ML23151A528

PR-020,035 - 59FR30724 - Criteria for the Release of Patients Administered Radioactive Material

ML23151A528
Person / Time
Issue date:	06/15/1994
From:	Hoyle J NRC/SECY
To:
References
PR-020, PR-035, 59FR30724
Download: ML23151A528 (1)

Text

ADAMS Template: SECY-067 DOCUMENT DATE: 06/15/1994 TITLE: PR-020, 035 - 59FR30724 - CRITERIA FOR THE RELEASE OF PATIENTS ADMINISTERED RADIOACTIVE MATERIAL CASE

REFERENCE:

PR-020, 035 59FR30724 KEYWORD: RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete

STATUS OF RULEMAKING PROPOSED RULE: PR-020, 035 OPEN ITEM (Y/N) N RULE NAME: CRITERIA FOR THE RELEASE OF PATIENTS ADMINISTERED RADIOACTIVE MATERIAL PROPOSED RULE FED REG CITE: 59FR30724 PROPOSED RULE PUBLICATION DATE: 06/15 / 94 NUMBER OF COMMENTS: 57 ORIGINAL DATE FOR COMMENTS: 08/29/94 EXTENSION DATE: I I FINAL RULE FED. REG. CITE: 62FR04120 FINAL RULE PUBLICATION DATE: 01/29/97 NOTES ON: SEE ALSO PRM-20-20 (56 FR 26945), PRM-35-10 (57 FR 08282), PRM STATUS l0A (57 FR 21043) AND PRM-35-11 (59 FR 37950). FILE LOCATED ON Pl OF RULE :

HISTORY OF THE RULE PART AFFECTED: PR-020, 035 RULE TITLE: CRITERIA FOR THE RELEASE OF PATIENTS ADMINISTERED RADIOACTIVE MATERIAL PROPOSED RULE PROPOSED RULE DATE PROPOSED RULE SECY PAPER: 94-054 SRM DATE: 05 /11/ 94 SIGNED BY SECRETARY: 06 / 09 / 94 FINAL RULE FINAL RULE DATE FINAL RULE SECY PAPER: 96-100 SRM DATE: 10 /11/ 96 SIGNED BY SECRETARY: 01/30 / 97 STAFF CONTACTS ON THE RULE CONTACT!: STEWART SCHNEIDER MAIL STOP: T-9C-24 PHONE: 415-6225 CONTACT2: MAIL STOP: PHONE:

DOCKET NO. PR-020, 035 (59FR30724)

In the Matter of CRITERIA FOR THE RELEASE OF PATIENTS ADMINISTERED RADIOACTIVE MATERIAL DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT

- 06/10/94 06/09/94 FEDERAL REGISTER NOTICE - PROPOSED RULE 07/06/94 06/29/94 COMMENT OF UNIVERSITY OF IOWA HOSPITALS AND CLINICS (JAMES A. PONTO) ( 1) 07/15/94 07/08/94 COMMENT OF UNIVERSITY OF TEXAS, MED SCHOOL AT GALVESTON (DR. ANTHONY R. BENEDETTO) ( 2) 07/25/94 07/11/94 COMMENT OF DR. CAROLS. MARCUS ( 3) 07/28/94 07/21/94 COMMENT OF PASCACK VALLEY HOSPITAL (CRAIG KOSTER) ( 4) 08/09/94 07/21/94 COMMENT OF DR. STEPHEN KAUFMAN ( 5) 08/09/94 07/21/94 COMMENT OF CARRIE NILER ( 6)

- 08/12/94 07/26/94 COMMENT OF 8. SCOTT DAVIDSON, CHP ( 7) 08/18/94 08/15/94 COMMENT OF RICHARD A WETZEL, M.D. ( 8) 08/19/94 08/14/94 COMMENT OF RICHARD D. LINDGREN , M.D. ( 9) 08/19/94 08/15/94 COMMENT OF MPI (J. LEONARD DAVIS, M.D., DABR) ( 10) 08/19/94 08/15/94 COMMENT OF MPI (MARVIN WEINER, M.D. DABR) ( 11) 08/19/94 08/ 15/94 COMMENT OF MPI (DARWOOD 8. HANCE, M.D., FACR, FACNM) ( 12) 08/19/94 08/15/94 COMMENT OF MPI (MICHAEL M. EDELSTEIN, M.D.) ( 13) 08/22/94 08/09/94 COMMENT OF AMERICAN ASSOC . OF PHYSICISTS IN MEDICINE (RAVINDER NATH , PH .D.) ( 14) 08/22/94 08/17/94 COMMENT OF OHIO CITIZENS FOR RESPONSIBLE ENERGY, INC (SUSAN L. HIATT, DIRECTOR) ( 15) 08/22/94 08/17/94 COMMENT OF MPI (DARWOOD B. HANCE , M.D.) ( 16)

