which benefits patient-. emotionally. In additioo. outpatient care costs

• patients less money than inpatient en.re. Patients who are responsible for various co-pays and percentage of total hospital charges face potentiaJly large bills for services which have no bearing on their treatment. Patients who reside in Agreement States which have not adopted section 35.75 clearly are subjecled to higher cost of care than patients who reside in NRC states. Family members also face the inconvenience and expense of visiting the patient in the hospilal when the patient could be at home.

2. BENEFITS 'l'O HOSPITAL STAFF Earlier release of patient,;; is preferable Lo physicians, Radiation Safety Officers, and other hospital sl.aff because they arc not burdened by inpatients who have been administered radioactive material. Earlier release decrease..,;; demands on physician and staff Lime, including the time it taJces Lo set up and take down an fapa.tieat room. Earlier relea.~e eliminates the burden of training and reminding nursing staff of the precautions of managing an inpatient who has been 31 Tahmnssian AZ, et aL, potential public exposure from thyroid carcinoma patients who have received therapeutic quanLities of Iodine-131. Manuscript in preparation.

1~(12/98 _.THU 13: 22 FAX 415 849 7548 COULTER PHARMACEUTICAL la!007 Secretary U.S. Nuclear Regulatory Commission November 12, 1998 Page6 administered radioactive material. Hospital staff who do not routinely deal with radiation arc concerned about radiation exposure and do not like caring for inpatient~ who have been administered radioactive material. Early release minimizes exposure to ho!.-pital personnel.

3. BENEFITS TO HOSPITALS Ho~itals benefit as well when care can be provided on an outpatient basis. Outpatient treatment decrct1ses time demands on staff. Inpatient room set-up and take down requires up to several hours. This slaff time is non-reimbursable and increases hospital cos Li;. Outpatient treatmenl also eliminates the need to "shuffle and/or allocate inpatient rooms. InpatienL(; need to be isolated and may necessitate that adjoining rooms be kept empty. In the era of managed care, many hospitals have capitated contracts. Outpatient treatment would lead to significant savings for these hospitals.

4. BENEFITS TO THE HEALTH CARE SYSTEM Outpatient treat.mcnt can markedly lower cost~ co the health core system without jeopardizing public health and safety. Outpatient release cno save $1,300 to $3,900 per patient (depending on the number of days a patient would have required. hospitalization). In 1991. the NRC estimated that adoptjon of the current patient release criteria would save an estimated 427,000 hospital day:s nationwide for then-existing procedures.41 Outpatient treatment provides a unique opportunity to save substantial health care resources without in any way diminishing patient care or the public health.

C. TRIPPING OF LAND Fn.L l>ETECl'ORS Is AN lNAlJF.QUATE REASON TO REvlsE T:IIB PATIENT RELF.ASE CRITERIA In soliciting comments on section 35.75, the NRC noled that "there is concern about the recent increase of radiation alarms going off at landftlJs caused by household tra,;h from a released patient." Coulter believes that this ..concern" is unjustified and, in any event, not a valid rei.tSon for the NRC to revise the rule. In essence, the frequency of activating landfill radiation detectors docs noL appear to be related to the patient release criteria of the state in which the landfill is located. In some states which follow the NRC rule, there are few rcpon.i; of alanns; in some states that do not follow the rule, there may be more frequent alarms. Jn summary, the frequency of radiation alarms going off appears to be unrelated to patient release. Rather, the frequency appears to be related to the 41 U.S. Nuclear Regulatory Commission, "Regulatory Analysis on Criterin for the Release of Patients Administered Radioactive Material" (NUREG-1492) at 27.

11/12/98 THU 13:22 FAX 415 849 7548 COULTER PHARllACEUTICAL '4!oos Secretary U.S. Nuclear Regulatory Commission November 12, 1998 Page7 trigger level, sensitivity of the specific detector, and the distance between the detector and the truck. None of these factors are standardized from one landfill to another. IV. THERE IS No LEGAL BASIS TO REVISE SECTION 35.75 Having conducted a lengthy and carefully considered. rulcmaking process to revise section 35.75 in 1997, the NRC cannot now change that rule simply by "soliciting public comment on whether any changes need to be made to the rclea"ie criteria in this rule .* , While Coulter believes that there is no sound scientific or policy bac.is to revise the patient release criteria in section 35.75, it believes that should the Com.mission disagree, a new notice of proposed rulcmaking must be published to pemtlt the public an opportunity to comment In 1970. the District of Columbia. Circuit articulated the standard of action for agencies seeking to change polices: the agency roust take a ..hard look and use reasoned analysis.. when setting or changing policy.5 "An agency changing its course must supply a reasoned analysis indicating that prior policies and standards ure being deliberately changed, and not casually ignored. Greater Boston Television Corp. v. FCC, 444 F. 2d 841,852 (1970) (footnocc omitted), cen. denied. 403 U.S. 923 (1971). The standard requiring "reasoned decision-making." the court observed, bad evolved over the "past forty or fifty years" to ensure that agency decision making would give Lhe public ""confidence in the process as well a.~ the judgments of its decision makers." Id. See also Moror V~hicles Mfrs. A.rs'n v. Stare Farm Mutual, 463 U.S. 29. 41 (1983); Advanced Micro Device.~ v. Civil Aeronautics Bd., 742 F.2d 1520. 1542 (D.C.Cir. 1984) (quoting Grealu Boston. 444 F. 2d at 852).

• When an agency acts Lo "change its mind or alter its policy," the agency must employ "reasoned analysis,., C!:.,-peCially if its actions "reverse" previous policy. Conference of Stale Bank Supervisors v. Office of Thrift Supervision, 792 F. Supp. 837,845 (D.D.C. 1992) (citing Motor Vehiclt's, 463 U.S. at 41). Moreover, when an agency seeks to revoke a rule. its action will be reviewed under the :c;amc standard as applied ro adoption of the rule. Motor Vehicles, 463 U.S at 2865-2866 (revocation of rule is rcviewable under same standard used to adopt rule on theory that rule is presumed prudent once agency has exercised informed judgment to adopt it unless agency explains reasons for rescission).

The "reasoned analysis requirement described in Gremer Bm*ron and Conference of State Bank Sup~rvisors imposes an obligation on agencies to carefully consider and explain Lbe rationale for their policy choices. When changing a rule, an agency should provide "an 51 The term "hard look, which ha.,; evolved to refer to the standard applicable to judicial

    , review of agency actions. originated in this case. See Nanon.al LimeA.ss'n v. EPA, 627 F. 2d 416,451 n.126 (1980).

11/12/98 THU ~~:23 FAX 415 849 7548 COULTER PHARMACEUTICAL raJ 009 Secretary U.S. Nuclear Regulatory Commission November 12, I 998 Page8 explanation for the reversal which is supported by the record and a discussion of what alternatives were considered nnd why they were rejected." Center Jor Sciena in the Public lnte~sr v. Dep't. ofTrt!asury, 797 F. 2d 995. 999 (D.C. Cir. 1986) (citing lntemationul ladies* Garment Workers' Union v. Donovan, 7;?.2F.2d 795, 817-18 (D.C. Cir. 1983)). ln view of the careful and detailed examination which led to the adoption of the patient release criteria contained in Section 35.75, it is difficult, if not impossible,'ro imagine how the Commission could now supply a "reasoned analysis" that reaches a contrary conclusion. V. PATIENT RE.I.EASE CRITERIA SHOULD BE C01',1PATIBil.ITY CATEGORY B When I.he current version of35.75 wa.,;; adopted.in 1997, it was assigned to compatibility category C, and it would remain in that calegory under the current proposal. Coulter believes that the NRC should assign section 35.75 to compatibility category B. When the NRC adopted its current compatibility policy in 1997, it explained the meaning of the different categories. Catcgorjes B and C are described as follows: B. Program Elements wilh Significant Transboundary Implications Toe Commission will limit this category to a small number of program elements (e.g., transportation regulations and sealed source and device rcgistrdl.i.on certificates) t.hnt have significant transboundary implications. Agreement State program elements should be

• essentially identical to those of the Commission.

C. Other Commission Program Elements These are other Commission progr.un clements (e.g .. reciprocity procedures.) that arc important for an Agreement State to have in order to avoid conflicts, duplications, gaps, or other conditions that would jeopardize an orderly pattern in the regulation of agreement material on a nationwide basis. Such Agreement State program elements should embody the essential objective of the corresponding Commission program elements. 62 FED. REG. 46.517, 46525. Coulter believes that placing section 35.75 in category C wai, in error and should be changed. In o.dopting the current version of 35. 75, the Commission made it clear that the rule was being revised to focus on a better measure of radiation protection: I.he total estimated dose equivalent, nu.her than the amount of radioactivity adm.inistercd. Thus, the new rule was intended to improve helilth prolection. Category C designation is jnappropriate for such a health-related issue; the issue is more than the "orderly pattern" of regulation; it certainly should be placed into category Bas having significant *tnmsboundary implications." ff Agreement States

.....! .1112/98 . . THU 13 : 23 FAX 415 849 7548 COULTER PHARMACEUTICAL f4J 010 Secretary U.S. Nuclear Regulatory Commission November 12, 1998 Page9 are to have a different patient release rule than NRC states and different rules among the different agreement states, the easy movement of patients across state lines means that significant transboundaiy implications could occur. In fact, the e:x.istence of different release criteria could cause some exposures that the NRC and the States would seek to minimize. For example, a patient treated as an outpatient with a radiopharmaceutical is more likely to spend time seated next to a stranger on public u-ansportation if the patient must travel to a neighboring state to receive treatment because his or her state requires that treatment be provided on an inpatient basis. Both patients, and medical institutions, would be benefited by a system that does not create disparities based on facility location. VI. CONCLUSIONS For the reasons discussed above, Coulter believes that the patient release criteria adopted by the Commission in 1997 are based on sound science, prudent analysis, and appropriate policy. By eliminating unnecessary hospitalization for some patients who receive radiopharmaceuticals, section 35.75 benefits patients, their families, hosp.itals and their personnel, and the health care system. Accordingly, Coulter believes that the only change which should be made to 35. 7 5 is to move it from compatibility Category C to Category B so that patients. their families, and hospitals and their personnel will benefit from the rule, regardless of the state in which they reside. Respectfully submitted, Virginia K Langmuir, MD Director, Clinical Development UC[>OCS: 137362. I

DOCKE1 TED DOCKETED US. C us ip. . . Texas Radiation Adv~OiQ' ~~ard "98 NOV 12 P4 :14 Jack S. Kroluner. Ph.D. 1100 West 49th Street E,c;ecutive Comm.inee Chair Austin, Texas 7~ c., 1 I o rl'omBumene (512) ~ :Ul~.K. Kin_g, D.V.M . f-{' ** * !Wiilham R. Underdown AOJLI~ A'i!J~Y ~r:ket, P.E. F November 12, 1998 DOCKET NUMBER ;i_ v 3 J.. J- 3J PROPOSED RULE - '/ U.S. Nuclear Regulatory Commission {63FYlL/3S16) Washington, DC 2055-0001 Attention: Rulemakings and Adjudications Staff I am submitting comments on proposed changes to 10 CFR Part 35 which Doctor W. Kim Howard has written in the enclosed letter. The Texas Radiation Advisory Board named a subcommittee of its Medical Committee to review the proposed changes to 10 CFR Part 35. Named to the subcornmittee were W. Kim Howard, M.D., Justin LeVasseur, M.D., and myself, Jack S. Krohrner, Ph.D. Doctor Howard chaired the subcommittee. Doctor LeVasseur and I have reviewed the proposal and Doctor Howard's comments and believe his statements represent our thoughts as well. Although the entire board did not meet to vote on the comments due to time constraints, I would venture to say that the board would whole-heartedly approve the points Doctor Howard made. Over several years, the board has considered the many issues concerning licensing radioactive materials for medical uses and has consistently made recommendations which I believe are very much in keeping with those Doctor Hovvard has vvritten. Especially, I would like to emphasize I agree with Doctor Howard that decreasing the training standards would not be a good idea; I would certainly oppose that action. Thank you for the opportunity to comment. If you have any questions or need further informa1 io~ please let me know. Sincerely, Jack S. Krohmer, Ph.D., Chair Enclosure

                                                             .,, * ,-. ~Ji. ,  I * .,
                                                         ..* '"'     .J* *        ,
,, ,.. ,, rr* r.: ~q nr"'  ~ ... P." ,..'"' 1f,J1;::iSIOf; 1AFF OF T ark Date     ~.J             IJ/17../~J-
      , leceive, L Add'I Copies Ref-               _6_ --:::::0.....----:---

Special Distribution.-LVC6L.:= ,;t....J:__:..;;;..;.;;~ -

"/2..o-f  hscl.., ltl.,,

DOCKETED Texas Radiation Adviso~-'9s '~* oarrl .L t,/ ; N

                                                                           *gs NOV )it    ~

Jack S. Krohmer, Ph.D . 1100 West 49th Street Executive Committee Chair Austin, Texas 78756 Tom Burnette (512) 834-6688 Glen K. King, D.V.M.

                                                                            -r     -                        William R. Underdown OF I

• 1-Jimmy Barker, P.E.

RL; - , ADJL'l. -

                                                                                                   .... 1 November 12. 1998 Po       3'1-ef" 35 U.S. Nuclear Regulatory Commission                                           ( ~3 Fl?J./3Slt)

Washington, DC 2055-0001

• Attention: Rulemakings and Adjudications Staff I am submitting comments on proposed changes to 10 CFR Part 35 which Doctor W. Kim Howard has written in the enclosed letter. The Texas Radiation Advisory Board named a subcommittee of its Medical Committee to review the proposed changes to 10 CFR Part 35. Named to the subcommittee were W. Kim Howard, M.D., Justin LeVasseur, M.D., and myself, Jack S. Krohmer, Ph.D. Doctor Howard chaired the subcommittee. Doctor LeVasseur and I have reviewed the proposal and Doctor Howard's comments and believe his statements represent our thoughts as well.

Although the entire board did not meet to vote on the comments due to time constraints, I would venture to say that the board would whole-heartedly approve the points Doctor Howard made. Over several years, the board has considered the many issues concerning licensing radioactive materials for medical uses and has consistently made recommendations which I believe are very much in keeping with those Doctor Howard has written. Especially, I would like to emphasize I agree with Doctor Howard that decreasing the training standards would not be a good idea; I would certainly oppose that action. Thank you for the opportunity to comment. If you have any questions or need further information, please let me know. Sincerely, A 1 1998 Jack S. Krohmer, Ph.D. , Chair Enclosure

• lJ . UCLEAR REGULATORY COMMISSIO RULEMAKINGS & ADJUDICATIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSION Document Slatislics Postmark Date // / 3 '> 8' * - -~ It J,:) /~ 3 Copies Received /

Add'I Copies Rep,wv'oa,,...A J;, D~ ooon~ ,-1 f ~

 ~~rD/' 72(bs                             _ _

1

                              . . . . . . ._,   I Walter Kim Howard, MD
                                              #2-1 Oak Forest Drive Longview, Texas 75605 November 6. J998 Dr. Jack Krohmer Texas Radiation Advisory Board Bureau <<Radiation Control 1100 W. 4g'l Street Austin. Texas 78756 Dr. Krohmer:

This is a compilation CI some thoughts I bad after reading the NRCs proposed chan~ to the 10 CFR 35 rules and the transcripts CI the March 1998 meeting of the Advisory Committee on the Medical Uses of hotopes.. Please feel free to distnaute these remarb as you deem appropriate. Hopefully they will be ~ some help. I would like to proceed with specific remarks regarding sectioos m. the proposed changes. A Training and Expericoce In the NCR release, it stated that the single issue drawing the most input and comments was that << requirements for training and experience. In the minutes rL the March, 1998 ACMUI meeting it states "Many prmes.uonal societies. as well ~ individual pbysic:ians, MrC concerned that a reduction in training

• • • 'WOUid not provide adequate training" and further stated "One professional society supported the reduction in training houn." This fact alone would suggest that there should be little, if any. change. If the boards <<the ACGMB have alrady adopted required training standards, why should the NRC undercut that authority? Obviously, this is an area mgreat concern and needs to be evaluated closely.

In medicine. we look to multi-center trials with statistical relevant numbers d patients to evaluate the merit of a cban8I' in methodology. The lack rL signific:ant numbem d radiation incidents is data that supports the rmtinuation rL the status quo. Where is thent data that supports a decrease in tr.lining for the use d radiopbannaceut? Many<< the people supporting such a change and most of the individuals \WIiting on the ACMUI are from large urban medical centem with well-established radiation safety progaams and prulUCOIA. Most have physiciats on staff and on site daily. Yet I dare say that most al the medical care in Texas is performed in smaller or mid-sized cities without these built in safeguards. Our institution performs over 120,000 radiographic exams per year, many mwhidt are in the area rl nuclear medicine. ya our pbysiciat is located in Houston, foar hours away and the physicians in charge m the nuclear procedures are primarily diagnostic radiologists and general cardiologists. Nuclear technologists in smaller facilities may be general radiology technologists who are trained on the job. The rules must tab into account not oaly the "ivory tOMn" but also the rural and mid-si7.ed programs that pndominate in this state. In smaller facilities, the rules help to ensure that the nuclear medicine programs are being nm appropriately and safely for the patients and staff'. Nuclear medicine is diffemtt from other areas fl radiation safety because G the aspect rL C)C)Dtamination. Once a radiographic exam is finished and the generator is off, there is no lingering radiation to expose others. In his renwks to the ACMIU in March Clfthis yur. the cardiologist on the committee stated that be didn't need to do wipe tests and other unnecessary procedures to perform his exam because he \\Ollld know not over expose his patient. just aa he did not need someone to explain to him how to safely manipulale a catheter through bis patient's heart. The n:ason radiation safety is so important in nuclear medicine is for the very reason that he missed. The isotopes effect not only the patient on the table. but also the other patients and penormel that subsequently utilize the room. The wipe test is not only to check for evidence Clf accidenlal leabge mthe radiophannaceaucal, but also to prevent contamination m

subsequent patients by residual from an earlier exam. The streu lab in many hospitals also serw.s multiple filllc:ticms such as a pulmonary lab or cmdiac lab for standard ECG exams. Wipe tests and the other rules thaa must be learned by physicians and athcn using the radiopbanmaauticala tq)leaeot our tapOIISl1Jility to protect those other patients and ltaf using the lab. The sar... bafldlin& prepuatioa. and adminiltration t#radiopbann!P'alrti1315 is complex and fmught with oppDl1uDity for mistakes leading to inappupi.a imdiation d. patients as well as other staff. The notion that the technologist is the one who handles the isotopes and should be the one trained the best is a pure denial d iesponsibility. The courts and peer nlYiew organizaticlm view the physician cm the "c:aplain d. the ship.. and, as such. the person with the sole respom,bility for the care d. the patient. Therefole be or she must be the most pi:epcued to handle any problem with the patient or the exam. This includes all aspects d. the exam from the handling, pepa.atiou and actministratioo d. the radiopbarmaceaUtica to the procedure protocols and intmpmalion. and aJI) saequent radiation issues that arise from the use d. these isotopes. That responsibility cannot and should not be relegated to others. That is precisely why training and n,gadation in nuclear medicine- is IllOTe rigorous than in many other areas d. medicine. The complexity rl nuclear medicine procedures is also the reason that adequate training in safety is requind. The NRC appan:udy tried to separaae didactic training and experience for one exam from the entire nuclear medicine training regimen in radiology and came up with a falsely low number mRIQUired

• hours. During a rmclear medicine training program in radiology, each exam performed is used as a training tool to fflCYDluate and reiufoo:e the radiation safety wocepts learned. This additional experience cannot be learned in the weekloog course rl 40 hours recommended by the NRC revision to 10 CPR 35.200, but is vital to the overall education mthe physician.

Pan 35.300 addressed the utilization d. unsealed byprocb:t material for treatment purposes. I cannot state strongly enough how important it is to remember that these are therapeutic doses and the possibility of injury to the patient and others is very real I personally have seen significant bone marrow suppasion after utilization c:L Strontium for bone pain as well as life-threatening ~ edema after I-131 treatment c:L a patient with metmtatic thyroid cancer to the 1~ Whether~ are discussing the treatment d coronary lesions with radioadive seeds on a catheter, prostatic cancer with implanted seeds, or the use<< a gamma knife by a neutOSUJpoll these are puely and simply therapeutic doles intended to destroy tissue. The NRC regulation& should t'fflWliU this fact and require extensive training. Thankfully. the ACMUI did see fit to m:ommend the status quo for the training requirements in parts 35.400 and 35.600 regarding the therapeutic used.sealed sources and devics. I do support the use c:L iodrpmdeol examinations to assist in evaluating the success d required training and I ~ feel that only ACGME m:o&APJS llhould be aJ1owt4 to provide the recmired tr:riaius I have personally seen too many imtances where physicians used an educational program only as an excuse to go skiing or to the lxa:h. If there are to be limited requirements for training then we must be assured that the training is truly rl high quality and only ACGME certified training mold assure that. Additionally. any preceptor shmld be willing to sign the form stating that his trainee has met the basic education rcquiremmts fur thar program Also. while I agree with the idea rl a risk-based approach to the regulations, after reading the minutes cL the March meeting~ the AOdUI, it seemed that the vote oo Sections 35. l and 3.5.2 were handled more as a matter<< expediency and received essentially no di!ICUSSion due to the late time. On day 2 mthat meeting further discumoo was squelched by the idea that the issue hai:l already been voted on and therefore needed no diseussion. I was also somewhat SUJprised by the lack d. a genera.1 diagnostir-radiologist on the board, at least based on what I aJUld gather from the introductions. B. Quality Management Progtam I support the ra:ommendatioos d the NRC.

                                  , _ . . ,.,.. , I              I JU * :.111 * ...,_ ,

C. Reportable Events I support the change of terminology from "misadministration" to ..reportable event... The minor changes in the part 3.5.33 were also appropriate for clarification. D. Precursor Events I support tbe position <<the NRC to not reqain, repnting mprecurs<< ~ E. Radiation Safety Committee The change to delete the requirement ma radiation safety committee does make it much easier for a small facility to eslablish a program adecplte to their needs. The newer requirements for the training of the RSO are somewhat rigid but shoold ensure that an appmpriate individual assumes that role. F'. Notification of Misadministration or Medical Event I agree that reporting problems to the NRC. ordering physician and patient is the most logical and appropriate step to tab. I also feel that t ~ should be some leeway in that if the ordering physician, in amf~ with the RSO, feels the aent notification should be withheld from the patient that may be done without repen:usaion from the NRC. The reasoning behind the withholding cL the incident infonnalion; how8wr, should be DOied in the report to the NRC. G. General I am cooocmed by possible changes to 1OCPR 3S. 7S ~ g the earlier release << individuals containing radiopharmaeuticals or implanted radioactive devices. I strongly urge the status quo to prevent 1mnr.cesmy irradiation of the public, especially children, who may be in the vicinity of these patients. It would be negligent and against the ALARA{As Law AS Feasooably Achievable) principles to allow these people access to the public. I feel confinement in a private room until safe levels are achieved is appropriate and should remain the standard care. u In summary, I cannot support the changes recommended by the NCR as pertains to 10 CPR 3.5.100 and 35.200. There is no valid reason for such a drastic cw in requin,cl training. Even the layperson on the ACMUI committee stated that if such a cut were to be considered it should be done slowly in small stages to see if the safety of the public is being compromised rather than making such a drastic change. For yems v.ie have practiced under the ALARA principle. Dr.mically undercutting the training requirements in no way n::mgni:zes tbat principle but rather tabs a cavalier approach to the whole idea d radiation safety. For the most part. I otherwise agree with the intended changes to the 10 CFR 35 rules with minor exceptions as noted above. Thank you for the opportunity to address these issues. I hope my statements are d some help to the board and the public.

NOV-12-98 THU 12:43 PM MCHV RADIATION ONCOLOGY FAX NO, 802 6562386 @P. 2 DOCKETED The U . US RC. rnvers1ty 01.

                                                                    .p , r.

vermon:t (;9LL~!>~DICINE. DEPAf.lTMENTOFRAl.)IOLOGY "98 Nov 1t. r '- * ~~ ICAL CENTER HOSPITAL OF veRMONT MARY f:LETCHER UNIT IIURLINGTON. VERMONT 0!5~0!5 (802) (j!',6,:,5\)3 or=, RUL r. I* : ,,J-F Secretary, Nuclear Regula~i?y~ohunission DOCKET NUMBER Washington, D.C. 20555-000 l ,OPOSED RULE ;i....o -3 ?-. J.-3S Attention: Rulemakings and Adjudications Staff [63FR.L/3516 Re: Proposed Changes to 10 CFR Part 35 November 12, 1998 Sir/ Madam:

• This is to comment on the proposed regulations of Subpart M. 35.3045 Reports of Medical Events.

The Nuclear Regulatory Commission should not regulate the occurrences that are included in this part. Events that result from poor practice would be covered in primary regulation of utilization of radioactive materials. This would be true, for example, of inadequate survey of the patient following a HDR treatment or improper calibration of a teletherapy unit. Other events that may be treated as medical events are often not clear cut and subject to interpretation. Examples, which result in no consequence to the patient, are movement of the patient during brachytherapy treatment or small variations in blocking during teletherapy treatments. By incorporating these "medical events" in a regulation with strict reporting requirements, the Part provides a means for enforcement in what is truly a medical situation. If the intent is information gathering, as implied in 35.3045 (f), this entire section should not be included in the proposed regulations.

         ,, -    ~~

(__~ ~ ~ . ~ 'rJ )

                            /7   ~Aµd)_      '

Thomas Roland. M.D . Professor and Chief Division of Radiation Oncology

                                                                                          ,,                 9

                ,*' f"'~~,. 1*"'.!,

1 ir1 r ' r, nc:r.;1 IU\TORY COMMISSIOl\1

                           '* 'DICATIONS STAFF
                                ,ECRITAR
                             '\1ISSION "tistics
 ~~1;,c.~~i'.
      ~

re.A. l ----,-

                                        /J 1,~/qc J.}"'-vt...e.,:/1 f:L4:.c..1~

lla-t lis chi &..- G µ,,,Ucu¥ /i,e.J-1 r:l O fL- 1 't2z h 5 _ _ ./ .

0 98 THU 12:45 PM MCHV RA IO O OLOG FAX 0. 802 6562386 P. Fl~tchE:tr DOCKETED US RC Q

                                                                                                    ~

All~n ~ HEALTH CAR;a_ "98 NOV 12 P2 :39 OF;: RLJL ADJL , Secretary, Nuclear Regulatory Commission Washington, D.C. 20555-0001 Attention: Rulemakings and Adjudications Staff Re: Proposed Changes to 10 CFR Part 35 November 11, 1998 Sir/ Madam: As medical physicists in Radiation Oncology, we would like to comment on the following proposed changes to 10 CFR Part 35. 35 .432: Full calibration measurements of brachytherapy sources (2) source positioning accuracy within applicators We feel that this requirement is too vague. Although the overall intent is good, it may be very difficult to quantify the accuracy of source within some . applicators and may indeed be irrelevant if the inaccuracies are small and if the final source position is utilized in the actual dose calculations. (c) a licensee shall make full ..... in accordance with published protocols by nationally recognized bodies There are two concerns with this statement. The protocols that are established may contain items for recommended practice, which were never intended to be adopted as regulation. Secondly, what constitutes a nationally recognized body? There may not be agreement amongst the various p r ofessional organizations, and in that case which recommendation is valid? We recognize that this statement is an attempt to move accepted practice into the regulations in a timely manner. However, without clarification this could lead to great confusion within the licensed community and by the enforcement ann of the NRC. 35.643:Periodic Spot checks .. .. (c), (2) Detennine output (weekly) We do not understand the need to check the output of the HOR on a weekly basis. Teletherapy systems are required to have output checks on a monthly MCMV Cam1nu1 , , Co l che s ter Avenue , Bu rl ington , VT 0540

• 4~9
• 802 656 :l346 I n a lli a nc e with tht. University of VermorLl

 .S. NtJr.1 i::111:l REGULATORY COMMISSION AULEMM' -J .... , & ADJUDICATIONS STAFF OFFICE OF THE SECRETAA OF THE COMMISSION Document Statistics Postmark Date F-a~ I J               /J J.. / %1:

Copies Received __'-_ _ _ _ _ __ Add'I Copies Special *

• NOV-12-98 THU 12:45 PM MCHV RADIATION ONCOLOGY FAX NO. 802 6562386 P. 5 basis. The source geometry of the HDR system is such that unexpected variations in output will not occur. A weekly check of the source positioning accuracy, as required in(C). (1) will also ensure that the output, corrected for decay, is accurate.

35.657: Therapy related computer systems This is much too vague. As stated above, there is a problem with relying on "published protocols from nationally recognized bodies" . Also, what endpoint is acceptable w h en verifying that the treatment planning system is operating "appropriately"? 1 J es H. Go dwin, M.S. Medical Physicist, Fletcher Allen Health Care Associate Professor, Dept. of Radiology, University of Vermont College of Medicine _,/"' fl1ut1llf<l& 1*V1. ]:}-'I,~ Marleen M. Moore, M.S. 1J1S. Medical Physicist, Fletcher Allen Health Care Associate Professor, Dept. of Radiology, University of Vermont College of Medicine

NOV-12-98 THU 12:43 PM MCHV RADIATION ONCOLOGY FAX NO. 802 6562386 P. 1 Coloneatar Ave. Burlington, VT 06401 Fax: 802 858-238e Fletcher Allen Health Care Fax To: Secretary, Nuclear Regulatory Fram: Marleen Moore, M.S Commission Fma 301 4151101 Pagua 6 Phone: Date: 11/12/98 Rec comments on proposed 10 CFR Part35 cc: To follow, please find three letters of comment on proposed 10 CFR Part 35. The originals will be sent by U.S. mail. If this is not acceptable, please contact me at 802 656 3506. Thank you, Marleen Moore

NOV-12-98 THU 12:44 PM MCHV RADIATION ONCOLOGY FAX NO. 802 6562386 P. 3 Fl~tc:h~r DOCK ETE D US, PC Q

                                                                                                               '<:!.:_1/

All~n~ HiiA L T H C A ~

                                                                                         '98 NO v 12 P2 :39 Secretary, Nuclear Regulatory Commission                                    o ;-~,

Washington, D.C. 20555-0001 UL_' I ADJU!_ It ~ .-FF Attention: Rulemakings and Adjudications Staff Re: Proposed Changes to 10 CFR Part 35 DOCKET NUMBER

                                                                                ~ ~FD RULE             2.0 32-(1---35 November 11, 1998                                                (_63FR-~., 5 16)

Sirs: The Radiation Safety Committee of Fletcher Allen Health Care, a teaching hospit.al affiliated with the University of Vermont Medical School, oppose the planned elimination of a mandatoxy Radiation Safety Committee. We feel that in institutions where there are multiple areas of use of radioactive materials a mandated Radiation Safety Committee provides the needed oversight of use. Without such a mandate, the existence of the Committee is subject to elimination whenever costs and time allocation are considered. We feel that this could result in an adverse effect on the radiation safety program. The elimination of many of the very proscriptive requirements of the Committee is acceptable. In keeping with the format proposed in the Part 35 revisions, it should be a function of the institution to develop Policies and Procedures that further define the duties of the RSC.

        ~r.-~

Jonathan Fairbank, M.D. Chair, Fletcher Allen Health Care Radiation Safety Committee 9 MCMV C*mpus 111 Colcriesuu Avenue, eu~llngton , VT 05401

• 1 a!:.li;i , 802 656 :.l:'.l45 In al li an,e wirh the Uni1;1rsity of V erm ont

1, U.S. NUCI !?A R REGULATORY COMMISSIO RULEM K rs & ADJUOICAT!ONS STAFF OH*ICE. Or fHE SECRETARY OF THE COMMISSI Document Statistics Postmark Date F~ul // /!~,!- Copies Received -4.--- -- - - - - Add'I Copies R

OOCKET NUMBER PROPOSED flJLE ~ 3 'L S---35 @ {6:J ,-Yl. LJ JS I 6) DOCKETED 448 Foothill Boulevard USrtR Oakland CA 94606 November 11 , 1998 *98 NQ I 12 P4 :20 Secretary, U. S. Nuclear Regulatory Commission Of~ * . (.

• I Washington, DC 20555-000 l AO,JI I Attention: Rulemaking and Adjudications Staff

Subject:

Proposed Revisions to 10 CFR 35

Dear Sir or Madam:

I am pleased to comment on the proposed revisions to l O CFR 35 published in the Federal Register on August 13 , 1998. I am a medical and health physicist who has been a radiation safety officer at medical facilities holding limited and broad-scope byproduct material licenses from the NRC. l possess a doctorate in nuclear engineering and am certified by the American Board of Radiology in Medical Nuclear Physics and Diagnostic Radiologic Physics. Overall, I support the "risk-informed, performance-based" approach of the proposed regulations. Moreover, I support the reduced prescriptiveness of the proposed regulations. I believe that the reduced prescriptiveness will permit licensees to devise radiation safety programs that successfully limit risk, but with a reduced burden of required activities, thereby increasing the resources available for the medical care of patients. Examples of reductions in prescriptiveness that I support include the removal of the requirement for thyroid bioassays following the administration oflarge activities ofl-131 sodium iodide and the deletion of the requirements in l O CFR 35 regarding radioactive gases and aerosols .

• I am opposed to the proposed deletion of the requirement for a Radiation Safety Committee. I recognize that medical facilities holding licenses of broad-scope would still be required by 10 CFR 33 to maintain a Radiation Safety Committee. However, there are many medical facilities that, despite holding licenses of limited-scope, have complex byproduct material use programs, often including diagnostic nuclear medicine, therapeutic nuclear medicine, biomedical research programs, and perhaps even brachytherapy and human research.

In my experience, management is unlikely to possess the expertise needed to evaluate a radiation safety program without the committee to provide oversight. Medical facility safety and environment of care committees usuall y lack the expertise of a Radiation Safety Committee, whose membership under the current IO CFR 3 5 includes an authorized user for each type of use permitted by the license. Although management is free under the proposed 10 CFR 35 to continue to have a Radiation Safety Committee, management seldom has the experience and understanding of radi ation safety to recognize the value of the Committee and, if the Committee is not required by regulation, management is likely to terminate it in the interest of "streamlining." Furthermore, the regularly-scheduled meetings of the Radiation Safety Committee ensure a continuing dialog between the users, the RSO, and management. I believe that deleting the requirement for the Committee will have a significant detrimental effect on V1 1998 ckn edQed by . . ....._ast1rzea11111111 Ill ew

U.S. NI Jt"'t PD ocr,I11.ATORY COMMISS Al I t:1

• 1; - v ncJvUDICATIONS STAFF OFHl.,E Of= THE SECRETARY OF THE COMMISSION Document Statistics Po.,+"1ark Date t:"'Jt{... (} v--<- ff '

M IA-1 1 1,/11/'11' Co "S Received--"- ' - - -- - - - - /

• Copies Reproduced ____ _ _ __

c. al Distributio1.__,._.L..c.:~=-',,-,...._:..;~ ..,...

Y/..c;-t

radiation safety and therefore I recommend that the current requirement for a Radiation Safety Committee be maintained. I was astonished at the statement in Section 111.A.5. stating, "However, it is important to note that an individual 's status as an authorized user, authorized medical physicist, authorized nuclear pharmacist, or Radiation Safety Officer means that an individual has met the requirements to handle byproduct material safely and is not an assessment of the individual's clinical or professional competency." This statement makes no sense whatsoever regarding the Radiation Safety Officer (RSO). An RSO must do much more than merely "handle byproduct material safely." An RSO must have the "professional competency" to manage a radiation safety program, which requires conducting or ensuring the performance of surveys, inventories, equipment testing, inventories, training, monitoring of personnel doses, various reviews, et cetera. I have major objections to the proposed qualifications for the Radiation Safety Officer (RSO) contained in the proposed 10 CFR 35.50. My first concern is regarding the "one size fits all" nature of this section. At a small nuclear medicine clinic, where the RSO is usually an authorized user physician, these requirements are certainly adequate. At the other end of the spectrum, a medical facility with more than one licensed modality and perhaps a research program and even research involving human subjects, the RSO should be a professional. In this case, a graduate degree in physics, health physics, or a related technical field should be required in addition to the other requirements. l am not sure how or even whether the proposed regulations can be modified to deal with this issue. I suspect that this issue of acceptable qualifications for an RSO for a particular program should be dealt with as a licensing issue in addition to regulatory requirements. If so, sufficient flexibility should be build into the regulations to permit a license reviewer to place ad ditional restrictions on RSO qualifications for a more complex byproduct material use program. I recommend that the NRC be required to, before approving a specialty board (10 CFR 35 .50 (a)) or a testing organization or entity (10 CFR 35 .50 (b)(3)), publish a notification of the request for approval in the Federal Register and solicit and consider comments, similar to the rulemaking process. I believe that it would be useful to clarify the training and experience requirements for physicians who perform research on human subjects using radioactive material. The majority of such research is performed at institutions holding Type A licenses of broad scope~ at these institutions, the radiation safety committee reviews the training and experience of prospective authorized users. However, sometimes such research is performed by limited-scope licensees and, in the past, there has been confusion regarding the training and experience required of such authorized users. A hypothetical example would be a case in which an endocrinologist wishes to administer tracer-levels of a carbon- I 4-labeled radi ochemical to human subjects to study a biochemical pathway in accordance with 10 CFR 35 .6. Is this investigator required to comply with the requirements of the proposed 10 CFR 35 .290, which was written to apply to common nuclear medicine non-imaging diagnostic studies?

I wish to suggest two modifications to the proposed 10 CFR 35 .60. (I) The detectors on most dose calibrators designed for assaying photon-emitting radionuclides are ionization chambers. For these machines, there is no reason that the accuracy test must be conducted with a source whose primary photon energy is less than 500 keV. For such dose calibrators, a calibrated source of cesium-13 7 (principal gamma ray energy of 662 ke V) is suitable. I suggest that 10 CFR 35.60 (b)(c) be rewritten to state, "Accuracy tests must be performed with source(s) with a principal photon energy greater than 100 keV whose activity is traceable . .. " (2) I recommend that you delete the requirement in proposed IO CFR 35.60 (b) (I) requiring a test for geometry dependence following repair. Current IO CFR 35.50 (c) requires only "appropriate checks and tests following adjustment or repair." For ion-chamber-based dose calibrators, I cannot think of a repair that would affect geometry effects without also affecting accuracy and linearity. Neither ANSI N42. l 3- I 986 nor NCRP Report No. 99 recommends geometry tests after repair. 10 CFR 35.49, under both the current and proposed regulations, has the effect of prohibiting medical facilities holding specific licenses of limited scope from participating in certain manufacturer-sponsored trials of medical devices conducted under U.S. Food and Drug Administration (FDA) approved Investigative Device Exemptions (IDEs). (Most medical facilities holding licenses of broad scope are exempted by license condition from the provisions of 10 CFR 35.49.) To me, it makes no sense that several broad-scope medical facilities may participate in a manufacturer-sponsored trial conducted under an IDE and yet a limited-scope licensee is prohibited by this regulation from participation in the same device trial. The effect of this regulation is to hinder the development of some medical devices. I recommend that 10 CFR 35.49 be modified to permit the participation of limited-scope licensees in multi-site manufacturer-sponsored medical device trials conducted under FDA-approved IDEs. Thank you for the opportunity to comment on the proposed regulations. Should you have any questions regarding these comments, please do not hesitate to contact me at (415) 744-6243 . Sincerel y yours, Edwin M. Leidholdt, Jr., Ph.D.

DOCKET NUMBE SM PROPOSED RULE (b3rFfl DOCKETED William A. VanDecker, M.D. U , 'P"' 3300 Henry Avenue Philadelphia, PA 19129 Assistant Professor of Medicine 215-842-6991 Associate Director 215-849-0547 Fax Non-Invasive Cardiovascular Imaging ALLEGHENY *98 NO 12 p4 :15 UNIVERSITY HOSPITALS MCP 0 November 1-,' 1998 LJ1,,,,.* 1,. Secretary U.S. Nuclear Regulatory Commission One White Flint North 11 555 Rockville Pike Rockville, MD 20852 Attn: Rule-Making and Adjudications Staff

Dear Sir/ Madam:

I thank you for the opportunity to submit comments on the proposed revision of regulations governing the medical use of byproduct materials (1 OCFR.35) . I submit these personal views as an individual. My background for these comments is as a clinician/scientist/educator at MCP/Hahnemann School of Medicine in Phi ladelphia , Pennsylvania. I have been Director of Nuclear Cardiology at The Med ical College of Pennsylvania Hospital since 1 989. I am a board certified cardiologist and certified by the Certification Council of Nuc lear Cardiology (CCNC). I have also served as Chairman of t h e Unive rsity Radiation Safety Committee at our School of Medicine for the past six years where I have interacted with many authorized users of many different modalities. I see the proposed medical policy statement as well-formulated. An era of interactive cooperation between the NRC and the professional medical societies will lead to improved health care delivery. I believe that the approach to radiation safety regulation based on risk and performance is extremely well founded. Diagnostic nuclear medicine w ith over twelve million procedures per year has a proven record of safety for decades and presen t s minimal risk to patients, staff, and the general public with the use of low dose radioact ive tracers. Diagnostic nuclear cardiology, a large percentage of nuclear medicine , is performed by more cardiologists than other specialists. The cardiology commun ity has done a very good job of creating structured educational programs in radiation safety consisting of both didactic training and supervised practical experience. I see no difference in our cardiology trainees in nuclear cardiology and the trainees from other specialties involved in nuc lear medicine in our institution in regards rad iation safety. This strong commitment to radiation safety by the cardiology community has been a key component in achieving the outstanding safety record of diagnostic nuc lear card iology . Allegheny Health, Education and Research Foundation Allegheny General Hospital

• Allegheny Integrated Health Group
• Allegheny University of the Health Sciences Allegheny University Hospitals
• Allegheny University Medical Centers
• St. Christopher's Hospital for Children

l'lill"' r * ,~ qcr-11LATORY COM~.A!S , lN JD vATI TA~F

                )F THE SECRETAR t-tE COMMISSION

U.S. Nuclear Regulatory Commission Page 2 As physicians, we realize there is no procedure that is 100% risk-free and no degree of regulation will guarantee zero risk (both due to human error and the nature of medical uncertainty). However, the benefits of medical isotope use are immense and it should be our goal to seek ways to competitively enhance the safe use of tracers for improved patient care. Nuclear cardiology services dramatically improve cardiac diagnosis safely (even in the geriatric population), allow for sharp prognostication , provide for more appropriate utili zation of diagnostic cardiac c ath eterization, and are vital in establishing appropriate revascularization strategies. As a medical school educator in the fie ld of nuclear cardiology, I fully support and agree with the proposed revision to 1 0CFR.35.292 to change the formal radiation safety training for physicians using radioisotopes for diagnostic imaging purposes to 120 hours (80 hours didactic and 40 hours practical). I beli eve this change reflects the low risk and safe nature of diagnostic isotopes. I believe it is very reasonable to expect a user of ionizing radiation to answer some radiation safety questions (focused on 10CFR, part 20). I strongly believe that these radiation safety questions can be administered through already existing examinations. This will save the added cost and travel and administration of yet another examination. I believe that Appendix A of the proposed rule will help identify appropriate examinations. Most importantly, I believe that it is a major step forward by removing "Dean's status" from the rule and plac ing acceptable certifying exams into the regulatory guidance. "A level playing field" is vital to high quality patient care delivery . I am reminded of an excerpt by Robert Pitofsky of the Federal Trade Commission in a speech of Fe bruary 13, 1997. " A vital function of { .... regulation ... } in the operation of health care markets is to keep markets open and competitive, so that new ways of delivering and financing health care services can compete for acceptance by purchasers." I would strongly support NRC approval of the test offered by the Certification Council of Nuclear Cardiology (CCNC). This exam meets the criteria outlined in proposed Appendix A . Currently, 19% of its questions deal with radiopharmaceuticals, radiation safety, and physics instrumentation. It is rap idl y becoming the standard clinical certifying examination in this area of knowledge. I also believe that remodeling needs to be accomplished of the Training and Experience Documentation forms in Append ix G. The term "clock hours" should only refer to the 80/40 required hours of training by t he rule. Related radiation exam scores should probably read "name of approved ra di atio n safety test passed" and scores should be reported only pass/fall. Point number 6 on " Formal Training" almost certainly relates to therapy. I believe there should be separate forms for diagnostic documentation versus therapy documentation to keep the approach risk-based. NRC form 313B once again asks for "clock hours" of specific isotope use whi ch is not a proposed requirement of the rule. The safety experience for diagnostic isotopes is similar and should be able to be extrapolated to all isotopes in 35.200.

U.S. Nuclear Regulatory Commission Page 3 I agree with allowing management a spectrum of options in the implementation of radiation safety programs. A small hospital with few modalities may not need the overhead of a Radiation Safety Committee but a large operation with many modalities should probab ly opt for a committee. I also believe it is important for an authorized user to be able to serve as a radiation safety officer for the modality in which they have training. This is especially important in the setting of a small private practice. Than k you for the opportunity to submit these comments . I look forward to a continued progressive time line for the completion of this important task . Sincerely, W illi am Van Decker, M.D . Assistant Professor of Medicine Associate Director, Non-Invasive Cardiac Imaging Director, Heart Station WVD:bas

OOCKET NUMBER

                                                                   . l()SED RULE             ;J...O) 3 ~ >-- 35 Tulane University Medical C                                             {_ 6 J ,:. '(l, '-/3 5 I 6J SCHOOL OF MEDICINE Department of Radiology SL54 1430 Tulane Avenue New Orleans, Louisiana 70112-2699 (504) 587-7567                                    '98 NOV 12 P4 :Q4 (504) 587-7616 FAX                                                 10 November 1998 Cat~y Haney, Chairperson of the Part 35 Worldrl.~~Bfoup ,~-

Mall Stop T8F5 ADJLf U.S. Nuclear Regulatory Commission

• Washington, DC 20555-0001 Dr. Haney:

Enclosed please fi nd eight separate comments on the proposed revision of 10 CFR Part 35, "Medical Uses of Byproduct Material", Proposed Rules. I think this format of separate comments is less cumbersome than my obvious alternative - a lengthy letter containing comments on all eight areas. For your reference I am enclosing comments concerning the following sections:

1) Subpart B, section 35.20 ALARA program

2) Subpart B, section 35.22 Radiation Safety Committee

3) Subpart C, section 35.60 Possession, use, calibration and check of dose calibrators

4) Subpart C, section 35.70 Surveys for contamination & ambient radiation exposure rate

5) Subpart D, section 35.120 Possession of survey instruments ,

Subpart D, section 35.220 Possession of survey instruments & Subpart E, section 35.320 Possession of survey instruments

6) Subpart D, section 35.205 Control of aerosols and gases

7) Subpart E, section 35.315 Safety precautions (a) (4) and(a) (7)

8) Subpart L, section 35.2063 Records of dosage measurement Sincerely, rl, T:!;);:D.,

A. DABR

                                                    ~~ted Medical Nuclear Physicist cc:     Michael Yester, Ph.D., Chairman of AAPM Nuclear Medicine Committee Chuck Kelsey, Ph.D., Chairman of AAPM Radiation Protection Committee Richard Lane, Ph.D., Chairman of AAPM Legislation & Regulation Committee ENC 99

U.S. NUCLEAR REGULATORY COMMISSION RULFMAKING.., & ADJUDICATIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmark Date ~ _, _ o_/--'1J-

                               =------

Copies Received I Add'I Copies Rer ~ Special Distribu

• Han.e..1 If ~7 Ylt:Jt- b re. h. l~--J. G,~ , ~ A.cry J?. 0 12--1-flr.IJ:f- _ _

Tulane University Medical Center SCHOOL OF MEDICINE Department of Radiology SL54 1430 Tulane Avenue New Orleans, Louisiana 70112 -2699 (504 ) 587-7567 (504) 587-7616 FAX 10 November 1998 Cathy Haney, Chairperson of the Part 35 Working Group Mail Stop T8F5 U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 Dr. Haney: I would like to comment on a portion of the proposed revision of 10 CFR Part 35, "Medical Uses of Byproduct Material" Proposed Rules. Specifically, I refer you to a section to be removed in its entirety: Part 35, subpart B, section 35.20 ALARA program (attachment). I would state first that the ALARA programs with which I have been involved have functioned quite well in keeping the licensee's attention focused on users who are receiving the highest radiation exposures. The cost in time and paperwork to comply with ALARA regulations has not been excessive. Through these programs, management, radiation safety personnel and higher risk users are forced to analyze their use of byproduct materials and to search for ways to keep radiation exposures low. Given that the true risk of low level radiation exposures is unknown (I would cite here the numerous NCRP and BEIR reports on this question) and that the effects of such damage may be passed on to future generations, it would seem still prudent to attempt to keep radiation exposures as low as reasonable achievable. No recent scientific report that I am aware of has revised the estimate of low level radiation risk downward. To remove an existing regulation, which so obviously protects employee safety and speaks to the heart of the stated purpose of Part 35, would seem entirely unjustified. It is unclear to me what purpose would be served by removing all ALARA regulations. Keeping this regulation in Part 35 is appropriate; regulations in Part 20 are not specific enough on this point. Thank you for your time in reading and in responding to my letter. As always I appreciate your office's efforts to ensure the safe medical use of byproduct material - a goal we share in common. Sincerely, k7 s A. Terry,~.p., DABR fied Medical Nuclear Physicist ENC

(c) The licensee shall mail the documents required in this section to the appropriate address identified in Sec. 30.6 of this chapter. Sec. 35.15 Exemptions regarding Type A specific licenses of broad scope. A licensee possessing a Type A specific license of broad scope for meclica1 use is exempt from-- (a ) The provisions of Sec. 35.13(b); (b) The provisions of Sec. 35.13( e) regarding additions to or changes in the areas of use only at the addresses specified in the license; (c) The provisions of Sec. 35.14(a); (d) The provisions of Sec. 35.14(b) (1) for an authorized user, an authorized nuclear pharmacist, or an authorized meclica1 physicist; and (e ) The provisions of Sec. 35. 49(a). Sec. 35.18 License issuance. (a ) The Commission shall issue a license for the meclica1 use of byproduct material if-- (1) The applicant has filed Form NRC-313 Application for Materials License in accordance with the instructions in Sec. 35.12; (2) The applicant has paid any applicable fee as provided in part 170 of this chapter; (3) The Commission finds the applicant equipped and committed to observe the safety standards established by the Commission in this chapter for the protection of the public health and safety; and ( 4 ) The applicant meets the requirements of part 30 of this chapter. (b) The Commission shall issue a license for mobile services if the applicant: (1) Meets the requirements in paragraph (a) of this section; and (2) Assures that individuals or human research subjects to whom radiopharmaceuticals or radiation from implants will be administered may be released following treatment in accordance with Sec. 35.75 . Sec. 35.19 Specific exemptions. The Commission may, upon application of any interested person or upon its own initiative, grant such exemptions from the regulations in this part as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest. Subpart B--General Administrative Requirements

                                                     ~              /,7~ e/4%L 1 Sec. 35.24 program.

Authority and responsibilities for the radiation protection (a) In addition to the radiation protection program requirements of

                                                                            -  I Sec. 20.1101 of this chapter, a licensee's management must approve in writing--

(!) Requests for license application, renewal, or amendments before submittal to the Commission;

Tulane University Medical Center SCHOOL OF MEDICINE Department of Radiology SL54 1430 Tulane Avenue New Orleans, Lou isiana 70112-2699 (504) 587-7567 (504) 587 -7616 FAX 10 November 1998 Cathy Haney, Chairperson of the Part 35 Working Group Mail Stop T8F5 U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 Dr. Haney: I would like to comment on a portion of the proposed revision of 10 CFR Part 35, "Medical Uses of Byproduct Material" Proposed Rules. Specifically, I refer you to a section to be removed in its entirety: Part 35, subpart B, section 35.22 Radiation Safety Committee (attachment). In my opinion, the requirement of a Radiation Safety Committee (RSC) should not be removed for medical institution licenses. It would not be advisable to replace the RSC with only two people: the RSO and the CEO (or his/her designee). While the RSO and management may have the loudest voices on such a committee, they should not be the only voices - many people are affected by changes in radiation material licensees and their varied perspectives should be taken into account - officially. Also, while a single individual may hesitate to confront an irresponsible, powerful authorized user or CEO, a group is likely to be somewhat bolder in its actions. Further, to remove the record of debates and votes concerning radiation safety, does not serve the public good and strikes at the stated purpose of Part 35. Such RSC records should be maintained and be available to regulators whose job it is to protect the public. Had such committees and their records uniformly existed in earlier years, some of the abuses of the "medical use" of byproduct material (that have recently come to light) might never have occurred. One change that might be acceptable is that the frequency of RSC meetings might be lessened at some medical institution licenses. However, it would be inadvisable to eliminate RSCs entirely. Thank you for your time in reading and in responding to my letter. As always I appreciate your office's efforts to ensure the safe medical use of byproduct material - a goal we share in common. Sincerely, dti!;~ t{eJ;,h.D., DABR Certified Medical Nuclear Physicist ENC

(c) The licensee shall mail the documents required in this section to the appropriate address identified in Sec. 30.6 of this chapter. Sec. 35.15 Exemptions regarding Type A specific licenses of broad scope. A licensee possessing a Type A specific license of broad scope for medical use is exempt from-- (a ) The provisions of Sec. 35.13(b); (b) The provisions of Sec. 35.13(e) regarding additions to or changes in the areas of use only at the addresses specified in the license; (c) The provisions of Sec. 35.14(a); (d) The provisions of Sec. 35.14(b) (1 ) for an authorized user, an authorized nuclear pharmacist, or an autho rized medical physicist; and (e) The provisions of Sec. 35.49(a). Sec. 35.18 License issuance. (a) The Commission shall issue a license for the medical use of byproduct material if-- (1) The applicant has filed Form NRC-313 Application for Materials License in accordance with the instructions in Sec. 35.12; (2) The applicant has paid any applicable fee as provided in part 170 of this chapter; (3) The Commission finds the applicant equipped and committed to observe the safety standards established by the Commission in this chapter for the protection of the public health and safety; and ( 4 ) The applicant meets the requirements of part 30 of this chapter. (b) The Commission shall issue a license for mobile services if the applicant: (1) Meets the requirements in paragraph (a) of this section; and (2) Assures that individuals or human research subjects to whom radiopharmaceuticals or radiation from implants will be administered may be released following treatment in accordance with Sec. 35.75. Sec. 35.19 Specific exemptions. The Commission may, upon application of any interested person or upon its own initiative , grant such exemp tions from the regulations in this part as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest. Subpart B--General Administrative Requirements

                                                       ~ ,o,_)              H.lL l L     ~e/4/4,;

Sec. 35.24 program. Authority and responsibili t ies for the radiation protection (a) In addition to the radiation protection program requirements of

                                                                              -  I Sec. 20.1101 of this chapter, a licensee's management must approve in writing--

(1) Requests for license application, renewal, or amendments before submittal to the Commission;

Tulane University Medical Center SCHOOL OF MEDICINE Department of Radiology SL54 1430 Tulane Avenue New Orleans, Louisiana 70112 -2699 (504 ) 587 -7567 (504) 587 -7616 FAX 10 November 1998 Cathy Haney, Chairperson of the Part 35 Working Group Mail Stop T8F5 U.S. Nuclear Regulatory Commission Washing ton, DC 20555-0001 Dr. Haney: I would like to comment on a portion of the proposed revision of 10 CFR Part 35, "Medical Uses of Byproduct Material" Proposed Rules. Specifically, I refer you to Part 35, subpart C, section 35.60 Possession, use, calibration and check of dose calibrators (attachment). Exempting licensees from the employment of dose calibrators to confirm patient dosages, would seem ill-advised at best. Admittedly mistakes by the radiopharmacies may be rare, but they are not entirely absent. True, there is some increased cost of time to make such measurements, but given the choice I don't know a single patient who would not like to know that the radiation dosage about to be injected into (inhaled by or otherwise administered to) them has been double-checked. I ask you one simple question: if your daughter or son was about to have a nuclear medicine study - would you want someone to have double-checked the dose? Beyond the argument that such diagnostic doses are of minor risk (we believe the risk to be low, but we really don't know the exact risk and we really don't know the extent of long term effects), there is the question of public perception. Hospitals and clinics who routinely use dose calibrators and make the recommended safety checks would suffer a backlash against the use of nuclear medicine procedures if some "low-budget" clinic was publicly revealed to have failed to catch an injection of the wrong dose or wrong radiopharmaceutical. In essence, this requirement needs to be maintained to keep the playing field level so that all licensees are held accountable

• for double-checking isotope dosages. Any greedy CEO too cheap to buy a dose calibrator doesn't need to be doing nuclear medicine imaging.

The stated purpose of Part 35 to protect the public would not be served by removing the requirement for all licensees to use dose calibrators. If the NRC actually proposes to so modify Part 35, I doubt that public watchdog groups, nuclear activists or members of the press will be generous in their praise for the NRC's "reducing the amount of regulations", and I would add that any public fight over this will only serve to hurt the medical licensees currently regulated by NRC. Thank you for your time in reading and in responding to my letter. As always I appreciate your office's efforts to ensure the safe medical use of byproduct material - a goal we share in common. S~ely, ~ tf-3i 7~;.A. MTe Cert1f1ed

                                                                            , Ph.D., DABR ical Nuclear Physicist ENC

an organization or entity approved by the Commission in accordance with appendix A of this part. Sec. 35. 5 7 Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized user, and nuclear pharmacist. (a ) An individual identified as a Radiation Safety Officer, a teletherapy or medical physicist, or a nuclear pharmacist on a Commission or Agreement State license before [date--6 months from p ubl ication of the Final Rule] need not comply with the training requirements of Secs. 35.50 and 35.51, respectively. (b) Physicians, dentists, or podiatrists identified as authorized users for the ((Page 4 3561 ] ] medical, dental, or pediatric use of byproduct material on a Commission or Agreement State license issued before [date--6 months from publication of the Final Rule] who perform only those medical uses for which they were authorized on that date need not comply with the training requirements of subparts C through H. Sec. 35.59 Recentness of training. The training and experience specified in subparts B, D, E, F, G, H, and J must have been obtained within the 7 years preceding the date of application or the individual must have had related continuing education and experience since the required training and experience was completed. Subpart C--General Technical Requirements /;:;; ..;i ~ Possession, use, calibration, and check of instruments to activity of photon-emitting radionuclides. (a) For other than unit dosa9!;.s, a licensee shall possess and use instrumentation to measure the activity of photon-emitting radionuclides prior to administration to each patient or human research subject. (b) If a licensee uses instrumentation to measure the activity of dosages of photon-emitting radionuclides, including unit dosages, it shall develop, implement, and maintain written procedures for proper operation of the instrumentation. At a minimum, a licensee shall-- (1) Perform tests, before initial use and following repair, on each instrument for accuracy, linearity, and geometry dependence; (2) Perform an accuracy test annually; (3) Perform a linearity test annually over the range of medical use; and (4) Check each instrument !or constancy and proper operation at the beginning of each day of use. (c) Accuracy tests must be performed with source(s) with a principal photon energy of between 100 and 500 keV whose activity is traceable to the National Institute of Standards and Technology (NIST) or by a supplier who has compared the source to a source that was calibrated by NIST.

(d) A licensee shall mathematically correct dosage readings for any geometry or linearity error that exceeds 10 percent if the dosage is greater than 1,11 MBq (30 <greek-m>Ci) and shall repair or replace the instrumentation if the accuracy or constancy error exceeds 10 percent. (e) A licensee shall retain a record of each check and test required by this section in accordance with Sec. 35.2060. Sec. 35.61 Calibration and check of survey instruments. (a) A licensee shall calibrate the survey instruments used to show compliance with this part and 10 CFR part 20 before first use, annually, and following repair. A licensee shall-- (1) Calibrate all scales with readings up to 10 msv (1000 mrem) per hour with a radiation source; (2) Calibrate two separated readings on each scale that will be used to show compliance with this part; and (3) Conspicuously note on the instrument the date of calibration. (b) A licensee shall consider a poi nt as calibrated if the indicated exposure rate differs from the calculated exposure rate by not more than 20 percent, and conspicuously attach a correction chart or graph to the instrument if the indicat ed exposure rate differs from the calculated exposure rate by more than 10 percent. (c) Survey instruments must be removed from use if the indicated exposure rate differs from the calculated exposure rate by more than 20 percent. (d) A licensee shall retain a record of each survey instrument calibration in accordance with Sec. 35.2061. Sec. 35.62 Possession, use, calibration, and check of instruments to measure dosages of alpha- or beta-emitting radionuclides. (a) For other than unit dosages, a licensee shall possess and use instrumentation to measure the radioactivity of alpha- or beta-emitting radionuclides. A licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha-or beta-emitting radionuclides prior to administration to each patient or h uma n research subject. (b) A licensee shall develop, impleme nt, and maintain written procedures for use of the instrumentation. At a minimum, a licensee shall-- (1) Perform tests before initial use, and following repair, on each instrument for accuracy, linearity, and geometry dependence, unless it is not appropriate for the use of the instrument; and make adjustments when necessary; (2) Perform accuracy annually; (3) Perform linearity tests annually over the range of medical use; and (4) Check each instrument for constancy and proper operation at the beginning of each day of use. (c) Accuracy tests must be performed with source(s) that are traceable to NIST or by a supplier who has compared the source to a source that was calibrated by NIST. (d) A licensee shall retain a record of each check and test required by this section in accordance with Sec. 35.2060. Sec. 35.63 Determination of dosages of unsealed byproduct material for

Tulane University Medical Center SCHOOL OF MEDICINE Department of Radiology SL54 1430 Tulane Avenue New Orleans, Louisiana 70112-2699 (504) 587-7567 (504) 587-7616 FAX 10 November 1998 Cathy Haney, Chairperson of the Part 35 Working Group Mail Stop T8F5 U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 Dr. Haney: I would like to comment on a portion of the proposed revision of 10 CFR Part 35, "Medical Uses of Byproduct Material" Proposed Rules. Specifically, I refer you to a section to be removed in its entirety: Part 35, subpart C, section 35.70 Surveys for contamination and ambient radiation exposure rate (attachment). In my opinion, it would be unwise to remove the requirement of daily/weekly surveys and contamination checks. It is not that unusual to find occasional areas of contamination in busy nuclear medicine departments. Obviously, from a radiation safety point of view, it is desirable to be aware of and clean up (or otherwise contain) these spills/contaminations. Contamination can also interfere with imaging if, inadvertently, the nuclear medicine patient (or technologist or equipment) becomes contaminated externally. Of course, additional time and effort is required to perform these daily/weekly tasks, but it is minimal and not without purpose. No employee desires to be exposed to any more radiation than is necessary to perform his/her job. No patient desires to be exposed to any more radiation than is necessary to complete his/her imaging study. Not surveying for contamination means accepting the fact that some radioactive contamination will occur and may be carried to areas outside of the sites specifically authorized for its containment. Public access to hospital/clinic areas where radioisotopes are used is controlled, and the public has some reasonable expectation that those areas will be free of external radioactive contamination. Unless licensees are willing to post signs in these areas indicating that "small amounts of detectable radioactive contamination may be present on floors, walls, tables, beds, etc." I would think it prudent to perform these minimal safety checks at the currently required frequency. Certainly, some hospitals and clinics would continue to perform these checks, but others would not if not required to do so. Would you want to know if the imaging study that is being performed on your daughter might be invalid due to a small amount of contamination left by yesterday's bone scan study? Would it bother you if you touched a "slightly contaminated" area and then picked up your small son? Should we expect public reaction to be restrained if it is revealed that a small amount of "radioactive substances" leave controlled areas so that our technologists can leave work 5 minutes early or so that a large hospital corporation can save 5 minutes of employee time on the clock each day? If a backlash against the use of nuclear medicine occurs because of a few minor "contamination" incidents it won't really matter that no one was killed with this small amount of radiation - instead patients may refuse needed studies or come to mistrust doctors or hospitals a little more. Both the public and the nuclear medicine community could be tangibly harmed due to the irresponsible actions of a few greedy or short-sited individuals.

Tulane University Medical Center SCHOOL OF MEDICINE Department of Radiology SL54 1430 Tulane Avenue New Orleans, Louisiana 70112-2699 (504) 587-7567 (504) 587-7616 FAX Any licensee unwilling to perform these minimal safety checks for the protection of the public/employees and to minimize contamination imaging artifacts for patient studies does not need to be performing medical imaging in the first place. I am not sure why the NRC would want to remove the requirement for daily/weekly surveys and contamination checks. I do not understand how this would serve to protect the public, the stated purpose of Part 35. Thank you for your time in reading and in responding to my letter. As always I appreciate your office's efforts to ensure the safe medical use of byproduct material - a goal we share in common. Sincerely, Ja s Te;, 2.. A. DABR ertified Medical Nuclear Physicist ENC

(e) If the leakage test reveals the p resence of 185 Bq (0,005 <greek-m>Ci) or more of removable contami nation, the licensee shall-- (1) Immediately withdraw the sealed source from use and store, dispose, or cause it to be repaired in accordance with the requirements in parts 20 and 30 of this chapter; and (2) File a report within 5 days of the leakage test in accordance with Sec. 35.3067. (f) A licensee need not perform a leakage test on the following sources: (1) Sources containing only byproduct material with a half-life of less than 30 days; (2) Sources containing only byproduct material as a gas; (3) Sources containing 3.7 MBq (100 <greek-m>Ci) or less of beta or gamma-emitting material or 0,37 MBq (10 <greek-m>Ci) or less of alpha-emitting material; (4) Sources stored for less than a 10-year period and not being used. The licensee shall, however, test each such source for leakage before any use or transfer unless it has been leakage-tested within 6 months before the date of use or transfer; and (5) Seeds of iridium-192 encased in nylon ribbon. (g) A licensee in possession of sealed sources or brachytherapy sources, except for gamma stereotactic radiosurgery sources, shall conduct a semi-annual physical inventory of all such sources in its possession. The licensee shall retain each inventory record in accordance with Sec. 35.2067. Sec. 35.69 Labeling and shielding of vials and syringes. (a) A licensee shall develop, implement, and maintain written procedures for-- (1) Labeling each syringe, syringe shield, or vial shield that contains a radiopharmaceutical to identif y the radiopharmaceutical name, or its abbreviation, and to ensure that the contents are conspicuously identified as containing radioactive material; and (2) Shielding vials and syringes containing radiopharmaceuticals. (b) A licensee shall instruct individuals, commensurate with the individual's assigned duties, in the procedures required by paragraph (a) of this section. Sec. 35.70 Surveys for ambient radiation exposure rate. (a) Except as provided in paragraph (b) of this section, a licensee shall survey with a radiation detection survey instrument at the end of each day of use all areas where radiopharmaceutjcals r e q u i r i n g ~ ~ written directive were reared for use or administered. -t/ icensee does not need to per orm e surveys required by paragraph (a) of this section in an area(s) where patients or human research subjects can not be released pursuant to Sec. 35.75. (c) A licensee shall retain a record of each survey in accordance with Sec. 35.2070. Sec. 35.75 Release of individuals containing radiopharmaceuticals or implants. (a) A licensee may authorize the re l ease from its control of any individual who has been administered radiopharmaceuticals or implants containing radioactive material if the total effective dose equivalent

Tulane University Medical Center SCHOOL OF MEDICINE Department of Radiology SL54 1430 Tulane Avenue New Orleans, Louisiana 70112-2699 (504) 587-7567 (504) 587-7616 FAX 10 November 1998 Cathy Haney, Chairperson of the Part 35 Working Group Mail Stop T8F5 U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 Dr. Haney: I would like to comment on a portion of the proposed revision of 10 CFR Part 35, "Medical Uses of Byproduct Material" Proposed Rules. Specifically, I refer you to Part 35, subpart D, sections 35.120 Possession of survey instruments, 35.220 Possession of survey instruments and subpart E, 35.320 Possession of survey instruments (attachment). The requirement of possessing survey meters with specific, minimum response ranges for use with unsealed byproduct material is not an unreasonable one. As equipment goes, good survey meters are not overly expensive, do not quickly become obsolete and, if properly maintained, can be used for many years. Radiation safety concerns would dictate that there be some way of monitoring potential radioactive contamination or the presence of unwanted radioactive sources that might inteifere with localization, uptake, dilution, excretion or imaging studies. In keeping with the stated purpose of Part 35 - to protect the public - I can find no logical purpose in removing the requirement of survey meter possession in medical clinics/hospitals. Keeping this regulation in Part 35 is appropriate; regulations in Part 20 are not specific enough on this point. Thank you for your time in reading and in responding to my letter. As always I appreciate your office's efforts to ensure the safe medical use of byproduct material - a goal we share in common. Sincerely, 2;,s A Te:, 2. DABR Certified Medical Nuclear Physicist ENC

ordinary trash if it-- (1) Monitors byproduct material at th e surface before disposal as ordinary trash and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its mos t sensitive scale and with no interposed shielding; and (2) Removes or obliterates all radiation labels; (b) A licensee shall retain a record of each disposal permitted under paragraph (a) of this section in accordance with Sec. 35.2092 . [ [Page 43563] J Subpart D--Unsealed Byproduct Material--Low Dose Sec. 35.100 Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required. A licensee may use for uptake, dilution, or excretion studies any unsealed byproduct material, except in quantities that require a written directive pursuant to Sec. 35.40, prepared for medical use that is either-- (a ) Obtained from a manufacturer or preparer licensed pursuant to Sec. 32.72 of this chapter or equivalent Agreement State requirements; or (b) Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in Sec. 35.292, or an individual under the supervision of either as specified in Sec. 35.27. Sec. 35 . 200 Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required. A licensee may use for imaging and locali za tion studies any unsealed byproduct material, except in quantities that require a written directive pursuant to Sec. 35.40, prepared for medical use that is either-- (a ) Obtained from a manufacturer or p reparer licensed pursuant to Sec. 32.72 of this chapter or equivalent Agreement State requirements; or (b) Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in Sec. 35.292, or an individual under the supervision of either as specified in Sec. 35.27. Sec. 35.204 Permissible molybdenum-99 concentration. (a) A licensee may not administer to humans a radiopharmaceutical containing more than 5.55 kBq (0.15 <greek-m>Ci) of molybdenum-99 per millicurie of technetium-99m. (b) A licensee that uses molybdenum-99/technetium-99m generators for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99 concentration of the first eluate after receipt of a generator to demonstrate compliance with paragraph (a) of this section. (c) A licensee that must measure molybdenum concentration shall retain a record of each measurement in accordance with Sec. 35.2204.

In addition to the requirements of Sec. 19.12 of this chapter, (a) A licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects that have received radiopharmaceutical therapy and can not be released in accordance with Sec. 35.75. To satisfy this requirement, the instruction must be commensurate with the duties of the personnel and include-- (1) Patient or human research subject control; (2) Visitor control, including-- (i) Routine visitation to hospitalized individuals in accordance with Sec. 20.1301( a ) (1) of this chapter; and (ii) Visitation authorized in accordance with Sec. 20.1301(a) (3); (3) Contamination control; (4) Waste control; and (5) Notification of the authorized user and the Radiation Safety Officer, or his designee , if the patient or the human research subject dies or has a medical emergency. (b) A licensee shall retain a record of individuals receiving instruction in accordance with Sec. 35.2310. 1-:--------- ~ S ~ S a f e t y precautions. (a) For each patient or human research subject that cannot be released in accordance with Sec. 35.75, a licensee shall-- (1) Provide a private room with a private sanitary facility; (2) Visibly post the patient's or the human research subject ' s room with a ' ' Radioactive Materials sign and note on the door or in the patient's or human research subject's chart where and how long visitors may stay in the patient's or the human research subject's room; and (3) Either monitor material and items removed from the patient's or the human research subject ' s room to determine that their radioactivity cannot be distinguished from the natural background radiation level with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding, or handle such material and items as radioactive waste. (b) A licensee shall notify the authorized user and the Radiation Safety Officer, or his or her designee, as soon as possible, if the patient or human research subject has a medical emergency and, immediately, if the patient dies. Sec. 35.390 Training for use of unsealed byproduct material for therapy or for use of unsealed byproduct material that requires a written directive . Except as provided in Sec. 35.57, the licensee shall require the authorized user of a radiopharmaceutical for the uses authorized under Sec. 35.300 to be a physician who-- (a) Is certified by a medical specia l ty board whose certification process includes all of the requirements in paragraph (b) of this section and whose certification has been approved by the Commission; or (bl (1) Has completed a structured educational program in basic radionuclide handling techniques applicable to the use of unsealed byproduct material consisting of both-- (i) 80 hours of didactic training in the following areas-- (A) Radiation physics and instrumentation; (B) Radiation protection;

Tulane University Medical Center SCHOOL OF MEDICINE Department of Radiology SL54 1430 Tulane Avenue New Orleans, Lou1s1ana 70112-2699 (504) 587-7567 (504) 587-7616 FAX 10 November 1998 Cathy Haney, Chairperson of the Part 35 Working Group Mail Stop T8F5 U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 Dr. Haney: I would like to comment on a portion of the proposed revision of 10 CFR Part 35, "Medical Uses of Byproduct Material" Proposed Rules. Specifically, I refer you to Part 35, subpart D, section 35.205 Control of aerosols and gases (attachment). The requirement of maintaining an environment where radioactive aerosols and gases can be controlled should be retained. Though the chances of large radiation leaks are small, the capacity to control the spread of radioactive gases is a reasonable burden for licensees who chose to utilize these types of byproduct materials. Where radioactive gas studies are performed, there will necessarily be some small loss of the radioactive material into the surrounding air. The requirement of having a negative pressure environment ensures that we have a measure of control over where escaping radioactive gases go. Should the public become aware, after a well-publicized accidental radioactive gas release, that the NRC removed these safety controls - I would expect a strong reaction from watchdog groups, nuclear activists and members of the press (since the NRC has been given the task of regulating the safe medical use of byproduct material). Certainly, everyone in the nuclear medicine community would serve to lose if this were to occur. Further, if the NRC does not retain this regulation, the EPA would likely create another in its place. Indeed the EPA has already taken steps in this direction. I would prefer to see the NRC continue to administer this use of byproduct materials, given its years of experience with the specific isotopes and with the types of licensees ordering these gases. Thank you for your time in reading and in responding to my letter. As always I appreciate your office's efforts to ensure the safe medical use of byproduct material - a goal we share in common. Sincerely, Lp-A. Te: 2., DABR

                                                     ~~1li~d Medical Nuclear Physicist ENC

ordinary trash if it-- (1) Monitors byproduct material at the surface before disposal as ordinary trash and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding; and (2) Removes or obliterates all radiation labels; (b) A licensee shall retain a record of each disposal permitted under paragraph (a) of this section in accordance with Sec. 35.2092. [ [Page 43563)) Subpart D--Unsealed Byproduct Material--Low Dose Sec. 35.100 Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required. A licensee may use for uptake, dilution, or excretion studies any unsealed byproduct material, except in quantities that require a written directive pursuant to Sec. 35.40, prepared for medical use that is either-- (a) Obtained from a manufacturer or preparer licensed pursuant to Sec. 32.72 of this chapter or equivalent Agreement State requirements; or (b) Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in Sec. 35.292, or an individual under the supervision of either as specified in Sec. 35.27. Sec. 35.200 Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required. A licensee may use for imaging and localization studies any unsealed byproduct material, except in quantities that require a written directive pursuant to Sec. 35.40, prepared for medical use that is either-- (a) Obtained from a manufacturer or preparer licensed pursuant to Sec. 32.72 of this chapter or equivalent Agreement State requirements; or (b) Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in Sec. 35.292, or an individual under the supervision of either as specified in Sec. 35.27. Sec. 35.204 Permissible molybdenurn-99 concentration. (a) A licensee may not administer to humans a radiopharmaceutical containing more than 5.55 kBq (0.15 <greek-m>Ci) of molybdenum-99 per rnillicurie of technetium-99m. r;:_,.--~ (b) A licensee that uses molybdenum-99/technetium-99m generators for preparing a technetiurn-99m radiopharrnaceutical shall measure the molybdenurn-99 concentration of the first eluate after receipt of a generator to demonstrate compliance with paragraph (a) of this section. (c) A licensee that must measure molybdenum concentration shall Oe /;,1-.e; retain a record of each measurement in accordance with Sec . 35 . 22 04. I,'-~. ~~

                                                                -  :'?'        -
                                                                  ~ 5S-,2-oS/

Tulane University Medical Center SCHOOL OF MEDICINE Department of Radiology SL54 1430 Tulane Avenue New Orleans, Louisiana 70112-2699 (504) 587 -7567 (504) 587-7616 FAX 10 November 1998 Cathy Haney, Chairperson of the Part 35 Working Group Mail Stop T8F5 U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 Dr. Haney: I would like to comment on a portion of the proposed revision of 10 CFR Part 35, "Medical Uses of Byproduct Material" Proposed Rules. Specifically, I refer you to two clauses to be removed in their entirety - in Part 35, subpart E, section 35.315 Safety precautions (a) (4) (attachment) which states: "Promptly after administration of the dosage, measure the dose rates in contiguous restricted and unrestricted areas with a radiation measurement survey instrument to demonstrate compliance with the requirements of part 20 of this chapter, and retain for three years a record of each survey that includes the time and date of each survey, a plan of the area or list of points surveyed, the measured dose rate at several points expressed in millirem per hour, the instrument used to make the survey, and the initials of the individual who made the survey." and section 35.315 Safety precautions (a) (7) which states: "Survey the patient's or the human research subject's room and private sanitary facility for removable contamination with a radiation detection survey instrument before assigning another patient or human research subject to the room. The room must not be reassigned until removable contamination is less than 200 disintegrations per minute per 100 square centimeters." Removal of the requirement to perform a radiation survey following a therapeutic administration of I-131 would be ill-advised. The survey is a quantifiable measure of the specific external radiation risk presented by a specific patient. This measurement is used to determine the amount of time (at a prescribed distance) during which visitors and staff can safely be present in the patient's vicinity. Since the record of the prescribed visitation time is recorded on the patient's door, it is not unreasonable to retain the record of the survey meter's measurements which are used in determining this time limit. This burden is not excessive. Likewise, removal of the requirement to perform a careful radiation contamination room survey should not be removed. Patients who will occupy the room following a therapeutic treatment have a right to expect a radioactive contamination-free area. While the specific contamination levels, might be raised, they should certainly not be eliminated altogether. Keeping this regulation in Part 35 is appropriate; regulations in Part 20 are not specific enough on this point. Thank you for your time in reading and in responding to my letter. As always I appreciate your office's efforts to ensure the safe medical use of byproduct material - a goal we share in common. Sincerely,  ?,._,~ es . Terry, Ph.D., R ertified Medical Nu ar Physicist ENC

In addition to the requirements of Sec. 19.12 of this chapter, (a) A licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects that have received radiopharmaceutical therapy and can not be released in accordance with Sec. 35.75. To satisfy this requirement, the instruction must be commensurate with the duties of the personnel and include-- (1) Patient or human research subject control; (2) Visitor control, including-- (!) Routine visitation to hospitalized individuals in accordance with Sec. 20.130l(a) (1) of this chapter; and (ii) Visitation authorized in accordance with Sec. 20.130l(a) (3); (3) Contamination control; (4 ) Waste control; and (5) Notification of the authorized user and the Radiation Safety Officer , or his designee, if the patient or the human research subject dies or has a medical emergency. (b) A licensee shall retain a record of individuals receiving instruction in accordance with Sec. 35.2310 .

• 1:----=---

 ~ ~ 1 s / s a f e t y precautions.

(a) For each patient or human research subject that cannot be released in accordance with Sec. 35.75, a licensee shall-- (1) Provide a private room with a private sanitary facility; (2) Visibly post the patient's or the human research subject's room with a Radioactive Materials sign and note on the door or in the patient's or human research subject's chart where and how long visitors may stay in the patient's or the human research subject's room; and (3) Either monitor material and items removed from the patient's or the human research subject's room to determine that their radioactivity cannot be distinguished from the natural background radiation level with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding, or handle such material and items as radioactive waste. (b) A licensee shall notify the authorized user and the Radiation Safety Officer, or his or her designee, as soon as possible, if the patient or human research subject has a medical emergency and, immediately, if the patient dies. Sec. 35.390 Training for use of unsealed byproduct material for therapy or for use of unsealed byproduct material that requires a written directive. Except as provided in Sec. 35.57, the licensee shall require the authorized user of a radiopharmaceutical for the uses authorized under Sec. 35.300 to be a physician who-- (a) Is certified by a medical specialty board whose certification process includes all of the requirements in paragraph (b) of this section and whose certification has been approved by the Commission; or (b) (1) Has completed a structured educational program in basic radionuclide handling techniques applicable to the use of unsealed byproduct material consisting of both-- (i) 80 hours of didactic training in the following areas-- (A) Radiation physics and instrumentation; (B) Radiation protection;

r ' Tulane University Medical Center SCHOOL OF MEDICINE Department of Radiology SL54 1430 Tulane Avenue New Orleans, Louisiana 70112-2699 (504) 587 -7567 (504) 587 -7616 FAX 10 November 1998 Cathy Haney, Chairperson of the Part 35 Working Group Mail Stop T8F5 U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 Dr. Haney: I would like to comment on a portion of the proposed revision of 10 CFR Part 35, "Medical Uses of Byproduct Material" Proposed Rules. Specifically, I refer you to Part 35, subpart L, section 35.2063 Records of dosage measurement (attachment). The requirement of maintaining a record of the expiration date of a radiopharmaceutical is not an unreasonable one; the paperwork burden is quite minimal. Many industries label products with expiration dates. The criteria used to establish an expiration date varies, as you might imagine, with the nature of the product. The radiopharmacy's reasons for setting an expiration date/time can include time limits on: sterility, dosages (taking into account radioactive decay), the effectiveness of radiopharmaceutical tagging, and the acceptable relative proportion of undesired radionuclides (due to different half-lives). I believe that retaining the expiration date/time as a part of the dosage record serves to underscore its importance. In most cases this expiration date is automatically included in the dose record either on a printed record of the dose or on the computer record. Removal of this requirement will not serve to appreciably (or even noticeably) lighten record keeping requirements. In keeping with the stated purpose of Part 35 - to protect the public - I can find no logical purpose in removing this requirement. Thank you for your time in reading and in responding to my letter. As always I appreciate your office's efforts to ensure the safe medical use of byproduct material - a goal we share in common. Sincerely, a ::::.i.

                                                           ~~fi~ Medical Nuclear Physicist DABR ENC

test, and the results of the test, and t h e name of the individual who performed the test; (c) For linearity, the model and serial number of the instrument, the calculated activities, the measured activities, and the date of the test, and the name of the individual who performed the test; and (d) For geometric dependence, the model and serial number of the instrument, the configuration of the source measured, the activity measured for each volume measured, and the date of the test, and the name of the individual who performed the test. Sec. 35.2061 Records of radiation survey instrument calibrations. A licensee shall maintain a record of radiation survey instrument calibrations required by Sec. 35.61 for 3 years. The record must include-- (a) A description of the calibration procedure; and (b) The date of the calibration, a description of the source used and the certified exposure rates from the source, and the rates indicated by the instrument being calibrated, the correction factors deduced from the calibration data, and the name of the individual who performed the calibration. Sec. 35.2063 Records of dosages of unsealed byproduct material for medica use. (a) A licensee shall maintain a record of dosage determinations required by Sec. 35.63 for 3 years. (b) To satisfy this requirement, the record must contain the-- (1) Radionuclide, generic name, trade name, or abbreviation of the radiopharmaceutical, and its lot number; (2) Patient's or human research subject's name, or identification number if one has been assigned; (3) Prescribed dosage and activity of the dosage at the time of determination, or a notation that the total activity is less than 1.1 MBq (30 <greek-m>Ci); (4) Date and time of the dosage determination; and (5) Name of the individual who determined the dosage. Sec. 35.2067 Records of possession of sealed sources and brachytherapy sources. (a) A licensee shall retain records of leak tests required by Sec. 35.67(b) for 3 years. The records must contain the model number, and serial number if one has been assigned, of each source tested, the identity of each source radionuclide and its estimated activity , the measured activity of each test sample, a description of the method used to measure each test sample, the date of t he test, and the name of the individual who performed the test. (b) A licensee shall retain records of the semi-annual physical inventory of sealed sources and brachytherapy sources required by Sec. 35.67(g) for 3 years. The inventory records must contain the model number of each source, and serial number if one has been assigned, the identity of each source radionuclide and its nominal activity, the location of each source, and the name of the individual who performed the inventory.

DOCKET NUMBER PROPOSED RULE '--eJJ 3 2 t1-JS UN I VE R S I TY O F CALIFO R NIA ( ~ 3 F 'f< t..J 3 SI 6) OCCKE1ED US}RC BERKELEY

• DAVIS
• IRVINE
• LOS ANGELES
• RIVERSIDE
• SAN DIEGO
• SAN FRANCISCO SANTA BARBARA
• SANTACRUZ

                                                                                                                 '98         NOV 12 P4 :17 OFFICE OF THE SENIOR VICE PRESIDENT -

BUSINESS AND FINANCE OFFICE OF THE PRESIDENT Environmental Protection ~,c~s_ m nn*- l I 111 Franklin Street, 61b Fl5o Oakland, California 94607- , (L r:, 1 Fax (510) 987-0752 u - ' November 10, 1998 Secretary U.S. Nuclear Regulatory Commission Washington, D. C. 20555-0001 Attention: Rulemakings and Adjudications Staff Re: Federal Register: August 13, 1998 (Volume 63, Number 156).

Title:

Medical Use of Byproduct Material~ Proposed Revision Action: Proposed rule.

Dear Sir:

• The following comments are in response to the Commission's solicitation for public comments on the proposed revision to 10 CFR Part 35. This letter augments the verbal comments the University of California made during the NRC Medical Rule Making Workshop held August 19 and 20, 1998, in San Francisco, and reflect input from medical, technical, and administrative staff throughout the University. The comments presented are under these broad categories:

A. General Issues B. Specific Issues Identified for Public Comment by the Commission C. Comments on Other Specific Issues A. General Issues The proposed regulatory changes seem to be a restating of the old regulatory framework with what appear to be minor changes. The overall specifics of Part 3 5 have not changed, nor have they been streamlined to ease the burden on the licensees. NOV 1 7 1998 Acknowtedoed by card ....----- .... -

 '!',. * ,. ,..... - ~ n p.-"' 11 I\Tr,nv ,..,., i* l!SSI IAFF Dncur'l     Statistics te _ // / _   11_/ _Cf ~

o ---

                     't;i
                              - I - -- - - -

., ... ..ii* s Heptuur v"'"' -"" - - - - , - - -

&t?.1nbution Spe                         l-t4:~e:!1~'?

s<-h , l~-r. [,!:z_ ;;)J~~~ -1'?. IJIL.7 ILLJJ- r

U. S. Nuclear Regulatory Commission November 10, 1998 Page2 The NRC staff described the new approach taken by the Commission as a move from a detailed and prescribed regulatory environment to a more "risk informed" criteria, yet there is no real definition of what "risk informed" is. It appears to be a purely subjective criteria defined on a case-by-case basis by the NRC staff. The Commission further describes the overall goal as one that is intended to focus the regulation on those medical procedures that pose the highest risk to workers, patients, and the public. The new regulations, however, do not eliminate any of the previous regulatory burdens, nor do they remove the focus from the low risk operations. There is ample data for the Commission to conduct a real risk assessment and to develop the new regulatory framework based on objective risk analysis criteria. In general, there seems to be a consensus that diagnostic nuclear medicine procedures are low risk activities, yet the new regulations do not account for this. As an example, Section 35.100 regulates uses of unsealed materials for uptake, dilution, and excretion studies. By any standard, this is an extremely low risk operation, at times using kits sold under a general license, yet the Commission retains the same regulatory control it has always had. If the new regulations were truly developed on a real risk-based criteria, then the licensees would be able to conduct their activities with a greater degree of freedom while utilizing cost-effective radiation protection measures. The Commission and the nuclear medicine and radiation protection community all share the common goal of providing the immense benefit of radioactive materials in medicine, while minimizing the potential harmful effects to the public. No individual working in the field, while dedicated to benefiting the sick, has a desire to participate in activities which will cause harm to themselves or the public at large. Therefore, it is crucial that the licensees be able to develop their own radiation protection practices such that: They are appropriate for the specific institutional uses conditions. They are appropriate for the level of risk that is relevant to their activities and is cost-effective. They have the freedom to modify the procedures as needed, without the need for license amendments, to reflect the changes in their practices.

• It will lead to better radiation protection of the workers, the public, and the environment.

It should be stated that the ALARA philosophy strongly advocates that the principles descnbed above be taken into consideration. An effective radiation protection program is not based on how thick the written procedures are but on how well the staff practices the basics of radiation protection in their daily activities. Therefore, a non-prescriptive regulatory framework must look beyond the past practices of detailed written procedures, step-by-step requirements, and other documentation protocols which must be followed precisely. It should rather advocate a thoughtful program, one which is dynamic and can be changed as needed to provide the best protection possible.

U. S. Nuclear Regulatory Commission November 10, 1998 Page3 The Commission expresses its desire to move toward a performance-based regulatory environment. To achieve this goal, it must define its basic standards of radiation protection and allow the licensees to develop their programs internally so that they can achieve the standards set. During the course of a day, there is a need to adjust practices to meet the needs of each patient. This may require deviation from practices employed for the previous patient. For example, an old patient might be more difficult to inject than a younger one. In this case, the use of a cumbersome syringe shield may be a hindrance, and, therefore, the requirement for such devices is not justified. Imagine if surgeons were asked to develop such detailed operative procedures, where any deviation from patient to patient would be a violation! To this end, there are a number of areas of concern which the Commission must address clearly to ensure the full implementation of a truly new regulatory philosophy that is performance-based.

1) The new draft, "Consolidated Guidance about Materials Licenses", NUREG -15 56, Vol.

9, is a well-developed guidance and resource document. However, it is extremely important that this be adopted as a "guide" and that the license reviewers be instructed to treat it as such. The licensees must not be asked, as in the past, to either commit to following the "guide" or submit alternate procedures. It should simply be a guide for those who need advice.

2) Most modem equipment has manufacturer-recommended quality control testing which is superior to certain procedures in the guide, which may be obsolete.

3) NRC form 313, included in Appendix B of NUREG - 15 56, Vol. 9, is supposedly intended to eliminate the previous requirement for detailed procedures. However, Item 10, Radiation Protection Program", amplifies the concerns regarding the Commission's continued request for prescriptive procedure. Draft NUREG-1556, Vol. 9, page 78, requires the licensee to submit information on the proposed radiation protection program to minimally include the following items (as applicable):

• Audit Program
• Leak Tests
• Operating and Emergency Procedures
• Material Receipt and Accountability
• Area Surveys
• Occupational Dose
• Public Dose
• Transportation
• Minimization of Contamination
• Mobile Nuclear Medicine
• Procedures for Administrations Requiring WDs

U. S. Nuclear Regulatory Commission November 10, 1998 Page4 This appears a simple shifting of commitments from the previous format of a checklist to submitting the information as a text. It is not a change in philosophy as discussed during the San Francisco workshop (August 19-20, 1998) nor is it compatiole with the written documents distributed by the Commission. It is business as usual: provide details as part of the license application and be held to it as part of the license. Deviations are either violations or need pre-approval (prescriptive rather than performance-based criteria). The only shift is that now the licensee has to define the prescriptive details which will be used. The Commission must move away from this degree of prescriptive licensing in "action" as well as in words. The Commission must define the criteria, such as maximum permissible occupational doses, acceptable contamination levels, and waste disposal criteria, and allow the licensee to develop their own criteria internally to achieve the prescribed goals. To continue asking for a detailed procedural submittal defeats the entire process defined even in the "risk informed" approach. The implementation of safe and sound radiation safety procedures is the ultimate goal of both the Commission and licensees; the means should be left to the institutional experts to develop internally for each institution. The licensee's compliance can easily be determined by regular NRC inspections, with the inspectors observing the operations and reviewing records, such as personnel exposure data, for confirmation of sound radiation protection practices. Of course, this will require trained and experienced medical inspectors who are capable of making such judgments in the field. If a licensee fails to meet the criteria set by the NRC, then the NRC could require that the licensee submit specific procedures as how they will ensure compliance.

4) Over the years, the licensing procedure has developed into its current prescriptive format to accommodate the needs of the NRC inspectors to develop simple checklist. This fact has been expressed by many license reviewers over the years. This issue appears to be the primary reason for requiring the detailed procedures in the license application. This can be easily remedied if the Commission would establish the following simple criteria:

• All inspectors reviewing Medical Licensees" at the minimum are qualified to be named as a Radiation Safety Officer for a similar institution.
• All inspectors reviewing medical programs have a working knowledge of current nuclear medicine practices.

Furthermore, since the risks of diagnostic nuclear medicine procedures are so small, based on well-documented history of at least 35 years with virtually no morbidity or mortality, the requirement for traditional type inspections appears totally unjustified by the risk level. It would be far more appropriate for the NRC to allow each diagnostic site to have the option of satisfying all inspection requirements via any on-site program sponsored by one of the recognized

U. S. Nuclear Regulatory Commission November 10, 1998 Page 5 professional organizations (e.g., ACNP, SNM, ACR). This would provide both radiation safety review and quality of practice review by qualified individuals and spare the NRC the requirement of retraining all inspectors. In summary, the draft regulations and the documents published by the Commission for comment are no different than those previously published. They are not eliminating any burdens from the licensees. They continue to:

• request detailed prescriptive procedures.
• regulate every aspect of the medical uses ofbyproduct materials.
• offer no relief to the licensees from unnecessary regulations .
• ignore many of the recommendations of the Institute of Medicine report.

One final note should be made regarding the comment period. The volume of material distnbuted for review and comment is over 900 pages. This, combined with the fact that the last public forum was held October 21-22, 1998 (90 days from the date of publishing), is not an adequate time period and should be expanded if the Commission is really interested in public participation and a true partnership . B. Specific Issues Identified for Public Comment by the Commission

1) Training and Experience Given the great public fear and overreaction to any potential or perceived radiation risk (despite the low actual risk of diagnostic nuclear medicine procedures), it is imperative that the NRC continue to restrict the medical use of byproduct material to those who have demonstrated the knowledge and experience that assures .appropriate, competent, and safe use in human subjects.

Physicians authorized to utilize byproduct radioisotopes for diagnostic procedures should have the ability to respond appropriately to the wide variety of possible radiation spills and emergencies that are possible in such a practice. Furthermore, they should have knowledge of the principles of radiation safety and ALARA as well as familiarity with appropriate regulations. In the past, NRC satisfied this need via recognition of appropriate ACGME Board Certification as evidence of adequate individual knowledge, experience, and performance under direct faculty observation. NRC also provided a short-cut pathway by establishing a training and experience requirement for specified hours in selected didactic subjects and a specified number of clinical hours of personal experience. These shortened requirements too often allowed authorization of individuals with poor clinical skills who also lacked the in-depth knowledge and experience to exercise appropriate judgment to assure radiation safety. Ignorance about basic principles of diagnostic nuclear medicine and radiation safety is commonplace among those practicing

U. S. Nuclear Regulatory Commission November 10, 1998 Page6 diagnostic nuclear medicine part-time. This fact is widely recognized throughout the diagnostic imaging profession.' The reason there have not been more severe problems is due to the inherent low risk of diagnostic nuclear medicine. The proposed plan to eliminate the authorization based on Board Certification and to markedly decrease the required hours of didactic training and clinical experience needed for the "short-cut" route of approval is likely to create a glut of even more poorly trained users and may possibly create frequent problems that might be perceived as significant radiation safety issues by the media and the public, despite the inherent low radiation risks of this activity. The NRC should get out of the business of assuming it can define the training and experience needed for assuring safe and appropriate use in humans by eliminating all "short-cut" pathways based on arbitrary hours in uncontrolled training environments. The NRC should delegate this decision to the ACGME Residency Review Committees and the appropriate Certifying Boards. The curriculum requirements of every training program are public information available in published format from the ACGME. Board Certification in those Residency Training programs that specify in writing that didactic training and clinical experience in diagnostic and therapeutic uses of radioisotopes and radiation safety should be utilized for NRC authorization for human use. The American Board of Nuclear Medicine Certification requires completion of all published program didactic and clinical requirements and assurance of practical clinical and radiation safety competence by the Residency Program Director before a resident candidate is allowed to take the written certifying examination. The published requirements in Nuclear Medicine and Radiation Oncology exceed any specific NRC training and experience requirements. Any other medical specialty that desires to provide its resident trainees with this route to NRC authorization need only change the formal requirements for training to include these topics and experience in the published Residency Review Program Requirements Document. When the published documents meet NRC requirements, then physicians certified by those specialty boards should be automatically granted authorization for the human use of byproduct material.

2) Section 35.2 It is important to define the term "medium dose-rate remote afterloader". Although the regulatory requirement of"high" and "medium" dose-rate remote afterloaders are very similar, the real radiation safety precautions are different and thus require a unique definition.

3) Section 35,6 It is not clear what the Commission is asking. The Commission should allow the current practice to continue without the need for additional requirements. It is not clear over what the Commission wants to extend its jurisdiction. The FDA regulates research and the Institutional Review Boards are responsible for review of such protocols. Existing regulations and guidelines for this practice provide adequate oversight, and there is no need for the Commission to add another layer of unnecessary burden.

U. S. Nuclear Regulatory Commission November 10, 1998 Page7

4) Section 35,24 No. The Radiation Safety Committee is perhaps one of the most effective committees at most institutions. It provides:

• A valuable forum with expertise from all aspects of the licensee's operations.
• For interaction among all levels of users and administration.
• An effective forum to develop and mandate the implementation of policies and procedures.
• A peer review forum for research protocols as they pertain to radiation safety practices.
• An excellent forum for enforcement actions against infractions of radiation safety practices.

The proposal to eliminate the RSC is not a good idea. The RSO often lacks the full expertise to provide all the necessary advice. The elimination of the RSC will, in the great majority of institutions, result in the degradation of the radiation safety program and its effectiveness. The requirement for RSC should remain in place with exemptions for institutions involved in 35.100 and 35.200. The RSC requirement for quarterly meetings should be eliminated and replaced by "as needed". This will allow for institutions to adjust the frequency of their RSC meetings to their own needs.

5) Section 35,75 No changes should be made. Regulatory Guide 8.39 provides ample guidance on the release criteria. The Commission should also consider expanding its protocol to allow for review and approval of patient release criteria for new therapeutic procedures. This will be especially valuable for new treatment regiments with new radionuclides, for which smaller licensees may not have the nece*ssary experience for development ofthe criteria. Under this procedure, the manufacturer would submit its proposal for review and approval. The licensees would then follow the approved protocol or develop their own equivalents.

There are a number of studies in which the potential radiation doses to family members of patients undergoing 1311 were issued film badges or TLD dosimeters. The results of these studies indicate that no member of the family received a dose in excess of0.5 mSv (500 mrem) [ Harbert J.C. and Wells N., Radiation exposure to the family members of radioactive patents. JNucl Med 15:887-888]. In addition, a recent study at UCSF indicated that individuals exposed to patients undergoing thyroid carcinoma with 1311 did not receive doses in excess of0.5 mSv [Ara Tahmassian, Ph.D., Robert J. Lull, MD, David C. Price, MD, Mark S. How, MSc., Vmcent Dentamaro, B.Sc., University of California San Francisco, paper under preparation for publication]. The studies have also shown that the use of Regulatory Guide 8.39 formulae will overestimate the dose to an individual by up to 75%, which provides an ample margin of safety.

U. S. Nuclear Regulatory Commission November 10, 1998 Page 8 The Commission has already addressed the issue of contamination from such patients in its initial rulemaking and accurately indicated that this is not an area of concern. In summary, there is ample evidence that when patients are released using the criteria set in Regulatory Guide 8.39, the total effective dose equivalent to an individual exposed to patients who have been administered radioactive materials will not exceed the 0.5 mSv (500 mrem) limits specified in 10 CFR Part 35.75.

6) Section 35.92 The proposed rule to allow decay in storage for byproduct material with a physical half-life ofless than 120 days should be implemented. This will reduce the space burden on licensees and provide for cost savings. The requirement to hold byproduct material for a minimum often half-lives should be deleted. Paragraph (a)(2) in current Section 35.92 is adequate.

7) Section 35.315 The provision for a private room should be eliminated. If the licensee can demonstrate that a second patient in the same room will not receive more than 5 millisievert (0.5 rem) from the other patient (pursuant to Section 35.75), then there is no need to impose a private room, or sanitary facility, requirement, although if both patients were undergoing 1-131 therapy, then the potential total effective dose equivalent from one patient to the other will be under 600 mrem during their stay in the same room. This is an insignificant dose, compared with what the patient receives as part of his treatment.

8) Section 35.415 The provision for private room should be deleted. Same discussion as above applies. In addition, 35.415(b) is again contrary to the philosophy being advocated by the Commission on being non-prescriptive. There is no need to list what is required for an emergency pack; the licensee must have the freedom to put what is necessary.

9) No comments.

10) No comments.

11) No comments.

12) Subpart L Yes, the record keeping requirements should be grouped into one subpart for easy reference.

U. S. Nuclear Regulatory Commission November 10, 1998 Page9

13) Subpart M Yes, once the need for all reporting has been determined, then the requirement should be grouped into one subpart for easy reference.

14) Section 35.3045 While the dose threshold provision would make this more tolerable than the current system, this entire process of data collection and NRC-mandated notification cannot be justified on the basis of any real risk to either patients or the public. This is precisely the type of low risk activity that the IOM report recommended for elimination by the NRC. Not only is this Medical Events Reporting requirement completely unjustified by the proven low risk, it is also duplicative of many professional requirements that already provide more that enough documentation and oversight of such events, such as required quality assurance programs, professional codes of conduct, hospital rules and regulations, and JCAHO requirements. The inherent risks do not justify such a blatant intrusion by the NRC into professional activities and the doctor-patient relationship.

C. Comments on Other Specific Issues Section 35.50 - Training for Radiation Safety Officer Maintain status, but for small licensees performing 35.100 and 35.200, only allow an authorized user to take the role of the RSO. Section 35.21 Written acceptance of Radiation Safety Officer duties and maintaining a record appears to be redundant. Accepting the position and agreeing to the license amendment naming the individual as an RSO is sufficient. The need for an additional paper trail appears to be unnecessary paper work with no safety value. It is yet another paperwork "trap" for citations. Section 35,69

• Labeling of the vial and syringe shield with radioactive warning sign is a good idea.

However, due to the size of these shields, especially the syringe shields, the information on the label needs to be limited to essentials. As an example, an institution may have developed a detailed color-coding system to identify various radiopharmaceuticals. This would be a better visual indicator than the requirement for the name of radiopharmaceuticals written on the label. Adequate flexibility requires that the

U. S. Nuclear Regulatory Commission November 10, 1998 Page 10 Commission change the wording to "means of identifying the radiophannaceuticals content of the syringe or the vial".

• The requirement for syringe or vial should use is too prescriptive. The current occupational dose limits set in Part 20 and Section 35.20 "ALARA Program" address this area adequately. To require additional procedures for shielding syringes and vials appears to be a deviation from the Commission non-prescriptive philosophy. The proposed rule appears to retain some aspects of the prescriptive approach without a clear reason.

Section 35.615 The Commission should delete the requirements in this section for licensees that are using beta-emitting sources. The lower doses from the beta-emitting sources present a very low risk. Section 35,310 This is another example of the prescriptive details of what should be included in instructions. The licensee is required under Section 35.75 to maintain TEDE to 500 or less for public, and should be given the freedom to decide on a case-by-case basis how best to achieve this. This requirement advocates a policy of one-size-fits-all, in a written protocol that will cover every aspect of the patient spectrum The University of California would like to thank the Nuclear Regulatory Commission for the opportunity to comment on the proposed rule. Sincerely, David Belle Director Environmental Protection Services Cc: Vice President Gurtner Assistant Vice President Bocchicchio Robert Lull, :MD Environment, Health & Safety Directors Radiation Safety Officers

                                                              ~~ RULE                      :i:.oJ-3*" ~3~

( 6 ?J f- R L/ 3 5 J6 EMORY UNIVERSITY SCHOOL OF~~J~ E ~ ENVIRONMENTAL HEALTH AND SAFETY 0 ~ C l* ~ 1462 Clifton Road. Suite 312 Atlanta. Georgia 30322 '98 NOV 12 P4 :16 (404) 727 -5922 Radiation Sa fety FAX.,: (404) 727-5904 OF' I , ' P.t ti . ADJu .. November 9, 1998 Secretary Nuclear Regulatory Commission Washington, De 20555-0001

• Attn: Rulemakings and Adjudications Staff Enclosed are our comments on the Medical Use of Byproduct Material~ Proposed Revision.

Several comments refer to areas in which public input was requested, while other comments arose directly from the review of the document. Sincerely, f~o~ Radiation Safety Officer Emory University s~~ Deputy Radiation safety Officer Emory University 1998 card ..__ _....._________.. THE ROBERT W . WOODRUFF HEALTH SCIENCES CENTER

u.~ "'" '" ,-',.., ocr.1 " IITn9y COMMISSION n:nNS STAFF t- r~ S, *C RETARY OF .,.HE COMMISSION Document Statistics Jostmark Date E~p r---'JJ / J/1 0/i;" Copies Received _ _;;/:__ _,--_ _ __ Add'I Copies Re - '- ----.-- - -

Comments Concerning NRC Part 35 Proposed Rule

1. Removal of Section 35.22 Radiation Safety Committee deleted in its entirety.

The effect of removing the Radiation Safety Committee from a medical institution will vary with the size and complexity of the institution and with the political climate within the facility. The Radiation Safety Committee with its required management representative in attendance provides access by the Radiation Safety Officer (RSO) which he/she may be hesitant to attempt via other channels. Safety issues may also be brought up in meeting which may not be conveyed to the RSO personally. The Radiation Safety Officer should be present at Committee meetings either as a member or as a technical advisor to the Committee.

2. Section 35.5 (b) (3) Passing of examination in accordance with Appendix A

• This requirement is not specified for Radiation Safety Officers in other areas. Present tests which fit the description in Appendix A administered by the Health Physics Society and the American Association of Physicists in Medicine extend well beyond the scope of the Radiation Safety Officer in a medical institution. Testing should be omitted~or, if maintained, a test should be developed which is more compatible with the duties of the position rather than requiring extensive preparation in medical physics and/or reactor physics.

3. Section 35.75 Release oflndividuals Containing Radiopharmaceuticals or Implants The hazards posed to the family and general public by a person containing radiopharmaceuticals depends totally upon the inclination and the ability of the patient to abide by prescribed restrictions for a specific period of time. It is extremely difficult to predict human behavior and impossible to control it outside the confines of the hospital. Some patients would go to a hotel or motel to prevent possible exposure of family members which would introduce unknown casual and occupational exposure to another segment of the public.

Undoubtedly many patients covered under this rule could be safely released from confinement. However many institutions must release I-131 therapy patients to nursing homes or even homeless shelters. It is extremely difficult to explain to a HMO, insurance company, or possibly to a government Medicaid or Medicare case worker the difference between an I-125 eye plaque involving a sealed source and a patient who has just ingested 200 mCi ofl-131 - why one may not require hospitalization while the other one would. This rule would interfere with an RSO ' s ability to protect public health and safety. When patients receive oral therapy doses of I-131 , the possibility of nausea and vomiting is a side effect, which is disclosed to the patient. This has occurred following a diagnostic dose ofl-131 on a sidewalk along a major

metropolitan thoroughfare near the hospital. A relative returned to the Nuclear Medicine Department, and a decontamination team headed by the RSO successfully decontaminated the sidewalk. Activity from a therapy dose would be much more difficult to remove. This could occur far from the hospital in the case of an out-of-town patient returning home. If the radiation factor became an issue, who would be responsible for decontamination? For reimbursement for decontamination? This rule would interfere with the RSO' s ability to control radioactive contamination. This rule would result in an increase of radiation alarms at landfills caused by household trash of released patients. The landfill regulations do not allow the burial of radioactive material, so NRC or State Offices would be notified. Radioactive material contained in patient excreta is no longer considered regulated, so where does financial liability reside? With the State or NRC? With the administering facility?

4. Section 35.61 (a) (1 ) Calibration of all scales with readings up to 10 mSv (1000

• mrem) per hour with a radiation source Allow survey instrument calibration by electronic means for low dose rate scales such as those which can measure no more than 0.2 mrem/hr. At these low levels natural background affects readings; yet, the accuracy of this scale cam be important to the researcher in location of small amounts of contamination.

Electronic calibration is more accurate at these very low levels. Section 35.61 (a) (1) could read: Calibrate all scales which measure more than 0.2 rnrem per hour up to those scales with readings up to 10 mSv (1000 mrem) per hour with a radiation source.

5. Section 35.315 For each patient who cannot be released in accordance with 35.75, a licensee shall provide a private room with a private sanitary facility.

This rule should be retained as is. Again the issue arises of demonstrating the need for a private room for one patient while possibly not for another patient as HMOs, insurance companies, and Medicaid/Medicare representatives seek to assign their patient to less expensive facilities. Experience dictates that bathrooms of I-131 therapy patients must be properly prepared to prevent contamination by even the very conscientious patient. Contamination from an unrestricted bathroom floor could be tracked through the hospital. Other users could become contaminated from faucet handles, doorknobs, etc., and some of the contamination could become internalized.

6. Section 35.415 Safety Precautions Not quarter a patient or research subject receiving brachytherapy in the same room as an individual whom is not receiving radiation therapy.

This rule should be retained.

The popular opinions currently held by members of the general public concerning radiation makes it socially and legally questionable to house a non-radioactive patient in a room, which has radiation posting on the door. Nursing staff would be understandably disturbed about receiving additional radiation exposure, if that were a factor, while caring for a non-radioactive roommate. Visitors and family members might be expected to experience some apprehension entering a posted room even if it was explained that external radiation exposure was not a factor.

7. Eliminate or reduce level of control for extremely low doses such as 1-125 iothalamate ( 35 microcuries), 1-125 Albumin ( 10 microcuries), Co-57 cyanocobalamin (1 microcurie) .

These tests involve minute risks. The requirement of a full board certified Nuclear Medicine physician to be the only person able to supervise administration of these tests is not as necessary as for an imaging procedure using multimillicurie doses. This could be done by redefining MEDICAL USE in 10 CFR 35.2 or by exempting these uses from Subparts C, D. and J restraints .

Fl~tc:h~r ~ All~n ~ DOC KETED '(!.::!} HEALTH C A R ~ USNRC "98 NOV 12 P4 :23 DOCKET NUMBER p;-:,. l")f)SED RULE Pft ~03 2 J-3S C63ff1l.t..t 3 r161 Secretary, Nuclear Regulatory Commission Washington, D. C. 20555-0001 Attention: Rulemakings and Adjudications Staff November 6, 1998 Sirs: This is to comment on the proposed changes in 10CFR Part 35. As practicing nuclear medicine technologists, we feel that the following proposed changes may be detrimental to patient safety. Elimination of the need for a dose calibrator when utilizing a commercial radiopharmacy. There are instances where assaying the dose prior to administration provides a necessary double check. This practice prevents accidental switching of doses when a patient is receiving two doses on the same day, as with cardiac studies. The assay in the department provides the only confirmation of the dose of radionuclide, assuring that the correct amount has been sent by the radiopharmacy. Elimination of the requirement for a Radiation Safety Committee at multiuse sites may result in less communication amongst users and less understanding on the part of administration of radiation safety issues. The Committee provides an opportunity for all involved to discuss radiation issues. Without a mandate, it is likely that administration would not support even the minimal time and involvement necessary. Elimination of the 10 half life decay time could lead to problems with the public. The use of both a meter and decay helps to assure that no radioactivity will be detected when waste then is transported to a landfill or other disposal process. If only the meter is relied on, a malfunctioning meter or insufficient time spent in the survey process may result in waste that then goes on to trigger a more sensitive meter at a waste station, leading to a public relations problem for all users of radioactive material. Reduction in the number of hours for training of physicians as authorized users could also seriously impact the training requirements for technologists. When observed that the requirement for a physician is significantly less than for a technologist, the training requirements for the technologist may be questioned. As exams and technology become even more sophisticated, a reduction in training could lead to poor quality studies, resulting in wasted radiation dose to the patient. 1 7 1998 Acknowledged by card... ..... . ,.. , , ** MC H V Campus 111 Co lcheste r Avenue , Burlington, VT 0540 1 - 1 429

• 802 656 2345 In alliance with the Uni*vers1ty of Vermont

UCU?AR REGULATORY COMMISSION LE!,1 *-~G..:i & ADJUDICATIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics J _/ q Postmark Date ....:..l..e.- -'-'=-/C,~f...__ _ __ Cooies Received .,___ _,___ _ __ r -,, ri,,rimrluced _,_/.J.- .; _ _ _ __

                 /-+4-n-e_y_                A.£.~

J1..p-f-l.,sc.~tfJ &Q.,1~ 12/J ll./ )ttfJJ

We do support the changes that result in a lower time commitment with what we feel is no lowering of safety standards. These include changing the wipe test and inventory to a six month frequency and changing the linearity test of the dose calibrator to annually. (\ "' \AA.,...,...- 1 '_.!._

                                                                                                  \
 ---+<LA~h.4~!.....J,!:L.....:::::::::..--J-...l...£~!,,,£....~-J--~\/1~....:....:....       I ~_         (Gretchen White, CNMT)

CiuDi)n (~~ Ca mr(Christin Caplette, CNMT)

 'fi!htl</_ a ~ { , / 1 )/ f(lcsteven                                                                              Relation, CNMT)

(Lisa McGovern, CNMT) (Edward Tumielewicz, CNMT)

 -----:...L------=::::::..::::*:::::_.1-/__:__-h-~~~~                 '3:'.'. S
                                                                              .:::::,._C
                                                                                       .:::::..:_M~WJ
                                                                                                    '-!. }     (David Gervais, CNMT) clear Medicine D

• zs
• Fletcher Allen Healt Burlington, VT 04501

DOCKET NUMBER PG 'J()',FD RULE )....0 3 2 J-JS

                                          / 6

(,_ 3 F-n I'- 43516' / 1 OOC t'E.fED USN~<C Office of Environmental University of California, San -~ncrt9&. _1_?., ~ci'htrl:JJiences Campus Health & Safety 50 Medical Center Way San Francisco, CA 94143 415 / 476-1300 OFI RU' AD,JL't.J::_ Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 Attention: Rulemakings and Adjudications Staff Re: Proposed Revision of 10 CFR, Part 35 .

• The comments in the following are in response to the Commissions solicitation for public comments on the proposed revision of 10 CFR Part 35. This document is to augment the verbal comments I made during the "NRC Medical Rule Making Workshop" held August 19 and 20, 1998 in San Francisco, CA. For sake eliminating repetitive inclusion it should be noted that I also fully endorse the comments submitted by the University of California, Office of the President. The comments are presented under these broad categories:

A) General B) Specific Issues C) Comments on other specific issues A) General

• The proposed regulatory changes are a restating of the old regulatory framework with minimal changes. Part 35 have not changed significantly, nor has it been streamlined to ease the burden on the licensees, in fact the 800 or so pages of documents distributed during the San Francisco Workshop contain numerous new additions.

According to the information provided by the NRC staff, the new approach tE!ken by the Commission is supposed to be a move away from a detailed and prescribed regulatory environment to a more "risk informed" criteria. Yet there is no real definition of what "risk informed" is, at best it is a purely subjective criteria defined on a case by ca$es basis by the NRC staff. A review of the documents published by the Commission indicates that this criterion is primarily used by the Staff to justify the continuation of existing prescriptive regulations. Depending on the end-point being targeted , risk informed could mean a very low-risk operation (e.g. dilution studies) or a high-risk activity (e.g. radiation oncology). The Commission needs to clearly define this concept and apply it uniformly throughout the regulatory process. The Commission further describes the overall goal as one that is intended to focus the regulation on those medical procedures that pose the highest risk to workers, patients, and the public. The new regulations however, do not eliminate any of the previous regulatory burdens, 1 998 rd .. _..._......,.... ,................

U.S. NI 1r1 ~11ci o~r,, 11 ATORY COMMISSI AU L.. M..,..,:Ju1SATIONS STAFF t F, E FT 1E SECRETARY OF ~HE COMMISSION Dorument Statistics Postmark Date . . :J_.,_

                  . t _l -=6c..../._t; Copies Received - -'-- - - - - -

Add'I Copies Reproduced --.a..._ _ _ __ Special Distribution Ha.t11~ F-/44 /<.., _64.-l[~h~.Jl-l ~t~

 ~ f} 1L1 'tU-;Jt                                      - 

Conments on: Revision of 10 CFR Part 35 - "Medical Use of by Product Material" nor does it remove the focus from the low risk operations (e.g. dilution studies). There is ample data for the Commission to conduct a real risk assessment and to develop the new regulatory framework based on an objective risk analysis criteria. In general there seems to be a consensus that diagnostic nuclear medicine procedures are low risk activities, yet the new regulations do not account for this. As an example Section 35.100 regulates uses of unsealed materials for uptake, dilution and excretion studies. By any standard this is an extremely low risk operation, at times using kits sold under a general license, yet the Commission retains the same regulatory control it has always had. This does not If the new regulations were truly developed on a real risk based criteria, then the licensees will be able to conduct their activities with a greater degree of freedom, while utilizing cost effective radiation protection measures. And many of the provisions of 10 CFR, Part 35 will be unnecessary. The Commission, the Nuclear Medicine and the Radiation Protection Community all share the common goal of providing the immense benefits of radioactive materials in medicine, while maintaining the potential harmful effects to the public to a minimum. No individual working in the field, who is dedicated to benefiting the sick, has a desire to participate in activities, which will cause harm to themselves or the public at large. Therefore it is crucial that the Commission recognize the varied environment of medical uses of byproduct materials, and the fact that a prescriptive approach does not provide for a logical protective structure. Instead the licensees must be able to develop their radiation protection practices such that:

• They are appropriate for the specific institutional use conditions appropriate for patient care situations on hand
• The are appropriate for the level of risk that is relevant to their activities and is cost effective
• They have the freedom to modify the procedures as needed, without the need for license amendments, to reflect the changes in their practices
• It will lead to a better radiation protection of the workers, the public and the environment.

It should be stated that the ALARA philosophy strongly advocates that the principals described above be taken into consideration. An effective radiation protection program is not based on how thick the written procedures are, but on how well the staff practices the basics of radiation protection in their daily activities. Therefore, a non-prescriptive regulatory framework must look beyond the past practices of detailed written procedures, step-by-step requirements, and other documentation protocols, which must be followed precisely. It should rather advocate a thoughtful program, which is dynamic and can be changed as needed to provide the best protection possible. The Commission expresses its desire to move towards a performance-based regulatory environment. To achieve this goal it must define its basic standards of radiation protection and allow the licensees to develop their programs internally so that they can achieve the standards set. During the course of a day there is a need to adjust practices to meet the needs of each patient, this requires deviations from practices employed for the previous patient. An old patient might be more difficult to inject than a younger one, in these cases uses of cumbersome syringe shields are a hindrance, therefore to require such devices as a must is 2

Cornnents on: Revision of 10 CFR Part 35 -

 "Medical Use of by Product Material" not justified. Imagine if surgeons were asked to develop such detailed operative procedures and that any deviation from patient to patient would be a violation!

To this end there are a number of areas of concern, which the Commission must address clearly to ensure the full implementation of a truly new regulatory philosophy that is performance based.

1) The new draft "Consolidated Guidance about Materials Licenses", NUREG-1556, Vol. 9 is a well-developed guidance and resource document. However, it is extremely important that this be adopted as a "guide" and that the license reviewers be instructed to treat it as such. The licensees must not be asked, as the past practice, to either commit in following the "guide" or submitting alternate procedures. It should simply be a guide for those who need advice.

2) Most modem equipment has manufacturers recommended quality control testing which is superior to certain Gf procedures in the guide, which are now obsolete.

3) NRC form 313, included in Appendix B of NUREG - 1556, Vol. 9, is supposedly intended to eliminate the previous requirement for detailed procedures. Item 10, "Radiation Protection Program", however, amplifies the concerns regarding the Commission's continued request for detailed and prescriptive procedure. Draft NUREG

          - 1556, Vol. 9, page 78, requires the license to submit information on the proposed radiation protection program to minimally include the following items (as applicable):

• Audit Program
• Leak Tests
• Operating and Emergency Procedures
• Material Receipt and Accountability
• Area Surveys
• Occupational Dose
• Public Dose
• Transportation
• Minimization of Contamination
• Mobile Nuclear Medicine
• Procedures for Administrations Requiring WDs.

This appears a simple shifting of commitments from the previous format of a checklist to submitting the information as a text. It is not a change in philosophy as discussed during the San Francisco workshop (August 19-20, 1998), nor is it compatible with the written documents distributed by the Commission. It is business as usual, provide details as part of the license application and be held to it as part of the license, and deviations are either violations or need pre-approval, prescriptive rather than performance based criteria. The only shift is now the licensee has to define the prescriptive details, which will be used, presumably this qualifies as non-Commission prescribed details. The Commission must move away from this degree of prescriptive licensing in "action" as well as in words. The Commission must define the criteria such as maximum permissible occupational doses, acceptable contamination levels, waste disposal criteria, etc. and allow the licensee to develop their own criteria internally to achieve the prescribed goals. To continue with asking detailed procedural submittal defeats the entire process defined even in the "risk informed" approach. 3

Conments on: Revision of 10 CFR Part 35-

 "Medlcal Use of by Product Material" The implementation of safe and sound radiation safety procedures is the ultimate goal of both the Commission and licensees; the means should be left for the institutional experts to develop internally for each institution. The licensee's compliance can easily be determined by regular NRC inspections, with the inspectors observing the operations and reviewing records such as personnel exposure data for confirmation of sound& radiation protection practices. Of course, this will require trained and experienced medical inspectors who are capable of making such judgements in the field. If a licensee fails to meet the criteria set by the NRC, then the NRC could required that the licensee submit specific procedures as how they will ensure compliance.

4) Over the years the licensing procedure has developed into its current prescriptive format to accommodate the needs of the NRC inspectors to develop simple checklist. This fact has been expressed by many of license reviewers over the years.

This issue appears to be the primary reason for requiring the detailed procedures in the license application. This issue can be easily remedied if the Commission would establish the following simple criteria:

• All inspectors reviewing "Medical Licensees" at the minimum are qualified to be named as a Radiation Safety Officer for a similar institution.
• All inspectors reviewing medical programs have a working knowledge of current nuclear medicine practices.

Furthermore, since the risks of diagnostic nuclear medicine procedures are so small, based on well-documented history of at least 35 years with virtually no morbidity or mortality, the requirement for traditional type inspections appears totally unjustified by the risk level. It would be far more appropriate for the NRC to allow each diagnostic site to have the option to satisfy all inspection requirements via any on-site program sponsored by one of the recognized professional organizations (e.g. ACNP, SNM, ACR ... ). This would provide both radiation safety review and quality of practice review by qualified individuals and spare the NRC the requirement of retraining all inspectors. In summary the draft regulations and the documents published by the Commission for comment are no different than those previously published, in fact they are more detailed and prescriptive. They are not eliminating any burdens from the licensees, they continue to:

• request detailed prescriptive procedures,
• regulate every aspect of the medical uses of byproduct materials
• offer no relief to the licensees from the unnecessary regulations
• ignore many of the recommendations of the Institute of Medicine report One final note should be made regarding the comment period. The volume of material distributed for review and comment is over 800 pages. This combined with the fact that the last public forum is held October 21-22, 1998, 90 days from the date of publishing is not an adequate time limit and this should be expanded if the Commission is really interested in public participation and a true partnership.

B) Specific Issues Identified for Public Comments by the Commission 4

Conments on: Revision of 10 CFR Part 35 -

 "Medical Use of by Product Material"

1. Section 35.2 - It is important to define the term "medium dose-rate remote afterloader".

Although the regulatory requirement of "high" and "medium" dose-rate remote afterloaders are very similar, the real radiation safety precautions are different and thus require a unique definition.

2. Section 35.6 - It is not clear as what the Commission is asking. The Commission should allow the current practice to continue without the need for additional requirements. It is not clear what the Commission wants to extend its jurisdiction over?

FDA regulates research and the Institutional Review Boards are responsible for review of such protocols. Existing regulations and guidelines for this practice provide adequate oversight and there is no need for the Commission to add another layer of unnecessary burden. Research by nature is dynamic and to ask for detailed procedures to be submitted for approval in advance is contrary to the basic tenants of research.

3. Section 35.24 - No. The Radiation Safety Committee is perhaps on of the most effective committees in most institutions. It provides:

• A valuable forum with expertise from all aspects of the licensee's operations
• Provides for interaction amongst all levels of users and administration
• Is an effective forum to develop and mandate the implementation of policies and procedures
• Acts as a peer review forum for research protocols as it pertains to radiation safety practices
• Is an excellent forum for enforcement actions against infractions of radiation safety practices. The proposal to eliminate the RSC is not a good idea! The RSO often lacks the full expertise to provide all the necessary advice. The limitation of the RSC will, in great majority of institutions, resu lt in the degradation of the radiation safety program and its effectiveness.
• The requirement for RSC should remain in place with exemptions for institutions involved in 35.100 and 35.200.
• The RSC requirement for quarterly meetings should be eliminated and replaced by "as needed". This will allow for institutions to adjust the frequency of their RSC meetings for the needs of the institution.

4. Section 35. 75 - No changes should be made, this section should remain as is.

Regulatory Guide 8.39 provides ample guidance on the release criteria. The Commission should also consider expanding its protocol to allow for review and approval of patient release criteria for new therapeutic procedures. This will be especially valuable for new treatment regiments with new radionuclides, for which smaller licensees may not have the necessary experience for development of the criteria. Under this procedure the manufacturer would submit its proposal for review and approval. The licensees would then follow the approved protocol or develop their own equivalents. There are a number of studies in which the potential radiation doses to family members of patients undergoing 131 1were issued film badges or TLD dosimeters. The results of these studies indicated that no member of the family received a dose in excess of 0.5 mSv (500 mrem) [ Harbert JC and Wells N. , Radiation exposure to the family members of radioactive patents. J Nucl Med 15:887-888]. In addition, a recent study at UCSF 131 indicated that individuals exposed to patients undergoing thyroid carcinoma with 1will not receive doses in excess of 0.5 mSv [Ara Tahmassian, Ph.D., Robert J. Lull, M.D., David C. Price, M.D. , Mark S. How, M.Sc. , Vincent Dentamaro, B.Sc. , University of California San Francisco, paper under preparation for publication, details are of this 5

Conments on: Revision of 10 CFR Part 35 -

 "Medical Use of by Product Material" study are provided by other commentators]. The studies have also shown that the sue of Regulatory Guide 8.39 formulae will overestimate the dose to an individual by up to 75%, which provide ample margin of safety.

The Commission has already addressed the issue of contamination from such patients in its initial rule making and accurately indicated that this is not an area of concern. In summary, there is ample evidence that when patients are released using the criteria set in Regulatory Guide 8.39, the total effective dose equivalent to an individual exposed to patients who have been administered radioactive materials will not exceed the 0.5 mSv (500 mrem) limits specified in 10 CFR Part 35. 75.

5. Section 35.92 - The proposed rule to allow decay in storage for by product material with a physical half-life of less than 120 days should be implemented. This will reduce the space burden on licensees and provide for cost savings. The requirement to hold byproduct material for a minimum of ten half-lives should be deleted. Paragraph (a)(2) in current Section 35.92 is adequate. The question that still needs to be addressed by the Commission is the term " in distinguishable form background". Due to the wide range of instruments used y various institutions and the background thresholds set for these instruments, it is crucial that the Commission define a level activity (or disintegration per second) as the acceptable level. This will eliminate the conflicts between licensees, regulators, landfills, etc.

6. Section 35.315 - The provision for a private room should be eliminated. If the licensee can demonstrate that a second patient in the same room will not receive more than 5 millisievert (0.5 rem) from the other patient (pursuant to Section 35. 75) then there is no need to impose a private room, or sanitary facility, requirement. Although if both patients were undergoing therapy with 200 mCi of 13 \ then the potential total effective dose equivalent from one patient to the other will be under 500 mrem during their stay in the same room. This is an insignificant dose; compared with the dose the patient receives as part of their treatment.

7. Section 35.415- The provision for private room should be deleted. Same discussion as (2) above applies. Also 35.415 (b) is again contrary to the philosophy being advocated by the Commission on being non-prescriptive. There is no need to list what is required for an emergency pack; the licensee must have the freedom to put what is necessary.

8. Subpart L - Once the Commission has identified the non-prescriptive elements of a radiation safety program, then, the record keeping requirements should be grouped into one subpart for easy reference. As indicated above the current proposed program is flawed in that it maintains the detailed prescriptive elements it has always had.

9. Subpart M - Yes, once the need for all reporting has been determined, then the requirement should be grouped into one subpart for easy reference.

10. Section 35.3045 while the dose threshold provision would make this more tolerable than the current system, this entire process of data collection and NRC mandated notification cannot be justified on the basis of any real risk to either patients or the public. This is precisely the type of low risk activity that the IOM report recommended be eliminated by the NRC. Not only is this Medical Events Reporting requirement completely unjustified by the proven low risk, but it is also duplicative of many professional requirements that already provide more that enough documentation and oversight of any such events, such as required quality assurance programs, professional codes of conduct, hospital rules and regulations, JCAHO requirements, ect. The inherent risks do not justify such a 6

Conments on: Revision of 10 CFR Part 35 -

 "Medical Use of by Product Material

blatant intrusion by the NRC into professional activities and the doctor-patient relationship. C) Comments on Other Specific Issues Section 35.50 Training for Radiation Safety Officer - Maintain status quo, but for small licensees performing 35.100 and 35.200 only allow an authorized user to take the role of the RSO. Section 35.21 - Written acceptance of Radiation Safety Officer duties and maintaining a record appears to be redundant. By accepting the position and agreeing to the license amendment naming the individual as an RSO is sufficient. The need for additional paper trail appears to be unnecessary paper work with no safety value. The Commission should require that the license amendment application submitted by the institution for addition of a new RSO include his/her signature. This not only provides the documentation of acceptance of the RSO duties, but it provides the licensing section with a copy of the RSO signature for future reference. This additional paperwork is yet another classic paperwork "trap" for citations and another addition included in the 800 pages of material distributed. Section 35.69 - Two comments:

• Labeling of the vial and syringe shield with radioactive warning sign is a good idea.

However, due to the size of these shields, especially the syringe shields, the information on the label needs to be limited to essentials. As an example an institution may have developed a detailed color-coding system to identify various radiopharmaceuticals. This would be a much better visual indicator than the requirement for the name of radiopharmaceuticals is written on the label. Adequate flexibility requires the Commission change the working to "means of identifying the radiopharmaceuticals content of the syringe or the vial".

• The requirement for syringe or vial should use is too prescriptive. The current occupational dose limits set in part 20 and Section 35.20 "ALARA Program" address this area adequately. To require additional procedures for shielding syringes and vials appears to be a deviation from the Commission non-prescriptive philosophy.

The proposed rule appears to retain some aspects of the prescriptive approach without a clear reason as to why. Section 35.615 ... The Commission should delete the requirements in this section for licensees that are using beta-emitting sources. The lower doses from the beta-emitting sources present a very low risk. Section 35.310-Again this is an example of the prescriptive details of what should be included in instructions. The licensee is required under Section 35. 75 to maintain TEDE to 500 or less for public, and must be given the freedom to decide on a case by case basis how best to achieve this. This requirements advocates a policy of one size fits all, in that a written protocol will cover every aspect of the patient spectrum. 7

Conments on: Revision of 10 CFR Part 35 -

  "Medical Use of by Product Material" In conclusion although the Commission's intent for moving towards a performance based criteria is commendable, its practices leave a lot to be desired. The proposed regulations in the introductory sections describe a methodology, which if implemented will certainly reduce the burden on licensees. However, the actual proposed regulations continue to present the old system with minor cosmetic changes. It not only does not remove any burdens, it in fact adds many new requirements which are as, if not more, prescriptive as ever. The Commission should extend the comment period and truly take the user community's comments into consideration and remove many of the burdens imposed upon them. This is in line with both the true spirit of a participatory process and the recommendation of the IOM.

Yours truly, Ara.,J::s~as:si~ ~ D . Diplo merican Board of Sciences in Nuclear Medicine A s1stant Vice Chancellor, Research Services 8

IEmile Julian - coMMENTs oN PROPOSED cAANGES To 1ocFR PART 35 Page 11 From: <Kirksey_Whatley/HCS/Alabama_Department_of_Public_Health@adp To: TWD2.1WP8{CXH) Date: Tue, Nov 10, 1998 11 :48 AM

Subject:

COMMENTS ON PROPOSED CHANGES TO 10 CFR PART 35

• 98 NO 10 PS :25 i
• r- J AD,.'

The following comments are offered for your consideration:

1. The definition of "authorized user" does not adequately define the term. As written the term means an individual who meets certain training/experience criteria and is named on a license. The definition does not "paint a picture" of an "authorized user. I suggest that with the KET NUM8ER 'J-0 32-->-35 addition of what the "authorized user is required to do, the definition OPOSED RULE..!..?!.- - -

would be much clearer. Perhaps by asking the question, What is an authorized user required to do", would help with the definition. There may ( 63 f-Yl~3 'i I fJ be a need for clarification for each type of "authorized use" of material. A clear understanding of this definition will go a long way to resolve many issues. The definition is too important to not adequately define.

2. I will preface my next comment by saying that I believe that training for all modalities of nuclear medicine is important. However, I remain perplexed as to why, under NRC "authorized user interpretations, a physician wishing to perform only diagnostic (non-iodine) studies is required to complete such {if any) training requirements. If the physician is not required to select patients, nor prescribe the dose, nor interpret the results, and radiation safety can be performed by a qualified physicist, what is the physician being trained to do? If the physician is trained for radiation safety only {you need only one RSO), why would it ever be necessary to name more than one physician on a license? This concern goes back to the definition of "authorized user.

3. I believe that a casual observation of many (if not most) nuclear medicine departments would reveal that technologists {non-physicians) "use" radioactive material on a day-to-day basis. The technologists handle the material, prepare doses, inject patients, keep records, and dispose of waste, etc. In my years of experience I do not recall a single physician having received significant exposure to extremities from such activities

{I'm sure there are exceptions). The exposure is to the technologists. To my knowledge, medicine represents the only area where training requirements for actual users are not specified. Exams are proposed for physicians who do not handle material to certify competency; yet, no training is specified for the ones who will be exposed and expose others - including the physician possibly. Training requirements should be specified for technologists and everyone involved - especially for someone so critical to the success of a nuclear medicine study as the technologists. In my opinion the requirements of 10 CFR 19 are totally inadequate. If Part 19 is adequate for the technologist, why not the physician?

4. As written, the proposed rule places responsibility for "supervision" with licensee management. I realize that management is ultimately responsible for everything. As written, I believe that this will become a

U.S ~,, '"' c ~~ oc:r.1 It ATf'IRV COMMISSIO F , .JuUU1vA1 0 S STAFF 0 F THE: SE:CRETARY HE COMMISSION L vCUment Statistics P ~tmark ~ e-J~~,.J- /J 10/tfr Cvp1es F ,Jd _ _..__,,...__ _ __ Add'I Co, ieproduced _ _ _ _ __ ~ 7;:]t~1;;11/2

IEmile Julian - coMMENTs ON PROPOSED cAANGES To 1oCFR PART 35 Page 21 loop-hole that will create many unnecessary problems. "Supervision" is too important to leave with such a vague identity as "management - which may not even be located in the facility, the same town, or perhaps even the same state.

5. The term "supervising authorized user" is used in the draft. The term encompasses the terms "supervision" (management) and "authorized user (a physician). I did not find a definition of "supervising authorized user.

As used the term appears to imply that the "authorized user is responsible for supervision; however, that authority was given to management. The term needs a definition.

6. I do not believe that NRC can, with any degree of certainty, issue a license without having more information than training of individuals, a description of equipment, and a sketch of a facility. I strongly recommend that NRC not abandon its practice of reviewing procedures prior to the issuance of a license. A licensee can still have flexibility to change certain procedures as long as the spirit of the rule is met. PRESCRIPTIVE should not mean the total lack of flexibility.

I believe that NRC has a responsibility to make a reasonable determination that radioactive material will be used safely prior to the issuance of any license. I believe that a review of operating procedures, prior to the issuance of a license is critical to that effort. Review of procedures should not be delegated to inspectors in the field. Licensing should try to prevent problems (by the review). Inspection time should not be spent reviewing procedures except where procedures are not adequate.

7. Before a license is issued, the adequacy of procedures and differences of opinion can be worked out with the applicant. Even at these early stages debates occur on certain issues. However, once the procedure is incorporated into the license, both the regulatory agency and the licensee know what to expect. As proposed, with no review prior to the issuance of a license, a NRC "management review board" type of set-up will likely be needed to resolve differences of opinion. As an example, I obviously disagree with the interpretation of certain "vague" statements in the proposal. Am I right or wrong? How would an inspector decide unless he is given some "prescriptive" interpretations. And if the inspector has them, the licensee should also. Put what you expect in the rules.

8. You requested specific comments regarding the placement of therapy patients in private rooms with private baths. I strongly support that.

ALARA demands that. Under no circumstances should an iodine therapy patient be placed in a room with other patients - even other therapy patients.

9. Warning signs should be placed on the entrance door to patient's room not perhaps hid in some obscure part of the patient's room. The sign should warn beforehand and not after the fact. This is an example of where a debate could occur between the licensee and the inspector if the sign is placed within the room where the inspector considers inappropriate but the licensee considers adequate. Putting the sign on the door is prescriptive but states exactly what should be done!

1O. If a visitor to a therapy patient's room is pregnant, and the fetus

IEmile Julian - coMMENTs oN PROPOSED cAANGEs To 1oCFR PART 35 Page 31 receives in excess of 0.5 rem, a report must be filled with NRC - but only if the "authorized user" knows that she is pregnant. How will a visitor know to tell the "authorized user" that she is pregnant, unless a sign is posted which instructs her to do so? If a report is required, a sign should be posted on the entrance door to the room. 11 . As written, the rules appear to require that surveys (of any type} be performed only where radioactive material that require a written directive are used. Good health physics practices would appear to require that surveys be performed at all locations of use. By not including this requirement, it appears that surveys are not needed for non-prescriptive use areas. In an institution where multiple types of uses occur, surveys should be done in all areas. Surveys perhaps more than anything else advises the RSO of the work habits of employees.

12. I believe that survey meter requirements are very useful and needed in the rules and should not be removed.

13. It would appear that "the Commission" expects physicians ("authorized users") to access the pregnancy and/or nursing status of their patients before radiopharmaceuticals are administered. For non-iodine, diagnostic studies the "authorized user" is not even required to see the patient, consult with a referring physician, or review the patient's chart. How will the physician access the pregnancy or nursing status of the patient that he/she never sees?

The following additional general comments are offered:

a. I believe that the Commission's directive to focus on areas where significant exposures could occur has been misinterpreted by staff. I cannot believe that the directive was intended to mean that lesser exposure areas should be ignored. That appears to be the case with many sections of the draft rule.

b. There is a place for prescriptive rules. All prescriptive rules are not bad. Again, I cannot believe that the Commission would have directed the staff to do away with all prescriptive rules. The word "prescriptive" should never be interpreted to exclude "flexibility". In NRC's nuclear medicine (and other} licensing courses, students were always taught that the intent of the rule was always to "get a job done". The goal was to accomplish the mission. Rules were not written in stone. The idea that licensing could not be flexible even with prescriptive" rules is a recent staff idea that should be changed. Reg. Guide 10.8 is an example. If a licensee is allowed to write procedures in the same "performance based" manner, then vagueness will prevail and inspection and enforcement will become a nightmare.

c. A little history. The current version of Part 35 was not written to punish anyone.Prescriptive rules were included with the idea of providing guidance and assistance to licensees. It is my opinion that most licensees would prefer to know exactly what is expected of them. I am not aware of any amendment ever being denied where the licensee demonstrated an alternate way of accomplishing the intent of the rule.

IEmile Julian - coMMENfs ON PROPOSED cAANGEs to 1ocFR PART 35 Page41 There is obviously a significant difference of opinion as to what is broken and needs fixing and how to go about accomplishing that task. The same was true with the previous re-write of Part 35. I commend you, your staff, and your working groups for your efforts. My comments are offered in a constructive and supportive manner. These comments represent my personal views and should not be interpreted to represent the views of the State of Alabama Board of Public Health or any member thereof. If you need clarification of any of my comments, please call at 334-206-5391 . Kirk Whatley Alabama Dept. of Public Health Office of radiation Control P. 0. Box 303017 Mpntgomery, Al 36130-3017 CC: GATED.nrcsmtp("dwalter@adph.state.al. us")

DOCKET NUMBER PROPOStD RULE :2-eJ1 3 '2 J- 3 S' (63 pYJ., '-135 /b American Association of Physi Office of the President Lawrence N. Rothenberg, Ph.D. Department of Medical Physics

                                                           *gs      NOV 10 A10 :20                 Memorial Sloan-Kettering Cancer Center 1275 York Avenue New York, NY 10021 Phone: (212) 639-7365 Fax: (212) 717-3010 E-mail: rothenbl@mskmail.mskcc.org November 4, 1998 Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Attention: Rulemakings and Adjudications Staff Re: Medical Use of Byproduct Material; Proposed Revision

DearSir,

The American Association of Physicists in Medicine (AAPM) is a scientific, educational, and professional organization of more than 4,000 medical physicists. Medical physicists are actively engaged in the medical use of byproduct materials and other sources of ionizing and non-ionizing radiation. Medical physicists provide the physics support for the clinical procedures being employed by the various physicians with whom they are associated, so that the patient will derive significant benefits. The AAPM offers to the U.S.N.R.C. the following comments on the proposed rule, which was published in the Federal Register, Vol. 63, No. 156, Thursday, August 13, 1998. The AAPM wishes to formally express its concern about "the rush to rule making" approach which is being forced upon the regulated community. The revision of Part 35 is a very important activity which is long overdue. It is the opinion of the AAPM that this activity is too important to

• be forced to meet a timetable reflecting terms of office for commissioners. This activity should define its own timetable, which should be long enough so that both the NRC staff and the regulated community can engage in thoughtful and considered discussions and reflections.

The AAPM is pleased that the NRC is proposing to adopt modem vocabulary when describing the medical physicist. Medical physicists have been making major contributions in the clinical application of byproduct materials for decades in both diagnostic and therapeutic applications (including both external beam and brachytherapy). The regulated community has reached a consensus definition for a qualified medical physicist which includes both board certification and continuing education. Paragraph 35.51 addresses the need for board certification. The definition of the details of the alternative pathway will be closely monitored by the AAPM. However, both paragraph 35.51 and paragraph 35.50 also include the following statement "and whose certification has been approved by the Commission". Unfortunately, the criteria for The Association's Scientific Journal is MEDICAL PHYSICS. Member Society of the American Institute of Physics and the International Organization of Medical Physics.

U.S NI 1r 1C:.\o oc:r-111 _A.TORY COMMISSION RL, J J !CATIONS STAFF C,t-t-lCE OF THE SECRETARY OF TliE COMMISSION Document Statistics

approval of the specialty board certification are not presented. The AAPM requests that the NRC publish its criteria for approval of the various specialty board certifications. It is the opinion of the AAPM that it is in the best interest of patients, the general public, and health care in general that government approval of the actions of private bodies for any purpose, including radiation safety, be conducted in an open and public manner, using well established and recognized criteria. The AAPM urges the NRC not to create its own criteria for approval of certifying organizations. Until there are published criteria by which the NRC will approve various specialty board certifications, the AAPM requests that this statement be removed from paragraphs 35.50 and 35.51. The AAPM is opposed to the elimination of the Radiation Safety Committee (RSC) from paragraph 35.24. It is the opinion of the AAPM, based upon the experience of its members who work in institutions ranging from community hospitals to large academic medical centers, that given the opportunity to eliminate the required RSC, licensee management will significantly lower its concern regarding radiation safety issues. It is the recommendation of the AAPM that the RSC be retained for all but the simplest programs, which are programs that offer procedures covered in either Subpart D, Unsealed Byproduct Material - Low Dose or Subpart G - Sealed Sources for Diagnosis. The AAPM supports the concept that the Radiation Safety Officer (RSO) acknowledge in writing responsibility for implementing the radiation safety program. It is the experience of many AAPM members that, at the community hospital level, the RSO title is assigned to a junior medical staff member who has significantly more pressing obligations. The AAPM supports the change in vocabulary from misadministration to medical event, which is defined in paragraph 35.3045. It is the opinion of the AAPM that this section needs further work. It is the position of the AAPM that any patient intervention should not result in a medical event. The current patient intervention wording, namely "that could not have been

• reasonably prevented by the licensee" will result in lawyers for the licensee and lawyers for the NRC debating whether or not specific actions were reasonable for a specific patient. The judgment of the health care providers in providing a specific patient with an appropriate level of care must be respected by the NRC. It is the opinion of the AAPM that with the proposed wording in paragraph 35.3045 the NRC will find itself in violation of Statement 2 of the proposed revised draft policy statement, in that the NRC will intrude into medical judgments.

The AAPM is opposed to the 20% criterion for brachytherapy and gamma knife therapy as found in 35.3045 (1) (i) as an action level for a medical event The AAPM is not aware of any data which support the 20% criterion for these two modalities. The AAPM is aware that there are clinical data which support this level for external beam therapy. The AAPM requests that the NRC be consistent with its proposed policy statement 3, which justifies regulation by risks to patients, by revising the action level criteria for the total dose delivered from brachytherapy procedures or gamma knife procedures from the prescribed dose to a level at which harm to patients has been demonstrated. Medical physicists and radiation oncologists understand that, for brachytherapy

procedures, a dose difference of 20% can be found in physical distances of only several millimeters and that no hann to the patient results if the dose distribution is shifted by several millimeters. Patients may, however, suffer psychological hann and loss of confidence in their health delivery team as a result of the federally required notification process. Medical physicists and radiation oncologists also understand that patient dosimetry for gamma knife patients generally involves prescribing to the 50% line, while for accelerator based stereotactic procedures it is common to use the 80% line. It is the opinion of the AAPM that the single criterion for all procedures, as is currently defined in the draft Part 35, is inappropriate in that it works against the best interests of the patient and that it is contrary to the proposed NRC policy statement. The AAPM recommends a 100% criterion as an action level for a medical event for brachytherapy and gamma knife therapy. The AAPM is opposed to the proscriptive clements contained in paragraph 35.40 relative to the elements which are to be contained in a written directive. The AAPM believes that, by defining the written directive in as detailed a manner, as it is defined in paragraph 35.40, the NRC is not only intruding into medical practice, but it is regulating to physicians the clements of the dose prescription. AAPM members report multiple disagreements with the NRC regarding the adequacy of their institution's specific documents in meeting the inspector's understanding of the elements of the written directive. Some institutions have created new forms, independent of the patient's treatment record, just to satisfy the instructions they have received from individual inspectors. It is the recommendation of the AAPM that the NRC revise this paragraph so that it requires the licensee to have only a written directive (dose prescription) which specifies the essential elements of the procedure. The essential elements of the procedure should be defined by the licensee and not by the regulations. The AAPM, through its TG 40 Report, and before that its Report 13, recommends to its members that brachytherapy sources be calibrated by the institution with the calibration directly

• traceable to the NIST. The dose delivered to patients is directly proportional to the activity of the brachytherapy source. The AAPM recognizes that many of its members have not followed this recommendation. The AAPM notes that there is no industry standard relative to the statement of source strength by the various vendors. For example, at least one supplier states the activity of its Ir-192 sources in terms of milligram radium equivalents, while at least one supplier of 1-125 seeds states the activity of its sources in terms of air kerma strength and apparent activity. The
• requirements imposed by regulation on the source vendors in the statement of the accuracy and precision of the source activity are not well known. In addition, the performance of the source suppliers in meeting their requirements is also not well known. The AAPM suggests that the calibration of low dose rate brachytherapy sources is an issue for which there is no consensus and that further efforts between regulators and the regulated community are required. The AAPM supports the requirement for the licensee to calibrate its HDR sources and notes that this has become a standard of practice.

The AAPM notes that there are some sources, e.g. Pd-103, which have been in clinical use for a substantial period of time without having a national calibration standard directly traceable to the NIST. It is the opinion of the AAPM that all sources used for therapeutic applications should be required by regulation to have an NIST traceable national standard. Tiie AAPM believes that it is inconsistent to require licensees to calibrate brachytherapy sources in the absence of national standards for all clinically used sources. The AAPM believes that Part 35 is strengthened by having all of the record keeping requirements grouped into one subpart and by having all of the reporting requirements grouped into one subpart. The AAPM believes that the goals of the NRC are well served by simplifying the licensing approach. In summary, the AAPM objects to the rush to rule making which has been forced on the regulated community, and believes that both the NRC and the regulated community would be better served if more time were allowed to consider some of the issues raised by the AAPM and by other members of the regulated community.

                                                                           /1~

Lawrence N. Rothenberg, Ph.D. President AAPM cc: Michael Gillin, Ph.D .

• Chair, AAPM Professional Council

ftERLANCER 975 E. Third Street Chattanooga, TN 37403 ""'°'7 Health System 423-778-7000 "9B NO'J 10 P3 :3S

                                                                                                                          )

November 2, 1998 DOCKET NUMBER 201 PROPOSED RULE :3').._J-JS C~3F~q351(1) Secretary U.S. Nuclear Regulatory Commission

• Washington, D.C. 20555-0001 Attention: Rulemaking -- Adjudication Staff This letter is specifically requesting that the "Deletion of the Radiation Safety Committee" proposal in revision of 10 CFR Part 35 nQ1 be done.

Erlanger Health System, Chattanooga, Tennessee, has a very active, effective Radiation Safety Committee, with broad-based representation, charged with the responsibility of overseeing Radiation Safety throughout its facilities. As such, it reviews policies, procedures, personnel qualifications and maintains active consultative services to the Office of Radiation Safety. A very consistent rigid meeting schedule is maintained. Therefore, due to the direct benefit and support the committee gives to the Radiation Safety Office, it is apparent that elimination of the committee would compromise and weaken the Radiation Safety program. Thank you. Sincerely, lf&.D.A.B.R. Ce1tified Medical Physicist Radiation Safety Officer V 1 7 1998 0 11\ ITANOOGA VNTT "r

 - Erlanger Health System* Erlanger East - Erlanger North

• F.rlanger Community Partnmhip- T.C Thompson Cltildrcn's Hospital ~AI/F- 11<" '
• Miller Eye Center - Alton Park/Dodson Avenue Community Health Centers - Greenleaf - LifeForce Health Plans, Inc. ~ - l F..w,~ I co l.llm-m* MED,c ir,11.c Health Alliance

          - Physician Support Services Organization - Contin-U-Care - Women's East P,,1vilion - Moore & King Pharmacies

u.~ ~" ,,..., t:/\Q QP'"!I II A.TORY coMM1ss10 t' - v " I 1% STAFF V SLC,RE: TARY OF I E COMMISSION Document Statistics Postmark Date  ;; /6 /'1J-Cop1es Received _/_ _ __ _ _ __ Add'! Copies A

LJVvr\C I p p (. ti!]) LOUISIANA STATE UNIVERSITY MEDICAL CENTER School of Medicine in New Orleans 1542 Tulane Avenue LSl.1Mhrn US RC New Orleans, LA 70112-2822 Telephone: (504) 568-4646 "96 NOV -9 P2 :40 Department of Radiology OFF1-RL1c t AD.;u-, F October 7, 1998 Attention: Rulemakings and Adjudications Staff Nuclear Regulatory Commission Washington , D.C. 20555-001

• Re: Proposed Revision of 10 C.F.R. Part 35; 63 Fed. reg. 43516

Dear Sir I Madam:

I am writing this letter with reference to the proposed revision of the Code of Federal Regulations 10, Part 35 (the rules governing release of patients following administration of radioactive substances or permanent implants). The current regulations (Part 35.75) as described in Regulatory Guide 8.39 are an excellent guide for physicians and other personnel involved in the care of patients receiving therapy with radioactive substances. Patient specific calculations allow release of patients after administration of much higher doses of radioactivity than was previously allowed. It has been shown that outpatient treatment is acceptable as long as a dose of 500 mrem to any member of the general public is not exceeded. These regulations are very reasonable, and have a sound scientific basis. They have made radionuclide therapy much easier for the patients, physicians and all other personnel involved in the process. Significant cost savings have resulted at the institutions where these rules have been implemented. Being part of an Agreement state, we have not been able to follow these rules so far. However, we do support the adoption of these new reguiations by the state of Louisiana, to conform to the Regulatory Guide 8.39. It is my professional opinion that any extent of reversion to the old rules allowing lower doses for outpatients is undesirable and would be detrimental to patient care. Sincerely, Kevin E. McCarthy, MD Associate Professor of Clinical Radiology Director of Nuclear Medicine School of Allied Health Professions School of Graduate Studies School of Medicine in Shreveport School of Dentistry School of Medicine in New Orleans School of Nursing

N-..11

• A'

 .::1.::1' ,

1Y)CK1!T*NUMBER. 4.._. hOPOSED RULE ;zo 3--'J..

                                                     ,~                  C63Ffl ~JS/6) r-or @             11. :1.

Kettering Medical Center ooucf~ ~Tlo

                                                                                          '98 NOV -9 P2 :J8 November 6, 1998 Or-Fit         -      ("

RI...)_ I ADJ U.__1 t-Secretary, U.S. Nuclear Regulatory Commission Attention : Rulemakings and Adjudication Staff Washington , DC 20555-0001 RE : Proposed Rule-Medical Use of Byproduct material, 10 CFR Parts 20,32 and 35.

Dear Sir/Madam :

The NRC is to be commended for the progress it is making in matching the appropriateness of the regulation to the risk of the activity. The proposed regulations are a good start but do not provide sufficient rel ief for low risk activities. Please consider the following comments in regards to radiopharmaceuticals used in a Nuclear Medicine. 20.1802 Control of material not in storage: Strict interpretation of this regulation requires numerous additional steps by personnel to assure compliance. Personnel must constantly lock and unlock doors as they move throughout the department, this is a burden to personnel. The impetus for these restrictions was based on the criminal actions of individuals in a few incidents. NRC regulations cannot protect against intentional criminal activity. If a person is so inclined and they know where the RAM is they will more than likely know how to defeat the security measures. This regulation adds no meaningful protection but adds a considerable burden to personnel. 20.1901 Caution signs: Allow for the symbol to be black on a white background for labels used on a radiopharmaceutical vial, vial shield or dose. This would allow for the printing of label information on a standard white label, eliminating the need for expensive preprinted labels with a magenta or black symbol on a yellow background. These labels would only be visible to Nuclear Medicine department personnel who are the end users. Caution signs used anywhere else wou ld continue to conform with 20.1901 . 20.1906 Procedures for receiving and opening packages: The monitoring provisions should only be required if there is evidence of degradation of package integrity, such as packages that are crushed, wet or damaged. To require the existing monitoring conditions one has to assume that (1) the package was prepared incorrectly at its point of origin or (2) the current DOT package requirements are inadequate such that during routine handling of the package leakage would be expected to occur. Clearly the record of the radiopharmaceutical industry is such that the first scenario is unlikely. In addition the DOT package requirements are more than adequate to maintain the integrity of the packages contents during routine shipments. Relief from 20.1906 would allow personnel to open packages and place the RAM in its shielded storage area more quickly, thereby reducing their exposure during these procedures. 3535 Southern Blvd. 937-298-4331 Kettering, Ohio Internet: www. ketthealth.com 45429 Fax:937-296-4226 \LLI*\:--.< I OI< Iii \I Ill

• crs. f\llJr.l i=11P ACGlJLATOAY COMMISSION P{Jlt.: r t..;...:i & ADJUDICATiONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics JStmark Date t J 6 / I 4' J-

 ,pies Received /
   ' I Copies Reorodu
                          ---=---------
       .,, L:,inbt tv n J2A p l)~=~~~:!,:J,..;=:;;-,...:.=:::::....,.,.

35.22 Radiation Safety Committee: The deletion of the Radiation Safety Committee is appropriate. From a radiopharmaceutical perspective the FDA's new drug approval process (NDA), investigational new drug (IND) review process or its radioactive drug research committee (RDRC) are more than adequate to review the use of radiopharmaceuticals. 35.32 Quality Management Program: The deletion of the Quality Management Program is appropriate. 35.41 Procedures for administration requiring a written directive: In regards to all radiopharmaceuticals the written directive requirements should be deleted completely. The administration of radiopharmaceuticals is regulated by state law. The risk of radiopharmaceuticals is no greater than that of pharmaceuticals, no additional controls are needed. 35.60 Possession, use, calibration, and check of instruments to measure activity of photon-emitting radionuclides; The frequency of testing is appropriate, especially when one considers the proven reliability of these instruments. 35.70 Surveys for ambient radiation exposure rate: The deletion of ambient radiation surveys is appropriate, (a) should be modified to perform surveys when a therapeutic radiopharmaceutical dose was prepared for use or administered. 35.204 Permissible molbdenum-99 concentration: The modifications to the testing frequency is appropriate. Subpart D and E: The delete the use of the term "written directive" for consistency with above comments. 35.2040 Records of written directives: This section should be eliminated, for consistency with above comments. 35.2060, 35.2063, 35.2070, 35.2092, and 35.2204 Records ... : Include initials as a sufficient means of identity. The number of records from the above sections could easily number 40-50 records each day in a busy department. To record the name of the individual performing each task would be burdensome and inappropriate. For example initials are appropriate and consistent with dosage records for all pharmaceuticals whether regulated by the state or NRC. Thank you for your consideration. Sincerely,

  ~~-J.,...,_o,-*- - -

steve Mattmuller, MS, RPh, BCNP Chief Nuclear Pharmacist Kettering Medical Center Department of Nuclear Medicine/PET 3535 Southern Boulevard Kettering, OH 454298 (937)298-3399, x7682 steve_mattmuller@ketthealth.com

Comments on the Proposed 10 CFR 35 Barbara L. Hamrick November 6, 1998 34 La Sierra Drive DOCKETED Pomona, CA 91766 US NRC (909) 629-6806 BLHamrick@aol.com "98 NOV -9 P2 :26 DOCKET NUMBER JJ PROPOSEDRUlE~~~~ I. The regulations pertaining to required training for unauthorized users are unneces~~ 3 convoluted. OF, / . * ~ '.~'=" RU  ; I

a. To!i .th~ki~ltl sections prescri6fng who may perform specific types of procedures (Secs.

35.2090, 35.292, 35.390, 35.490, 35.590 and 35.690), and the training requirements corresponding to those sections (Secs. 35.910, 35.920, 35.930, 35.940, 35.950 and 35.960, respectively) are each entitled the same thing. For example, Sec. 35.292 is entitled, "Training for imaging and localization studies, and Sec. 3 5. 920 is also entitled "Training for imaging and localization studies." This, in and of itself is confusing, but the matter is further complicated by the fact that these two sections do not cross-reference one another, and provide substantially different criteria for becoming an authorized user. This is true for each "pair of sections, and creates unnecessary confusion.

b. Furthermore (using Secs. 35.292 and 35.920 as an example, although the following problems apply to each "pair"), it appears the intent in Sec. 35.292 was to offer two methods for authorizing a physician to use "radiopharmaceuticals and generators" (why reagent kits aren't listed as they are in Sec. 35.920 is a mystery).

1. The first method in Sec. 35.292(a) requires, in part, that the physician be certified by a medical specialty board "whose certification has been approved by the Commission." Such approval of"medical specialty board[s]" seems to inhere in Sec. 35.920, but that should be made clear in Sec. 35.292(a).

2. Sec. 35.292(b) offers an alternative method of approval, presumably to allow for additional board-type certifications, however alternative (b) appears to also require that a licensee obtain an amendment to its license prior to allowing an authorized user, qualifying under Sec. 35.292(b),

to act as an authorized user. That additional requirement, that the authorized user not only have the required training, but also be named on a license, is only apparent after reading Sec. 35.13(b).

3. There is, in fact, a third alternative method of approval. This third alternative, which appears in Sec. 35.920(b), does not appear to require that the authorized user be specifically named on a license (i.e., the licensee is not obligated to seek an amendment to allow him/her to perform the procedures in Sec. 35.292), however this is not clearly stated anywhere in the rule.

c. I would suggest eliminating all the training requirements in Subparts D - H, and clearly stating the requirements in Subpart J. For example, for each type of use, Subpart J could have a section for each type of use (as it does now),with the three alternatives clearly stated:

1. NRC approved certifications, not requiring further NRC approval (i.e.,

notification only required, no requirement for amendment to be named on a license before use). This section should include the list of board certifications that the NRC accepts by regulation.

2. Equivalent training not requiring further NRC approval (i.e., notification only required, no requirement for amendment to be named on a license before use). This would be those requirements listed in Secs. 35.910(b), 35.920(b), 35.930(b), 35.932(b), 35.934(b), 35.940(b), 35.94l(b),

35.950(b) and 35.960(b).

3. NRC approved certifications not adopted by regulation, and which require further NRC approval prior to allowing the use of licensed materials (i.e, the user must be named on a 1 998

l ** , lJ.S r,.11 ,r, r

• 0 ocr-, tt /\TORY COMMISSI F, Tl NS STAFF

0. ICE uf- THE SECRETAR OF THE COMMISSION Document Statistics Postmark Date £-N-t.; l-vfa I J Copies Received--'- ' ------

Add'I Copies Reprod s ' ' .

Comments on the Proposed 10 CFR 35 Barbara L. Hamrick November 6, 1998 34 La Sierra Drive Pomona, CA 91766 (909) 629-6806 BLHamrick@aol.com specific license). This would be those requirements currently listed in Secs. 35.290(b), 35.292(b), 35.390(b), 35.490(b), 35.590(b) and 35.690(b).

d. In addition, if the NRC intends to allow the medical use of radioactive materials by person not specifically named on any license (as it appears to), then there should be a requirement for the licensee to retain a record of the basis for "authorizing" a user to use radioactive materials at their facility, and to retain all concomitant training records.

e. Sec. 35.14 seems to imply that an authorized user must be a) board certified (without reference to whether or not this means only those boards adopted by regulation, or includes those certifying organizations described in Appendix A), orb) be named on a license, or c) be "permitted" by a "broad scope licensee" in order to use radioactive material to treat humans; however, this seems to conflict with Sec. 35.13(b)(l), which permits persons to act as authorized if they meet the requirements of Secs .

35.910(b), 35.920(b), 35.930(b), 35.932(b), 35.934(b), 35.940(b), 35.941(b), 35.950(b) and 35.960(b). None of these sections require that the user be a) board certified, b) named on an NRC or Agreement State license, or c) "permitted" by a "broad scope licensee." II. Sec. 35.61 is unnecessary because this is covered in 10 CFR 20.1501. III. Sec. 35.70 is very unclear. Does the exemption refer to the actual room in which a "non-releasable" patient is staying? Or, to any area where the dosages for those patients are prepared, administered, etc.? IV. Sec. 35.80(a)(4) is not explicit enough with respect to studies performed by a a mobile nuclear medicine service on in-patients. Such a study will necessarily result in the mobile nuclear medicine service leaving behind contaminated material in the form of IV tubing, catheters, etc. (i.e., material contaminated by the patient after the study is complete).

a. Is the intent of this regulation to require the mobile nuclear medicine service to provide 10 CFR 19.12 training to the unlicensed facility staff who may handle this waste? Is the mobile nuclear medicine service responsible for returning the day after the study to retrieve this waste?

b. HPPOS-034 states, "It is an OELD opinion that the exemption in 10 CFR Part [20.2001 and 20.2003) for excreta applies only to excreta discharged to a sanitary sewer and does not apply to excreta remaining on disposable diapers placed in trash cans or disposed of otherwise .... [D]iapers are not exempt from the requirements of 10 CFR [20.2003) because they contain excreta residue, and therefore, must be labeled as contaminated waste ... Waste destined for normal trash disposal must be placed in a suitable holding area as contaminated waste until the radioactivity has decayed to nondetectable levels."

This position clearly requires that waste generated by a patient releasble under Sec. 35.75 still be treated as radioactive waste, and disposed in compliance with 10 CFR 20. This leaves mobile nuclear medicine services in a difficult position if they perform studies on in-patients who are technically releasable under Sec. 35.75.

c. I recommend that in addition to the exemption from sewer release restrictions for patient excreta, that the NRC explicitly exempt from regulation materials contaminated by patients releasable under Sec. 35.75, when such waste (in whatever form) is generated by the patient after the administration of the radiopharmaceutical.

V. Sec. 35.92, the requirements for "decay-in-storage" should be removed to 10 CFR 20. 2

Comments on the Proposed 10 CFR 35 Barbara L. Hamrick November 6, 1998 34 La Sierra Drive Pomona, CA 91766 (909) 629-6806 BLHamrick@aol.com VI. Sec. 35.292 does not reference "reagent kits," although its "companion" regulation Sec. 35.290 does. This appears to be an error. VII. Several items in the teletherapy, remote afterloader and stereotactic surgery calibration and "spot check" sections are unclear.

a. For example, Sec. 35.633 requires that, for remote afterloaders, the licensee "calibrate" the "source guide tubes" and "length of connectors." If the NRC means that these items should be measured to assure they are within some tolerance, they should state that in regulation, because the term "calibrate" in this context is vague and confusing.

b. Sec. 35.633 also requires that the licensee "calibrate" the timer accuracy and linearity.

There is no discussion in the guidance document about what this means, nor what type of calibration is sufficient. For example, is it sufficient for the timer's accuracy to be compared to that of a human operated stop watch?

c. The same types of problems exist in requirements proposed in Secs. 35.632, 35.635, 35.642, 35.643, 35.644 and 35.644. The common NRC response that these are not "new requirements" and should be regulated in the same way as their predecessors will not suffice in this case, because the "old" requirements have never been clear, and it is time these concerns were addressed.

d. The NRC should consider requiring that many of these items be checked for gross error which could effect the efficacy of the dose to the patient, or result in unnecessary exposure to the operator.

VIII. Sec. 35.2061 is covered in 10 CFR 20.2103. IX. Sec. 35.2070 is covered in 10 CFR 20.2103. X. Sec. 35.2092 should be removed to 10 CFR 20. XI. With respect to the NRC'S "Health and Safety" designations for determining Agreement State requirements, it appears that this designation is a "back door to compatibility requirements, which may be unevenly and/or inappropriately enforced. I would recommend that if a requirement must be adopted in some form by an Agreement State in order for that state's program to be found "adequate," that the requirement be assigned a "compatibility" designation, so that the states clearly understand what is requried of their program. 3

November 6, 1998 NOTE TO: Emile Julian Chief, Docketing and Services Branch FROM: Carol Gallagher ADM,DAS

SUBJECT:

DOCKETING OF COMMENT ON PROPOSED RULE, "MEDICAL USE OF BYPRODUCT MATERIAL (PART 35)" Attached for docketing is a comment letter related to the subject proposed rule. This comment was received via the rulemaking forum website on November 6, 1998. The submitter's name is Barbara L. Hamrick, 34 La Sierra Drive, Pomona, CA 91766. Please send a copy of the docketed comment to Cathy Haney (mail stop T9-F-31) for her records.

Attachment:

As stated cc w/o attachment: C. Haney

II........

          £ :a 6if!!!!!!!!: .ii!!!!!!!
      ,,,,~ii,ilal,- **-                       DOCKET NUMBER PROPOSED RULE              )-.{!J 3 ?- ~     oor ".:ETE0 Setting Standards for Excellence                    C63 Ff<'-/3 s      t -6                   U~
                                                                                               ..... R'"'
                                                                                                     . L, J ! ve!g~r   S: 1~ § :49 Secretary                                                                 OFr-,

RuL ': U.S. Nuclear Regulatory Commission ADJL" _ Washington, D.C. 20555-0001 Attention: Rulemakings and Adjudications Staff RIN 3150-AF74

Dear Madame Secretary:

The National Electrical Manufacturers Association (NEMA) appreciates the opportunity to comment on the proposed rule in 63 Federal Register 43515, August 13, 1998, which seeks to revise 10 CFR Parts 20, 32 and 35, pertaining to the Medical Use of Byproduct Material. NEMA is the largest U.S. trade association representing and serving America's electroindustries. The Diagnostic Imaging and Therapy Systems Division of NEMA represents over 95% of the manufacturers of x-ray imaging, computed tomography, radiation therapy, magnetic resonance, diagnostic ultrasound, nuclear medicine imaging and medical imaging informatics devices. NEMA wishes to express its concern with the proposed amendment of 10 CFR 35.63, which would specifically seek to eliminate the requirement of a licensee to conduct measurements of the activity of unit doses of radionuclides for medical use. In the proposed rule, NRC states as its goals to focus NRC' s regulations on those medical procedures which present the greatest risk to workers, patients and the public, and to "structure its regulations to be risk-informed and more performance - based .... " Further, in its Staff Requirements Memorandum dated March 20, 1998, the Commission declared that it supported the continuation of the Medical Use regulations program with improvements, with decreased oversight of low-risk activities and continued attention on high-risk activities. While we commend NRC for taking this enlightened view of regulation, we feel that elimination of the unit dose measurement requirement, by adoption of the new section 35.63 would impede, tather than enhance the achievement of these goals. National Electrical Manufacturers Association 1300 North 17th Street, Suite 1847 Rosslyn, VA 22209 (703) 841-3200 FAX (703) 841-3300 Ackno edqed

tll.S. N11r 1.' '} ') :4i::r;1 JLATORY COMMISSION F.lUL_1 ~... IJ !CATIONS STAFF OFFICE 0 F f HE SEGRETARY OF THE COMMISSION Document Statistics Postmark Date J 1 5 q J-I- 3' ----- Gopies Received _,c__ _ _ _ __ _ Add'I Copies Reproduced _o Special Distribut10 /i,a.,,tt c.yy Fl 6-C k.., fl.a-thrch, lpv, ~e,"ll+gh~v-. R!rJaJ t?.If.l c. 7

More specifically, well-established clinical practice has accepted the direct measurement of unit doses of radionuclides as an integral part of quality control in nuclear medicine. The test is simple to perform on a variety of instrumentation and does not impose an undue burden in terms of time and resources upon the nuclear medicine technologist. While the measurement of unit doses of radionuclides is straightforward, its value in clinical practice far outweighs its simplicity. Performance of the test serves as a quality control check in drastically reducing the incidence of misadministrations. Reduction of the occurrence of misadministrations is critical to patient safety in nuclear medicine examinations. In conclusion, NEMA wishes to express its strong support for retention of the unit dose measurement requirement. \Ve believe that adding flexibility to the regulatory process should not compromise safety considerations. We look forward to working with you to maintain quality control in the operation of the medical use program. If you have any questions, please feel free to call me at (703) 841 - 3248.

• Il, Industry Manager

                                                                                 ~

cc: NEMA Nuclear Section

00-CKETEO US, . C

                                                                           °98 NOV -9 p 2 :34 4 November 98 Secretary, U.S . Nuclear Regulatory Commission Washington, DC 20555-0001 Attention: Rulemaking and Adjudications Staff RE: Changes in Education and Training Requirements for Authorized Nuclear Pharmacists

Dear Committee Members:

The purpose of this letter is to express the viewpoint of the American Pharmaceutical Association, Section on Nuclear Pharmacy membership regarding the proposed changes to IO CFR Part 35 Training and Experience rule text. While the intent of the regulatory changes appear sound, we have specific concerns about implementation of the proposed rule. We support the proposal to maintain the number of contact hours and believe this training necessary to assure the quality or nuclear pharmacy practitioners. While we recognize it is important to assure safe handling of RAM, we question the use of the proposed radiation safety exam to demonstrate competency in this area. To develop such an exam according to the guidelines set forth in Appendix A is a time-intensive and very expensive undertaking. It is not realistic that such an exam could be developed and validated within the proposed two-year time frame . . Of further concern are the proposed criteria for the examining organization outlined in Appendix A. Instead of creating a new examining organization, it would seem more feasible to partner with an existing independent professional examination organization. For example, the structure of the Board of Pharmaceutical Sciences, Specialty Council on Nuclear Pharmacy, meets many of the administrative criteria required of the examining body. Unfortunately, the current Board-certification exam does not fulfill all of the proposed requirements. It is also feasible to partner with University-programs with expertise in exam development. As the rule currently reads, however, those universities that offer nuclear pharmacy training/ education are. prohibited from participating in the examination process, as are nuclear pharmacy corporations. While this assures the examining organization is not biased, it may encourage formation of an examining organization without the input of leaders in the nuclear pharmacy field . Brigette McGhee, MS, PharmD, BCNP 61 S Queen's Harbour Blvd. Jacksonville, FL 32225

Uc: ~,, rrr c ~ P oi:~t lLATORY COMMISSION

-1~

                  ,1-
                      ~    r ATI0NS STAFF THE SECRETARY i: COMMISSION Document Statistics ived --- - - - - - - -
 ! Copies R

Given the difficulty of implementation of this competency exam, perhaps there are other alternatives to accomplish the objective of assuring safe handling of RAM. Perhaps competency is better demonstrated by annual retraining of personnel, or participation in an accredited continuing education program. It is reasonable to assume that ongoing training more effectively assesses competency than a certification exam.

• We support the continued requirement to have a signed preceptor statement of training for ANPs. However, the addition of the caveat to allow ANPs to by approved by certain nuclear pharmacies raises some questions. By what criteria will the NRC approve these pharmacies?

Does this mean that every nuclear pharmacy requires approval by the NRC prior to training an ANP? Upon recognition of a nuclear pharmacy as an approved provider of training, will the NRC further approve the content of its training program as it would for a university or corporation? While the intent of the regulation is laudable, we have serious concerns about its practical implementation. Please, consider these comments while engaged in the revision prior to publication of the final rule. We appreciate your attention to this matter . Brigette McGhee, MS, PharmD, BCNP Member-at-large, Section on Nuclear Pharmacy American Pharmaceutical Association, Academy of Pharmacy Practice and Management

COMMENT NO. 418 IS NOT A

• PART 20, 32 & 35 COMMENT (It has been coded correctly and redistributed under the correct rulemaking, Pr-50, 52 & 72 - 63FR56098)

DOCKET NU BER PROPOSED RULE (63 f R ~3SJ6)

                                                       'J..- 01 :3 1. J- 3S DOCXETED B 11 USi'JRC RADIATION SAFETY 1000 Blythe Blvd, Charlotte, NC, 28203             (704) 355-5370          *9a  N 1*1 -9 P2 :JS To: Secretary, USNRC, Washington DC, 20555-0001 Attn: Rulernakings and Adjudications Staff From: Richard Mc Keown MS, RSO, Radiology Admin.