DOCKET NO. PR-020, 035 (59FR30724)

DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 08/22/94 08/10/94 COMMENT OF NC DEPT. OF ENVIRONMENT, HEALTH & NAT. RESOURCES (WENDY 8. TINGLE, HEALTH PHYSICIST) ( 17) 08/22/94 08/16/94 COMMENT OF UNIVERSITY OF TEXAS, DEPARTMENT OF RADIOLOGY (LOUIS K. WAGNER, PHO) ( 18) 08/22/94 08/18/94 COMMENT OF T.K. CHAUDHURI, M.D. ( 19) 08/24/94 08/16/94 COMMENT OF AMERICAN MEDICAL LABORATORIES, INC.

(IRA D. GODWIN, M.D.) ( 20)

- 08/25/94 08/16/94 COMMENT OF TEXAS MEDICAL CENTER (E. EDMUND KIM, M.D.) ( 21) 08/26/94 07/26/94 COMMENT OF MS. SUSAN POTEAT ( 22) 08/26/94 08/10/94 COMMENT OF UNIVERSITY OF PITTSBURGH (DENNIS P. SWANSON, RPH) ( 23) 08/26/94 08/19/94 COMMENT OF RADIOLOGY ASSOCIATES OF NASHVILLE (RONALD E. OVERFIELD, M.D.) ( 24) 08/26/94 08/25/94 COMMENT OF MR. PETER CRANE ( 25) 08/26/94 08/20/94 COMMENT OF DAVIDE. CUNNINGHAM, PH.D. ( 26) 08/28/94 07/13/94 COMMENT OF DEPARTMENT OF VETERANS AFFAIRS (LYNN MCGUIRE, RSO) ( 27) 08/28/94 08/26/94 COMMENT OF UNIVERSITY OF TEXAS (E. EDMUND KIM, M.D.) ( 28) 08/28/94 08/23/94 COMMENT OF UNIVERSITY OF PITTSBURGH (MICHAEL SHEETZ, M.S., CHP) ( 29) 08/28/94 08/22/94 COMMENT OF JOHN U. HIDALGO ( 30) 08/29/94 08/25/94 COMMENT OF UNIVERSITY OF CINCINNATI (JOHN BRENEMAN, M.D. ET AL) ( 31) 08/29/94 08/25/94 COMMENT OF AMERICAN COLLEGE OF NUCLEAR PHYSICIANS/SOC NUC MED (WILL IAM H. MCCARTNEY, M.D. ET AL) ( 32) 08/29/94 08/26/94 COMMENT OF MALLINCKRODT MEDICAL, INC (PAUL EARLY, DIRECTOR) ( 33) 08/29/94 08/26/94 COMMENT OF MAYO CLINIC (GREGORY WISEMAN, M.D ., ET AL) ( 34) 08/29/94 08/22/94 COMMENT OF F.C. PETTY, M.D. ( 35)

DOCKET NO. PR-020, 035 (59FR30724)

DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 08/29/94 08/25/94 COMMENT OF RICHARD J. HAMMES ( 36) 08/29/94 08/29/94 COMMENT OF AMERICAN SOCIETY OF HOSPITAL PHARMACISTS (D. LANCE KING, R.PH) ( 37) 08/29/94 08/29/94 COMMENT OF AMERICAN COLLEGE OF RADIOLOGY (BRADLEY W. SHORT, ASST DIRECTOR) ( 38) 08/30/94 08/23/94 COMMENT OF MAYO CLINIC (CLAIRE E. BENDER, MD) ( 39) 08/30/94 08/29/94 COMMENT OF HERBERT C. ALLEN, JR., MD ( 40)