10/30/98 Re: Medical Use Byproduct Materials I r eviewed the proposed c hanges to medical use rules. I have several comments: A. The term "medical event" is much more appropriate than misadminstration. B. I think that it's a great idea to do away with the QMP review. At this facility, the QMP review was redundant since we did quarterly inspection of authorized users and reported results back to the Radiation Safety Committee as needed. C. I' ve al re ady e xpre ssed my wr i tten opinion on the proposa ls for specific "testing" in radiation safety. I feel that this is an unwise requirement t hat places an undue financial burden on rural and small medical facilities. It is, however, a terrific boon to consultant medical physicists and testing boards. I'd also encourage the NRC to eliminate the proposed requirements for letters from preceptors. D. I'm concerned about the NRC eliminating Radiation Safety Committees. The RSO derives a good deal of authority through this group. I suggest that NRC eliminate Radiation Safety Committees for specific licenses, but retain it for broad scope licenses. Also, allow the RSO the liberty to determine the committee make-up. Since laboratories a re eliminating RIA, there is very little need for a Pathologist on the RSC. Nurses also have little to contribute, unless they are specifically trained in Oncology or Radiology. E. I think that it a great idea for the NRC to scale down the license writing process. I've found that the license application is as large as the dept procedure manual. It is repetitive and bulky. F. I see that the NRC is planning to revise the enforcement process. This is overdue. The current policy puts enforcement before education and creates an antagonistic atmosphere during inspection. The bulk of non-compliance is based on misunderstanding of rules rather than a deliberate intent to create a hazard. It's counterproductive threatening people's jobs when splitting hairs over minor degrees of non-compliance.

U ~ *" ,~, c" o ncr., I\T()RV COMMISSIO

                                         .JNS STAFF r         ECRETARY
                "        ~OMMISSION

_ment Statistics

    ..irnarK Date I I/ J I

, rJd'I Copies Reproduced , r,ih11tion "IC

 .. ~:es Received _ ___::::J_ _ _ _ __
                              ...!il....- --.-:::-.---.--

J;-1/H! CA,/ . ,- 4. '- I<;, tu, t""'- s-~ Ld/' 6~te...., ~ J 1J,,__YJ_)-r.:'l-J~ - _ fl.:.I;fJS

G. I am very concerned about the proposal requiring NRC notification when a fetus receives un-intended dose exceeding 500 mRem. Pregnancy tests are not done on all patients prior to admission, especially not for emergency. Does NRC really want to delay emergency scans pending the completion of a pregnancy test on all female patients? Does the NRC have a age range for the testing requiremnt; ie 8 to 60 years of age? Technologists ask, when the patient is conscious, about pregnancy. Unfortunately, the menstrual status is not the most reliable indicator of pregnancy, especially if the women has irregular periods. Also how far back does this reporting and notification go? I f a patient says she's not pregnant and then finds out that she was, does the Hospital have to notify NRC several months afterward? How does the NRC propose calculation of conception dates? How does NRC propose to address minors and questions about pregnancy? Do the parents have to leave the room when the child is asked, other wise the child may not be truthful? I am cur ious a bout the source of the d ose calculation. Most Nuclear Medicine Technologists will probably use the package insert for the dose calculation. This however, does not take into account, for example, free technetium-99 that breaks off of a macromolecule and crosses the placenta for a direct fetal uptake. You can't know exactly what the binding efficiency for the radio pharmaceutical is or what the potential fetal uptake is. I suspect that the NRC is going to get a large number of these reports. But I question their accuracy or utility. I can see notifying the NRC if the dose exceeds 10,000 mRem and the physicist has to recommend terminating the pregnancy, but not reporting for 500 mRem. H. I appreciate the NRC requiring that an employer formalize the duties of the RSO. I suspect that this is already done with the "job description." I doubt that a letter from Administration will have the effect of increasing the authority of the RSO. The RSO is only as powerful as the person to whom he/she reports. If the RSO reports to the Director of Radiology, then he/she only controls activities in Radiology and must persuade other areas to cooperate. If the RSO reports to senior management, a senior vice-president, then he/she derives more authority. If NRC stipulated that the RSO report directly to senior management, then you increase our power. When the RSO regularly reports to senior management in the chain of command for .area that he inspects, it carries more weight than a one time letter of authority. I. It's a good idea to do source inventory at the same frequency as source wipe-testing, semi-annual.

J. It' s a great idea to allow for on site decay with tl/2 of 120 days. Releasing gamma waste when it's background, rather than 10 tl/2 is very sensible. I agree that you should maintain the 10 tl/2 rule for beta or alpha nuclides. K. I'm concerned about repeated call for annual training. It's obviously helpful to annual re-train nurses about radiation exposure on floors for brachytherapy, but it's not helpful to re-train certified Technologists in Rad Therapy. It would be better if the language specified that "persons without specialized training in handling radioactive materials receive annual re-training." Under the summary of specif ic issue identi fied for public comment

1. The requirement to verify competency by test is not a good idea. Documented training should be the sole criteria.

Please review C above and my prior letter of 10 / 30.

2. With the current evolution radioactive materials to prevent in-stint restenosis during cardiac catheterization there is a need for the term "medium dose rate remote after loader".

Typically, <500 mCi of Ir192 is used, which is higher the Cs137 brachytherapy and lower the HDR for bronchial cancer. Interlocks are probably not needed though, just locked doors.

3. In light of the proposal to do away with Radiation Safety Committees, it's probably a good idea to require review by an IRB for approval of human use of radionuclide. 35.6 doesn't say anything about RSO involvement, which should be specified.

4. Please see D and H above addressing the RSC and RSO respectively.

5. It's a terrific idea to release I131 patients when the dose to the public is going to be less than 500 mRem. I am concerned that Manage Health Care organizations will pressure RSOs to release ALL patients promptly, where some should be held. I'm also concerned about agreement states and their interpretation of variables in the calculation of 500 mRem to the public.

We're going to implement this slowly and only for old people living alone.

6. It's a great idea to eliminate the 10 t / 12 rule, see J.

7&8 I can't see any circumstance where it would be ok to allow the sharing of a posted restricted room with another uninvolved patient in Hospital. If were going to keep someone in Hospital, we should restrict their activities to one room and one bathroom. We should decontaminate the room afterward or at least survey it. I know that this is inconsistent when we are discharging some patients to their homes. I'm more concerned about the Hospital housecleaning staff getting repeated exposure when the same rooms are used for 1131 therapy patients. A patient discharged to home will not repeatedly contaminate the area after one therapy dose and with good biological clearance. 9 No comment, but I'd go along with the NRCP guidelines and AAPM task group recommendations. 10 This makes sense only if the manufacturer recommends the restriction for the particular device. Otherwise it' s t oo presc riptive. 11 35.615 should be expanded to specifically cover Beta sources, not waived. The Physicist should be on site during the procedure and survey should still be done with a sensitive enough GM mylar pancake probe. The staff exposure controls could probably be waived for Beta. 12 Interlocks are not needed for low dose rate remote after loaders, if the procedure specifies closing the door.

13. No comment.

14 Record keeping should be under the individual section that it &15 addresses, not broken into a separate subpart. However, reports of medical event probably needs it's own subpart. 16 No comment. 17 Please see G. Thank you for your attention in this matter. Please let me know if you require more specific information.

.J 0OCKET NUMBER POSED RULE       ~o, 3;J...1-1S

{ 6'3 F P- ~ 3 5 t V DOCKETED Ca~linaa ladical c.tlt*r US NC?C RADIATION SAFETY 1000 Blythe Blvd, Charlotte, NC, 28203 (704) 355-5 ~ NOV -9 P2 :37 To: Secretary, usr:rnc, Washin~tor:i DC~ 20555-0001 Of-Fl ,. Attn: Rulemakings and AdJudications Staff RU~ From: Richard Mc Keown MS, RSO, Radiology Admin *AD 'li[*11 ,

• 10/30/98 Re: Medical Use Byproduct Materials .., * * /,,,

I reviewed the proposed changes to medical use rules. I have several comments, but I'll forward this one immediately so I can meet the 11/12 deadline. There is a tremendous conflict of interest inherent in the NRC rulemaking process that requires "testing" of individuals in radiation safety . The proposed NRC emphasis on "testing" is an attempt on the part of accredited individuals to monopolize physics consulting in Radiation Safety. NRC should continue to specify a required number of hours in core subjects, but dispense with the proposal for testing . Frankly, I can already envision an academic orientated test made so hard that only a limited number of participants can pass. Also, this test could be a very expensive proposition for small or rural nuclear imaging clinics. If the test is administered in the manner that the ABR uses for accreditation, it could be a very expensive and drawn out proposal. FDA encountered this conflict of interest during the MSQA process where board certified Medical Physicists proposed that only those ABR accredited could test mammography machines. This would have been a tremendous financial burden on medical facilities due to the limited number of accredited Medical Physicists. It also represented a monopoly for ABR physicists. FDA wisely wrote alternative rules. The requirement for testing serves no purpose other than to restrict the number of qualified individuals. The initial training requirement assures individuals receive adequate preparation in radiation safety. The NRC inspection process assures that individuals maintain adequate Radiation Safety practice in the clinic. Tests do nothing other than reward academics, testing bodies and individuals specifically prepared for the test ahead of time. If there is a true concern about maintaining proficiency in radiation safety, then the NRC should require that individuals obtain Continuing Medical Education credits in radiation safety related topics.

U.S. N' 1r1 i:aP oi::GIILATOAY COMMISSIUN R... ~ _ . - , ,1 ;01CATIONS STAFF OFf:ICf o>= THF SECRETARY OF THE COMMISSION Document Statistics Postmar~ Date t J f~/ 'to Copies Received _ _ / ~.--- - - - Add'! Cooies Reproduced-- -.......-:--~ ~. ,. . ,. ~~~ L ~J<.., ~-t l,.5()tL/

 /JO fL I #.. t:. v.5 c,~µ          ~_he_v

On a related issue, there is little gained from r e quiring that ind ividuals obtain a specific letter from preceptors about their training in radiation safety. The NRC requirement about initial training is adequate documentation that a person was trained in radiation safety. Requiring additional documents from preceptors serves no purpose. I can foresee instances where the preceptor cannot be contacted or is unwilling to supply the requested letter. If an individual left a job, a disgruntled preceptor could interfere with the new job by with-holding the letter. I see this as an attempt to limit the number of individuals that can offer services as Radiation Safety Officers. Essentially, you have to behave on your last job under a board certified medical physicist or the letter is withheld. I realize that I am casting board certified Medical Physicists and the ABR in a very poor light. I am currently in the process of obtaining board certification and recognize it as an appropriate career goal. However, I object to board certification as the sole indicator of a physicist's training or value. I know many physicists, physicians dosimetrists and technologist that are not ABR certified, but are very capable in matters of radiation safety. I would caution the NRC to beware of certified individuals urging certification and preceptorship for everyone. Thank you for your attention in this matter. Please let me know if you require more specific information .

DOCKETED Nuclear Medicine Section :lo 3aJ--35 us Re Elmhurst Memorial Hospital { ~3F~ J./ 3 Slftl} 200 Berteau St. Elmhurst, IL 60126-2966 "98 NOV -4 P2 :37 PHONE 630-941-4561 October 30, 1998 Offl r ~L All.* , ADJUf ll ~ _.. ,_ Secretary, U.S. Nuclear Regulatory Commission Washington, D.C., 20555-0001 ATTN: Rulemakings and Adjudications Staff RE: Proposed Rulemaking for 1o CFR 35 "Medical Uses of Byproduct Material"

Dear Sirs:

• I am writing to you today to register disagreement with the following portions of the above captioned proposed rulemaking:

Proposed section 35.63- relieving the licensee-end user of the necessity of calibrating with a dose calibrator a dose of radiopharmaceutical prior to administration to a nuclear medicine patient for diagnostic purposes if the dose was calibrated and dispensed by a unit dose pharmacy- I feel that this deletes an important "check and balance" in the chain of actions leading up to administering a patient a dose of byproduct material. In the not-too-distant past episodes of Molybdenum-99 breakthrough in excess of permitted amounts occurred in Technetium-99m generator eluates. Because of malperformance on the part of a unit-dose pharmacist, many doses of Tc-99m based pharmaceuticals were released to hospitals with excess Mo-

99. Only by the act of calibrating the dose of radiopharmaceutical in a dose calibrator at the hospital prior to patient administration was something found to be amiss and this was ultimately found to be excess Mo-99 breakthrough. Revising 10 CFR 35 to eliminate this seemingly-duplicative step would eliminate also this important ultimate check on the radiochemical identity of an injectate intended for human use. While the Mo-99 breakthrough incident was a rare one, it serves to remind us of the need for checking and rechecking doses before human administration. Furthermore, lackadaisical attention to mathematical decay equations, "fudged" records, and "low cost, fly-by-night" nuclear medicine clinic operators are encouraged by such a revision. Leave the requirement for dose calibration as it is currently, please.

Proposed 35.24- eliminating a prescriptive regulation requiring a Radiation Safety Committee- I feel this opens the door for a lack of attention to radiation safety. While it is true that many licensees may feel burdened by the quarterly meeting requirement, quorum requirement, minute taking and dissemination requirement, my sense is that if you eliminate a prescribed Radiation Safety Committee, then the functions of such a (Continued}

SSI D p stfll Cop1e

                       ~

rlrl'I pies Re ~ 11:0:¢;/;i; ie<;I? Dist( * . f Secretary, NRC, October 30, 1998 page 2 of 2 committee will be diluted and ignored when subsumed by a hospital safety committee. It is possible that OSHA and other regulations would be paid more attention and that radiation safety officers or licensed authorized material users would not even have a place on a general safety committee. The concept of ALARA as an institutional commitment would suffer. Again, the deletion of the requirement for a Radiation Safety Committee would have economic benefit for the fly-by-night nuclear medicine operator or the hospital administrator who is very ready to cut cost even at the expense of the ALARA principle. The present prescriptive regulation may be a pain-in-the-derierre, but "it ain't broke"-please don't fix it by deleting it. Proposed section 35. 75- changing the criteria for patient release from hospital after certain doses of therapeutic radiopharmaceuticals- I have been in the Nuclear Medicine business for 16 years. I have seen individuals with PhD degrees be unable

• to secure urine and stool such that they can't contaminate bathroom or bed area floors with lodine-131 . I have had occasion to have patients vomit after large doses of lodine-131 , stuff up toilets with trash such that they overflow and carry small amounts of secreted 1-131 onto hospital floors, sneeze and contaminate windows and window frames, urinate in showers and contaminate shower drains etc., etc. Note that I serve a suburban Chicago population that is not cerebrally challenged, inbred or otherwise mentally defective. My point is that very normal and intelligent people have the consummate ability to spew 1-131 all over the place in the first 24-48 hours after administration. I don't care if somebody can calculate an alleged safe exposure rate from such patients-no one can account for the vagaries of human behavior as they relate to body secretions/excreta such that persons receiving 30 mCi or more of 1-131 are not exposing others in their immediate environment to 1-131 . I would, for the sake of ALARA, much rather see that such environmental contamination be controlled in a hospital room behind a closed door than to be ignored in a patient's house, hotel room, flophouse, YMCA room, or cardboard box abode. Again, I ask that you do not accede to the demands of the moneygrubbing insurance companies or fly-by-night nuclear medicine operators--the present rule is adequate, and if too expensive for some, then that's too darn bad. The ALARA principle is at stake here in a major way, and no amount of finagling with dosimetry equations will account for environmental leakage of 1-131 in any meaningful and predictable fashion. Please don't change the present regulation.

Lastly, may I commend the NRC for proposing to keep the training requirements for medical authorized users as they are currently. Diluting the requirements is counter ALARA and plays into the hands of "fast-buck" nuclear medicine operators. S~r~ / ,t tiiiJ.. /JC,¢'

                                                           ~i~w.~.D.

Medical Director, Nuclear Medicine

DOC TE D SOUTHWESTERN CHAPTER US RC SOCIETY OF NUCLEAR MEDICINE 1998 - 1999 '98 NOV -4 A1 1 :08

                                                                                        ~O 3~ J    35""' OF (l,'3Fii+~61~)          ADJUL The Secretary                                                      October 30, 1998        (ijj)r11.1 U.S. Nuclear Regulatory Commission                                                               T      President 71           Lamk M. Lamki, MD Washington, D.C. 20555-0001 President-Elect Att: Rulemakings & Adjudication Staff                                                                     Jay A. Harolds, MD Secretary

Dear Madam/Sir:

Bill Byrd, MD Treasurer I am writing as the President of the SouthWestern Chapter of the Society of Ramesh Dhekne, MD Nuclear Medicine, which is comprised of members from the states of Texas, Historian Arkansas, Louisiana, Oklahoma, and New Mexico. We have had considerable Charles M. Boyd, MD discussion of the proposed revision to 10CFR Part 35 in the SouthWestern Technologist Section President ~ apter, and we would like to express our thoughts in this regard. Specifically: Laura L. Burnley, CNMT W, We have significant concerns regarding the level of training and Trustees Richard J. Campeau, MD supervision of physicians using radioisotopes in their medical practice. Angle Ramos-Gabatln, MD We strongly recommend that a high level of training and experience be Javier Villanueva-Meyer, MD maintained by the requirements of 10CFR35. We are concerned that the Julie A. Wendt, MD proposed revision does not provide for adequate training of physicians in Al Landry, Jr., RPh, BCNP Michael F. Hartshorne, MD radiation safety and management. In addition, it is subject to abuse and Richard S. Rome, MD misinterpretations. It is most critical that the level of training requirements James M. Sylvester, MD be bona fide. John C. Morrison, MD William T. Phillips, MD Robert J. Telepak, MD

2) We are strongly opposed to 10CFR35.27 relating to supervision. David W. Weiss, MD "Supervision" is already being misinterpreted by several practicing Voting Past Presidents physicians. The wording of this regulation allows large numbers of physicians Joseph A. Volpe, MD Stanley L. Mills, PhD not qualifying for a licen~e to practice to all use the license of one physician Harold R. Neely, MD with virtually no supervision. Problems include: Milton J. Guiberteau, MD

• Donald A. Podoloff, MD Ralph Blumhardt, MD
• Retrospectively reviewing a few percent of the cases per year per Executive Director physician - not necessarily in the presence of the supervisor. Joan Saluzzi
• Attending one lecture per year (not necessarily given by the supervising Associate Director physician) is sufficient to represent supervision. Charles Metzger
• One supervising physician may "supervise" 20 or more physicians, even when out of town.
• The supervising physician need not have passed any board certification in nuclear medicine nor have passed any test in nuclear medicine.
• It is possible to practice (and charge patients) as a "supervised" physician for decades without ever satisfying NRC basic qualifications for safe use of radiopharmaceuticals. Texas, as an agreement state, has no specific provision for a supervised physician.

44th Annual Meeting 1998 March 26 - 28, 1999 Santa Fe, NM PO Box 411106

• San Francisco, CA 94141-1106
• Phone: 415/487-9802
• Fax: 415/487-9803
• info@swcsnm.org Website: www.swcsnm.org

GU :rORY

    & ADJUDICATI THESECREt OF THE COMMISSION

To: The Secretary, USNRC Attn: Rulemaking & Adjudication Staff From: Lamk M. Lamki, M.D., President, Southwestern Chapter, Society of Nuclear Medicine October 30, 1998. Page 2 of3

3) The proposed changes of section 10CFR35.27 should at least bring requirements up to minimal Accreditation Council for Graduate Medical Education (ACGME) teaching requirements for physicians, even if the total time is shorter than a residency. At any ACGME certified training institution, an individual being trained has all the cases reviewed by the teaching physician and interacts with the supervisor on all cases. There is an oral or written questioning by the supervisor. There are multiple lectures a week, and there is a final test by an ACGME approved body, with consequences for failure. If one teacher is away, another supervises. The trainee cannot bill for those services as a specialist.

In radiology, there is an ACGME requirement of at least one staff physician per resident. The ACGME nuclear medicine teacher has passed a nuclear medicine test and is Board Certified. The training program should have goals and objectives, a curriculum, handouts, a reading list, etc. There is a time limit on getting certified. The ACGME reviews the program.

4) Any clinician who desires to become licensed in handling radioactive products should do so through an ACGME accredited program, like several other specializations in medicine. There is no pressing need to increase the number of physicians authorized to use such materials. To our knowledge, no one is denied the care they need. We recognize the valuable expertise that various clinical specialists, such as the endocrinologists, can bring to managing patients, e.g.

thyroid disorders. However, we feel strongly that the superior knowledge of a physician fully trained in nuclear medicine brings valuable expertise to these patients, and is vital in quality care of our community. There is already a mechanism by which clinicians can become licensed in the use of radio-iodine and other radio-isotopes. Any further relaxation of these requirements by the NRC would be a grave error, and an act of injustice to our patients.

5) Unlike all other training, there is no punishment for failure. It may be possible to follow the letter of the law but not the spirit of the law. Any "licensed provider," as per the revisions, may not be adequately trained to ensure the safety and quality of care that our community deserves.

We have all seen the disaster that occurred in the early days of mammography, before the MQSA requirements and the need for mammography certification. There were many centers causing terrible abuse to patients through poor quality, expensive examinations done on substandard equipment, and through interpretation by incompetent practitioners who felt they were competent. The intervention of the federal government put an end to this dreadful situation.

To: The Secretary, USNRC Attn: Rulemaking & Adjudication Staff From: Lamk M. Lamki, M.D., President, Southwestern Chapter, Society of Nuclear Medicine October 30, 1998, Page of 3

6) We are opposed to lowering the minimum requirements for radiation safety training for supervised physicians. Any change to the minimum standards of training required by 10CFR35, we feel, has to be for the betterment of patient care, and not for physicians' benefit. Otherwise, a similar situation will arise in the radioactive materials use scenario. The best interest of patients dictates that we maintain minimum standards in training requirements of physicians.

7) We applaud the NRC's willingness and desire to minimize interference with good care, cut taxpayer expenses, and in general, promote the field of nuclear medicine and other uses of radioactive materials in medicine. We feel that the changes proposed by the NRC to 10CFR35, in terms of the authorized users and supervisors, will not serve that purpose. They will cause an explosion and lead to poor quality procedures that will increase the cost of care and ill serve the patients' needs.

8) It is the strong opinion of the Southwestern Chapter of the Society of Nuclear Medicine that the NRC should not abandon the nuclear community at this critical period. A close involvement of the NRC is essential to the further growth and advancement of nuclear medicine, and patient care. It would be of questionable judgement for us to radically depart from our past, with its proven track record and with its development, stemming from close collaboration between the founding patriarchs of both nuclear medicine and the NRC. They demonstrated a great deal of wisdom that benefits us greatly today.

9) The NRC regulation should clearly separate "supervision" requirements for physicians from those requirements for supervising technologists and other assistants. Regulations that are meant for laboratory assistants are not always applicable to physicians, who should be seeking appropriate and proper training. The system is currently either misintetpreted or abused. The NRC supervision regulations have opened a huge loophole that almost completely defeats NRC minimum training requirements. The NRC may also incur a liability by allowing this.

We urge you to seriously consider the impact of inadequate requirements for physician training in both the handling of radioisotopes and lax supervi.sion regulations. In addition, the safety requirements need to be strengthened and not loosened any further - for the benefit of our patients, as well as for cost-effective delivery of health care to our community. Respectfully,

 ~~----~

Lamk Lamki, MD, F ACR, FRCPC, President, SouthWestern Chapter, Society of Nuclear Medicine

DOCKETED ~ DEPARTMENT OF VETERANS AFFAIRS U f<C ~ Medical Center Bay Pines FL 33744 "98 NOV -3 P3 :QQ October 29, 1998 OF Rl. ADJUu Attention: Rulemakings and Adjudications Staff In Reply Refer To: 516 / 115

• Nuclear Regulatory Commission Washington, D.C. 20555-001 Re: Proposed Revision of 10 C.F.R. Part 35; 63 Fed. Reg. 43516

l.o13~ .,J-3S (b3FR4351 ~)

Dear Sir/Madam:

I am writing this letter in strong support of the recently approved revision of the Code of Federal Regulations 10, Part 35 (the rules governing release of patients following administration of radioactive substances or permanent implants). The current regulations (Part 35.75) as described in Regulatory Guide 8.39 are an excellent guide for physicians and other personnel involved in the care of patients receiving therapy with radioactive substances. Patient specific calculations allow release of patients (who are carefully screened to insure Radiation Safety compliance) after administration doses of radioactivity exposing no members of the general public to not more than 500m rem. This follows the ALARA safety guideline of one tenth of the 5 rem yearly allowance permissible for radiation workers. These regulations are very reasonable, and have a sound scientific basis. They have made radionuclide therapy much easier for the patients, physicians and all other personnel involved in the process with significant cost savings of reduced hospitalization. I am practicing at a Veterans Affairs hospital, and we are in the process of amending our radioactive materials license to allow outpatient therapy according to these new NRC regulations. It is my professional opinion that reversion to the old (30 mCi for 1-131) rules for outpatients is undesirable, would be detrimental to patient care and eliminate the cost savings in reduced hospitalization achieved by the newly revised regulations. Sincerely, STEVEN J. HARWOOD, M.D. 1 98 Acknowfedae yea ....- - - - -

DOCKETE D Bloomington Hospital us fl[' Radiation Oncology Center 2620 Cota Drive Bloomington, IN 47403 *9a NOV -3 P3 :OQ Catherine Haney OH-; ... Office ofNuclear Safety and Safeguards R" ADJlJI Nuclear Regulatory Commission Washington, DC 20555-0001 Re: Proposed Part 35 .201 3~.;-35

Dear Ms. Haney:

( fo3 FRc/ 35I'} I appreciate the opportunity to submit comments with respect to the proposed rule

• changes in Part 35. As with any changes, there are things I like about the proposal and things I don't like about it. There are also things that are just different and will require getting familiar with.

I agree with the philosophy that the emphasis should be placed upon the uses that have the greatest potential for personnel and public exposure. In connection with this, I find it very strange that there are no training requirements for the personnel who handle most of the radiopharmaceuticals and perform most of the routine radiation safety surveys and related record keeping. I am making reference to the nuclear medicine technologists and to a lesser extent the radiation therapists. I know that the wording places them under the supervision of the authorized users, but I also know from many years of experience that the authorized users very seldom get involved with the day to day routine safety aspects. In most institutions, the authorized users (physicians) are involved in the imaging or treatment but not in the routine aspects of isotope preparation and radiation safety. Along the lines of training and the philosophy mentioned above, I find it inconsistent that the use of unsealed byproduct material for therapy requires far less training than the use of sealed byproduct material does. It seems even more inconsistent that the use of a Sr-90 eye plaque requires even less training that the other two uses. I have worked around ionizing radiation for more than 25 years and using an eye plaque still makes me nervous. The proposed rule changes do away with the requirement for a radiation safety committee (RSC) and place the responsibility solely upon management and the radiation safety officer (RSO). I have always viewed the RSC as a forum for both decision making and education. My experience has been that the only forum for which some of the authorized users keep up with changes in the regulations is at the RSC meetings. Not requiring a RSC will further distance the RSO, management, and the authorized users. I feel very uncomfortable with the requirement in 35.24 for a written agreement between the RSO and management to ensure compliance. A written agreement seems more appropriate between management and the authorized users or between the NRC and the kno edged b card-- - 998

t

authorized users to ensure compliance. Often the RSO is not an authorized user and has most of his/her responsibilities outside of the area where most of the day to day licensed activities take place. I think that narrowing the scope of responsibility is a move in the wrong direction. I have always felt that increasing the responsibility of the authorized users would be an improvement. Under the current structure and even more so under the proposed structure, there is very little incentive for the authorized users to become familiar with the details of the radiation safety aspects of the licensed activities. Part 35 addresses the training and certificate requirements for the RSO. In many smaller institutions, the person who is most familiar with the radiation safety requirements and in the best position to see that they are carried out is the nuclear medicine technologist. The proposed rules will make it very difficult, if not impossible, for a nuclear medicine technologist to be appointed RSO. If these rules get approved as proposed, I hope that there is a mechanism established to provide the necessary training and testing for a qualified nuclear medicine technologist to be approved as RSO at a reasonable cost and

• in a reasonable time frame.

I am concerned about Part 35.67 (g) with respect to the storage of extra brachytherapy seeds. Will all seeds that are in storage while awaiting disposal have to be inventoried because they are sealed sources? I feel that Part 35.92 could use some clarification so that these seeds can be treated as decaying waste. I am generally in agreement with Part 35.432. Although I feel that an institution should assay sealed sources, I do not feel that it is cost justified requiring every institution to purchase the necessary calibration equipment for this purpose. For some institutions, the purchase of a few sealed sources may occur once every 5 to 10 years. Also, it is unrealistic to calibrate every brachytherapy seed when a 100 or more seeds are received. Many ofus in the radiation oncology community are concerned about the medical events in brachytherapy. The 20% limit is reasonable for external beam therapy or for quantities of unsealed therapeutic radiopharmaceuticals. In brachytherapy, however, a few mm can make a tremendous difference in dose. Also, how does one interpret the 20% limit for permanent seed implants? Is it a medical event when the pubic arch prevents the placement of seeds in the optimum location? Some provision should be made in the regulation to exempt brachytherapy or to drastically change the limit. Again, thank you for the opportunity to express my feelings on the proposed regulations. Sincerely yours,

 '}f)~ ) ~ th~ J 1'. j)_

William G. Van de Riet, Ph.D. Radiological Physicist cc. Mark Crain, Michael Gillin, Ph.D.

OOCKE:TEO 11s* JF*r. I.. * ., UNIVERSITY OF WISCONSIN-MADISON *9a NOV - 3 A11 :18 MEDICAL SCHOOL OH R. : October 23, 1998 ADJUt_ Catherine Haney Mail Stop T8F5 U.S. Nuclear Regulatory Commission Washington DC 20555-0001

Dear Ms. Haney:

Attached for your information is a copy of comments I have sent to the NRC on the proposed revision of 10 CFR Part 35. It seems much improved from the prevision proposed revision .

• Sincerely,

   ~~

Bruce Thomadsen Department of Medical Physics 1530 Medical Sciences Center 1300 University Avenue Madison, WI 53706-1532 608/262-2170 FAX 608/262-2413

UNNERSITY OF WISCONSIN-MADISON MEDICAL SCHOOL October 22, 1998 Secretary U.S. Nuclear Regulatory Commission Washington DC 20555-0001 Attention: Rulemakings and Adjudications Staff I wish to comment on the proposed revision to 10 CFR Part 35 published in the Federal Register August 13, 1998. While I currently serve as the Chair of the University of Wisconsin's Radiation Safety Committee, the comments below reflect my own opinions,

• and not necessarily those of the University.

General Comments:

1. Radiation Safety Committee-In the "Resolution" section on page 43526 of the Federal Register, the NRC proposes deleting the RSC and transferring its functions to licensee management. While the deleting of the prescriptive membership is a positive step (my experience is that the prescribed members seldom brought much to the committee), management persons seldom have any knowledge (and often dangerous misconceptions) regarding radiation or radioactive materials. This leaves the RSO working alone without support, and possible against the management staff.

I would suggest the reinstatement of the Radiation Safety Committee.

2. The American Association of Physicists in Medicine (AAPM) has published several excellent reports lately that impact on radiation safety. Of particular interest are:

High dose-rate brachytherapy treatment delivery: report of the AAPM Radiation Therapy Committee Task Group No. 59. Medical Physics. 25(4):375-403, 1998; Code of practice for brachytherapy physics: report of the AAPM Radiation Therapy Committee Task Group No. 56. Medical Physics. 24(10):1557-98, 1997; Comprehensive QA for radiation oncology: report oi AAPM Radiation Therapy Committee Task Group 40. Medical Physics. 21(4):581-618, 1994. These reports make many suggestions relevant to safe practice with respect to radioactive materials. The proposed part 35 seems not to reflect these reports that define the state of practice and codes of conduct. Specific Comments: 35.404(a) This section requires a survey of a brachytherapy patient immediately after insertion of the sources to confirm that no source has been misplaced. This directive proves unworkable. With the sources in the patient, the background around the patient is too high to detect an errant source. Inclusion of this impossible task will lead to a false sense of safety and false statements that a(n effective) survey was performed. Deparbnent of Medical Physics 1530 Medical Sciences Center 1300 University Avenue Madison, WI 53706-1532 608/262-2170 FAX 608/262-2413

35.432(b) This paragraph allows the use of manufacturer-provided calibrations for brachytherapy sources. The use of such calibrations without verification by the licensee poses serious hazards for the patient. The medical physicist should be required to assay the sources before use. In this day, such a requirement should pose no problem for facilities performing brachytherapy. The AAPM Task Groups recommend sampling 10% of sources used for permanent implants. This is not a large number, but is better than none. Certainly all temporary implant sources should be assayed. 35.610(c) This paragraph requires posting at a device control console the location of the procedures required by 35.610(a), yet 35.610(b) required the procedures themselves be posted by the console, making 35.610(c) unnecessary. 35.633(c){l){A) This section requires calibration of the guide tubes for remote afterloaders. Many uses of the afterloaders base dosimetry on the position of dummy markers that pass through the guide tubes, but where the length of the guide tubes themselves has no affect on the dosimetry. Calibrating the tubes serves no function, and what exactly would be calibrated remains unclear. The section should require calibration of any accessories that affect patient dosimetry. 35.633(c){l)(B) This section requires calibration of the timer accuracy and linearity. Proper timer function is critical for correct patient dose, and that depends on timer consistency and linearity. Timer accuracy implies that a minute on the timer corresponds to one true minute. Such correspondence is irrelevant to dosimetry as long as the timer functions the same at the time of treatment as at the time at of calibration, and responds linearly. If one minute on the timer actually corresponds to two minutes, that factor of two cancels when incorporated in the calibration and the treatment. Consistency and linearity can be very well measured with ionization chambers; accuracy cannot be measured well by most hospitals. A stopwatch measurement tells more about the reaction time of the operator than the function of the unit. 35.643(a)(l) and (2) Section (2) requires periodic checks at the beginning of each day of use, while (1) requires the periodic check at the beginning of each week. Section (2) would cover the requirement of (1) if the first treatment day fell on Monday. If the first treatment day of a week fell on some other day, what is

• served by requiring periodic checks on that Monday without a treatment? This requirement should be dropped.

Subpart JMuch of this section is redundant with, but not identical to, the training listed in the individual sections. The requirements in the two sections should be identical, or only listed once. 35.900(a)(6) The listing of certifications for the RSO for the American Board of Medical Physics should also include that board's Medical Health Physics certification. Subpart L Some records are to be kept for 3 years, other for 5. Making all record keeping durations the same could simplify compliance. Sincerely,

     ~~

Bruce Thomadsen, Ph.D. Part 35 comments 2

--t~~late-:==~ ~ r1.r-=-

                     -&W~   Mru:~, ~ ~     r'711eldL. 8" 1P~ .

DOCKETED USN C Octob~_21, 1998

                                                                                            -~ NOV -3 All :J 1 Jay A. Harolds, M.D.

14421 Wilson Road R\JLl0 2, u ** US t~RC or. Edmond, OK 73013 R' ., - 'I ADJG .J U.S. Nuclear Regulatory Commission Washington, D.C. 20555 OCKET N 0 ROPOSED ,Ro 3:J.d-35'

Dear Sir,

(~3PRl/35lt-This letter is in response to your request for comments regarding NRC regulations. I am very strongly opposed to 10CFR35.27, in regard to Supervision. Preferably, the entire section should be left out of the regulations. The agreement state of Texas, for example, has no provision for a supervised physician and none is needed. If for some reason it is desired to retain this regulation, it will be necessary to make changes so that this becomes a teaching opportunity rather than a huge loophole to basically almost completely work to eliminate NRC minimum training requirements. Restrictions on supervision should include the following:

1. The supervising physician must be in the same city and preferably in the same building when supervising another physician. Certainly they should not be on vacation or in another state.

2. There must be a limit placed on the number of physicians that can be supervised at any one time. It is suggested that there be a least one supervising physician for every physician being supervised. This is the requirement, incidentally, for the Accreditation Council for Graduate Medical Education (ACGME) .

• 3. There must be a time limit placed on the time that a physician can operate as a physician under supervision. Otherwise this can go on for numerous years for physicians who have no intention of ever getting a NRC licensure. It is suggested that this be for one year.

4. A teaching physician should not merely have passed minimum licensing requirements for the NRC, but should have additional requirements to insure the ability of the teacher to teach. This could include board certification by Nuclear Medicine, Radiology or Radiology Special Competence in Nuclear Medicine or possibly the Certification Council for Nuclear Cardiology. Publications should be required in addition if the latter is allowed.

Certainly, no one should be allowed to be a supervising physician without having passed a certification examination.

5. The supervised program should have a curriculum, goals and objectives, handouts, a reading list, conferences, and oral and written testing. Most of these are even required by Continuing Medical Education Category 1 requirements.

NOV 5 1998_ Acknowfedqed by card ..____

LJ.S. NUCLEAR REGULATORY ISS10 RULEMAKINGS &ADJUDICATIONS STAFF OFFICE Of THE SECRETARY OF THE COMMISSION

6. Obviously a physician being supervised does not bill for any study that is done by the supervising physician.

7. Obviously any study done under supervision must have the name of the supervising physician on it.

8. There must be significant records kept and all times that a supervised study is being done should be recorded.

9. The NRC obviously should be notified that a supervised physician program is in effect and this should be specifically inspected periodically according to guidelines that the NRC should come up with regarding this.

Incidentally, I am also opposed to lowering the minimum requirements for radiation safety training for physicians. Sincerely, a

DOCKETED William Que, Ph.D. US ,IPC Medical Physics Department Toronto Sunnybrook Regional Cancer Centre

                       '98 NOV - 3 Al 1 :11                              2075 Bayview Avenue Toronto, Ontario OF,-1                                                    Canada M4N 3M5 1 r                           Tel: 416-480-4317 RtJ ADJU 1J(                                                Fax: 416-480-6801 Oct. 21, 1998 Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff

• Re: Proposed revision of 10 CFR Part 35 Sec. 35.432 Full calibration measurements ofbrachytherapy sources. (a) A licensee authorized to use brachytherapy sources for medical use shall perform full calibration measurements on brachytherapy sources before the first medical use of the source or source/applicator con.figuration.

Comment: Exceptions should be made for short half life sources such as Iodine-125 and Pd-103 seeds used for prostate permanent implants. A typical implant requires about 100 seeds, it is not practical to calibrate all seeds. Note that AAPM TG-56 report (Medical Physics 24, 1557-1598, 1997) recommends that at least 10% of the batch be calibrated. Sec. 35.432 (c) To satisfy the requirements ofparagraphs (a) and (b) of this section, full calibration measurements must include determination of-- (]) The output or activity within +l-5 percent; Comment: This 5% accuracy is not possible to achieve with I-125 seeds at present. The ADCL calibration for well chambers used for I-125 calibration currently has a +/-5% error margin; on top of that seeds are specified in ranges of about +/-4% from the midrange value. An error margin of at least +/-10% is needed for single seed I-125 calibration. Thank you for considering my comments. William Que, Ph.D. 1998 Acknowledged by card------ --

DOC KE T[D FRED F. CIAROCID, M.D., F.A.C.P., F.A.C.E. US ~P.C 903 S. Main Street, Suite 101 Duncanville, Texas 75137 "98 NOV - 3 Al 1 :14 Phone: (972) 296-994 7 Fax: (972) 296-9949 OH-. HL'i DIPLOMATE ENDOCRINOLOGY AND METABcfils.M. -F AMERICAN BOARD OF INTERNAL MEDICINE October 19, 1998 1~ ' t :ftonorable l Greta Dicus uclear.Regulatocy Commission 1 White Flint North Bldg. 11555 Rockville Pike Rockville, MD 20852-2738

Dear Honorable Dicus:

I am an endocrinologist who is currently licensed to use radioactive iodine for the treatment of hyperthyroidism. During my endocrine fellowship I spent two years working with various radioactive isotopes, especially 1-131 and 1-125. I think the consideration to require that radioactive iodine only be given by radiologists may be inappropriate. It is very important to understand that giving radioactive iodine inappropriately, or to a patient who is quite hyperthyroid, may result in illness and death. Most of my radiological colleagues are not trained in recognizing and treating hyperthyroidism. The degree of hyperthyroidism is best ascertained by someone who has specific clinical training in that area. For this reason, I request that you allow the existing legislation to stand so that radioactive iodine therapy can be given by a licensed endocrinologist. Thank you for your attention to this matter. Sincerely, i~=r~ t _ ~ Ml) Fred F. Ciarochi, M.D., F.A.C.P., F.A.C.E. FFC/jm Acknowledg ov S 1998 b card __,____.......

f::J fs2 lJ S UCLEAR REGULATOR MAKI GS &ADJUDf""'""'"or-FFICE OF THE SECRETA OF THE COMMISSI I

MEDICAL COLLEGE OOCK~TEO

                                                                                                 !J ... , R, October 27, 1998          OF WISCONSIN                        *9a ov -2         P3 :09 Radiation Oncology J . Frank Wilson , M.D., FACR Chairman                                                                                  or (414) 805-4450                                                                                I Roger W. Byhardt, M.D.

Ao._* (414) 384-2000, Ext. 2585 Secretary, U.S . Nuclear Regulatory Commission Beth A. Erickson, M.D. Washington, D.C. 20555-0001 (414) 805-4460 OCKETN Colleen A. Lawton, M.D. (414) 805-4470 Attention: Rule Makings and Adjudications Staff ROPO  ;/{) 3~J36 Kevin J . Murray, M.D. IP3~R.t/15t,) (414) 805-4475

Dear Sir:

Elizabeth M. Gore, M.D. 805-4465 This letter contains comments on the review of the proposed revision of Part 35, her J. Schultz, M.D. 5-4480 focusing on brachytherapy. In several places the draft document, e.g. 35.600, the Julia R. White , M.D. sealed source and device registry is mentioned. This particular registry is (414) 805-4485 unknown to me. The proposed revision would be strengthened if there were an Medical Radiation Physics indication as to the nature of this registry and how to obtain a the copy. Michael T. Gillin, Ph .D. Ron Zhu, Ph .D. Daniel F. Grimm, M.S. William R. Hendee, Ph .D. The details of the written directive are presented in paragraphs 35.40 and 35.41. It Francisco Lopez, M.S. Jason Rownd, M.S. is my opinion, based on numerous discussions as a result of NRC inspections, that (414) 805-4460 substantial time is wasted in discussions relative to whether a specific approach by Radiation Biology the institution meets the exact requirements found in Part 35. It is my suggestion John E. Moulder, Ph.D. (414) 456-4670 that the NRC revise these paragraphs to the extent that while they require the Clinic (Patient Scheduling) licensee to have a written directive which specifies the essential elements of the (414) 805-4400 procedure, the regulation no longer define the individual elements. If the written nagement directive is really meant to be a tool to communicate between the authorized user

           -4375 and their support staff, then there should be substantial flexibility in its limitation.

A nistration Timothy Longden, FHFMA The institution should define the essential elements of the procedure, not the (414) 805-4495 regulations. For example, the paragraph requires the inclusion of the total dose for Quality Management Cheryl Glisch, M.S. remote afterloading. The number of fractions and the dose per fraction are (414) 805-4484 required and thus, by easy mathematics, the total dose. My concern is that the written directive may lead to confusion in a medical event if two different doses are required on the written directive. In paragraph 34.41 (b)(3) I would recommend adding the "/or" after the word "and" to acknowledge that either manual or computer generated dose calculations. In paragraph 35.4910CFR Part 30 is referenced. I do not know iflr-192 seeds and ribbons which are not a sealed source, are included. Paragraph 35.62 would require my institution to obtain dose calibrator for the 4 -8 Sr-89 therapies which we perform each year ifwe did not use unit doses. I believe

                                                                                                                             ,998 8701 Watertown Plank Rd.                                        I  Ill  1n,.,

Milwaukee, Wisconsin 53226 Ackno edged b *o Ill l I FAX: (414) 805-4369

J. UCLEARRE UL MAKI GS &ADJUOK~)NSmnl~ OFFICE OF OFTHE

that this is a reasonable development. It is my opinion that each institution has responsibility to determine the radiation dose or the activity to be delivered to their patients. I do not know if there is an NIST traceable source for Sr-89. Currently, we are trusting the vendor. Paragraph 35.415(b)(4) requires supplies necessary to surgically remove applicators and sources from a patient. It is my opinion that this requirement is too vague to be reviewed during the inspection process. It is not clear to me what supplies should be where either about the multiple rooms we use for brachytherapy. Paragraph 35.633 is devoted to full calibration measurements on remote afterloaders. Unfortunately, there is no reference to paragraph 35.630, which describes dosimetry equipment. I would recommend referencing paragraph 35.630. Paragraph 35.643 discusses spot checks at the beginning and end of each week and at the beginning of each day. I am favor of eliminating the requirements for the beginning of each week and incorporating them into each day of use. The time required to verify source position, determine the source strength and to compare with the decayed value is very small and should impose a hardship on users. These parameters are very important to insure patient safety. Paragraph 35 .657 relates to therapy computer systems. It is my opinion that this

• paragraph is not very useful. Great efforts are made to ensure that planning systems are "operating appropriately". However, I do not know any method to guarantee that software "shall" always operate appropriately, despite substantial time and effort. Operating systems for computers are very complicated software packages. As the current Y2K issues indicate it is difficult to know if an operating system is "operating appropriately". It is also noted t~at there is no reference to new versions of planning or operating systems software. New software versions require extensive testing.

Paragraph 35.432 discusses full calibration measurements ofbrachytherapy sources. The purpose of the word "full" is not clear. It is my opinion that the requirement for each institution to calibrate brachytherapy sources is reasonable and is consistent with AAPM TG40 recommendations. For the last decade plus at my institution, we have calibrated every source or a sample of sources which have been used for brachytherapy. It is my belief that the institution is responsible for the dose delivered to the patient and the appropriate calibration of the source is part of confirming the dose delivery. This is consistent with one as standard of 2

practice for external beam therapy. We have a calibration system traceable to the NIST for 1-125 seeds, Cs-137 sources, and Ir-192 seeds. The requirements of (C)(2) are simply NOT possible for prostate implants in which seeds are loaded in needles under sterile conditions at the time of the procedure. The definition of applicator is not clear, nor is it included in paragraph 35.2. A list of the applicators would be helpful. Paragraph 35.3045 uses the phrase "reasonably prevented by the licensee". The judgment as to what is reasonably prevented is clearly a medical judgment. This version of the regulations will most likely lead to extensive legal discussions between the licensee and the NRC. It is my opinion that any patient intervention should not result in a medical event. Thank you for the opportunity to comment on these draft regulations. Michael T. Gillin, Ph.D. Professor MTG:bb 3

                                                                                                        @)

DOCKETED Department of Natural Resources US NRC 4244 International Parkway ~0 1 3 :i J 3S Suite 114 ( C,3FR 4 351~) *98 OCT 30 P3 :04 Atlanta, GA 30354 01-*r Sf. RU ..... AD UD ,_. . r-Release criteria creates problems - hot material ending in dumps requiring investigation time (and Fed Gov should give States the$ to do this increased work), and will have public feeling underprotected .... .I like the general paragraph covering usable brachy and sealed sources ... .for teletherapy calibrations, you should state who can vouch for "nationally-recognized bodies" ..... please clarify: must brachy sources be calibrated before 1st medical use period or 1st use at given facility? ... why only survey at end-of-day if used material requiring a written directive? No health hazard, but ALARA would suggest survey if used any rad mat ..... Thomas Hill received via rulemaking website on 10/26/98

                                                                                             - 2 1998 rknn Pd ed      Cai    -        * * * * ._..,

(§) American Association o .J' E *sOtS *In

                                                         ~v.i*e                  M ed"1cme .

Office of the President Lawrence N. Rothenberg, Ph.D. Department of Medical Physics

                                             '98    OCT 29 P 3 :Sl                                 Memorial Sloan-Kettering Cancer Center 1275 York Avenue New York, NY 10021 Of-F                                                       Phone: (212) 639-7365 Fax: (212) 717-3010 RI_ -                                                  E-mail: rothenbl@mskmail.mskcc.org ADJU: ~

October 28, 1998 Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555 ~o 3~J-.35 Attention: Rulemakings and Adjudications Staff ( 1,3Pf?J./351'1) Re: Medical Use of Byproduct Material; Draft Policy Statement

Dear Sir:

The American Association of Physicists in Medicine (AAPM) is a scientific, educational, and professional organization of more than 4,000 medical physicists. Medical physicists are actively engaged in the medical use of byproduct materials and other sources of ionizing and non-ionizing radiation. Medical physicists provide the physics support for the clinical procedures being employed by the various physicians with whom they are associated, so that the patient will derive significant benefits. The AAPM offers to the U.S.N.R.C. the following comments on the draft Policy Statement, which was published in the Federal Register, Vol. 63, No. 156, Thursday, August 13, 1998. It is the opinion of the AAPM that the recently published draft proposal is an improvement over the 1979 policy statement. The AAPM notes that the previous policy has been in effect for approximately twenty years and urges the NRC to review this important policy more frequently, e.g. every ten years. The proposed policy consists of four statements. Statement 1 is a reaffirmation of the NRC's authority to regulate this activity. It mentions workers and the general public, but does not mention patients. Statement 2 directs the NRC not to intrude into medical judgments affecting patients, except as necessary to provide for the radiation safety of workers and the general public. Again, patients are not explicitly considered. The AAPM urges the NRC not to intrude into medical judgments, as medical judgments are the domain of physicians and other medical professionals. Physicians and other medical professionals are regulated by the states and by specific institutions which grant medical privileges. The NRC lacks expertise in this area. It is the opinion of the AAPM that the change from "minimizing" to "not intruding" is an important and significant change. ov 2 i998 Arknnwf Mr,Pd card .....-..-***-**----*- The Association's Scientific Journal is MEDICAL PHYSICS. Member Society of the American Institute of Physics and the International Organization of Medical Physics.

u.s RIJ

The AAPM finds Statement 3 to be troublesome. Statement 3 explicitly mentions patients and states that the NRC will regulate the radiation safety of patients when justified by the risk to the patients. The AAPM is distressed by the use of the word "primarily" in Statement 3 in that it permits the NRC to be active in other areas besides assuring the use in accordance with the physician's directions. The AAPM urges the NRC to strike the word "primarily" from Statement 3. If the NRC wishes, in the future, to use other criteria besides "in accordance with physician's directions", then the AAPM recommends that the NRC propose a new policy statement which would be open to public comment. The current version of Statement 3 in the draft policy statement is open ended and appears to be in conflict with Statement 2, in that the NRC may find itself intruding into medical judgments. The AAPM supports the concept of regulation justified by risk analysis. The AAPM hopes that, if the NRC adopts a risk based approach, that the NRC will share with the regulated community the risk analysis, and will engage in public discussions with the regulated community on specific issues involving the risk analysis for various procedures. Statement 4 commits the NRC to consider industry and professional standards in developing the regulatory approach. The various Task Group reports of the AAPM represent the latest standards of practice for medical physicists and should be considered by the NRC in defining acceptable approaches for achieving radiation safety. The AAPM urges the NRC to consider the evolution of the various practice accreditation programs, such as the one developed by the American College of Radiology in Radiation Oncology. An accredited practice has been found to meet published standards of practice by peer review. JCAHO is recognizing the importance of this peer judgment by establishing deemed status for radiation oncology accredited practices. It is the opinion of the AAPM that the NRC should also consider providing to accredited practices some type of regulatory relief. Thank you for your consideration of our comments . enre N.RL~ President AAPM

tAREN L TH't.lRMAN COMMITTEE ON WAYS AND MEANS 5TH OtSTRICT, f tORIOA SL:BCOMMITT'EE 0 1,ERSIGH

        >,,                 ~

WASHINGTON OFFICE 440 CANNON BUILDING WASHINGTON, DC 20515 202/225-1002 C!Congrcgg of tbc ~nitcb ~tatcg \0 00

                                                               ,t,Jougr of l\rprrgrntatibrg 0

C) C) October 20, 1998 ffi,1S'bington, lB<C 20513 C"")

                                                                                                                                                  <=n (f) '

N .z: :,r;: I..O  :::0 f'T1 o---4 Dr. Shirley Ann Jackson  ;:t::, rr, CJ Chairman -.J Nuclear Regulatory Commission ~o 3:lJ-35 N A Mail Slot# 16Cl (~3FRl/35H,) -+, Washington, D.C. 20555

Dear Dr. Jackson:

I am enclosing a copy of a letter that I have received from Dr. Steven M. Kraft of Gainesville, Florida. Dr. Kraft strongly supports the more reasonable level of regulation for the training needed for diagnostic tests and the NRC' s proposed reduction in required training for the medical use of radioisotopes. Any assistance that you could provide in helping me respond to his inquiry would be greatly appreciated. I look forward to your prompt reply.

                 ~~

Karen L. Thurman Member of Congress KLT\jc:ca enc ov 998

                                                                                                                  ~
                                                                                                             '>-4  0 u
                                                                                                             !:.J nOME OFFICES:                         222J H      -    jJ. .\
                                                  ~!...3-!,!:)

s

• s ~ J25(/) 1:=J t '* L 326< >t '

1*2 JJJ 30JJ 152 336 o6'J Col ~ ~ r,, <REE .0 .... a (.) 8

                                                                                                             ~    ,o C:   (*J

r nf +

>nstm"1       - /'\tr -1..Q_/~ 8 / °I 8

'X>p11:.

• l'{O(X;NU' I Adel'! Copic,r, licx - ~

Spc.-cial Dlr.tril,l. f-{~)) ~ ~ .g/4d-.

                                          ~
  / ( ~ , ~                                   I 7
   ?'D~ 1 ~1Ds

INTERVENTIONAL CARDIOLOGISTS OF GAINESVILLE Howard W. Ramsey, M.D. (Retired) Preston T. Green, M.D. Luis J. Cintado, M.D. Thomas G. Plavac, M.D. Steven M. Kraft, M.D. Jay C. Koons, M.O. Gregory A. lmperi, M.D. Otakar Quadrat, M.D. nterast NAAE August 17, 1998 4.sslgned r.- . Karen L. Thurman

                                                              *1
                                                    -r,._., .,,*,1~d  .;; 8 '*

U.S. House of Representatives 440 Cannon House Office Building Washington, DC 20515-0905

                                                   '-q J. ,. ....*ij ',.,,.. .--

J . E , Nuclear Regulatory Commission Revisions to Training and Experience Requirements for the Medical Use of Radioisotopes

Dear Congresswoman Thurman,

The Nuclear Regulatory Commission (NRC) is currently in the process of revising its regulations concerning the medical use of radioisotopes in an effort to make the training and experience requirements more reflective of the level of radiation risks they present. Two areas of concern are diagnostic nuclear cardiology and experimental intravascular brachytherapy. The NRC's advisory council for the medical use of isotopes has endorsed streamlining the radiation safety training and experience requirements for diagnostic nuclear cardiology because of its minimal risk to patients and public safety. I strongly advocate the more reasonable level of regulation of the training needed for these diagnostic tests and strongly support the NRC staff's oposed reduction in required training. Radioisotope have been used for several decades to create images of e heart with minimal risk to patients and public safety. The cardiology community has developed effective training programs for cardiovascular specialists who perform nuclear cardiology procedures. These physicians are also trained in the use of medical isotopes. Intravascular brachy therapy is an experimental procedure which hopefully prevents arteries from reclosing after being opened by "balloon angioplasty" or other such procedures. In this procedure, a cardiovascular specialist exposes the coronary artery walls to a low level radioactivt: source whiie clearing the arterial blockage. Because it is so experimental, this procedure is only being performed in large academic medical centers under the approval of institutional review boards using strict protocols. These cardiologists are teaming with medical physicists and radiation oncologists to determine the best method for using this form of therapy. The radiology community, however, is telling members of Congress that the changes being proposed by the NRC will "jeopardize patient care" and cause incidents "deleterious to patient care" to occur with greater frequency. I am unaware of any evidence that supports these claims. Pagel of 2 1131 Northwest 64th Terrace

• Gainesville, Florida 32605-4218 Telephone: (352) 331-8570
• Fax (352) 332-3614

~.,_.-;,_ ,~~~... ,, Page2 Please be advised that there are two sides to the issue. I wish to request you to contact the NRC and voice your support of its risk based approach to revising its training and experience requirements for the medical use of radioisotopes. It is too early for the NRC to set any definite training and expertise requirements for physicians using intravascular brachytherapy. Myself and the American College of Cardiology suggests that the NRC reserve judgement in this area until the technology has developed to the point where regulatory standards can be developed with confidence based on the risks of the radioisotopes selected. Thank you for your attention to this matter. Steven M. Kraft, M.D.,F.A.C.C., F.A.C.P SMK/bds

COMMITTEES MAX CLELAND GEORGIA ARMED SERVICES GOVERNMENTAL AFFAIRS

         ,3521 .

WASHllll" TCN, DC 20!j.!0 SMALL BUSINESS tinittd ~tatts ~tnatt WASHINGTON, DC 20510-1005 October 14, 1998

                                                                                                                  ~

CJ C) C""l CD

                                                                                                                   -         (/)n
                                                                                                                                ... ::x::

JoJ ".3 ~ J 35" N

                                                                                                                  \.Q

0 (Tl o-1 Chairman Shirley Jackson ( '73Ff'/351i,) :i::,

rri 0

                                                                                                                  -J U.S. Nuclear Regulatory Commission N

Washington, D.C. 20555 ~

Dear Chairman Jackson:

Please find enclosed a copy of a letter I received from a constituent, Dr. Jerre F. Lutz, regarding the recommendations of the Advisory Council for the Medical Use of Isotopes to classify intravascular brachytherapy as an emerging technology. I would appreciate a response to Dr. Lutz's comments and concerns regarding this issue. Thank you for your time and attention to this request. Most respectfully,

                                                               ~           and(l(\,rl\f United States Senator

• MC:kbn

                                                                                                  !i,.o     ti',

0 c..J 0 98 U)

                                                                                                            ;J
                                                                                                 ~
                                                                                                         ~
                                                                                                ~       ....

t.> (J 8 n:; ,....0,

4

, ). FRUM

                                        -~

I MORY HEALTHCARE - HEART CENTER Emery Ccnt&!r Por Hean failure Therapy September 18, 199 1364 Olfrnn lwo.l, NI-: Swrc F-508 Atbaca. GeorJ:ja 30J2.: ~40tnt2-7967 Fu 404m2-S9-40 United States Senat Senator Max Clela" I Dear Senator Clel

• The medical cardiol CClIDrnunity in Georgia recurnmends the NR.C follow the recommendations o its Advisory Council for the Medical Use of Isotopes to classify intrava!CUI bra.chytherapy as an emergillg technology.

Please contact the C in support of the proposed reduction in training and experience hours fo nuclear cardiology and to retrain. from assigning definitive training and experi ce requirements for experimerital intravascular brachytherapy

                       ~ thi~time .

November 13, 1998 NOTE TO: Emile Julian Chief, Docketing and Services Branch FROM: Carol Gallagher /l _. .I . Q. ~ ADM, DAS ~

SUBJECT:

DOCKETING OF COMMENT ON PROPOSED RULE, "MEDICAL USE OF BYPRODUCT MATERIAL (PART 35)" Attached for docketing is a comment letter related to the subject proposed rule. This comment was received via the rulemaking forum website on November 11, 1998. The submitter's name is Robert D. Forrest, 1412 Blockley Hall, Philadelphia PA 19104. Please send a copy of the docketed comment to Cathy Haney (mail stop T9-F-31) for her records.

Attachment:

As stated cc w/o attachment: C. Haney

November 13, 1998 NOTE TO: Emile Julian Chief, Docketing and Services Branch FROM: Carol Gallagher /1 n {1 _ ~ ADM,DAS (;0-,tt'V

SUBJECT:

DOCKETING OF COMMENT ON PROPOSED RULE, "l\1EDICAL USE OF BYPRODUCT MATERIAL (PART 35)" Attached for docketing is a comment letter related to the subject proposed rule. This comment was received via the rulemaking forum website on November 11, 1998. The submitter's name is Kenneth H. Douglass, WVU Radiation Safety, PO Box 9006, Morgantown, WV 26506-9006. Please send a copy of the docketed comment to Cathy Haney (mail stop T9-F-31) for her records.

Attachment:

As stated cc w/o attachment: C. Haney

November 13, 1998 NOTE TO: Emile Julian Chief, Docketing and Services Branch FROM: Carol Gallagher ~Q-~ ADM,DAS

SUBJECT:

DOCKETING OF COMMENT ON PROPOSED RULE, "MEDICAL USE OF BYPRODUCT MATERIAL (PART 35)" Attached for docketing is a comment letter related to the subject proposed rule. This comment was received via the rulemaking forum website on November 12, 1998. The submitter's name is Gina Dunning, Director, HHS Regulation and Licensure, 301 Centennial Mall South, P.O. Box 95007, Lincoln, NE 68509-5007. Please send a copy of the docketed comment to Cathy Haney (mail stop T9-F-3 l) for her records.

Attachment:

As stated cc w/o attachment: C. Haney

November 13, 1998 NOTE TO: Emile Julian Chief, Docketing and Services Branch FROM: Carol Gallagher /0 A . * ; * (}_, ~ ADM, DAS (_,;0,-Yu\/

SUBJECT:

DOCKETING OF COMMENT ON PROPOSED RULE, "MEDICAL USE OF BYPRODUCT MATERIAL (PART 35)" Attached for docketing is a comment letter related to the subject proposed rule. This comment was received via the rulemaking forum website on November 8, 1998. The submitter's name is Bill Byrd MD, 4001 Van Tassel, Amarillo, TX 79121. Please send a copy of the docketed comment to Cathy Haney (mail stop T9-F-3 l) for her records.

Attachment:

As stated cc w/o attachment: C. Haney

MEMORANDUM TO: Emile Julian FROM: Theresa Lee Kendall ~ L ~

SUBJECT:

MATERIAL TO BE DOCKETED DATE: November 2, 1998 (Second submittal of the day) I am forwarding the attached correspondence, which I received today, for docketing in response to the August 8, 1997, FRN (62 FR 42219) on the request for public input on the revision of Part 35, Medical Uses of Byproduct Material. If there are any questions, please call Diane Flack on 415-5681 or Cathy Haney on 415-6825.

tL L MEMORANDUM TO: Emile Julian FROM : Theresa Lee Kendall

SUBJECT:

MATERIAL TO BE DOCKETED / ~ DATE: November 2, 1998 I am forwarding the attached correspondence, which I received today, for docketing in response to the August 8, 1997, FRN (62 FR 42219) on the request for public input on the revision of Part 35, Medical Uses of Byproduct Material. If there are any questions, please call Diane Flack on 415-5681 or Cathy Haney on 415-6825.

DOCKET NUMBER 0 ROPOSED R LE ~o 3~J~ Beaumont ( h3FR'/36Jt,) DOCKETED US RC William Beaumont Hospital November 10, 1998 Royal Oak "98 NOV 17 P 3 :28 Secretary, U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 Attention: Rulemakings and Adjudications Staff RE: Comments on Medical Use of Byproduct Material; Proposed Rules Please consider the following comments on the proposed revision of 10 CFR Part 3 5 which were compiled from the members of our Radiation Safety Committee. Section Comment Definitions "Prescribed Dosage" - in favor of the new definition.

• 35.10 Implementation - extend the period to allow implementation up to one year from publication of the Final Rule. This would allow at least one "budget cycle" to plan for increased expenditures necessary to properly implement the revised rules.

35.40 (6) brachytherapy- (i) Omit number and strength of sources. The written directive allows for optimization of dose delivery, the number and source strength need not be listed prior to treatment. 35.60 Clarify that this section does not apply to brachytherapy. 35.60 (a) Delete "For other than unit doses," and require that all radiopharmaceutical doses above 10 microcurie are assayed in the dose calibrator prior to administration .

• 35.60 (b)

This is a standard medical practice which has prevented dose variances from occurring when centralized radiopharmacies have made inadvertent errors. (2) Perform a linearity test annually - in favor of the reduced frequency since nonlinearity problems are very infrequent on modem dose calibrators. Most dose calibrator problems are identified by the daily constancy testing. 35 .60 (c.) Extend the keV range for accuracy testing from 100 to 700 keV to include the use of Cs-137 as a accuracy calibration source. 35.61 (a) (2) Address the calibration of newer instruments which have auto scaling and the requirement for "two separated readings on each scale." 35.62 Clarify that this section does not apply to brachytherapy. 1 NOV 2 0 199 Aefmowledged by card........... .. ..................- 3601 West Thirteen Mile Road Royal Oak, Michigan 48073-6769 (810) 551-5000 Vt+I\ 'v1errber Jt Voluntdry Hospitals ~t Amer*ca. Inc ,

u . u REGULATORYOO)tms-:ON RULEMAKINGS &~u"""""' OFFICEOFTHESECRETARY OF THE COMMISS

35.67 (g) Requires semi-annual inventory of all sealed sources - in favor of the reduced frequency for inventories. The quarterly inventory was an overly burdensome requirement. This revision will allow the inventory to be conducted on the same time schedule as the leak testing without compromising health and safety. 35.70 Daily surveying of all areas where radiopharmaceuticals are used or stored is no longer required - in favor of the increased flexibility this revision allows. Each Department can tailor their survey program to provide the necessary radiation safety, without prescriptive record keeping requirements. 35.92 Decay-in-storage revision - in favor of revision which does not require a minimum holding period of 10 half-lives prior to disposal. Discarding waste when it is indistinguishable from background radiation levels will provide improved sanitary conditions and more efficient use of storage space .

• Subpart D 35.204 Rename this section - Unsealed Byproduct Material - Doses Not Requiring a Written Directive. This will avoid the use of"High Dose" later in subpart E.

Mo-99 breakthrough testing frequency revision - in favor of testing for Mo-99 breakthrough for the first elute or the beginning of the week. At our medical center, Mo-99 breakthrough has rarely occurred and always with the first elution. 35.290(b)(l) (ii) Change 20 hours to 40 hours or one week of supervised practical experience under the supervision of an authorized user. To adequately cover the necessary the topics listed and to achieve competency sufficient to function independently requires at least 40 hours. 35.292(b)(l) (ii)Change 40 hours to 80 hours or two weeks of supervised practical experience under the supervision of an authorized user. To adequately cover the necessary the topics listed and to achieve competency sufficient to function independently requires at least 80 hours. Subpart E Rename this section - Unsealed Byproduct Material - Doses Requiring a Written Directive. Avoid the use of"High Dose" as a title for regulations which include diagnostic doses ofl-131. 35.315 (a) (3) Strongly in favor of the revised survey requirements. The previous rules were too prescriptive in nature, and the experience at our medical center demonstrates that those rules are not warranted for reasons of health or safety. 3 5.390(b)( 1) (ii) Change 40 hours to 100 hours of supervised practical experience under the supervision of an authorized user. To adequately cover the the rules for doses requiring a written directive and to achieve competency 2

sufficient to function independently requires at least 100 hours. 35.490(b)(l) (ii) Due to the lack of risk associated with these procedures, delete the word "ordering" from (A) and all of (D). 35.432 Change the title of this section to: "Verification of calibration measurements of brachytherapy sources." 35.432 (b) Omit the wording after "manufacturer." 35.432 (e) Replace "full calibration" with "spot check." These terms are more consistent with established terminology. Also, include a paragraph requiring an initial "spot check assay" as referenced in AAPM TG-56 or TG-40. This should be standard practice for state of the art brachytherapy service. 35.610 (b) and (c.) Change the wording for posting the instructions to "in the immediate vicinity of the device console." Requiring the copy of instructions and procedures to be posted only at the device console is too prescriptive. 35.610 (d) Remove the term "full calibrations." 35.615 (1) (i.) Change the wording from "or" to "and." The authorized user should also be physically present during the initiation of all patient treatments involving low dose rate devices. This is an appropriate standard of care for all brachytherapy treatments. 35.615 (1) (ii) Clarify that "radiation oncology physician" does not include "resident in training." 35.633 (a) (3) Not in favor of 120 day interval for full calibration. This requirement should be deleted because it gives no useful information unless a spot check during this time interval would indicate a deviation from the initial calibration. Full calibration is not necessary for a decaying sealed source. All that should be required is to spot check the calibration. The frequency for this spot check should be monthly. 35.633 (b) (2) Not in favor of the +/- I mm source positioning accuracy. Two millimeter is reasonable for a stepping source for HOR One millimeter of positioning accuracy has no clinical significance. For LDR remote afterloaders, positioning accuracy within five millimeters is appropriate. See AAPM TG-59. 35.633 (b) (3) Not in favor of requirements for source retraction with backup battery upon power failure. This is not feasible for the users to do. This is a preventative maintenance inspection issue conducted by the manufacturer, and not a calibration 3

issue. 35.633(c){l) (i)(A) Delete calibration of the source guide tubes. These are not calibrated and there is no comparison to be made. 35.633(c){l) (i)(B) Timer accuracy and linearity should be included as a separate sentence under the HDR section only. Move this to Section 35.633 (a){2){ii). 35.633(c)(l) (i)(C) Delete the length of connectors because it is included in the source positioning accuracy. 35.633(c)(l) (ii) Clarify that these requirements apply to source tube guides and connectors that are muse. 35.633(c){2) Clarify that these requirements apply to a continuous use machine, and are not

• 35.633 (g) required during quarters when the machine is not in use.

Change this requirement to eliminate that decay corrections must be performed by the authorized medical physicist. Dosimetrists are also qualified to perform decay corrections. 35.643 (c)(2) Delete the requirement for output measurements because the output measurements will not change except for decay correction week to week unless there is a loss of the source which would be detected by currently required survey measurements. 35.643 (d)(6) Delete timer constancy, since it is unclear what this applies to. 35.643 (g) Change the wording in this section to be more flexible, because in some instances a

• back up device may be available which will allow patient treatments to continue without compromising patient safety. For example, if the room monitor was not functioning correctly, it is appropriate to use a second survey meter rather than discontinue scheduled patient treatments until the unit can be serviced.

35.644 (a)(5) Delete timer constancy because it is not a credible source of risk to the patient, with the current timer technology. 35.644 (d) In favor of this requirement for LDR because the unit may not be under constant surveillance. 35.2630 (a) Delete for the "duration of the license." This is overly burdensome and should be changed to "three years after the last calibration." 35.2633 (b) (3) Delete the "source guide tube and connector lengths." These calibration are 4

not applicable as stated above. 35.2652 (a) Delete the requirement for keeping these records for the duration of the use of the unit. Change this to three years instead. 35.3045 (a) (1) This should be changed to the wording used under 35.3045 (a) (2) because it is not important whether these doses differ from the prescribed doses. 35.3045 (a) (l)(i) In favor of this revision - not requiring reporting of under dosages which can be corrected by an additional dose administration and do not adversely effect the patient's treatment. 35.3045 (a) (3) Define how the "dose expected" is determined (such as, maximum point dose, or dose averaged over a volume). Change the "20 percent" to " 120 percent."

• 35.3045 (d) 35.3047 (a)

In favor of this revision - more flexibility in the notification of the patient's referring physician is appropriate. Increase the dose for reporting from 500 millirem to 1000 millirem. There is no significant health effect to an embryo/fetus at a dose of 500 millirem, as demonstrated by the healthy births of children who were exposed to radiopharmaceuticals in utereo for the purpose of diagnosing the mother of these children. 35.3047 (b) Increase the dose for reporting from 500 millirem to 1000 millirem. There is no proven or significant health effect to nursing child at a dose of 500 millirem. The following are general comments on the proposed revision of 10 CFR Part 3 5.

1. The deletion of the requirements for a Radiation Safety Committee allows more flexibility and is favorable for smaller health care facilities, which do not offer therapeutic radiation modalities.

2. The changes in record keeping which do not require initials and signatures are favorable. This will facilitate paperless record keeping systems in the future.

3. The deletion of the Quality Management Program is reasonable because it removes the prescriptive nature of the regulation while retaining the requirements for the written directive and patient identity.

Since ely, ~~ Cheryl ulver Schultz, M .S. Corporate Radiation Safety Officer Cfr35nrc.n98 5

From: To:

                     <nychealth9@erols.com>

lWD2. TWP8(CXH)

                                                                              ~!J 3iJ 35DOuClNER1ro Date:                 Fri, Nov 13, 1998 8:15 AM

( fp3FT?t/361 <,)

Subject:

Comments on proposed Part 35 "98 NOV 17 P12 :23 To cxh@nrc.gov From: Gene Miskin, New York City Dept.of Health- Bureau of Radiological Hea Ftj[:; , ; 1 ADJUCl'>*

Subject:

Comments on proposed Part 35 §35. 75 Release of individuals containing radiopharmaceuticals Comment- This section is inconsistent with §20.1301 . Language in §35. 75 should include an explanation/reason for the apparent inconsistency. §35.290 Training for uptake, dilution and excretion studies and §35.292 Training for imaging and localization studies Comment- I do not think it is possible to obtain the practical experience outlined in these two sections in the 20 hours (two and a half days) or 40 hours (five days) sited successively. Additional general comments for Training and Experience Training and experience requirements for cardiologists wishing to use intravascular brachtherapy sources need to be included in §35 and should be stringent enough to make board certification in Nuclear Cardiology an attractive and practical alternative. When the Part 35 rulemaking becomes effective, Agreement States that have more strict training and experience requirements for non- board certified physicians will not be able to accept as authorized users, those individuals who have met the less restrictive requirements needed to become authorized users on NRC licenses. The private sector organization(s) approved to conduct the exams of non-board certified physicians should be different from those organizations conducting the training. §35.24 Authority and responsibilities for the radiation protection program. Comment: The requirement for a radiation safety committee for medical institutions should be retained. Health and safety issues relating to radioactive materials need to be reviewed on a regular basis by the qualified individuals in an institution that are authorized to use these materials. If the intent is to relieve small institutions from the requirement of having an RSC, the language of the rule should allow for flexibility in determining the makeup of the RSC based on the size and scope of the institution*s programs. Requiring licensee*s management to review the radiation protection program without the collected expertise of an RSC makes no sense and could reduce the evaluation of health and safety matters to a bottom line issue. 2 9

                                                    ~() 3:t .J--3S 1

3 (h FR<135) DO CKETED From: <tconley@kdhe.state. ks. us> To: TWD2. TWP8(CXH) USNRC Date: Thu, Nov 12, 199811:56AM

Subject:

Comments on the Proposed 10CFR35 "98 NOV 17 Pl2 :23 Cathy, _ Attached are comments from the State of Kansas regarding the l Wbs~d ;r changes to 10CFR35. It is in WordPerfect format and if you hav,._~~ ~ b ir . I AFF problems receiving this please let me know. My phone is 785-296-r s-165. Please accept these comments as a timely submittal. We will follow this up with a hard copy also. Thank You (See attached file: Part 35 comments from kansas.wpd) 9

KANSAS DEPARTMENT OF HEAL TH & ENVIRONMENT BILL GRAVES, GOVERNOR Gary R. Mitchell, Secretary November 12, 1998 Cathy Haney U .S. Nuclear Regulatory Commission Washington, DC 20555

Dear Ms. Haney:

After careful review of the proposed revisions to 10CFR35 the State of Kansas Radiation Control Program respectfully submits the following comments:

1. We feel the comment period for a revision of this magnitude has been too brief to allow a comprehensive review of the rule, the licensing guide and the compatibility list. In particular since the rational for the assignment ofthe compatibility issues will not be published until after the comment period has expired it is not possible to perform an adequate review and make comments. Therefore we request an extension to the comment period for the proposed rule, license guide and compatibility list. This extension should be for ninety days after the rational for the compatibility is published .

• In addition, notwithstanding the above comment we submit the following comments:

2. Page 43528 (3)(b) ofVol 63, No 156, August 13, 1998 states: "The proposed rule provides for an overall change in regulatory philosophy. Consistent with a risk-informed, performance-based approach to medical use licensing, the amount ofinformation needed from an applicant to possess and use byproduct material would be reduced. An applicant for an NRC medical use license would have to submit a signed application, documentation of the training and experience of the individuals named on the license, and the facility diagram and list ofinstrumentation. While licensees would be required to develop, implement, and maintain procedures required by the regulations, they would no longer be required to submit these Division of Environment, Bureau of Air and Radiation (785) 296-1565 Radiation Control Program. Forbes Field, Bldg. 283 FAX(785)296-0984 Topeka, Kansas 66620-0000 Printed on Recycled Paper For up to date information on radiation in Kansas visit our website http://www.ink.or~dheybar/barradhtml

procedures as part of the license application. Furthermore, licensees will be provided maximum flexibility in developing their procedures because most of the requirements for procedures provide performance-based objectives to be achieved, rather than a list of prescriptive details that need to be addressed in the procedures." The appearance is that of a reduction in regulatory requirement. However, it actually represents a potentially serious problem to the licensee. The PR in various places require procedures to be written by the licensee. These procedures must be adequate to insure compliance with the regulations. The licensee must certify in the license applications that these procedures exist and will be followed. Without prior NRC review of these licensee written procedures the licensee will have no assurance that upon inspection the procedures will be considered adequate. No licensee wants to leave such serious matters to be decided during an enforcement conference. We think that most licensees after reviewing the above will elect to protect themselves by adopting the model procedures found in NUREG 1556 volume 9. Thus this apparent reduction becomes a pseudo-voluntary requirement that is far more difficult to comply with than the existing Part 3 5.

3. 35.24 Radiation Safety Committee.

Reinstitute the requirement for a Radiation Safety Committee with a graded approach. NCRP Report 127, Section 3 on Organization and Administration of a radiation safety program clearly expresses the importance of a Radiation Safety Committee (RSC) and the responsibilities of a Radiation Safety Officer (RSO). In particular, the NCRP recommends that the primary functions of the RSC is in formulation of the institutional radiation safety policies, review and audit the effectiveness of the radiation safety program, and provide guidance to the RSO on the operational uses of radiation and radioactive materials." Further recommended is The RSC should include individuals who are knowledgeable about the use of the radioactive materials and radiation-producing equipment in the facility". It is recognized that there are a number of committees associated with medical facilities. However, these committees do not necessarily have members who are knowledgeable in the use of radiation-producing equipment and radioactive materials. Therefore, they would not necessarily have the ability to formulate radiation safety policies or review and audit the effectiveness of the radiation safety program. It is also possible and probable that such a committee assigned the RSC responsibility might have it's emphasis on some other aspect of safety other than radiation safety. There is also concern that management would not have the expertise to effectively evaluate the radiation safety program or the qualifications of individuals who would work as authorized users, nuclear pharmacists, medical physicists or RSOs. Also, the absence of an RSC eliminates the buffer between the RSO and authorized Division of Environment, Bureau of Air and Radiation (785) 2%-1565 Radiation Control Program, Forbes Field, Bldg. 283 FAX (785) 296-0984 Topeka, Kansas 66620-0000 Printed on Recycled Paper For up to date information on radiation in Kansas visit our website http://www.ink.org/kdhe/bar/barrad.htrnl

users or the RSO and administration. Report No. 127 clearly defines the responsibilities of the radiation safety office (RSO) as well as the qualifications ofan RSO. The requirement in the proposed 35.24(c) that "A licensee's management shall appoint a Radiation Safety Officer, "who agrees in writing" to be responsible for implementing the radiation protection program" hints at the fact that qualified, committed RSOs have not been appointed in the past. It also implies that without such agreement in writing, the responsibilities of the RSO might not be carried out. Recommend that only competent, qualified and committed individuals be appointed as RSO and that they fulfill the responsibilities as outlined in Report No. 127, Section 3. There sh~uld be provision made to allow for a minimal committee at the lowest levels of usage, but not a minimal one for licensees engaged in research or therapy. If an RSO in a small licensee is going to be a nuc med tech, then the path of responsibility needs to lead to a Committee, not someone at the bottom of the authority chain.

4. 35 .50 Training for Radiation Safety Officer This part requires modification. The section is inconsistent in its specification for the qualifications of a Radiation Safety Officer for a medical licensee, ranging from an "authorized user (or medical physicist or nuclear pharmacist)" through a board certified professional. It also specifies a fixed amount of training (200 hours) for the alternative where none of the other qualifications are present. We believe that the qualifications of an RSO should be specified in terms of competencies, matched to the scope and complexity of the radiation safety program in which the RSO is expected to function. For example, it is neither necessary or practical to recruit a certified health physicist to function as an RSO for a small, focused clinical program which only involves limited low risk modalities, such as routine nuclear medicine diagnostic procedures. Alternatively, it is inappropriate for an "authorized user" to function as the RSO at a large complex program which includes nuclear medicine, radiation therapy, research on humans and which may also involve a Type A license of broad scope.

In such a case, the licensee needs to recruit an individual with a breadth of training and experience that assures competent leadership over the radiation safety program. Suggested language for this Part is as follows: 3 5. 50 Radiation Safety Officer Division of Environment, Bureau of Air and Radiation (785) 296-1565 Radiation Control Program, Forbes Field, Bldg. 283 FAX (785) 296-0984 Topeka, Kansas 66620-0000 Printed on Recycled Paper For up to date information on radiation in Kansas visit our website http://www.ink.org/kdhe/bar/barrad.html

The licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer (RSO) as provided in a35.24 to be an individual who, by training, experience and/or professional certification possesses the competencies required to conduct the licensee's radiation safety program. Those competencies shall be commensurate with the scope and complexity of the radiation protection program conducted by the licensee and shall include: (A) Thorough knowledge of the regulations to be met by the licensee; (B) Expertise in the principles of radiation protection applicable to the medical uses of byproduct material authorized by the license; (C) Expertise in monitoring for radiation exposure and radioactive contamination appropriate for the medical uses of byproduct material authorized by the license; (D) Skill in developing and implementing corrective measures to reduce exposure to by product material radiation and radioactivity; (E) Expertise in monitoring for and using engineered controls to reduce releases ofbyproduct material to the workplace and environment from medical uses authorized by the license; and (F) Expertise in the management and disposal of radioactive waste forms generated by the medical uses of byproduct material authorized by the license.

5. 35.75 A reconsideration of the release criteria for individuals contammg unsealed radiopharmaceuticals is recommended. It should be noted that although this regulation is unchanged from the previous revision comments were specifically requested when it was published in the Federal Register August 13, 1998.

NCRP Report No. 37 "Precautions in the Management of Patients Who have Received Therapeutic Amounts ofRadionuclides, NCRP Report No. 105 "Radiation Protection for Medical and Allied Health Personnel" and NCRP Report No. 124 "Sources and Magnitude of Occupational and Public Exposures from Nuclear Medicine Procedures" all address the need for hospitalization, for radiation protection purposes, following certain therapeutic nuclear medicine procedures .

a. The Reg Guide 8.39 does not take into consideration the dose to convalescent care workers who may have to deal with several individuals.

b. There will be significant added cost to the States due to responding to monitor trips, spills etc.

c. There is a large perceived risk by the public which this change ignores.

d. It is not consistent with other regulations. This allows the release of relatively large amounts of radioactive material which under other circumstances would not be allowed.

e. The 5 mrem/hr at a meter release criteria is useful and easy to understand when technologists or physicians are releasing patients and relate to general risk. The 500 mrem Division of Environment, Bureau of Air and Radiation (785) 296-1565 Radiation Control Program, Forbes Field, Bldg. 283 FAX(785)296-0984 Topeka, Kansas 66620-0000 Printed on Recycled Paper For up to date information on radiation in Kansas visit our website http://www.ink.org/kdhe/bar/barradhtml

to a maximally exposed family member creates another need for more policies to be written that are confusing and many feel that pressure from the HMO's will mandate use of this whether or not the RSO's or Physicians are comfortable with the conditions.

6. Sec. 35.80(a)( 4) is not explicit enough with respect to studies .performed by a a mobile nuclear medicine service on in-patients. Such a study will necessarily result in the mobile nuclear medicine service leaving behind contaminated material in the form of IV tubing, catheters, etc. (i.e., material contaminated by the patient after the study is complete). There should be clear direction as to how the mobile service is expected to handle this waste. If the mobile service is providing nuclear medicine services to an unlicenced facility then the mobile service should be responsible for providing I 0CFRI 9 training to that facilities employees and disposal of of waste generated by the procedures.

7. 35. 92 The requirements for "decay in storage should be removed to 10 CFR 20 as they apply generically to all licensees not just medical licensees. The requirement for holding waste for ten half lives should be retained to ensure licensees do not 'jump the gun" when disposing of contaminated material. A licensee should be able to request a shorter period if for example long lived isotopes are only used in quantities which would decay to background levels in fewer halflives. It is recommended that the phrase "disposal in ordinary trash" be changed to "disposal without regard to radioactivity." As worded the regulation suggests that infectious materials (e.g., syringes, needles, bloody gauze generated in nuclear medicine) can be disposed in ordinary trash.

8. 35.390 Recommend adding (l)(t) "Issuing radiation safety directions in the event of death of the patient or human research subject."

9. It is suggested that all the training requirements in Subparts D - H be eliminated and clearly stated in Subpart J. For example, clearly state the three alternatives:

I. NRC approved certifications, not requiring further NRC approval (i.e., notification only required, no requirement for amendment to be named on a license before use). This section should include the list of board certifications that the NRC accepts by regulation.

2. Equivalent training not requiring further NRC approval (i.e., notification only required, no requirementfor amendment to be named on a license before use). This would be those requirements listed in Secs. 35.910(b), 35.920(b), 35.930(b),

35.932(b), 35.934(b), 35.940(b), 35.941(b), 35.950(b) and 35.960(b). Division of Environment, Bureau of Air and Radiation (785) 296-1565 Radiation Control Program, Forbes Field, Bldg. 283 FAX (785) 296-0984 Topeka, Kansas 66620-0000 Printed on Recycled Paper For up to date information on radiation in Kansas visit our website http://www.ink.org/kdhe/bar/barradhtml

3. NRC approved certifications not adopted by regulation, and which require further NRC approval prior to allowing the use of licensed materials (i.e, the user must be named on a specific license). These are the requirements currently listed in Secs.

35.290(b), 35.292(b), 35.390(b), 35.490(b), 35.590(b) and 35.690(b). ick L. Cooper Chief Radiation Control Program Bureau of Air & Radiation Thomas A. Conley, CHP Public Health Physicist Bureau of Air & Radiation Radiation Control Program Division of Environment, Bureau of Air and Radiation (785) 296-1565 Radiation Control Program, Forbes Field, Bldg. 283 FAX(785)296-0984 Topeka, Kansas 66620-0000 Printed on Recycled Paper For up to date information on radiation in Kansas visit our website http://www.ink.org/kdhe/bar/barradhtml

J{)1 3 ~J-35 ( '13 FR 'I 35l fo} From: <Kirksey_Whatley/HCS/Alabama_Department_of_Public_Health@adph.state.al.us> To: TWD2.TWP8(CXH) Date: Thu, Nov 12, 1998 5:09 PM

Subject:

Additional Comments on Draft Changes to 10 CFR Part 35

                                                                                           ~

CJ z c::> co

• I U>o

                                                                                           -..J zA
                                                                                                * ..., fTl
                                                                                                . - -4 fT1 To: Catherine Haney                                                                         :9          CJ N

U.S. Nuclear Regulatory Commission -~ I N 77 11 w Please accept the following additional comments regarding the draft changes to 10 CFR Part 35:

1. I have given additional thought to my previous concern that radiation safety procedures would no longer be required to be submitted with an application for a nuclear medicine license. For certain large hospitals and institutions this is not as great a concern as it is for the smaller hospitals and private practice clinics who have minimal staffing, and perhaps even minimal training and experience (this represents the majority of medical licensees located in this State). Time, and maybe the needed adeptness to adequately modify procedures, may often be lacking in smaller facilities.

If any licensee is allowed to develop and/or modify procedures without prior NRC approval, the licensee can never be assured that the procedures are adequate until reviewed and evaluated by the inspector. A licensee, believing that procedures are adequate, will likely be disturbed to find otherwise. The burden will be placed upon the inspector. I believe that my earlier comment that a procedure similar to the NRC/Agreement State Management Review Board review process may be necessary to resolve differences may very well be valid .. Question: Has the working group considered allowing applicants to submit procedures with the application and have NRC comment on the adequacy of those procedures before the license is issued? This would appear to provide the applicant some degree of surety that the procedures were acceptable. Adequacy would, as always, be determined by inspection. I have a philosophical problem with this concern in that I believe that a review of procedures prior to the issuance of a license helps prevent incidents/mistakes from happening. To review procedures only in response to incidents/mistakes is simply foreign to my training and experience.

2. I believe that the Radiation Safety Committee, when it functions properly, can play a vital role in radiation safety at a large hospital

11/1&,/9 8 I l.o

             .               ~

"?])£ 1 J< I 'P-S /

and/institution. I believe that the committee is important enough to warrant the name Radiation Safety Committee and not be incorporated into another committee. The relationship of a committee with management is much more effective that one individual's relationship (ie; the RSO). I agree that with "small licensees" a committee is impractical. Any licensee doing research and multiple, complex procedures, with numerous physicians should benefit from a functioning Radiation Safety Committee. The Radiation Safety Committee should be preserved for certain types of licenses - especially for all types of complex, multiple discipline licenses.

3. I am aware of the "controversy" over what to do about release limits for therapy patients. At the All Agreement States Meeting on October 31 ,

1998, a paper was presented that would lead one to believe that minimal concern was needed regarding releasing patients if they were properly instructed. I believe that the paper failed to address all areas of concern associated with this subject. I also believe that the author was on the right track but that the study was not complete. Without any evidence to justify a change in release criteria, I recommend that, at minimum, current criteria be maintained until further studies are completed. Although perhaps of not much concern to some licensees, contaminated waste from released therapy patients does find its way to waste landfills and sets off alarms. Even though iodine-131 on a diaper in a landfill poses no significant hazard, a response from the regulatory agency is always necessary to rule out other radioactive material which might actually pose a hazard. That effort is always time consuming and expensive, both for the landfill operator, the waste collector, and the regulatory agency. Although lacking supportive data, I believe that increases of patient release limits will lead to increased landfill incident responses. If the material at a landfill is not readily identifiable, what Federal Agency would be expected to respond to a landfill alarm?

4. With a change in training requirements and a need for passing competency examinations, what provisions are made for physicians, pharmacists, physicists, and RSO's currently listed on licenses to continue to practice after the rules go into effect? Are there "grandfather

provisions? If a physician currently listed on a license moves (three years from now) to another state, and applies to practice nuclear medicine on a "new" license, will he/she have to meet the new training criteria? If "grandfathering" is to be considered, is there a provision for such in the draft rule? Perhaps I have overlooked an explanation of these questions in the rule. Again thank you for the opportunity to offer my comments.

CC: GATED.nrcsmtp("dwalter@adph.state.al.us") DOCKETED John Peter Jacobus USN RC Radiological Health Physicist 3050 Traymore Lane . 98 NOV 16 p 3 :O 2 Bowie, Maryland 20715-2024 (301) 464-1518 OH IC~-

• Ru U~ ,

ADJUL: N*._()ve.~ef-12,

                                                                                          ~i.,. 1 1998 do() 3~ .,._.35 Secretary                                                            ( fo3Ff<'/351 ~

U. S. Nuclear Regulatory Commission Attention: Rulemakings and Adjudications Staff Washington, DC 20555-0001

Dear sir or madam:

The Federal Register Notice of August 13, 1998 (Volume 63, Number 156, Pages 43515-43580) requested comments to the Proposed Revision to the Medical Use of Byproduct Material be submitted. I have been the Radiation Safety Officer at two military hospitals, and have maintained an active interest in hospital health physics. Following a review of the draft revision, I would like to submit the following comments. Sec. 35.13 License amendments. A licensee shall apply for and must receive a license amendment-- (c) Before it changes Radiation Safety Officers;

• This seems confusing to me as, in the discussion of this part, you indicate that if the RSO abruptly leaves, the licensee should consider appointing an authorized user as the RSO.

This is not indicated in the draft regulation, and could leave open the question of how long the licensee is permitted to have a temporary RSO. I think it should say "changes permanent Radiations Safety Officer," and require that the licensee appoint a nt:w, permanent RSO within 30 days. Sec. 35.24 Authority and responsibilities for the radiation protection program. (c) A licensee's management shall appoint a Radiation Safety Officer, who agrees in writing to be responsible for implementing the radiation protection program. The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements in the daily operation of the licensee's radiation protection program. (d) A licensee shall establish in writing the authority, duties, and responsibilities of the Radiation Safety Officer. (e) A licensee shall provide the Radiation Safety Officer sufficient authority, organizational freedom, time, resources, and management prerogative, to-- 8 1998

LA J '"""'""" HE ~:iFTAl~Y HE CO t~~3:cl:i~

Comments on draft revision to 10 CFR 35 I believe that requiring the appointed RSO to agree "in writing to be responsible for implementing the radiation safety program" may raise legal and ethical questions. First, you are directing the licensee to establish a condition of employment on the RSO that may be beyond the normal hiring practices of the licensee. Should the authorized user, authorized nuclear pharmacist, or authorized medical physicist be required to make similar commitments to the radiation safety program or their assigned duties? Second, this clause may allow the licensee to sue the RSO for "a breach of contract" if it believes that the RSO did not fulfill the commitments if violations were noted during inspections. Does this allowing the licensee to reduce its responsibility to supply the necessary resources in support of the radiation safety program? Third, while RSOs are required for radiography (10 CFR 35.41) and irradiator (10 CFR 50) licenses, you do not require a written commitment. Are their operations less of a radiation safety risk to the workers or to the general public? Fourth, if the licensee appoints an authorized user to be a temporary RSO, does this individual have to agree "in writing to be responsible for implementing the radiation protection?" I would also point out that there is no comparable paragraph or statement similar to the draft Section 35.27(d) that states that the "licensee ... is responsible for the acts and omissions of the supervised individual." Does this imply that the RSO is solely responsible for supervised staff? Sec. 35.27 Supervision. I note that there are no requirements for written commitment to implement any of the assigned duties delineated in this section that is required of the RSO. In addition there is no Please feel free to contact me if clarifications of these comments are needed. Sincerely, 2

e NATIONAL 1412 Willowood Court P~ £-r-'N""i,...,._.,_ CONSULTANTS, Ltd. Facsimile (440) 350-1239 Painesville, Ohio 44077-5471 Phonemail (800) 790-3032 Telephone (440) 350-1242 or (440) 975-2176 NOV 1 6 1998 November 9, 1998 \\, DOCKET PROPOSED :io 3fl~35 Secretary -............. , ____ ~-~ ,.,. U.S . Nuclear Regulatory Commission F'R <l35t i) Att. Rulemakings and Adjudications Staff Washington, DC 20555-0001 To whom it may concern, I am writing to comment on the proposed revision to Part 35. We are a consulting medical physics firm with members having as much as 25 years of experience. We consult to medical facilities of all sizes, from private physician offices to broad scope facilities. I believe the breadth of our experiences can provide some useful insights. Regarding the direction of the proposed changes, we agree with the goal to make Part 3 5 less prescriptive. Some of the current Part 3 5 requirements are excessive for smaller facilities. A lot of time and effort has gone into complying with the prescriptive requirements of Part 35 but resulted in no benefit to the radiation safety program. Further, the prescriptiveness prevented reasonable variations in the more minor procedures and recordkeeping documents that have trivial impact on the radiation safety program. Giving more latitude to the licensees in these areas is admirable. We also agree that it is unnecessary to submit as many radiation safety procedures in the licensing process. A lot of time was unnecessarily spent arguing with license reviewers about minor details in these procedures. And a lot of facilities were required to accept procedural details that have no safety impact and are excessive for the particular facility. However, these details are considered necessary by the license reviewer simply because the detail is in the licensing guide and the reviewer is uncomfortable accepting alternatives. We do not agree with the proposal to separate the recordkeeping and reporting requirements from the paragraphs to which they apply. We see no benefit in this separation. We find the similar separation in Part 20 confusing. Often, one must flip back and forth between a regulatory paragraph and its associated recordkeeping paragraph several times to fully grasp the regulatory impact. A number of individuals have misinterpreted sections of Part 20 simply because of this separation. Further, the grouping of the recordkeeping requirements would primarily be of benefit only to auditors of the records alone. The facility would rarely want to do this. The separation of the requirements would be of no particular benefit to the facility in determining their regulatory commitments. In the past, grouping these recordkeeping paragraphs together may have been of value to the NRC inspectors. However, this would run counter to the NRC's proposed philosophy of performance-based inspections. We recommend the NOV , 8 1998-Aeknowfedoed by card ....___ .......-

UCLEAR REGULATORY COMMISSION ~MAKINGS &AOJUDK'ATIONS STAFF OFFICE OF THE SECRETARY OFlllECOMMl~ION

recordkeeping requirements be kept with its associated regulatory requirements. We feel that the requirement for a radiation safety committee should be left in Part 35. This committee provides great utility to the facility in maintaining its radiation safety program, provides a venue for the radiation safety officer to be more effective, and provides a useful and necessary mechanism for information exchange. This is true even for small facilities. However, the prescriptive requirements of the current Part 3 5 should be reduced. Many of the complaints concerning the committee requirements are due to this prescriptiveness. By reducing the prescriptiveness in the requirements for membership, frequency of meetings, and minutes, management will be given more flexibility in meeting the regulations, but still maintain an effective committee. Also, the requirements for the committee can be a function of the authorizations for which the facility is licensed. For example, a facility licensed for 35.100 and 35.200 only, may on!y need to have a committee meeting annually, while a facility licensed for 35.400, may need to have the committee meet quarterly. Having a nursing representative on the committee can be required only if the facility is licensed for inpatient therapies from 35.300 or 35.400. Having one set of requirements for all types of licensees does not work well. There is an area of inconsistency in the training requirements. To be named as an RSO, if not board certified, requires 200 hours of didactic training and one year of experience. However, an authorized user is automatically accepted as an RSO. The inconsistency is that, to be an authorized user under 3 5.292, if not board certified, requires only 80 hours of didactic training and only 40 hours of experience. To be consistent, either the training requirements for an RSO must be reduced (especially if a competency statement and exam are required) or additional requirements should be placed on an authorized user before they are considered acceptable as an RSO. We have some problems with 35.200 being redefined as imaging procedures not requiring a written directive and 35.300 being redefined as those procedures using unsealed material requiring a written directive. In effect, this removes the procedure for whole body imaging using I-131 sodium iodine from 35.200 authorizations to the 35.300 authorizations. This would prevent physicians that are imaging specialists from performing the procedure and allow physicians who are therapy specialists to do the procedure. The obvious, and commendable, concern is that I-131 produces significant doses to the patient, even at diagnostic dosages, and the material should be supervised by individuals trained in the use and hazards of I-131. A misadministration of a diagnostic dosage of I-131 will produce biological effects. However, the diagnostic procedure is an imaging procedure. Would not the best choice for the supervision of the procedure be an imaging specialist? There are a number of physicians who are authorized for therapeutic procedures only. These physicians are not experienced in the establishment of imaging procedures, the necessary QC procedures for the imaging equipment, the collimators or imaging parameters to be used for optimal image quality, or the interpretation of the results. The ideal candidate to supervise these procedures would be a physician authorized for both 35.200 and 35.300. However, if they are not authorized for both, do you exclude the

imaging specialist and automatically approve the therapy specialist? The whole body 1-131 imaging procedure is a true cross-over procedure, with arguments both for and against inclusion in 35.200 or 35.300. The procedure does not readily fit into either category. Perhaps the procedure should not be shoe-homed into either category. We propose that the use ofl-131 sodium iodide for diagnostic procedures (over 30 uCi) be listed as a line item authoriz.ation and not included in either 35.200 or 35.300. Physicians authorized for both 35.200 and 35.300 would be automatically approved for 1-131 diagnostic procedures. Physicians authorized for 35.200 but not 35.300, or vice versa, would be required to show additional training in that procedure (maybe five cases to be consistent with 35.390). Physicians currently authorized for 35.200 would continue to be authorized to supervise 1-131 diagnostic procedures In the proposed 35.390(b), to be an authorized user for 35.300, if not board certified, requires 40 hours of practical experience nt a medical institution. The requirement that the experience be at a medical institution is excessive. Acceptable training can occur at clinics, especially for treatments for hyperthyroidism. Some clinics perform more of these therapies than do a lot of hospitals. It is especially valid that the training will be acceptable at a clinic if a competency statement and an examination are required. The proposed 35.60 deletes the requirement for a dose calibrator for facilities that use only unit doses. We believe the requirement for a dose calibrator should remain. There have been many instances where a radiopharmacy has sent a mislabeled dose and it was caught before administration because it was checked in the dose calibrator and was found to be the wrong activity. This is an extra concern for 35.300 materials. Also, few facilities will benefit from this regulatory change. While most facilities no longer use generators, most do need to make kits on occasion or to adjust the dosage received (such as when a dose is to be used earlier than it was calibrated for). However, an exemption for emergency use should be provided. For example, when a dose calibrator is out for repair, authoriz.ation to administer the dose without assaying it in the dose calt'brator should be provided if it is for emergency use only and only if the dose was received as a unit dose. Currently, in these cases, a facility must get a loaner/rental and perform all the tests on it before it can be used. This.is often difficult and time consuming. An option to use unit doses only in the interim would be acceptable to most facilities and would not introduce significant risk. We agree that the frequency for the dose calibrator linearity test should be annually as stated in the proposed 35.60(b)(3). We have evaluated and/or performed thousands of linearity tests over many years. The frequency of dose calibrators that truly fail this test is extremely low. And in virtually every case, there has been another indicator of dose calibrator failure. The current requirement to perform this test quarterly is excessive. In the proposed 35.65(d), we agree that the limit on the amount ofTc-99m that can be used as a calibration source should be removed. Often large amounts ofTc-99m must be used to perform the linearity test on dose calibrators.

There is a typo in 35.65(c). The activity in parentheses should be 200 uCi. We agree with the proposed changes in 3 5. 67, Requirements for the possession of sealed sources and brachytherapy sources. The current requirements are excessively restrictive. Changing the inventory requirement to semi-annual is appropriate so as to be consistent with the requirement for non-medical licensees. We agree with the proposed changes in 35.92. Increasing the half-life for radionuclides that may be stored for decay to 120 days is appropriate, useful and consistent. Further, we agree that eliminating the requirement to hold waste for at least 10 half-lives is appropriate. A lot of the waste generated in medical facilities is minimally contaminated to start with. The material often decays to background levels in less that 10 half-lives. The requirement to retain the waste for the longer period just adds to the volume of waste that has to be stored without benefit. Many facilities do not have a lot of storage space. We agree with the proposed changes in 3 5. 315 with one exception. The requirement in (a)(l) that the patient shall be in a private room should be changed to allow the patient to be in a room with other patients who are being confined for compliance with 35.75. This sharing of the room with another therapy patient is authorized under 35.415 for brachytherapy patients. The exposure from one therapy patient to another is trivial as compared to the therapeutic dose they will receive. In 35.432, Full calibration measurements ofbrachytherapy sources, paragraph (d) requires that brachytherapy sources be caltbrated with an instrument described in 35.630(a). We are not sure that this isn't overly restrictive. The instrumentation historically used for the 35.630 requirement is a devices used for teletherapy applications. This device may be appropriate for HDR applications, but may not be effective for manual brachytherapy sources. Some manual brachytherapy sources contain less than 1 mCi producing an exposure rate that is perhaps too low to be accurately measured with a teletherapy device. It is hoped that other types of caltbration instruments are not excluded from use with manual brachytherapy devices because of the reference to 35.630. The best calibration device for many manual brachytherapy sources is a well type ionization chamber (essentially an appropriately calibrated dose calibrator). Also, a number of facilities perform brachytherapy, but do not perform teletherapy. These facilities would not have the instrumentation historically associated with 35.630. Requiring these facilities to purchase an electrometer with a Farmer-type chamber instead of a well type ionization chamber would be inappropriate. Your consideration of these concerns is appreciated. We find the reporting requirements of35.3047, Report of a dose to an embryo/fetus or a nursing child to be excessive. This is especially true at the reporting level of 500 mrem. Biological effects are not expected at this level. Concerning the nursing child, section 35.75 requires that instruction be provided to patients who are nursing children if the child could receive a dose in excess of 100 mrem if there was no interruption in breast feeding. Surely, the NRC is not suggesting that these patients be monitored to assure they are complying with the instructions. And, if not, then facilities would not know that the 500 mrem dose has been exceeded. Therefore, there would be no knowledge of any instance to report. We feel this reporting

requirement will achieve no benefit as there will be no reports, even if the events occur. Concerning the dose to the embryo/fetus, we feel the reporting requirement to be of no benefit at this level. Perhaps a requirement to make a record of such instances may be useful. This information may be of use in improving procedures to minimize such events in the future. Any reporting of these instances, if any, should be limited to those cases when biological effects are more likely. A reporting level of 5 rem would be more practical. Thank you for considering these comments. If you have any questions, feel free to contact us. Sincerely,

 ~~

David Close, Physicist

DOCKETED USNRC l\1EMORANDUM "98 NOV 16 P3 :O 1 TO: Secretary, U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 Attention: Rulemakings and Adjudications Staff FROM: Robert D. Forrest, CHP 1412 Blockley Hall Philadelphia, PA 19104-6021 DATE: November 11, 1998 RE: Comments on the Proposed 10 CFR 35 Revision and NUREG SR1556, Vol 9 I submit the following comments for the proposed revision to 10 CFR 35 and NUREG SR1556, Vol 9. The comments are referenced to the applicable sections as they appear in the proposed regulations. Thank you for your time and consideration. Proposed 35.l0(e) and (g) Comment: This regulation effectively eliminates any regulatory burden relief offered by the proposed regulations. If the NRC believes that a regulation can be relaxed or eliminated without a reduction in radiation safety then the NRC should allow licensees to change their programs accordingly without license amendment. Proposed 35.ll(a) Comment: Changes in the health care environment have created affiliations between hospital groups which may or may not be under a single NRC license. This regulation can prohibit the cost savings created by these affiliations not under one license. For example, if a Radiation Oncology group from a large hospital network provides services to a smaller hospital under a different NRC license, the Oncology group cannot order seeds for a permanent implant under the license of the large hospital and transfer the seeds to the smaller institution. This may cause the smaller hospital to pay higher costs because of this regulation. If the sources are received from a licensed distnbutor and handled properly, there should be some flexibility in transferring the sources between licensees. Proposed 35.24 Comment: The regulations should require a radiation safety committee (RSC) for all medical licensees. The RSC is a extremely important management tool that enables the radiation safety officer (RSO) to effectively perform his/her function. The RSC transforms policy decisions from the perception of unilateral decisions by a single individual to consensus decisions made by peers of the authorized and supervised users. NOV 1 8 1998 Acknowledoed by card,, ..... , ,,., .,.,.,,,.,...-.=

t.J.S. NUCLEAR REGULATORY ~ 0 0 RULEMAKlNGS & A D ~ m'AFF OFFICE OFTHEset'REfARY OF T H E ~ *

             ~~

Postmark Oam--~----- CopiGs RGOOM,d-~~~~-- Add'I Cof;s ~ - - - - - Spooal ~ - - - - - -

The NRC in NUREG 1516 stated that the RSC is just as important as management and the RSO in a successful radiation safety program. This guidance is still valid and should guide the NRC in this particular rulemaking. The regulation, however, does not need to be as prescriptive as the previous regulations. The NRC should give the RSC a broad charge (e.g., oversight of the radiation safety program and development of radiation safety policies). The licensee should be given significant flexibility to determine the membership of the RSC (although requiring a management representative and the RSO would be a minimum), establishment of a quorum, meeting frequency, etc. In this manner, the licensee can develop a committee which meets its needs. Without the requirement for a RSC, the NRC is setting the RSO (and consequentially, radiation safety programs) up for failure. This is contrary to the NRC responsibility to promote the health and safety of the public, patients and workers. Proposed 35.26(a)(2) Comment: The regulation, as written, is too ambiguous and subjective. The licensee should be permitted to make any change to its radiation protection program that is in compliance with all applicable regulations and all applicable license conditions. Proposed 35.27(d) Comment : By explicitly stating that the licensee is responsible for the acts and omissions of individuals performing supervised activities, it implies that the licensee is not responsible for the acts and omissions of authorized users nuclear pharmacists, medical physicists, and radiation safety officers. This regulation should be e1iminat.ed. Proposed 35.40(a) Comment: The requirement for a written directive indicates that the authorized user mll$1 be prepared, dated, and signed by the authorized user. A licensee would, therefore, be in non-compliance if the written directive was prepared by someone other than the authorized user even if the authorized user signed the directive. Also, senior NRC staff have stated publicly that a supervised physician may sign the written directive but regional inspectors have interpreted the regulation differently. Therefore, the regulation should explicitly indicate that either that the written directive may only be signed by the authorized user or that a physician under the supervision of the authorized user may sign the written directive depending on regulatory intent. Proposed 35.40(b)(6)(ii) Comment: This requirement means that the physician is in non- compliance if he/she indicates the total dose on the written directive prior to implantation. This is overly prescriptive. The words, "After implantation but" should be deleted. An example where strict compliance with this regulation as written is dangerous is the use of Sr-90 eye applicators. These procedures take on the order of a minute. So does the NRC really want the physician to be writing and signing a directive (to his/herself) while at the same time holding the applicator in position?

Proposed 35.49 Comments: The wording of this regulation needs to be improved to make it clear that only sealed sources or devices manufactured, labeled, packaged, and distributed in accordance with a Part 30 and Sec. 32.74 license may be used for medical use. As worded, the regulation can be interpreted to mean that the sealed sources or devices manufactured, labeled, packaged, and distnbuted in accordance with a Part 30 and Sec. 32.74 license may be used only for medical use. If the latter interpretation is used, Cs-137 brachytherapy sources could not be used for shielding evaluations because this is not a Omedical use6. Secondly, does the rules eliminate the use of sources and devices from international manufacturers that may not have an NRC or agreement state license to manufacture, package and distribute said sealed source or device? Proposed 35.50 Comments: The section is inconsistent in its specification for the qualifications of a Radiation Safety Officer for a medical licensee. The RSO can either be: (1) Board Certified and have a Preceptor statement; (2) Have training (200 hours) and experience (1 year) and have a Preceptor statement; (3) an authorized user, pharmacist, or physicist with Oexperience6 with radiation safety aspects of similar uses. Inconsistencies include: (1) Board Certification demonstrates a level of competence much higher than number (2) or (3) yet this individual still needs a preceptor statement (0 ... certification process includes all the requirements in paragraph (b) of this section ... 6- Paragraph (b) requires a* Preceptor statement). (2) Training and experience: 200 hours and 1 year of experience is not even close to the training and experience requirements for. ABHP certification nor most certification boards. (3) Authorized Users, Pharmacist, or Physicists: These individuals do not need a Preceptor statement nor are they required to have the same required 200 hours of training requirement and one year of experience as the Oqualified individuals6 listed in number (2). The requirements for each category should be equivalent.

Proposed 35.61 Comment: Calibration of survey meters is covered in 10 CFR 20, so the specific requirements for survey meter calibrations should be eliminated from 10 CFR 35 (as have the specific requirements for performing surveys). Proposed 35.62(b)(2) Comment: The word "tests" should be between "accuracy" and "anm1a11y" Proposed 35.63(b) Comment: This regulation requires a licensee to decay correct or directly measure alpha, beta, and photon emitting unit doses of radionuclides. Currently, licensees can use the manufacture6s measurement for alpha and beta emitting nuclides. Is there really a need to decay correct unit doses of long lived isotopes (e.g., Sr-89) from the exact

• calibration time listed by the manufacturer? The old rule seemed to be acceptable.

Proposed 35.63(<1) Comment: Diagnostic procedures have generally been viewed as low risk procedures and therefore, ranges of prescribed activities have been allowed. The proposed rule appears to require a specific dose be prescribed for diagnostic doses and a dose should not be used if the it varies from the prescribed dose by more than 20 %. If ranges will no longer be acceptable, why? If ranges are still acceptable, how will .the rule be enforced? Proposed 35.65(a) Comment:

1. 11 kBq should be 1. 11 MBq Proposed 35.67(a) and (g) Comment:

The phrase "any sealed source" includes small check sources, exempt sources, etc. Are we really supposed follow and retain the mfg. instructions for check sources attached to survey meters? Sources distnbuted as exempt quantities should be excluded from this requirement. Proposed 35.92 Comment: This is a positive change to the regulations. Is there a reason that storage for decay requirements are not included in 10 CFR 20 instead of 10 CFR 35? The need for a specific license condition on non-medical licenses would be e1iminated by moving the requirement to Part 20. Proposed 35.3045 Comment: The proposed Medical Policy Statement states that the ONRC will not intrude into medical judgments affecting patients, except as necessary to provide for the radiation safety of workers and the general public.6 However, the ONRC will, where justified by the risk to patients, regulate the radiation safety of patients primarily to assure the use of radionuclides is in accordance with the physician6s directions. 6

The more than 20 % standard seems to be arbitrary and may in fact cause little or no risk to the patient. Nevertheless, the licensee must give the patient the appearance of risk by informing them and a Federal agency of the O:medical event6. The 20% threshold should be examined and justified. Furthermore, the use of effective dose equivalent concept in medical applications is questionable because as stated in ICRP 26, Othe values of wT (weighting factors) given in paragraph 105 are recommended as appropriate for the protection of WORKERS6. Proposed General Training and Experience Requirements Comments: Although the proposed revisions offer more realistic training and experience time requirements over the current requirements, do these standards provide any level of added worker or general public protection. Is each licensee and their radiation safety officer any less responsible for the actions of their physicians if the physicians have completed the training and experience requirements? In general, what is the goal of these requirements and how do physicians meeting these established requirements accomplish that goal? General Comments: The vast majority of changes to Part 35 are extremely beneficial. Many of the prescriptive regulations have been correctly removed from the regulations. These include but are not limited to, the elimination of the requirement for daily surveys, weekly wipes, weekly waste surveys, and requirements for controls of aerosols and gases. NUREG 1556, Vol. 9 Proposed Appendix R Comments: 1-125 is included with 1-129 and transuranics in Table R.3, Acceptable Surface Contamination Levels in Unrestricted areas in dpm/100 cmA2. Some justification for the inclusion of 1-125 with transuranics should be given. Proposed Appendix U Comments: Example 2, Thyroid Cancer in Supplement B to Appendix U shows a release calculation for the administration of 200 mCi of 1-131 using the standard assumptions. In the example the patient is deemed releasable because the calculated dose to a member of the general public is 453 mrem and therefore less than the 500 mrem limit. This calculation does not include a contribution for internal dose which is shown in example 4, Internal Dose. This example states that Olnternal doses may be ignored in the calculations if they are likely to be less than 10% of the external dose ... 6. In the 200 mCi dose example the dose from internal is 106 mrem which is 23 .4 % of the dose from external. Because the internal is greater than 10% of the external, the internal should be included in the calculation. The patient receiving a 200 mCi dose would therefore not be releasable based on the standard assumptions. Either the example should be corrected or the internal requirement should be modified.

                                                                                                              @)
                                                                      ,J. O 3 ~ <t~S-          DOCKETED

( ltJ3 Pf!i/35 lt,j USNRC Comments on proposed 10CFR35 Given the regulatory climate in which we work, I generally agree with and support the o;~n ~ osdffiiy p 3 :Q1 and direction of the proposed rule. OF:: l*.. Section 35.6 - There are occasions when a clear definition of what constitutes a rese~~ ~ ~ure -;1 F would be useful in deciding which procedures must be approved by the IRB or the RadiatJ.on Safety Committee. Broad scope licensees should be exempted from the requirement to amend their license. Section 35.24 - The requirement for a Radiation Safety Committee should be retained. Both the RSO and the management representative should be members of the committee and must be present for the committee to function. It should also be made clear that 'management' refers to upper level administration with overall hospital responsibilities and not to a departmental administrator. According to NUREG-15 16, "Management of radioactive material safety programs at medical facilities", hospital management, the RSO, and the users represented by the committee form three legs on which the radiation protection program stands. The proposed regulation knocks out one of those legs. Unless management participation in the committee is required, management will not participate, and the committee will not be effective. Committee support for the RSO is essential in obtaining management backing and resources. While the RSO is responsible for implementing the radiation safety program, a successful program requires both management backing and user support. Section 35. 75 - I support the current regulation for release of patients. Section 35.92 - Elimination of the 10 half-life holding period is appropriate and a welcome change. This should be included in 10CFR20 and apply to all licensees. Section 35.315 - Agreed. Section 35.415 - Agreed. Subpart L - Agreed. Subpart M - Agreed. Sections 35.60 and 35.62 - Changing the linearity check from a quarterly test to an annual one is appropriate and welcome. The proposed tests for instrumentation used with beta-emitting radionuclides should be clarified. In particular, acceptable sources for these tests should be specified as in Section 35.60 for gamma emitters. Initial accuracy and geometry tests clearly should be performed with each beta-emitting radionuclide that will be used clinically. Later accuracy, linearity and constancy tests performed with a gamma emitter would show that operation of the instrument has not changed, and therefore the tests described in Section 35.60 would apply. This should be stated explicitly, since beta-emitting sources suitable for testing dose calibrator accuracy can cost over $2000. Comments prepared by and Kenneth H. Douglass, Ph.D. Director, Radiation Safety Radiation Safety Officer WVU Radiation Safety P.O. Box 9006 Morgantown, WV 26506-9006 November 11 , 1998

.. r ..

West Virginia University Hospitals, Inc. West Virginia University

OOCKFTED November 12, 1998 1t,3 FR t/35!"} US!h<C Secretary, U. S. Nuclear Regulatory Commission Washington, DC 20555

                                                                            °98      OV 16 P3   :oo Attention: Rulemakings and Adjudications Staff OF.

Reference 63 FR 43516, Medical Use of Byproduct Materials, PropoJ ..~~yi~ions Comments due: November 12, 1998 Nebraska Health and Human Services Regulation and Licensure, Radioactive Materials Program submits the following comments on the significant regulatory issues, selected specific issues identified for public comment, and the compatibility designations for Agreement States (a request for extension of the comment period is made under "Compatibility"). SIGNIFICANT REGULATORY ISSUES A. Training and Experience - Two areas should be addressed in greater detail by the proposed revision. The first is training for the nuclear medicine technologists who typically handle the radioactive materials. The Commission has chosen to focus on the written directive for the higher risk radioactive materials as the mechanism to ensure health and safety are protected. It would be more straight-forward to require minimum education and training requirements for the technologists. A test for competency could also be included in the requirements. The second area is training for the Therapeutic Use of Unsealed Sources and the proposed "deletion of specific training and experience requirements for treatment of hyperthyroidism and thyroid carcinoma". Physicians who are authorized for use via the training and experience requirements frequently request to be authorized for a new therapy using the preceptor approach. A blanket requirement for "5 cases for each procedure" may not always be appropriate. For the therapy cases, it may be necessary to continue to list the procedures and the number of required cases in the regulations. This particular area seems to fall between specialties as many doctors are authorized for diagnostic and then preceptor in for the therapeutic uses. The oncology certifications seem to address only sealed sources. B. Quality Management Program - We agree with deletion of the OMP. However, as noted above, training and experience requirements for technologists may enhance health and safety. As stated in the proposed rule, misadministrations occur because individuals did not ask questions. There should be a better mechanism than just requiring another procedure be written. C. Reportable Events - We concur with the proposed name change and the rule as proposed. D. Precursor Events - We support deletion of any reference to "precursor events" in this rule.

E. Radiation Safety Committee - This requirement should not be deleted. It is a vital part of the Radiation Safety Program and functions to bring different departments and disciplines together and specifically focus on radiation safety. This should not be diluted by allowing another committee to take over the role as part of a larger mandate such as environmental issues. We would support retaining the requirement for the membership to include a representative of management, the RSO and representative(s) of the use areas as determined by the licensee. The prescriptive requirements for quarterly meetings could be changed to "six months or at a minimum of annually" F. Notification - We support the rule as proposed. G. General - We do not support deletion of submission of procedures. The review of procedures during application and renewal process is a good mechanism to ensure that the licensee has established procedures that will be likely to keep their program in compliance with and performing to protect public health and safety. Typically, this is a good opportunity to see if their program is current with the regulations. Most licensees do not routinely revise procedures and therefore, this is an area that does not need to be "fixed". - In addition, we support adding a section which clarifies the specific responsibility of the authorized user. This is only indirectly addressed under the supervision section. It may be appropriate to consider that the authorized user has responsibility to select the patient, prescribe the study, evaluate the results, and for therapy-administer the dose. - There are several places where it states the NRC assumes most IO CFR licensees would have a particular item/practice as part of their radiation safety program. If this item/practice is important enough to assume that it is in the licensee's radiation safety program, why not keep the requirement in the regulations to ensure that it is followed. It seems like licensees provide and do only what is required to comply with the regulations, opening up the regulations to general interpretations of a philosophy like ALARA and taking away specific requirements to ensure ALARA practices are followed, allows for numerous interpretations of the regulations and will make it hard to regulate. SPECIFIC ISSUES IDENTIFIED FOR COMMENT (selected)

1. Training and Experience - We support the requirement that the examining organization and the instructing organization not be the same. The requirement for a competency exam serves to enhance radiation safety and is warranted.

4. Radiation Safety Committee - Deletion of this requirement will impact negatively on the licensees effectiveness in carrying out its radiation protection program. We would support relaxing the frequency of the meetings, especially for smaller programs, but think an annual meeting should be a requirement. If the requirement for a RSC is retained, then both the RSO and a representative of management should be explicitly identified as members.

5. Patient release criteria - We support the current rule. However, additional language may be required to ensure that the patient that is released is going home to an area with relatively low exposure potential for any other individual. Instances were related at the 1998 Organization of Agreement States Meeting where individuals were going directly to have another medical procedure.

6. Retain the requirement to hold radioactive material for ten half lives due to concerns about properly measuring low energy beta-emitters.

7. Private room requirement - Private room upholds the ALARA principles but if there are studies that support the extra dose is of little effect to the other patient, it may be reasonable to permit two radiopharmaceutical patients to share a room.

8. No shared room with non-therapy patient - Retain this part of the rule as it is not ALARA to a member of the general public.

14. The requirements for record keeping should be grouped if the regulated community has expressed a particular interest in organizing them in this fashion.

COMPATIBILITY Section 35.80 - Provisions of mobile service - The proposed rule states that "since there is no potential for medical use of byproduct material in other regulatory jurisdictions under reciprocity" the section is designated a D compatibility. This is not a true statement. Nebraska currently has a mobile nuclear medicine van coming into the state under reciprocity. As an Agreement State, we would like to see similar requirements in place and suggest a re-evaluation. An extension of30 days is requested to permit review of the justification of the current designations for both compatibility and health and safety. The NRC staff has indicated that this justification will be available "shortly. The degree of flexibility allowed the Agreement State is an important issue and should not be omitted from the discussion because information was not available in a timely manner. Gina Dunning, Director HHSRegulationandLicensure 1 301 Centennial Mall South, P.O. Box 95007, Lincoln, NE 68509-5007 E-mail from: Cheryl K. Rogers, Manage~ crogers@hhs.state.ne.us Radioactive Materials Program Nebraska HHS Regulation and Licensure

BER cP°-' 3 :i...; 35 ( "'3FRt/3S 11,) DOCKE TED From: Charles E Finney <Charles.E.Finney@kp.org> US l~RC To: 1PM Return requested Receipt notification requeste ... Date: Thu, Nov 12, 1998 8:24 PM *

Subject:

Comments on Proposed Revisions to 10CFR, Part 3g8 NOV 16 P3 :QQ Section 35.24 should not delete the requirement to have a radiatif?~fE;!ty committee in facilities with inpatients, because of the nature of caring for inpatierifs. LNursing, environmental services, etc. should be represented on a radiation safety commit~ ~LID,. TJ,FF 8 1998 ekno

November 1 2, 1 998 DOCKETED Secretary, U.S. Nuclear Regulatory Commission US Rr. Washington, DC 20555-0001 Attention : Rulemakings and Adjudication Staff "98 NOV 16 p 3 :QQ OF. F( Re: Medical Use of Byproduct Material; Proposed Revisionl\OJ1_ 10 CFR Parts 20, 32 and 35 RIN 3150-AF74

/01 3Pd35

Dear Sir or Madam:

( fo3FR</:i5lt,,} This comment accompanying this letter is filed on behalf of the Cook Group, Inc. (" Cook"), a holding company of international corporations engaged in the manufacture of diagnostic and interventional products for radiology, cardiology, urology, gastroenterology, emerg ency medicine and surgery . Cook has pioneered the development of products and techniques for interventional cardio logy and radiology . Cook products benefit patients by providing doctors with a means of diagnosis and intervention without the necessity of invasive surgery. Cook sells over 15, 000 different products which can be purchased in 130,000 combinations. We commend the Commission for the enormous effort it has made in preparing the proposed regulation and we are very grateful for this opportunity to comment on one small aspect of the rule . Specifically, we are concerned about training requirements for physicians performing endovascular brachytherapy procedures. The attached comment presents what we believe is a reasonable , risk-based approach for determining the extent of training required for physicians and ancillary personnel involved in the use of radionuclides, equipment and specific procedures for endovascular brachytherapy. Thank you for considering our views. Respectfully, Steve Ferguson , EVP/COO Cook Group Incorporated P.O . Box 1608 4 05 N. Rogers Street Bloomington , IN 47404-3780 Telephone : 812-331 - 1025 FAX: 812-331-8990

u

Comments on Proposed Rule Changes for Nuclear Regulatory Commission 10 CFR Parts 20, 32 and 35 Medical Use of Byproduct Material; Proposed Revision Draft Policy Statement Proposed Rules There is a limited number of radiation oncology centers located throughout the United States. Limiting the licensing of all endovascular brachytherapy procedures, regardless of actual risk, to a level that requires the training of a radiation oncologist would severely limit the access of patients to a potentially life-saving/life-extending and cost-effective therapy. It is well recognized that not all endovascular brachytherapy systems and procedures have the same level of risk (to either the patient or medical personnel) associated with them. The risk will vary with the energy of the specific radionuclide, its physical form, half-life, ability to accumulate in organs, potential for anisotropy, and the predictability of the dose (i.e ., the need for expert treatment planning) . Because the various proposed materials and procedures for performing coronary endovascular brachytherapy encompass a wide range of risk, we believe the licensing of centers and the licensing and training of personnel authorized to conduct such limited-use therapy should be tailored to the complexity of treatment planning involved and the potential risk (to both the patient and personnel) reasonably associated with the specific material , device and procedure. This could be accomplished by assigning proposed procedures to specific levels of risk based on the energy of the radionuclide , the predictability of dose (i.e . need for complex treatment planning) , and the need for expert personnel to assure safe and clinically effective use of the material. Table 1 presents a matrix for assigning risk-based categories.

Background:

Reliable clinical and historical justification exists for current authorized user guidelines for the medical use of teletherapy, most types of brachytherapy, and unsealed application of potentially therapeutic doses of radio-liquids. Current ABR requirements for Board Eligibility/Board Certification require a minimum total of 5 years of accredited residency training for Radiation Oncology. Th e American Board of Nuclear Medicine has required 3-4 years of formal residency training for Board Certification. Clinical and surgical application of radiation to deliver relatively moderate to high single or multiple doses of ionizing radiation to the human body for medical benefit at specific dose quantities and tissue targets requires intricate knowledge, clinical training, and experience for treating morbid and mortal disease. It is well documented that many thousands of patients have significantly benefited from careful and precise delivery of radiation treatment. The use of megavoltage external beam radiation or high energy/high activity brachytherapy sources (i.e. Cs-137, lr-192), as well as radionuclide sources such as P-32, Y-90, or 1-131 requires patient specific and disease specific dosimetry with known radiation biology/pathology effects and in depth radiation safety support. In addition, these and oth er radiation sources have a documented history of some very serious patient complications (including death), many radiation safety incidents, detailed protocol requirements, and expensive equipment and personnel support, as has been demonstrated over the past twenty five years. Therefore, such conventional, yet proven, radiation procedures pose unique risks/concerns in order to optimize clinical efficacy, minimize side effects, ensure radiation safety, and maintain cost effectiveness. Alternately, there has historically been a small subset of specific radionuclides which have been allowed for limited, specific medical use by physicians with much less formal training and holding limited use licenses. Typically, this represents certain radiosources whose emission energies, activities, and applications have met criteria based upon their level of predictable radiation safety, in vivo dosimetry distributions, and history of contaminations and misadministrations. Examples may include diagnostic doses of technetium-99m and thallium-201 for cardiac studies, microcurie quantities of 1- 1 25 or P-32 for laboratory assays, and single dose administration of microcurie amounts of C-14 for H-Pylori breath tests. As such, there likely could be certain radionuclides in spedfic physical form (e.g., inert gas) that when applied with a specific closed radiation system would demonstrate very similar expectati ons such that the radiation safety profile, predictability of dosimetry, and limited requirements of expert support personnel would allow relatively predictable safe medical use by limited license authorized users. Such a system could therefore further allow the use of single administration, local brachytherapy to high risk vessels in order to minimize restenosis, to become more patient accessible and to benefit more persons qualified for treatment but not near major academic centers or readily available rad iation oncologists.

The attached chart and the outline of training requirements set forth what we believe is a sensible approach to defining risk and training for endovascular brachytherapy procedures. We respectfully urge the commission to adopt these concepts. Appropriate training for physicians using byproduct materials is crucial. However, requiring more training than is justified by risk analysis will limit the availability of very important procedures to American patients . Table 1. Risk-based Categories for Brachytherapy Procedures Risk Energy of Predictability of Dose Need for Expert Level Radionuclide (Need for treatment planning) Personnel High ~ 300 Kev (avg) photons

• Effective dose > 5mm from vessel
• Physicists/dosimetrists target tissue. essential for treatment

         ~ 2 MeV (max) electrons

• Personnel unable to remain bedside planning.

(s: 1 meter) during treatment.

• Essential for safety.
• Requires image verification of
• Treatment administration, radionuclide placement to assure dose analysis, and proper dosimetry planning. prescription by radiation
• Potential for anisotropy. oncologist/ nuclear
• Risk for personnel - excessi ve physi cian.

exposure.

• Individualized full dosimetry.
• Significant risk for "off-center" inhomogeneity.

Medium <300 Kev and

• Dosimetry is reasonably predictable
• Essential for safety.

         ~ 90 Kev (avg) photons;     and does not require complex

• Low to moderate t reatment planning . May have frequency, but serious

         < 2 MeV and                 "off-center" inhomogeneity.            accidental organ dose

• Some limitations to personnel accumulation and

         ~ 500 Kev (max) electrons   bedside exposure.                      contamination risk.

• Dose s: 5mm - > 2mm from target
• May require afterloading tissue. apparatus or mechanistic
• Long half life materials (~ 60 days) source handling.

and storage/waste concerns.

• Significant risk for organ/dose accumulation (radioliquids) .

Low < 90 Kev (avg) photons

• Dosimetry is highly predictable and
• Not necessary for

         < 500 Kev (max) electrons   does not require complex physics for   adequate safety treatment planning .                   verification and

• Very limited potential for over or enforcement (technologist under dosing of target and normal level satisfactory with tissues. R.S.O.).
• Very limited risk for accidental
• Well established safety physiologic dose accumulation.

track record even for

• No bedside/access restrictions.

excessive doses.

• No effective dose ~ 2mm from target tissue.
• Single dose commercial
• Inert radiogas. availability (no generator
• Routine depth dose homogeneity requirements) .

and conformality to exposed target

• Standard protective "lead" tissue.

jackets/apparel effective for photon energies.

Level of training required: High risk protocol:

• Board Eligibility/Certification (ABR/ABNM): Broad-licensed physician to assess, administer, prescribe, and supervise treatment.
• Board Eligibility/Certification: Medical physicist for safety and dosimetry support.
• High dose/activity suite radiosafety construction.

Medium risk protocol:

• Broad-licensed physician needed to actually administer. and subjectively prescribe dose.
• Medical physicist needed for radiation safety preparation and monitoring.
• Liquid contamination risks and specific handling experience, i.e. experience to calculate organ dose accumulation/elimination rates; track contamination trails and radiochemistry/radiopharmacy training.

Low risk protocol:

• Accredited training/handling course for limited/single use licensed physician.
• Tissue dosimetry pre-established for clinical indication: Treatment time table based upon used activity.
• Negligible risk of exceeding personnel/public exposure limits or prolonged organ/environmental conta mination.
• R.S.O. or certified nuclear technicians qualified for routine safety evaluation and maintenance.

I ,;lo 3~ "3~ ( ~3PRt/351'1 DOCKETED From: Naomi Alazraki <nalazra@emory.edu> USNRC To: TWFN_DO.twf4_po(CAG) Date: Thu, Nov 12, 1998 2:15 PM "98 NOV 16 p 3 :oo

Subject:

Comments on proposed revisions to Part 35 OFFt**. November 12, 1998 Ru* 1 r ADJUD1, To : Secretary, US Nuclear Regulatory Commission l~.,_F Attention: Rulemakings and Adjudications Staff I am a nuclear medicine physician, practicing in a VA Medical Center and an academic university department. I am writing to express concern about the proposed changes in training and experience requirements for physicians to use radioactive materials in diagnostic and therapeutic nuclear medicine. In diagnostic nuclear medicine, although the risk to any single patient is very small, I believe that we should be concerned that physicians with very little training, experience, and knowledge of radiation sciences would be in a position to receive large levels of activity associated with many patient doses ordered at one time. That inexperienced physicians might be responsible for safely storing, dispensing and/or disposing of substantial quantities of Technetium 99m, Iodine 123 or 131, Indium 111 , Gallium 67, is cause for concern. Accidents resulting from inexperience and lack of training could potentially be hazardous to hospital or office-based personnel and to the general public. The safety record in diagnostic nuclear medicine has been excellent over the past 20-30 years. I see the proposed rule changes on training and experience as placing in jeopardy that previously excellent record. In therapeutic nuclear medicine the seriousness of the proposed decrease in

• training and experience requirements for physicians is I believe, a very serious error. Just as physicians in radiation oncology are appropriately required to have extensive training and experience because radiation safety practice is tied to medical competence, so it is for physicians using unsealed sources for therapy. In fact, handling unsealed sources for therapy is potentially dangerous and demands much more training and experience than current regulations require.

In summary, as a nuclear medicine physician with more than 25 years of practice experience, I am very uneasy about accepting the proposed changes in physician training and experience for diagnostic and therapeutic nuclear medicine. I urge that reconsideration be given and that relaxation of requirements be done more gradually and with due attention to assessing the effects of the changes. Sincerely, Naomi Alazraki, MD Chief Nuclear Medicine

\

 .A VA Medical Center, Atlanta Professor of Radiology Emory University School of Medicine

                                                          ;)o) 3:) .,;- 35'

( '43F'12 l/sSI~) DOCKETED From: Jerry Staiger <staig001 @maroon.tc.umn.edu> US RC To: TWFN_DO.twf4_po(CAG) Date: Thu, Nov 12, 1998 7:28 PM

Subject:

Comments on Proposed 10CFR35 Revision *9a NOV 16 P3 :QQ

Dear NRC Representative,

                                                                                           \t F My apologies for waiting until the last day to forward my comments concerning the proposed revisions to the NRC medical use rules, 10CFR35, but I thought better late than never.

I appreciate the efforts the NRC staff have extended in the process of allowing review and comment on these rules through the workshops held this Summer and Fall. I had the opportunity to be in attendance at the workshop in Kansas City, MO in September, and was impressed with the fair and open conduct of the workshop by Mr. Cameron, and the level of expertise and knowledge relative to the history and rational for the proposed rules changes exhibited by Ms. Haney at this workshop. There a few areas of concern I would like to express relative to the proposed rules.

1. The proposed rule would eliminate the requirement for a radiation safety committee. Based on my experience of over thirty years in radiation safety in the medical use of radioactive materials, I think this is proposal is ill advised. Having a radiation safety committee, and requiring participation by upper level administration, is in my experience one of the most effective ways to assure that central administration has knowledge of the need for radiation safety and of the applicable rules required to assure radiation protection in the medical use of radioactive materials at there institution. I have been around long enough to have experienced that this was not always the case, and that more recent NRC emphasis on management responsibility and participation in the radiation safety committee has resulted in a very positive effect on the maintenance of radiation safety programs.

2. The proposed rule would put the burden of compliance on the RSO while eliminating the radiation safety committee (RSO to acknowledge in writing responsibilty for implementing the the radiation protection program).

Again, it is my opinion and experience that unless the rules require active high level management involvement and support of the radiation protection program and the RSO, it will be very difficult for the RSO to be successful in maintaining the program and assuring NRC rules compliance. It is my opinion that upper level administration should be required to also sign the statement that requires implementation and adequate support of the program and the RSO to assure compliance, and as stated above, that the radiation safety committee should continue as a requirement of the rule. This is especially critical in the current managed care environment where bottom r-n;I o

line initiatives are constantly seeking ways to cut staffing and costs. Radiation safety, will not be spared in this process unless the rules clearly mandate that the upper level managers be made responsible for involvement in and support of the radiation protection program and the RSO.

3. With respect to emerging technologies, I found the w9rkshop discussions and varying perspectives on intravascular radiation therapy very interesting and compelling. The potential benefits seem to argue for an expedited rules process to enable use of this technology, but the radiation safety concerns for the patient and staff must not be circumvented in this process. There have been recent reports of incidents involving misadministrations due to source placement or inability at position or retract sources within the scheduled time frame. Because of the high dose rates inherent in some of the methods used to deliver the dose, it is important that the delivery systems and safeguards be weell tested and proven before wide spread application of the technology. Also, the long term radiobiological outcome of these therapies needs to be determined before more general use is allowed.

Thank you for this opportunity to comment on these important revision to the medical use rules. Please acknowledge receipt of my comments via return e-mail. Thanks, Jerome W . Staiger, RSO II/II/II/II/IllIllIllIIIIII/IllIII/II II Jerry Staiger II II Radiation Protection Officer II

• II II (612) 626-6764 phone II (612) 624-1949 fax II/III/II/IIllII/II/II/II/II/II/II/II II II Environmental Health and Safety II II University of Minnesota II II II CC: TWD2. TWP8(CXH)

OHIO DEPARTMENT OF HEALTH DOCKETED us ,~,_; 246 N HIGH STREET GEORGE V VOINOVICH Post Office Box 118 Governor Columbus, Oh,o 43266-0118 Telephone 1614) 466-3543 WILLIAM RYAN Director of Health

                                                                                                                      *9s NOV 16 P2 :59 0:  I A.D.1 Secretary                                                                               November 12, 1998 U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 Attention: Rulemakings and Adjudications Staff The Bureau of Radiation Protection (BRP) has reviewed the 'Medical Use ofByproduct Material; Draft Policy Statement; Proposed Rules ' as found in Part III of the Nuclear Regulatory Commission, Federal Register, dated Thursday, August 13, 1998. As noted, the comment period expires November 12, 1998. Comments by BRP on various issues associated with this rulemaking action are discussed in detail in the noted sections:

Section 1 - §35.32. The current requirements of a Quality Management Program (QMP) should be maintained as per §35.32. Proponents of doing away with the QMP cite it as being prescriptive, burdensome and ineffective. However, ODH-BRP feels the QMP provides:

1) Mechanism for reporting medical events

2) Licensees have already developed QMP plans that meet the current intent of the rule

3) Annual review of the QMP evaluates the effectiveness of the therapy program

4) Program reviews are documented and distributed to appropriate management

5) A methodology to identify precursor events In addition, a requirement that an authorized user be present whenever a therapeutic dose is administered could significantly reduce the number of misadministrations as cited on page 43523 B.2.

Section 2 - §35.32. on page 43529 under 10 CFR Part 35 - Medical Use of Byproduct Material, the definition of "written directive " would be revised to delete the provision for the date the directive was signed, and the signature of the authorized user before administration of any byproduct material or radiation from byproduct material to a specific patient or human research subject. These specific requirements have been moved to §35.40. Currently, the authorized user checks the written directive for 'appropriateness of study ' before signing his/her signature to the document before treatment. This practice is part of the Quality Assurance Program developed by the Joint Review on Accreditation of Hospital Organization (JCAHO) in reviewing the written directive for 'appropriateness of study ' in determining whether the treatment plan is appropriate which would include dose, route of administration, and radiopharmaceutical form (if §35.300 study) before NOV 1 8 19 HEA 6413 !Rev 5/97) An Equal Opportunity Employer/Provider Aeknowfedoed by card~--*....---

u UCLEftR MAKINGS F~ICEOF a~r FTHE Dnc* os~mari< Date _1_1/l:;)_/-9_8_

,op1es Receivr        ._ _ /           - *         -.

A.drl'I r.nplAi: ~rnrl"t1 -b r ,., ~ ** :::J.,,f. J_ rf.-~ ~-;IJ.~1~/

-P-P£,?1r:u'                           '?f~  ~ *,

dosing. This practice should remain intact as a part of the QMP requirements in the present standard. Section 3 - 35.22. Elimination of the Radiation Safety Committee (RSC). Requirements for a RSC - on page 43525 E. l Radiation Safety Committee, the discussion centered around two issues: J) whether the RSC plays a valuable role in all medical institutions, regardless of size and use of byproduct material; and 2) whether the current RSC requirements in Part 35 are too prescriptive. The (RSC) plays an important element of a radiation safety program, and, therefore recommend that the requirement for a committee be maintained in facilities that utilize therapeutic, high-dose, sealed and unsealed byproduct materials. Without a requirement for a RSC in these facilities, the following concerns are presented: I) Administrative support for the RS O could decline

• 2) Decreased management involvement in the radiation safety program

3) Interdepartmental communication between modalities concerning safety issues and precursor situations could suffer Facilities that utilize therapeutic, high-dose, sealed and unsealed byproduct material should be required to have a RSC (§35.300, §35.400, and §35.600). Facilities that use diagnostic, low-dose, sealed and unsealed byproduct material might not be required to have a RSC (§35 .100 & §35.200). Small facilities with limited use of material (nonQMP) would not be required to have a RSC. However, retention of the requirement for a RSC at larger facilities (QMP) is an effective way to ensure that management is involved in the operation of the RSC program. RSC requirements should recognize the differences between large and small institutions and between low- and high-risk procedures. The lessening of prescriptive requirements for smaller, diagnostic facilities is recommended.

Regulations place an unnecessary burden on facilities that perform few studies per year but are required to conduct quarterly meetings. An alternative may be to modify the definition of medical institution to only include those facilities that perform more than one radioactive material modality. However, the primary belief of the Bureau is that a RSC must be maintained whenever therapy is conducted in a medical institution. Section 4 - §35.50 (b)(3) - Revision to perform linearity checks on an annual basis instead of a quarterly basis. On page 43533 licensees would be required to perform accuracy, linearity, and geometry dependence tests before initial use andfollowing repair; perform accuracy tests annually; perform linearity tests annually over the range of medical use ... Currently linearity tests are performed every 3 months on the dose calibrator. Many facilities use dose calibrators that are of vintage age. Many of these dose calibrators have problems with linearity over a range from the highest dosage that will be administered to a patient or human research subject down to 1.1 megabecquerels (30 µCi). By testing linearity on an annual basis, many of these older models can be appreciably out of range

and the dosage administered to a patient can vary appreciably. The three month linearity test should remain in §35.50 (b )(3). Section 5 - §35.53(a)- If a licensee uses only unit dosages of radiopharmaceuticals, the new §35.63 would allow the licensee to determine the dosage by a decay correction based on the measurement by a manufacturer or preparer licensed pursuant to §35.72 or equivalent Agreement State. If a licensee chooses to determine the dosage using this method, it would not be necessary for the licensee to possess instrumentation to measure the activity of the photon-emitter. Although not ordinarily a misadministration or recordable event (§35.100 & §35.200), a double check of the unit dosage helps minimize errors. The first check involves measuring the dosage by the nuclear pharmacy or unit dose preparer. Only misadministrations or recordable events are reported to the U.S.N.R.C. However, many incidents concerning wrong radiopharmaceuticals and/or dosage activities are kept in licensee or nuclear pharmacy files. Some of these incidents provide information on nuclear medicine technologists (NMTs) determining that unit dosages provided were

• incorrect by using the dose calibrator as a double check. Without a dose calibrator, the licensee's effectiveness in carrying out its radiation protection program could be diminished. The dose calibrator is the first line defense in determining prescribed dosage versus the administered dosage. The Bureau strongly believes that the requirement for a dose calibrator should be maintained.

Section 6 - §35.75 Patient Release based on U.S.N.R.C. Regulatory Guide 8.39. On page 43535, concern is expressed about the recent increase of radiation alarms going offat landfills caused by household trash from a released patient. As a result of these concerns, the Commission is specially soliciting public comment on whether any changes need to be made in this rule. The Ohio Department of Health is recently averaging 1 to 2 landfill runs each week. The radionuclide in question is predominantly 1-131 in the radiopharmaceutical form 1-131 sodium iodide. Thyroid carcinoma and hyperthyroid patients are given 1-131 Nal in an oral or capsule form and are usually released on an outpatient basis per Regulatory Guide 8.39. Unfortunately, monitors are triggered at the landfill sites and regulatory bodies are dispatched to these facilities to isolate the contamination waste (diapers, tissues, etc.) from these patients. According to EPA regulations, radioactive materials are not to be buried at these sites. The landfills are not U.S.N.R.C. or OOH licensed sites and most often, the generator (outpatient) of the waste is not known. The waste is usually isolated, secured, and put into decay-in-storage at the facility. The OOH feels that changes need to be made concerning the release criteria to this rule. Taking necessary precautions could perhaps lower the limits to 1 mSv (.1 rem) or instructions to patients should be more stringent concerning potential precautions and/or contamination risks. We also had one experience with a physician releasing a middle school student to go back to school. These continuing concerns result in the Bureau believing that the standard should be revised to be consistent with the previous standard and ALARA.

Section 7 - §35.75 Patient Release based on U.S.N.R.C. Regulatory Guide 8.39 (includes Section §20.1301). On page 43528, IV. Discussion of Text of proposed Rule, 10 CFR Part 20 - Standards for Protection Against Radiation, dose limits for individual members of the public, would be revised The proposed rule responds to the petition from the University of Cincinnati by amending §20.1301 to allow a licensee the discretion to permit visitors to receive upto 5 mSv (0.5 rem) in a year from exposure to individuals who are not releasable pursuant to §35. 75. Cullently, visitors are limited to 1 mSv (0.1 rem). The merits of allowing a visitor to receive up to 0.5 rem should only be warranted on a case-by-case basis, since in certain instances this certain individual could receive a 10 mSv (1.0 rem) dose from a combination of visiting a patient who cannot be released pursuant to §35.75, and then later receive a 5 mSv (0.5 rem) because of exposure from the released patient pursuant to §35.75. This should be allowable in the sense that visitors can provide emotional and physical comfort to the patient during treatment. It is acknowledged that a pregnant women could receive a theoretical exposure of 10 mSv (1 .0 rem) by not voluntarily declaring her pregnancy status, but that is her perogative to do so. The Bureau does not believe that the possible benefits that are derived from this outweigh the need to maintain dose to other persons at levels that are consistent with 10 CFR20. Section 8 - new §35.70 (a) - The new proposed rule would require that licensees survey, at the end of each day of use, all areas where radiopharmaceuticals requiring a written directive were preparedfor use or administered with a appropriate radiation detection survey instrument unless the material was preparedfor use or administered in the area where patients or human research subjects could not be released pursuant to §35. 75. The new rule would eliminate the current §35.70 (a) - a licensee shall survey with a radiation detection survey instrument at the end of each day of use all areas where radiopharmaceuticals are routinely prepared for use or administered. Notice that regular diagnostic study surveys have been removed from the proposed §35.70 (a) revision and surveys would be required only for therapy (written directive studies). The interpretation of daily surveys in the diagnostic arena is left to §20.1101 and §20.1501 sections. Since daily surveys are not specifically specified in 10 CFR 20, the licensees have a wide range of interpretation to what constitutes "proper surveys." The current section §35.70 (a) should not be amended. Section 9 - The issue of training and experience for authorized users should be left alone in Subpart J §35.910 - §35.961. The thrust of the proposed new Part 35 would be that the U.S.N.R.C.'s role in medicine would be less prescriptive. The Commission's specification of proposed clinical training and experience requirements is a serious intrusion into the practice of medicine and; therefore, should be re-evaluated since it would constitute more prescriptiveness than at present. The Bureau of Radiation Protection supports the status quo requirements for diagnostic and therapeutic medical uses (generally requiring either medical specialty board certification or a specified number of hours of classroom and laboratory training) because such requirements have

served patients and the public well. Board certification ensures the appropriate level of training and experience and changes could diminish assurance of competency. The Bureau does believe that competancy examinations as proposed in the rules are a good addition for radiation safety. Section 10 - Proposedrevision of §35.92 (a)(J) - The requirement to hold byproduct material for 10 half-lives would be deleted The proposed rule precludes disposal of radioactive material as ordinary trash until radiation levels adjacent to the material do not exceed background levels. Sulfur-35 sodium sulfate is used in medicine for the measurement of extracellular fluid volume. A licensee's ability to detect low levels of some beta-emitters without the 10 half-lives requirement could be compromised. The average energy of S-35 (~-energy 167 keV (100%) is 56 keV and the detection capabilities of average GM survey meters can be less efficient. Perhaps a stipulation for proper instrumentation for low energy ~ emitters detection can be added to §35.92. Otherwise, the 10 half-lives provision in the current §35.92 (a)(l) should remain since it assures the licensee a timeline for decay-in-storage and surveying for background levels. The Bureau believes that the current practice should be maintained. Section 11 - Mobile Services. A category "D" designation means the requirement does not have to be adopted by an Agreement State for purposes of compatibility. The U.S.N.R. C. specifically requests comment on this issue relative to whether mobile medical licensees operate under reciprocity in other regulatory jurisdictions. The Ohio Department of Health had issued a reciprocity with I mobile nuclear medicine service based out of Illinois {Agreement State). A mobile service based out of Pennsylvania has inquired about reciprocity for mobile nuclear medicine. The rules and regulations governing these mobile services would follow §20 and §35 guidelines. ~~-c.~~ R~g;? Suppes Bureau Chief Bureau of Radiation Protection Ohio Department of Health

DOCKETED Kettering Medical Center US~P.C "98 NOV 16 P2 :52 November 11, 1998 OFh : I

                                                                                    'l ' i* ,

ADJL.[ 1 Secretary US Nuclear Regulatory Commission Washington, DC 20555-0001 Attn: Rulemakings and Adjudications Staff

Dear Secretary:

The Radiation Safety Committee would like to comment on the following changes proposed for 10 CFR 35 .

1. Eliminate the Radiation Safety Committee at certain kinds of institutions, including Kettering Medical Center.

This change would leave the RSO solely responsible for the Radiation Safety program. It would cut off a vital communications link between the RSO and the Authorized Users. It would weaken administrative support for the RSO. We feel that the Radiation Safety Committee should be left in place.

2. Require an Authorized Medical Physicist to have an active role in HDR brachytherapy and gamma stereotactic radiosurgery.

This change has the benefit of ensuring proper treatment when using radioactive sources. The proper calibration and decay of such sources, plus the planning required for their safe use, are of such vital importance that they can only be performed by a properly trained physicist. We support the proposed change.

3. Require an Authorized User and Authorized Medical Physicist to be physically present during gamma stereotactic radiotherapy and HDR brachytherapy.

HDR brachytherapy is an active therapy in which a source moves within the patient continuously throughout the treatment. Gamma stereotactic radiosurgery is a passive therapy in which the patient lies in one place while being exposed to radiation. Gamma stereotactic radiosurgery docs not require continual morJtoring by multiple people. The requirement should be for continual monitoring, but only by one person at a time. The Authorized User should only be required to monitor the start and end of the treatment.

4. Eliminate the requirement to assay unit dosages of radionuclides purchased from a 00 radiopharmacy or commercial manufacturer at the place of use.

We have received several such unit doses which have been mislabeled. An assay performed by our staff guarantees the safe diagnosis and treatment of our patients. We believe the assay requirement should be kept.

5. Eliminate the requirement to verify the operation of a survey meter with a dedicated check source prior to use.

A dedicated check source is such a simple and reliable way to ensure the proper operation of a survey meter it makes no sense and accomplishes nothing to remove this requirement. 3535 Southern Blvd. 937-298-4331 Kettering, Ohio Internet: www.ketthealth.com 45429 Fax:937-296-4226 All LT

U S UCLEAR REGULATORY RULEMAKI GS &ADJU rn STAFF CFFICE Of THE SECRETARY FTHE MISSION

6. Eliminate the requirement for a daily survey if no procedures requiring written directives have been performed.

Hospitals such as ours handle Curie amounts of radiopharmaceuticals daily. The end-of-day survey guarantees that all materials are properly stored and all areas decontaminated before releasing the areas of use for house cleaning. In addition, the daily survey prompts safe handling of materials and enforces the ALARA concept. We feel this requirement should be kept

7. Eliminate the Quality Management Program.

While the QMP is eliminated, many of its elements are kept in place, including the Written Directive and the definition of a misadministration (now called a medical event). Apparently it is only some of the review and reporting requirements that have been eliminated. Nonetheless, we welcome this relief from paperwork. Finally, we note that the new 10CFR35 eliminates many requirements for surveys (bioassays, Xe-133 traps, etc.). However, 10CFR20 still requires an active ALARA program. The effect is that the burden of proof is now on the users to demonstrate either

• that we do not need to make a particular survey or that we are making adequate surveys to ensure that no one is being exposed excessively. When we are inspected neither we nor the inspectors can merely appeal to the regulations. We must demonstrate to the inspector's satisfaction that we have an adequate ALARA program in place. We are concerned that this subtle distinction between parts 35 and 20 may be missed, especially in smaller institutions.

We ask that the NRC, perhaps in the replacement of Reg Guide 10.8, make clear the requirements of 10CFR20. Thank you for the opportunity to comment on the proposed rules.

                     ~
                                                 ~~

Sincerely Roy~ D Steven Cartwright, PhD, DABR Vice-President, KMC Radiation Safety Officer Chair, Radiation Safety Committee

Syncor lnternationaP~~lion The Service Difference* DOCKET NUMBER '98 NOV 16 P2 :52 PROPOSED RULE'PII /It) 3:J ,I- '.5 November 11 , 1998 r:m:35/t, .~r

                                                                           \Jilf
                                                                           ,A.[).:

Secretary U. S. Nuclear Regulatory Commission One White Flint North 11555 Rockville Pike Rockville, Maryland 20852 Attention : Rulemakings and Adj udications Staff To whom it may conce rn : The attached comments are respectfully submitted pursuant to the proposed revisions of 10 CFR Parts 20, 32, and 35 on the Medical Use of Byproduct Material. These comments are based on the proposed revision published in the Federal Register Volume 63, No. 156 on Thursday, August 13, 1998. Thank you for the opportunity to comment on these substantial changes to 10 CFR 35 and associated changes to Parts 20 and 32 . Sincerely, rt, RPh, BCNP NOV 1 8 1 Acfcnowfed(ted by card .... ___ _998 6464 Canoga Avenue

• Woodland Hills, CA
• 91367
• 818-737-4000

LI.S. UCLEAR REGULATORY COM lSS'O I AULEMAKINGS &ADJUDICATI SSTAFF OFFICE OF THE SECRETAR OF THE COMMISSION DocunentStatfsticr Postmark Date II I 3 18 FE Copies HOO:!IVeC I Add'I Co~ Rep uce:d '- ~~ 9-¥,

--PDR 1

1<,tjJL __~_ -/

Comments on Proposed Revisions to 10 CFR 20, 32 and 35 Training and Experience: The requirements for training and experience proposed in the revisions to Part 35 are significantly different from the current requirements. Of note are the different requirements for Authorized User Physicians, Radiation Safety Officers, and Authorized Nuclear Pharmacists. The training and experience requirements for Authorized Nuclear Pharmacists are significantly more than that required for an Authorized User Physician or Radiation Safety Officer. Although we support the 700 hour requirement for ANP's, we are discouraged that the proposed rule allows significantly less training and experience for Authorized User Physicians. All the "authorized" classifications require independent testing , as well. Since each of these types of users will handle and use radioactive materials in somewhat different ways, one would assume that the tests provided to these groups would be different. Each of the classifications would need a test to be

• developed, implemented, and maintained . Testing for this purpose, essentially a requirement for employment in the field, requires that the test be defensible, validated , and regularly updated. This requires an significant infrastructure to support it. The small numbers of candidates in each of the categories to be tested would not likely benefit from any economies of scale from the significant requirements for this type of testing. The overall cost would be spread among a very small number of individuals tested annually.

I believe the testing requirement for new authorized nuclear pharmacists will cause an unnecessary increase in cost without adding benefit or value. All current providers of the didactic training and education for authorized nuclear pharmacists utilize testing as part of their educational program. This has been going on for many years without problems with this methodology. The testing

• has worked historically, identifying those participants who did not meet the educational objectives of the didactic training and thus were not awarded a certificate of completion. Even before the classification of ANP was added in 1994, this validation system of testing as part of the didactic training component worked . It still does.

There are less than 75 pharmacists who enter the practice of nuclear pharmacy annually, many of whom work in Agreement States. The need for an independent testing agency to develop, administer, and maintain a system for testing for the portion of those ANP candidates who would work in NRC states, would not likely be cost effective. Additionally, with few candidates each year, it is likely that the testing would not be offered frequently. The expected infrequency of the testing would have a significant negative impact on the ability of an individual to work in the field at the time the training requirement was

completed . This could have negative staffing implications for nuclear pharmacies and it could actually negatively impact compliance and safety. With the additional training requirement for ANP's (700 hours) compared to that req uired for authorized user physicians (60 to 120 hours) or RSO's (200 hours), it seems that the testing requirement is not meaningful. Therefore, I propose that the testing requirement be deleted, at least for ANPs, but NRC should consider deleting the testing for the other classifications as well. For authorized nuclear pharmacists this testing requirement does not bring added value compared to the current system and it can likely add significant cost and unintended negative effects. It is likely the same applies to the other "authorized" classifications, as well. Sealed Sources Section 35.65 (a) in the proposed rule states that "Sealed sources manufactured and distributed by a person licensed pursuant to Section 32.74 of this chapter or equivalent Agreement State regulation", etc. continues language from the current Part 35.57 .

• It is suggested that NRC consider changing the language in this section to clarify that other licensees could distribute sources manufactured by 32.74 licensees.

For example, the manufacturer of the source, licensed under 32. 74, could distribute the source to Part 35 licensees through a 32.72 licensee. Nuclear pharmacies currently acquire sealed sources from 32.74 licensed manufacturers and distribute these sources to Part 35 licensees who are authorized to receive these sources under the current Part 35.57. Suggested language: "Sealed sources manufactured by a person licensed pursuant to Section 32.74 and distributed by a person licensed pursuant to Section 32.74 or 32.72 of this chapter or equivalent Agreement State regulation .... " Section 35.49 Suppliers for sealed sources or devices for medical use should reflect similar language in 35.49 (a) to include 32.72 licensees in distribution of the sources. This change would clarify the distribution portion of this language. Section 35. 13 License Amendments The Discussion of Text of Proposed Rule that was published in the Federal Register on 8/13/98 recognizes the conditions that arise when an RSO leaves a facility with little or no advanced warning . It suggests that a licensee may want to use an authorized user to fill the position until appointment of a new RSO. However, the rule language does not appear to discuss this possibility. Does NRC intend to add this language to the rule? Would it appear in regulatory

guidance? Since an authorized nuclear pharmacist or authorized medical physicist would meet the qualifications defined for an RSO in 35.50, it is suggested that these categories also be mentioned along with the authorized user. Section 35.27 Supervision. Supervision for receipt , possession , use or transfer, addressed in 35.27 (a) refers to "an individual under the supervision of an authorized user" but does not specify authorized nuclear pharmacist. However, the following provision of 35.27 (b) addressing supervision during preparation of byproduct material for medical use does include the authorized nuclear pharmacist. It is suggested that the authorized nuclear pharmacist is also specified in 35.27 (a) as it is in 25.27 (b) since in order to prepare material for medical use, it must first be received , possessed , and used. Section 35.57 Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized user, and nuclear pharmacist. Section 35.57 (a) calls out RSOs, physicists, and nuclear pharmacists, but only refers to the training requirements for RSOs and physicists. It is suggested that the language be restated to include nuclear pharmacists: " ... need not comply with the training requirements of Secs. 35.50, 35.51 , and 35.55, respectively ... " to include the training requirements for nuclear pharmacists. Section 35.92 Decay-in-Storage The requirements of this section include removal or obliteration of all radiation labels before disposal in ordinary trash. This may be hazardous to workers if the material decayed in storage included medical sharps, labeled with radiation

• labels pursuant to the proposed Section 35.69, and used for patient injection or other purpose that would include potential for exposure to a biohazardous substance such as blood. The potential for biohazard exposure should be considered in this section , even after the radioactive material would have decayed to background. It is recognized that the intent of this requirement is to avoid labeled materials disposed in landfills, discovered later and thought to be radioactive. Incineration of labeled items which have been decayed-in-storage should be included in 35.92 as an option .

Changes in Record keeping requirements NRC should be complimented in some of the changes in the record keeping requirements, such as record retention time, which are proposed in this revised Part 35. However, some of the record keeping requirements appear to be prescriptive and may not be practical. As an example, Section 35.2026 requires

records of changes in the radiation protection program be maintained . However, it requires that the licensee include "a copy of old and new procedures" and the signature of the RSO and licensee management that reviewed and approved the change. First, the specifics of an old procedure are immaterial to the new one, and could be confusing to workers. Second, the requirements for signatures precludes maintaining such records electronically. Licensing Actions: It is important that NRC not impose requirements in the licensing process that conflict with the intent of this change in regulation. If the philosophy of the regulation and the subsequent licensing activities are not aligned , then this rulemaking exercise is meaningless. However, if the approach of the licensing branch is in alignment with the less prescriptive, performance-based , risk informed approach of this rulemaking , then this exercise will be a step forward toward better regulation. Thank you for the opportunity to comment on these proposed changes.

Mayo Clinic OOCI\ET ED Rochester, Minnesota 55905 I S jp r~ Radiation Safety Telephone 507 284-3332

                                               .98 NOV 16 P2 :51 November 9, 1998 lf Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, DC 20555 I 3:1  <35'
                                                                                    /,3F~    4i3S1i.}

Attn.: Rulemakings and Adjudications Staff Re: Proposed Revision of IOCFR Part 35 We appreciate this opportunity to comment on the proposed revision of the Part 35 medical use regulations. Removal of the prescriptive radiation safety requirements without reduction in safety is viewed as a positive step; these include such items as removing the requirement to measure dose rates when performing sealed source inventory, and removing the requirement to inventory a gamma knife. Two other favorable changes are the written material organization and radiation safety/risk based requirements (versus those potentially interfering with medical profession practice). Our responses are organized into two sections. The first section is composed of specific responses to proposed text of Part 35 . The second section is in response to the NRC's solicitation of comments for certain items as outlined in the proposed rule. Section I: Specific Comments 35.lO(d)(e)(g): These sections state that a licensee shall comply with the most restrictive requirement of either their license or Part 35, and that an amendment is required to change any license conditions that tie the licensee to the "old" Part 35. We are requesting the NRC consider allowing licensees, if institutionally feas ible and upon written request, to comply with the "new" Part 35 without regard to the restrictive nature of the license and without requiring an amendment. Many licensees have sections from the "old" Part 35 in their license applications and a general license condition holds the licensee to items in the application. When the "new" Part 35 is enacted, licensees should be able (if institutionally feasible) to adopt the new regulation. An example might be that the license application states sealed source inventories will be performed quarterly - the licensee should be allowed, with no amendment, to change this to semi-annually when the "new" Part 35 goes into effect. This allowance would not apply in cases where a specific condition has been added to the license by the NRC. 35.12(d)(2): This states that the "applicant or licensee shall (my emphasis) also provide any other information (my emphasis) requested by the Commission in its review of the application. Provision should be made for protection of confidential and proprietary information. 35.26(a)(4): The requirement to "instruct all affected individuals on the revised program before changes are implemented" should be removed in it's entirety. This requirement only add~ work with no resultant increase in safety. This is not consistent with the NRC's philosophy of risk based requirements. Admowfedoed by card .... _..V____ 18_ 1998

U5. UCLEAR REGULATORY COM RULEMAKINGS &ADJUD JIONS . OFFlCEOFTHESECRETARY OF THE COMMISSION Postmark Data c~ ReCt:ltVecl II '!J /:It _ 1 _ Acid'! Copies Repr ~(:, CGCl~I Jlstributir 1 .l **J{~

~4dr_~~                                ~
-Pt>~, 'RI~

35.67(g): As it has in the past, this paragraph states that all sealed sources (except gamma stereotactic units) must be inventoried. We are requesting the NRC consider exempting sources from the inventory that are exempt from leak testing. Suggested modification to the current wording: "A licensee in possession of sealed sources or brachytherapy sources, except for gamma stereotactic radiosurgery sources and those sources exempt from leak testing. shall conduct a semi-annual .... ". 35.80(a)(2): Suggested modification: "Check instruments as described in Secs. 35.60.(hlffi and 35.62.(hlffi before medical use at each address of use or on each day of use, whichever is more frequent." The minimum requirements to be performed at each site should be a check for constancy and proper operation, as these are adequate quality control methods to identify changes in instrumentation daily and between locations of use. Reference to 35.60 and 35.62 in their entirety implies that accuracy, linearity, and geometry tests must be conducted. This is impractical if not impossible and unduly prescriptive. 35.400(a): A survey of the patient after brachytherapy sources have been implanted, for the purpose of looking for misplaced sources is a difficult result to achieve. The meters of choice when looking for misplaced sources are either a Geiger-Mueller or sodium iodide. However, upon entry into an implanted patient's room with one of these meters, the background present due to sources in the patient diminishes the ability to locate a misplaced source if one is present. Suggested modification to current wording: "Immediately after implanting sources in a patient or human research subject, the licensee shall make a radiation survey of the patient or the human researeh subjeet B:H:d the adjaeent area of use source preparation area, and areas adjacent to the patient's room and source preparation area to confirm that no sources have been misplaced". Section II NRC Solicitation of Comments Item 1. Training and Experience We believe it is too prescriptive to not allow examining organizations to test individuals they may also have instructed. It is common practice within many professional organizations to hold classes to be attended by individuals who will take the professional organization' s certifying exam. Also, since certification is not a requirement within the training and experience criteria (it is, instead, an option), an exam to demonstrate a minimum level of competence is acceptable. Item 2. Defining medium dose-rate afterloader We don't believe this definition is necessary and could lead to confusion since it's definition would overlap with the current NRC definition of a high dose-rate afterloader. Item 3. Medical or research procedure We don't believe this requirement is necessary since the Food and Drug Administration has rules defining what a research procedure is and how it differs from a standard clinical procedure, e.g. if paid for by research money. It is standard practice for an institution performing human use research to have protocols reviewed by an Institutional Review Board who is responsible to make those decisions. Item 4. Radiation Safety Committee We do not support elimination of the Radiation Safety Committee. Having responsibilities in writing vs. carrying the authority of a committee will diminish the power of Radiation Safety Officers and, hence, their effectiveness. The National Council on Radiation Protection and Measurements clearly supports the Radiation Safety Committee (Report No. 127), especially in the formulation of policies, review and audit of program effectiveness, and guidance of the RSO. Item 5. Release criteria We support current release criteria as it is consistent with NRC philosophy of risk based requirements. Limiting criteria still must be met but they are now based upon a conservative exposure risk assessment.

Item 6. Holding waste ten half-lives It is appropriate to delete this requirement while maintaining the requirement that a thorough survey of the waste materials must be performed with no interposed shielding. Item 7. Private room with private sanitary facility and Item 8. Sharing rooms We support the requirement for private rooms. Without this requirement, medical institution management and insurance companies could exert pressure to not use private rooms or single occupancy of a double room for cost reasons. Insurance companies may decide not to reimburse for a private room or single occupancy which increases patient costs. A private room decreases exposure to members of the general public and hospital staff. A private sanitary facility lessens the opportunity to spread contamination and decreases general public and hospital staff exposure. It would be difficult to limit visitation by family members to a non-therapy patient who is roomed with a therapy patient thereby possibly exposing them to unnecessary radiation as well. Item 11. Remote afterloaders with beta sources. Afterloaders with pure beta emitters should be exempt from the requirements of 35.615(b), (c), and (d). Item 14. Recordkeeping We do not support keeping all recordkeeping requirements in one section; having the requirement within the section to which it refers is preferable. Item 15. Reporting We support keeping all reporting requirements in one location; it simplifies the identification of these events. Item 16. Patient intervention and treatment site We support the exemption of patient intervention as a cause for a medical event, however, we are curious how the NRC will interpret the word reasonable in the following statement [from 35.3045(a)], " .. .that could not have been reasonably prevented by the licensee ... ". Use of the word 'reasonable' leads to ambiguity and many subsequent interpretations. Another item, not specifically numbered, requested comments on whether mobile medical licensees operate under reciprocity in other regulatory jurisdictions. Mayo's mobile service operates in states regulated by the NRC as well as Agreement States. We operate under reciprocity when we conduct byproduct studies in states other than Minnesota. Again, we thank you for the opportunity to comment. If there are questions regarding any of our remarks, please call me. Sincerely, Richard J. Vetter, Ph.D. Radiation Safety Officer cc: Radiation Safety Committee

DOCKET'ED U~NP.t; November 9, 1998 .?~ 3:1 J-3S American ( t,3fR'1351') °98 NOV 16 A1 :(M>llege of Nuclear The Honorable Shirley Ann Jackson

                                                         @)          OFFt.            Physicians RUL.l- '  I Chairman, U.S. Nuclear Regulatory Commission                     ADJLJCI          C~tifornia Mail Stop 016G15 Chapter Washington, DC 20555 Dorothy Duffy Price Executive Director Box 31

Dear Chairman Jackson:

Los Altos, CA 94023 TEL 14151 949-1341 Enclosed is the response and comments of the California Chapter FAX 14151949-1341 of the American College of Nuclear Physicians (ACNP) to the NRC's

• proposed revision of 10 CFR Part 35. This response was developed by our Government Relations Committee and approved by our Executive Committee.

The California Chapter of the ACNP believes that the proposed revision of Part 35 is seriously flawed and that a one year delay is required in order to resolve the many outstanding problems. This could not be accomplished in the public hearings because responses were severely limited by the frame of reference and restricted questions imposed unilaterally by the NRC's "Working Group" and "Steering Group". The California Chapter believes that the restrictive format is a large handicap that prevents us from commenting on each of the proposed new regulations. Our response, therefore, takes the form of an Executive Summary of our comments and concerns followed by a detailed discussion of these matters with suggested language for many revised regulations. A one year delay in the revision of Part 35 should give ample time for the success of a good faith efTort of the NRC and concerned professional organizations to resolve the many remaining problems. Sincerely yours, 11jtU#1() g ~ Marvin B. Cohen, M.D. President, California Chapter American College of Nuclear Physicians MBC:sfd

                                                                 $-4     ~

u N [:J Cl)

i CRITIQUE-10CFRPARTJ5..1 l-9&.CSM lxt ~

                                                                ~

0 ~ C:l er: 0

.S

A CRITIQUE OF MEDICAL REGULATIONS, LICENSE CONDITIONS, RISK CONSIDERATIONS, AND COST ANALYSIS PROPOSED BY THE NUCLEAR REGULATORY COMMISSION (Fed Reg. 63(156): 43516-43586, 13 Aug 98; NUREG-1556, Vol. 9; 0MB [7590-01-P]) by THE AMERICAN COLLEGE OF NUCLEAR PHYSICIANS CALIFORNIA CHAPTER NOVEMBER, 1998 CRIIlQUE-10CFRPART35-1 l-98.CSM 1

EXECUTIVE

SUMMARY

The California Chapter of the American College of Nuclear Physicians (ACNP) represents the nuclear medicine physician specialists of the State. California performs about 20% of the nation's yearly 10-12 million nuclear medicine procedures, 99.5% of which ar~ diagnostic and O.~% of which are therapeutic. Our

  *-members also belong to the Northern and Southern California Chapters of The Society of Nuclear Medicine (SNM).

Nuclear medicine began in California in 1936, and this State has played an outstanding role in the research and development of this field. California was one of the first Agreement States, and has had a fine record of safe and responsible radiation regulation. In response to a mandate from Governor Wilson, and the personal and professional commitment of Edgar Bailey, Chief of the Radiologic Health Branch of the California Department of Health Services, the Medical Program in California is undergoing progressive improvement with the participation and cooperation of the nuclear medicine community. We believe that California's Medical Program should remain completely independent ofNRC so that it can continue to improve.

• We testified at the Agreement States meeting in October 1997 with the expectation that NRC would listen to the advice of the regulated community and woultl produce meaningful changes based on this input. We have been grossly disappointed. We believe that such a massive undertaking as a complete revision of 10 CFR Part 35 can not be fast tracked and requires sufficient time for all parties to communicate fully and for all disputes to be adjudicated and resolved. We, therefore, request that the finalization of Part 35 be delayed for one year. To expedite this process, The California Chapter of ACNP offers its critique of the "strawman" version of the revised Part 35. Rather than responding to each regulation in this "strawman" version, which we consider to be seriously flawed, we will critique the concepts that form the base for the proposed revisions.

CR1TIQUE-10CFRPARTJ5.-11-98.CSM 2

The U.S. Nuclear Regulatory Commission (NRC) embarked upon a "fast track" effort to improve all its medical regulations after the publication of a National Aca'demy of Sciences-Institute of Medicine (NAS-IOM) report entitled "Radiation in Medicine: A Need for Regulatory Reform". This $2.25 million, 2 year, 300-page study was contracted by NRC at the urging of its Advisory Committee on Medical Uses of Isotopes (ACMUI). The report, published in early 1996, contained strong objections to NRC's medical program, and the NAS-IOM recommended that statutory authority in this area be removed from the NRC and given to the States, as intended in Sec. 274 of the Atomic Energy Act (AEA) as amended. The NRC responded with a one-sentence insult to the NAS-IOM charging that its

• recommendations were "not substantiated", and refused to scientifically or medically defend against a single NAS-IOM criticism over the nearly three years that have passed since the publication of the report. 1 Instead, NRC proposed a "partnership process" with the nuclear medicine community, vowing to make extensive use of the advice of nuclear medicine professionals gained at public meetings and through public comment. The Commissioners ofNRC gave assurance that the new medical regulatory construct would be completely based upon scientifically valid risk assessment and that performance standards would replace prescriptive regulation. NRC management publicly promised the nuclear medicine community that NRC would begin a reconsideration of its entire medical program with "a clean sheet of paper". In response to a strong recommendation for appropriate general licensing and an abandonment of the grossly inappropriate present licensing process, NRC promised very serious consideration of this request.

1 At the bottom ofp. 43584 of the Proposed Medical Policy statement, there is a statement that references the SRM of20 March 97, SRM-COMSECY-96-057, and quotes the first sentence. The full quote, including the second and last sentence, is as follows: "With respect to the medical programs, the Commission was not persuaded by the NAS-IOM report that recommends that NRC should not be the federal agency involved in the regulation of ionizing radiation in medicine. 1be Commission continues to believe that the conclusions in the report were not substantiated and that the recommendations should not be pursued." We are aware of extensive documentation of the NAS-IOM conclusions, but are not aware that any of NRC's Commissioners went over to the NAS-IOM building to study this. In any case, it was all referenced in the NAS-IOM report The reference material submitted by ACNP and SNM was separately sent to each Commissioner upon ta1cing office. CRITIQUE-10CFRPARTJ!-11-98.CSM 3

The 1/30/98 draft of 10 CFR Part 35 clearly demonstrated that virtually none of NRC's vows and assurances were kept. Despite extensive comment by the professional nuclear medicine community, the Draft Proposed Rule published 13 Aug. 98 and the associated licensing NUREG are far worse than the 1/30/98 draft. The Commission StafTRequirements Memorandum (SRM), written before the public meetings, used no risk analysis whatever, and instructed staff to basically tweak the program a bit. The staff deliberately refused to use any risk analysis in its evaluations, claiming that the Commissioners had not given them enough time to prepare one. At a public meeting in Chicago in November of 1997, it was pointed out that at least two risk analyses for nuclear medicine exist, both paid for by the NRC. One appears in Chapter 4 of the NAS-IOM report, and the other is NCRP Commentary no. 7, published in 1991. At that public meeting, the participants representing nuclear medicine, radiation oncology, nuclear cardiology, nuclear endocrinology, nuclear pharmacy, nuclear medicine technology, the*National Association for Cancer Patients, and the American Hospital Association voted unanimously to strongly recommend that the Commission revise its SRM, and that it be based on a valid risk analysis. Again, this has been completely ignored. The concept of general licensing was abandoned immediately by NRC without any public discussion at all. It appears to have been a ruse. At NRC request, a risk analysis was submitted to NRC by SNM/ACNP in final draft form in Dec., 1997 and in final form in Aug., 1998, but NRC now denies that appropriate risk data exist at all. The "partnership process" excluded one half of the "partnership". NRC appointed its own "Working Group" and "Steering Group", and excluded partnership control, or any control at all, by SNM or ACNP. The NRC also decided which concepts and regulations would be discussed publicly. Others were to be ignored. While the Nuclear Medicine community is free to comment, we have no power. Not unexpectedly, the resulting Proposed 10 CFR Part 35 resembles a confusing, alarming and unnecessary collection of proposed regulations, some of which were CRITIQUE-10CFRPART35-11-98.CSM 4

wisely avoided by a previous Commission, including astonishing requirements that would~ patient and staff morbidity and mortality. It is especially disturbing that nearly all of.the proposed regulations are scientifically without valid basis. The Proposed Part 35 package restricts qualified nuclear medicine physicians from freely choosing among drugs for various patient conditions by limited procedure by procedure licensing. It restricts qualified nuclear pharmacists and physicians in the compounding of radiopharmaceuticals for patient use. It has an "emerging technology" clause which is undefined and may be used arbitrarily to restrict the use of any radiopharmaceutical, including radio biologicals such as monoclonal antibodies. It has expanded a preposterous "misadministration" standard for therapy of+/- 20% to include a +/- 20% requirement for diagnosis as well. It has sneaked in a dangerous pregnancy rule and kept a terrible lactation rule. It plans to interfere with research. It invites reasons to remove the 500 mrem Patient Discharge Rule without data. It forbids nuclear medicine professionals from using established mathematics to calculate radioactivity, and demands measurements instead. It denies that appropriate data exist for a risk analysis and has spent our User Fee money to support a scientifically worthless poll by Scientech to evaluate radiation risk. This flawed poll appean clearly designed to provide a basis for unscientific claims, which might impact the Final Rule. The Proposed Part 35 decreases the requirements for Authorized User status in nuclear medicine by the ruse of NRC evaluation of draft specialty boards questions. The NRC has never demonstrated the medical expertise for such a task. This will result in more licensees, create more User Fees, but will further detract from the quality of nuclear medicine practiced in this country. The NRC is not even limiting boards to those recognized by the American Board of Medical Specialties. The Proposed Part 35 will deal the Agreement State Program a death blow, by demanding that every Agreement State adopt the essential portions of NRC's new Part 35 under threat of not only being "incompatible", but also "inadequate". This may cause states to give back their programs, forcing licensees to pay NRC instead of their states. The procedure requirements, recordkeeping requirements, and "inspectability" requirements have expanded, and patient privacy and confidentiality is ignored with a requirement to CRITIQUE-10CFRPARTJS-11-98.CSM 5

have NRC records of the patient's name, social security number, or hospital number for every dose, diagnostic and therapeutic, and with instructions concerning lactation preautions and penonal behavior after receiving therapeutic radionuclides. Contrary to NRC claims, performance standards have not been substituted for prescriptive regulation. The coup de grace is an alarming reinterpretation of Section 104 of the AEA. NRC now proclaims that it has complete jurisdiction over all of nuclear medicine, and that the "minimal regulation" in the law only refers to the use of "special nuclear material". In addition, NRC conveniently "forgets" its transfer of responsibility for byproduct tracen for clinical and research use to FDA in 1975.

• NRC has now proclaimed dual regulatory privilege and superior regulatory power over 50 State Boards of Medicine and 50 of Pharmacy, the FDA, JCAHO, OPRR, OSHA, and professional medical quality assurance programs. It has ignored the Declaration of Helsinki, and imposed enormous cost, which HCFA refuses to reimburse. After the NAS-IOM Report, the Commission failed to prevent threatened employees from bending the truth to avoid regulating themselves out of jobs.

We object to this work product in its entirety: the Proposed Rule, the Medical Policy Statement, the Licensing NUREG, the 01\IB Submission, the Regulatory Analysis, the SRM upon which the Proposed Rule was based, the constitution of the "Working Group", the constitution of the "Steering Group", the arbitrary limitation of items to be discussed, and the ludicrous NRC claim that this is a "partnership process" with "public participation". There may be no way to use this proposed rulemaking package for negotiation, beause it is completely unacceptable as a starting point. NRC has failed scientifically and medically to substantiate almost everything in it. A one-year delay is needed to resolve these problems. We formally object to NRC's process as well as its product. Our more detailed criticisms of the rule making package follow, but we have also included some of the CRITIQUE-10CFRPARTJS..11-98.CSM 6

draft regulatory language that we want and deserve, based upon our own knowledge and the recommendations of the NAS-IOM. We have submitted this before, but NRC has not commented meaningfully upon our recommendation. CRlITQUE-10CFRPART.35-11-911.CSM 7

SPECIFIC COMMENTS

1. :MEDICAL POLICY STATEMENT "1. The NRC will continue to regulate the uses of radionuclides in medicine as necessary to provide for the radiation safety of worken and the general public."

SNM and ACNP agree, provided "radionuclides" u changed to "source, by-product, and special nuclear material", and believe that thu goal is adequately served by U11uring substantial qualifications, including evidence of mastery, of basic nuclear and radiation sciences of those professionals involved in nuclear medicine. The standards of 10 CFR Part 20 apply here, and are sufficient. In accordance with NAS-IOM recommendations and 10 CFR Part 20.2301, the recordkeeping requirements should be removed virtually entirely. Nuclear medicine has been practiced in this country since 1936, and NRC has no evidence that qualified nuclear medicine professionals do not already adequately provide for tbe radiation safety ofworken and.the general public. As has been continually shown, all of nuclear medicine of

• reactor and accelerator origin, is low radiation ruk to worken, memben of the general public, and patients.

             "2. The NRC will not intrude* into medical judgments affecting patients except as necessary to provide for radiation safety of worken and the general public."

SNM and ACNP believe that this sentence should end with the word "judgments". The rest is unacceptable. We are already required to conduct our practices in accordance with the standards of 10 CFR Part 20. None of the medical judgments of qualified nuclear medicine professionals harm workers or members of the general public, but NRC is setting the stage for CRITIQlJE.. lllCFRPAll.TJ5.11-91.CSM 8

widespread, onerous, heavy handed control of medicine and pharmacy with this statement.

           "3. NRC will, when justified by the risk to patients, regulate the radiation safety of patients primarily to assure the use of radionuclides is in accordance with the physician's directions."

SNM and ACNP disagree vehemently with the NRC. This is the appropriate function of medically competent ovenight groups, such as professional quality assurance programs, (e.g. ACNP Practice Audit Program), JCAHO, and State boards of Medicine and Pharmacy. NRC's disastrous foray into this area has been a contemptible failure, creating "sin" and "malpractice" where it did not exist, such as its+/- 20% "misadministration" rule. At the meeting of the Organization of Agreement States in Oct., 1997, and the public meeting in Chicago in Nov., 1997, all of the representatives at both meetings voted unanimously to insist that NRC abandon its "Quality Management" and related rules. The NAS-IOM strongly recommended the same, as have SNM, ACNP, other medical groups, and the 0MB. NRC's own report showed the failure of the Quality Management rule to accomplish anything. Nevertheless, NRC is keeping this rule for therapy and essentially expanding it to include diagnosis. It is interesting that the word "primarily" did not exist in the 1/30/98 draft. What other areas of medical.interference does NRC have in mind? It is quite apparent that NRC intends to control which drugs are used for which diseases. Given the lack of medical competence of the NRC, and the fact that such essentials of medical practice are already in the hands of appropriate regulators of drugs and medical and pharmacy practice, this is unacceptable in the extreme. Several near-deaths caused by NRC's drug restrictions in the 1987 10 CFR Part 35 resulted in NRC requesting a petition to remedy the CRITIQUE-10CFRPARTlS-11-98.CSM 9

situation.1 A petition worked on by both SNM/ACNP and NRC, submitted in 1989, had 496 comment letters, all but about three in support of the Radiopharmacy Rule. NRC is proposing to take this rule away by licensing, and this must stop. Section 104 of the AEA is clear about the minimization of NRC intrusion into medicine. While NRC Office of General Counsel has recently argued that this section only compeh NRC to minimally regulate the medical use of special nuclear material (e.g. uranium, thorium, plutonium), we disagree with this recently spin-doctored interpretation of the law. Uranium, thorium, and plutonium have never been used as treatments for patients in nuclear medicine. It would be preposterous to imagine that the Congress sought to deregulate something non-existent and dangerous, but maximally regulate very low risk nuclear medicine instead. The "special nuclear material" alluded to in this section of the AEA is the reactor fuel needed to make radionuclides for nuclear medicine use. All medical uses of the resulting radionuclides were included for minimal regulation. NRC's Medical Policy should come from Section 104 of the AEA, as interpreted by the mainstream of nuclear professionals, knowledgeable lawyers, the Congress, the Atomic Energy Commission, and the NRC itself for 40 yean.

          "4. The NRC, in developing a specific regulatory approach, will consider industry and professional standards that define acceptable approaches of achieving radiation safety."

We believe that this statement does not belong in a Policy Statement, and in any case, NRC has always said this and always ignored it. NRC should not make any regulations or license requirements out of industry or professional 2 Cases include patients at the V.A. Martinez, the U. of Oklahoma Medical Center, and an AIDS patient in Ohio. The detailed accounts are in the reference material sent by ACNP and SNM to the NAS-IOM, and is in the possession of the Commissioners who signed off on this regulatory package plus Commissioner Greta Dicus. CRITIQUE-10CFRPARTJ5--11-'8.CSM

standards. Rather, it should recognize that these standards exist to be implemented by other appropriate oversight bodies, and that therefore NRC is not needed and has no place here at all. For example, USP writes standards for radiopharmaceutical quality. These are enforced for manufacturers by FDA, and for physicians and pharmacists by State boards of Medicine and Pharmacy, with FDA as a "safety net" regulator. NRC has no business or competence here at all, and should not try to make regulations out of USP standards, which NRC bas nevertheless done, and done very badly. For example, NRC uses the USP standard for a target molybdenum/technetium-99m generator. Such generators have not been used in the United States for several decades, and their USP standards are not appropriate to the generators we have been using. In addition, the appropriate USP standards apply to the manufacturers only, which answer to FDA. The purchaser of the generator does not have to prove that the generator meets USP standards, any more than a pharmacist or a physician has to weigh aspirin tablets to make sure that each weights 325 mg. CRITIQUE-10CFRPARTJS-11-911 C8M 11

2. RISK ANALYSIS AND RELATIVE RISK All of nuclear medicine is low risk, both absolute and relative. In its 21 July 98 SRM, the Commission finally undentood that radioiodine therapy, the highest risk of our low risk procedures, is also low risk. This should have set the stage for the deregulation of nuclear medicine.

Initially, the Commission required that a valid risk analysis be performed for all requirements. The staff refused to perform a risk analysis, complaining that it did not have "enough time". Existing risk analyses (by the NAS-IOM, NCRP, and SNM/ACNP) were ignored. At a meeting of the Working Group in late 1997, Kathy Haney announced that NRC would use its "best hunches" instead. The final rulemaking package claims that it is "risk-informed", bu.t this defies credibility. No risk analysis was done for anything. At the Agreement States meeting in October, 1997, Don Cool asked SNM/ACNP to submit a risk analysis that could be used by NRC. This was done. Why was it not used? On p. 43583 of the Federal Register article, NRC commits the startling act of denying that appropriate data for risk analysis exists at all, and further states that even if data for relative risk were available, it could not be used because the AEA requires the use of absolute risk. While NRC's contorted argument is fundamentally illogical-nothing in the AEA prevents NRC from using relative risk-- the logical conclusion to NRC's weak claim that it cannot use relative risk is that it must deregulate medicine completely. Medicine is, after all, an exercise in relative risk. We start with sick or i_njured patients; this is the baseline risk. The object is to improve the patient's outcome (assuming that nothing were to be done) by using procedures with appropriate risk relative to the baseline risk. The CRITIQUE-10CFRPARTJ!..11-98.CSM 12

object is an improved outcome. Very high-risk procedures are perfectly reasonable with very high baseline risk. That is medicine. H NRC cannot play in the relative risk arena, it must leave medicine. The only way to remove all risk from medical procedures is to stop doing all the procedures. This is "regulation by obliteration", and appears to be the goal of some ofNRC's employees. NRC's actual statement is as follows:

          "The Commission (as well as others, such as NAS and ACMUI) has recognized the lack of acceptable data to compare the risks from medical use of byproduct material with risks in other medical modalities. In the absence of acceptable data, regulation on the basis of "comparable risk" would be regulation to an inadequately understood level of risk. In addition, there is not an expressed authorization in the AEA to regulate any use of byproduct material on the basis of an insufficiently known "comparable risk". Without acceptable data or an express statutory authorization, justifying the significant departure from the Commission's established policy with respect to risk to patients would be, at a minimum, problematic."

Well, problematic though it may be, NRC needs to embrace it. What do we call it when NRC removes Part 20 standards in emergency situations (10 CFR Part 20.2) and recommends no more than 50 rem to workers during that emergency? Sounds like a Commission policy of "relative risk", doesn't it? We also call the Commission's attention to a section of the Federal Register article, p. 43527(G)(l)(b). This section appears to have been added after the Commission and the ACMUI reviewed the original rulemaking package. The section alludes t() a "study" on risk being performed by. NRC. This appears CR1TIQlJE..11CFRPAJI.T38-l 1-98.CSM 13

to be a study contracted out to Scientech, Inc." This "study" is not a scientifically valid study at all It is a "touchy-feely", "Do you still beat your wife?"- type questionnaire, or poll, put out on the internet, asking the public how it "feels" about radiation risk to members of the public and to radiation worken. It is obviously constructed to produce material to be used in the production of unscientific anti-nuclear medicine claims. The second part of this "study" is a scientifically valueless questionnaire for Agreement State regulaton, the purpose of which appean also to provide material for unscientific claims. The Scientech "study" is not an example of mere NRC lack of scientific competence. It appears purposeful and calculated, funded by the misallocation of User Fee money. We ask that the Chairman direct the Inspector-General to investigate all NRC personnel responsible for the Scientech "study" and its interpretation. In its earlier comments to the Commission on this Proposed Rulemaking, ACNP and SNM strongly recommended that NRC use the final report of the PresidentiaVCongressional Commission on Risk Assessment and Risk Management for its analysis. The report is entitled, "Risk Assessment and Risk Management in Regulatory Decision-Making". There is a companion report entitled "Framework for Environmental Health Risk Management", and a summary entitled "A Public Health Approach to Environmental Protection". AU three documents were published in 1997. NRC has not used the information in these documents, and has not even alluded to them in this Federal Register article. We believe that their use is the appropriate way to perform a risk analysis, and we ask to Commission to explain why it was not used. CRITIQUE-111CFRPARTJ5..11""'8.CSM 14

3. PERFORMANCE STANDARDS NRC states repeatedly that the proposed rule is "performance based". This is untrue. The NRC has taken precise prescriptive regulation and substituted vague prescriptive regulation. Because licensees are free to write their own procedures, and NRC will not review these procedures before issuing a license, NRC erroneously call this "performance based". However, in the event of a mistake, NRC inspectors will review the procedures to see if they are "adequate". "Adequacy", according to Joseph Delmedico of the Office of Enforcement on 10/21/98 at a NRC public meeting, is that it is comparable to the model procedures in NUREG-1556 Vol. 9. This will result in massive disagreement over "adequacy", huge costs, and probably lawsuits. This is certainly not an improvement. It i!I worse than befori NRC's model procedures in NUREG-1556 Vol 9 are unacceptably poor; it would be difficult to ever practice nuclear medicine at all complying with these procedures. However, there is no guarantee that NRC will accept an alternative, an~ it will not be approved at the time of licensing. Alternate procedures will be seen only by an inspector not qualified to practice nuclear medicine. This is 1macceptably risky.

H, as NRC repeatedly states, licensees may have the flexibility to write th~ir own procedures, then NRC must realize that there are many acceptable procedures to accomplish a specified goal. Why should a licensee be forced to pick one and only use that one? Why couldn't a licensee use any of a large number of procedures, u long as the performance standard is met? If the NRC truly doesn't care which procedure a licensee uses, it should not care if a licensee uses many. These procedures become prescriptive requirements. CRITIQUK-lDCFRPART.15--11-98.CSM 15

We want no prescriptive requirements or prescriptive regulations at all,

• precise or vague.

We want performance standards. CRITIQUE-lOCFJIPARTJ5-11-98.C8M 16

4. PUBLIC PARTICIPATION Despite the repeated claims by NRC that this rulemaking provided for much more public and professional input than usual, virtually none of the important recommendations of the nuclear medicine professionals were heeded. The concept of "professional participation" is purely for show.

The NRC Commissioners convinced the nuclear medicine community to help reform NRC's regulations as a "partnership process". Then, when we accepted, we were effectively removed from the entire endeavor. Not one representative from ACNP (or SNM) were on either the "Working Group" or the "Steering Group". On p. 43581 of the Federal Register, NRC states that the meetings and workshops with the nuclear medicine community

          " *.. were not designed to seek "consensus" in the sewe that there is agreement on how each issue should be resolved .*. ".

What then, is a "partnenhip process", if not to establish "consensus"? CIUTIQUE-18CFRPARTJ5..11-98.CSM 17

5. UNACCEPTABLY SHORT COMMENT PERIOD We are used to getting 90-120 days to comment on a new rule; longer for licensing guides. This rulemaking is over 100 new rules, license conditions, model procedures with hidden requirements, and interpretat,ions of rules, licensing conditions, and model procedures with hidden requirements. We would need at least a year for commenting on anything this massive. The NRC is trying to railroad through a huge regulatory package-over 800 pages. This is foolish and dangerous for the nation's patients and healthcare providers *

• The added insult of announcing on 16 Sept 98 that a new regulatory guide for broad licensees is available, with comments due by 7 Dec. 98; makes the public review process a sham. It also leads us to question the NRC internal review process. We sincerely doubt that very many individuals at NRC have read this entire package carefully, and that this is the reason for questionable material which appeared in the final document. It also helps to explain the very poor quality of the technical work, although it is questionable whether more time would have improved it very much .
• We ask that the entire rulemaking package--Medical Policy Statement, Proposed Rule, NUREG-1556 (9), the 0MB submission (7590-01-p), and the Regulatory Analysis--be retracted to correct inaccuracies and permit time for revision of problematic issues.

CRITIQUE-10CFRPARTJ5..11-98.CSM 18

6. UNACCEPTABLE VAGUENESS Precise regulation and licensing requirements may be debated pro and con because one knows what they mean.

Vague regulation and licensing requirements cannot be adequately debated because their interpretation is unknown. Vagueness itself is a reason to condemn a rule or requirement for the very reason that it cannot be undentood. As an example, let us take 35.1000. Why is it here? It appean to limit us in excess of sections D and E. The proposed license requirements negate the rights of 35.300 under Subpart E. What is going on? This seems to say that NRC will ordinarily not allow unlabeled indications except perhaps for broad licensees, and possibly only as research. This is not only vague and confusing, but appean to be dangerous and will negatively impact the delivery of high quality healthcare. This is the opposite of the NRC's stated intention. As another example, what is an "emerging technology"? NRC tried several years ago to call monoclonal antibodies new and dangerous. While it is completely inappropriate to call monoclonal antibodies an "emerging technology", or new, or dangerous, will NRC try to do so and limit their use? We do not know what NRC will do or what this phrase means . CR1TIQUE-10CFRPARTJ5..11-98.CSM 19

7. GRANDFATHERING OF NUCLEAR MEDICINE AND NUCLEAR PHARMACY COMMENTS, LEITERS, TRANSCRIPTS, MEETINGS, ETC. SINCE 1985 One of the most frustrating aspects of this rulemaking is that we have been saying the same things over and over again to NRC since 1985. By judiciously keeping the Commissioners ign*orant of history, NRC staff wastes our valuable time. Numerous cubic meters of material have been sent to NRC since 1985 pertaining to all aspects of this rulemaking.

We insist that all of nuclear medicine and nuclear pharmacy comments, letten, transcripts and minutes of meetings be "grandfathered" as comments for this rulemaking. We are not prepared to waste our valuable time continually repeating ounelves* CRITIQUE-lllCFRPARTlS-11-'8.CIIM 20

8. AGREEMENTSTATEADEQUACYANDCOMPATIBILITY REQUIREMENTS We reject nearly all ofNRC's plan on Agreement State adequacy and compatibility. The practices of medicine and pharmacy do not have "transboundary implications", and should be changed from "B" to "D".

These are state functions. All category "C" items should be changed to "D" because they are too restrictive. All "Health and Safety" (H and S) requirements for adequacy should be removed because they are not necessary for "Health and Safety". "Health and Safety" u accomplished by starting with qualified professionals who follow professional standards. Despite the NRC's contention otherwise, there is no State in the United States in which citizens are inadequately protected from the hazards of byproduct material. CRITIQUE-10CFRPART35-11-'8.CSM 21

9. 0MB ESTIMATE The 0MB estimate is severely flawed, grossly underestimating the costs of nuclear medicine compliance by conveniently omitting numerous big ticket items. These include writing procedures for everything one could possibly imagine doing in such a way as to outwit NRC inspection and enforcement police, an entirely separate and new recordkeeping mechanism for administered doses that maintains patient confidentiality, the huge costs of writing procedures because NRC's model procedures are useless, increased legal costs, increased amendment costs, costs from discarded diagnostic doses, etc. Hundreds of millions of dollars are "missing" from this estimate.

HCFA has decided not to pay for any of these regulatory costs. HCFA is correct--they have no added value to healthcare. However, HCFA needs to convince Congress to cut the costs, by eliminating unnecessary regulations and requirements, or Chairman Jackson needs to convince HCFA to pay for them. The government can't have it both ways without regulating much of nuclear medicine out of existence. CRmQUE-10CFRPARTJ5-1 l--98.CSM 22

10. QUALIFICATIONS FOR PHYSICIANS We firmly believe that NRC should limit its requirements for physicians to those necessary for expertise in radiation safety. We believe that these qualifications must be substantial and comprehensive, as the physician must not only handle radioactive material, but also supervise and instruct othen in safe procedures for their handling of radioactive material as well. Often, the physician is the Radiation Safety Officer, and is broadly responsible for all radiation activtties at his institution. Compliance with 10 CFR Part 20 requires substantial knowledge of basic nuclear and radiation science.

• Physicians need to be knowledgeable enough to handle misshipments of incorrect radionuclides and incorrect quantities, accidents involving spills of radioactive material, mistakes involving the administration of radioactive material to the wrong patient, mistakes involving the wrong radioactive material given to the correct patient, the overall management of radioactive material in their practice, and the supervision of technologists and othen. We disagree with NRC's implied concept of "proportional" radiation safety. That is, the fewer the procedures one does the leu one needs to know about radiation safety. While one needs less clinical knowledge and experience if one performs few rather than many different procedures, the basic nuclear and radiation science knowledge needed for radiation safety is the same. For example, it doesn't matter whether one uses the radioactive decay equation for one radionuclide or ten. It takes the same time to learn it.

We fear that the Proposed Part 35 will cause NRC to define "competence" at such a low level that the quality of physicians licensed to use byproduct material will be even lower than it is now. At present, we feel that a substantial proportion of physicians li~ensed by NRC do not possess adequate levels of working knowledge of basic nuclear and radiation sciences, but judgments of their competence seem nevertheless to be made by NRC employees who CRITIQUE-10CFRPARTJ5-l l-98.CSM 23

themselves lack the level of basic nuclear and radiation science competence needed to appropriately and safely practice nuclear medicine. Furthermore, the NRC has a conflict of interest, and will act in such a manner as to bring in increased User Fees, even if it licenses physicians with questionable qualifications. We therefore believe that the assessment of specialty boards questions needs to be made by a separate group with respected standards for nuclear medicine, not NRC with lack of competence and obvious conflict of interest. In addition, we insut that the JCAHO standard of using only ABMS approved boards should be very seriously considered by NRC. Otherwise, the whole mechanism breaks down, as there is no limit to how low the standard can sink. We also firmly believe that substantial and comprehensive medical qualifications to practice nuclear medicine need to be enforced by medical groups such as JCAHO, Practice Privilege Committees, and State Boards of Medicine. NRC should make it clear in writing that it expects these qualifications to come from and be enforced by the medical sector, and that NRC licensure is a measure of radiation safety training and should never be used as an indication of medical competence. For comparison, it u instructive to look at the situation in Canada. In that country, all nuclear medicine procedures are performed by physicians who are board certified in nuclear medicine. This is accomplished by denying payment for nuclear medicine services to any physician not board certified in this specialty. Due to the cheapening of qualifications for licensure by NRC, the odds of an American having a nuclear medicine procedure performed by a physician board certified in nuclear medicine is now less than 1 in 5. The "Balkanization" of nuclear medicine in order to optimize User Fee income is destroying nuclear medicine as a specialty and bodes ill for patient care. CRfTIQUE-lGCFRPARTJ5.. l l-'8.CSM 24

11. PROCEDURE OVERLOAD Once NRC has made the determination that a physician is competent to handle radioactive material safely, the regulations and requirements must reflect that determination of competence. Instead, the present and proposed regulations assume virtually no competence at all No written procedures of any kind need to be submitted to NRC for review or need to be "promised" for later review, and no procedures should be license conditions. This goes for diagnostic procedures, therapy procedures, laboratory procedures, procedures for checking packages, procedures for monitoring work areas, procedures for patient identification, etc.

What we need, and what we have stated repeatedly for over a d~de, is a performance standard. As long as NRC cannot show that public dose limits, worker dose limits, or environmental limits are exceeded, and after 62 yean of our specialty, NRC cannot show any such valid data at all, the NRC should be* content to leave ovenight of the* practice of nuclear medicine and nuclear pharmacy to the appropriate medical and pharmacy professionals. For example, a diagnostic procedure manual is a general guide written by the Authorized User Physician to his/her technologists. It will be departed from frequently, u patients differ, practice parameters change and resources change, and the manner in which a procedure manual is to be interpreted is between the physician and the technologist. It is an internal document, and by nature incomplete, as procedures are infinitely variable. The "control freak" mentality with which NRC proposes to rigidly hold us to our diagnostic procedure manual tell! us much about the lack of medical npertise of NRC. The only effective purpose of the proposed manual really is to give NRC a tool with which to abuse doctors. It will not improve patient care or radiation safety. A deviation from the manual by NRC thinking is a "violation". NRC has no ability to comment in any valuable way about the medical quality of the procedures themselves, and never has. NRC has no valid evidence that any of these procedures is a danger to workers or the general public. NRC will merely keep an army of bureaucrats CRmQUE-10CFRPART35-11-91.C8M ) 25

busy pretending to review procedures which are none ofNRC's business, and apparently intends to license physicians procedure by procedure, and drug by drug. Thu is not only an abuse of the NRC's duties and the AEA of 1954, but is also scientifically and medically absurd, horribly time consuming for the person writing the procedures, and of no earthly value. It is dangerous to patients, and will produce a mindless NRC bureaucracy of paper pushing personnel which costs hundreds of millions of dollan in compliance costs to support. The cost is not in User Fees, so much as in the non-reimbursed cost in valuable hours to

• produce all the paper NRC craves to keep its paper people looking busy, be they licensing people or inspectors. All the procedure manual requirements in the .

Proposed Part 35 draft should be omitted. NRC's "procedure mania" appears to have come from the dominance ofNRC's nuclear navy mentality, in which every activity is prescriptively carved in stone in a couple of procedure manuals. We do not presume to pass judgment on the running of the nuclear navy, but we will say that it has nothing of value to pass on to the pr:actices of medicine and pharmacy. The NRC does not understand the differences between the rigidity of mechanical systems and the wide normal variations inherent in biological systems. No other field of medicine is cursed with procedure mania, and no other field of medicine is safer than nuclear medicine. We categorically reject the notion that NRC has any need for us to produce or comply with written procedures, so long as only qualified physicians are permitted to handle or supervise the handling of radioactive material in the lint place. That many of us will continue to have internal procedures for other purposes is the business of medical professionals, not NRC. CRITIQUE*IOCFRPARTJS.11_.CSM 26

12. RECORDKEEPING The exhaustive record-keeping requirements of NRC, like "procedure overload", serve no legitimate safety purpose. What national database is being built, and for what scientifically appropriate reason! What is the que,tion being asked, and how will these data be analyzed to answer it? Will the answer be important? What will it lead to? There are no acceptable answers to these questions, because there is no legitimate purpose to this excessive record keeping in the first place.

The purpose of the proposed record keeping appears to be to produce massive quantities of meaningless paper for swarms of NRC inspecton to inspect. NRC will insist to 0MB every time that this is the only way NRC can assure compliance with its requirements. In fact, the only valid way to assure compliance is to inspect process. A competent inspector will watch worker techpique, observe the types of radiation monitoring equipment on hand, and observe certain facilitie,, such as a place for storage to decay. Very few pieces of paper are needed to know whether a facility is using radioactive material safely. That is, if the inspector is competent. Most of NRC's inspectors are graduates of a 5-week crash course in how to be a radiation inspector, and lack the scientific background, intrinsic education, training, and experience to infer compliance by observing process. Their job has therefore been reduced to the inspection of paper, and creating and filing this paper in an immediately retrievable manner costs us many millions of dollan a year with no demonstrable benefit in improved patient qire or radiation safety of the public or ofworken. All state, already require certain records from practitioners of medicine and pharmacy. ACNP-CA, therefore, recommends that all record-keeping requirements be removed except: (1) documentation of worker overdoses, (2) documentation of CRITIQUE-10CFRPARTJ5-11-98.C8M 27

general public overdoses, (3) documentation of exceeding the environmental standards of Part 20, (4) documentation of leaky commercially available sealed sources. Recording of patient doses is a JCAHO requirement, and NRC need not dual regulate here. The total national yearly record-keeping for nuclear medicine would effectively be reduced to a few pages, but that is all that would be necessary to record. After all, hazard is seldom involved. The standards are set so conservatively that even substantial noncompliance does not result in true hazard

• CRITIQUE-lOC'FRPART35-l 1-98.CSM 28

13. THE QUALITY MANAGEMENT (Q/M) RULE REMAINS, FOR THERAPY AND NOW IN ESSENCE FOR DIAGNOSIS Despite an NRC report documenting the failure of the Q/M rule to accomplish anything, despite the extreme opposition to this rule by ACNP, SNM, ACR, the ACMUI twice, the NAS-IOM, the 0MB, the Agreement States, and all representatives at the Chicago public meeting on this rulemaking, NRC has not only kept it in with some cosmetic change, but by a combination of regulation and license condition, imposed it on diagnosis as well. This is absolutely unacceptable, will be terribly destructive to the practice of diagnostic nuclear medicine, and is nonsensical. We oppose the Q/M rule for therapy and diagnosis.

California has never accepted NRC's Q/M rule. There has been one nuclear medicine therapy "misadministration" in the past 6 years, and the physician was not board certified in nuclear medicine. This record is so superior to NRC's record that NRC needs to learn from California. When did the Commission order a Q/M rule for diagnosis? Why was it never discussed in the public meetings? Why was it not presented to the ACMUI for their consideration? Why was it not in the 1/30/98 draft? Where is NRC's risk analysis? Why this ugly stealth? We would like to remind NRC that in the ACNP/SNM lawsuit against the Q/M rule, NRC testified that it would not be applied to diagnosis. Has NRC forgotten? CRmQUE-tOCFRPARTJS-11-98.CSM 29

14. PATIENT NOTIFICATION The standard of medical practice is to inform patients u appropriate. This professional standard should substitute for NRC's Patient Notification rule. We reject NRC's requirement and we also reject NRC's analysis of the AMA Guidelines; AMA itself rejected this when NRC's analysis tint appeared in 1994.

NRC's notification rule would force physicians to "lie" to patients, indicating that a mistake has happened and that they got the "wrong" amount of a radiopharmaceutical when they merely exceeded an arbitrary +/- 20% window for dosage. This is outrageous for nuclear medicine (we are not addressing radiation oncology here). The physician should decide the range permitted, which may well differ for different patients, and should not tell the patient of a "mistake" unless the physician's range was not adhered to and harm can be expected as a result. When two physicians, treating the same Graves' disease patient, can vary their prescriptions by 600%, or by 1000% for an 1-131 metastatic survey, a+/- 20% window is absurd

• CRmQU&-10CFRPARffl..11-98.CSM 30

15. PATIENT DISCHARGE RULE With no scientifically valid database for back up, the Commission has requested comments on the 500-mrem Patient Discharge rule. There seems to be a collaboration with The Conference of Radiation Control Program Directors (CRCPD) who do not know how to regulate patient contamination in sanitary landfills and object to going out when radiation meters set near background are triggered.

This represents a failure of CRCPD and a failure of NRC, because patient contamination has always gone to sanitary landfills, is not hazardous, and can be "cured" by setting the thresholds higher. However, NRC will not write standards, nor will CRCPD, and it is every state for itself. California does not have a serious problem with contamination due to the Patient Discharge Rule (the California version) and Los Angeles County Radiologic Health has had no problem at all. However, in California, the 500 mrem Patient Discharge Rule is only for those physicians who understand the physics and will counsel their patients in radiation protection. Perhaps that is the secret. Smart docton and smart regulators mean that there is no problem and large cost savings. So, we wish to keep the 500 mrem rule, California-style. Managed care organizations which try to disallow payment for appropriate hospitalization of radionuclide therapy patients need to be "educated" by the regulated community and the State Radiological Health entity. This is not a significant problem, and is not a valid reason to remove the rule. CRITIQUE-IOCFRPARTJ5-l l-98.CSM 31

16. PREGNANCY AND LACTATION This Proposed Part 35 has slipped in a new requirement concerning pregnancy that a previous, wiser Commission avoided. The ACMUI recommended against it as well While the comments of ACMUI memben are on the public record, the essentiah of the arguments are as follows:

The overwhelming majority of nuclear medicine procedures are safe to perform on pregnant patients. In fact, they are often the tests of choice, u other radiologic procedures frequently involve higher radiation doses. In the limited situations in which it is important to avoid giving a radiopharmaceutical to a pregnant woman, usually involving Nal-131, pregnancy information is ascertained in a careful manner. Usually, this involves a pregnancy test. However, this costs money. If a woman has had a hysterectomy, why should she pay for a pregnancy test? Ha nun swears chastity, why should she? So occasionally, a pregnancy test is not done, almost always, for good reason. Once in a great while, a patient lies* or is misinformed, refusing a pregnancy test and denying the possibility of pregnancy, only to be found to be pregnant later, after the administration ofNal-131. In a very rare event like this, the mother is counseled that the baby may be born without a normal thyroid and therefore be on one synthroid pill a day for life. As spontaneous congenital absence of a functioning thyroid is common, we know that such babies on thyroid hormone replacement for life are perfectly normal otherwise. This is a complex medical situation, and involves the state of pregnancy, the personal ethics of abortion, and the possibility that under certain circmrutances it may be necessary to knowingly harm the baby to treat the mother. This is all none of NRC' s business; it is the essence of a very private patient-physician relationship. CRITIQUE-10CFRPA1!.TJ5-11-'8.CSM 32

NRC is now making it effectively mandatory to get a pregnancy test on every woman of childbearing age before performing many nuclear medicine procedures, diagnostic u well as therapeutic. As a urine test is not as sensitive u a blood test, a blood test will be done. It may take one or several days to get the results, and the results may be unexpected and bear repeating. Necessary nuclear medicine tests will be held up for one or more days. Patients will refuse to pay for the pregnancy tests. Physicians will refuse to do the nuclear medicine procedures. As the blood pregnancy test will be negative in early pregnancy, it is still possible to have a pregnant patient without knowing it The bottom line will be that some women of childbearing age will be denied care or get alternative radiology procedures that have more radiation dose than a nuclear medicine procedure, if that alternative is available, and even if it costs more. Many physicians, all too aware of the vicious misrepresentation of events by NRC, and huge costs of NRC-inspired inspections and lawsuits, will simply refuse to perform any nuclear medicine procedures on women of childbearing age, period. Many women will not have diseases recognized in time, or will be treated for diseases they do not have because documentation of absence of that disease was not available. Some will suffer permanent disability. Some will die. The Commissioners of NRC will be at fault L~ck of adequate data make it virtually impossible to accurately calculate radiation doses to embryos and fetuses at various gestational periods from various radiopharmaceuticals. "Conservative" calculations can be gamed to achieve doses of 500 mrem or more quite easily, the dose limit in NRC's rule. Given the fact that 500 mrem is not a "hazard"---this is somewhat less than the yearly background rate in Denver, CO--this NRC requirement will only cause hysteria. Why doesn't the NRC recognize the potential to create needless hysteria? CRITIQUE-10CFRPART35-l l-9S.CSM 33

We have been told that the pregnancy rule bad to be inserted into the new Part 35 because of the latest set of" Abnormal Occurrence" (AO) criteria by which NRC chooses to report events to Congress. It is not Congress that sets out AO criteria, it is NRC. The most recent set of AO criteria was not approved by the ACMUI. The same staff who tried in vain to make a pregnancy rule in previous years helped put it in the AO Criteria, thereby creating tbu byzantine situation of regulatory complexity. The simple solution u to throw out the pregnancy rule and the AO criteria, and only report radiation-induced injuries and deaths from radiopharmaceuticals and radiologic devices that were due to accidents and that were NOT reportable to FDA. There has been one such event involving a radiopharmaceutical in the United States in the past 62 years, and over 300,000,000 non-events. The NRC should stop disguising its reactor problems by inventing medical "problems" for the Congress. That would be a good thing. The Lactation Rule is a similar situation, but it was sneaked into another rule in January, 1997. It was piggybacked onto an unrelated rule regarding patient discharge after radiophannaceutical administration. It was based on one incident involving a patient who wu a nurse who bid both her pregnancy and her lactation from her physicians. The lack of good faith behavior of the NRC regarding this rule has been completely covered in public documents submitted by NRC's medical consultant on that case. The Lactation Rule needs to be exorcised along with the pregnancy rule. The standard of medical practice adequately covers situations of pregnancy and lactation, as it is even more important to other areas of medicine with drugs that create real hazard. NRC should not regulate in these areas at all. The other point, of course, is that NRC regulation in this area does no good. It has no national value. NRC simply publicly punishes mothers and physicians. By CRITIQUE-10CFRPARTJS...11-'8.CSM 34

identifying the licensee and the approximate date, patient confidentiality is blown. CRITIQUE--10CFRPARUS-11-98.CSM 35

17. MEDICAL RESEARCH In 1975, the NRC relinquished radiopharmaceutical drug review for byproduct material to the FDA. NRC also relieved itself of oversight of drug research for eventual drug approval, and research with byproduct tracers for non-drug-approval purposes, such as basic biochemistry and physiology research. The human research with investigational drugs went under FDA requirements, and the tracer research for non-dmg approval required new FDA regulation (21 CFR361.1).

About 15 years later, NRC bureaucrats decided to regulate this research again, creating more regulatory work for themselves of a completely dual regulatory nature. There u no need for any NRC involvement in nuclear medicine research. Between the FDA and the Office of Protection from Research Risks (OPRR), both under the Department of Health and Human Services, we have all the regulation we need, and more. In this Proposed Part 35, NRC tries to take research that u not regulated under the Federal Policy for the Protection of Human Subjects for itself. However, FDA is not a signatory of the Federal Policy; it has its own, similar requirements. The draft as it stands thus has dual regulation by NRC and FDA. As NRC doesn't even understand any of this, and u the FDA/OPRR duo controls all of our research, it is time NRC disappeared once more, as it did in 1975. All the present Commissioners were sent a copy of the 17-page 1975 Federal Register article chronicling FDA "lifting its exemption" for byproduct material (upon insistence by NRq. It was NRC's plan to then end the medical program. After all, FDA had received statutory authority over radiation-producing machines in 1968, and board certification for nuclear medicine occurred in 1972, CR1TIQUE-10CFRPARTJ5-1 l-911.CSM 36

and it wu felt that by giving byproduct radiophannaceuticals and tracen to FDA, that NRC no longer had a unique role. That wu the last time NRC made any sense on this issue. Twenty yean later, the NAS-IOM said the same thing. We'll say it again now. NRC's medical program has no unique function, and should no longer exiJt. It is not only dual-regulatory, it is dangerous. In this Propo5ed Part 35, under section 35.6, provisions for research involving human subjects, NRC states (p. 43529): " .*. the Commission is soliciting comments on whether this section should be revised to require that licensees develop, implement, and maintain procedures for evaluating when a medical procedure would be considered to be a research procedure". Such ignorance on the part of the Commission is astonishing. Medical procedures are primarily performed for the patient, and may include established, new, or untried approaches. Research procedures are done for the primary purpose of collecting scientific information and may also include established, new, or untried approaches. It is primary intent that distinguishes them. Medical institutions and government agencies other than the NRC already have sufficient controls over medical research, including the use of ionizing radiation . What is really going on here? Hu NRC staff arranged to get an opinion from an FDA employee that unapproved drugs and unlabeled indications are called "invatigational" by FDA, are therefore "research", and doing such procedures requires IRB approval, consent forms, and of coune, no reimbursement! This is not so far-fetched, considering that an FDA employee tried recently to accomplish this for PET radiopharmaceuticals, and wu, in the end, ove~umed by Commissioner David Kessler after being approached by an angry Senator. Considering that this FDA employee is married to an NRC employee working on the new Part 35, it is worrisome. NRC is now using a claim of possible radiation hazard by FDA to forbid intravascular radiation therapy with byproduct CRITIQUE-10CFRP AR'OS-11-911.CSM 37

material, even though this is rapidly becoming the standard of practice in outstanding radiation therapy departments. Patients deprived of this procedure may suffer myocardial infarctions or leg amputations. What is NRC doing? It is evident that the Commi11ion has not read the Declaration of Helsinki. Article II (1) states, "In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic measure, if in bis or her judgment it offen hope of saving life, reestablishing health, or alleviating suffering." The United States honors the Declaration of Helsinki for research and for clinical care, and NRC is therefore expected to comply as welL CRrI'IQUE-lllCFRPARTJ5-11-98.CSM 38

18. FORBIDDEN MATHEMATICS Proposed 35.63(c) says that dosage must be determined by direct measurement or a combination of measurement and calculations. This situation is completely inappropriate. Often only mathematics is needed.

The rationale is simple, really. The inspectors, as well as the staff and management, do not fully understand the mathematics of radioactive decay, of radiopharmacokinetics, of internal dosimetry, of external dosimetry, of generator elution, or of basic statistical analysis. Having avoided math whenever possible, and having actually published statistical nonsense (e.g. in the sampling method for the Q/M Rule), radiophannacokinetic junk (Reg. Guide 8.39, now Appendix U), and external dosimetry showing inability to use time, distance, and shielding correctly (the Indiana, PA accident), NRC has apparently decided to stop being criticized for incompetence and disallow as much math as possible. This is fascinating, because in draft 35.292(b)(1 )(iii), NRC requires physicians to learn "mathematics pertaining to the use and measurement of radioactivity". That is, we must learn math, but we may not use it fully because the inspectors are not smart enough to keep up with us. Another example concerns NRC's request for comments on whether radiopharmaceutical therapy patients must have private rooms and baths. H NRC could do the dose calculations, it would not ask such an unnecessary question. H we assume two thyroid cancer patients in a room together, each receiving 200 mCi 1-131, 2 meters a part, for 48 hours, occupancy factor 1.0, with a 1 % 1-131 uptake in the residual thyroid and a 12 hr. halflife for renal clearance, then using the corrections for shielding and line source (Sparks RB, Siegel JA, Wahl RL. Health Physics 75 (4): 385-388, 1998), the radiation absorbed dose from Patient A to Patient B is about 85 mrem ede. The radiation absorbed dose from Patient A to himself is about 385,000 mrem ede. Regardless of the fact that NRC has not done any risk analysis, and has denied the use of CRITIQUE-IOCFRPART.15-11-'8.CSM 39

      "relative risk" in its entirety as being against the AEA, the answer to a competent professional is that of course two therapy patients can be together.

One could even justify the company of a non-therapy patient Another example is limits, in dpm/100 cm2 of removable contamination. First, the whole concept of numerical limits is flawed, and the old 2000 dpm/100 cm2 for all radionuclides except 1-131, which was 200, is already arbitrary and capricious. Only radiation absorbed dose matters. However, without a shred of scientific justification, NRC lowers the 2000 to 1000, keeps the 200 for 1-131, and makes a limit of 20dpm/100 cm2 for 1-125. Radiation absorbed dose from such levels ofl-125 are absurdly miniscule. We do not even have equipment that can detect this. Background in a Nal (TI) system at the 1-125 setting is commonly about 30 cpm, and in a typical liquid scintillation counter is about 35 cpm. Efficiency for a Nal (Tl) bioassay system is about 1 %. NRC's thyroid bioassay requirements for Nal-131 are outdated and unnecessary. All commercial products are stabilized against volatility, and have been so for over 10 years. NRC has been sent the full scientific database at least three times showing extremely low volatility. Why cannot NRC understand and use these data? In California, thyroid bioassay is not required when using stabilized products. The Commission needs to be concerned about the apparent lack of technical expertise among its staff and management Its medical expertise is even worse. The requirement in Appendix X to remove the sharps from the sharps box to avoid any shielding is a massive OSHA violation. It could, for example, kill workers from hepatitis B or C, or AIDS. CRITIQUE-10CFRPARTJ5..11-'8.C8M 40

19. DOSE CALIBRATORS Nuclear medicine in its present form began in 1936, with accelerator-produced radiopharmaceuticals. During the Second World War, the secret reactor built at Oak Ridge sent medical isotopes to Berkeley, and they were then distributed as though they were accelerator produced. After the war, reactors were built all over the nation, and many medical schools used their own for radionuclide production. "Dose calibrators", which are simply ion chambers with variable potentiometen, made it easier to determine the activity of various radionuclides because of the ease of building in, or dialing in, calibration factors. We in nuclear medicine did without "dose calibrators" for 35 years (we used math and physics and other radiation detectors), and many did not use the first "dose calibrator" models, which were not sophisticated instruments. NRC's regulators still do not really undentand how modern (silicon chip, not vacuum tube) dose calibrators work, or their calibration needs. NRC does not, and has not, even understood that the accuracy needed depends on the procedure, not the state of the art of technology, at any cost The accuracy needed is up to the physician. H the accuracy of a medical procedure requires knowing the administered activity of a radiopharmaceutical +/- 30%, why worry about accuracy of +/-5% or 10%

which will require NIST-traceable calibration sources at significant expense? No qualified nuclear medicine physician ever prescribed" 1 teaspoonful of Tc-99-radiopharmaceutical". We have ways of estimating activity within the needed accuracy. NRC should omit all dose calibrator requirements, and all requirements to tell it how we ascertain activity. NRC determines that we are competent; after that it should omit such elementar:y considerations from its regulations altogether.

    "Dose calibrator fixation" is another source of volumes of paper for NRC inspectors to inspect. Why? It has no effect on basic radiation safety. The dose CRITIQUE-IOCFRPART.lS-11-98.CSM 41

re~orded does not necessarily match the dose administered. H the phy1ician knows that the difference is unimportant, why is NRC concerned? CRITIQUE-lOCFBPARTJS..11-98.CSM 42

20. SEALED SOURCES, SOLID SOURCES, LEAK TESTING The construction of certain types of sealed sources can fail and the sources can leak. Solid sources, such as dry radionuclides embedded in acrylic, cannot leak.

There is no reason to leak test them. It is a waste of time and money. Although NRC's unyielding fixation of leak testing creates huge amounts of paper for inspecton to inspect, it is an obvious example of overregulation in nuclear medicine. Exempt solid sources. How many nuclear medicine sources have leaked over the last 20 yean? If any have, has radiation dose to anyone been significant? What is the fuss about? If we find a leaky commercial source, we should notify the manufacturer, who will contact others who have that source to make sure the othen do not leak. The manufacturen report these defects to FDA Center for Devices and Radiologic Health. Of what value is NRC here? Such information, on RADSAFE, will reach the whole country (and other countries) in one day. What does NRC do with the information that the licensee, the manufacturer, and the FDA haven't done already? CRITIQUE-lOCFHPARTlS-11-98.CSM 43

21. MOLYBDENUM BREAKTHROUGH NRC should remove itself completely from issues of radiopharmaceutical quality control This is safely in the hands of far more qualified groups, such as USP, FDA, and 50 State Boards of Pharmacy and of Medicine. Sec. 35.204 should be removed. NRC has no undentanding of this area, and no one needs NRC to dual regulate those who do.

The USP standards apply tG those who manufacture generators. Those who use them need not show that USP standards are met, as FDA has already checked the manufacturer's compliance. The Mo-99 standard is not a hazardous amount, and does not represent a safety limit. HNRC would perform the dosimetry, it would understand that. In addition to adding a needless quality control exercise, NRC is using the wrong standard. It is using the standard for target Mo-99. We have used fission Mo-99 for over two decades, and the USP standards for the manufacturer are different. CRITIQUE-10CFRPART.lS-11-98.CSM 44

(J

22. LABELING OF VIALS, SYRINGES, AND SYRINGE SHIELDS Sec. 35.69 should be removed in its entirety. This is another example ofNRC regulating pharmacy and medical practice, when other more qualified regulators are in firm control A variety of circumstances will result in variation in information labeling, none of which are radiation hazards or NRC's concern.

H NRC ended this regulation, nothing would change. Appropriate labeling is the standard of medical and pharmacy practice. As far as classic syringe shields are concerned, they may generally be regarded as an ALARA violation. One receives more radiation dose screwing on the syringe shields than one gets using other techniques. Syringe shields are a patient hazard, in that they do not permit efficient venipuncture and often obscure subtle visualization of syringe contents. CRmQUE-10CFRPARTlS-11--911.CSM 45

I'

23.

GENERAL COMMENT

S There are many other comments that could be made in the same vein as the previous ones. Basically, we are asking NRC to remove itself from medicine, pharmacy, research, and related areas now that other regulaton have jurisdiction. We require a valid risk analysis for every other requirement. We require good science and correct math. Twice before, NRC has tried to end its medical program, and twice it bu been stopped. Commissioner E. Gail de Planque and Chairman Selin tried to do it a third time a few yean ago, but failed. Chairman Selin did not feel NRC could ever end its own program because of the bureaucratic survival activities of so many of its employees. He advised us a month before he resigned to get some legislation to Congress and he would support it. We did not use this opportunity, but may have little choice now. The current direction ofNRC will destroy much of our specialty in the United States* CRITIQUE-10CFRPART35-11--98.C8M 46

24. REGULATORY DEATHS We believe that the issue of risk.analysis u a critical one, and that it is essential that NRC stop ignoring an absolutely essential component of a valid risk analysis, which u the risk of regulatory cost in general, by any agency. For every approximately $9 -$12 million spent in regulatory compliance, one random person dies. This is because the money wu not spent on other aspects of safety.

For example, a patient who spends an extra $100 on a nuclear medicine

• procedure because of the cost of NRC compliance does not have that money to buy better tires for bu car. In any case, a regulator has to weigh the people he will kill by the very cost of regulation against the number that he will save. H NRC's present proposed regulations were similarly adopted by Agreement States and for accelerator as well as byproduct material, the cost of nuclear medicine regulation has been estimated to be roughly $1 billion/year. That means that 83 people/year would be killed by NRC's medical regulatory cost alone. If NRC saved 10,000 people a year, it might be worth it. However, there is no evidence that NRC saves any patients a year because of its nuclear medicine regulations. Therefore NRC's nuclear medicine program is a net hazard to the United States. NRC is not "just being careful". NRC kills people. And, by restricting radiopharmaceutical use and adding its pregnancy rule, it will kill even more.

CRITIQUE-10CFRPARTJS-11-98 C8M 47

25. THE CHAIRMAN'S FAJLURE None of the NRC management will take personal responsibility for this rulemaking. Hugh Thompson, Carl Paperiello, Don Cool, and Kathy Haney have all blamed the Chairman. The Chairman bas refused to meet with nuclear medicine leadenhip, refused to consider the unanimous vote at the Chicago public meeting to significantly revise the original SRM, refused virtually all our recommendations ~nd refused even to be educated by a member of the NAS-IOM Committee, SNM's Past President, Dr. Barbara Croft, who graciously offered her services.

The Chairman bas failed to lead and to administrate. Deceived by her underlings, she signed off on a potentially grotesque regulatory disaster. The Chairman is a clear and present danger to patients and to nuclear medicine healthcare professionals trying to care for them. CRITIQUE-10CFRPART35-l l-99.CSM 48

27. UNBUDGETTING NRC POSITIONS The NRC Medical Program staff, management, and support staff and management (OGC, 01, OE) have no function any longer. Originally set up to "mind the store" until appropriate medical specialties were established, the bureaucracy, once settled in, refused to go away.

FDA was given responsibility for radiation-producing machines in 1968, and radiopharmaceuticals in 1975. The EPA was given radiation standards in 1970. OSHA handles workplace safety. Board certification for Nuclear Medicine was established in 1972, for Nuclear Pharmacists in 1982 and for Nuclear Medicine Technologists in 1978. As over 90% of the use of radiation in medicine is not regulated by NRC, all states have radiation regulaton for that 90%. (Wyoming, which closed its tiny program, can always restart it if needed.) JCAHO and professional Q/A programs oversee medical quality and 50 state boards of medicine and boards of pharmacy oversee professional behavior. There is nothing left for NRC to regulate EXCEPT BY DUAL REGULATION. As this is unwelcome and counterproductive, Chairman Jackson should simply unbudget the Medical Program personnel. CRITIQUE-10CFRPARTJS..11-98.CSM 49

25. WHAT THE NEW PART 35 SHOULD SAY The new Part 35 should heed the findings of the NAS-IOM, the recommendations of the leadership of professional nuclear medicine, and the recommendations of Commissioner E. Gail de Planque and Chairman Ivan Selin. NRC's regulations should, at this point in time, focus only on worker, non-patient public, and environmental safety, a program requiring minimal FfE's because nuclear medicine has not been shown to be a significant risk in these areas.

Part 35 should address basic nuclear and radiation science qualifications of Authorized Users, and the designation of professionally competent outside groups for testing purposes. NRC should not try to validate medical board exam questions or make competency decisions itself. Part 35 should require that a licensee submit the name, address, phone, fax, and e-mail numbers of its Administrator and of its designated radiation management individual (whether called a "Radiation Safety Officer" or a more appropriate term). The licensee should inform NRC of any radioactive material, sealed or unsealed, which could represent a public health and safety hazard in the event of a catastrophe which could effectively remove it from the usual competent oversight, such as a fire or severe earthquake. The licensee should be licensed for atomic no. 1-83, in any chemical or physical form and in any activity needed for medical use, teaching, research and development (human, animal, or laboratory), calibration, quality control, and related professional purposes. "Medical use" includes nuclear pharmacies as well as healthcare organizations and private practices. CRTITQUE-10CFRPARTJS-11-98.CSM 50

It The requirements of Part 20 should be lifted, except for the essence of this part: the dose limits to workers, members of the public, and the environment. Due to the inherent safety of nuclear medicine in the hands of qualified professionals the burden of proof will be on NRC to show that the licensee is not safe. The licensee should not have to prove it is safe. The difference between these two concepts is hundreds of millions of dollars a year. CIUTIQUE-10CFRPART35-11-9S.CSM 51

tlebe amerimn 1Soarb of 1'abiolom, Diapoltic RadiololJ Racliat1oa 0nco1ou Radl~ ~ D M. Paul Capp, M.D., Executive Director ~ RC 1 Ofllcen Aslistant EllecudYe Dlrecton Wil6-J. C-lla. M.D .. ,,.,.._ Aai.a.Oeorsia "98 NOV 16 A11 :4~i!=~--o;.,...,11i< ...o1or. llobort ll " - , . M.D.* 111c*. ,,.,......., Noveml>er 5~ 199& Lawm,cc w. 0.*11. M.D .* R,..;,,,;,... Olt<olor,*

   ........... M i . -                                                                                                                            AIIMI&. Gcorpa WiUiaa R.      ~ ...D .. J<<mar:v*T_,....,,                                                                       CC.11          ~     ,- ,       Edwanl L. Chaney. P!i.D .. Rodiolo11e l'#r.*sil:1 Mil*IIIUI. IV.-ia                                                                                         O  j  i 11 ~* *

• I Chapel Hill. Nonh Carolina R LL.i * '

U.S. Nuclear Regulatory Commission ADJUCI'_ l Washington, DC 20555 Diapmdc RacUoloaY l'llilip O. ~ M.D. MewY..._:o,&e..Ycn To the Commissioners: :u~ 3~ <1-35 ',1,iW- J. C-lla. M.D ( l, 3Ff? 'l3 511.) Allaala. Qoarsia no..S.Hllle.M.D. The American Board of Radiology (ABR) writes to express its concerns with the IV-Salo& Nole Caoliaa NRC' s proposed rule making for Part 35 CFR and to make recommendations for improvement llobort ll ~ - M.D.

   .__.M~                                   in the aspects of the proposal related to education and testing .

Gemtol. ~ Sa . M.D. Calilonia The ABR believes that knowledge of the principles of safety and physics related to the M.D. medical utilization of unsealed and sealed radionuclide sources is extremely important For over 30 years the ABR has successfully administered a written examination that contains material on these subjects as part of its certification process for qualified radiologists and

c. 0,,q,.. !lea~-. !lt.o:

Wi--Salan. - C.rui- radiation oncologists. The safety record of these diplomates in using radionuclide sources in

 ~nctrr,.K........*11<*. M.D.

0nn,.,.m,-* practice is superb. The ABR believes that such training and testing should continue to be Hclelo C Redman. M.D. performed only by medical organizations that have documented qualifications to do so, i.e., Dalla.. Tcus

,.... s-n.M.D those approved by the American Board of Medical Specialties (ABMS) and with Accreditation Lo- Allpln. Calir.,,.,.                  Council on Graduate Medical Education (ACGME) - approved residency programs. The ABR
'lld*"!'II H. Sclniba. M.D.

Gal-T*au opposes medical training, testing or examination control by any agency inexperienced in these

........ , . Slaalty. M.D.                  matters, including government agencies such as the NRC .
\l,cllatl A. S.11i,*a11. M.D.

S.-Orle-.Lotn-With respect to testing of qualified candidates, the ABR proposes that each ABMS board with training related to the use of sealed or unsealed radionuclide sources (e.g., ABR, JOINS E. Youet. M.D. Milwaullat. IVIICOMI* the American Board of Nuclear Medicine - ABNM, the American Board of Internal Medicine - ABIM, American Board of Pathology) continue to create its own examination and continue to administer the examination to its own candidates without NRC oversight. Regarding the Radiation Oncol0&1 quality and components of the examination in radionuclide safety, the ACMUI should be S-11S.Doaaldooa.M.D. S..tanl. Caliranoa available in an "advice only" capacity should the boards seek such advice about their examination. Such examinations that currently are accepted for licensure should continue to be O.¥id H. " - , . M.D. accepted without further requirements. lonC"")'.lon To provide a source of testing for physicians not under the purview of one of these Satvn A. Ltillel. M.D. NcwYort.!ffwYcn boards, the relevant exam questions from each of the boards could be pooled and a ltodacy ll Millioo. M.D. Gl&Ms*ille. Flon4I representative sample selected by a consortium of the involved boards or by ACMUI. This H. llodety Wtdltn. M .D. representative examination then could be delivered to a reputable third party testing agency Loi Aapln. Cali(onia such as Kaplan, Princeton Testing Service (both organizations administer SATs and other written examinations nationwide) ACT or NBME for administration to all other physicians who meet appropriate qualifications (see below). Thus, a representative examination would be Radlolosk Physics l!AlwMI L ~ - PII.D. available in any region of the nation and presumably on short notice. The details of the third QapelHill.Sonllc-liu party test administrator's relation to the boards could be developed through an RFP issued by

 ,,.,.:=!..~*                               a consortium of the boards. The ABR is strongly opposed to such testing being done by (less a.,lls---.,.......0 .                      qualified) private testing agencies. If such agencies are allowed tote~~ the ABR believes that l.aiapa. KeMIIClry                      there will be an inevitable decline of quality in safety and the ~r wilN)e open for numerous unqualified practitioners to gain licenses to use radionuclides. ~                              :;f

• 5255 E. WILUM$ CIRCLE, SUrTE 3200
• TUCSON, ARIZONA 85711-7-109 *PHONE ( ~ ~
• FAX (520) 790-3200 A...._, 8-datllleAfflalcall ec-tat Medlclll Speciallea(A8MS) c!I  :>

u w

                                                                                                                                            ~

0

Regarding the qualifications necessary for individuals other than diplomates of the ABR, ABNM, ABIM or AB Path to sit for the examination, the ABR believes that safe utilization of sealed and unsealed radionuclide sources can be learned only when safety training is integrated with broad-based clinical understanding of the effective utilization of the procedures. Only in this way can physicians utilizing radionuclide sources possibly comply with ALARA principles in their practices. If broad-based clinically relevant training is not required, over-use and mis-use of radionuclides will inevitably occur. The ABR currently requires six months of training in Nuclear Radiology to qualify radiologists in the diagnostic uses of unsealed sources. This is in compliance with the current NRC regulations and those of the Residency Review Committee for Radiology of the ACGME. A recent vote of Council of the American College of Radiology recommended a 4-month requirement for such clinical training. If the NRC and other relevant constituencies agree, the ABR would support this somewhat shortened requirement, into which could be integrated the 120 hours of specific safety training that the NRC proposes to require by law. The ABR would still, however, require a full 12 months of training for those radiologists wishing to require more sophisticated

• levels of understanding of radionuclide uses in diagnostic imaging, i.e., those who wish to qualify for a Certificate of Special Qualification in Nuclear Radiology.

To avoid restraints on the availability of radionuclide training, this four-month experience would have to be available to physicians who are not qualified to be diplomatcs of the boards. The ABR recommends that you consider a model similar to the model proposed for the testing phase. A consortium of relevant boards could design a clinical curriculum to integrate safety, handling and other requirements with clinical appropriateness training. The curriculum might contain an identical core of experience (e.g., 6-8 weeks) followed by training directed specifically at the area or areas of intended utilization of radionuclide sources. The ABR believes that this training should be administered only within programs or program consortia that are ABMS-approved. These programs exist in every state of the nation, so access should not be a problem. The ABR believes that the safety record for utilization of radionuclides in medicine has been excellent. This outstanding record has been obtained by limiting licenses to those individuals who have been trained and tested within relatively narrowly defined boundaries. The ABR believes that this outstanding safety record can be maintained only if training and testing continues to be done by reputable, accountable medical organizations that teach safety within the context of clinical applications. We have proposed a way that such programs could be developed and could be made available to all physicians who are willing to make the investment in time and energy to acquire the necessary skills. These are not the approaches that have been proposed by the NRC in its new Part 35 proposal. To proceed with the currently proposed rule making would be a major step backward in education and, ultimately, in safety for patients, healthcare workers and the public. The ABR requests that the comment period for the Part 35 rule-making proposal be extended significantly with specific directions to the ABR to develop the consortia-based testing and training programs proposed in this letter. We look forward to your comments. Sincerely,

                                                   ~

William J. Casarella, MD President, American Board of Radiology

Sent by: ASSOC IN MED PHYSICS 21 6247 3015 11/13/ 98 5:04PM Job 577 Page 1/2 DOCKETED ASSOCIATES IN NEDICAL p~~s~cs_ , ~~ me A NATIONAL MEnlCAL PHYSICS CONSlllXING <,IU)L P "98 NOV 13 P4 :Q 7 PIIONE: (2 16) .51il-4 3.50 52X4 TRANSPORTATION DI.VD . [if.(x\: (2 L6)*,*ssi-436t Cl EVELAN D . OJI 44125

                                                                                              't l *. I.-~,-

j MEMO

                                                                                                               ~~ 3,:; .J- sS-( (,3F'R'/'$!:,-lf.j DATE:            N0'\1ember 13, 1998 TO:              Secy USNRC, Washington DC Att.: Rulcmaking and Adjudication Staff Paul Early as President of Associates in Medical Physics. LLC RE:              Changes in 10CFR35 In response to suggestions that were made in the meeting that was held in Rockvi lle wi1hin the last month re: this material, I was hoping that the NRC would agree that some changes were to he made in the material about which we were to comment, and therefore, there would be an extension of Lhe comment period, with a possible republication of the material in the FR.

However. at the time of this writing. it appears that that is not the case. Therefore, in addilion 10 my comments and those comments of others at the Rockville meeting. I would like to submit rur1 hcr comments as a representative of our national medical physics consulting group .is follows:

          .'5.22 Radiation Safety Committee We think that it is imperative that the RSC continues to be a part of these regulations .ind that it not be a decision of the hospital administration. The RSC is the "clout" that the RSO requires lo do his joh, in certain difficult circumstances. It is the power of peer pressure that becomes the ullimate force for change. Further, because there are so many committees in hospitals today. if ii 1s becomes unnecessary to have a RSC as a consequence of the removal of its need from the CFR. then there will not be one! It would be appropriate that the Management determine the membership and frequency of meeLings, based on the size of the Nuclear Medicine program. IL is most urgent that this 35.22 rule be reinstated.

35. 75 Release of Individuals We hclit:ve that the suggested changes for release criteria arc acceptable. However, the rell!ase of individuals wilh high dosages of radioactive material can cause considerable problems with radioactive waste disposal. Even before the changes. a patient could be released with a dosage or

CU!'l u/ 13/q ~ to/ ~~,~~ 7P~ ~IDs I ~ I I

Sent by: ASSOC IN MED PHYSICS 2162473015 11/13/98 5:05PM Job 577 Page 2 / 2 29.9 rnCi . A recent case became a problem when a sanitary napkin of the patient was placed in the home trash, carried by Lhe trash truck Lo the dump site, only to be stopped because the radiation tripped the sensitive portal monitors. The problem then is whose responsibility is it. This problem wilJ be exacerbated with the current allowances thal a patient with even 200 mCi (with appropriate instructions, etc.) is allowed the leave the hospital. The reasonable solution is to allow the dump site to accept the contaminated material, put it under its usual 4 feet of dirt. and allow it to decay away. For l-131, that would be 80 days. This is the usual culprit in tht',se instances. The regulations should address this. (I am aware of the BRC fiasco several years ago) Hioassays I 0CFR35.3 I 5(a)(8) dictates that .. for each patient ... receiving radiopharmaceutical therapy ,mt! lwsf}italized ... a licensee shall measure the thyroid burden of each individual who helped prepare or administer a dosage of 1-131 within 3 days after administering the dosage. In the past, this has not been a problem because all patients given> 30 mCi were hospitalized. However. with the recent changes in 10CFR35.75, the release criteria allows for the administration of > :10 mCi to patients who may be alJowed to leave the hospital. This suggests that bioa.~says must be done on only hospitalized patients, while not required on non-hospitalized patients. This is not consistent. At the same time, I 0CFR20 . I 502 requires licensee to monitor all occupationally exposed personnel who may receive, in one year, an intake in excess of I 0%, oft.he applicable ALI in Appendix 8 to I 0CFR20. It would be appropriate, then, that 10CFR35 . l 5(a)(8) be restated to conform with Parl 20 such that "and hospitalized" be removed and verbiage such as " .. .a Hcensee shaH measure the thyroid burden of each individual who helped prepare or administer a dosage of 1- 13 1 within 3 days after administering the dosage ({there is a likelihood that they would reaive >10% of the A.LI in Appendix B to J0CFR20."

• -P~ ~r

DOCKETED Bill F. Byrd, M.D. US~RC

                                                       °98 NOV 13 P2 :57        ,,1 Cj f<J) %November 98 The Secretary Or*cFI . . ,. ,-:s,1 l_

• RULf .

US Nuclear Regulatory Commission ADJULJ C Washington D.C. 20555-0001 ATT: Rulemaking and Adjudication Staff

Dear Madame or Sir:

I am a private practice N uclear Medic.i.11e Doctor located in Amarillo, Texas. I am engaged full time in the practice of Nuclear Medicine and am Radiation Safety Officer of our area's largest hospital. I am writing to endorse Dr. Lamk Lamki's position in his letter to you of 30 Oct 98 regarding the proposed revision of 10 CFR 35. Dr. Lamki argues very logically and eloquently that the proposed rule will be a disaster for patients. I wholly agree that patient safety will suffer and I reiterate to you all of Dr. Lamki's arguements. I must also argue that the rule will affect the safety of the general public. Anyone who comes in contact with a facility operating under the new rule may be in danger. Not only patients, but employees, casual visitors, janitorial staff and other tenants of the building will ultimately be exposed to medical radiotracers. The level of expertise required by the new rule will result in 131 Iodine inhaled by individuals who have no idea of their risk. People are going to carry contaminants of Thallium and Cardiolyte home to their children. Please do not assume that medical entrepreneurs will not open a shop in the Mall. I can see the ads: "Christmas heart scans, have a stress test to make sure you'll make it through the stress of the holidays." I am very proud of the expertise I have acquired and of the quality of work my laboratory produces. How will I be able to continue careful quality control and radiation safety practices, when my hospital administration notes that my costs are so much higher than the entrepreneurial clinic down the street. This rule will destroy Nuclear Medicine as a profession to be proud of. Sincerely

        ~

Bill Byrd MD 181998 Acknowledged by card ....- - - - (806) 359-8102 o Fax (806) 355- 1397 o 4001 van Tussel Amarillo. Texas 79121

lJ.S. NUCLEAR RE ULATORY RULEMAKINGS & ADJUDICATIONS srAfF OFFICE OF THE SECRETARY OF THE COMMISSION

                                                                                                                               @)

STATE ~Ft1aOLORADO I Roy Romer, Governor Patti Shwayder, Executive Director Dedicated to protecting and improving the health and environment of the people of ~ orado , 4300 Cherry Creek Dr. S. Laboratory and Radiation Services Division NO\ 13 P2 :S4 Denver, Colorado 80246-1530 8100 Lowry Blvd. Phone (303) 692-2000 Denver CO 80220-6928 Located in Glendale, Colorado (303) 692-3090 or-. J. Colorado Department http://www.cdphe.state.co.us fll.l l of Public Health AO,JL and F.nvironment November 11, 1998 Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 Attention: Rulemakings and Adjudications Staff The following are Colorado's comments on the proposed revision to Medical Use of Byproduct Material, reference 63 FR 43516. SPECIFIC ISSUES IDENTIFIED FOR PUBLIC COMMENT Training and Experience It is appropriate for the examining organization to ensure that examinations are not given to individuals who have also been instructed by the examining organization in the same subject area. Having separate organizations train and test will help insure the integrity of the training and testing process. Section 35.24--Will the deletion of the requirement for a Radiation Safety Committee and proposed new requirement for the Radiation Safety Officer to acknowledge, in writing, responsibility for implementing the radiation protection program impact the licensee's effectiveness in carrying out its radiation protection program? The proposed criteria could improve radiation safety if it included additional criteria. First, while the regulations (both current and proposed) require that the RSO have certain responsibilities, the RSO often does not have signatory authority for hiring and purchases, which is sometimes necessary to correct problems. Therefore management needs to be involved. While the proposal requires management's involvement, the management designee may be the RSO, thereby eliminating the higher levels of management from active participation with the program. The definition of"Management" should be limited to an individual involved in the management of the licensed facility, not just the radiation safety program.. V

• rim wledoed by card-*-~*-

FE

   ':I

-,11£4 ,I

'77>£, /?IDs I - ,-

U.S. Nuclear Regulatory Commission November 11, 1998 Page2 Secondly, there should be more guidance for the "interdepartmental/interdisciplinary coordination." Management (see above) must be part of this process. Perhaps the guidance could be added to NUREG-1556 Vol. 9 when finalized. The existing criteria for a Radiation Safety Committee would be a reasonable model. If properly structured, the proposed "interdepartmental/interdisciplinary coordination." could function as effectively as the current Radiation Safety Committee requirements. In regard to the RSO, she/he needs to be at least an ex officio member of the coordinating group. Section 35.92 -- Is it appropriate to delete the requirement to hold byproduct material for a minimum of ten half-lives? Yes, provided the material has an easily detectable gamma-emitter. Section 35.315 and 35.415-- Safety Precautions The final rule should include a prohibition against placing a therapy patient in the same room as a non-therapy patient. This requirement should apply not only for patients confined pursuant to Sec. 35.75, but to any patient where another individual in the room could receive over 1 mSv. Limiting the requirement to only patients confined pursuant to Sec. 35.75 is not ALARA. Section 35.605--Should the restrictions in paragraph (a) (limitation on installation, maintenance, and repair) of the proposed rule apply to low dose-rate remote afterloaders? Yes. Persons who can preform installation, maintenance and repair are routinely limited for generally licensed devices and other gauges that are not applying radiation to humans. This is not an issue of just source or cable replacement, but could also include electronics and software modifications. None of the certification programs identified in the proposed regulations provide for this kind of training. Section 35.615--Should the requirements in this section be waived for licensees that are using remote afterloaders with beta-emitting sources? Yes.

U.S. Nuclear Regulatory Commission November 11, 1998 Page3 COMPATIBILITY ISSUES NRC has not consistently indicated the essential objective of the requirements. In order for Agreement States to concur with proposed designations, the essential objectives must be clearly stated. States should concur with the essential objective of a regulation before the regulation is drafted. Items designated Health and Safety (H & S) in Part 35 should be designated either Category "C" or Category "D". NRC's H & S designation would be appropriate only ifthere were only one way to accomplish the objectives in this Part. This is not the case. It is unfortunate that at a time the NRC is trying to relieve the regulatory burden of its licensees, it is increasing the regulatory burden on the Agreement States. The following are examples of areas that have been assigned the wrong compatibility designation.

1. 20. 130l(a)(3) - Dose limits for individual members of the public visiting patients - should not be a Category "A". An exposure of 5 mSv to a member of the public by an NRC licensee is a specific exemption to a basic standard. It is an action between the person exposed, the NRC licensee and the NRC. It is neither a basic standard nor necessary for a common understanding. The proposed increased exposure is analogous to patient release criteria (35.75) which is only a Category "C". However, because the patient is not moving across state boundaries, the compatibility category of20.130l(a)(3) should be "D" .

• 2. 35.24 - Authority and Responsibilities - should not be classified H&S. While management should be responsible for the areas identified here, there may be other ways to insure radiation safety. Further, for small facilities where the authorized user/RSO is management's designee, the intent of this requirement will be defeated.

3. 35.40 - Written Directives - should not be designated H&S. There are other methods to ensure the right dose is delivered to the right patient. For example, a state could require the authorized user to be present during a therapy treatment. If the authorized user is present, the essential objective for written directives could be met without a written document.

Furthermore, prescription and administration of medical treatment needs to comply with both State medical and professional criteria. Radiation programs need to be able to work with State medical boards and professions, not dictate Washington standards of practice.

U.S. Nuclear Regulatory Commission November 11, 1998 Page4

4. 35.61 - Calibration of survey instruments - Noting the date of calibration on the instrument is not a H & S issue. Further, specifying the length of record retention is not a H & S issue, and should be designated Category "C" in all areas of the regulations.

5. 35.67(a) - Requirements for possession of sealed sources and brachytherapy sources should be a Category "C". If a licensee can develop better procedures, they should be able to have those procedures approved by the licensing agency.

6. 35.610 and 35.615 - These sections should be a Category "C", as there can be other ways of meeting the essential objectives of this section.

• OTHER REGULATORY ISSUES

1. Licensees should be required to submit procedures together with new or renewal application. This would allow the license reviewer to determine whether the applicant understands the scope of an adequate radiation safety program. With this addition, we concur with the proposed regulations that the licensee may make modifications to procedures without a license amendment.

2. The responsibilities of the authorized user are not easily identified. During the Agreement States meeting, there was discussion as to whether a facility even needed an physician on the license. Only by piecing together various sections of the regulations does it become clear that a nuclear medicine licensee needs to have physicians that are authorized users, and what the authorized user's responsibilities are. The responsibilities of the authorized user should be set apart for clarity, as was done for the Radiation Safety Officer.

3. The definition of"written directive" should be changed. Facilities are moving to computerized systems, and away from written information.

 ~ obert M. Quillin, Director Laboratory and Radiation Services Division RQ:wj

UNIVERSITY DO C .ET ED OF KENTUCKY l_!SilRC College of Medicine Chandler Medical Center . Department of Radiation Medicine 98 NOV 13 P2 :52 Lexing ton, KY 40536-0084 Phone: (606) 323-6486 FAX: (606) 257-4931 November 10, 1998 DOCKET PRO ~o 3Q .1 35 Secretary US Nuclear Regulatory Commission f? t/-351/o Washington, DC 20555

Dear Sir or Madam:

I am writing to comment on the proposed rule changing part 35 of the NRC regulations, as published in the Federal Register, Volume 63, No. 156, Thursday, August 13, 1998. As a practicing Clinical Medical Physicist, the regulations of the NRC have a great impact on my responsibilities and contributions to the medical care of cancer patients. The revisions to part 35 update the description of the medical physicist. However, the statement "and whose certification has been approved by the commission" raises questions about the criteria for approval of specialty board certification. The AAPM has published a definition of "qualified medical physicist" which addresses board certification, continuing education, and licensure. The NRC may wish to consider the AAPM definition (which has been adopted, in almost exactly the same language, by the American College of Radiology and the American College of Medical Physics). The proposed revisions eliminate the Radiation Safety Committee. As a member of the Radiation Safety Committee at the University of Kentucky, I am concerned that university and hospital administrators will see this as an opportunity to reduce costs, and consequently reduce the attention paid to radiation safety concerns. I believe that a compromise position might be appropriate for smaller institutions with limited use of radiation and radioactive materials, but for larger institutions, the role of the radiation safety committee is important and its visibility should be maintained. At the same time, I support the NRC proposal to enhance the visibility of the radiation safety officer by requiring the function of the RSO to be described in writing. My colleagues and I are pleased to see the NRC's proposal to change the term "misadministration" to "medial event" as defined in paragraph 35.3045. However, the existing wording gives lawyers and administration officials too much opportunity for debate regarding the appropriateness of specific actions for a particular patient. The NRC ov 181998 Acknowtedged by card .. _...,._........ An Equal Opportunity University

RREGUI.A AKINGS& OFF'CL=OFTHE OFTHECOMMI D un "1S . " a K Date -

          // II 98 Jf - - -

f/ rLJ~ J

should not intrude into medical judgement in this fashion and shquld develop more specific language describing a medical event. I am disappointed that the NRC has retained the 20% criterion for brachytherapy and gammaknife therapy as an action level for a medical event. Given the extremely high dose gradients found in these two modalities, dose differences of 20% can be found across distances of no more than several millimeters. There is no clinical evidence that a shift in the dose distribution of a few millimeters can result in physical harm to the patient. In contrast, patients may suffer psychological harm and loss of confidence in their health delivery system as a result of the federally required notification process. The criterion should be raised, preferably to 100%, if it is to be expressed in this fashion in defining a medical event. In paragraph 35.40, the NRC has stepped beyond its authority and is defining medical practice. The NRC should not be defining the essential elements of medical procedures,

• but requiring only that a written directive (dose prescription) be written before a treatment to a patient is delivered.

The NRC, in this revision of part 35, attempts to dictate to radiation therapy practitioners procedures for calibrating low dose rate brachytherapy sources. However, at this time there is little consensus in the radiation therapy community about how best to accomplish the calibration of these sources. The community has made great strides recently in developing national calibration standards for low dose rate sources, but as of yet there is no industry standard. Until consensus is reached among the practitioners and suppliers, the NRC should work with the radiation oncology community to develop standards of practice. Finally, I wish to commend the NRC by strengthening part 35 through the grouping of record keeping requirements into one subpart, and separating reporting requirements into another subpart. The result in simplification of the licensing approach will be welcomed by the radiation therapy community and help obtained the goals of the NRC. Thank you for this opportunity to comment. Sincerely yours,

  ~

Geoffrey S. lbbott, Ph.D. Associate Professor and Director of Physics GSJ/hlg

DOCKETED *.... r, U ...) \ .,., Health Physics Stanford University "98 NOV 13 P2 :58 Stanford, CA 94305-8006 desk (650) 725-1407 fax (650) 723-0632 nm~elroy@ leland.stanford.edu O~*F1: November 9, 1998 t-il U~, ADJUD" Secretary US Nuclear Regulatory Commission Washington, DC 20555-0001 Si r, eJ~ .?:J. d35 Ref: 63 FR 43516 l6s~R'Is.51~) I submit the attached personal comments on the proposed revision of 10 CFR Part 35, Medical Use of Byproduct Material. If you have questions, please contact me. Sincerely, df:ds{! y 1998

lJ CLEAR REGULATOR R LEMAKI GS & ADJUDtCATI OFFICE OF THE SECRf:TAR OF THE COMMISSI DocunentSta

• Norman L. McElroy 63 FR 43516 Comments on 63 FR 43516 The Atomic Energy Act of 1954, as amended. We find conspicuously absent a discussion of the Commission's charter to regulate medical use. If memory serves us correctly, "The Commission shall also establish general and specific licenses for

 ... medical therapy . . .and other useful applications." Despite the fact that charter appears as no more than a single term in a catchall sentence, the Commission has interpretted this to mean that Congress meant to establish a federal Bureau of Radiation Medicine. We are unconvinced.

The level of detailed regulation imposed by the Commission when compared to associated risk flies in the face of reason. The Commission exhorts licensees to keep radiation dose as low as reasonably achievable below the limits imposed by the regulation. We believe a degree of reasonableness in regulatory detail is also called for. The proposed rule does not meet that standard. Ill. B. Quality Management Program. We are pleased to see that the Commission's abuse of its charter may have peaked and taken a turn towards reason. Internal auditting for compliance with the current rule can suck as much as 0.1 FTE from a large hospital. We realize this is well below the Commission's budget truncation point, but to us in the hinterlands it represents real resources distracted away from real problems. Ill. C. Reportable Events. Will the Commission ever realize that not every problem requires a federal solution. The Commission may have a statutory responsibility to make reports to Congress, but the Commission should be honest with the public and clearly state that the Commission, not Congress, sets the reporting threshold. The Commission could set a threshold that would capture every unplanned event. The current threshold is self-serving, providing not a measure of public health and safety, but rather an excuse to visit Capital Hill. Ill. D. Precursor Events. We commend the Commission for its exercise of discretion and its decision to not abuse its authority by requiring an investigation of every leaf that drops in the forest. The Commission apparently has the resources to study every nature of possible technical or policy question; we recently reviewed the rosters of the working groups convened within the Commission to oversee medical use issues. There is a Part 35/Medical Working Group, and a Part 35/Guidance Document Working Group, and a Part 35/Medical Steering Group, the last of which is staffed two-fifths by attorneys, with nary a physician or medical physicist in sight. Parenthetically, we were reminded of Winston's working group that convened in the closing chapter of 1984. He had been appointed to a sub-committee of a sub-committee which had sprouted from one of the innumerable committees dealing with minor difficulties that arose in the compilation of the Eleventh Edition of the Newspeak dictionary. They were engaged in producing something called an Interim Report, but what it was that they were reporting on he had never definitely found out. It was something to do with the question 1

Norman L. McElroy 63 FR 43516 of whether commas should be placed inside brackets, or outside. There were four others on the committee, all of them persons similar to himself. There were days when they assembled and then promptly dispersed again, frankly admitting to one another that there was not really anything to be done. But there were other days when they settled down to their work almost eagerly, making a tremendous show of entering up their minutes and drafting long memoranda which were never finished--when the argument as to what they were supposedly arguing about grew extraordinarily involved and abstruse, with subtle hagglings over definitions, enormous digressions, quarrels--threats, even, to appeal to higher authority. And then suddenly the life would go out of them and they would sit round the table looking at one another with extinct eyes, like ghosts fading a cock-crow. [George Orwell, 1984, ©1949.] We were, furthermore, non-plussed to see on one Part 35 working group a senior management official who once told a licensee, in reference to the basic quality assurance rule, "We need these rules to keep you from injecting radioactive shit into your patients." Does not that statement in and of itself appear a precursor event that ought to be investigated as a matter of conflict of interest or abuse of civil post. Those of us in the hinterlands simply do not have the unlimited resources the Commission enjoys. Ill. E. Radiation Safety Committee. The Commission's resolution of this issue appears to fly in the face of reason. Almost all hospitals run by committee. Yet the Commission withdraws the power base needed by the Chief of Nuclear Medicine and the Radiation Safety Officer to be heard amongst others competing for finite resources. None-the-less, given that it may be a federal criminal act to not convene the committee each three months, whether or not there is business to transact, and to take roll, perhaps it would be best to eliminate this requirement. Ill. F. Notification. The Commission invokes an FDA rule to defend its requirement for patient notification. Could the Commission not find anything in its own charter. We are curious that, in its late 1980's quality assurance initiative, the Commission determined as inadequate and irrelevant Congress' directive to Health and Human Services to develop a data base of physicians against whom judgments of negligence had been rendered. Does the Commission recognize those directives and initiatives it likes, and not recognize those it dislikes. We humbly request that the federal government get its nose out of the examining room. The nuclear medicine and radiation therapy departments are not the only two places in the hospital where things go wrong in medical care; whatever followup action is required ought to be in the context of medical care, not the Atomic Energy Act. Subparts L and M. For an organization that inspects licensee compliance by examination of records, to separate the record requirement from the prescriptive requirement is to play "hide the regulatory peanut." The argument that "that's the way we did it in Part 20" is hollow. Part 20 was written for reactors; only recently has it 2

Norman L. McElroy 63 FR 43516 been amended to reflect the special needs of hospital safety programs. Hospitals are not electric boats. Hospitals are not reactors. The same comment holds for reports. Leave the recordkeeping and reporting requirement with the text of the prescriptive requirement that initiates the record or report. IX. Compatibility. The Commission should try to understand that different states have different health and safety problems, but they do not necessarily have the same apparently infinite resources available to the Commission. (We remind the Commission that the last revision to 10CFR Part 35 was performed using five years of 0.8 FTE. At a briefing, one commissioner asked that staffer, "Have you ever considered full-time work.") The instant project has consumed a veritable brigade of staff time paid for with power-plant-size fees wrung from a diminishing licensee base. (Beware, the teat is running dry.) Or, they may believe that x-rays pose a greater potential risk to the population than byproduct material. These are not unrealistic or reckless public health and safety policy opinions. We remind the Commission that about 40,000 individuals die in automobile accidents each year. Can the Commission tell us how many people die of byproduct material poisoning. If a commissioner were a state or local public health and safety official, would he allocate a new FTE to highway safety or byproduct material safety. We remind the Commission that the R in ALARA stands for "reasonable." Part 35 should not be a matter of compatibility beyond requiring that a state have a system for authorizing medical use of byproduct material. Authority (end Table of Contents), and §35.4002. We do not have ready access to either the United States Code or unlimited legal counsel the agency enjoys, but we recommend that the authority citation not permit the agency to unleash Kenneth Starr on someone who is a day late fil ing a report or making a measurement or convening a meeting. Criminal sanctions should only be held over the head of a malfeasant who is reckless or hurts someone. Sealed source. Would the Commission clarify whether the epoxy vials used for testing dose calibrators are sealed sources. We believe they are not; they are more correctly characterized as monoliths, and ought not be subject to leak testing.

 §35.6 Provisions for research. Can the Commission explain why medical use licensees need special permission to participate in manufacturer-sponsored medical research. There is no apparent need for that provision. Any medical research approved by an Institutional Review Board and within the scope of the authorized inventory should be permitted. When the Commission invokes an FDA rulemaking to defend its own stand, how does it explain its refusal to observe well-established Health and Human Services authorizations.
 §35.26 Radiation protection program changes. Can the Commission explain the following logical disconnect. The licensee establishes a very conservative program requirement, for example environmental monitoring of an uncontrolled area.

3

Norman L. McElroy 63 FR 43516 After a year of operating experience, the licensee makes a review and determines that a less conservative survey program requirement, or perhaps no survey at all, conforms to the ALARA principle. Yet, to revise the program for economy, being less safe by conducting fewer surveys but still within regulatory limits, is to reduce safety, which is not allowed. We find amusing the argument that licensees did not clearly understand the term "ministerial changes." The term was in fact proposed by NRC's Office of General Counsel after the 1986 Commissioners got in a dither over the scope of the term of art "minor change." This proposed rule in fact ratchets back down the little bit of flexibility that was provided under the current §35.31. Does the Commission not trust a licensee to read the regulation and make a determination that the proposed change is in compliance with Part 20 and Part 35. If it does not, it ought not issue a license. Licensees should be required to ensure their procedures meet regulatory requirements and nothing more .

• §35.40 Written directives. Would the Commission please incorporate the footnote into the body of the text.

 §35.50, 35.51, 35.55, 35.57, 35.59 et alia Training for. . . It is not clear why the Commission has broken up regulatory requirements that will theoretically be consulted day by day with lengthy prescriptive training requirements that will be consulted once or twice in a practitioner's professional life. Requirements about training should remain consolidated in a single section.
 §35.57 Training for experienced Radiation Safety Officer. This section should be revised to include senior level health physicists with several years of experience who do not hold the title of RSO at a medical institution, because there is only one such position, but who none-the-less have essentially the same training, experience, and responsibilities as the incumbent RSO.
 §35.61 Calibration and check of survey instruments. The Commission has left the term "check" in the title of the section, yet does not describe any checks in the text. It appears the title was not editted to reflect a revision of requirements.
 §35.63 Determination of dosages. We applaud the Commission's elimination of the dosage measurement requirement for unit dosages prepared and measured by a pharmacy. We are a little confused that the Commission exhorts licensees to adhere to ALARA principles, yet for the past approximately thirty years imposed a regulation that ran counter to ALARA.
 §35.67 Requirements for possession of sealed sources and brachytherapy sources. See comment Sealed source above.

The Commission has reviewed leak test results during its unannounced compliance inspections for at least the past thirty years. Absent manhandling, how many leakers have been uncovered by licensee leak testing. (Or have the inspectors been told to simply ensure that the tests were done and timely filed, but not to examine the results.) 4

Norman L. McElroy 63 FR 43516 We believe an analysis of the number of spontaneously leaking sources would indicate that the cost of this requirement far outweighs the benefit. The requirement should be modified to require leak testing only after abuse, misuse, or loss and retrieval. Lest the Commission reply that leak test criteria are provided in the Sealed Source and Device Registry, we remind the Commission that the individuals who applied a criterion when making an entry in the registry probably only had a six-month or one-year or three-year menu to choose from. We repeat, absent manhandling, how many leakers have been uncovered in the last thirty years.

 §35.80 Provision of mobile service. We believe the Commission should re-visit its refusal to allow dosages to be delivered directly to the client. This may impede the delivery of quality medical care by requiring the mobile service to use a dosage that has been carried around several hours and is approaching expiry.

If the Commission responds that the client could always get a license, we reply that it would be silly to set up a docket and impose license and inspection fees on a package drop. With the client's permission, the mobi le service should be able to notify the Commission that the client's facility is an additional location of use after having provided appropriate instruction to whoever would receive and inspect the packages. Common carriers handle packages under a general license; receiving and stowing a package is no more hazardous. Lest the Commission reply that the package may be leaking, we ask how many leaking packages have been received by medical use licensees over the last thirty years. The Commission has reviewed package survey results during its unannounced compliance inspections for at least the past thirty years. Absent manhandling, how many compromised packages have been uncovered by licensees. (Or have the inspectors been told to simply ensure that the package surveys were done and timely filed, but not to examine the results.)

 §35.92 Decay-in-storage. We applaud the Commission's elimination of the holding period for waste demonstrated to be uncontaminated.
 §35.204 Permissible molybdenum-99 concentration. We commend the Commission for reducing the measurement requirement to the first elution, in accordance with good ALARA practice. Perhaps in the next revision this will be removed as no longer necessary. We repeat the question we posed above regarding sealed sources. During its examination of test results while conducting on-site unannounced compliance inspections over the past thirty years, how many generators demonstrated excess Mo99 concentration. Or have the inspectors been told to simply ensure that the tests were done and timely filed, but not to examine the results.
 §35.315 Safety precautions. This section should be revised to permit the licensee to package contaminated items and instruct the patient to not unpackage and use the items until a predetermined date that is calculated to ensure the remaining 5

Norman L. McElroy 63 FR 43516 activity is small. To throw out a patient's personal property because it has short-lived contamination is silly. To have the licensee store the items pending decay is unreasonable. §35.400 Use of sources for man ual brachytherapy. The licensee is told to use only sources in the Sealed Source and Device Registry. Perhaps the Commission could explain here how the licensee should access that Registry. §35.406 Brachytherapy sources inventory. Here again, the Commission has excised prescriptive inventory requirements and moved them to a recordkeeping subpart. The information recorded obtains from steps taken for compliance with this inventory section. Thus, the recordkeeping requirement should not be separated from the handling safety measures. §35.415 Safety precautions, and §35.615 Safety precautions. . .. The requirement for keeping certain surgical tools on hand is imposed. We read in the statement of considerations, page 43538, that this codifies requirements currently imposed by license condition. We humbly request that the Commission stop thumbing its nose at the Admin istrative Procedures Act, which calls for notice and public comment on proposed requirements, rather than imposing them as standard license conditions by administrative fiat. This ratcheting strategy, which has been going on for years, is sneaky at best. The term "standard license condition" is oxymoronic; license conditions should pertain to specific, unique characteristics of the licensee. Proposed requirements that apply to a class of licensees should stand public examination in the light of day, and not be drafted and approved by a committee convened in a windowless meeting room. Why must "supplies necessary to surgically remove applicators" be kept in the patient's room or at the nursing station? Does the Commission propose licensees perform surgery in a non-sterile environment. We are furthermore curious why additional license conditions had to be imposed atop the regulations that the Commission approved effective in April 1987. Did the staff believe the Commissioners erred by leaving out some key element from a set of safety measures that had been five years in development. Is there some reason these safety measures were so important to public health and safety that they had to be imposed without opportunity for public comment. Does the staff find the Commission negligent. §35.432 Full calibration measurements of brachytherapy sources. Because of the difficulty of making accurate measurements, we believe the licensee should use the measurement provided by the manufacturer, perhaps supplemented with a check to ensure that fresh seeds, and not spent seeds, were supplied. Is the Commission's failure to provide criteria for sampling lots of seeds, for which individual measurement of each seed is not consistent with ALARA, a tacit permission for licensees to develop those criteria. 6

Norman L. McElroy 63 FR 43516 An unsolicited word of warning to the staff. This commenter authored and tried to sell to the medical community the quality assurance rule that was ordered by the Commission and published October 2, 1987. After three years of discussion with the ACMUI and people from large and small, east and west, urban and rural, public and private hospitals, it had become clear that there were radiation safety problems from other than byproduct material in the hospital setting. Then one day he got a telephone call from a senior management official, who asked, "What do you think about this QA rule?" "We will do what you tell us to do." "I know, but what do you think of it?" "We will do what you tell us to do." "I know, but what do you personally think of it." "Personally, I am concerned that it might have inadvertent adverse impact by distracting resources away from unregulated things [viz, linear accelerators and computerized treatment planning systems] that may pose greater risk." "Oh. Goodbye." Six weeks later he was given four hours to clean out his desk. We have submitted a variety of comments for staff consideration. But we warn the staff to not forward to the Commissioners anything other than what they have ordered up. The "Open Door Policy" is not, as they say, worth the paper it is written on. Forewarned is forearmed. But it's probably safer to just hunker down until retirement. If pressed, a shibboleth might work. "He failed to substantiate his findings." 7

DOC 'ETED November 9, 1998 us~1ss Secretary, U. S. Nuclear Regulatory Commission "98 NO 13 P2 :58 Washington, DC 20555-0001 Attention: Rulemaking and Adjudications Staff OFh. . RL'. _ r ADJlY; I

Dear Secretary,

I would like to take this opportunity to comment on the rule changes to 10CFR 35. I am an ABR certified Medical Physicist with over 12 years experience in both Diagnostic and Therapy physics. I have worked in small 200 bed rural community hospitals, State Cancer Centers, and large 1000 bed private urban hospitals as both a medical physicist and as the Radiation Safety Officer. I applaud you for your efforts to revamp the 10CFR35 regulations for medical use of byproduct material. I feel many of the proposed new regulations are appropriate and will serve the medical community well. However, there are several areas I strongly disagree with. I. Radiation Safety Committee/Radiation Safety Officer Of the proposed changes, the one I feel would adversely impact the Radiation Safety program the most would be deletion of the Radiation Safety Committee and putting the entire burden for Radiation Safety on one individual - the Radiation Safety Officer. I have either been RSO or served on the RSC at 6 different facilities. This background allows me to state unequivocally that:

• Management is much more likely to listen to a committee representing a multitude of interests and backgrounds such as physics, nursing, radiologists, radiation oncologists, cardiac cath technologists, etc. than one individual (i.e., the RSO). This is true regardless of the size of the facility.
• There are often issues that receive far better reception from the physicians if it comes from a physician on the Committee. A recent example was a notice sent out by the Radiation Safety Committee Chairman (a radiation oncologist) to the physicians in the hospital requesting they solicit assistance from the RSO and the Medical Physicist if a patient required a diagnostic exam, but was pregnant. A similar request from the RSO or management would have had far less impact.
• Policy and procedure changes are much better received if someone from the department involved has input into its evolution and can explain the reason for the changes to others in the department. Examples are nursing and cardiac cath radiation safety policies. There is no more time efficient way of doing this than via a RSC meeting.
• The NRC has attempted to address cooperation among departments by calling for a policy on interdepartmental cooperation in Radiation Safety issues. But from experience, I can predict what will happen. The RSO will spend most of his/her time going to each department individually, soliciting comments and assistance when trying to implement a new policy.

There will be no talk among departments, other than that with the RSO. No other viewpoints or ideas will flow. 8 i99S r o edged by card... .. ,r**-* ---~

The Radiation Safety Committee works. And one of the reasons it works is that it is required ' .. in the NRC regulations. It is a time-saver for the RSO. It takes the burden off his back and distributes the responsibility among appropriate parties. Don't abandon it. You need not be prescriptive on how it performs its function, other than requiring the RSO and management to be present at meetings. But do not abandon it. A final point: Why should the RSO be required to sign off on his/her duties when the authorized users, authorized medical physicist, and authorized nuclear pharmacists are not required to do so? Management is ultimately responsible for the Radiation Safety program. To require the RSO to sign off on his/her duties while not requiring the authorized users, authorized medical physicist, and authorized nuclear pharmacists to do so is juvenile, insulting, and unnecessary. Management is the responsible party! . II. Training and Experience of the Authorized Medical Physicist I am concerned about the lack of differentiation between physicist, health physicist and medical physicist in the new 10CFR35 rules, particularly in Section 35.51 . Training for authorized medical physicists. I attended graduate school at the Georgia Institute of Technology in the early 1980's. Georgia Tech had a masters program in heath physics and a subspecialty in medical physics. Health physics is radiation detection and radiation safety, and is a highly desirable degree for a Radiation Safety Officer at a large institution. Medical physics involves radiation detection and health physics, but with additional emphasis on treatment planning, therapy, and dosimetry. There is currently much confusion over the difference between a health physicist and a medical physicist and the proposed new changes in Section 35.51 muddy the waters even more. Do you realize that with the new regulations, a solid state physicist with a masters degree, but who has never had a course in medical physics or dosimetry, could work for two years on the radiation safety aspects of Sections 35.67, 35.632, 35.633, 35.635, 35.642, 35.643, 35.644, 35.645, and 35.652, learn to calibrate an HOR unit, take a test on Radiation Safety only and then be to call himself an authorized medical physicist?. I applaud you for trying to make sure authorized users, medical physicists, RSO's, and nuclear pharmacists are competent in radiation safety by passing an exam. However, in doing so, you are circumventing the credentialing process and handing out an identical title. The exam is appropriate for an RSO, but obscures the differentiation between health physicist, medical physicist, and plain physicist and cannot be endorsed for clinical safety reasons. III. Compartmentalization of Record-keeping Requirements As an experienced Radiation Safety Officer, the separation of the record-keeping requirements from the section ,it refers to is inconvenient. When auditing a radiation safety program, it is much less time consuming to have everything in one place. The separate new Report section is not as inconvenient, since it is seldom used on a day to day basis. I also find it inconvenient to have to refer back to 10CFR20 for survey instrument requirements, surveys, and labeling. I found the old 10CFR35 very easy to use, since basically everything needed for medical radiation safety compliance was in one, concise section. This is a step backwards. IV. Full Calibration of Brachytherapy Sources

I appreciate the emphasis being placed on areas of higher risk by the NRC. Caution must be taken, however, not to substitute over-regulation of brachytheiapy for over-regulation in Nuclear Medicine. For years we have been accepting the manufacturer's calibration of sealed sources as the final word. In my experience, they've been up to 5% off and are usually no more than 2-3% accurate. Yet they currently have the same equipment for calibration as I have. Should we accept the manufacturer's calibration or expect them to calibrate the sources to the same degree of accuracy? No. Their job is to provide the source, not to provide the medical physics, dosimetry, and QC on it. Because of my past experience, I would double check the output, regardless. Requiring the manufacturer to calibrate with the same precision I do would add unnecessary expense to brachytherapy sources. Full calibration of all sources is an excellent move. However, repetitive annual output checks oflong-lived sources such as cesium, is unnecessary. If the sources are not leaking (as proven in the leak tests every 6 months), their output is not going to change. The same holds for each Iridium source used in HOR therapy. Once a source is calibrated, weekly checks of output are redundant, unnecessary, and over-regulation. More frequent checks on various safety features of the units are helpful, but output is not going to change if positioning and leak testing and other safety features are functioning. Monthly output checks ofHDR sources are adequate. V. Private Sanitary Facilities and Rooms for Inpatient Radiopharmaceutical and Implant Patients Sharing a hospital room with another person is difficult enough, but sharing a room with a radioactive implant patient or someone who has received a therapeutic radiopharmaceutical adds to a patient's and his family's stress. The requirement should stand. Respectfully submitted,

• Denise J. Noonan, Ph.D., DABR Medical Physicist

                                  /tftJOAIAN,,,.    <Jnc.er-    ~

2000 PEPPERELL PKWY OPELIKA, AL 36801-5452

I RADIATION SAFETY COMMITTEE Environmental Health & Safety, Box 0942 DOC .ET ED University of California, San Francisco US R

                                                   *98 NOV 13 P2 :52 November 6, 1998 OFFI, R lI
                                                                            -F ADJUL Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 Attention: Rulemakings and Adjudications Staff JD 3:l-t ~
                                                                                                    "3F~'l351~

Re:Proposed Revision of 10 CFR, Part 35 (§ The following comments are on behalf of the Radiation Safety Committee (RSC) at the University of California, San Francisco (UCSF). We fully endorse the specific comments submitted by the University of California, Office of the President. The comments presented here are directed towards Section 35.24 of the proposed new regulations. By means of background, UCSF operates under a broad-scope license issued by the California Department of Health Services, Radiologic Health Branch. UCSF is a major biomedical research institution with schools of medicine, pharmacy, dentistry, nursing and a graduate division. In addition, UCSF operates _three fully licensed medical centers with comprehensive diagnostic and therapeutic uses of byproduct materials. The RSC is charged with the oversight of both clinical and research uses of all radioactive materials at all facilities under the license. We believe that the RSC is one of the most effective committees in our institution. Its membership includes experts from a wide range of campus activities. The RSC meetings provide a valuable forum to discuss policies, procedures, radiation safety practices, and other pertinent aspects of our operations. The RSC also:

• Provides for interaction between all levels of campus users, the Radiation Safety Officer (RSO) and administration.
• Is an effective forum to develop and mandate the implementation of policies and procedures.
• Acts as a peer review forum for research protocols that pertain to radiation safety practices for the protection of patients and staff
• Is an excellent forum for enforcement actions against infractions of radiation safety practices. As a peer group it is much more effective in requiring users to follow the established standards than a "top-down" mandate from the administration.
• The RSO alone may not have the expertise to oversee every area of radiation use in a diverse biomedical research setting. The elimination of the RSC will, in a majority of institutions, result in the degradation of the radiation safety program and its effectiveness.
• The requirement to maintain a Radiation Safety Committee should remain in place with exemptions for institutions involved in small scale, low risk operation such as those defined in Sections 35.100 and 35.200.
• The RSC requirement for quarterly meetings should be eliminated and replaced by "as needed." This will allow for institutions to adjust the frequency of their RSC meetings to meet the needs of their institution. At UCSF, the RSC meets monthly.

8dq by

Secretary, NRC November 6, 1998 page2 In conclusion, we strongly recommend against the proposal to eliminate the RSC as a requirement for medical licensees. Yours truly, ~ Ge.~ *c:::'"'~ic:.....--- Michael Banda, Ph.D. Chairman, Radiation Safety Committee cc: RSC Members 717 University of California , San Francisco . . . A HeatI h Sciences Campus 0 ffice of Environmental Health & Safety 50 Medical Center Way San Francisco, CA 94143-0942

MEM©RIAL HOSPITA L DOCKETED US11PC Cancer Treatment Center "98 NOV 13 P2 :55 November 2, 1998 Ort*h. :* 1 I RU! L::., ADJUu 1* Secretary, U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 DOCKET NlU PROPOSED A Attn .. : Rulemaking-Adjudication Staff This letter is specifically requesting that the "Deletion of the Radiation Safety Committee" proposal in revision of 10CFR Part 35 not be done. Memorial Hospital, Chattanooga, Tennessee has a very active, effective Radiation Safety Committee, with broad-based representation, charged with the responsibility of overseeing Radiation Safety throughout its facilities. As such, it reviews policies, procedures, personnel qualifications and maintains active consultative services to the office of Radiation Safety. A very consistent rigid meeting schedule is maintained. Therefore, due to the direct benefit and support the committee gives to the Radiation Safety Office it is apparent the elimination of the committee would compromise and weaken the Radiation Safety program. Thank You. Sincerely,

 ~G;-;<3 Chairman, Radiation Safety Committee D. R. Stone, Ed.D., D.A.B. R.

Radiation Safety Officer FK./jp r<<JV 1 8 1998 Acknowfedged by card ...,..............u,eeeene,, ... ,N H. Clay EVOIIS JohnsonCan~r Treatment Center 2525 de Sales Ave.

• Chattanooga, TN 37404 * (423) 495-7730

LEAR REGULATORY COMMISSION AKINGS & ADJUDICATIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics P riark Date c es Received _ _ _ _ _ _ __

t. iifiii!!_~-;1-.Viil-,

1 Copies Reproduced _ _ 1c1 istribution

                  . 7 --:;¥,~       ;

7>,p~ _'j? /l}_S'

ITheresa Kendall - Fwd: Part 35 comments Page 1) From: Lloyd Bolling To: Catherine Haney Date: Thu, Nov 12, 1998 2:24 PM

Subject:

Fwd: Part 35 comments Cathy: Attached are comments on the Part 35 (Proposed Rule) from Tom Hill of the Georgia Radiation Program. Lloyd CC: Paul Lohaus, Richard Bangart

ITheresa Kendall - Part 35 comments Page 1 l From: Tom Hill <Tom_Hill@mail.dnr.state.ga.us> To: TWFN_DO.twf1_po(LAB) Date: Thu, Nov 12, 1998 1:05 PM

Subject:

Part 35 comments Lloyd, here is the e-mail version. Fax version will be sent shortly. Thank you THill

Georgia Department of Natural Resources 4244 International Parkway, Suite 114, Atlanta , Georgia 30354 0QC Kr TEO Lonice C. Barrett, Commissioner 1 1c- '.--R r. Environmental Protection Division Harold F. Reheis, Director 1 1.. ;:) , _., (404) 362-2675

                                                 *9s NOV 19 ~:.7e1nber 12, 1998 Secretary U.S. Nuclear Regulatory Commission C

Washington, DC 20555-0001 , I Attention: Rulemakings and Adjudications Staff BER U ~01 3~,;-35 Gentlemen: 1p3 FR 'l-~51~) The following comments are written in response to Federal Register Notice, August 13, 1998 (Volume 63, Number 156), Proposed Rules for 10 CFR Part 35, Pages 43515-43580 .

• COMPATIBILITY An explicit statement of how NRC staffjustified the key compatibility and "health and safety" designations is needed. It is not provided in the Federal Register notice and staff indicates such will be available in a "few weeks" (but after the comment period closes). This justifies an extension of the comment period to allow states and others to review the actual basis for the compatibility designation. We request that the comment period, for compatibility designation only, be extended to 30 days following the release and distribution of such justification of the compatibility designations.

SUMMARY

OF SPECIFIC ISSUES IDENTIFIED FOR PUBLIC COMMENT

1. Training and Experience - There is a definite need for training and experience requirements for those individuals who actually handle radioactive materials (generally known as "nuclear medicine

• technologists"). Please note that this could easily be justified by the proposed policy statement that NRC will focus on assuring that "the use of radionuclides is in accordance with the physician's directions". Although the need for training and experience for technologists was pointed out during the facilitated public workshops, NRC has not addressed this issue or explained its rationale for ignoring the comments.

We believe it is appropriate, given the potential public health impact, that a certifying exam be accomplished by an organization other than the one providing the essential training. We support the idea that a radiation safety competency exam is warranted for all individuals involved in the application of radiation to humans. That includes the persons actually handling the sources of radiation. In that regard, more effort should be spent in identifying and requiring appropriate training and education for technologists.

2. Section 35,2--Should the term medium dose-rate remote afterloader" be defined since it is not used in the rule? (Requirements for medium dose-rate remote afterloaders have been grouped with high dose-rate remote afterloaders in this rulemaking. )- The terms high dose and low dose afterloaders are defined. A high dose-rate afterloader delivers a dose rate in excess of2 gray (200 rads) per hour and a low dose-rate remote afterloader delivers a dose rate of less than 2 gray (200 rads) per hour, both at the point or surface where the dose is prescribed. By these two definitions, NOV 1 8 Aekn edged by card..... . ....._.......- ........

lJ . UCLEAR REGULATORY COW. R LEMAIO GS&ADJUDICATIONS OFACE OF THE SECRETAl=I OF THE COMMISSION s 1g / 11/J/?? :fa,yd I

                         ) !,    }

1

         ~ll>S

Page2 Secretary it would imply that a medium dose-rate afterloader would deliver a dose at 2 gray since the other two types of afterloaders deliver doses on either side of this exposure rate. If the term medium dose-rate afterloader is used, then it should be defined or not used at all. The term as used in this section does not add clarity to the rule.

3. Section 35.6--Should this section be revised to require that licensees develop, implement, and maintain procedures for evaluating when a medical procedure would be considered to be a research procedure? - It is not clear how such a requirement is protecting public health and safety.

No matter what type of radiation is delivered to a patient, radiation safety for the patient, the worker and the public, must be maintained. ALARA must be maintained. All of the proposed paperwork required above will not add (in a positive manner) to these requirements.

4. Removal of Section 35.22 Radiation Safety Committee deleted in its entirety, - For the small, diagnostic use type facilities, the elimination of the Radiation Safety Committee should not adversely impact radiation safety. The effect of removing the Radiation Safety Committee from a medical institution will vary with the size and complexity of the institution and with the political climate within the facility. What is important is that the Radiation Safety Officer still has a direct line of reporting to management on radiation safety issues. At larger institutions with multiple disciplines (diagnostic nuclear medicine, teletherapy, remote afterloaders, nuclear cardiology... ), using radioactive materials throughout the facility, a Radiation Safety Committee may be needed to coordinate all of the reporting activities and to ensure that basic radiation safety is being consistently achieved in each area of the facility.

Currently, the Radiation Safety Committee with its required management representative in attendance provides access by the Radiation Safety Officer (RSO) which he/she may be hesitant to attempt via other channels. Safety issues may also be brought up in meetings which may not be conveyed to the RSO personally. The Radiation Safety Officer should be present at Committee meetings either as a member or as a technical advisor to the Committee.

• Overall, the rule is too prescriptive as it applies to the Radiation Safety Officer reporting to management. As written, the rule implies that management has given the RSO the "responsibility" of maintaining a radiation safety program but is not allowing the RSO any "authority" in managing the program. Radiography licensees do not have such restrictive and prescriptive procedures on implementing a radiation safety program. Why does medical? If these parts of a radiation protection program are so important for management oversight, then why aren't they included in a more generic fashion in Sec. 20.1101? No other radiation protection program is impacted with as much management oversight in rulemaking as medical. The management/RSO relationship/reporting requirement is not applicable to a radiation safety program for private practice with only one physician on staff who is the owner/president and the radiation safety officer.

5. Section 35 75 Release of Individuals Containing Radiophannaceuticals or Implants.- The hazards posed to the family and general public by a person containing radiopharmaceuticals depends totally upon the inclination and the ability of the patient to abide by prescribed restrictions for a

Page3 Secretary specific period of time. It is extremely difficult to predict human behavior and impossible to control it outside the confines of the hospital. Some patients would go to a hotel or motel to prevent possible exposure of family members which would then introduce unknown casual exposure to another segment of the public. Undoubtedly many patients covered under this rule could be safely released from confinement. However many institutions must release I-131 therapy patients to nursing homes or even homeless shelters. It is extremely difficult to explain to a HMO, insurance company, or possibly to a government Medicaid or Medicare case worker the difference between an I-125 eye plaque involving a sealed source and a patient who has just ingested 200 mCi of I-131 - why one may not require hospitaliz.ation while the other one would. This rule would interfere with an RSO's ability to protect public health and safety. When patients receive oral therapy doses of I-131 , the possibility of nausea and vomiting is a side effect. This side effect is disclosed to the patient. Nausea and vomiting has occurred following a diagnostic dose ofl-131. In one instance a sidewalk along a major metropolitan thoroughfare near the hospital was contaminated. A relative returned to the Nuclear Medicine Department, and a decontamination team headed by the RSO successfully decontaminated the sidewalk. Activity from a therapy dose would be much more difficult to remove. This could occur far from the hospital in the case of an out-of-town patient returning home. If the radiation factor became an issue, who would be responsible for decontamination? For reimbursement for decontamination? This rule would interfere with the RSO's ability to control radioactive contamination. Also to consider: This rule would result in an increase of radiation alarms at landfills caused by household trash of released patients. The landfill regulations do not allow the burial of radioactive material, so NRC or State Offices would be notified. Radioactive material contained in patient excreta is no longer considered regulated, so where does financial liability reside? With the State or NRC? With the administering facility or the patient?

• 6. Section 35.92 - On deletion ofholdina material held-for-decay for IO halflives.- Although the proposed wording is more clear and is less burdensome to the licensee, it does not adequately address the beta emitter concern (such as S-35, P-32, or I-125), which are difficult to detect. By requiring the calculation of 10 half lives, we have provided a reliable timetable for scheduling hard to detect material for disposal which acts as a deterent for assuring facilities do not "jump the gun" when disposing of beta emitters.

Pertaining to Sec. 35.92(a)(2) which states that prior to disposal all radiation labels will be obliterated or removed. This requirement is not in keeping with guidance published in IN 97-03, "Defacing Labels to Comply with 10 CFR 1904(b)". Removing or obliterating labels on medical use materials is flirting with a biohazard. This rule is not in keeping with current technology or OSHA standards. The rule needs to be rewritten to allow for other acceptable methods of disposing of used syringes/vials without defacing the labels as described in the information notice. 7 . Section 35.315 - For each patient who cannot be released in accordance with 35.75, a licensee shall provide a private room with a private sanitaiy facility. - This rule should be retained as is. Again the issue arises of demonstrating the need for a private room for one patient while possibly

Page4 Secretary not for another patient as HMOs, insurance companies, and Medicaid/Medicare representatives seek to assign their patient to less expensive facilities. Experience dictates that bathrooms ofl-131 therapy patients must be properly prepared to prevent contamination by even the very conscientious patient. Contamination from an unrestricted bathroom floor could be tracked through the hospital. Other users could become contaminated from faucet handles, doorknobs, etc., and some of the contamination could become internalized.

8. Section 35.415 - Safety Precautions - Not quarter a patient or research subject receiving bracbytherap_y in the same room as an individual who is not receiving radiation therapy. - The popular opinions currently held by members of the general public concerning radiation makes it socially and legally questionable to house a non-radioactive patient in a room, which has radiation posting on the door. Nursing staff would be understandably disturbed about receiving additional radiation exposure, if that were a factor, while caring for a non-radioactive roommate. Visitors and family members might be expected to experience some apprehension entering a posted room even if it was explained that external radiation exposure was not a factor.

This rule should be retained since subjecting a member of the public to close proximity to a radiation source is not the patient's choice and is not in keeping with ALARA. The argument has been presented that public education is the answer and not rulemaking. However, health physicists have been trying to educate the public for years but with little success.

9. Section 35.432- No comment

10. Section 35.605--Should the maintenance restrictions in paragraph (a) of the proposed rule apply to low dose-rate remote afterloaders? - We do not allow users of nonmedical devices to perform these types of services unless procedures are submitted that show they have had appropriate training in performing these services on the specific devices.

11 . Section 35,615--Should the requirements in this section which requires the expeditious removal of a decoupled or jammed source be waived for licensees that are using remote afterloaders with beta-emitting sources? - No. The requirements should not be waived for remote afterloaders with beta-emitting sources. This is not in keeping with ALARA. Also Section 35.615(f) outlines further requirements for the following: (1) For low dose-rate remote afterloader devices, require ... (2) For high dose-rate remote afterloader devices, require .. . (3) For pulsed dose-rate remote afterloader devices, require ... These seem to be generic requirements for all afterloaders. Each of the above sections is worded exactly alike, except for the type of afterloader. There does not seem to be a real need to write the same requirement for each type of afterloader. Why not combine the three into one requirement addressing all afterloaders as the title of this section does?

Page 5 Secretary

12. Section 35.644--Should the restrictions for electrical interlocks and audiovisual systems apply to low dose-rate remote afterloaders? - It depends on the exposure rates in the room when the source is exposed as to whether or not interlocks and audiovisual systems should be required.

13. Section 35,981--What is the impact of deleting this section? - This section may be deleted, but it is replaced by Sec. 35.55, Training for an authorized nuclear pharmacist, which has many of the same requirements. Therefore there would be no impact.

14. Subpart L--Should all record keepini requirements be irouped into one Subpart or should they be incorporated into the section requirini the record? -

A It makes it easier for the licensee to reference and determine record keeping requirements and therefore makes it easier for them to maintain compliance. B. In addition to the comments solicited in the summarized questions, the body of the draft solicited the following additional comments on the rule: The Commission is soliciting specific public comment on which record keeping requirements could be deleted in the final rule and the basis for the deletion. For example, should the record keeping requirements in Sec. 35.2063 be retained for byproduct material administered pursuant to Secs. 3 5 .100 and 3 5 .200 because of the low risk associated with this type of use?" - The record keeping requirements should not apply to byproduct material administered pursuant to Secs. 3 5 .100 and 35.200 because of the low risk associated with this type of use. C. Sec, 35,2067(b) may need to have an additional reference which states that additional brachytherapy records may be required by 35.2406. D. Also, Section 35.2024, Records of authority and responsibility for radiation protection proiIJll11S, and Sec. 35.2026 Records of radiation protection program safety changes,

• are far too prescriptive and burdensome for record keeping. It is not applicable to a radiation safety program for a private practice with only one physician on staff who is the owner/president and the radiation safety officer. These types of facilities are becoming more numerous, so it does have an impact on our licensees.

E. Sec 35,2067 - Pertaining to leak test records - This seems to be highly prescriptive as to what information is required on a leak test record. Other leak test rules in 10 CFR only require that a leak test record be kept in units of microcuries and kept for inspection by the Commission. What is the performance based criteria for having all of the information listed in the proposed rule on the leak test record for medical sources, when performance based (rules) criteria for norunedical sources do not require this information?

Page6 Secretary

15. Subpart M--Groupina ofReportina Requirements -

A. It should make it easier for the licensee to reference and determine reporting requirements and therefore makes it easier for them to maintain compliance. B. The following nine items share the same comment:

1. Sec, 35,2632(8) Records of teletherapy full calibrations requirina the siioature of the authorized medical physicist who performed the full calibration.

2. Sec, 35,2633(4) Records ofremote afterloader full calibrations requiring the siinature of the authorized medical physicist who performed the full calibration.

3. Sec, 35,2635(5) Records of iamroa stereotactic radiosuriery unit full calibrations requitini the signature of the authorized medical physicist who performed the full calibration.

4. Sec, 35,2642(9) Records of periodic spot-checks for telether~y units requiring the signature of the authorized medical physicist who reviewed the record of the spot-check.

5. Sec, 35,2643(5) Records of periodic spot-checks for remote afterloaders requirini the siinature of the authorized medical physicist who reviewed the record of the spot-check.

6. Sec, 35,2645(5) Records of periodic spot-checks for aamma stereotactic radiosu[iery units requiring the signature of the authorized medical physicist who reviewed the record of the spot-check.

7. Sec, 35,2647(5) Records of additional technical requirements for mobile remote afterloaders requiring the signature of the individual who performed the check.

8. Sec, 35,2652(4) Records of surveys ofther~eutic treatment units requiring the sianature of the individual who performed the test.

9. Sec, 35,2655(0 Records of 5-year inspection for telether~y and gamma stereotactic surgery units requirina the signature of the inspector, The record should only contain the name of the individual. This appears to be a prescriptive and not a performance based requirement. A signature does not necessarily mean the individual has actually read/reviewed the report. By allowing the

Page7 Secretary use of just the name the file can be maintained electronically using current and/or future technology.

16. Section 35.3045-Do the proposed rule chanaes adequately address patient intervention and wrong treatment site? - The rule should have an exemption to some of the reporting requirements when the cause of the medical event is patient intervention. For example, the licensee should not be required to respond to part (c}(l} (vi) of the rule which requires "What improvements are needed to prevent recurrence; or (vii) Actions taken to prevent recurrence;" if the licensee did all that they could to prevent the occurrence from happening in the first place. Discussion was provided in the draft to support this by stating:

            "Generally speaking, patient intervention involves actions by the patient such as dislodging or removing treatment devices or prematurely terminating treatment. In cases where patient intervention is probable, the licensee should take reasonable actions (e.g., extra sutures, taping, or more frequent checks by the nursing staff) to avoid a medical event. Factors which may be considered in determining whether a licensee's actions are reasonable include whether the licensee monitors the patient routinely and whether the licensee responds properly once it becomes aware of the disruption of treatment."

17. Section 35,3047--Should the Abnormal Occurrence Policy Statement criteria for reporting of exposures to an embzyo/fetus or nursing child be modified? Is there a better term than

 responsible relative or guardian" that could be applied to those situations where the mother is not notified, e.g., in the referrina physician's medical judgment telling the mother would be hannful; the mother is a minor; or the mother is not competent to make decisions regarding medical care? What is the impact of the proposed reportina requirement on licensee procedures, activities, or medical practices? - The physician should be able to determine whom to notify. In some cases the best notification may be the pediatrician (or future pediatrician) and this option is not listed in the rule.

After all, who will be caring for the child medically? In most cases it will not be the mother's referring physician. There does not seem to be a better term than responsible relative or guardian" to apply to those situations in which the mother is not notified. Hopefully the term "responsible" is not being used as a substitute for "legal". The term "responsible" should allow for the notification of someone in the minor's life that cares for the minor who may not be a blood relative or legal guardian. However, not telling the mother only because she is a minor is not a responsible rule. The other two parts of the rule would cover the notification: i.e. it would be harmful to the mother or the mother is not competent. The medical community and the laws of each state will determine if a mother is allowed information that may affect her child if she is a minor. The rule as written is inappropriate. I also agree with the comments in the analysis of the rule that in many incidents involving pregnancy or nursing mothers, the licensee might not have been able to prevent the incident because the individual may not have been aware of the pregnancy or may have opted not to disclose her pregnancy or nursing status. The regulatory burden in these cases is too much as the reporting will not prevent a reoccurrence.

Page 8 Secretary NRC COMMENTS SOLICITED BUT NOT IN THE SUMMARIZED SECTION; Section 35,80 would be retitled, Provision of mobile service, and revised and Section 35 647, Additional technical reQuirements for mobile remote afterloaders: NRC specifically reQuested comments on these issues relative to whether mobile medical licensees operate under reciprocity in other reilllatory jurisdictions. We agree with the analysis and comments in the Statements of Consideration. The State of Georgia's "Rules and Regulations for Radioactive Materials" do not allow for medical licensees to operate under reciprocity. Additional Comments Sec, 35,27 Supervision.- 35.27(c) ofthis rule can be omitted. Rule making will not stop a misadministration caused by poor management; either by an abusive manager who will not tolerate any questions or by poor management of a "too knowledgeable person" who will not ask questions . Sec, 3 5 ,41 Procedures for administrations reQuiring a written directive. - 3 5 .41 (b) is really not necessary. It is too prescriptive. (3) and (4) of (b) can be combined with (a). If a licensee has to develop a plan that provides high confidence that (1) and (2) occur then it follows that (b) may not be necessary. Aren't we now telling them how to write the plan? Isn't that what we are trying to get away from? Sec, 35,50 Training for Radiation Safety Officer - 35 50(b}(2) states, "Has obtained written certification, signed by a preceptor RSO ," and 35 S0(c) states, "Is an authorized user, authorized medical physicist, or authorized nuclear pharmacist identified on the licensee's license and has experience with the radiation safety aspects of similar types of use of byproduct material for which the individual has RSO responsibilities," Comments are: 35.50(b)(2) Why not have the licensee's management sign a statement that the person has meet the training criteria? Many times the old RSO leaves and will not sign a preceptor statement for a person. Also, if the RSO is a poor manager and management wants to replace him, but will still allow him privileges at the licensee's facility, the RSO is not about to sign off on someone else taking their place. Too many times egos get in the way of good people being allowed to do the job correctly. 35.S0(c) Why not a person certified by a board approved by the Commission who is either identified on the license or the licensee has notified the Commission as prescribed in Sec. 35.14? This could possibly allow for certified/registered technologists, who many times would be a better choice as an RSO than an authorized user. Registered technologists would certainly meet the second part of paragraph (c). Sec, 35,65 Authorization for calibration and reference sources,- 35,65(c) Any byproduct material with a half-life longer than 120 days in individual amounts not to exceed 7,4 MBQ ( 200

 <Greek-l>Ci) each and not to exceed 1000 times the Quantities in appendix B of Part 30 of this chapter whichever is more limiting. - We believe the "and" should be "or.

Page9 Secretary Sec. 35.69 Labelina and shieldina of vials and syrinaes.- 35.69(b) is covered under Section 19.12, "Instruction to Workers". It is also covered by another federal agency under the "Workers Right to Know Act". As worded, the rule is not needed under this section. It does not need to be repeated a third time. GENERAL TRAINING REQUIREMENTS: Many things have changed in the training requirements making the current requirements look very liberal compared to past requirements. Should the term "preceptor" be defined in the regulations as coming from an institution or will anyone be allowed to be a preceptor (i.e. private practice radioactive materials licensee)? Sec. 35.630 Dosimetry eqyipment. - 35.630(a)(l) should use the abbreviation "NIST" after National Institute of Standards and Technology as was done with Association of Physicists in Medicine (AAPM). The abbreviation "NIST should be used in 35.630(a)(2) in place of National Institute of Standards and Technology to maintain continuity of writing style. Sec. 35.652 Radiation surveys. - 35.652(a) states in part, " ... a licensee shall make such surveys as defined in the Sealed Source and Device Registry to assure that the maximum radiation levels and averaae radiation levels from the surface of the main source safe with the source(s) in the shielded position does not exceed the levels stated in the Reaistry. Maximum radiation levels and average radiation levels could be made a generic number as with radiography cameras and source changers. Radiographers do not have to comply with readings on the SSD registration sheet. They have to survey to ensure the source is in the proper place and that a generic exposure rate is not exceeded. The radiation level numbers for each device are tedious to look up. There is no need for such specificity for each type of afterloader. It may make sense to put in the average acceptable reading

• for each type of afterloader (i.e. high does rate, low dose rate, and pulsed), than for each brand and model number. Generic readings would also be more in keeping with Part 20 and less prescriptive than the proposed rule while at the same time alerting the licensee to a potential problem if a certain radiation level is exceeded.

Sec. 35.900 Radiation Safety Officer.--35.900 (6) American Board of Medical Physics in radiation oncoloay ph_ysics; and (7) Royal Colleae of Physicians and Suraeons of Canada in nuclear medicine; - Need to capitalize "radiation oncology physics" and "nuclear medicine" for consistency with existing Part 35 and for internal consistency. Sec. 35 900 Radiation Safety Officer.--Sec. 35.910 Trainina for uptake, dilution, and excretion studies; and Sec.35.920 Trainina for imaaina and localization studies. - All three of these need to include the American Board of Cardiology for cardiology studies and for RSO of same. The Revision of NRC's Reaulatmy Proaram discusses that, "(l)Regulatory oversiaht alternatives for diaanostic procedures that are consistent with the lower overall risk of these procedures; ... and (2) Redesianina Part 35 so that reaulatory requirements for new treatment

Page 10 Secretary modalities can be incorporated in a timely manner." - Significant changes have been made in Nuclear Cardiology in the past 15 years. Changes are currently on-going (e.g., beta restinosis). Based on the low-risk associated Sec. 35.100 and Sec. 35.200 there does not seem to be a performance based reason not to include the new Board for cardiologists. Section 35.2070, Records of surveys for ambient radiation exposure rate, would require the licensee to maintain records of radiation surveys for 3 years. One change has been made from the current record keeping reqyirements for radiation surveys. The name of the individual performing the survey rather than the initials of the individual would be reQJJired to be recorded.- Why the change to a name instead of initials? I have always been able to identify the individual by their initials during inspections. This does not seem to be a performance based requirement. Thank you for the opportunity to comment on and to participate in development of the revisions to 10 CFR Part 35. Thomas E. Hill, Manager Radioactive Materials Program

ITheresa Kendall - Fwd: Part 35 Comments Page 11 From: Lloyd Bolling To: Catherine Haney Date: Thu, Nov 12, 1998 2:30 PM

Subject:

Fwd: Part 35 Comments Cathy: Attached are comments on Part 35 (Proposed Rule) from Liz Drinnon, GA Radiation Program. Lloyd CC: Paul Lohaus, Richard Bangart

ITheresa Kendall - Part 35 Comments Page 11 From: Elizabeth Drinnon <edrinnon@mail.dnr.state.ga.us> To: TWFN_D0.twf1 _po(LAB) Date: Thu, Nov 12, 1998 1:59 PM

Subject:

Part 35 Comments Attached are my comments to draft Part 35. I am also faxing you a hard copy. Thanks for your time on this. CC: GATED.nrcsmtp("Tom_Hill@mail.dnr.state.ga.us")

Geor 4 44 International Parkway, Suite 114, Atl 30354 Lonie missioner Environmental Protection Division Harold F. Reheis, Oirector (404) 362-2675 "98 NOV l 3 P2 :25 November 12, 1998 Secretary OFf-1 U.S. Nucle.ar Regulatory Commission RUl *.* - ADJUu,...._ ' .1-F Washington, DC 20555-0001 Attention: Rulemak.ings and Adjudications Staff.

tD; 3:l d35 Gentlemen: ( (p3FR'/-3 5 I loJ l11e following comments are written in response to Federal Register Notice, August I 3, 1998 (Volume 63, Number 156), Propose.d Rules for 10 CFR Part 35, Pages 43515-43580 .

COMPATlBILITY An explicit statement of how NRC staff justified the key compatibility and "health and safety designations is needed. It is not provided in the Federal Register notice and staff indicates such will be available in a "few weeks (but after the comment period closes). This justifies an extension of the comment period to allow states and others to revie.w the acn1al basis for the compatibility designation. We request that the comment period, for compatibility designation only,. be extended to 30 days followi.ng the re.lease and disn*ibution of such justification of the compatibility designations.

SUMMARY

OF SPECIFIC IS~UES TDRNTTFIED FOR PUBLIC COMM'l<;NT

1. Training and Experience - There is a definite need for training and experience requirements for those individuals who actually handle radioactive materials (generally known as "nuclear medicine technologists"). Please note that this could easily be.justified by the proposed policy statement that NRC will foe.us on assuring that "the use of radionuclides is in accordance with the physician's directions. Although the need for training and experienc.e for technologists was pointed out during the facilitated public. workshops.

NRC has not addressed this issue or explained its rationale for ignoring the comments. We believe it is appropriate, given the potential public health impact, that a certifying exam be accomplished by an organization other than the one provid ing the essential training. We suppo11 the idea that a radiation safety competenc.y exam is wan*anted for all individuals involved in the application of radiation to humans. That in\.~ludes the persons actually handling the sources of radiation . ln that regard, more effort

 ~*  should be spent in identifying and requiring appropriate training and education for tec.hnologists.

2. Section 35 .2--Should the term "medjum qose-rate remote afterloader be defined since it is not use.d in the nile? (Requirements for medium dose-rate remote aftcrloaders have been grouped with high dose-rate remote afterloaders in this rulemaking.)- The terms high dose and low dose afterloaders are defined.

A high dose-rate aftedoader delivers a dose rate in excess of2 gray (200 rads) per hour and a low dose-rate remote afterloader delivers a dose rate of less than 2 gray (200 rads) per hour, both at the point or surface where the dose is prescribed. By these tv*O de.finitions, it would imply that a medium dose-rate afcerloader would deliver a dose at 2 gray since the other two types of afterloaders deliver doses on either sjde of thi.s exposure rate. If the term medium dose-rate after loader is used, then it should be defined or not used at all. The term as used in this section does not add clarity to the rule. ( 99 0T / 2'd

Secretary C Page 2

3. Secrion n.6.. Should this section he revised to require that licensees develop, implement, and maintain procedures for evaluating when a medical procedure would be corisi!1,er,ed to be a research proc.edure?

  - It is not clear how such a requirement is protecting public health and safety. No matter what type of radiatioo is delivered to a patient, radiation safety for the patient, the worker and the public, must be maintained. ALARA must be maintained. All of the proposed paperwork required above will not add (in a positive manner) to these requirements.

4. Removal of Section 35 .22 Radiation Safety Committee deleted in it." entirety, - For the small, diagnostic use type facilities, the elimination of the Radiation Safety Committee should not adversely impact radiation safety. The effect of removing the Radiation Safety Committee from a medical institution will vary with the size and complexity of the institution and with the politic.al climate within the facility. What is important is that the Radiation Safety Officer still has a direct line of reporting to management on radiation safety issues.

At larger institutions with multiple disciplines (diagnostic nuclear medicine, teletherapy, remote afterloaders, nuclear cardiology ... ), using radioactive materials throughout the facility, a Radiation Safety Committee may be needed to coordinate all of the reporting activities and to ensure that basic radiation safety is being consistently achieved in each area of the facility. Currently, the Radiation Safety Committee with its required management representative in attendance provides access by the Radiation Safety Officer (RSO) which he/she may be hesitant to attempt via other channels. Safety issues may also be brought up in meetings which may not be conveyed to the RSO personally. TI1e Radiation Safety Officer should be presen.t at Committee meetings either as a member or as a technic.al advisor to the Committee. ( Overall, the rule is too prescriptive as it applies to the Radiation Safety Officer reporting to management. As written, the rule implies that management has given the RSO the "responsibility" of maintaining a radiation safety program but is not allowing the RSO any "authority" in managing the program . Radiography licensees do not have such restrictive and prescriptive procedures on implementing a radiation safety program. Wh>* does medic.al? If these partS of a radiation protection program are so important for

• management oversight, then why aren't they included in a more generic fashion in Sec. 20.1101? No other radiation protection program is impacted with as much management oversight in ruleniaking as medical. The management/RSO relationship/reporting requ irement is not applicable to a radiation safety program for private practic.e with only one physician on staff who is the owner/president and the radiation safety officer.

5. Section 35.75 Release oflndjv jduals Containing Radiophamiaceuticals or Implants.- The hazards posed to the family and general public by a person containing radiopharmaceutical,s depends totalJy upon the inclination and the ability of the patient to abide by prescribed restrictions for a specific period of time. It is extremely diffic.ult to predict human behavior and impossible to control it outside the confines of the. hospital.

Some patients would go to a hotel or motel to prevent possible exposure offamily members which would then introduce unknown casual exposure to another segment of the public. Undoubtedly many patients covered under this rule could be safely released from confinement. However many institutions must release l-131 therapy patients to nursing homes or even homeless shelters. lt is extremely difficult to explain to a HMO, insurance company, or possibly to a government Medicaid or Me-die.are case worker the difference between an 1-125 eye plaque involving a seale,d source and a patient who has just ingeste-d 200 mCi ofl-13 l - why one may not require hospitalization while the other one would. This rule would interfere with an RSO's ability to protect public health and safety. (

Secretary C Page 3 When patients receive oral therapy doses of I-131 , the possibility of nausea and vomiting is a side effect This side effect is disclosed to the patient. Nausea and vomiting has occurred following a diagnostic dose of 1-131. In one instance a sidewalk along a major metropolitan thoroughfare near the hospital v,*as contaminated. A relative returned to the N ucle.ar Medicine Department, and a decontamination team headed by the RSO successfully decontaminated the sidewalk. Activity from a therapy dose would be much more difficult to remove. This could occur far from the hospital in the case of an out-of-town patient returning home. If the radiation factor became an issue, who would be responsible for dec.ontamination? For reimbursement for decontamination? This mle would interfere *with the RSO's ability to c.ontrol radioactive contamination. Also to consider: This rule would result in an increase of radiation alam1s at landfills caused by household trash of released patients. The landfill regulations do not allow the burial of radioactive material, so NRC or State Offices would be notified. Radioactive material contained in patient excreta is no longer considered regulated, so where does financial liability reside? With the State or NRC? With the administering facility or the patient?

6. Section 35. 92 - On deletion of hold in~ material held-for-decay for 10 half Jjyes.- Although the proposed wording is more clear and is less burdensome to the licensee, it does not adequately address the beta emitter concern (such as S-35, P-32, or 1-125). which are difticult to detect By requiring the calculation of l Ohalf lives, we have provided a reliabl.c timetable for scheduling hard to detect material for disposal which acts as a deterent for assuring facilities do not '1ump the gun" when disposing of beta emitters.

Pertaining to Sec. 35.92(aX2) which states that prior to disposal all radiation labels will be obliterated ( or removed. This requirement is not in keeping with guidance published in IN 97-03 0 <<Defacing Labels to Comply with 10 CFR.1904(b)". Removing or obliterating labels on medical use materials is flirting with a biohazard. This rule is not in keeping wi th current technology or OSHA standards. The mle needs to be rewritten to allow for other acceptable methods of disposing of used syringes/vials without defacing rhe labels as described in the information notice.

7. Sec.tion 35.315 - For each patient who c.anpot he rele~sed in accordance with 35 .75. a licensee shall pnwige a private room wjth a Drivate sanitan facility.- This rule should be retained as is. Again the issue 1

arises of demonstrating the need for a private room for one. patient while possibly not for another patient as HMOs, insurance companies, and Medicaid/Medicare representatives seek to assign their patient. to less expensi\'e facilities. Experience dictates that bathrooms of 1-13 l therapy patie.nts must be pmperly prepared to prevent contamination by even the very conscientious patient. Contamination from an unrestricted bathroom floor c.ould be tracked through the hospital. Other users could become contaminated from faucet handles, doorknobs, etc., and some of the contamination could become internalized.

8. Section 35.41 S - Safety Precautions - Not Quarter a patient or re.~earch subject receiving bracbytherap_y in the same room as an jndjyjdual who is not receiving radiatil)n therauy.- The popular opinions currently held by members of the general public concerning radiation makt:s it socially and legally questionable to house a non-radioactive patient in a room, which has radiation posting on the door. Nursing staff would be understandably disturbed about receiving additional radiation exposure, if that were a factor, while caring for a non*radioactive roommate. Visitors and family members might be expected to experience some apprehension entering a posted room even if it was explained that external radiatil)n exposure was not a factor.

Secretary ( Page4 This rule should be retained sinc.e subjecting a member of the public to close proximity to a radiation source is not the patient's choice and is not in keeping with ALARA. The argument has been presented that public education is the answer and not rulemaking. However, health physicists have been trying to educate the public for years but with little success.

9. Section 35.432- No comment

10. Sectjon 35,605-Should the maintenance restrictions in paragraph (a) of the proposed rule. apply to low dose-rate remote afterloaders?- We do not allow use-rs of nonmedical devices to perform these types of services un.less procedures are submitted that show they have had appropriate training in perfom1ing these services on the specific devices.

11. Section 35.615--Should the requirements in this section which requires the expeditious removal of a decoupled or jammed source he waived for licensees that are using remote afterloaders with beta-em ittine sources? - No. The requirements should not be waived for remote afterloaders with beta-emitting sources.

This is not in keeping with ALARA. Also Section 35.6 lS(f) outlines further requirements for the following: (1) For low dose-rate remote afterloader devices, require ... (2) For high dose-rate remote afterloader devices, require ... (3) For pulsed dose-rate remote afterloader devices, require ... These seem to be generic requirements for all afte.rloadcrs. Each of the above sections is worded exactly alike, except for the type of afterloader. There does not seem to be a real need to write the same ( requirement for each type of after loader. Why not combine the three into one r~quirement addressing all afterloaders as the title of this section does?

12. Section 35.644--Should the restrictions for electrical interlnc.ks and audiovisual systems apply to lnw dose-rate remote ;!fterh~aders? - It depends on the exposure rates in the room when the source is exposed as to whether or not interlocks and audiovisual systems should be required.

13. Section 35.981--What i~ the impact Mdeletjng this section? - This section may be dele-ted, but it is replaced by Sec. 35.55, Training for an authorized nuclear pharmacist, which has many of the same requirements. Therefore there would be no impact.

1.4. Subpart L--Should all rernrd keepini r~uiremen1~ be grouped into one Subpart or should rhey be incorporated into the ~ection requiring the record? - A. It makes it easier for the licensee to reference and determine record keeping requirement.~ and therefore makes it easier for them to maintain compliance. B. In addition to the comments solicite.d in the summarized que~tions, the body of the draft solicited the following additional comments on the rule: The Commission is soliciting specific public comment on which record keeping requirements could be. deleted in the final rule and the basis for the deletion. For example, should the record keeping requirements in Sec. 35.2063 be retained for byproduct material administered pursuant to Secs. 35. t 00 and 35.200 because of the low risk associated with this type of use?"- The record keeping requirements should not apply to byproduct material administered pursuant to Secs. 35.100 and 35.200 because of the low risk associated with ( this type of use. 0L*S "d i"*,tlS/3S Od3 dtllJ te Wd52:20 85, 21 N)tJ

Secretary ( Page 5 C. Sec. 35.2067(b) may need to have an additional reference which states that additional brachytherapy records may be required by 35.2406. D. Also, Section 35;2024, Records of authority and responsibility for radiation protection programs, and Sec. 3S.2026 Records of radiation protection program safety s-hanQC~, are far too prescriptive and burdensome for record keeping. lt is nor applicable to &t ro1diation safety program for a private practice with only one physician on staff who is the owner/president and the radiation safety offic-er. These types of facilities arc bec.oming more numerous, so it does have an impact on our licensees. E. Sec. 35.2067 - J>ertaining to leak test records - This seems to be highly prescriptive as to what infonnation is required on a leak test record. Other leak test m les in l OCFR only require that a leak test record be kept in units ofmicrocurics and kept for inspection by the Commission.

                 'What is the performance based criteria for having al I of the information listed in the proposed rule on the leak te.st record for me.dical sources, when performance based (rules) criteria for noM1edical sources do not require this infonnation'?

15. Sl!bpart M--Groupine ofReportin11 Regµirements -

A. It should make it easier for the licensee to reference and detennine reporting requirements and therefore makes it easier for them to maintain compliance. B. The following nine items share the same comment: (

1. Se.c . 3S.2632(8) Records ofte1etherapx full calibrations re.quiring the signature of the authorjzed me;djcal physicist who performed the foll calibration.

Sec. 35.2633(4) Records of remote afterloader full c~libratjons requiring the 2. sjgnature of the authorized medical physicist who performed the full calibratjpn.

3. Sec.. 35.263 5(5) Recnrds of gamma stereotactic radiosur&:ery unit full calibrations reguirinG the signature of the authorized mcdi9l phrsjcjst who performed the full calibration.

4. Sec 35,2642(9) Records of periodic spot-checks for te!etherany units requirini the signature of the authori7.ed medical physicist who reviewed the record of the spot-check.

5. Sec. 35.2643{5} Records of periodic ,i;pot-checks for remo~ afterloaders reguirin,a the signature of the authorjzed medical physicist who reviewed the record of the

                           ~pot-check.

6. Sec. 35.2645(5) Records of periodic spot-c.heckF for gamma stereotactic radior-ur11ezy ynjt,; requiring the signature. of the authorized medical physicjst who reviewed the record Qf the ~pot-check.

7. Sec. 35.2647(5) Records of additional technical requirements for mobile remote afterloaders requiring the signature of the indiyjdual who performed the check.

(

Secretary C Page6

8. Se.c. 35.2652£4) Rec.ords of surveys of therapeuti~. treatment units regujripg the ii8nature of the jndividual who performed the test.

9. Sec, 35.2655(0 Record$ of5-year inspection for teletherapy and gamma stereotactic sun,:ery units reguirjn~ the ~ignature of the inspector.

The record should only contain the name of the individual. This appears to be a prescriptive and not a performance based requirement. A signature does not necessarily mean the individual has actually read/reviewed the report. By allowing the use ofjust the name the file can. be maintained electronically using current and/or future tec.hnology.

16. Section 35.3045-Qo the proposed rule changes adequately addre,c;~ patient intervention and wrong treatment site? - The rule should have an exemption to some of the reporting requirements when the c.ausc of the medical event is patient intervention. for example, the licensee should not be required to respond to part (cXl) (vi) of the rule which requires "What improvements are needed to prevent recurrence; or (vii) Actions taken to prevent recurrence;" if the licensee di d all that they could to prevent the occurrence from happening in the first place. Discussion was provided in the draft to support this by stating:

              "Generally speaking, patient intervention involves actions by the patient such as dislodging or remo*.-ing treatment devices or prematurely terminating treatment. ln cases where patient intervention is probable, the licensee should take reasonable actions (e.g., extra sutures, taping, or more frequent checks by the nursing staff) to avoid a medical event. Factors which may be considered in determining

( whether a licensee's actions are reasonable include whether the licensee monitors the patient routinely and whether the licensee responds properly onc.e it becomes aware of the disruption of treatment."

17. Section 35.3047*-Should the Abnomial Occurrence Policy Statement criteria for reporting of exposures to an emhn*o/fetus or nur~ins ch ild be modified? ls there a better term than "responsible relative or guardian that could be applied to those situations where the mother is nnt notified, e.g., in the referring physjcian's medical judgment telling the mother would be haanful; the mother js a minor; or the mother is not Cllmpetent to make. decisions regarding medical care? What is the impact of tht, prQposed reporting reguirement on licensee procedures, activities, or medical practices? ~ The physician should be able to determine whom to notify. In some cases the best notification may be the. pediatrician (or future pediatrician}

and this option is not listed in the rule. After all, who will be caring for the child medically? In most cases it will not be the mother's referring physician. There*does not seem to be a better tenn than responsible relative or guardian" to apply to those situations in which the mother is not notified. Hopefully the tenn "responsible" is not being used as a substitute for "legal". The tenn "responsible" should allow for the notification of someone in the minor's life that cares for them inor who may not be a blood relative or legal guardian. However, not telling the mother only because she is a minor is not a responsible rule. The other two parts of the rule would cover the notification: i.e. it would be harmful to the mother or the mother is not competent. The medical community and the laws of each state will determine ifa mother is allowed information that may affect her child if she is a minor. The rule as written is inappropriate. I also agree with the comments in the analysis of the rule that in many incidents involving pregnancy or nursing mothers, the licensee might not have been able to prevent the incident because the individual may not have been aware of the pregnancy or may have opted not to disclose her pregnancy or ( nursing status. The regulatory burden in these cases is too much as the reporting will not prevent a reocc urrence. 0t L' d

Secretary Page 7 NBC COMMENTS SOLICITF;D BUT NOT IN THE SUMMARIZED SECTIONi Section 35.RO would be retitled, Provision of mobile ,seryjce. and revised and Section 35.647, Additional technical reguirements for mobile remote aftgrloade~: NRC specifically regye~ted comment,c: Q.n these issues relative to whether mobile medical licensees gperate under rec iprocity in other regulatorv

  .iurisdictions .

We agree with the analysis and comments in the Statements of Consideration. The State of Georgia's "Rules and Regulations for Radioactive Materials" do not allow for medical licensees to operate under re.ciprocity. Additional Comments

• Sec. 35 .27 Supervision.- 35.27(c-) of this rule can be omitted. Rule making will not stop a misadministration caused by poor management; either by an abusive manager who will not tolerate any questions or by poor management of a "too knowledgeable person" ""ho \\'ill not ask questions.

Sec. 35.41 Procedures for administrations requiring a written djrectiye.- 35.41.(b) is rcalJy not necessary. It is too prescriptive. (3) and (4) of (b) can be combined with (a). If a licensee has to develop a plan that provides high confidence that (I) and (2) occur then it follows that (b) may not be necessary. Aren 't we now telling them how to write the plan? Isn't that what we are trying to get away from? Sec. 35.50 Trajnjn~ for Radiation Safety Officer - 15.50(b}<2} states. "Has ohtained written ( certification, signed by a preceptor RSO ..." and 35,50(c} states "Is an authorized user, authorized medical physicjst, or authorized nuclear pharmacist identified on the licensee*s license and ha,:; experience with the radiation ~afety 3,c:pects of similaLtypes nf u$e of byproduct material for which the individual has RSO responsibiljtjes" CommenB are:

• 35.S0(b)(2) Why not have the licensee' s management sign a statement that the person has meet the training criteria? Many times the old RSO leaves and will nor sign a preceptor statement for a person. Also, if the RSO is a poor manager and management wants to replace him, but will still allow him privileges at the licensee's facility, the RSO is not about to sign off on someone else taking their place. Too many times egos get in the way of good people being allowed to do the job correctly.

35.S0(c) Why not a person certified by a board approv~.d by the Commission who is either identified on the license or the licensee has notified the Commission ss prescribed in Sec. 35.14? This could possibly allow for ce1t ified/registered technologists, who many times would be a better choice as an RSO than an authorized user. Registered tec-hnologists would certainly meet the second part of paragraph (c). Sec. 3 5 .65 Authorjzation for cal ibratinn and reference sources.- 3S.65(c} Any bvproduct material with a half-life longer than l 20 days in individual amounts not to exceed 7.4 MBg ( 200 <Greek-l>Ci} each and not to exceed 1000 times the quantities in appendix B of Pan ~0 of this chapter whichever is more limiting. - We believe the "and" should be "or". ( ovs*d fltfS/35 Od3 ~1-.JQ te WdtE :20 86 , 2t AOl*-1

Secretary ( Page 8 Sec. 35,69 Labeling and !;hielding ofvials and svringes.- 35.69(b) is coYered under Section 19.12,

 *;Instruction to Workers". It is also covered by another federal agency under the "Workers Right to Know Act". As worded, the rule is not needed under this section. It does not need to be repeated a third time.

GENERAL TRAINING REQUIREMENTS: Many things have changed in the training requirements making the current requirements look very liberal compared to past requirements. Should the term ,;preceptor" be defined in the regulations as coming from an institution or wilt anyone be allowed to be a preceptor (i.e. private practice radioactive materials licensee)?

 ~,;. 35.630 Dosimetry equipment. - 35.630(a)(l) should use the abbreviation "NIST' after National institute of Standards and Technology as was done with Association of Physicists in Medicine (AAPM). The abbreviation NIST should be used in 3 S.630(a)(2) in place of National Institute of Standards and Technology to maintain continuity of writing style.

Sec. 35.652 Radjatinp surveys. - 3S.~2(a) states in part, ". .. a li~cnsee shall make such sum:ys a:; defined in

• the Sealed Source and,De)rice Regjstzy to asc;ure that the maxim um.radiation levels and average radiatil)n levels from the surface of the main source safe with the source(s) in the shielded position does not exceeg the leye)s

 ~din the Registry.

Maximum radiation levels and average radiation levels could be made a generic number as with radiography cameras and source changers. Radiographers do not have to comply with readings on the SSD ( registration sheet. They have to survey to ensure the source is in the proper place and that a generic exposure rate is not exceeded. The radiation level numbers for each device are te-dious to look up. There is no need for such specificity for each type of afterloader. (t may make sense to put in the average acceptable reading for each type of afterloader (i.e. high does rate, low dose rate, and pulsed), than for each brand and model number. Generic readings would also be more in keeping wirh Part 20 and less prescriptive than the proposed rule while at the same time. alerting the licensee to a potential problem if a certain radiation level is exceeded. Sec. 35.900 Radiation Safety Officer.--35.900 (6) American Board of Medical Physjcc; inradiation oncology physics* and Gl Royal Colle~e pf Physicians and Surgeons of Canada in nuclear medicine; - Need to capitalize radiation oncology physics and "nuclear medicine" for consistency with existing Part 35 and for internal consistency. Sec, lj,90Q Radiation Safety Qffiicer,--Sec, 35 910 Trajning_for uptake, dilutil)O. and excretjon studies: and Sec.35.920 Training for imaging and localization studies. - All three of these nee.cl to include the Amer;can Board of Cardiology for cardiology studies and for RSO of same. The Revision ofNRC's Regulatory Program disc.usscs that, "(I }Regulato~oversight a!tematives for diagnostic procedures that are consistent wjth the lower overall risk of these procedures:, , and (2) Re.designing Part 35 so that regulatory requirements for new treatment modalities can be incorporated in a timely manner," - Significant changes have been made in Nuclear Cardiology in the past 1S years. Changes are currently on-going (e.g., beta restinosis). Based on the low-risk associated Sec. 35.100 and Sec. 35.200 the.re does not seem to be a perfom1ance based reason not to include the new Board for cardiologists. ( 0T/6'd t-.t!S/3S Qd3 ~-J*J 1:15 Wdl£ :20 86. 2t t\01-J

(_ Secretary Page9 Section 15 2070, Record~ of imrveys for ambient radiation ex,posur,e rate, would regujre the licensee to. maintain records of radjation surveys for 3 years. One change has been made from the current record keepjn" requirements for radiation s1m eys, The name t)f the individual perfonning the survey rather than the 1 injtja)$ of the indiv idual would be rec;iuired tn be recorded.- Why the change to a name instead of initials'? l have always been able. to identify the individual by their initials during inspections. This does not se.em to be a performance based requirement. Thank you for the opportunity to comment on and to participate in development of tl1e revisions to I 0 CFR Part 35. s&jjJ/;-/ J~ Elizabeth L. Drinnon Environmental Radiation Specialist Radioactive Materials Program ( ( ovm*d

Georgia Department of Natural Resources 4244 Internationa l Pa rkway, Suite 114, Atlanta , Georgia 30354 Lonice C. Barrett, Commissioner Environmental Protection Division Harold F. Reheis, Director {404) 362-2675 ber 12, 1998 Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 Attention: Rulemakings and Adjudications Staff. dO, 3 :l. .J-35 Gentlemen: ( (,3F1<"351t,,) The following comments are written in response to Federal Register Notice, August 13, 1998 (Volume 63, Number 156), Proposed Rules for 10 CFR Part 35, Pages 43515-43580. COMPATIBILITY An explicit statement of how NRC staff justified the key compatibility and "health and safety" designations is needed. It is not provided in the Federal Register notice and staff indicates such will be available in a "few weeks" (but after the comment period closes). This justifies an extension of the comment period to allow states and others to review the actual basis for the compatibility designation. We request that the comment period, for compatibility designation only, be extended to 30 days following the release and distribution of such justification of the compatibility designations. SPECIFIC ISSUES IDENTIFIED FOR PUBLIC COMMENT

• 1. Section 35.2--Shouldthe term "medium dose-rate remote afterloader" be defined since it is not used in the rule? (Requirements for medium dose-rate remote afterloaders have been grouped with high dose-rate remote afterfoaders in this rulemaking. )- The terms high dose and low dose afterloaders are defined. A high dose-rate afterloader delivers a dose rate in excess of2 gray (200 rads) per hour and a low dose-rate remote afterloader delivers a dose rate of less than 2 gray (200 rads) per hour, both at the point or surface where the dose is prescribed. By these two definitions, it would imply that a medium dose-rate afterloader would deliver a dose at 2 gray since the other two types of afterloaders deliver doses on either side of this exposure rate. If the term medium dose-rate afterloader is used, then it should be defined or not used at all. The term as used in this section does not add clarity to the rule.

2. Section 35.6--Should this section be revised to require that licensees develop, implement, and maintain procedures for evaluating when a medical procedure would be considered to be a* research procedure? - It is not clear how such a requirement is protecting public health and safety. No matter what type of radiation is delivered to a patient, radiation safety for the patient, the worker and the public, must be maintained. ALARA must be maintained.

All of the proposed paperwork required above will not add (in a positive manner) to these 0 1 8 998

R llU OR GS&ADJUDI EOFTH RY l=THE D

requirements.

3. Removal of Section 35.22 Radiation Safety Committee deleted in its entirety. - For the small, diagnostic use type fac ilities, the elimination of the Radiation Safety Committee should not adversely impact radiation safety. The effect of removing the Radiation Safety Committee from a medical institution will vary with the size and complexity of the institution and with the political climate within the facility. What is important is that the Radiation Safety Officer still has a direct line of reporting to management on radiation safety issues. At larger institutions with multiple disciplines (diagnostic nuclear medicine, teletherapy, remote afterloaders, nuclear cardiology ... ), using radioactive materials throughout the facility, a Radiation Safety Committee may be needed to coordinate all of the reporting activities and to ensure that basic radiation safety is being consistently achieved in each area of the facility.

Currently, the Radiation Safety Committee with its required management representative in attendance provides access by the Radiation Safety Officer (RSO) which he/she may be hesitant to attempt via other channels. Safety issues may* aiso be brought up in meetings which may not be conveyed to the RSO personally. The RSO should be present at Committee meetings either as a member or as a technical advisor to the Committee . Overall, the rule is too prescriptive as it applies to the RSO reporting to management. As written, the rule implies that management has given the RSO the "responsibility" of maintaining a radiation safety program but is not allowing the RSO any "authority" in managing the program. Radiography licensees do not have such restrictive and prescriptive procedures on implementing a radiation safety program. Why does medical? If these parts of a radiation protection program are so important for management oversight, then why aren't they included in a more generic fashion in Sec. 20.1101? No other radiation protection program is impacted with as much management oversight in rulemaking as medical. The management/RSOrelationship/reporting requirement is not applicable to a radiation safety program for private practice with only one physician on staff who is the owner/president and the RSO .

• 4. Section 35. 75 Release oflndividuals Containin~ Radiopharmaceuticals or Implants.- The hazards posed to the family and general public by a person containing radiopharmaceuticals depends totally upon the inclination and the ability of the patient to abide by prescribed restrictions for a specific period of time. It is extremely difficult to predict human behavior and impossible to control it outside the confines of the hospital. Some patients would go to a hotel or motel to prevent possible exposure of family members which would then introduce unknown casual exposure to another segment of the public.

Undoubtedly many patients covered under this rule could be safely released from confinement. However many institutions must release 1-131 therapy patients to nursing homes or even homeless shelters. It is extremely difficult to explain to a HMO, insurance company, or possibly to a government Medicaid or Medicare case worker the difference between an 1-125 eye plaque involving a sealed source and a patient who has just ingested 200 mCi ofl-131 - why one may not require hospitalization while the other one would. This rule would interfere with an RSO's ability to protect public health and safety. When patients receive oral therapy doses of 1-131 , nausea and vomiting are very common side effects. This side effect is disclosed to the patient. Nausea and vomiting has occurred

following a diagnostic dose ofl-131 . In one instance a sidewalk along a major metropolitan thoroughfare near the hospital was contaminated. A relative returned to the Nuclear Medicine Department, and a decontamination team headed by the RSO successfully decontaminated the sidewalk. Activity from a therapy dose would be much more difficult to remove. This could occur far from the hospital in the case of an out-of-town patient returning home. If the radiation factor became an issue, who would be responsible for decontamination? For reimbursement for decontamination? This rule would interfere with the RSO's ability to control radioactive contamination. Also to consider: This rule would result in an increase of radiation alarms at landfills caused by household trash of released patients. The landfill regulations do not allow the burial of radioactive material, so NRC or State Offices would be notified. Radioactive material contained in patient excreta is no longer considered regulated, so where does financial liability reside? With the State or NRC? With the administering facility or the patient?

5. Section 35 .92 - On deletion of h9ldin~ material held-for-decay for IO halflives. - Although the proposed wording is more clear and is less burdensome to the licens~e, it does not adequately address the concern of beta-emitters (such as S-35, P-32, or l-125), which are difficult to detect. By requiring the calculationof 10 half lives, we have provided a reliable timetable for scheduling hard-to-detect material for disposal which acts as a deterent for ensuring that facilities do not "jump the gun" when disposing of beta emitters.

Pertaining to Sec. 35.92(a)(2), which states that prior to disposal all radiation labels will be obliterated or removed: This requirement is not in keeping with guidance published in IN 97-03, "Defacing Labels to Comply with 10 CFR.1904(b)". Removing or obliterating labels on medical-use materials is flirting with a biohazard. This rule is not in keeping with current technology or OSHA standards. The rule needs to be rewritten to allow for other acceptable methods of disposing of used syringes and vials without defacing the labels as described in the information notice.

6. Section 35,315 - For each patient who cannot be released in accordance with 35,75, a

• licensee shall provide a private room with a private sanitary facility,- This rule should be retained as is. Again, the issue arises of demonstrating the need for a private room for one patient while possibly not for another patient as HMOs, insurance companies, and Medicaid/Medicare representatives seek to assign their patient to less expensive facilities.

Experience dictates that bathrooms of I-131 therapy patients must be properly prepared to prevent contamination by even the very conscientious patient. Contamination from an unrestricted bathroom floor could be tracked throughout the hospital. Other users could become contaminated from faucet handles, doorknobs, etc., and some of the contamination could become internalized.

7. Section 35.415 - Safety Precautions - Not to house a patient or research subject receivinti brachyther~y in the same room as an individual who is not receivin~ radiation therapy.-

The popular opinions currently held by members of the general public concerning radiation makes it socially and legally questionable to house a non-radioactive patient in a room which has radiation posting on the door. Nursing staff would be understandably disturbed about receiving additional radiation exposure, if that were a factor, while caring for the non-radioactive roommate. Visitors and family members might be expected to experience some apprehension entering a posted room even if it was explained that external radiation exposure

was not a factor. This rule should be retained since subjecting a member of the public to close proximity to a radiation source is not the patient's choice and is not in keeping with ALARA. The argument has been presented that public education is the answer and not rulemaking. However, health physicists have been trying to educate the public for years but with little success.

8. Section 35,605--Should the maintenance restrictions in paragraph (a) of the proposed rule apply to low dose-rate remote afterloaders? - We do not allow users of nonmedical devices to perform these types of services unless procedures are submitted that show they have had appropriate training in performing these services on the specific devices.

9. Section 35,615--Should the requirements in this section which reqyire the exPeditious removal of a decoupled or jammed source be waived for licensees that are using remote afterloaders with beta-emitting sources?- No. That is not in keeping with ALARA. Also, Section 35.615(f) outlines further requirements for the following:

(1) For low dose-rate remote afterloader devices, require .. . (2) For high dose-rate remote afterloader devices, require .. . (3) For pulsed dose-rate remote afterloader devices, require ... These seem to be generic requirements for all afterloaders. Each of the above sections is worded exactly alike, except for the type of afterloader. There does not seem to be a real need to write the same requirement for each type of afterloader. Why not combine the three into one requirement addressing all afterloaders as the title of this section does?

10. Section 35,644--Should the restrictions for electrical interlocks and audiovisual systems apply to low dose-rate remote afterloaders? - It depends on the exposure rates in the room when the source is exposed .

11. Section 35,981--What is the impact of deleting this section? - This section may be deleted, but it is replaced by Sec. 35.55, Training for an authorized nuclear phannacist, which has many of the same requirements. Therefore there would be no impact.

12. Sub.part L--Should all record-kee_ping requirements be grouped into one Subpart or should they be incor.porated into the section requiring the record? -

( 1) The latter makes it easier for the licensee to reference and determine record-keeping requirements and therefore makes it easier for them to maintain compliance. (2) In addition to the comments solicited in the summarized questions, the body of the draft solicited the following additional comments on the rule: The Commission is soliciting specific public comment on which record-keeping requirements could be deleted in the final rule and the basis for the deletion. For example, should the record-keeping requirements in Sec. 35.2063 be retained for byproduct material administered pursuant to Secs. 35.100 and 35.200 because of the low risk associated with

this type of use?- No, because of the low risk. Sec. 3 5 .2067(b) may need to have an additional reference which states that additional brachytherapy records may be required by 35.2406. Also, Section 35.2024. Records of authority and responsibility for radiation protection pro2rams. and Sec. 35.2026 Records ofradiationprotectionpro2ram safety chan2es, are far too prescriptive and burdensome for record-keeping. It is not applicable to a radiation safety program for a private practice with only one physician on staff who is the owner/president and the RSO. These types of facilities are becoming more numerous, so it does have an impact on our licensees. Sec. 35.2067 - Pertaining to leak-test records - This seems to be highly prescriptive as to what information is required on a leak-test record. Other leak-test rules in 10 CFR only require that a leak-test record be kept in units of microcuries and kept for inspection by the Commission. What is the performance based criteria for having all of the information Jisted in the proposed rule on the leak-test record for medical sources, when performance-based (rules) criteria for nonmedical sources do not require this information?

• Subpart M--Groupin2 of Reporting Requirements -It should make it easier for the licensee to reference and determine reporting requirements and therefore makes it easier for them to maintain compliance. The following nine items share the same comment:

(a) Sec. 35.2632(8) Records of teletherapy full calibrations requiring the siinature of the authorized medical physicist who performed the full calibration. (b) Sec. 35.2633(4) Records of remote afterloader full calibrations requirin2 the siimature of the authorized medical physicist who performed the full calibration. (c) Sec. 35 .2635(5) Records of 2amma stereotactic radio surgery unit full calibrations requiring the signature of the authorized medical physicist who performed the full

• calibration.

(d) Sec. 3 5 .2642(9) Records of periodic spot-checks for teletherapy units reguiring the siiJlature of the authorized medicalphysicist who reviewed the record of the spot-check. (e) Sec. 35.2643(5) Records of periodic s_pot-checks for remote afterloaders requiring the signature of the authorized medical physicist who reviewed the record of the spot-check. (t) Sec. 35.2645(5) Records of periodic s_pot-checks for iamma stereotactic radiosur2ery units requiring the signature of the authorized medical physicist who reviewed the record of the spot-check. (g) Sec. 3 5 .2647(5) Records of additional technical reqyirements for mobile remote afterloaders requiring the signature of the individual who performed the check. (h) Sec. 35.2652(4) Records of surveys of therapeutic treatment units requiring the signature of the individual who performed the test.

(i) Sec. 35.2655(0 Records of 5-year inspection for teletherapy and gamma stereotactic surgery units requiring the signature of the inspector. The record should only contain the name of the individual. This appears to be a prescriptive and not a performance based requirement. A signature does not necessarily mean the individual has actually read or reviewed the report. By allowing the use of just the name the file can be maintained electronically using current and future technology.

13. Section 35.3047--Should the Abnormal Occurrence Policy Statement criteria for reporting of exposures to an embryo/fetus or nursing child be modified? Is there a better term than

         responsible relative or guardian" that could be applied to those situations where the mother is not notified, e.g., in the referring physician's medical judgment telling the mother would be harmful; the mother is a minor; or the mother is not competent to make decisions regarding medical care? What is the impact of the proposed reporting requirement on licensee procedures. activities, or medical practices? Not telling the mother only because she is a minor is not a responsible rule. The other two parts of the rule would cover the notification: i.e. it would be harmful to the mother or the mother is not competent. The medical community and the laws of each state will determine if a mother is allowed information that may affect her child if she is a minor. The rule as written is inappropriate.

NRC COMMENTS SOLICITED BUT NOT IN THE SUMMARIZED SECTION: Section 35.80 would be retitled, "Provision of Mobile Service", and revised: and Section 35.647, Additional technical requirements for mobile remote afterloaders: NRC specifically requested comments on these issues relative to whether mobile medical licensees operate under reciprocity in other re~ulatory jurisdictions. We agree with the analysis and comments in the Statements of Consideration. The State of Georgia's "Rules and Regulations for Radioactive Materials" do not allow for medical licensees to operate under reciprocity .

• ADDITIONAL COMMENTS

1. Sec. 35.27 Supervision.- 35.27(c) of this rule can be omitted. Rule-making will not stop a misadministrationcaused by poor management; either by an abusive manager who will not tolerate any questions or by poor management of a "too-knowledgeable person" who will not ask questions.

2. Sec. 35.41 Procedures for administrations requiring a written directive.- 35.41(b) is really not necessary. It is too prescriptive. (3) and (4) of (b) can be combined with (a). If a licensee has to develop a plan that provides high confidence that (1) and (2) occur, then it follows that (b) may not be necessary. Aren't we now telling them how to write the plan?

Isn't that what we are trying to get away from?

3. Sec. 35.50 Training for Radiation Safety Officer- 35.50(b)(2) states, "Has obtained written certification. signed by a preceptor RSO.,." and 35.S0(c) states. "Is an authorized user.

authorized medical physicist. or authorized nuclear pharmacist identified on the licensee's license and has eXl)erience with the radiation safety aspects of similar types of use of byproduct material for which the individual has RSO responsibilities," Comments are:

( 1) 3 5.50(b)(2) Why not have the licensee's management sign a statementthat the person has meet the training criteria? Many times the old RSO leaves and will not sign a preceptor statement for a person. Also, if the RSO is a poor manager and management wants to replace him, but will still allow him privileges at the licensee's facility, the RSO is not about to sign off on someone else taking their place. Too many times egos get in the way of good people being allowed to do the job correctly. (2) 35.50(c) Why not a person certified by a board approved by the Commission who is either identified on the license or the licensee has notified the Commission as prescribed in Sec. 35 .14? This could possibly allow for certified/registeredtechnologists, who many times would be a better choice as an RSO than an authorized user. Registered technologists would certainly meet the second part of paragraph (c).

4. Sec. 35.65 Authorization for calibration and reference sources.- 35.65(c) Any byproduct material with a half-life longer than 120 days in individual amounts not to exceed 7.4 MBg_

( 200 <Greek-l>Ci)each and not to exceed 1000 times the qyantities in 3J.1pendix B of Part 30 of this chapter whichever is more limiting. - We believe the "and" should be "or" .

• 5.

6. Sec. 35.69 Labeling and shielding of vials and syringes.- 35.69(b) is covered under Section 19 .12, "Instruction to Workers". It is also covered by another federal agency under the "Workers Rightto Know Act". As worded, the rule is not needed under this section. It does not need to be repeated a third time. Sec. 35.630 Dosimetr.yeg_uipment. - 35.630(a)(l)should use the abbreviation "NIST" after National Institute of Standards and Technology as was done with Association of Physicists in Medicine (AAPM). The abbreviation "NIST should be used in 35.630(a)(2) in place of National Institute of Standards and Technology to maintain continuity of writing style.

7. Sec. 35.652 Radiation surveys. - 35.652(a) states in part. " ... a licensee shall make such surveys as defined in the Sealed Source and Device Registry to assure that the maximum radiation levels and average radiation levels from the surface of the main source safe with

• the source(s) in the shielded position does not exceed the levels stated in the Registry.

Maximum radiation levels and average radiation levels could be made a generic number as with radiography cameras and source changers. Radiographers do not have to comply with readings on the SSD registration sheet. They have to survey to ensure the source is in the proper place and that a generic exposure rate is not exceeded. The radiation level numbers for each device are tedious to look up. There is no need for such specificity for each type of afterloader. It may make sense to put in the average acceptable reading for each type of afterloader (i.e. high does rate, low dose rate, and pulsed), than for each brand and model number. Generic readings would also be more in keeping with Part 20 and less prescriptive than the proposed rule while at the same time alerting the licensee to a potential problem if a certain radiation level is exceeded.

8. Sec. 35.900 Radiation Safety Officer.--35.900 (6) American Board of Medical Physics in radiation oncology physics; and (7) Royal College of Physicians and Surgeons of Canada in nuclear medicine; - Need to capitalize "radiation oncology physics" and "nuclear medicine" for consistency with existing Part 35 and for internal consistency.

9. Sec. 35.900 Radiation Safety Officer.--Sec. 35.910 Trainini for uptake, dilution, and excretion studies; and Sec.3 5 .920 Trainini for imaging and localization studies. - All three of these need to include the American Board of Cardiology for cardiology studies and for RSO of same.

10. The Revision ofNRC's Regulatory Proiram discusses, "( 1)Reiulatoryoversight alternatives for diagnostic procedures that are consistent with the lower overall risk of these procedures; .** and (2) Redesigning Part 35 so that regulatory reqyirements for new treatment modalities can be incorporated in a timely manner." - Significant changes have been made in Nuclear Cardiology in the past 15 years. Changes are currently on-going (e.g., beta restinosis). Based on the low-risk associated Sec. 35.100 and Sec. 35.200 there does not seem to be a performance based reason not to include the new Board for cardiologists.

11. Section 3 5 .2070, Records of surveys for ambient radiation eXPosure rate, would require the licensee to maintain recm:dfil>f rfilliati@..fill.rYeysJorl.y~s One chanie has been ma-fmm the current record-keepini requirements for radiation surv eys. The name of the individual performini the survey rather than the initials of the individual would be required to be recorded.- Why the change to a name instead of initials? I have always been able to identify

• the individual by their initials during inspections. This does not seem to be a performance based requirement.

Thank you for the opportunity to comment on and to participate in development of the revisions to 10 CFR Part 35. Sincerely, Lauren McGaughey Senior Radiological Health Specialist Radioactive Materials Program

DOCKETED US HR C BY HAND .98 NOV 13 A10 :SQ October 30, 1998 The Honorable Shirley Jackson Chairman U.S. Nuclear Regulatory Commission Washington, DC 20555 Re: Urgent Request for Extension of Comment Period; 63 Fed. Reg. 43516 (Aug. 13, 1998); RIN 3150-AF74

Dear Chairman Jackson:

The undersigned organizations are writing to request that the Commission extend the comment period for the ongoing revision of 10 C.F.R. Part 35 to allow for the development of the risk analysis and the rule accordingly. As you may have been informed by staff, it was the unanimous view of participants in the Medical Use Rulemaking Workshop held on October 21-22, 1998 that there was simply insufficient time to offer meaningful comments on the proposal by the expiration of the comment period on November 12, 1998. Concern was also raised that the current activity surrounding risk analysis (the uncompleted report from the Nuclear Byproduct Material Risk Review Group) is not adequate. We recognize and appreciate that this program has involved a substantial effort by the Commission and the staff, as evidenced by the presence of Commissioner McGaffigan and Deputy Executive Director Hugh L. Thompson, Jr at substantial portions of the workshop. Because the regulations the Commission adopts are to be based on risk-informed, performance-based criteria, per your March 20, 1997 and June 30, 1997 SRMs, we believe that the entire rulemaking extension must take into account the need to conduct an appropriate risk analysis. The target implementation date of any final rule should also be adjusted by a similar period of time. Because we recognize that the Commission will want to consider this issue carefully, we believe that an immediate extension should be granted. Last week's workshop made it abundantly clear that the medical community does not believe .the proposed rule adequately reflects the stakeholders concept of risk informed rulemaking nor the Commission's directive to develop risk-informed requirements. In fact, there was a strong belief that many elements of the proposed rule bear no meaningful relationship to the risk of the materials involved. We are prepared to present to the Commission a proposal that describes in detail the type of the risk analysis we believe must be performed along with an estimate of the time involved. Representatives of the medical community will be contacting your office to set up meetings to discuss this further.

                                                                               >-      t."\

u w

n

i l'.:l ~

a 0 t-8 [,rl ('I_:'. ~

                                                           *,Jo~ l,PPV I                             '"l~O:)

N'ff""'_.- ""W'7J '-4.I (7-1'I .:J /.._ t;;(q':)

             .., -                        i * --H... _tl_.h,.,**'*  'tll,

, The Honorable Shirley Jackson October 30, 1998 Page 2 We recognize that the Commission's decision to rewrite Part 35 was, in part, responsive to the medical community's discontent with the existing regulations. Despite that discontent, there appears to be a consensus that operating under the existing rules on a temporary basis, in order to develop an appropriate repla~ement, is preferable to an incomplete and unsupported proposed regulation.

• The undersigned organizations hope that you will promptly grant our request for an extension of the comment period. This will allow consideration of our proposal that describes in detail the type of the risk analysis we believe must be performed. If you have any questions or require further information, please contact Mr. David Nichols, Director of Government Relations for ACNP/SNM at (703) 708-9773 .

Sincerely, Amer~can College of Nuclear Physicians Society of Nuclear Medicine American College of Radiology Council on Radionuclides and Radiophannaceuticals Nuclear Energy Institute National Electrical Manufacturers Association American College of Nuclear Medicine American Association of Physicists in Medicine cc: The Honorable Edward McGaffigan, Jr., Commissioner The Honorable Nils J. Diaz, Commissioner The Honorable Jeffrey Merrifield, Commissioner The Honorable Greta Joy Dicus, Commissioner Hugh L. Thompson, Jr., Deputy Executive Director Carl J. Paperiello, Ph.D., Director - NMSS

UNITED STATES NUCLEAR REGULATORY COMMISSION WASH I NGTON , D.C. 20555--0001 MEMORANDUM TO: Emile Julian FROM: Theresa Lee Kendall ~

SUBJECT:

MATERIAL TO BE DOCKETED DATE: November 24, 1998 I am forwarding the attached correspondence, which I received today, for docketing in response to the August 8, 1997, FAN (62 FR 42219) on the request for public Input on the revision of Part 35, Medical Uses of Byproduct Material. If there are any questions, please call Diane Flack on 415-5681 or Cathy Haney on 415-6825.

MEMORANDUM TO: Emile Julian FROM: Theresa Lee Kendall ~ L (~

SUBJECT:

MATERIAL TO BE DOCKETED DATE: November 23, 1998 I am forwarding the attached correspondence, which I received today, for docketing in response to the August 8, 1997, FRN (62 FR 42219) on the request for public input on the revision of Part 35, Medical Uses of Byproduct Material. If there are any questions, please call Diane Flack on 415-5681 or Cathy Haney on 415-6825.

OFFICIAL TRANSCRIPT OF PROCEEDINGS UNITED STATES OF AMERICA ~ NUCLEAR REGULATORY COMMISSION

Title:

PUBLIC MEETING: PROPOSED REVISION OF PART 35 AND THE NRC'S MEDICAL POLICY STATEMENT

                                                      ~o, Ja J-35" Docket No.:                                        ( b3FR'/3 5 t ')

Work Order No.: ASB-300-410 LOCATION: San Francisco, CA DATE: Wednesday, August 19, 1998 PAGES: 1 - 238 ANN RILEY & ASSOCIATES, LTD. 1250 I Street, NW, Suite 300 Washington, D.C. 20005 (202) 842-0034

1 1 UNITED STATES OF AMERICA 2 NUCLEAR REGULATORY COMMISSION 3 4 *** 5 PUBLIC MEETING: 6 PROPOSED REVISION ON PART 35 AND THE 7 NRC'S MEDICAL POLICY STATEMENT 8 9 Ana Hotel 10 50 Third Street 11 San Francisco, California 12 13 Wednesday, August 19, 1998 14 15 The public meeting commenced, pursuant to notice, 16 at 9: 04 a.m. 17 18 PARTICIPANTS: 19 FRANCIS CAMERON, Facilitator 20 ROBERT J. LULL, M.D. 21 RICHARD HEUSER, M.D. FACC 22 MARY PAT MANNING 23 Cl!ARLIE SHOWALTER 24 MELISSA C. MARTIN 25 DAVID NEBLETT ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

2 1 PARTICIPANTS: [Continued] 2 KATHY s. THOMAS, MHA, CNMT 3 w. A. EHMIG 4 SUSAN MCLAUGHLIN 5 DAVID BELK 6 DALE AUSTIN 7 NIKKI HOBSON 8 EDGAR D. BAILEY 9 TERRY FRAZEE 10 DR. DONALD A. COOL 11 CATHY HANEY 12 DIANE FLACK 13 ROY BROWN 14 DAVIS LARSON, M.D. 15 JAY W. MILLSON 16 17 18 19 20 21 22 23 24 25 ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

3 1 P R O C E E D I N G S 2 [9:04 a.m.] 3 MR. CAMERON: Let's get started here. If 4 everybody can take their seats? 5 And we probably will have some people that are 6 joining us as we go along and we'll introduce them when the 7 time comes. 8 What I'd like to do now is before I go over some 9 of the ground rules for the meeting is to have Don Cool talk 10 about -- Donald Cool from the NRC welcome us to this 11 meeting. 12 And on your agenda you can see that Don was going 13 to be talking about the objectives and philosophy of the 14 rule. 15 Well, we're going to switch things a little bit 16 and I will go over the ground rules after Don gives a short 17 welcome and we'll turn to him for the objectives and 18 philosophy of the rule. And the, most importantly, turn to 19 all of you to introduce yourselves. 20 Don, do you want to welcome everybody? 21 DR. COOL: This is one of those great times when 22 your facilitator sets you up. 23 Thank you, Chip. I appreciate this. 24 MR. CAMERON: All +ight. 25 DR. COOL: I do want to welcome each of you here ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 200~6 (202) 842-0034

4 1 to the first of the series of meetings that we're planning 2 to hold related to Medical. Regulations Part 35. Now that we 3 actually have a proposed rule on the street, this is 4 actually something like meeting four or so, of you go back 5 and count the series that we did about this time last year 6 as we were trying to .get your initial ideas. 7 I hope that in your looking at the rule you'll see 8 that we -- we're listening to at least a few of the things 9 that were talked about. And I'm looking forward to today to 10 continuing that discussion, picking up and seeing how we can 11 now take what the Commission has taken or what they have 12 agreed is a good proposal to go out on the street and start 13 through trying that process what the weakness is, what the 14 strengths, and see how we can best now move towards a final 15 rule making. 16 So that I don't then just completely preclude 17 everything that was Chip was going to do, I'll turn it back 18 to him so that he can tell us how we are all going to 19 behave, act and organize ourselves during the next couple of 20 days. And then we'll actually get on about the business of 21 working on this. 22 MR. CAMERON: Okay. Thanks, John. 23 As most of you know, my name is Chip Cameron. I 24 am the special counsel for public liaison at the Nuclear 25 Regulatory Commission and it's my pleasure to serve as your ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

5 1 facilitator over the next couple of days. 2 And I would just like to add my welcome and thank 3 you to all of you for taking the time to participate in the 4 workshop. 5 And as you can see from the participant list we 6 have tried to get representatives from all of the broad 7 spectrum of interest that might be effected by this rule

  .8 making or knowledgeable about some of these issues. And we 9 have a lot of expertise around the table and I think we can 10  look forward to a good discussion.

11 Now, the focus of the discussions will be among 12 you around the table. But we also do have people in the 13 audience and we will be going to the audience after each 14 major issue area to see if there's any comments out there. 15 For those of you in the audience I would just ask 16 you, for purposes of our transcription, our Court Reporter, 17 Nancy, is taking a transcript for us. That you'd just state 18 your name and affiliation, if appropriate, when you make 19 your comment or ask your question. 20 Those of you around the table will not have that 21 burden because Nancy is keeping track of who is speaking. 22 And for those of you up here, if you do want to 23* speak if I can just ask you to raise your name antenna like 24 this and that will relieve you of the pressure of having to 25 continually raise your hand or keep your hand up. And it ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

6 1 will also help us to get a cleaner, so to speak, transcript 2 of the -- of the session. 3 One of the things that I'm going to try to help 4 you with ts to keep the discussion focussed and relevant. I 5 will try to take the name antennas as they come up in order. 6 We may need to keep on a particular topic and may need to 7 defer a.particular corrnnent or question until later on in the 8 meeting because it doesn't fit the discussion. 9 For those issues that we raise that we'll come 10 back to later, I'm going to write them down up here in what 11 I like to call a paddock, because my interest in horses. 12 But it's also known as a parking lot. We'll put that as 13 those issues to make sure that they get there. 14 I would also just ask you to just speak one at a 15 time so that we can listen to what other people have to say. 16 And I think we're going to have time for all of 17 the discussion that we need to have. There may be times 18 when we need to move on to another area and I'll just ask 19 you to -- to perhaps quickly summarize or to defer a conunent 20 until: until later on in the day. 21 Now, as Don-had mentioned we did have two 22 workshops last year on the development of the proposed rule. 23 And the purpose of those workshops was to -- to get again 24 the broad spectrum of interests who were effected by the 25 rule here, to talk about how the rules in Part 35 should be ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

7 1 changed. And just as important is why they should be 2 changed or why they should be kept the same. 3 Now, the*staff considered those comments in 4 preparing the draft proposed rule. And I think *that you can 5 see, reading through the what's called the Supplementary 6 Information to the proposed rule. The explanation in the 7 beginning the Staff laid out what we heard at the 8 facilitated workshops, what the Advisory Committee on 9 Medical Use of Isotopes stated and what the written public 10 comments were on various issues of concern. 11 I think one thing that may be instructive as we 12 have our discussions is perhaps the Staff can illuminate 13 what what the Staff proposal was in certain circumstances 14 and how the Commission might change that Staff proposal when 15 it went through a Commission review. 16 Now, many of you may -- may not feel that the 17 correct position was adopted on a particular provision. 18 Then again, you may agree with that. 19 You may think that the Staff or the Commission did 20 not go far enough in a particular area in terms of revising 21 it or that we didn't establish a sufficient rationale for 22 what we did. Or in some cases perhaps we didn't 23 sufficiently explain what the intent of the rule -- that 24 particular provision of the rule is. Or how it's supposed 25 to operate. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 101-4

                   . Washington, D.C. 20036 (202) 842-0034

8 1 Well, now we have the opportunity to actually 2 focus _on a proposal from the Connnission and the Staff would 3 like to hear your views on the provisions in the proposed 4 rule should they be adopted, should they be modif.ied, why or 5 why not, what's the objective of the particular provision in 6 the rule, and is there another way to achieve that 7 objective. And this is where we can try to get creative in 8 terms of corning up with alternatives, perhaps, that may be 9 less onerous on the medical profession but still may be an 10 objective of the Connnission in a particular provision. 11 And in some cases you may not think that there is 12 enough data to support a particular provision. And we'd 13 like to hear that and perhaps how we could get more data. 14 So, I'd like to challenge all of you, including 15., the NRC Staff, to -- to try to think creatively on this. 16 And the agenda today focusses on what I like to 17 call the underpinnings of the proposed rule. We're going to 18 take a look at what the risk basis is. I'm sure that all of 19 you has heard that the rule is supposed to be what's called 20 "risk informed." And I know that there's differing opinions 21 on whether *it is really risk informed. 22 Well, we're going to take a look at the risk basis 23 for the rules and Don Cool will be leading off that 24 discussion. 25 And I think we're going to turn to Dr. Lull to ANN RILEY & ASSOCIA~ES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

9 1 give us a short presentation on another look at a risk from 2 the society -- or from the perspective of -the society of 3 nuclear medicine. 4 The second matter is for certain areas of the rule 5 are there standard in the medical profession that mignt 6 accomplish the same thing that *we're trying to accomplish 7 with the rule. And therefore we could defer in some case. 8 And I think you'll see a lot of discussion of that also in 9 the supplementary information to the rule. 10 And this section of the discussion is not just are 11 there professional standard out there that could be used 12 instead of an NRC regulatory approach but also are there 13 economic incentives that might serve the same purpose. 14 So, we're fortunate to have Dale Austin with us, 15 who's over to my left here, from the Federation of State 16 Medical Boards, who is going to give us a presentation on 17 -how medical boards operate. And we want to put that into 18 the discussion. We'll use that to kick off the discussion 19 of that second rationale on justification issue. 20 We will, at future workshops, have representatives 21 from the Health Care Financing Administration and also from .22 the Joint Conunission on the Accreditation of Health Care 23 Organizations with us to give that view point. 24 I don't think -- has Jim Miller, from the FDA, 25 made it? ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

10 1 Okay. Well, he may be at future workshops also. 2 Now, the third rationale and justification issue 3 is compliance issues. And this takes a look at -- at the 4 cost of compliance to date takes a look at the 5 enforcement issues. And that finishes us up for today. 6 The important thing about all of these rationale -- the three rationale issues is to try to 8 connect it, give some examples from the proposed rule where 9 you think that there's implications about, fqr example, you 10 haven't shown the risk basis for this particular provision. 11 I try to connect it up to the rule. 12 The second day, we*re going to come back and we're 13 going to go through the major provisions of the rule and get 14 your comments on those. So, today will sort of be a warm up 15 for a specific discussion tomorrow. 16 And I would just ask you to remember that you're 17 not just hereto talk to the NRC staff and also to talk to 18 each other. And I would just ask you to relax and speak 19 your mind and enjoy the discussion. 20 As I mentioned, we're keeping a transcript. But 21 also, we are going to do summary minutes from each of these 22 workshops that we will not only get out to participants in 23 the workshop but, perhaps more importantly, we'-re going to 24 send those minutes to the Commission so that they can sort 25 of keep current on what the comments what the ANN RILEY & ASSOCIATES, LID. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

11 1 perspectives are on the proposed rule as we move through the 2 workshop process. 3 And I guess I'd just like to finally recognize the 4 fact that -- that you may not have gotten very much time 5 with the final version of the proposed rule and we apologize 6 for that. There was some delay in Commission approval of 7 the rule some time past what the schedule was so that we 8 could do this particular workshop. 9 Luckily, I think that by focussing on some of the 10 underpinning issues today perhaps you might not have needed 11 as much time. But we do realize that you're all very, very 12 busy people and that you might have had to do a crash course 13 on these materials. And for that we apologize. 14 I guess that what I'd like to do now is to ask Don 15 to talk about objectives and philosophy and then go to all 16 of you for introduction. 17 And I know there's going to be some questions for 16 Don on his presentation and perhaps we can work that into 19 the introduction. 20 But before we go to Don are there any questions 21 from anybody on the agenda or the format, ground rules or 22 the discussion over the next couple of days? Does anybody 23 want to test their name antenna to see if it really stands? 24 Okay. Well, good. Well, let's go to Don. 25 DR. COOL: Okay. Thank you, Chip. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

12 1 If I can have Penny or Sam or Joe or Lloyd, some 2 one of my folks who are back there go flip on the projector. 3 Although I think most of you also have a paper copy of the 4 slides. 5 It's early in the morning. We can probably get 6 away with having the lights dimmed a little bit. Hopefully, 7 most of you had your requisite one or more cups of coffee 8 and we are awake. This would be a much more dangerous, 9 risky process if we were to do it right after lunch, for 10 example. 11 What I wanted to do is to spend a couple of 12 minutes this morning to go through and resent the base line 13 for everyone who was here. Some of you I know, and we have 14 been part of some of the previous discussions. Some of* you 15 are relatively new to the process. 16 I'm being told that somehow I'm supposed to go 17 back a slide. I don't think I'm going to actually do that. 18 The first sheet that you have on your handouts was 19 the previous list of information from the earlier Commission 20 direction to us. 21 For those of you who are not familiar with how the 22 Commission goes about giving the Staff guidance, the nominal 23 process is that we send to the Commission an information or 24 a requested proposal. They consider it. They sometimes ask 25 us a great deal of questions ourselves. And then eventua1ly ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

13 1 they provide us a series of directions in what are called 2 Staff Requirements Memorandum, that which we are supposed to 3 go over and we are required to do. 4 The Commission back now over a year ago had sent 5 this off on a process to try and revise 10 CFR Part 35, as 6 well as consider possible changes to the Medical Policy 7 Statement and take a re-examination of the whole approach. 8 Those of you who have been in this for any length 9 of time know that that was a step in what was actually a 10 much longer process in terms of looking at various issues, 11 some external audits, the National Academy of Science's 12 review of the whole medical topic program area, the 13 Commission's consideration as part of its overall efforts in 14 strategic assessment, and then getting to a series of 15 specifics that they wanted to find -- have us examine. 16 We took that direction. I don't think there's any 17 real reason to go back and go through all the things they 18 asked us to do a year ago. And started down a process last 19 year which looked at each of those items, tried to look at 20 some of what we referred to at that time as some 21 cross-cutting issues, things that cut across the various 22 modalities and the chronologies for dealing with different 23 aspects ano uses of nuclear medicine. 24 Taking a look*at what kind of philosophy should be 25 used. And this is, I think, the first thing that's kind of ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

14 1 important. There is a little phrase that gets tossed around 2 the Commission a great deal: a risk-informed performance 3 based regulatory approach. And to deal with that, I think 4 it's probably easiest to break that into a couple of 5 components. 6 First is that first half of the phrase, "risk-7 informed." And we're going to spend some time this morning 8 talking about risk because risk-informed does not 9 necessarily mean that you have an exact correlation of a 10 different level of risk. That you're in an engineering mode 11 and you had done your wonderful lily bent trees (phonetic) 12 and your fault trees and could quantify all of this then you 13 could express that in a nice, probabilistic, tentative minus 14 (phonetic), whatever per event kind of situation and 15 everyone would have some agreement as to what you -- what 16 you meant by that. 17 Risk-informed, here in this context, means a great 18 deal more than that because there's a lot of factors that 19 don't fit neatly into that kind of mathematical engineering 20 analysis sort of situation, equation. So, what the Staff 21 tried to do was to try and step back and take a look at what 22 does -- what are the various risks or the various signatures 23 to those risks in the things that we do. At least, in some 24 extent, what is the context in which that's occurring. 25 And then to use that as guideposts in terms of ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

15 1 constructing the regulatory requirements that would be in 2 the proposed rule. In general, that would mean that for 3 things that were less risky, put that in quotes if you'd 4 like. That there ought to be correspondingly fewer or 5 simpler kinds of requirements that would be in place for 6 those uses. And as you went to more complexity, higher 7 activities, greater risk, whatever kind of scaling factor 8 that you might be using there, that you'd then have 9 correspondingly a greater level of detail and more 10 specificity, more requirements, additional sorts of things 11 to be looked at or specified. So, in general, the sort of 12 structure of the risk and for what kind of approach. 13 The second half of that -- they're actually quite 14 separable in a lot of cases -- is a performance based kind 15 of approach to the regulation. 16 In general, you can write requirements for people 17 in at least a couple of ways. Again, those who are 18 engineers or otherwise have who have been involved or where 19 you have a system that's really well defined and you have a 20 lot of experience with it, you can write a relatively 21 prescriptive set of things because you know you're covering 22 all the aspects of that particular activity. If you do A, 23 B, C, D everyone will be very, very happy. 24 And a lot of the requirements that are in the 25 current regulations in both in the medical arena and other ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

16 1 uses of radioactive material tend to be written in those 2 ways for a whole variety of reasons. 3 What the Corrnnission has challenged us to do not 4 just in this arena, but challenged the NRC Staff more or 5 less across the board in all of the areas, in the reactors 6 to everything else -- is to determine whether or not there 7 are ways to move to a more performance oriented approach, 8 wherein you establish the base line of what you want to be 9 accomplished, what in general needs to happen in tenns of 10 perfonnance. 11 And we -- at least some of, or in many cases, all 12 of the individual specificity of how you accomplish that 13 particular piece of performance to the licensee and the 14 conduct of their particular activities. 15 What you have in the proposed rule is a mixture of 16 those two. And, in fact, the Connnission, if you went back 17 to the Staff Requirements Memorandum from over a year ago, 18 explicitly told us that we expect that you will probably 19 come back to use with a mission. There are going to be some 20 things which will be perfonnance oriented, because we want 21 you to look at that. And there will be some things which 22 will be more prescriptive, because they are either more 23 closely related to risk or if they are such key attributes 24 that they need to be specified in any case. 25 But one of the things that I would like for us to ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

17 1 be able to explore throughout this, and particular as w~ go 2 through all of the details, is to what extent have we moved 3 in the direction of the performance organization. And we 4 moved too far? Because certainly there are some who think 5 that we have done that. Have we not moved far enough? And 6 I think there are a few people who are in that camp who feel 7 we haven't gone far enough in that. That may mean, if I'm 8 getting shot from both sides, I having done too bad a job 9 putting together the proposal. 10 But to what extent can you do that? One of the 11 dangers, if you're sitting in the Commission's chair or the 12 Staff chair, of a performance based rule, is there are a lot 13 future things that you can grab onto with any certainty as 14 you do a licensing review or as you do an inspection review. 15 So, you'll see that this rule has a number_ of 16 places where it states that kinds of activities have to be 17 specified. And in a number of cases, what those 18 specifications or the procedures that have to be done need 19 to include. 20 You'll see that we have stopped short in this 21 proposal of what we used to do which is, "Send it all to 22 me." In the context that we're all big boys and girls, 23 we've had a lot of practice in this now, there's a lot of 24 methodology that's been built up over the course of time, 25 and it's really not necessary, maybe not even appropriate ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

18 1 for all of that a priori review to be going on. 2 The downside, of course, is that if something goes 3 wrong it's a lot more difficult to find, okay, where exactly 4 in this nice little bead chain of events did the particular 5 break happen? Because that's what everyone tends to do. 6 And I include our friends down on Capital Hill because that 7 tends to happen. The second something goes wrong we get 8 hauled down in front of Congress and otherwise get to 9 explain why it is that we could ever possibly allow X to 10 happen. That resulted in the course of time in the present 11 rule which I think most of you probably are aware, has been 12 driven by a series of events. And we go in and try to fix 13 whatever particular bead everyone perceived was broken on 14 that approach. 15 The proposed rule that you have in front of you 16 breaks a lot of that mold. And we need to consider whether 17 or not we have, in fact, gone far enough or too far in some 18 of those arenas in terms of doing that. 19 You have a huge notebook of material. We tried to 20 generate enough information so that somewhere within that 21 finding it might be a tad more difficult -- there is is at 22 least some explanation for how we got there. 23 And in particular one of the things that was 24 included -- and I think there's one on all of the chairs 25 is the guidance document that would go along with the ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

19 1 licensing aspects of this. 2 This, again, was an effort -- I won't quite say 3 the first time -- but really one of the first times where we 4 had tried to develop, in parallel with developing the rule 5 of -- the guidance that would be used in terms of applying 6 for and reviewing a particular license application. 7 You will probably find, if you go through it with _8 a fine tooth comb, that we have some places where there's 9 some slight discrepancies. That always happens whenever 10 you're trying to do things in parallel. I want to publicly 11 extend my compliments to the team that did this because it 12 is a tremendous effort to go through and lay this out. 13 That guidance document was also laid out in the 14 context of minimizing the things that would be reviewed. 15 So, it doesn't say, "Submit all of these procedures." 16 Instead, it takes an approach of, "Here are the minimum 17 things that need to be part of this. And you can do it 18 either by -- if you are a relatively small licensee or just 19 want to take a standard approach there are a whole series of 20 things that you can adopt, the standard format of the NRC or 21 submit these kinds of impressions, deal with these 22 particular topics." 23 So, I would encourage you to look at the NUREG 24 1556 Volume 9 document that is the consolidated guidance 25 draft. In parallel of this, write down side by side, see ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

20 1 whether it works or not because what we have found is that 2 when you go to actually write down what we want submitted 3 and how we are going to look at it, we discovered things 4 that, "Oh, gee, if I had just written the rule a little bit 5 differently then I either wouldn't have had to ask for this 6 or everyone would know -- would have known that I would have 7 wanted it but no one knows because it's not written in the 8 rule. 11 9 And in fact, there are a number of cases where the 10 rule has lists of -- I call them minimum cut stats, minimum 11 sorts of things, because as we've tried to write the 12 guidance document we concluded that there were three or four 13 key things that really needed to be addressed somewhere in 14 the procedure, even if it wasn't being submitted to us or 15 somewhere in that particular activity. And that's how that 16 would have ended up in the rule. 17 So, I would challenge you to look at that side by 18 side in the same relationship. A little but later today 19 we're going to talk about the enforcement of inspection 20 because that's the third piece of this equation. 21 We did not have the opportunity with the schedule 22 which we were on to try and write a new inspection procedure 23 that would go along with this. That's one of the things 24 that we would attempting to do as we now move with this 25 particular process and move towards a final rule. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

21 1 But again, what are we going to look at when one 2 of my inspectors walks outside or one of the state people 3 walks in to the corresponding location in their state? What 4 sorts of things will we look at? At what point, in what way 5 will we be asking for documentation? 6 Because it isn't very helpful to you if, indeed, 7 and all we had managed to do was to change the review from 8 the license reviewer sitting in the office to the individual 9 who walks onto your site and then proceeds to do all of 10 that -- write you up a long -- list of all the things that 11 that particular individual wasn't terribly happy with in the 12 context of that particular review. 13 So, that's a third piece of the equation that we 14 need to look at. 15 You will find that there are some things missing. 16 Put that in quotes. No longer present in this proposed 17 addition of Part 35. 18 We've operated under the philosophy that if it was 19 covered someplace else, any particular Part 20 -- it didn't 20 need to be repeated. There are a few places where we have 21 referenced back to Part 20, so that everyone clearly remembers that it is sitting over there, but tried not to do 23 a lot of repetition. That maybe was to pool a number of 24 things back out of the rule. That doesn't mean that the 25 whole concept of surveys have otherwise just vanished, but ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

22 1 rather that they were we felt that they were adequately 2 addressed by the Part 20 requirement, which is a more 3 performance oriented radiation protection standard than 4 trying to reduplicate it, add to, amend to and immeasurably 5 confuse ourselves with a second accounting in Part 35. 6 So, there was -- that's some of the underlying 7 ph~losophy that goes along with that. And maybe before we 8 thought it was going to work and it doesn't. 9 Okay. We took a process a number of you 10 participated in which included a working group, steering 11 group. Most of the members of the working group who did the 12 yeoman's job of drafting this 16, 18 hour days, weekends, 13 nights, at home, dealing with computers that crashed, 14 dealing with version controls and all the other things to 15 put together the document. 16 As Chip had mentioned, we had some facilitative 17 meetings during the development of the process. We met with 18 our advisory corrnnittee on the uses of isotopes -- the full 19 committee and a number of subgroups, special groups looking 20 at particular issues. Finally went on to the Commission. 21 We got to see a strawman, put that in quotes if you want to, 22 back in January time frame. 23 We went to the Commission at the end of May this 24 year, briefed them on June 17th. At that point the Staff's 25 proposal, called a SECY paper which is, I believe, included ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

23 1 in your notebook, was released s0- that everyone had a chance 2 to start looking at it. 3 We also now have the Staff requirements memorandum 4 which the Commission gave us a couple of weeks ago, in late 5 July, with their agreement, asking for us to do certain 6 things. 7 You'll see that the Commission took some positions 8 and things got left in. Some things got taken out from the 9 Staff proposal on the basis of the Commission's directions. 10 So, you will find some differences between that which the 11 Staff proposed to the Commission, beginning in June, and 12 that which is now in the Federal Register. And as we go 13 through this you'll be able to see some of those. Some of 14 those are very much in keeping with some of the comments 15 that we've gotten here. 16 The Commission, in essence, having seen what we 17 what they've asked us to bring them said, "Yeah, you're 18 right, that doesn't make a lot of sense." 19 And there were some other things which the 20 Commission concluded it wanted to stay with an approach 21 closer to that which it had in the existing rule, means less 22 participation of the vacation issue. Having looked at all 23 the options and then informed by the discussions we had 24 here. So, we've gone through that particular process. 25 We have three meetings coming up over the next ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

24 1 couple of months. Here in San Francisco. We will be in 2 Kansas City in another two weeks. There will be some 3 discussions in Washington D.C., a little bit later at that 4 beginning of October. There will also be discussions at the 5 All Agreements State Meeting in New Hampshire at the end of 6 October. 7 The comment periods, and there are actually three 8 if you add up all the documents. There's the comment period 9 on the proposed rule itself, which I believe closes on 10 November 12th. 11 Catherine Haney will keep me correct if I mess 12

• this up.

13 The comment period on the proposed medical policy 14 statement, which was also published in the same edition of 15 the Federal Register, which closes on the 13th. Don't ask 16 why there's a difference in those dates. You get different 17 people who do the math a different way on the day it's 18 published. So, you've got one extra day on the medical 19 policy statement. 20 And you have the comment period on the NUREG 1556 21 draft guidance document which we are going to close the same 22 time as we closed rule on the 12th. 23 Now, the reality is if it gets here on the 13th, 24 yes, we will probably still have an opportunity to think 25 about it. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

25 1 But the other reality is that we are still very 2 much on a tight schedule. In order to be able to deliver 3 the package back to the Corrnnission'in May of 1999, not that 4 many months from now. 5 So, with the corrnnent period that we have the 6 Corrnnission will listen to a number of things. The ACMUI 7 medicine, a number of others, looking to see if they can 8 extend the corrnnent period. In fact, that was extended in 9 the Staff's proposal for the legal base line of 75 days to a 10 90 day period. So, it does go into early November. 11 We will not be able to go a lot farther than that, 12 so that we can go back and interact with the ACMUI and be 13 able to interact with the Corrnnission in the spring of next 14 year. 15 So, that's where we are in the process and that's 16 a little bit about the underlying philosophy and approach 17 that we've taken in trying to derive this. Is it a perfect 18 book? No. Obviously not. We can always work on refining 19 things. 20 There ~re obviously -- there are some places where 21 we had to put down a proposal. And you can tell that 22 because if you had a chance to read through that volume of 23 supplementary information you'll discover that there are 24 questions sprinkled all through there. In fact, we tried to 25 synopses them at one place and it ends up being a very long ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

26 1 list of specific areas where we really are specifically for, 2 very seriously, additional input and refinement because 3 those particulars we know need to be refined. 4 Does that mean that we're not willing to consider 5 connnent in any of the other areas? No. Obviously not. 6 It's all open for consideration. But that gives you some 7 idea of some of the areas where we're particularly looking 8 for additional input, additional kinds of information, 9 additional ideas and approaches. 10 The other thing I would like to suggest to you as 11 you go through your connnent book during these meetings and 12 after you leave when you think about these discussions and 13 prepare some connnents that you can send to me is that 14 connnents on the positive aspects, the things that you 15 particularly want to say, because that's the way you would 16 like to see them, are as important as connnents on the things 17 that you would like to change. 18 Just as we now go through the process of looking 19 at all the connnent and trying to adjust towards a final rule 20 on the basis of that connnent it's going to be very critical 21 for me to know those things which you find really important. 22 that we did write the first time. 23 So, as not to undue that which was the good of the 24 proposal as a result of negative comments one way or another 25 as we move towards the final. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

27 1 So, I would ask for both that whi~h works and why, 2 as well as that which needs to be adjusted a little bit and 3 brought so that we can develop that proposal. 4 With that outline and sort of an overview of the 5 approach I'll turn it back to Chip and be ask to answer any 6 questions. We can engage in a general discussion of some of 7- your issues and start to explore some of the details. Chip? 8 MR. CAMERON: Okay. Thanks for that overview, 9 John. If we could have the lights back up. What I'd like 10 to do now is to -- to have you around the table introduce 11 yourselves so that we can start to get to know one another. 12 And I think since I wanted to also introduce the 13 NRC Staff that are all sitting in the bleachers out there in 14 the back corner. And we have so few in the audience maybe 15 it would be useful to see who's with us there. 16 Now, I think we can go to John for some questions 17 about general philosophy. Remember that Cathy Haney, after 18 the break, is going to lead us through sort of an overview 19 about the proposed rule. So, let's start with Cathy and go 20 around counter clock wise. 21 Introduce yourself. If you have an affiliation 22 tell us about that. Tell us perhaps what your general or 23 specific areas of concern with the proposed rule are. 24 I'll note for Cathy and Diane that their concern 25 is that they're being worked to an inch of their life with ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

28 1 this thing. And I'll mention that for you. 2 MS. HANEY: My name is Cathy Haney. I am a 3 section leader in the division of industrial medical nuclear 4 safety. I'm also chair of the Part 35 working group. And 5 the NRC Staff in the back is working with the working group. 6 We also had a subcommittee under the working group that 7 developed the guidance document. 8 MS. FLACK: Diane Flack. Also part of the Part 35 9 working group. I'd just like to take the opportunity to 10 back up what Don said about providing comments. I think 11 everybody realizes that the net product that you're going to 12 see next year will be a balance of all the comments we 13 received. So, the positive part is extremely important. 14 The other thing is when to send a comment in and 15 say that, "This is wrong, it needs to be changed", is not as 16 helpful to us. We really appreciate it if you could tell us 17 how it needs to be changed and also, if you have the time 18 and information to provide us with the text that we need to 19 respond to your comment. This needs to be changed, why? In 20 other words, we're really searching for all of your help. 21 We tried to do the best we could with the proposed rule, but 22 please help us make it even better. Thank you. 23 Mr. Lull: I'm Robert Lull. I'm a nuclear 24 medicine physician, chief of nuclear medicine at San 25 Francisco General Hospital where I am actually engaged in ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

29 1 patient care. I'm also a director of the residency training 2 program at the University of California, San Francisco. I'm 3 here today representing the Society of Nuclear Medicine, the 4 American College of Nuclear Physicians, and also on behalf 5 of the University of California. 6 And I'm not sure if you want us to, you know, if 7 you want us to make some cormnents. I'd make to cormnents or 8 two issues that are of concern, perhaps. And do you want to 9 do it at this time or did it at another time? 10 MR. CAMERON: Well, why don't you -- why don't you 11 do it right now. - I would ask everybody to be sort of brief. 12 DR. LULL: Okay. This is kind of informal. Some 13 little scribbled notes here. So, it's part of the 14 informa~ity of the whole thing. 15 First, I'd like to make a cormnent that I 16 appreciate the opportunity to participate in the hearing 17 and, in the process, the revision of Part 35, which effects 18 the lives of all of us who are practicing nuclear medicine, 19 and all of the trainees I have currently in our training 20 program who are learning the skills to practice nuclear 21 medicine appropriately. This will have an impact on their 22 future careers in their field and on the patients that they 23 care for. 24 And I think that it's very important that we all 25 speak honestly and openly about what is happening so that we ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

30 1 can achieve the -- the best outcome that will enhance 2 radiation safety concerns and provide the maximum benefits 3 to patients in need of nuclear medicine procedures. 4 And that's one -- my first point, basically, and 5 one that I'll be addressing later on is the point that 6 whatever is accomplished in terms of federal regulations of 7 the practice of medicine using radioactive isotopes needs to 8 be done in the context of risk benefit and cost benefit 9 analysis. And data needs to be looked at in a formalized 10 way. 11 I would ask some questions and perhaps these might 12 be answered later by the NRC Staff. We know that for a 13 number of years now the NRC has been collecting data about 14 what is going to be called in the future apparently medical 15 events but which in the past has been called 16 mis-administrations. Now, that is the -- when the does that 17 a patient receives either for a diagnostic procedure or 18 therapeutic procedure is off by a certain amount than what 19 was intended. 20 I'm this data has been collected. I'm 21 wondering if the NRC and the Staff has done what would be 22 seem to be prudent and that is to look at what's happened 23 and what the experience has been with this as we start 24 looking at revising the regulations and this is one of the 25 issues. For instance, there should be lot of data now about ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

31 1 how much does it cost to implement the misadministration 2 program. *so, what is the cost of doing that? And then what 3 has been the measured benefit of that program? In other 4 words, has there been a benefit that's been achieved for the 5 costs that have been incurred. And has there actually been 6 any effect on risk reduction? In other words, have we 7 measured the risk and have we shown that this program has 8 done a reduction in risk? 9 You know, we're talking about lots of regulations 10 and regulatory authority. We should look at what's our real

• 11 12 13 experience been with something that's been controversial and what has the outcomes of that been. As an example, as a trial, as a exercise in the risk benefit/cost benefit 14 analysis.

15 My other point that I wish to make is that we're 16 looking at the probability of significantly decreasing the 17 experience requirements for authorized use of radioactive 18 materials in the health professions. The-~ the 19 authorization to use will be based primarily on meeting 20 minimum radiation safety requirements. In the regulations

21. as I read the voluminous material in the last two days will 22 be basically geared towards primarily and solely towards 23 radiation safety requirements for both the public and the 24 environment.

25 I think that it's very important that any ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

32 1 authorization to use radioactive material clarify what's a 2 very corrnnon problem and corrrrnon misperception and it should 3 do so in writing on each license that's issued for an 4 authorized user under any revision that occurs as a result of these hearings to part 35 in which it states clearly that 6 the authorization to use is based on the individual meeting 7 minimum radiation safety requirements and experience. And 8 the experience part of this is experience in radiation 9 safety, not in clinical aspects. And it should specifically 10 state that this in no way -- no way reflects clinical 11 competence in the application of. radiation -- radioactive 12 materials in the practice of medicine. This is a point 13 which I think is important because there's great confusion 14 out in the real world about whether NRC authorization 15 implies clinical competence. And I think one of the points 16 that the Society is making is that this is being divorced 17 and it should be clearly stated to clear up this confusion. 18 Those are my two informal corrnnents. Thank you 19 very much. 20 MR. CAMERON: Great. Thank you, Robert. Kathy? 21 MS . THOMAS : My name' s Ka thy Thomas . I am a 22 supervisor in nuclear medicine in Los Angeles, California. 23 And I also represent Society of Nuclear Medicine technology 24 section. 25 A couple of the issues that we're concerned about ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

33 1 first would be any standards that are created have a 2 positive impact on radiation safety. And if we can't 3 demonstrate that there is this this positive impact, that 4 there's -- that the level of radiation of radiation is not 5 improved in some way then let's delete it and get rid of it. 6 The second issue is the importance of not 7 diminishing what professional organizations as well as 8 credentialing agencies have already established, and that's 9 the standard or practice -- a standard or care within the 10 medical field. And often we see when government regulations 11 come in there can be the potential of diminishing those 12 standards by setting this minimum level that is far below 13 what we all know and practice in today's medical 14 environment. So, those are the two issues that techs are 15 concerned about. 16 MR. CAMERON: Okay. Thank you, Kathy. Terry? 17 MR. FRAZEE: I'm Terry Frazee, the State of 18 Washington, Division of Radiation Protection. I'm 19 supervisor of the radioactive material section. The couple 20 of issues that I'm interested in -- as the State Radiation 21 Control Agency we're called out on all sorts of events. 22 We've noticed an increase in the number of hot loads 23 received at sanitary waste facilities in the state. And the 24 majority of those hot loads have been due to patient 25 Title 31. The patient waste. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

34 1 We also -- we got some anecdotal infoilllation about 2 what patients will agree to doing just to get out of the 3 hospital. And in fact they'll do just about anything else. 4 So, issue number one is what is the real impact of 5 releasing patients with higher activity levels then we've 6 seen in the past. 7 Another issue deals with technologists. From our 8 perspective the folks that are really hands on, particularly 9 with low -- low risk -- are the technologists. And we've 10 supported training or testing of technologists and that has 11 been discussed and that's not a topic for here, but I'd like 12 to just raise that as an issue again. 13 And finally, as of reinstate we will have to be 14 compatible and equipped with the NRC and some of the 15 designations we'd like to take a closer look at. 16 MS. HOBSON: I my name is Nikki Hobson and I'm 17 in the process, I guess, of being appointed to the patient's 18 rights seat on this corrnnittee and very excited about 19 serving. 20 My organization is the National Association of 21 Cancer Patients. So, my comments be a little bit skewed 22 towards that group of patients. But you will forgive me if 23 I do. I'm sure that some of our concerns would be just as 24 valid for other patient groups. 25 Primarily, I think, you know, we are concerned ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

35 1 about risk and about safety. But, you know, a cancer's 2 patients concern about risk is kind of relevant to other 3 health problems that they have and sometimes they are 4 willing to accept more risk if there is a potential of 5 benefit. 6 So, we don't think risk, you know, should -- or 7 could be just ruled out. That is a sort of necessary 8 element of treating cancer patients. 9 We are concerned about access to an every day 10 medical process that would possibly benefit us. We want 11 that -- we want those processes delivered by a competent, 12 well-trained personnel, medical personnel. Clinical 13 clinical competence, as Bob was saying, but also 14 well-trained in radiation safety. You know, there's no 15 point in taking unnecessary risk if there's no benefit, so 16 we do expect our health care providers to be good.radiation 17 safety experts in addition to their clinical competence. 18 We want these processes available at reasonable 19 cost. And easily available. That is, that an average 20 patient would not have to travel more than SO miles to get 21 any procedure that would benefit the condition. 22 Now, to the extent that regulation such as what 23 we're looking at here support those goals, access, 24 availability, competence and low cost, we think that those 25 type of regulations are really good. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

36 1 If the regulations, in our view, would tend to be 2 hind~ring or diminishing these areas then we might have some 3 questions about why it should be that way. 4 Anyway, I'm looking forward to serving. 5 MR. CAMERON: And I would just clarify that the 6 committee that Nikki is talking about is the NRC's official 7 advisory committee, The Advisory Committee on the Medical 8 Use of Radioisotopes. 9 MR. BELK: My name is David Belk. I'm the 10 director of Environmental Protection Services at the 11 University of California in the office of the president in 12 Oakland. The reason I mention that is I'm not on the 13 .campus. And they wanted representatives here for the 14 University from the medical side and the -- were 15 representatives in the audience. 16 What I'm going to do is I'd like to go into the 17 administration side of the University of California and some 18 of our -- what some of our issues are when it comes to 19 supporting the medical use of radioisotopes. 20 One of the the two issues that we have we think 21 should be considered is broad scope licenses at a 22 university, sort of institutional licenses, some 23 consideration should go to why are so many questions asked 24 in details? Why are the licenses so restrictive? Shouldn't 25 the individual institution have more authority for ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

37 1 essentially determining authorization for the use of 2 radioisotopes? 3 We think that -- well, I'll give you sort of an 4 anecdotal bit of history about my personal dealing with the 5 licenses for the individual campuses. 6 Four or five years ago I asked over the phone for 7 copies of the licenses for the individual campuses. And 8 even on the phone I could see people's eyes glazing over. I 9 finally had the -- that recalled the licenses, she 10 discovered it when she was sick. So, there's a lot of 11 administrative support required internally for the 12 University of California for these licenses. 13 Institutional -- an institutional license would go 14 a long way in improving the efficiency of these licenses. 15 Another issue that we would like to see considered 16 is the clarification of the word "guide" or "guidance" in 17 the regulations. 18 Also, dealing with other regulatory agencies, 19 state or local agencies within California, these guides 20 often become de facto regulations. And that should be 21 reported. Going to back some of the issues that you were 22 raising. A performance based approach to the regulations is 23 one being considered by some state agencies where these 24 guidances or even regulations are looked at as guidance on 25 how to best lead an organization to meet the goal of a ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

38 1 specific regulation rather than a prescriptive regulation 2 giving us ad nauseam details to follow. They don't really 3 contribute to the benefit of the use of the material. 4 MR. CAMERON: Thank you. David Larson? 5 DR. LARSON: I'm David Larson. Good Morning. I'm 6 from the University of California, San Francisco Department 7 of Radiation Oncology. I'm training director of our 8 residency program. 9 There are two -- two large organizations, 10 professional organizations, in the United States 11 representing radiation oncology. One of them is called 12 ACRO, A-C-R-O, or American College of Radiation Oncology. 13 And I'm representing that organization today. 14 There's an another organization called ASTRO, 15 A-S-~-R-O, American Society for Therapeutic Radiology and 16 Oncology. That will be represented tomorrow, not today, by 17 Dr. John Earle, E-a-r-1-e, from the University of 18 California, Davis. 19 ACRO has -- has one main concern. One predominant 20 concern has to do with training requirements and 21 regulations. The current regulations provide comprehensive 22 training requirements for radiation oncologists using 23 teletherapy or garrnnanized therapy. And those requirements 24 and regulations have served -- have served patients and 25 physicians well in the sense that typical patients being ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

39 1 treated by radiation oncologists have a fair degree of 2 confiqence in the safety and efficacy of treatment. So, 3 ACRO was concerned over any potential move that you relax or 4 if you wrote training requirements. 5 I would like to at least make the first of, 6 hopefully, many positive statements. Dr. Lull asked for an 7 oncology statement. As I read your proposal it appears that 8 there is no move to relax the training standards as far as 9 teletherapy, brachytherapy and gamma therapy is concerned. 10 And so we'd like to support efforts on it. 11 MR. CAMERON: Thank you very much. 12 MR. SHOWALTER: I'm Charlie Showalter. I'm with 13 the staff of the American College of Radiology. 14 We have a couple of concerns that are not well 15 formulated yet because some of our folks were wanting to see 16 the actual proposal and didn't really get a chance to do 17 that yet. And so we hope to have more positive* things to 18 say later on in some of the later meetings. 19 But I think in general our concerns are in the 20 area of training and experience. We share the view of Dr. 21 Larson, I believe, on the radiation oncology area, but have 22 some remaining concerns of the diagnostic medical medicine 23 area. We hope to have some proposals or some suggestions, 24 some ideas to kick around in some of the later meetings on 25 that. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

40 1 And the other area that we're concerned about that 2 I don't know that the Staff can do anything about, but if we 3 can support you in any way to try to help, we'll be glad to. 4 And that's the schedule that you're under. 5 This is such an important revision of such a 6 complex rule that, you know, we're really not very happy 7 about the fact that you have been told to complete it by 8 next June. And we think that's unfortunate. 9 MR. CAMERON: Okay. Thanks, Charlie. 10 David, did you have a -- clarification before we 11 get it today. 12 DR. LARSON: Very quickly. I misspoke. I said 13 that there were two professional organizations. There's 14 actually three. The American College of Radiation is 15 extremely important. Sorry. 16 MR. MILLSON: My name is Jay Millson and I'm on 17 staff at the American Association of Clinical 18 Endocrinologists. I'm standing in for Dr. Joe 19 Prendergast certainly kept him away from the meeting. 20 today. And he will be here tomorrow. 21 But the main concern that we had and I think we 22 stated it clearly at previous workshops as well as making 23 corrrrnents -- an increase in 40 hours of practical training 24 for the treatment of hyperthyroidism, thyroid carcinoma. 25 I understand the corrnnents have been made through ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

41 1 the Commission to the Staff and I understand that the 2 information is being submitted back to the Staff that 3 they're working with it or what not. So, we don't have a 4 concern over substantiating the need to increase those hours 5 based upon -- this -- they're all supplying the -- with such 6 uses. 7 We've continued to support that concept at the 8 incoming meetings as well as working with the NRC Staff to 9 see what we can come up with. 10 MR. CAMERON: Okay. Thanks, Jay. Bill? 11 MR. EHMIG: Good morning. I'm Bill Ehmig. I'm 12 representing CORR, the Council on Radiopharmaceuticals and 13 Radionuclides. This is an industry trade group of companies 14 that make, di~tribute Radiopharmaceuticals, radionuclides, 15 sealed sources, unsealed sources. 16 I have one concern. I'm going to defer most of 17 the concerns of CORR to my colleague, Roy Brown, who's a 18 regulatory type and is much more knowledgeable. 19 But I have a socioeconomic one. In an environment 20 where 35 percent of medicine is practiced in public sector 21 medicine, Medicare, Medicaid, Medi-Cal. You call it. And 22 in nuclear medicine a disproportionately larger percent of 23 the patients are being paid for by federal agencies. 24 And in an environment when ~CVA is trying to 25 rachet down reimbursement, when practice expense for a ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

42 1 physicians can reduce 15 to 30 percent, depending on the 2 _ specialties, I would be very loathe to see a regulatory 3 environment change that would induce significantly 4 additional costs with little or no benefit to either the 5 manufacture, distribution or clinical use of radionuclides 6 and Radiopharmaceuticals. It just isn't cost effective. 7 And I think it could do great harm to the practice of the 8 profession. 9 MR. CAMERON: Thank you, Bill. And we will have 10 some opportunity at future workshops for some input from 11 ICVA people. And I would just also add at this point the 12 point that Charlie made about future workshops. This is 13 sort of evolutionary, so that when representatives from the 14 various organizations come to the Kansas City early October 15 workshop we may have an opportunity to clarify a point on 16 some of the -- some of the issues that you're talking about 17 today. 18 Richard? 19 MR. HEUSER: Yes. Thanks. I'm Rich Heuser. I'm 20 a cardiologist representing the American College of 21 Cardiology. 22 I'm a practicing cardiologist. I've been doing 23 interventional cardiology for about 20 years and training 24 fellows. And I really appreciate Nikki's corrnnents because I 25 guess the number one thing for me are the patients. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034.

43 1 The American College has been involved with this 2 organization from the diagnostic side, obviously. But also 3 what I'm concerned about and -- is the intervascular 4 brachytherapy, which is still very much investigational for 5 us in cardiology. 6 We have welcomed the involvement with radiation 7 oncologists, medical physicists, NRC, our institutional 8 review boards as well as our state boards for regulation in 9 that this is a very exciting field but a new field. Half a 10 million procedures are done. 11 Angioplasty type procedures are done around the 12 United States right now. Forty percent of those fail. The 13 patients come back. The early results in patients suggests 14 that intervascular brachytherapy, brachytherapy may reduce 15 the recinossis (phonetic) by 50 percent. 16 I say that with very, very small numbers. This is 17 very early. And I think that that's important because there 18 are 25 to 30 different trials going on with totally 19 different sources, different utility of devices. For 20 instance, there's studies done with radioactive stints. 21 Believe me, I've fished stints out of Hong Kong, Japan. 22 I've done it all over the world. I've lost tens of 23 patients. It happens. That's part of the procedure. 24 That's going to be a lot different. If that's approvable 25 and if the device that's used around the world or, ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

44 1 specifically, United States. Then if beta radiation at the 2 time of an angioplasty is done. 3 Do, we don't even know what's going to be out 4 there. And I think it's in a state of evolution. And the 5 reason I say that is that I think that at this time, from 6 the American College of Cardiology standpoint, and as a 7 practicing cardiologist I'm happy you are involved with 8 putting regulations, but I'm a little surprised with the 9 small numbers, Really. The numbers are so small it's 10 certainly not proven to the field of cardiologists out there 11 and if it ends up that it*s as widely applicable as it could 12 be, l think the onus is on us to make it available to 13 patients so they don't have to travel a l~ng distance. 14 Right now there are only 35 centers doing this. 15 If it's widely applicable and approvable for a simpler 16 device, then I think the training and expertise is going to 17 be different than if it's a wide spread of different devices 18 out there. And I think that that's why we would support, 19 since it's not approved at this time, that our training 20 program in intervention cardiology for our first 21 certification board is on November of 1999. Training for 22 radiation safety is going to be an important aspect of that 23 training. And I think when we get approval of this device 24 we'll be able to define exactly what the training is. But 25 right now we would really support considering intervascular ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

45 1 therapy in the example of emergent technology from the 2 standpoint of regulation. 3 MR. CAMERON: Thank you. Susan? 4 MS. MCLAUGHLIN: My name's Susan McLaughlin. I am 5 director of environmental clinical and safety standards with 6 the American Society of Health Care Engineering. ASHCE is 7 one of the personal membership groups of the American 8 Hospital Association in Chicago and I am here representing 9 the AHA. 10 In my role I am involved with health care safety 11 and regulatory compliance .. And that's the perspective with 12 which I will be looking at what we do here today. 13 From the standpoint of safety obviously in the 14 health care organizations, both for the patients, the staff 15 and everyone else involved. 16 And also from the standpoint of regulatory 17 compliance, both in terms of feasibility, for practically 18 implementing these rules, and also from the financial 19 standpoint. 20 MR. CAMERON: Thank you very much, Susan. 21 MR. NEBLETT: My name is Dave Neblett. I 22 represent the American College of Medical Physicists. And I 23 thank you for this opportunity to be here. 24 We, like a number of others, do not feel very well 25 informed concerning these regulations, although many of us ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 \

46 1 are ditch digging physicists and have been digging through 2 these ditches for 25 or more years, to respond in such a 3 short period of time is an extreme stress and strain. 4 And whatever we can do to assist you in getting a little bit more time so that we can respond, we are very 6 deeply involved in many of the technical and minute aspects 7 of these regulations and therefore need time to consider, to 8 discuss and come back with positive solutions to common 9 problems. 10 And we also are looking to provide the best 11 patient care and best patient public safety that is 12 attainable within a reasonable cost. 13 MR. CAMERON: Okay. Thank you for that offer 14 there. 15 MS. MARTIN: Hi. I'm Melissa Martin and I'm 16 representing the American Association of Physicists in 17 Medicine. 18 Basically, to follow up on what several people 19 have commented, the number one comment that we solicited 20 from the quick round table discussion of the representatives 21 that are coming to the future meetings as well as this one 22 is at this point we have not identified or certainly haven't 23 time to make an official response. 24 I am really sitting here today to provide what 25 input I can. Again, the AA.PM would be most interested in ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

47 1 whatever we could file with you to get an extension on the 2 comment period. We -- we know it came out literally, we're 3 sitting here reading it along with everyone else trying to 4 get suggestions back from our members that we can forward to 5 you for just those occasions where you're asking for what 6 are suggested practical considerations. We realize the same 7 problem. It does no good to say, "Change it" if we can't 8 give you a suggestion of how to change it. 9 The one thing that hasn't been brought up that at 10 least the physicists felt at our round table last week at 11 the national meeting was that -- I think one of the 12 discussions that's coming up is when do we have to have a 13 radiation safety committee or when should a radiation safety 14 committee be required. As a point of discussion, our 15 philosophy was as soon as you institute any facility that's 16 going to perform therapy procedures we should require a 17 radiation safety committee because that's an oversight 18 committee that coordinates nursing, physicians, 19 technologists, all the personnel involved. And when you're 20 doing therapeutic procedures we felt very strongly that that 21 should be a requirement. 22 MR. CAMERON: Okay. Thank you, Melissa. We'll 23 have further discussion on that, that specific requirement 24 later on. 25 MS. MANNING: I'm Mary Pat Manning and I'm a ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

48 1 clinical nurse specialist in radLation oncology. And I'm 2 representing the Oncology Nursing Society. And I am glad to 3 be here and I've heard a lot of things that I would have 4 expressed already having been said. So, I look forward to 5 giving my comments as we move along, positive as well as 6 constructive. 7 MR. CAMERON: Thanks Mary Pat. Roy? 8 MR. BROWN: My name is Roy Brown. I'm the 9 director of regulatory compliance for Malprod. Malprod is a 10 -major radiopharmaceutical manufacturer. I'll be here today 11 and tomorrow. I'm here representing CORR, the Council on 12 Radionuclides and Radiopharmaceuticals. I'm chairman of 13 their health care committee. 14 Two philosophical comments. I'll have more 15 specific comments later. But two philosophical comments. 16 First of all, on the risk informed performance 17 based concept. This is something CORR's been pushing for 18 all along. It went back to DSI 7 and the strategically base 19 lining and even back as far as the IN report. 20 This is something we've felt very strongly of. We 21 wanted to see what was the activity, such as diagnostic 22 nuclear medicine, de-emphasized or even deregulated. 23 At one point we were even hoping for a general 24 license for low risk diagnostic nuclear medicine, as we see 25 in the Part 35, but we didn't get there. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

49 1 I do want to comment that it seems like a lot of 2 prescriptive regulations have been removed and we really are 3 going more towards performance based, which we really 4 appreciate. Maybe we didn't go as far as we would have 5 liked to have seen, but we definitely see the improvements 6 in the proposal. 7 The second philosophical comment was on the 8 medical policy statement. I think a lot of the concerns 9 that the industry has had over the last several years is 10 really NRC Staff adherence to the medical policy statement.

• 11 12 13 The old statement from '79 had language in there about being intrusive and interfering with the practice of medicine.

And I think that's where a lot of the concerns from the 14 industry have come from. 15 I like the revisions you've made, or the revisions 16 you're proposing. I think they make sense. But I also do 17 want to point out I think it's very important the Staff 18 follow the medical policy statement. I think that's what 19 most of the problems and most of the concerns from the 20 industry come from. 21 MR. AUSTIN: I'm Dale Austin with the Federation 22 of State Medical Boards and I'm.pleased to be here. 23 I guess first of all to share a perspective on the 24 work that medical boards do in this country. 25 And then secondly to, I guess, to articulate on ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite _1014 Washington, D.C. 20036 ' (202) 842-0034

50 1 their behalf a -- a need for information flowing in the 2 other direction as well that if there are actions or 3 sanctions or problems with -- with individuals, physicians 4 in particular, as it relates to whatever rules are adopted, 5 finalized, those need to get back into the medical 6 regulatory arena. I'm not sure that they do today from -- 7 well, I can discern in talking with both member boards as 8 well as our own evidence. So, that would be my other issue. 9 MR. CAMERON: That's an interesting topic that 10 we'll revisit. More of a routine information flow to the

• 11 12 13 medical board community from the -- from the NRC, perhaps.

Good. Thank you. Ed? MR. BAILEY: My name is Ed Bailey. I'm chief of 14 the Radiologic Health Branch in the state of California. 15 We are an agreement state with the Nuclear 16 Regulatory Commission. However, for the most -- for the 17 time I've been here, which is going on about 10 years now, 18 we've been a disagreement state. And we have had a great 19 deal of disagreement with regard to the regulation of -- of 20 the use of radioactive materials in medicine. We are one of 21 the states that never got around to adopting the QNP. We 22 don't see that we have that many more misadministrations 23 and/or medical events than RC. 24 I do sympathize with the University of California 25 because I know they do have the largest broad license in the ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

51 1 world for UCSF with 129 conditions on it. So, when they 2 started copying that it was quite a job. 3 I'm here also representing the Health Physics 4 Society who has been active in this process. I was asked by 5 President Keith Danger to come to the meeting and begin to 6 gather information for them in preparing their comments. 7 One of -- I guess the things that I will be 8 looking at, particularly, as we discuss this proposed rule 9 is the impact of the proposed rule on the agreement states 10 which will get to the levels of compatibility that are

• 11 12 13 identified in the proposed rule.

I will also be looking at it from the standpoint of its impact upon health physicists. And I would hope that 14 those -- those concerns are almost parallel. 15 One of the issues that has been raised is the 16 committee. And I think both the Health Physics Society and 17 certai~ly California, as an agreement state, would urge that 18 there be somewhere in the regulations identified a radiation 19 safety committee with responsibilities and authorities to do 20 things. 21 The third thing that is a concern to me, since I 22 do work for a public health agency, the California 23 Department of Health Services, is the quality of medical 24 care and public health. And I think that those two do not 25 have to be mutually exclusive. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

52 1 I did notice in my notebook that I got, just to 2 prove that I looked at it, that I think you did an admirable 3 job in the present Part 35 by eliminating every other page. 4 You definitely shortened down the rule by about half. 5 MS. HANEY: That was a test to see if you read it. 6 We did have a couple of binders that went out that we and we 7 caught two of them. If there are any others, if you'd let 8 us know we will -- we do have copies to hand out. 9 MR. BAILEY: You'll always be treating me special, 10 so I --

• 11 12 13 MS. HANEY:

MR. BAILEY: MS. HANEY: We do. I appreciate it. The other two binders went to NRC 14 Staff, so that -- that makes it any better. 15 MR. CAMERON: And they might not notice. 16 MR. BAILEY: They've got it memorized. 17 MR. CAMERON: That's right. That's what I meant. 18 Let's go out to -- to the audience. And we will 19 get a hand held mic shortly so that will facilitate people 20 talking out here through the -- the next day. So, today and 21 the next day. 22 We do have people here from the NRC Staff and also 23 people who have been on the state federal working group that 24 spent a lot of work to develop this rule. And I'd just like 25 them to introduce themselves right now. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

53 1 David, why don't you go to the mic and -- 2 MR. WALTER: My name is David Walter and this is 3 not on. 4 MR. CAMERON: Is that mic working? 5 THE REPORTER: Yes. 6 MR. CAMERON: Okay. 7- MR. WALTER: My name is David Walter. I'm with 8 the licensing division of the Office of Radiation for the 9 State of Alabama. I'm also -- on the Part 35 working group 10 working with the NRC is reforming and revising these set of

• 11 12 13 rules.

here. And I appreciate any type of input that we can get And I will tell you right now that input that we 14 received during the previous public meetings last fall was 15 definitely used in the revisions that occurred. And if the 16 revisions could continue to go on long after the January 17 30th draft was posted to the web, there are so many changes 18 that occurred. If you look at the two of them you'll see it 19 has been an extremely dynamic document, right up until last 20 Friday. If it couldn't have gotten out any earlier, it 21 would have been. I was getting daily e-mails, "Well, it's 22 here." And this is being changed and this is begin changed. 23 So, please believe me, everything that you got was got to 24 you as quickly as possible. 25 MR. CAMERON: Thanks David. Lloyd? ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

54 1 MR. BOLLING: I'm Lloyd Bolling. I'm with NRC's 2 Office of State Programs. And my particular interest in 3 this rule making is the applicability to the agreement 4 states. So, if you have any comments or questions in that 5 area, I'll be glad to receive them and present them to the 6 working group. 7 MR. CAMERON: Thanks Lloyd. Penny, do you want to 8' go ahead? 9 MS. ZISERA: I'm Penny Lan Zisera. I'm with the 10 NRC's Region One. I'm also a member of the working group

• 11 12 13 and the -- each document that you have is part of my group's work as well. So, any comments you have. Particularly, which document, and I'll be here in this particular city.

14 MR. CAMERON: Thanks Penny. Marjorie? 15 MS. ROTHSCHILD: I'm Marjorie Rothschild with the 16 USNRC Office of the General Counsel, Division of Rule 17 Making. And I'm also a member of the NRC Staff working 18 group. 19 MR. CAMERON: Thanks Marjorie. Sam? 20 MR. JONES: I'm Sam Jones. I work with Cathy 21 Haney. I'm a member of the NRC working group. If you have 22 any comments on the medicine area. Discussion during the 23 break -- the meeting. 24 MR. CAMERON: And Joe? 25 MR. DELMEDICO: I'm Joe DelMedico. I'm the senior ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

55 1 enforcement specialist with the NRC's Office of Enforcement. 2 My background is nuclear medicine technology and 3 radiopharmaceutical science. I just say that so you 4 understand I am not an attorney. 5 I'm interested in your comments on the NRC 6 ,enforcement policy. There's sort cf a window of opportunity 7 to effect some change in the policy. Cathy set aside a 8 little bit of time this afternoon for me to tell you about 9 that. I can, you know, listen at that time. We can also 10 meet informally -- the corrnnents. I certainly don't want to

• 11 12 13 go back to my management and say, "No one had any comments."

If I do that they won't send me to anymore of these meetings. 14 MR. CAMERON: Okay. Well, good. We'll look 15 forward to that when we get to the compliance issues. 16 I'd like to get at other people in the audience 17 and I should say that some of the people here, including 18 someone that will introduce themselves next, have been a 19 tremendous help to us in terms of identifying participants 20 for the particular meetings and also helping to identify 21 agenda issues. And I just wanted to thank them here and 22 now. 23 And David, do you want to introduce yourself? 24 MR; NICHOLS: My name is David Nichols. I'm with 25 the American College of Nuclear Physicians and Society of ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

56 1 Nuclear Medicine and served as their director of public 2 relations. 3 I think we talked a.bout a couple of issues that 4 we'd like to see addressed during this workshop and part of 5 the rule making process. 6 The first is how conunents from the workshop and 7 the stakeholders throughout the conunent process are 8 incorporated into the Conunission's decisions. And one 9 decision the Conunission made on patient notification was one 10 that really surprised us in light of the fact that at almost 11 all of the workshops that the NRC held and all the comments 12 and the comments they have from their advisory committee 13 recommended that they not have a federal requirement for 14 patient notification. But that still made it to the final 15 rule. 16 So, l think it will be interesting in hearing how 17 the Commission will be reviewing the transcripts that come 18 out of this and summaries that come out of these workshops 19 so that we are convinced that they are aware of the public 20 corrnnents and that they justify why they're going into a 21 consensus of stakeholders. 22 The issue is the fact that we're concerned, as the 23 process goes along as this continues to evolve, that new 24 requirements will come up as you start to develop the final 25 rule. And that we could be in a situation where there are ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

57 1 regulations that have not been reviewed by the public or not 2 have any comment on, put into the final rule, and then 3 there's no opportunity to have those changed or evaluate 4 their impact. And those are the two issues. 5 MR. CAMERON: Okay. Thanks David. And we will be 6 trying to alleviate the problem that you referred to a 7 little bit by the meeting summaries-that we will be 8 forwarding to the Commission. 9 There's another aspect to that whole problem is 10 that the Commission may know about it, but for various 11 reasons decided not to adopt the position it was -- that was 12 recommended. And I think on that substantive aspect when we 13 get to patient notification perhaps Cathy, Don or Diane can 14 perhaps fill us in a little bit more about what was 15 motivating the Commission in terms of that particular 16 requirement. 17 So, thank you. Andrew, do you want to introduce 18 yourself? 19 MR. WOODS: I'm Andrew Woods. I'm a partner in 20 Charlton, Hasting and Provage (phonetic) in Washington, 21 legal counsel to the American College of Radiopatient 22 Oncology. 23 MR. CAMERON: Okay. Thanks, Andrew. Let's see. 24 Is this on? Okay. 25 MS. SCHWEYAR: I figured I was in front so I'd be ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

58 1 one of the first ones. 2 MR. CAMERON: That's right. 3 MS. SCHWEYAR: I'm Jill Schweyar. I'm the vice 4 president of regulatory medical oncology affairs from 5 industry. The name of the company is Isostint, 6 Incorporated. We are actually in the business of 7 international work, radiotherapy using radioactive stints. 8 So, having had a real opportunity to study the rules and 9 regulations for it,* we have multiple areas of concern. I'll 10 just list those briefly. We will prepared at future 11 meetings to make a more formal statement. But basically, 12 we're concerned in the area of turning requirements, and we 13 do appreciate the Commissions approach in this performance 14 management. I think that's going to lead us in the right 15 direction. Especially with out technology. 16 We're also concerned about the licensing 17 agreements for hospitals if this technology does become 18 available. We want to make sure that if it does become 19 available and it is going to be medically available to all 20 patients who need the therapy. 21 We're also concerned about misadminsitrations. 22 Because stints during interventional cardiology procedures 23 do have a tendency occasionally to be dislodged or can be 24 placed at a different location in the vessel. So, they are 25 concerned about how that will be recordable. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

59 1 Also, we're concerned about the NRC also getting 2 into the areas that are actually regulated by the Food and 3 Drug Administration. So, we want to make sure there is a 4 separation there_. 5 Also, our therapy is low does rate and we want to 6 make sure that it doesn't get confused and regulated as a 7 high dose rate radiotherapy source. Then, of course, 8 there's the sealers and unsealed source category and trying 9 to make*sure that our stints do remain an unsealed source. 10 Thanks. 11 MR. KNIGHT: I'm Dean Knight and I'm also with 12 Isostint, chair at Johnson Severson (phonetic). 13 MR. PRICE: I'm Dr. David Price. I'm the nuclear 14 medicine physician practicing here with UCSF. In that sense 15 I'm with the University of California and with the Society 16 of Nuclear Medicine and the ACMP. I've been practicing 17 nuclear medicine for 13 years and I've seen a lot of changes 18 in that time. 19 There are two issues which I wanted to mention 20 which are not simple resolution issues, but which troubled 21 me. One is we're talking about setting the resolutions 22 based, amongst other things, on risk -- called risk 23 informed. And my concerned is what is the expertise in the 24 NRC on assessing risk. Radiation risk is one of the most 25 controversial issues, as you all know. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

60 1 There isn't any medical expertise in the NRC. Dr. 2 Pollica (phonetic) has been vising for several years, but 3 there really isn't a permanent position there. I don't know 4 of a radiobiologist, and I may be wrong there. But again, 5 my question is we in the nuclear medicine and the 6 community are very concerned when the risk is the basis for 7 establishing regulations and really what is the actual 8 tease. The -- community is a community that meets on an 9 occasional but regular schedule and is an advisory 10 committee, not a fundamental part of the NRC. 11 The other issue that concerns me is that there has 12 been sufficient concern recently to reduce public exposure 13 from .5 gram to .1 gram. On the other hand, we're talking 14 about changing regulations of the way which we used to set 15 training requirements. And! find a fundamental dichotomy 16 in that position by the NRC that they're concerned about 17 radiation exposure on the one hand and yet they're willing 18 to relax standards of education on the other. So, again, 19 we'll put that on the table as something that needs 20 resolution. 21 MR. CAMERON: Okay. Thanks Dr. Price. And I 22 think we'll have an opportunity to visit both of those 23 issues as we come along, particularly the first one about 24 the need for risk information and indeed, who is going to 25 supply that. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

61 1 MR. HOW: My name is Mark How and I'm the service 2 health care radiation safety officer of the University of 3 California, San Francisco. 4 I'm interested in the topics that Dr. Price has 5 just raised. 6 MR. TAHMASSIAN: My name is Ara Tahmassian. I'm 7 the assistant vice chancellor for research support, which 8 includes radiation safety. I am the author, of the 421 each 9 license in -- division with 120 -- I do have, obviously., a 10 comment to make. 11 But seriously, I think that as a group making 12 process for this I think what we need to do is really focus 13 on what is important versus what is sort of good for the 14 purpose of your having paperwork. We can have all the 15 paperwork you want. We can have piles and piles of 16 document. It would not be a safe program. We can have a 17 program with four pages of documentation and it would be the 18 safest program. 19 One other thing that I would like to put on the 20 table. I have worked under about 16 different agreement 21 states. I've needed an NRC license, you know, for several 22 years. There is this -- this new licensing versus 23 enforcement licensing, they can say anything they want with 24 regards to the process of granting a broad spectrum license, 25 being, you know, sort of performance based. But trust me, ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

62 1 when you get to the bottom line, it's licensing because if 2 the micro detail that you have to make life easy for the 3 enforcement folks because they have to go through the 4 checklist. And I want to make sure that in tgis process we 5 get an opportunity to address that very specific issue. 6 Thank you. 7 MR. CAMERON: Good. Thank you. And we will 8 address that this afternoon. 9 MR. HOLMES: John Holmes. I'm at Stanford 10 University. The same town, sir. Also, in the UC Stanford 11 Health Care System South and the Palo Alto Veterans 12 Administration Affairs Hospital. 13 MR. CAMERON: Thank you. 14 MR. HICKMAN: John Hickman. I'm with the State of 15 California. I'm in medical licensing. And you should have 16 seen Ara's license before I put it down. 17 MS. GOODE: I'm Tara Goode. I'm a medical license 18 reviewer for the State of California, the radiological 19 branch. 20 MR. CLIFFORD: I'm Jeff Clifford with the State of 21 California, radiological health branch. And I'm medical 22 license reviewer also. 23 MR. PAY: My name is Steven Pay. I'm with the 24 radiological health branch, State of California. And I'm a 25 compliance inspector with inspection compliance enforcement. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

63 1 MR. CAMERON: Great. Thank you. I'm glad to see 2 that our some of Staff people from our code regulators 3 are -- from the State of California are here today. And Ed 4 and Terry, I know you don't mind me using the "C" word, code 5 regulator. 6 Okay. Well, I think we have a great group, both 7 in the audience and around the table to do some productive 8 discussion of these issues. And we're a little bit behind 9 time for our break. But I think Don has been listening to 10 many of the -- well, I know he's bene listening to many of 11 the issues that have been raised. 12 Does anybody around the table have any questions 13 for Don about regulatory philosophy, schedule, broad issues 14 such as that before we -- we take our morning break here? 15 [Discussion off the record.] 16 MS. HANEY: Okay. In the area of the general 17 technical requirements, under the proposed rule, where you 18 see the requirements for the training and experience of the 19 radiation safety officer, for the medical physicist. Then 20 you go into what we start -- started calling the modality 21 specific sections of the rule. 22 What we tried to do was to maintain somewhat of a 23 current framework that in the current ruling you have the 24 requirements for the 35-100 uses which would be the use for 25 in your -- for uptake and dilution studies. That was in one ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

64 1 area of the rule. Then you would go in~o the next section 2 of the rule, which was your 35-200 uses, which would be your 3 imaging and localizations studies. And the 35-300, which 4 would be the use of the unsealed material for therapy uses. 5 And that broke down to really the subparts D and E. 6 What the difference -- the split in these two 7 sections is, when you need a written directive and when you 8 don't need a written directive. 9 If you're using radioactive materials for a use 10 where a written directive is not required, you would find 11 the requirements in subpart D. 12 If you were looking to use material where a 13 written directive would be required, now you're into subpart 14 E. 15 The requirements for the authorized users would be 16 found under those sections. 17 The next subpart that you'll see is manual 18 brachytherapy. To let you know, we did attempt, at one 19 point, to combine the manual brachytherapy with the 20 therapeutic medical devices into one part because there were 21 a lot of similarity in the technical requirements. But we 22 did it and we started -- it really got to be too much of a 23 mess. So, we split them off into two separate areas. So, 24 when you are reviewing line by line, word by word of the 25 rule, you may start to see some duplication between subpart ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

65 1 F and subpart H, but we recognize there was duplication but 2 the alternative was to really jumble it all and start doing, 3 except for this and except for that, which would have been 4 much worse. 5 The subpart Dis your -- are your requirements for 6 the sealed sources for diagnosis. Again, the training and 7 experience requirements for an individual wishing to work 8 under this area would be found in that subpart. 9 Subpart His a very large subpart because it's 10 intended to cover teletherapy, garrnna stereotactic 11 radiosurgery and your HDR use. 12 I would ask, especially of the physicists in the 13 group, that when they are reviewing these sections in detail 14 that they look very closely at the requirements for the HDR 15 units and for the gamma stereotactic radiosurgery units. 16 We did use the AAPM reports to generate the 17 requirements in this section. We tried to make a cut 18 between what was a requirement for safety and was a quality 19 assurance sort of requirement that should be left to the 20 physicist to decide whether that needs to be done or not. 21 Again, we tried our best. We may have made that 22 cut at the wrong place and we're looking for feedback in 23 that area. 24 Subpart J are the training and experience 25 requirements and you're going to say, "Well, you just said ANN RILEY &*ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

66 1 that the training and experience ~equirements were in the 2 other subpart." Once we got into this process we realized 3 that with out proposal for training and experience that 4 we'll be discussing in depth tomorrow where the authorized 5 users would have to take an exam and NRC would be approving 6 exams and certifying bodies that we couldn't make that part 7 of the rule go immediately effective. Because otherwise, 8 once the date that the rule went into effect, then no one 9 could become an authorized user, an authorized medical 10 physicist, until NRC approved the boards, which that was not 11 really a very good situation for patient care. 12 So, we have decided to maintain the current 13 training and experience requirements in the rule and this 14 these requirements would stay in effect for up to two years 15 from the implementation date of the rule. 16 If we go along in the final rule with what we're 17 proposing in this rule, at the end of two years, subpart J 18 would be removed from the regulation. 19 Now, there's a lot more I can say on the training 20 and experience requirements but I'll save that for tomorrow 21 when we get more in depth. But I want you to know why that 22 one subpart was maintained. 23 Subpart K has been referred to as the emerging 24 technology section. If we use the term "emerging 25 technology" we were going to have to define it in definition ANN RILEY & ASSOCIATES, L'ID. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

67 1 space and we didn't want to do that so we _kind of took the 2 easy way out and just set up a subpart*K that was for any 3 other medical use that's not described in another subpart. 4 And this -- so, in subpart Kit's a very short 5 section of the rule, if you had the opportunity to look at 6 it. But the purpose of having subpart K is that if a new 7 technology comes into use that we would be easily -- we 8 would very easily be able to adopt it into the regulatory 9 framework. About the best example that I can give you for 10 this is when HDR units came into being. There really was

• 11 12 13 nothing in the rule that would make for easy regulation of an HDR unit. And with those that had licenses, teletherapy licenses, and they got the HDR unit, what we started to do 14 was say -- reference the teletherapy section in the rule and 15 say, "Except don't do A, B, and C, but do E and F if you 16 have an HDR license." And that became, again, a very 17 difficult, non-user friendly way of regulating.

18 So, we have this -- this subpart K with -- for the 19 purpose of a new technology comes into NRC, we are certainly 20 going to ask for information, radiation safety related 21 information on the use of this material. As we get more 22 experience. As the users get more experience with the use 23 of the material in this area -- you know, five years down 24 the line, six years, whatever -- we would finally get to the 25 point where we could do a proposed rule that would be ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

68 1 specific to this one use and then we would just, in a chunk, 2 put it into the existing Part 35. 3 The other two sections, Land M, what we did was 4 take all the reports that were required under the current 35 5 and all the records that were required and moved them into 6 one section. This was done really as to parallel what was 7 done with Part 20, for those *of you that are familiar with 8 part 20. 9 Our thinking is that if someone says, "Well, Gosh, 10 what are the records I need to keep in order to be in 11 compliance with Part 35", they just go to subpart Land they 12 see the entire list. 13 If they want to know what reports they need to 14 keep to make to NRC then they just go to the report section. 15 And it's not a matter of having to read through the entire 16 document to see, you know, is there a record buried in here 17 some place? Is there a report buried in here? And risk 18 missing something. 19 One of the questions that we have asked in the 20 supplementary information is, "Do you like this approach of 21 moving all the records to one section, of moving all the 22 reports to one section?" 23 So, when you are coming back with formal comments, 24 you might just want to say, "Yes, we like what you did", or 25 "No, we don't like what you did." Throw it back into the ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

69 1 section where you discuss the specific requirement. 2 Subpart N deals with enforcement. These are just 3 two sections, more administrative sections that need to be 4 entered in the rule. Other than updating them to reference 5 the proposed section, they're very similar to what's in the 6 current rule. 7 Appendix A, it's a new appendix. It does not 8 appear in the current Part 35. This has to do with the 9 examining organization or entity. Again, we'll talk about 10 this a little bit more in depth tomorrow. But one of the

• 11 12 13 requirements of the rule is that NRC would approve a board or examining entity.

the requirements. And this particular appendix contains What we would be looking for in that 14 board or in *that examining organization. 15 And I'm just going to stop there for now with that 16 because -- since I will go into that a little bit more in 17 depth tomorrow. 18 The next slide that you see are some specific 19 questions, as I've said, on subpart Land M that may be 20 if Chip will give us a couple of minutes we can just address 21 those to get some preliminary views on the record. 22 And then the last thing that I would like to talk 23 about from the standpoint of an overview of Part 35 deals 24 with -- and now you've got an HP operation of a remote 25 control. So. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

70 1 Okay. This has to do with the sections that we 2 deleted from Part 20. Don made reference earlier to one of 3 the items -- one of our things that we wanted to start out. 4 The working group objectives was that if the requirements 5 are discussed in another part of the rule that we would not 6 discuss them in detail in Part 35. Again, this is a little 7 bit of a step away from the prescriptive nature of the 8 current Part 35. 9 What we had tried to lay out in the statements of 10 consideration for some of these is that although these 11 requirements no longer appear in Part 35 it doesn't mean 12 that a licensee doesn't have to do it. 13 In the case of the current rule 3520 requires that j

• 14 the licenses have an alarm program. That does not appear in 15 the proposed rule.

16 Part 20 requires the licensee to have an alarm 17 program. And that alarm program would be geared to the 18 uses. So, for example, if you were using very small 19 quantities, you would not have a large alarm program. If it 20 was a large facility, the alann program might be totally 21 different. 22 The specific requirements for surveys for 23 contamination and ambient radiation exposure rates has not 24 been deleted in total. We did keep one requirement in the 25 therapy area that served in the use of unsealed material for ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

71 1 therapy. But some surveys need to be performed. We 2 recognize this as a prescriptive requirement; however, 3 because of the potential for the risk associated with that 4 we felt that this small aspect of this requirement should 5 still be maintained in the rule. 6 I won't go step by step through all of these. But 7 suffice it to say the licensee would still need to address 8 all of these particular items, but they would be doing it 9 under a Part 20 requirement rather than a Part 35 10 requirement and we would not be as specific in our rules 11 based on how the licensee would address these items. 12 One thing that I touched on when I was discussing 13 the training and that I think should be brought out at this 14 point for the discussion on the rule is our implementation 15 schedule for the rule. What we are proposing is that the 16 proposed rule would state that the rule, with the exception 17 of the training and experience requirements, would go into 18 effect six months after its publication, which we're 19 probably looking at the summer of 2000 for an implementation 20 date for the rule, with the exception of the training and 21 experience. 22 The training and experience requirements would be 23 two years from the date that the final rule is published. I 24 explained why. Mostly because we need that time to get in 25 to approving the boards. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

72 1 The reason for the six months, there are some 2 additional procedures that the proposed rule would require 3 that you adopt and those -- we'd give it six months -- 4 should provide adequate time for those procedures to be 5 developed. 6 Some of the other changes and we'll, again, 7 discuss in detail the quality management program no longer 8 is required by the rule but there would be some modification 9 to some procedures that would need to be made because the 10 QNP has been deleted as a stand alone program. 11 So we, again, we feel that the six months would 12 give an adequate time but of this time of discussion, you 13 know, comments on whether you think the six months are 14 adequate or not for the implementation of everything but the 15 trading experience would be appreciated. 16 So, I think I'll turn it back to Chip. 17 MR,. CAMERON: Okay. Thanks, Cathy. We will visit 18 the subparts Land Mas specific issues. But I think that 19 we'll do that tomorrow in the context of a more specific 20 discussion on this. 21 But to make sure that everybody understands this 22 frame work and, again, given that we're going to be 23 discussing some of these tomorrow,. But I just wanted to 24 make sure that everybody widerstands the road map for this 25 rule. Questions from any of you on this at this point? Ed? ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

73 1 MR. BAILEY: Could we get Cathy to give us a copy 2 of that slide? That one might be 3 MS. HANEY: This one? 4 MR. BAILEY: Yeah. That would be very beneficial. 5 MR. CAMERON: Okay. Great. We'll do that. Roy? 6 MR. BROWN: Chip, I have a quick question. I 7 thought at one point you guys were shooting for publishing 8 the final rule in sunnner of 1999. But it seems to be 9 effective at the end of '99. 10 MS. HANEY: Well, that's what Diane just wrote me 11 a note here that I messed up. And see, I was going to try 12 to just, you know, correct it at the Kansas meeting. 13 If we, you know, based on how we did with the 14 proposed rule we're probably looking at a publishing date 15 for the final rule of around August, which would, in six 16 months from August, be probably more in the February time 17 frame. I just want like longer summers. 18 Now, I'm going to get corrected again from my 19 left. 20 DR. COOL: Now, I'm going to give the other piece 21 of the procedure which is different for a final rule than a 22 proposed rule, which has to do with how the federal 23 government operates. 24 Agencies can publish proposed rules simultaneously C 25 with submitting to the Office of Management and Budget the ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

74 1 information collection requirements, and those processes go 2 on in parallel. 3 Where the final rule, the Commission would approve 4 the rule. The Office of Management and Budget, 0MB, would 5 have to clear the information requirements before the agency 6 would actually be allowed to publish the final rule. 7 So, there is an additional step before the rule, 8 such that August would be some period of time. 0MB has been 9 known to act fairly quickly. Sometimes 0MB can take up to 10 90 days, I believe. Marjorie may be able to help me out 11 with that, although I'm not sure any of our folks were 12 specific about the clearances. So, there is an additional 13 time step in there. 14 So, the reality is somewhere between -- parallel 15 to what happened this year and three, four months for 16 additional when you go through the final rules stage. 17 Simply because of the processes which the federal government 18 uses in order to meet all the Congressional mandates. 19 So, somewhere between those two. Probably not 20 quite as late as summer of 2000, although I've seen things 21 extended for a long period of time. And probably not quite 22 as quick as Cathy's optimistic odds. How is that? 23 MR. CAMERON: Okay. Bill? 24 MR. EHMIG: I have a quick question. How is the 25 NRC addressing the year 2000 issue, and will that effect ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

75 1 this? 2 MR. CAMERON: That sounds like a question for Don 3 Cool: 4 MS. HANEY: Well, I have a specific -- I have a specific and Don can do global. 6 MR. CAMERON: Okay. 7 MS. HANEY: From a specific standpoint of Part 35 8 spacing, it really comes into* a major play in the area of 9 the therapy uses. And we have .added a requirement relative 10 to computer systems to make sure that they are basically 11 doing what they're supposed to doing. So, the year -- the 12 Y2K problem would fall under that particular item. 13 We do make mention of it in the Statements of 14 Consideration as an example of something that you would be 15 checking when you were showing -- trying to snow compliance 16 with this section. 17 So, from a real specific nature that's what we're 18 doing with 25. I'm going to let Don do the more global 19 check. 20 DR. COOL: There are a whole series of activities 21 going on in the agency. Computers -- the 2000 computer 22 program. A lot of that has focussed on bigger licensees. In particular, our 110 operating reactors. Some of the fuel 24 facilities and other facilities where there are a lot of 25 computer controlled process controls in various activities. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

76 1 And the materials around, we face the entire 2 range. On one of the spectrum of my licensees I have fuel 3 facilities and gaseous diffusion plants. On the other end, 4 I have my portable gauge users who don't have any 5 electronics at all that relate to safety. Pure mechanical 6 air locks. In between, I have all the range of things in 7 the medical device arena and everything else. 8 We have been trying to work very closely with FDA 9 in terms of the devices and device approvals because most of 10 the responsibility in terms of the actual software devices 11 rests on that side of the house. 12 'l;'here have been several information notices that 13 we even tried to get out to all of our licensees, and I 14 think those have been sent over to the states for 15 transmission and state licensees. 16 On that, things we have learned from FDA. Some 17 things that we have learned through a series of questions 18 that we've been asking licensees and manufacturers. We-'ve 19 gone to folks that manufacture some of the data devises 20 asking where they stand in terms of their year 2000 problem 21 so that we can try to get that information out. 22 The next meeting that we have with FDA is, in 23 fact, scheduled before the end of this month just to try to 24 make sure that what we're hearing and what they're hearing 25 is coordinated and that information gets out. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

77 1 So, that's a multi step piece going on. We're 2 participating in the executive presidential committees. 3 We've been in various health care and environmental arenas. 4 Have been providing information and testimony to the 5 Congressional side committees that have been looking at it. 6 And we could spend a lot more time talking about 7 various and sundry other details. 8 If you have -- I'll just put it out there. If you 9 have specific groups within your societies that are looking 10 at the issues I would love to, as a sidebar, get together 11 with you so that we could be communicating directly back and forth between the individual societies to pick up any 13 information and get that out to people. 14 And let's not loose sight of the fact -- that 15 issue too. It's not like that's a real productive 16 MR. EHMIG: But I've asked a question. You really 17 dealt there in your answer, which I thought was very good, 18 with your outreach to your regulated people. I've talked to 19 people in the Department of Energy and the Department of 20 Defense who say that they will not be compliant with all 21 those -- or all of the Y2K until between 2002 and 2004. How 22 are you going to be internally for your own role out of 23 regulations, maintenance records and the ability to go out 24 and investigate sites, looking at it yourself, not at the 25 regulated people? ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

78 1 DR. COOL: Okay. The second half. Obviously it's 2 locations he's doing internally. And they are both a series 3 of things which are under direct the direct control of our 4 chief information officer. Identify the business critical 5 systems and, for most of the systems, they will, in fact, 6 are on track to be year 2000 compliant through upgrades to 7 the various software packages, for those for which it is 8 cost prohibitive and ridiculous to take over mainframe 9 systems and do all of the changes. We're doing some of 10 those. 11 There is a second tier which is -- I'm going to 12 get the year 2000 terminology messed up -- there's compliant 13 and then there's a second category which means you have the 14 contingency plans built in place where if it prints out 15 reports and puts the wrong date stamp or something on the 16 bottom, that you have a way of segregating. You run a 17 report up to here and then you run a second report secondly, 18 which are also being developed so that we can continue to 19 track. 20 We've already been facing this because we've been 21 looking at inspection dates and licensing dates well out 22 beyond the year 2000. So -- and the materials are made. 23 Our basic tracking systems, like the licensing tracking 24 system and some of those things, have already had to deal 25 with this because we're already running dates that are 2001, ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

79 1 2002, 2003. 2 MR. CAMERON: And for those of you who want to 3 take Don up on the coordination issue I would suggest that 4 you talk to Don or his staff sometime during this meeting to 5 set that up. 6 Any other questions before we move on to risk? 7 Does anybody in the audience have some general 8' questions on Cathy's presentation? 9 Okay. Well, let's move into our first rationale 10 and justification issue. And this is the whole idea of 11 risk. And we heard a number of people talk about risk and 12 risk benefit, cost benefit and the need for data and what 13 data does the NRC have. Bob Lull mentioned that. And we 14 heard Dr. Price's corrnnents about the knowledge set necessary 15 to assess risk. And Nikki brought something up this morning 16 about -- that risk is relative to a cancer patient facing 17 treatment. 18 What we're going to do is start off with some

• 19 20 21 contacts for you. Don Cool is going to talk about what the NRC is doing, along the risk lines.

And Bob Lull has been nice enough to consent to 22 give us an overview of what the Society of Nuclear Medicine 23 views as risk. 24 And there is a handout connected to Bob's 25 presentation that will be handed out by David Nichols to ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

80 1 everybody. And I think we'll just hold -- we'll use their 2 presentations to start the discussions. And we'll let both 3 of them go first before we do that. Don? 4 DR. COOL: Thank you, Chip. As I mentioned a 5 little bit earlier when I was outlining the whole thing and 6 talking about philosophy, the Commission that we presently 7 have, in particular Chairman Jackson, has been encouraging, 8 pushing, driving -- you can use some other phrases, less 9 friendly terms as well -- the Agency in the direction of 10 using what risk information is available for various

• 11 12 13 contacts and settings in regulation and licensing inspection and other regulations.

The Agency has, quite frankly, much more 14 experience in date systems with the reactors, systems where 15 you can go through and do tremendously detailed. You're 16 talking about reams of paper analysis that give bent trees 17 and fault trees and a whole category of things which is 18 known collectively as probabilistic risk assessment or 19 probabilistic safety assessment type of activities, giving 20 bend trees and fault trees and the notes and diagrams. 21 And assigning probably as a failure or a success 22 to that we're doing a wonderful analytical methodology which 23 works extremely well when you have systems which have 24 engineering or which you have a lot of very detailed, 25 predictive data on failures of particular components of the ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

81 1 system, where you have a general -- a defense in depth or 2 multiple layer type of approach and it allows you to build a 3 wonderful methodology and construct for dealing with things 4 where you can then look and say, "What is the effect of 5 changing a particular system, taking out a service or 6 whatever it is, on the overall probability of failure, 7 measured as a quarter mil frequency or something like that." 8 That works real great in an engineering arena, 9 large system arena. Unfortunately, it 1 s much more difficult 10 to model humans and to model human interactions and human 11 failures. It's a whole other category of human factors and 12 human performance and performance shaping factors and a 13 series of things which go into that. 14 It's also more difficult where you don't have the 15 same sort of structures and systems and defenses which are 16 typically in place in a large facility where a lot of the 17 safety, if you will, to use that term somewhat loosely, or 18 the control mechanisms for dealing with material, defending 19 material from being where it's not supposed to be or 20 applying it in a way it's not supposed to be applied. Deal 21 with procedures for human reactions. 22 That comes most clearly to the fore into in 23 this area that we're dealing with here in medical. Because, 24 in fact, the only way that the material can effectively do 25 what we want it to do in that instance of therapy is to have ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

82 1 it directly applied to, interacting with a human.

2. For a cell physicist -- I'll wear that hat as 3 well we fundamentally try to deal with a time distance 4 issue. Keep it away from me. Keep it as low as reasonably 5 achievable. And that is also not a context which directly 6 applies because simply minimizing those, I think as you were 7 telling me, is not what you want to do. You want to 8 minimize the material necessary to achieve your objective 9 for that. Sort of to add some words to that. But you're 10 objecting to the parts and certainly you need a good image, 11 or you need to achieve this effects, or you want to have the 12 dose that is going to result in achieving that which you 13 want to achieve.

14 So, risk then has a new dimension to it, or maybe 15 even multiple dimensions to it, in trying to balance off the 16 applications and the activities. 17 So, the questions which you get asked, which are 18 sort of follow up questions. What can happen? How like is 19 it? And what are the consequences? Have tnuch more 20 complicated answers because they have to be answered in the 21 context of systems which you do not insist are the model as 22 well. 23 And systems for which the answer to the question 24 may even have vastly different answers depending on who you 25 ask that question of because if it is the patient and it's ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

83 1 availability and it's the chose between one form of risk and 2 killing this thing which is killing me or another form, 3 there's going to be a vastly different perspective on how 4 far you might be willing to go in order to try to achieve 5 killing that thing which is killing me then you would in a 6 different context. 7 So, it was a very different application from that 8 which we deal.with. We're dealing with environmental 9 radioactivity or decommissioned criteria or issues 10 associated with releasing sites or releasing material or 11 even -- back to the medical corrnnunity -- how we deal with 12 routine control in the labs and in the practice. And what 13 we start to worry about when we drop the syringes and other 14 things like that. So, we have a whole variety of aspects. 15 That has overall background in terms of some of the things 16 that we're struggling with in risk. 17 The Commission's challenged us to look at that 18 from that perspective. Yes, there is a lot of data around 19 there. How many times particular kinds of events happen. 20 And some data associated with how successful or unsuccessful 21 regulations have been in trying to prevent certain 22 undesirable outcomes. 23 If you go back 10 years or so ago the Agency was, 24 in fact, collecting data which gave information associated 25 with events in some of the diagnostic areas. The Agency ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034-

84 1 concluded that there wasn't a lot of benefit to getting that 2 kind of information. We were seeing lots of things. They 3 didn't have particular things where it appeared that a 4 regulation could have any value that was associated with it. 5 And, in fact, we haven't had a reporting of that kind of 6 event since '92, '93 type of time frame. On the other side of the equation you still have 8 continued reporting of the higher events in terms of dose 9 differences in the therapy arena and some comparisons have 10 been done with that associated with whether or not the 11 quality management program had mentioned in California 12 hadn't adopted it. History may, in fact, prove that 13 California was right. 14 Bu*t what -it said when we looked at that data is 15 there were two or three things when you looked at the events 16 that seem to always still be there as contributors. And so 17 that's why you have the proposal now in terms of what 18 remains. 19 Make sure that you have the right patient. Make 20 sure that that which has been written down actually got 21 translated correctly into the machine. 22 Make sure that you haven't gotten yourself trapped 23 in European time versus US time, day, week, month, month, 24 day, year sorts of things. Reversing a couple of those 25 contributes to some interesting things. Did you mean micro ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

85 1 or milli? It wasn't written down real clearly, that 31 is a 2 92 right there. Some of those sorts of things keep cropping 3 up when you look to the data. And so what we've attempted 4 to do here is to try and focus with this proposal on some of 5 those activities as part of the proposal and get away from a 6 great deal of the other prescriptiveness in the -- review 7 which, quite frankly, our retrospective analysis, that 8 didn't help much at all in terms of having any benefit. 9 Several of you mentioned earlier that there are 10 always costs associated with regulations, what are the 11 benefits associated with it? And the answer is that's an 12 experiment in that arena which appears that there wasn't a 13 lot of benefit for a large number of those kinds of 14 activities. 15 Is there enough data around to be able to say that 16 those particular regulation in fact changed the rate of this 17 administration or medically that means we would be using the 18 teacher. Difficult to say because of the statistics of 19 small numbers. The average number of events was in the 30s 20 if you go back six, seven years ago. The average number of 21 the event is now in the low 20s. With the statistical power 22 of that we cannot say whether that's a trend or not. 23 We had a time about two years ago where we went 24 through about six months with no event. And everyone's 25 going, "We have finally seen the data." Unfortunately, it ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

86 1 was the week right after that where we had four show up. 2 So, those sorts of statistics may be kind of 3 difficult to draw long term trends for this particular 4 process. But that's at least a partial answer back to some 5 of the suggestions. Very good comments about, "Is there 6 data?" Yes, there is some data. "Can you give us a clear 7 answer?" No, I can't necessarily. 8 "Can it give us some clues?" Yes, I think it can. 9 We have attempted to reflect some of those in the kinds of 10 requirements that we made in the proposed rul.e. 11 "Is diagnostic low?" Well, if I'm looking at it 12 from the context of the other hat that r have to wear in 13 dealing with EPA, no, not at all. Arn I dealing with it in 14 the context of the other risk that you might otherwise run 15 into in a comparative, relative sense in diagnosing the 16 difficulty that you have or in treating that, then the 17 answer is probably yes, significantly less than some of the 18 other possibly more evasive mechanisms that you would 19 otherwise have to use to figure out exactly what's going on 20 in the system. 21 "Is therapy always a high risk?" Well, again, I'm 22 not sure what the answer to that question is. Certainly, if 23 I were to -- from a radiation standpoint, yeah, that's some 24 of the highest doses that we ever deal with around here. 25 We're used to dealing with very low doses. On the other ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

87 1 hand, if I'm looking at it from a relative standpoint, it's 2 risk may be less lower compared to some of the chemical 3 agents or the surgical intervention agents that would 4 otherwise have to be used. 5 What's the base line and is that base line, in 6 fact, something that you can even establish for any period 7 of time? I'm posing these as questions because I quite

.8 frankly don't have a good answer. I'm not sure whether we 9 can generate a good answer. Overall. But these are the 10  questions I think we need to continue to face and to look 11  at. And then to use that information to try and calibrate 12  the extent to which we have laid out the regulations and the 13  r~quirements that we have in place.

14 And with that as an introduction from some of the 15 things that are going on in the Agency, I'll turn to Chip. 16 MR. CAMERON: Let's go to Bob for his 17 presentation. And then let's use that as a springboard for 18 discussion. 19 And David Nichols is going to be passing out some 20 copies of Bob's presentation so we'll give him a chance to 21 get those out. 22 And I think during our discussion we'll also be 23 going back to Don to -- then ask harassment. That's what 24 Don whispered up here and that's basically what I had in 25 mind, but I wasn't going to say that. But to ask him about ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

88 1 some of the ongoing activities that the Agency's engaging in 2 that might be trying to answer some of these difficult 3 questions. Some of the challenges that are evident from 4 Don's presentation. 5 DR. LULL: I'm Bob Lull and I'd like each of you 6 to take this document that David is handing out because I'm 7 going actually to be following from this document. We did 8 no create slides or overheads in the short period of time 9 that we had before this meeting. 10 But this document is one that has been circulated 11 and studied and evaluated by the Society of Nuclear Medicine 12 and the American College of Nuclear Physicians. And relates 13 their summary of feelings about risk and relative risk and 14 the important role that risk analysis should play in the 15 drafting of regulations to control this. 16 And I'm going to read for you from the regular 17 summary and then I want to go through and highlight some 18 portions of this document. I don't want this to be 19 something that just kind of flashes up on the screen and 20 then disappears from your life. 21 We've all been through lots of meetings where we 22 end up hearing the presentation, what is said, and then it 23 goes away and that's kind of a past part of your life that 24 never comes back again. 25 I want you to really kind of focus on this. Take ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

89 1 this opportunity now to try and focus on ,the document and 2 not any -- the points that we're trying to make because I 3 think th~y*re very important points that if taken to heart 4 will have a real impact on the outcome of this draft of new 5 regulation. And I think that they'd play a very important 6 role for trying to get i't right and get it appropriate. 7 Some of this kind of I'll read from the "Executive 8 Surrnnary 11 for a moment: 9 "Nuclear Medicine has been the subject of 10 regulatory scrutiny since it first entered 11 wide-spread clinical use in the 1950s." 12 Of course, nuclear medicine started -- we just 13 celebrated our 100th year two years ago of the discovery of 14 artificial radioactivity in 1896. But clinical, modern-day 15 nuclear medicine really dates back to the late '50s and 16 early *sos. 17 "The NRC has steadily increased its 18 involvement in the regulation of Nuclear 19 Medicine even though there hasn't been 20 really much change in the basic nature of 21 the radioactivity that they use. 11 22 I talk here about the number of diagnostic nuclear 23 medicine procedures that are in the millions, depending on 24 whether one includes the in vitro techniques or not and the 25 60-70,000 therapeutic nuclear medicine procedures. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

90 1 I would point out the distinction here that the 2 nuclear medicine and therapeutic procedures are distinct 3 from radiation oncology, which uses sealed sources. And in 4 nuclear medicine we're talking only about unsealed 5 radioactive sources. 6 This is an issue in that many of the statistics on 7 risk that the NRC has been using and coding mix together 8 radiation oncology incidents and events with nuclear 9 medicine incidents and events and thereby dilutes or 10 increases the relative potential risk assessment for nuclear 11 medicine in an unfair manner since those should not be mixes 12 and need to be separate and, indeed, its distressing to me 13 and many others in the Society of Nuclear Medicine and 14 American College of Nuclear Physicians that this continues 15 to be the case, that events that occur in the medical 16 practice of radiation oncology are mixed in as -- lumped 17 together with the events in the nuclear medicine 18 therapeutics. And that should not be the case. Those need 19 to be separated and distinguished. 20 The second paragraph of the "Executive Summary" 21 talks about NRC regulating nuclear medicine properly and 22 talks about the relative radiation dose and we'll emphasize 23 this again when I get into some of the body of this 24 document, that the average dose for a diagnostic nuclear 25 medicine procedure is 440 milligrams effective dose ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

91 1 equivalent, which is really equiv~lent to somewhere in the 2 midrange of the normal annual background radiation in this 3 country. We're talking about a very low level of radiation 4 exposure and associated risk, if any. 5 Now, there's a detailed discussion of cost 6 regulation and subsequent impact. And there's some folks 7 here I want to reference and read this part here in the 8 "Executive Summary." 9 "Because any review of regulation and its 10 impact on the regulated corrmrunity must 11 include a discussion of the negative impact 12 of cost on morbidity and mortality." 13 In other words, we're not talking about the risks 14 that you're *preventing by action or the risks that may occur 15 through inaction, but you have to look at the risks that you 16 create by using resources for actions that could be used in 17 other places. 18 Because resources, as we're learning more and more 19 in a managed care medical environment, are limited. And 20 there aren't unlimited resources for things. And we need to 21 use and we need to look at risk not only in terms of 22 the the focus and the topic that's being focussed on but 23 also in terms of what hold may be left in some other aspect 24 of the lives of our country by using resources that could be 25 targeted at greater needs then on something that is ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

92 1 essentially a very low risk activity like diagnostic and 2 therapeutic nuclear medicine. 3 Well, we recommend some books here and some 4 readings. Supreme Court Justice Breyer's book, Breaking the 5 Vicious Cycle Toward Effective Risk Regulation, I think is 6 something that's kind of must read. 7 "The exact cost of NRC regulation of 8 byproduct material in medicine is not very 9 well defined." 10 It would be nice to have a better handle on what 11 the costs of regulation are because there are significant 12 costs that will correlate when properly defined with 13 mortality and morbidity that could be prevented in other 14 arenas. 15 "It is also clear, from the National Academy 16 of Science Institute of Medicine report that 17 the NRC regulations have no positive impact 18 on mortality and morbidity." 19 That is all the regulations of nuclear medicine, 20 according to this very detailed study report have had no

21. demonstrable impact on mortality and morbidity.

22 We also recommend reading Bernie Cohen's text. It 23 says that pages from his text are attached but they're not. 24 But the concepts are included in the body of this document 25 that you've just been handed. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

93 1 Well, we think that the NRCs approach to a risk 2 based regulation creation and review is an important one, 3 but we feel that the NRC should formulate its regulations 4 based on actual risk and not perceived risks of nuclear 5 medicine and other medical uses of radioactive material, 6 byproduct materials, that are under the NRC's purview. 7 So. I'd like to hand out -- talking to some 8 specific points contained in this document so that it's not 9 just a pile of paper there. 10 First of all, let's turn here to the first page. 11 If everyone would follow through with me here. The 12 "Framework for the Regulation of Nuclear Medicine." We have 13 an introduction that explains what the two major 14 professional o~ganizations for nuclear medicine are about, 15 the American College of Nuclear Physicians and the Society 16 of Nuclear medicine. 17 And I won't go into more detail about that other 18 than that they represent the individual who have a concern 19 about the rules and.regulations that you are discussing in 20 these meetings and how they will be applied to patients that 21 they care for. 22 We have a very good section here on the history of 23 nuclear medicine. And I advice you to look at this. Its 24 how in 1946 the first thyroid cancer patient had successful 25 treatments showing the potential significant role of ANN RILEY & ASSOCIATES, LTD. Court Reporters

• 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

94 1 radioisotopes in the ~herapy of very specific diseases such 2 as thyroid cancer and how, later, the treatment of 3 thyroidtoxitosis (phonetic) became a significant part of the 4 material describing how nuclear medicine has evolved to 5 where we now do over 100 nuclear medicine imagine procedures 6 that provide unique information about the function of organs 7 within the body and that these are done with a relatively 8 small number of radioactive isotopes that are tagged to an 9 eve~ larger number of nonradioactive carriers. 10 Now, the section Bon page two -- let me turn to / 11 page two -- starts a history and has a succinct history of \ 12 the regulation of nuclear medicine from the Atomic Energy 13 Act authorization for the regulation of reactor-generated 14 radioactive byproduct materials and emphasizing that the NRC 15 does not regulate, accelerate or produce radioisotopes. So 16 that there is a large body of radioactive materials that do 17 not come under the purview of NRC regulations, but rather 18 are regulated by the states. 19 It describes in some detail and gives you some 20 historical points which I'm not going to go into in much 21 greater detail here. 22 I'd just like to point out that on page three we 23 see that in 1976 there was another example here of the NRC 24 confusing nuclear medicine and radiation oncology and 25 applying regulations based on incidents that occurred in ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

95 1 radiation oncology to nuclear medicine. 2 This is something that continues on and I think 3 that even some of the statistics that were spoken by Don 4 Cool included a mixture of nuclear medicine and radiation 5 oncology events. To get a clear picture of nuclear medicine 6 those need to be distinguished. 7* On page four of the document that you have before 8 you I would like to emphasize that the paragraph that says: 9 "Thus, it is clear that the language of the 10 Medical Policy Statements states that the 11 NRC would regulate patient safety only when 12 justified by the risk but yes over the last 13 20 years the NRC has been decreasing its 14 regulation when there has been no 15 demonstrable increase or change in risks. 16 And the risks have remained very, very low." 17 We need to have more -- look at the relative risks 18 of nuclear medicine in terms of the regulatory responses 19 here. 20 We note that he -- in 1994 when the NRC, in 21 response to the unhappiness that our organizations have 22 expressed over the increasing regulations in the face of low 23 and unchanging risks that the NRC Commission contracted the 24 National Academy of Science as its Institute of Medicine to 25 review its regulatory program and that final report, as ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

96 1 described on page five of the handout, was released in March 2 of 1936. And I'll leave you to read that. 3 Basically the report stated that the risks from 4 nuclear medicine, which the National Academy of Sciences 5 looked at and evaluated were minuscule and that the 6 regulations had basically outlived their original purpose 7 and that the regulations did not necessarily relate to the 8 risk and that a whole new view of this regulatory 9 environment needed to be taken. 10 The Society totally agreed with this, but I 11 believe portions of the report had been rejected by the 12 Commission. 13 Then to push forward here to page eight and 14 emphasize to you here we start describing nuclear medicine. 15 It gives you a greater description of what we do and also 16 how people are currently being trained for nuclear medicine 17 and what the requirements of training programs are in terms 18 of education and physics, radiopharmacy, radiation biology, 19 patient evaluation, radionuclide therapy and diagnostic 20 studies and the board certifications that are available. 21 It doesn't describe in great detail that occurs 22 for other specialties, such as the diagnostic radiology 23 residents who also are being trained within our nuclear 24 medicine facilities and provide a very large amount of the 25 nuclear medicine clinical care that occurs out in the real ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

97 1 clinical environment. 2 On page nine we have a section that describes 3 diagnostic nuclear medicine and section B that talks about 4 the risks associated with diagnostic nuclear medicine. And 5 I would like to quote from the last part of that paragraph 6 about risk: 7 "In fact, it appears that there has been only 8 one radiation-induced death from a nuclear 9 medicine error since 1936, when the 10 specialty began. And that specifically, 11 about 35 to 40 years ago a patient appears 12 to have died from liver failure due to the 13 fact that the patient was administered gold-14 198-colloid at 1000 times the intended 15 dose." 16 I don't think there is any other human activity, 17 and there's certainly no activity in health care, which can 18 claim that they've only been associated with one death in 19 the entire history of that activity. This is, on the face 20 of it, extremely low risk. 21 And so I think it's safe that one can agree with 22 the conclusion at page 10 here at the top: 23 "Because of the attendant low radiation 24 absorbed doses, Nuclear Medicine diagnostic 25 materials have little risk." ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

98 1 Again, we emphasize the average ~ose is 440 2 milligrams radiation dose and patients on diagnostic -- 3 studies. 4 And table one on page 10, continued on the next 5 page, gives you some comparison radiation exposure rates 6 starting with a chest X-ray at 20 milligrams and going all the way up to doses that actually can produce morbidity and 8 mortality just to give you a relative perspective on the 9 radiation average dose in a nuclear medicine diagnostic 10 procedure. 11 Now, on page 11 we now turn to therapeutic nuclear 12 medicine where we have about 60-70,000 procedures performed 13 per year. 14 Therapeutic nuclear medicine is primarily utilized 15 for treating thyroid cancer, patients with hyperthyroidism, 16 usually to due Grave's disease or multinodular toxic 17 goiters. 18 Also is used for relief of pain in patients with 19 sever bone metastases. There are other applications that 20 are being utilized that aren't as routinely used as the ones 21 I just mentioned. 22 All of these do result in significant higher doses 23 to the patient, by intent, but still, our low risk to the 24 patients in that even with therapeutic applications of 25 nuclear medicine there have been no documented deaths due to ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

99 1 this activity. 2 It's also considered to be very low risk for the 3 public and for the workers. And all of that is described 4 under paragraph 0. 5 On page 11 we also make some distinctions about 6 nuclear pharmacy and emphasizing that nuclear pharmacy 7 practice is controlled and regulated by the states and by 8 the State Boards of Pharmacy. And distinguishing between 9 the compounding that occurs within a nuclear medicine 10 department and that which happens to have been a centralized 11 nuclear pharmacy or radiopharmacy which also is regulated 12 predominantly by state activity. 13 On page 12 just to point again to make that 14 nuclear medicine is distinct from radiation oncology and 15 that even therapeutic uses of radioisotopes in nuclear 16 medicine and any events associated with those should not be 17 lumped together with sealed sources and events in radiation_ 18 oncology. If you want to get a true picture of the relative 19 risks for nuclear medicine section procedures. 20 Now, in section four on page 12 we arrive into a 21 discussion of the concept of comparative risk. Now, risk as 22 Don had mentioned or not, isolated and you need to look at 23 things in comparison. 24 We quote here of the speech that was given by Dr. 25 Gail de Planque, a former NRC Commissioner, on the 13th of ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

100 1 October to the National Academy of Science's Institute of 2 Medicine group reviewing NRC regulations of nuclear 3 medicine. 4 And I think that there's very useful information 5 there which I will only highlight some aspects of. 6 She ended up giving a speech about comparative 7 risks to help put in context how low the real risk for 8 nuclear medicine procedures are, pointing out that smoking a 9 pack of cigarettes, you know, fines that a death from a 10 related cause of about 28 percent of smokers. So, people 11 who smoke a pack a day increase their risk of dying from 12 related thing about 28 percent. Motorcyclists deaths at 11 13 percent. The chance of dying in a motorcycle accident. You 14 drive a car like I did to get here today, I have a 1 15 percent. Those of you who flew in by air only had .02 16 percent. You kind of do these comparison analysis and as 17 pointed out previously, they can drive you somewhat crazy 18 but they also perform a very valid, relative risk evaluation 19 that helps you put things in perspective. 20 And we think that that's what's very important, is 21 to put things in perspective and see why are we doing so 22 much regulation of something that is of so low risk. And 23 why are we doing all that regulation of something that's a 24 very low risk. And her statements on page 14 where she goes 25 on to discuss that therapeutic misadministrations of ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

101 1 byproduct material, she ended up calculating about .6 out of 2 1000 or .0006 percent risk of death from a therapeutic 3 misadministration. 4 While this was stated there again, even Dr. de 5 Pianque ended up, you know, confusing by including radiation 6 oncology in her statistics. So, that nuclear medicines risk 7 is actually significant lower then even that because that 8 included radiation oncology events. And therapy with 9 generally much sicker patients then in nuclear medicine. 10 So, I tend to sununarize here that the ACNP and 11 the -- and the Society of Nuclear Medicine feel that in 12 order to formulate properly a risk based policy that it's 13 important that the NRC examine the risk of nuclear medicine 14 as they compare, really, to other medical modalities and 15 also every day risks that people are willing to assume for 16 the general public. 17 Now, they also ought to look at things that occur 18 in medicine that have some -- where there's been an 19 intent -- a definite intent not to regulate these events in 20 nuclear medicine. Why nuclear medicine, the least risky of 21 all the health care enterprises, should be so heavily 22 regulated whereas so many other practice of medicine have 23 very little regulation and seem to be doing just fine is a 24 conundrum that needs further explanation if we're going to 25 continue that degree of regulation. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

102 1 Page 15, where we talk about nuclear medicine 2 versus other medical modalities, do you see that there's a 3 table two associated with that. It relates to nuclear 4 medicine, it related to risks associated with various X-ray 5 procedures and also it shows that the Radiopharmaceuticals 6 have orders of magnitude lower than those associated with

  ":J regular drug administration, such as drugs like penicillin, 8   heparin, even aspirin carries significant greater risk than 9   the diagnostic administration of any radiopharmaceutical.

10 And in terms of the documented potential side effects. 11 We also talked about nuclear medicine versus every ' 12 13 14 day risks assumed by the general public. Let me give you a number of a usual standard set of tables here. Basically, our risks are so low that even comparing them to the list of 15 normal activities that are generally accepted and acceptable 16 to the public shows that we are extremely low compared to 17 even these normal human activities. And that's table five. 18 Table three shows you the list of death in sports. 19 Table four shows you the conunonplace, acceptable risks of 20 death by non-cancerous risks due to a number of activities. 21 And table five shows you the occupational risks of death on 22 different kinds of occupations. You've probably seen some 23 of these things in the past, but it's useful to have this 24 available. Remember that compared to all of these, nuclear 25 medicine through it's experience over the past 15 years, has ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

103 1 shown no deaths except maybe that one case of liver failure 2 from a misadrn.inistration. 3 And so we -- in some way we take the NRC at its 4 word that it's going to actually look at risk based 5 regulatory past approach and in view of this and the minimal 6 risk that's posed by nuclear medicine, ACNP and SNM believe 7 that the regulatory burden imposed by the NRC on nuclear 8 medicine and also by states on nuclear medicine and 9 basically address the following questions which are 10 contained on page 22, the last page of your hand out. And 11 that is: 12 "What is the problem sought to be solved or 13 prevented?" 14 In other words, you need to be real clear about 15 what is -- what is the problem? What is the risk that 16 you're trying to address with these regulations and is this 17 a significant risk? How high is that risk? How big is that 18 risk relative to the risks that people have in general in 19 their lives and that other agencies decide to or not to 20 address by regulatory response. 21 "Number two. Is there a voluntary standard 22 that successfully can address the issue 23 that's consistent with the final policy 24 statement?" 25 In other words, are there other ways where other ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

104 1 than NRC regulations where you can end up accomplishing the 2 same goal, or whether that same goal has already been 3 accomplished. 4 I think there's a large movement to try to 5 minimize intrusive federal regulations, regulations on a 6 federal level if you don't need it. And I think this is the 7 example where, carefully looking at what's already in place 8 available within the states or within professional 9 organizations, you know, we'll end up serving many of the 10 purposes that regulations have attempted to do in the past.

• 11 12 13 But it's just superfluous.

                    "Also, is there another regulator that has a mandate already?"

14 There are the state organizations that regulate 15 things. There are a number of other regulators of health 16 care, such as Joint Commission on Hospital accreditation 17 that had significant regulatory control. 18 The standards of practice from our professional 19 organizations are factors which also serve to limit and 20 maintain low risk. And particularly I think that's 21 something which is an inherently a low risk activity like 22 nuclear medicine. 23 And finally if you look at what's the cost 24 benefit: "What is the least costly and least restrictive 25 way to genuinely solve the problem? ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

105 1 We think that after the NRC looks at these 2 questions in context of the proven low risk and the actual 3 real risks associated with nuclear medicine, not just the 4 perceived potential risk, that they will find opportunities 5 to withdraw much of the regulatory force that is being 6 brought to bear upon the practice of nuclear medicine. 7 In that case, I've taken you through the document. 8 Please hang onto it. This represents some organization of 9 the Society of Nuclear Medicine and the American College of 10 Physicians' view on risk assessment and the diagnosis and 11 therapeutic applications of radioisotopes. Thank you. 12 MR. CAMERON: Okay. Thanks very much, Bob, for 13 that overview. It raises some intriguing questions and I 14 think at some point we need to get into the issue of what 15 are the implications for the provisions of the proposed 16 rule. 17 In other words, is the data in at least for 18 nuclear medicine? You made a distinction between nuclear-19 medicine and radiation oncology. Is the data in and, if so, 20 what should we what should we do with that in terms of 21 the provisions some of the provisions in the proposed 22 rule? 23 And I guess I would just open it up now for 24 discussion of -- on some of the provocative information that 25 Bob presented and also some of the challenges that Don ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-003_4

106 1 identified. 2 MR. BROWN: First of all,* let me thank Bob for 3 that presentation*-- government relations board -- for 4 putting that together. I think it does a really good job of 5 putting the risk involved with diagnostic nuclear medicine 6 really in perspective and really points out how low risk it 7 really is. 8 I do want to raise a question. I was a little 9 disappointed to see that the risk -- the work on the risk 10 review group was not incluoed in the Part 35 and their 11 reconunendation is coming sometime later this fall. l 12 What is your plan? I mean, depending on what they 13 reconunend how can you go back and -- I mean, I know you can 14 change it before the final, but we were hoping you'd correct 15 their reconunendations and how their reconunendations would 16 impact the proposal. 17 MR. CAMERON: And Don, can you explain to 18 everybody what Roy is referring to in case they don't know? 19 DR. COOL: Okay. I'll try to do that and then 20 I'll attempt to answer your question. 21 As a separate initiative, which actually stamped 22 out another one of the strategic assessment direction 23 setting issues, I have asked my staff to take a look at the 24 risks posed by the various uses of byproduct material, not 25 just medicine, which are under the jurisdiction of the ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

107 1 Commission. So, this is in the United States Regulatory 2 jurisdiction, Part 3339, by the Department of Internal Uses. 3 A group of NRC and a grievance -- folks have now 4 been engaged in that process for about the last seven months 5 or so at this point, using some contractor assistant and I 6 taking a look at the various systems to use their lingo. 7 Put that in quotes, if you like. A system might be a 8 radiography and all the things associated with the camera to 9 conduct~- conduct and activity. 10 Various kinds of gauging devices constitute 11 various system~. And certainly medical uses constitute 12 certain kinds of systems and they're not consistent with 13 excluded from this particular study. 14 We are by Commission production to be providing 15 the Commission with the technical basis report coming out of 16 that study. And some recommendations to the Commission in 17 terms of directions to proceed, changes which that study 18 would indicate in terms of 10 CFR Parts 30 to 39 at the end 19 of this year. 20 That study is to be completed this fall to be 21 provide those recommendations to the Commission. 22 One of the things that we did with that, both in 23 terms again of trying to keep the task itself to a 24 manageable activity was to focus upon the uses of the 25 material in the occupational public exposure contents. I ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

108 1 kept them out of patient context -because that would have 2 opened up an area, unique area -- unique to this one 3 particular part. 4 And part of what we were attempting to do was to 5 put by an analysis which would allow us to look at the 6 various uses of byproduct material and occupational and 7 public exposure and make some reconnnendations to the 8 Commission on the kinds of forms of licensing and inspection 9 which will be conducted. 10 When we provide those reconnnendations to the 11 Connnission we will certainly need to look at -- I would 12 expect that we would be trying to answer Roy's exact 13 question. 14 Are there implications for the medical rule which 15 will at that point be off of public connnent in terms of what 16 should be considered and moving forward for a final 17 approval. 18 If those reconnnendations are such that we need to 19 suggest to the Commission that there are some fundamental 20 changes, that this would dictate some things which would go 21 beyond that which are already on the table, some changes for 22 sure are already part of this proposal. That would mean 23 that we would effectively be asking the Commission to stop 24 that present rule and go back to an alternative proposal. 25 One of the things that was mentioned earlier, ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

109 1 whether it should be put in the padding (p~onetic) or not is 2 the simple fact that there are changes that can be made to 3 the proposed rule to the final rule on the basis of comment. 4 If there are things which go beyond that band, are not 5 directly a outcome of a comment process, that were discussed 6 in the workshops, were part of the written comment record, 7 which is the Agency basis, then we wouldn't need to 8 re-propose. Certainly that is a possibility. 9 I think there is a much greater possibility, 10 without trying to prejudge where that studies going to come 11 out. 12 But the initial set of changes that the Staff is 13 going to suggest to the Commission will be more in the 14 device sealed source in some of the gauging arenas and some 15 of the other things that are going to be conducted. We're 16 going to let them in areas such as medical, where there are 17 a lot of human interactions. I'm not sure where all those 18 will play out at that time if the report is not completed 19 and we will have to see where we are at the end of the year 20 and see at that point what that might or might not suggest 21 to the Commission in terms of the Staff in terms of whether 22 that process will proceed. 23 So, we're in a very dynamic sort of position. In 24 an ideal world, yes, we would have that memory, we would go 25 back and we would take a-look at that. The Commission will ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-D034

110 1 be given that opportunity. What the Corrrrnission will choose 2 to do with it is yet to be determined. 3 Roy's is back up and I know -- 4 MR. CAMERON: Go ahead, Roy, and then we'll see if

• 5 Marjorie has a clarification on your description of the 6 legal situation.

7 MR. BROWN: Yes, just a couple of follow ups. If 8 they concentrated on a dose to the bones of a patient, is it 9 likely that may change the recorrrrnendation for the University 10 of Cincinnati proposal? 11 And second of all, once they make their 12 recorrrrnendations will the public get another crack through 13 the Administrative Procedures Act to review any proposed 14 changes of results on that? 15 DR. COOL: The answer to the second one is much 16 easier than the answer to the first. Hidden changes that we 17 suggested the Corrnnission would then go into a standard rule 18 making process, which means that they would approve and 19 develop a rule making plan, there would be a proposed rule 20 developed, there would be public corrrrnent on that proposal. 21 MR. BROWN: That would go in a parallel track then 22 as Part 35? 23 DR. COOL: It certainly would for all the things 24 that were not related to medical uses. Again, r- don't know 25 whether the Corrrrnission would want us to make any adjustments ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

111 1 with this rule and whether they would tell us to do that in 2 parallel to -- I suspect they might, given some of the other 3 actions they've taken. 4 This effort to get a basic revision in place and 5 at least move us back that step in the process. 6 Having answered that in a little more detail I was 7 going to -- can you come back and give me the first one or 8 did I manage to 9 MR. BROWN: Yeah, do you*know if your Cincinnati 10 proposal? 11 DR. COOL: I'm going to guess there's not a lot of 12 chances that that -- that this will change that particular 13 proposal. I can't prejudge it because not all of that 14 analysis is in. But I'm willing to guess right now. It's 15 my personal guess that that's not going to have a great 16 impact on that proposal. 17 MR. CAMERON: And let me before Marjorie speaks 18 let's ask Don to clarify. If this study forms the basis for 19 something in the final rule or either a modification goes in 20 the proposed rule or to continue with an aspect of the 21 proposed rule as opposed to just confirming things, are you 22 saying that people would get a crack at looking at the 23 methodology, not only the data behind the study, but also 24 the methodology that was used to derive those data? 25 DR. COOL: I could shorten your question, Chip? ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

112 1 :MR.. CAMERON: Probably. 2 DR. COOL: Because I think the question you asked 3 was will the study itself and how we did it be available for 4 people to scrutinize and the answer would be yes. 5 :MR.. CAMERON: And there was a little bit more. 6 Okay. So, he found his words for me. This may cause a 7 indeed cause a change -- could cause a change with the 8 schedule on any reciprocal aspects. I guess that's all fair 9 game then, right? 10 DR. COOL: If there's a result of this, the 11 Commission wants us to change or modify things of Part 35 12 that effects this ruling, the obviously all of that will 13 have to come back and we'll have to do whatever main 14 proposals we will need to do and make sure it's been subject 15 to copican (phonetic). 16 Again, sort of answering Roy's question, my 17 personal ~owledge is that based upon other decisions that 18 the Commission has made that they probably would want to 19 have the renditions stay on track and take advantage of the 20 fact that that process was already well on to gaining 21 advantages, gaining by the proposed rule. And to move it 22 parallel 23 with -- for any other changes or additional modifications. 24 That's based both on the fact that the Commission has 25 usually opted to try and complete those processes where it ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

113 1 can be because you can go on almost further and modify, 2 modify, modify. 3 And also because the Commission got us into this 4 study in large measure because of it'~ concern with regards 5 to some of the devices, gauging devices, accountability 6 issues and a number of things related to that and I would 7 personally guess that they would want us to focus the first 8 rule making efforts that would come out of that stud in that 9 arena which would take more than six months between December 10 and when this revision we'll give to the Commission. 11 MR. CAMERON: And Marjorie, do you want to add 12 something? 13 MS. ROTHSCHILD: Yes. All I was going to say was 14 that the question about whether there would have to be 15 republication of the proposed rule has not presented to the 16 general counsel and that would have to be considered if, in 17 fact, that issue or set of facts comes to pass. 18 So, we really at this point, we are not 19 considering that. And I just wanted to clarify that. And 20 that would be a case obviously on the specific facts at the 21 time. 22 MR. CAMERON: Okay. Thanks for that 23 clarification, Marjorie. 24 Let's go to Melissa and then go back over to this 25 side of the table. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

114 1 MS. MARTIN: I would just like a point of 2 clarification. Maybe I'm the only one in the dark. You 3 said you have 30 reports of what your significant 4 administrations or at least something that caught your 5 attention at that level. 6 Can you differentiate as to which ones of those 7 were diagnostic and which ones of those were therapeutic so 8 that we've got a break down of which ones -- or nuclear 9 medicine, radiation oncology, how do you -- I just would 10 like to have some kind of information on the break down of 11 those if you could. 12 DR. COOL: You certainly can based on the 13 individual reports and the material that's in the database. 14 I can't, at this moment,* give you a break down that tells 15 you that four were teletherapies and three were 16 brachytherapies. But the database is certainly sufficient 17 to allow that kind of break down of those that were reported 18 under the existing requirements. 19 I just can't note do it for you today right off 20 the top of my ~ead. And it's changed over the course of 21 time. You've seen -- as you've seen a raise of the certain 22 kinds of modalities, you've seen a rise in their relative 23 contribution to ~he net number. 24 MR. CAMERON: Don, that does raise -- Melissa's 25 question, I guess, raises the issue that Bob raised in his ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

115 1 presentation about the fact that of all misadministrations 2 being lumped together rather than separating out 3 misadministrations with nuclear medicine implications from 4 those with radiation oncology. 5 Would you care to respond to how we do use these 6 reports in terms of trying to arrive at risk based 7 decisions? I think you spoke to that earlier. In other 8 words, there's data but it isn't sufficient to provide 9 complete answers but it gives us some hints. And maybe you 10 could talk about those hints. 11 DR. COOL: I'm going to try to do this quickly 12 because we could spend all afternoon. There are a whole 13 series of uses that this gets put to. Starting with the 14 individual report coming in which gets examined and followed 15 up on that particular basis, one of the things that we then 16 try to do is we try to look at it for generic implications. 17 I have a standing group of staffing managers 18 within my division that goes and looks at all of the event 19 reports and all the other activities. This being only one 20 of the pieces of input. And says, "Have you seen others 21 like this?" Was there something underneath it that 22 contributed to it that either we need to send out 23 information, "Watch out, this was a contributor", or in fact 24 we need to consider a change to the regulations as a result 25 of this. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

116 1 So, there are a series of uses that get done. We 2 go back and do some retrospective analysis. There was a big 3 review that was conducted back a year or so ago on the 4 things that had beert reported related to the quality 5 management rule to try and determine whether or not there 6 was value. This is what I mentioned a little earlier. That 7 there were some underlying themes that keep coming up. When 8 you go back and look at the data, the contributing factors 9 that came out of each of these analysis. 10 They are also all resident in a database, the 11 nuclear materials event database. Medical being only one 12 small subset. You'll find all events related to materials 13 use involve the gauge uses events and all the fuel cycle 14 events and some of the safeguard transportation issues 15 within that database which contains both NRC data and state 16 data. 17 One of the other things we will find sometimes is 18 we've seen one and after we poke around a little bit we 19 discover that if you go looking more broadly you'd find some 20 others and, indeed, you can learn some things about trans. 21 MR. CAMERON: Okay. Thanks, Don. Nikki? 22 MS. HOBSON: Well, I'm kind of going to shift 23 gears. But something kind of really caught my attention on page one of Dr. Lull's report. 25 It seems to me that knowing what the cost of ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

117 1 regulating the medical uses of isotopes would be a reai 2 useful piece of information. And the fact that, at least 3 according to Dr. Lull, you don't really know what -- what's 4 spent on regulating medical uses. 5 And I'm wondering, is that is that a function

                                               )

6 of your accounting or budgeting system or is it just that no 7 one has really ever sat down and tried to figure it out? 8 Couldn't we do that? 9 DR. COOL: That's an excellent question for which 10 there is no single excellent answer, which is part of the 11 reason -- in the situation, without trying to justify it. 12 In no one place, at this point, do I think you have the kind 13 of data that would enable you to complete an analysis. 14 Certainly, there are things within the Agency that 15 individuals did in the Agency about staff time, dollars 16 contracted out, things that are spent in that part of the 17 equation. 18 That's actually the small component. And Dr. Lull 19 also addressed to -- what I think he was referring to which 20 is how much effort, time, did these records otherwise are 21 net generated in the corrnnunity associated with one way or 22 another with the regulations. And then without justifying 23 it but simply to note that one of the confounding variables 24 that goes along with that is the fact that in one sense you 25 could attribute certain activities to the particular regime. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

118 1 And you could say if you eliminate that particular 2 requirement then that expenditure wouldn't take place. 3 I think you would find -- I'm going to wear a 4 health physics hat and Ed might want to comment from the 5 Health Physics Society perspective -- _that some of those 6 might be conducted maybe not in exactly the same arena, in 7 other case for other reasons irrespective simply because it 8 constitutes the good practice regulation protection and 9 other things that go along with that. 10 And what you find has happened over the course of 11 time and this happens lots of places, not just here -- is 12 that regulation feeds good practice, good practice feeds 13 regulation. And a variety of things go back and forth such 14 that when you then go and try and do the kind of study that 15 you're referring to and try to tease out what is the exact 16 cost attributable to the regulation versus that what you 17 might do irrespective because that is the appropriate way to 18 handle the material, different people will give you 19 different sets of answers with regards to how far industry 20 would have taken itself or a particular segment of society 21 would have taken itself irt the conduct of the activities. 22 And that answer will change over the course of time 23 depending on all of these pressures, managed care, and 24 otherwise that they might not balance it out. 25 So, it's several pieces to a complicated question. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

119 1 I hope that helps you a little bit. 2 MS. HOBSON: Well, can I just pursue it just one 3 little bit further? 4 Recognizing that all the things that you say are 5 true that, you know, there are people out there doing things 6 at some cost because of. the regulations and we can't measure 7 that. 8 Is there a way of measuring the direct 9 expenditures, say, at NRC and then you should be able, I 10 would think, look at least where the agreement stays and who 11 are basically doing what the NRC would otherwise be doing, 12 and calculate at least a ballpark figure or -- it's not just 13 dreaming and wishing on it, right? 14 DR. COOL: The answer is yes. 15 MR. CAMERON: There is going to be a presentation 16 on regulatory analysis later this afternoon that may give 17 some of that data. And Cathy may want to say something 18 about it. 19 But I think that I'd like to explore -- anybody 20 else who wants to say something about the cost issue because 21 that could be very pertinent. 22 Cathy, did you want to say anything about the 23 regulatory analysis at this point? 24 MS. HANEY: Let me just say a couple of sentences. 25 What we did is part of the rule making to try to come up ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

120 1 with an idea of what the cost of the rule of the impacts, 2 what's to do with the current regulatory analysis where we 3 go through each section of the rule and say, "Is this an 4 increase on the licensee? Is it a decrease on the 5 licensee?" And the same thing to NRC. And when we went 6 through and came up with some -- a total savings and I'll 7 give you some numbers this afternoon -- we did not go back 8 and do a base line that says, you know, "Right now, Part 35 9 costs X." It can be done, but we looked at it more from a 10 standpoint of will this proposed rule reduce or increase the 11 burden on licensees, and we showed a reduction. 12 So, those numbers are available in one form or 13 another to get the impact. And I'll go into some numbers 14 this afternoon. 15 We also have what we call and ONB report that we 16 need to do in order to support the rule. Don made mention 17 of it earlier. With ONE what we have to look at is what is 18 the burden on the licensees and NRC for the records and 19 reporting. 20 So, again, we use some certain base line numbers 21 of what the hourly rate of staff is, the number of records 22 that need to be maintained and how much time it needs to 23 maintain each record and to prepare each record. The same 24 thing with reports. 25 Both of those documents are in the public domain ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

121 1 for connnent. And it's something that during review of the 2 rule .individuals can look at and say, well, you know, you 3 think that it would take someone that gets paid $30 an hour 4 is going to complete this report. That's not the case. 5 It's going to be someone that gets paid $100 an hour. 6 Therefore, your estimates are off a factor of three, so 7 you're not saving as much as you think you are. 8 So, those things are out in the public for 9 connnent. 10 MR. CAMBRON: Before we get to David who, I

• 11 12 13 believe, has also a connnent on cost, Nikki, what's your idea of why this information would be useful and how it could be used?

14 MS. HOBSON: Well, there are, I mean, off the top 15 of my head a couple of ways. 16 First of all, I found this paragraph really quite 17 intriguing. You know, if you do consider the negative 18 impacts of regulatory costs, you know, if you're spending 19 $12 million, according to this, on regulating an activity 20 that clearly doesn't kill people, you have on the other hand 21 not spent the money on maybe another activity that does kill 22 people.

• 23 So, I do think that -- that you can make a more 24 rational allocation of your resources if you kind of knew 25 what resources you were spending.

ANN RILEY & ASSOCIATES, LTD .. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

122 1 But second, and more di~ectly connected with the 2 patient point of view, is regulation as cost to the final 3 product that's delivered to the patient. And, you know, a 4 lot of the regulations are great and we need them and we 5 want them, but if the regulation isn't really serving a 6 useful purpose, but it's costing the patient more money, 7 then we would oppose it, you know. I mean, it's just sort 8 of a self-interested kind of thing from the patient point of 9 view. 10 MR. CAMERON: Okay. Good points. I guess the 11 first point goes to the point that Bob Lull brought up from 12 the study that if you're spending resources on low risk 13 activities you could be using those resources somewhere 14 else. 15 David? 16 MR. BELK: Yes. I just wanted to sort of comment 17 on the issue of the cost of regulations in sort of a general 18 sense. 19 Speaking for the university -- a community as 20 large as the university, some 130,000 folks state wide, the 21 cost of regulation is significant. However, as was pointed 22 out -- Don pointed out -- to tease the exact cost of 23 regulatory compliance out of the operation -- the 24 operational part of the university, is extraordinarily 25 difficult, for a number of reasons. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

123 1 Several of them are just almost impossible to 2 describe where we already have staff programs developed to 3 address other related issues. If you were to ask, well, 4 specifically in the region safety program on a specific 5 campus, how much does it coast for Part 35? There's 6 essentially almost no way I could think of of doing that. 7 But again, I think it's fairly commonly understood 8 the cost of regulation is significant, particularly to an 9 institution as large as the university. 10 And yes, it does -- the cost of regulation does 11 take away from other functions of the university. Obviously 12 here we're primarily concerned about medical applications 13 and medical services. However, it also impacts the cost of 14 a kid's diploma. I mean, there's no way you can put that 15 under it, you know, how much of a cost for an education. 16 But it's there and it is significant. 17 Due to the autonomy of the different campuses and 18 the way budgets are administered and accounted for, 19 collecting information for this sort of purpose would be 20 extraordinarily difficult although I agree it would be 21 useful. But I'm not exactly sure how we would begin to 22 approach it. 23 MR. CAMERON: Okay. Thank you. 24 I know that we're sort of getting into the -- 25 we're going to have a break for lunch here. We do have time ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

124 1 after we come back to continue to discuss this particular 2 topic.. But I realize people are probably getting hungry. 3 Why don't we go to Bob for a comment and we'll see 4 where we are then. 5 DR. LULL: I have basically two comments. I'll 6 keep it brief because I'm hungry, too. 7 And by the way, I would like to compliment the 8 NRC, the excellent selection of restaurants they had in the 9 front of the book. That was an example of really very good 10 research. 11 MR. CAMERON: Risk benefit. 12 DR. LULL: Well, actually, I would also point out 13 that actually eating your lunch today is a higher risk than 14 getting the diagnostic nuclear medicine information. 15 MR. CAMERON: For those of you who would rather do 16 that. 17 DR. LULL: And it's even higher if you go to lunch 18 with someone who does not know the Heimlich maneuver. 19 Okay. My two comments are this: First of all, 20 what I'd like to hear sometime this afternoon is a 21 continuance of this discussion and what the NRC has or is 22 planning to do to develop both the structure and the 23 function that I see is needed. 24 They need a structure that is in place within the 25 organization that has the function that analyzes risk and ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

125 1 acts as a filter. So that if things are being proposed or 2 anything that comes up for a sunshine review should pass 3 through that filter. And if it doesn't show an adequate 4 risk and benefit analysis outcome, then it -- it shouldn't 5 go forward. 6 And when we talk about risk I think we're talking 7 about risk of harm. 8 Now, I want to introduce the concept of 9 pseudo-risk. You know, that is things that people talk 10 about as risk, but they really don't produce any harm. Risk 11 is really defined in terms of the harm that it could 12 produce. And unless you have a real harm -- a real harm, 13 then it's maybe a pseudo-risk. 14 Things that are like pseudo-risks are, for 15 instance, we heard earlier from someone about the technetium 16 (phonetic) or gallium contaminate in a diaper triggering a 17 landfill monitor. Well, there's no real harm to a 18 technetium or a gallium diaper going into the landfill. 19 That's a pseudo-risk in my definition of pseudo-risk. And 20 we need to distinguish those from real risk. 21 A diagnostic mis-administration or a medical event 22 of the future, what is the real harm associated with those 23 in terms of actual follow ups and outcomes of the 24 mis-administrations that have occurred diagnostically? 25 This is not a real risk. There's no real harm ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

126 1 that happens to the patient as a result of one of those. 2 Media reaction to some radiation event or 3 announcement is a pseudo-risk. It may impact regulatory 4 agencies through congressional reaction to it, but media 5 events are considered oftentimes as risks and they are 6 certainly real. And they impact us and they drive a lot of 7 what we do. 8 But you have to understand that they don't 9 necessarily produce real harm, except through adverse and 10 uncalled real reactions ,that aren't based on real risk and

• 11 12 13 real harms.

So those are my two corrnnents about pseudo-risk and the structures for doing real risk analysis on an ongoing 14 basis within the NRC. 15 MR. CAMERON: Yeah, I think some of our regulators 16 might have some corrnnents after -- or do you want to make one 17 corrnnent on that right now, Terry? 18 MR. FRAZEE: Sure. Actually, it sort of falls in 19 line with the corrnnents that we've already heard about the 20 cost, the dollars and cents. When we get into dollars and 21 cents, that's where an interesting discussion goes on. 22 But the real -- and the pseudo-risk of contractors 23 in the landfills is a dollars and cents kind of thing, 24 because we do have to respond to the cost of that. It's not 25 directed to the medical corrnnunity or the patient, but it is ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

127 1 to the regulatory agency and certainly to the landfill 2 operator. So there's a cost involved there. 3 But the risk to the plant is, you know, the 4 dollars and cents. Well, let's sort of cut to the chase. 5 When you look at the low-risk modalities used in medicine 6 and you look at what is the worse thing that could happen to 7 what were medical -- business administration's now medical 8 defense, if you look at the bottom line, what are the 9 consequences to the patient and -- not in every case, but 10 invariably, almost, no harm to the patient, no long-term 11 consequences are expected. 12 Obviously, in my case, it must be a low risk 13 thing. So why are you bothering? And where there is some 14 sort of an impact on the patient, it's like, "Well, okay," 15 we wiped out his thyroid, but, hey that's a simple 16 treatment. Your choice is now having to pop a pill for the 17 rest of your life. But, you know, no one's dying. 18 So, I think that generally speaking the impact to 19 the patient is so, so, so low, why are we bothering? 20 So I tend to agree that, you know, use of 21 medicine, hey, we're expending a lot of resources and, 22 therefore, you're talking dollars and cents. But I don't 23 see us focused so much on, well, we've got to calculate the 24 cost, the dollars and cents, because, gee, then we'll be 25 arguing on, "Well, is it greater than a certain amount or ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

128 1 more" -- let's look at the patient. Is there a risk to the 2 patient? Has there been harm? 3 No? Well, why are we bothering? 4 MR. CAMERON: Okay. That brings us back to this 5 issue, again, that we have to sort of remember about whether 6 we're talking about the cost side of the equation or the 7 risk side, it's what are the implications for the proposed 8 rule and the proposed regulatory that we're achieving here. 9 DR. LULL: I just want to close the loop on the 10 diaper issue, you know, since -- you know, we're kind of 11 down at this end here. You know, the appropriate response 12 to diapers tripping monitors and the cost associated with 13 that and a landfill is not to have more burdensome 14 regulations on the generator of those diapers, but to do 15 something about the monitor at the landfill that's picking 16 things that don't create any harm. 17 They need to be monitoring by isotope, by amount 18 of level of radiation, and not set down to background 19 levels. You know, they need more rational approaches so 20 that their approach to regulating that is based on risk 21 rather than pseudo-risk. 22 MR. CAMERON: Why does this remind of the BRC 23 discussion? 24 Let's take the remaining cards and see if we can 25 finish up here by 1:00, so that we can break for lunch. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

129 1 Let's go to Dave and then over to this side and then over to 2 Kathy. 3 DR. LARSON: I just have one very simple question. 4 I may be the only person that hasn't heard the answer, but 5 doesn't the NRC currently subscribe to the notion that the 6 degree of regulation ought to be related to the degree of 7 risk, or not? 8 MR. CAMERON: Well, the answer was "yes." 9 Do you have any follow-up on that in terms of how 10 faithfully we're following that? 11 DR. LARSON: Well, as I read the proposal, it 12 appears to me that regulations tend to be rather uniform in 13 terms of volume of regulation or effort required in various 14 other areas, such as imaging or therapy, nuclear medicine, 15 or radiation oncology. And yet probably all of us would 16 agree that risks are quite different. 17 MR. CAMERON: Any response from the NRC at this 18 point? You can wait until after lunch, if you choose. 19 Let's go to Dave on this side. 20 MR. NEBLETT: I think we're looking for positive 21 suggestions to problems. And I suggest to you that you 22 cannot manage or regulate that which you do not measure. 23 And in the areas of your reports, specifically 24 mid-administration, are in terms of percentages of dose. 25 Which does not correlate-with risk. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

130 1 These reports should be in terms of risk.

                                                      ?

2 MR. CAMERON: Okay. Thank you, David. That's 3 interesting bit to explore when we come back. 4 Kathy? 5 MS. THOMAS: Are we're already talking about the 6 same thing, because mine relates right to that. We're 7 talking about risk and we get the reports for 8 administrations. But the question is if there's not 9 clinical outcome to that risk, okay, so there is an 10 insignificant risk -- whether it's a pseudo-risk or whatever 11 you call it. But does the NRC look at the clinical outcome 12 and is that where the regulations are derived from? Or are 13 they just saying, "Yes, there's a risk. The patient's been 14 exposed to radiation. Therefore, this area needs to be 15 regulated"? 16 So my question is are you looking at the final 17 outcome of that risk or are you -- it's just because there's 18 been a mis-administration that there is some perception that 19 there's a need to more heavily regulate that area to make 20 that go away, even though there's not a clinical outcome 21 associated with that? 22 MR. CAMERON: That's a good question. And, also, 23 I'd like to add to it. What are the -- depending on the 24 answer, what are the implications for what we have in the 25 proposed rule? ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

131 1 So I'd like to keep bringing you all back to the 2 proposed rule on this one. 3 Don, do*you have anything -- do you want to say 4 anything on that now? 5 DR. COOL: A very brief response, because I think 6 you would find that history indicates that a number of the 7 regulations in the past have been driven by the fact that 8 there was an exposure. Some of the bigger ones 9 teletherapy and others -- were driven by clinical severe 10 outcomes, severe burns, death -- whatever it was. Some of 11 the other ones, I think you would end up attributing to an 12 exposure to the place which was indirectly related to 13 whether or not there was a long-term clinical follow-up or 14 intervention that was needed in the ~rocess. And history 15 will lead you in both directions. 16 MR. CAMERON: Okay. Thanks, Don. 17 Let's go to Ed Bailey for a final corrnnent before 18 we break for -- to lunch. And I think this is a good intro 19 to be examined. And then perhaps we can see if anybody in 20 the audience has anything to say right now. But, go ahead, 21 Ed. 22 MR. BAILEY: When we talk about the risk and the 23 reporting of mis-administrations by whatever name you 24 want to call it -- I think those present a problem for 25 agreement states in that if we use the definition similar to ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

132 1 what we have for radioactive materials for our X-ray 2 facilities, every time a film wasn't good it had to be 3 repeated. That would be a mis-administration. 4 And we get into some real problems of having sort 5 of an equal enforcement for the same physical agent 6 attacking the body, if you want to look at it that way. 7 That has always been a problem, I think, with the 8 agreement states looking at. Some of them actually, in 9 adopting the mis-administration rule, did include X-ray for 10 a while. And then they had to go back and basically take it 11 out, because it is a problem. 12 The other thing, the question about the increased 13 number of landfill alarms and so forth, I think that.there 14 is an opportunity for those of us who are regulators -- and 15 everybody else, for that matter, in their own arena -- to 16 help educate the landfill operators and the medical waste 17 processors -- or whatever they're called now. 18 We have done that -- or we have tried to do that, 19 particularly with regard to medical waste handlers. Where 20 we're set up procedures so that, you know, somebody doesn't 21 go out every time the alarm goes off. There are procedures 22 set up, there are requirements on the people that are going 23 to do medical waste processing. 24 ( We've also tried to do it somewhat with the solid 25 waste facilities. And I think our experience right now has ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036

                       ,(202) 842-0034

133 1 been that most of the alarms we're getting right now are not 2 coming from the therapy doses, anyway. They're coming from 3 diagnostic. They're coming from magnesium and they're 4 coming from galvin (phonetic). And those, we're not going 5 to stop, regardless of what the release rate is. 6 So keeping those kind of thoughts in mind as we 7 look at the release rates. 8 MR. CAMERON: Okay. Thank you, Ed. 9 David Nichols, you have some comments on this? 10 MR. NICHOLS: David Nichols, American College of 11 Nuclear Physicians and Society of Nuclear Medicine. 12 A couple of issues that I think I'd like to have 13 addressed after lunch, we're talking about some of the 14 processes that have gone into the regs, and in a proposed 15 rule the NRC mentioned there are several documents that they 16 considered when formulating their risk as far as this 17 proposed rule. 18 There was one document in there which was a 1,993 19 senior internal management review of risk. That document is 20 not available in the public document room, and I think it 21 would be important to make that available to the public, so 22 that they can clearly look at all the documents that have 23 gone into this, as much as Roy mentioned seeing the outcome 24 of the risk review group and their comments. 25 Also, I think a comment on the study ongoing with ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

134 1 Scientech (phonetic) and some of the questions that that 2 consulting firm has asked, both license fees and agreement 3 sales. We think that that is a really poor way of gathering 4 data to determine risk, and particularly in light of some of 5 the questions that are there. 6 Also, to.answer some of the questions that came up 7 earlier as far as cost: One cost that we are aware of that 8 the nuclear medicine community figures are staggering is the 9 paperwork cost. And the ONB paperwork request, information 10 accrual request that NRC had submitted, those costs were 11 upwards of $130 million just for the paperwork. 12 And that does not go into all of the other 13 associated regulatory costs that are out there, as far as 14 compliance and outside of the paperwork costs. 15 Also, on the number of mis-administrations, when 16 you look at the data pool that NRC has, we find that less 17 than half of those mis-administrations are nuclear medicine 18 -- therapeutic nuclear medicine-related. And out of that 19 data pool, a lot of those mis-administrations result in no 20 harm to the patient, as was mentioned earlier. 21 So there are very few mis-administrations that 22 have any detrimental effect on the patient that were 23 reported to the NRC, and subsequently reported to the 24 Congress. 25 MR. CAMERON: Okay. Thank you very much, David. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

135 1 A final comment, Dr. Price? 2 DR. PRICE: Yes, thank you. David Price from San 3 Francisco. 4 I just want to make a comment, because my time may 5 not be available later on. On this risk issue there are a 6 number of numbers that we work with now, the .5 gram initially, the (inaudible) -- is based on estimates of risk that aren't reasonable. The .1 gram is based, I think, on 9 EPA risks of one death in 10,000 -- assuming that the person 10 gets .1 exposure in one year, or get it every year for her 11 whole life. These are not reasonable assumptions. 12 I think a simpler approach to this would be to 13 simply categorize risks and estimate the low, an 14 intermediate, and a h~gh category of risk. One might use, 15 for example, the HPS 5 gram policy statement level. Below 16 that level, there's no evidence -- excuse me, the linear and 17 threshold model holds. 18 And if one may categorize risks by low, 19 intermediate and high, and said that for low risk incidents 20 or low risk usages, exposures, there is no requirement for 21 paperwork or excessive documentation. For intermediate 22 risk, that there's a certain low level of documentation 23 required. For high risk, much more documentation required. 24 Use this sort of a simple approach and then 25 identify the low, intermediate and high by agreeable ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

136 1 criteria, that this might simplify a great deal and 2 certainly make my field -- nuclear medicine -- a lot easier 3 to work with. 4 *MR. CAMERON: 'l'hank you for that suggestion, Dr. 5 Price. 6 I think we'll want to continue on the same vein. 7 There are some issues that have been proposed, and I think 8 that's at least a first suggestion of how a rule might be 9 altered based on the assessment of risk. 10 I think it's fair to say, also, that I think the 11 staff has already tried to factor in some of these 12 assessments of risk into what they've done in the proposed 13 rule and let's try to continue on that vein when we come 14 back. 15 Why don't we be back at 2:00? That gives us an 16 hour, which should be sufficient at this point. 17 [Whereupon, at 2:00 p.m., the public meeting was 18 recessed, to reconvene at 3:00 p.m., this same day.] 19 20 21 22 23 24 25 ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

137 1 A F T E R N O O N E E S S I O N 2 [3:00 p.m.] 3 MR. CAMERON: I suggest that we -- I don't want to 4 channel off this discussion that we've been working on, but 5 let's reevaluate where we are at 3:00. Because at this 6 point, we may be here all night. 7 But let's go until 3:00. I put up a simple-minded 8 schematic here, I think, on what we were talking about. 9 This assumes that risk-inform regulation is a good 10 goal. I think that everybody -- it seems like they agree 11 that that's a good goal for the NRC. 12 We get to this point, then: What is low risk? 13 Granted there is some problems with a definition of that. 14 Has it been demonstrated what's been low risk? And, if so, 15 what should be changed in the proposed rule? 16 And a corollary of that, that I want the staff to 17 address, is we've already done some work in this figure. In 18 other words, trying to eliminate the parts of the existing 19 regulatory scheme that we don't think are in the high risk 20 category. 21 If it hasn't been demonstrated, what needs to be 22 done and by whom to generate the necessary data? And this 23 includes this filter issue that Don raised, and that we 24 still owe the group an answer on, Don. In other words, what 25 is high risk benefit or cost benefit? And fold it into our ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

138 1 decision making process. 2 And just to clean up one detail, the study that 3 David Nichols brought up before lunch -- David isn't here 4 now. 5 Cathy, why don't you tell the rest of the group 6 about the status of that particular study? 7 MS. HANEY: I think that when I stepped out it was 8 right before lunch. Dave brought up a study. It was an 9 internal audit that was done by NRC management of the 10 medical program.

• 11 12 13 I'll be checking this week to find out whether it can be released or not.

The package right now is with our corrnnissioners 14 for -- it's not for a formal vote, but it's just for an okay 15 to release. I'll ask that the office try to get an answer 16 by 5:00 tomorrow, so that I can pass it on to everybody or, 17 you know, just put it on the record that it is -- it's at 18 the last point for someone to make a decision on whether it 19 can be released or not. 20 MR. CAMERON: Roy, you have a question on that? 21 MR. BROWN: Yeah. A question specific to that, 22 the Scientech survey. I guess the question -- the concerns 23 that were had was that looking at the survey itself and the 24 questions and the data you would get from that, it was 25 difficult to make that quantum leap, to take that data and ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

139 1 put it into some kind of risk assessment. It didn't really 2 seem like an appropriate study. 3 MS. MANNING: This is a different report from 4 Scientech. This is a 1993 report. 5 MS. HANEY: This is a different study. 6 MR. CAMERON: And I guess that goes to -- I know 7 some of you have concern about the Scientech study which was 8- referred to by Don as the regulatory review group, okay, 9 this morning. That's the Scientech study. Scientech is a 10 contractor working for the Connnission. 11 And Don addressed, one, what are the implications 12 of that study for the Part 35 rule making. And I think that 13 it is going to be folded in. It sounds to me like some 14 people around the table have problems with the methodology 15 that was used to generate those data that are in there. 16 Let's go to Ed. Or, Bob, do you have a question 17 about -- 18 DR. LULL: Yes -- I'm not sure I can clarify, but 19 I've got a question about it. You say it may be released or 20 it may not be. As far as, NRC doesn't have secret or top 21 secret categorization. Doesn't the Freedom of Information 22 Act mean everything's releasable? Can you clarify that? 23 MR. CAMERON: No, unfortunately it doesn't. Or I 24 shouldn't say "unfortunately." Who am I to say that? 25 DR. LULL: You'.re a citizen, that's fine. There ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

140 1 are things that the government do~s ought to be available to 2 the citizens. I mean, that's what the Freedom of 3 Information Act is about, isn't it? 4 MR. CAMERON: Marjorie, do you want to -- do you 5 want to clarify what's available -- general what's available 6 or what's not? 7 MS. ROTHSCHILD: I don't deal with the Freedom of 8 Information Act issues except in our regulations. I believe 9 it's Part 2, .10 CFR. I believe that 10 MS. CHANEY: It is 10 CFR, Pa~t 2. 11 MR. CAMERON: It's 2.790. 12 MS. CHANEY: There are some categories of 13 documents that are not releasable. One example is if it 14 contains social security numbers. And there's a list of 15 about four or five criteria. 16 But because this was a document that was generated 17 under our executive director of operations and it was mailed 18 to the Commission, we're just going through the formal 19 administrative steps of can this be released, yes or no. 20 It's not something that someone at my level can make a 21 decision that it can be released. 22 DR. LULL: Okay. I guess I'm just really being 23 simplistic. I thought that, you know, when the government 24 operates and creates documents using our tax dollars to fund 25 the creation of them, that the principle of the Freedom of ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

                                                            - 141 1 Information Act was that they might blank out things that 2 are unacceptable to let get out, but that the basic document 3 is always releasable under that act, unless it's a top 4 secret-something military thing.

5 MR. CAMERON: There's six exemptions, basically, 6 to the Freedom of Information -- to the free release under 7 the Freedom of Information Act. And one of the exemptions, 8 Exemption 5, is for pre-decisional information. In other 9 words, information that's being used in a decision-making 10 process that hasn't yet been completed yet. And that can 11 cover a whole lot of materials. 12 But it allows the agency to hold back those 13 documents. But as a policy matter, the agency can release 14 those documents. And I didn't want to spend a whole. lot of 15 time on this. I just hope that the document that Cathy is 16 talking about is released and then we won't have to worry 17 about whatever the rationale is. 18 Kathy? 19 MS. THOMAS: This is just getting back to what you 20 were going over. Can we step back to the beginning, where 21 you're saying risk-informed regulation is a good goal? 22 Would you mind defining to me what "risk-informed" means to 23 you? 24 MR. CAMERON: I think it's probably appropriate to 25 turn to Don, actually. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

142 1 What does "risk-informed regulation" mean to the 2 Conunission? 3 DR. COOL: How long do you have? 4 MR. CAMERON: A very short answer to that. 5 DR. COOL: There's actually a very short answer to 6 that. The Conunission has been developing a lengthy report, 7 trying to define some of these terms so there can be consistent usage, because different people do have some 9 different views. 10 I'm not sure that the Connnission has actual~y 11 finalized those definitions. So what I would tell you is in 12 some sense a risk-informed -- a risk-based document would be 13 a document where whatever was being developed -- the 14 regulations, the guidance, the criteria for review and 15 approval -- was strictly, linearally based on a mathematical 16 analysis related to a quantitative calculation of risk. 17 There's no deviation. You write down the equation and 18 whatever the equation gives you, is the answer and specifies 19 a given action. 20 A risk-informed approach is to take risk insights 21 generated by maybe a variety of activities, including the 22 things that we*ve talked about here, as well as quantitative 23 data, and use that to infonn the developer of the particular 24 regulatory product. 25 The difference being that there is not an ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

143 1 automatic specification correlation, but simply that there 2 should be a relationship between the two and the risk data 3 used as part of the process to develop and set the criteria. 4 MS. THOMAS: So if you can't demonstrate a risk 5 associated with whatever the action is, then we don't need 6 to worry about it? 7 MR. CAMERON: What's literally hands-on. You know 8 -- I mean, what is "love"? 9 MS. THOMAS: Right. 10 MR. CAMERON: Okay? That can be obviously in the 11 mind of the beholder. What does that mean in terms of -- we 12 were talking about actual or perceive. You get into any 13 sort of balancing of costs -- in other words, is there a 14 risk that is not worth the additional cost of a regulation? 15 Don's explanation, I-think, is probably the best. 16 These type of issues have not really been defined as part of 17 a risk-informed approach. And that's fair game for all of 18 you to say what should be risk-informed approach and terms, 19 and we've been dealing with that. What should be a 20 risk-informed approach in terms of Part 35? 21 Let me go to Ed and then to Roy, and then we'll 22 come back over here. 23 MR. BAILEY: As we broke for lunch, I remembered 24' from a discussion about a risk base and then we got into 25 essentially saying cost could also be a risk. But I think ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

                                                              - 144 1  in general we've been talking about health risk.

2 But if we go to cost as a risk, then I would 3 suggest that we would have to look at the amount of 4 regulation that goes on in medicine compared to the amount 5 of regulation that goes on in generally-licensed gauges. 6 I think there could be a tremendous differential 7- in actual cost from the inadvertent melting of 8 generally-licensed ga~ges. And yet we don't seem to want to 9 go in that direction, to where we're regulating them, 10 although we know that there have been millions and millions 11 and millions of dollars that have resulted -- of costs that 12 have resulted from the melting of these and the attendant 13 loss of work by the people at the still foundries. 14 So if you try to balance medical and 15 generally-licensed gauges, there's a whole lot more 16 regulation in the medical. 17 MR. CAMERON: And you're using cost in the terms 18 of regulating to prevent -- 19 MR. BAILEY: Economic gain. 20 MR. CAMERON: -- the economic end. And then that 21 gets into the whole -- 22 MR. BAILEY: Yeah. I don't know that -- I think 23 as we're talking here, we're talking solely about risk in 24 terms of health effects. 25 And we have not gotten too much into the cost, ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

145 1 although we did, right before the break, begin to talk about 2 the cost of doing this, or the cost of funding the record 3 keeping of something and what you can't spend that money on 4 as a result. 5 I just happen to have a document from the 6 University of Arizona that, for instance, said that they're 7 going to spend a half a million dollars building a facility 8 to store low-level waste. And they would rather not spend 9 that half a million dollars doing that. They'd rather spend 10 that half a million dollars in research or funding research. 11 So I think the same thing comes here. 12 MR. FRAZEE: Yeah, I think that we don't want to 13 you can get real global with these discussions, in terms 14 of what the trade-offs should be. And I think that w.e 15 probably have to -- I think there's enough to do possibly 16 just within this one rule, to say that if we identify the 17 low-risk areas and eliminate the money and time that might 18 be spent complying with regulations in low-risk areas, that 19 that money and time could be spent in other higher-risk 20 areas or doing something else. 21 So I think we're back to this: What is a low-risk 22 activity? And I think that, at least from what I gather 23 from what Bob has been saying, is that you think that you 24 have a pretty good handle on what are low-risk activities. 25 I still haven't heard, other than what Dr. Price ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

146 1 said today, is where this rule -- if you think that we have 2 demonstrated low risk at some point, then what do you throw 3 out of the rule? Okay? Who do you throw out of the 4 proposed rule for a policy statement? 5 And I realize there may be a spectrum of things 6 that you would deal with there. 7 This is what he's been working on. 8 DR. COOL: There's no question of what you propose 9 with the Part 35 is better than the existing Part 35, and 10 certainly down the way from some other descriptive writings 11 and we've clearly gone to more of a conformance base. So I 12 think it's been a very positive move. 13 But we've spent the last couple of years talking 14 about this, three public workshops for the last go-around 15 and three this go-around. We have scores of written 16 comments. We've done all we can do to try to justify and 17 try to demonstrate that diagnostic nuclear medicine and 18 nuclear pharmacy is a low-risk operation. 19 We've got the numbers here. You've got the 20 treatise on low risk in front of you. What are we missing 21 to get to a general license diagnostic nuclear medicine or a 22 two-tier approach that we talked about in Philadelphia and 23 Chicago? What are we missing? What else can we give the 24 Commission to make them take the next step, to say, "Okay. 25 We feel it's safe enough to allow people in diagnostic ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

147 1 nuclear medicine a general license, providing you meet 2 certain guidelines and training and experience"? 3 MR. CAMERON: Do I have anybody -- I'll ask the 4 staff to address that. And I know that there's a lot of 5 facets to that and that it's difficult to answer. 6 DR. COOL: I wish I could give you a list that 7 would tie in and there was a success path. I'm not sure of 8 the latter statement, though. There would seem to be places 9 that are weaker. 10 The first one of those is -- and I think the 11 discussions today have fallen under a similar vein all 12 the focus on the patient as the receptor of the risk. And 13 the areas that are weaker are dealing with the other two 14 aspects that the Commission has to consider, which is 15 occupational and other members of the public. 16 Now, the other members of the public may not be a 17 significant factor. And if you're in unit doses, then you 18 may be able to argue successfully, but I don't think that 19 argument has necessarily been put together as crisply as_ 20 what we've been talking about here earlier with regards to 21 things like emission control, occupational exposure, and 22 otherwise. 23 But when you start to talk about things related to 24 fabrication of labeling, quantities of unsuitable materials, 25 then some of the things, I believe, crawl in which are not ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

148 1 related to the actual administration to the patient. Would 2 you give a general license in that aspect, which is less 3 attractive. 4 And I would suggest to you that if there were a 5 success path, part of the success path might be trying to 6 define a mechanism which carves out an area which avoids 7 some of the occupational and public steps. And then 8 because there were some discussions on this. Having carved 9 that out, whether that then is such a small arena that it 10 doesn't make sense to try and have what would amount to a 11 potentially a more complicated system of what am I doing, 12 under what structure, and what arrangements, and do I 13 effectively have to have a license, because of those things 14 that I'm doing, except for a clinical situation, such that 15 it does end of being useful? 16 Because that was part of the problem that we ran 17 into the first time. Because as a result of those 18 discussions, I'll tell you very frankly, we looked at, "Can 19 you do a general license for certain kinds of aspects?" 20 And we concluded that the nitch created was not of 21 the size that it would really be beneficial in terms of all 22 the other aspects, the administration and the things that 23 the university or the clinic would otherwise have to be 24 looking at, because of the way -- and perhaps the data set 25 is wrong. The materials that we used -- such that you end ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

149 1 up having a specific license, anyhow, because of other 2 things that you were doing. And so it didn't help you that 3 much, because it created another layer of documents. 4 But that's sort of the weakness. So I don't think the argument's been carved out to really make a case yet. 6 MR. CAMERON: I'd say there's a legitimate 7 question for the NRC to ask. What could Roy or Bob or the

,8 rest of the people bring us in terms of risk data that would 9 convince us to take either this type of an approach or make 10  other changes?   And we need to identify some other changes, 11  perhaps in a rule.

12 And, Bob, why don't you go ahead? 13 DR. LULL: Well, I mean there is data. The data 14 is out there. We've been measuring radiation doses and 15 occupational and exposed personnel in medicine for years. 16 There's a huge amount of data and it's all negative. 17 I mean, it's a real problem. Just as the patient 18 data is very out there and shows that it's not a problem. 19 You can end up talking about hypothetical and theoretical 20 risk. And I think my general conunent is that we could be 21 accused of being real fuzzy in terms of our use of that word 22 "risk." We're using that word "risk" in about 10 different 23 times within a matter of space of a minute or two. And 24 we're not being real precise in terms of tbe use of this. 25 I'm simply concerned that, you know, you set up ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

150 1 this straw man potential theoretical risk where you do 2 linear extrapolation from high doses down to low doses, and 3 say, well, that's not a definition of risk from radiation. 4 But the fact of the matter is you can end up calculating all 5 kinds of ridiculous things out of that. We can measure 6 radiation levels down to very low levels. 7 I once did -- went through the drill of 8 calculating out how many people in this country 9 theoretically die because they spent eight hours sleeping 10 next to their mate who has potassium 40 that radiates them 11 into a level that we can measure. And it's about five 12 people a year who die in this country. 13 Now, you can say that. But does anybody really 14 believe that? 15 I mean these are hypothetical, theoretical risks. 16 We're talking about real risk, based on real harms that are 17 measurable, and there aren't any in nuclear medicine. I 18 don't know what else you need. 19 The data is very clear cut and it's out there. 20 MR. CAMERON: Okay. Thank you, Bob. 21 Melissa? 22 MS. MARTIN: I think I'm coming back to the same 23 point. I was -- for point of clarification, if I'm reading 24 the general consensus of what I'm hearing, is that basically 25 the adoption -- the policy of the Commission is that there ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

151 1 is a no tolerance and no risk assumed level. Is that clear? 2 In other words, or what we're looking for -- what is the 3 policy to define what is a low risk? Is the definition 4 right now that there's a zero tolerance, period? 5 MR. CAMERON: Don? Cathy? Diane? 6 DR. COOL: I guess I'm not quite sure I understand 7 the question yet. The Commission has certainly been looking 8 in a direction of being risk~informed. That is, having risk 9 insights and levels of risk in forming the regulatory 10 process. 11 Does that mean that there is a point at which it 12 will walk away from material? I think there, in theory, 13 certainly is, because there are release criteria for 14 materials. There are exemptions for certain kinds of 15 materials or quantities of materials that are present. l6 Tnere are materials that can be released to the environment 17 which you construe as a de facto level. But I'm not sure 18 that that's quite the same as whether the Commission -- and 19 here's where I'm not quite sure what your reference to zero 20 tolerance is. Zero tolerance of what? 21 MS. MARTIN: Okay. I didn't make that clear. 22 What I'm basically fo~lowing up on, what 23 information is needed, besides what is already available, to 24 define what is an acceptable, quote, low risk? At which 25 point has that policy been defined? Is it one occurrence in ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

152 1 a million* cases? Is it one mis-administration of a 2 diagnostic study in 10,000 cases? Where is that line being 3 drawn? 4 That's what I'm asking. Is where do you get -- 5 who makes the call? Has it been made that there is never 6 as long as there's one diagnostic mis-administration, is 7 that going to be a reason to have all of these regulations? 8 Or is one mis-administration of a diagnostic isotope in 9 every 10,000 cases acceptable? 10 MR. CAMERON: And, Don, you may explain while 11 you're addressing that, you might also want to talk about 12 how this information typically does get into the decision 13 making processes at the NRC. That's still turf that Bob 14 Lull was talking about. So I think it's all wr.apped up 15 together. 16 DR. COOL: I think the answer to that question in 17 reality is that it's not written down and that the 18 Commission is, in fact, struggling with it. 19 If you look at some of the transcripts of the 20 Commission briefings, some of the considerations on the 21 policy statement, the Conunission is -- the Commissioners 22 themselves were asking questions about what kinds of things 23 you would use as the benchmarks for this and at what point 24 would that number translate into an action. 25 So I don't believe the Corrrrnission itself has in ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

153 1 its mind now a particular number, as it has in the reactor 2 arena, where anything over 10 to the minus 6 means you're 3 going to take some action. 4 MS. MARTIN: That's what I mean, something like 5 that. 6 DR. COOL: And 10 to the minus 6 would be 7 translated into doses and millicuries, single digits. 8 So be careful about where you use that, because 9 they're not in the same breath. They're not talking about 10 risk in an absolute, automatic-related sense. That's where 11 -- that's why the Commission talks about risk-informed. 12 Letting the risk insights guide the process, but not driving 13 to a particular number. 14 Because if you want to go to that arena, the 15 arguments that you've made here probably won't fly at all, 16 because they will be in the face of a larger set of data 17 where it says tbat other actions have been taken. 18 Let me go to the second question that you asked me 19 to identify. I'm n9t sure whether I can really 20 satisfactorily address the two or three times that this has 21 been brought up. 22 But depending upon the process that you're in -- 23 and at the moment we're in a rule making process. So in the 24 rule making process there are a number of places where the 25 information can come into play. We're generating some here. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

154 1 They get reflected, than, in a series of 2 documents. You'll find descriptions of how they got used or 3 what the net result was as part of the statement of 4 considerations. You will find cost data analysis associated 5 with alternatives and options in the relative sense of 6 preparing options for goodness or lack of goodness, as part 7 of th~ regulatory analysis, which is part of the document. 8 You will find estimate of burden associated with 9 that limited subset of record_keeping and reporting, as 10 defined by ONE, as part of the ONE clearance. 11 The data such as the med data gets processed as 12 part of the consideration. And if you're looking for where 13 is it written down that qualified events were done, usually 14 the statement of consideration doesn't get to that level of 15 detail. We wrote too many reams of paper as it was already. 16 But it was underneath some of those analysis. 17 Does that help the question? I'm not sure whether 18 I got back to your point. 19 MR. CAMERON: No, I don't it does, because it's an 20 accurate representation of what goes on in the agency. We 21 do have regulatory analysis guidelines that require 22 identification of certain types of costs and benefits to go 23 into the rule making process. 24 But that's pretty basically, I think, the filter 25 that all of this information goes through, first on a staff ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

155 1 level and then ultimately on a.cormnission level. 2 Let me go down to Bill, because I know he has 3 MR. EHMIG: You've asked if we can make some 4 suggestions. 5 MR. CAMERON: Yes. 6 MR. E:EIMIG: I'm going to make a suggestion based 7 on a hypothetical case. But let me give you the case. 8 Dr. Lull prescribed a patient to get 20 9 millicuries of technetium MDP (phonetic) injection for a 10 bone scan. 11 MR. CAMERON: Do you mind being a guinea pig in 12 this? 13 DR. LULL: No, not at all. 14 MR. EHMIG: And either through a pharmacy unit 15 dose or by his own technologist, making up an dispensing and 16 administering the doze, the patient gets 23 millicuries and 17 you have a reportable mis-administration. Which is 18 absolutely ludicrous because if he administers and orders 30 19 millicuries and gets 30 or 29 or 31, there's no issue. 20 Now, you can extrapolate that and say he's already 21 200 millicuries of iodine 131 for metastatic thyroid cancer 22 in the lungs, and he gets 15 percent more. Yes, I would 23 agree that's a serious incident. 24 MR. CAMERON: Yes, I would think so. 25 MR. EHMIG: Not life threatening, but it's ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington,*D.C. 20036 (202) 842-0034

156 1 serious. 2 But I think the issue is you can't take a linear 3 relationship between worse case and innocuous. 4 MR. CAMERON: Cathy, do you want to -- 5 MS. HANEY: Yes. I guess the example that you 6 gave is in the diagnostic area. That probably would not 7 have triggered a medical event -- or a mis-administration 8 report. 9 And that's where I think we're saying we're not -- 10 back in the '80s. it might have. But we've changed. 11 MR. EHMIG: But in some of the agreement states it 12 still may. 13 MS. HANEY: Okay. 14 MR. EHMIG: I from Illinois. 15 MS. HANEY: Okay. So to answer from any -- at 16 least part of the question from the NRC's standpoint, that 17 is where we have brought in a certain amount of dose-based. 18 Is that it would not have triggered a medical event with the 19 diagnostic range. We would not need to hear about it if 20 under the proposed 35, it would not even considered a 21 recordable event. Something that we would ask the licensee 22 to even look at. 23 One would hope that internal hospital procedures, 24 however, would cause them to go look. And what we're trying 25 to say that that's the licensee's business. NRC doesn't ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

157 1 care about that. It's in a low-risk area that not to exceed 2 our dose threshold. 3 However; when you're looking at the therapeutic 4 doses, then that would trigger a medical event. And then we 5 would want to know about it. And, hence, the regulation at 6 that threshold. And -- I mean, is that what you were trying 7 to get at with that example? 8 MR. E:EIMIG: I guess I'm coming from the issue of 9 an event,and IDMS (phonetic) jurisdiction from some time. 10 That there's 36 sets of rules around the country, and I 11 don't know that we'll ever change that. But my thought is 12 that NRC should be leading the pack. 13 MR. CAMERON: And'it's not mine to say that we're 14 leading the pack too much. That does happen occasionally. 15 Roy, go ahead. 16 MR. BROWN: Don, I just have a follow-up to what 17 we've been talking about. Since you guys look at different 18 ways of doing this -- for example, perhaps licensing or 19 certifying an RSO or any position practicing diagnostic 20 nuclear medicine to come in under the umbrella of that RSO 21 or nuclear-involved facility, any number of physicians could 22 come in and practice in a group or a pharmacis}}