- 08/30/94 08/22/94 COMMENT OF BEAUMONT HOSPITAL (CHERYL CULVER SCHULTZ) ( 41) 08/30/94 08/29/94 COMMENT OF CLEAN WATER FUND OF NORTH CAROLINA (CARL RUPERT) ( 42) 08/31/94 08/26/94 COMMENT OF ARKANSAS DEPARTMENT OF HEALTH (GRETA J. DICUS) ( 43) 08/31/94 08/29/94 COMMENT OF UNIVERSITY OF WISCONSIN-MADISON MEDICAL SCHOOL (MICHAEL A. WILSON) ( 44) 09/02/94 08/29/94 COMMENT OF ILLINOIS DEPARTMENT OF NUCLEAR SAFETY (STEVEN C. COLLINS) ( 45) 09/06/94 08/26/94 COMMENT OF COUNCIL ON RADIONUCLIDES &RADIOPHARM.

(LEONARD R. SMITH) ( 46)

- 09/06/94 09/02/94 COMMENT OF KAISER PERMANENTE (MITCHELL S. Y. COHEN) ( 47) 09/09/94 09/01/94 COMMENT OF NUCLEAR ENERGY INSTITUTE (FELIX M. KILLAR, JR.) ( 48) 09/12/94 07/28/94 COMMENT OF AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS (H. JACK BASKIN) ( 49) 09/12/94 07/07/94 COMMENT OF KOOTENAI MEDICAL CENTER (LARRY K. HATCH) ( 50) 09/12/94 08/11/94 COMMENT OF ALABAMA DEPARTMENT OF PUBLIC HEALTH (STATE ALABAMA DEPT OF PUBLIC HEALTH) ( 51) 09/12/94 09/01/94 COMMENT OF NATIONAL INSTITUTES OF HEALTH (ROBERT A. ZOON) ( 52) 09/30/94 09/23/94 COMMENT OF PENNSYLVANIA HOSPITAL (LEONARD SHABASON) ( 53) 10/03/94 09/30/94 COMMENT OF AMERICAN ASSOCIATION OF PHYSICISTS IN MEDICINE (RAVINDER NATH) ( 54)

DOCKET NO. PR-020, 035 {59FR30724)

DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 10/03/94 10/03/94 COMMENT OF COLORADO ASSOCIATES IN MEDICAL PHYSICS

{GERALD A. WHITE) { 55) 10/24/94 10/19/94 COMMENT OF SALEM HOSPITAL {DR. ROBERT CACAK) { 56) 02/02/95 01/24/95 LETTER FROM CAROLS . MARCUS , UCLA , INQUIRING ABOUT THE NRC ' S DELAY IN PROCESSING THIS RULEMAKING 02/24/95 02/23/95 COMMENT OF PETER CRANE { 57)

- 01/24/97 I I 01/23/97 I I FEDERAL REGISTER NOTICE - FINAL RULE

DOCKET NUMBER PROPOSED RULE ~D 35' DOCKETED USNRC (5q FR 307 :J.t/)

NUCLEAR REGULATORY COMMISSION OFFICE O SEC, ETARY 10 CFR Parts 20 and 35 DOCKE T! G & ::E.RYICE RIN 3150-AE41 BRANCH Criteria for the Release of Individuals Administered Radioactive Material AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule.

SUMMARY

The Nuclear Regulatory Commission (NRC) is amending its regulations concerning the criteria for the release of patients administered radioactive material. The new criteria for patient release are based on the potential dose to other individuals exposed to the patient. The new criteria are consistent with the recommendations of the National Council on Radiation Protection and Measurements (NCRP) and the International Commission on

- Radiological Protection (ICRP). This final rule requires the licensee to provide written instructions to patients on how to maintain the doses to others as low as is reasonably achievable if the total effective dose equivalent to any other individual exposed to the released patient is likely to exceed 1 millisievert (0.1 rem). This final rule responds to three petitions for rulemaking regarding the criteria for release of patients administered radioactive material.

-vr/ ~ :;_ ~ 1191 EFFECTIVE DATE: (120 dayg fellewing publicatiaR iR the Federal

-Regirter) :-

fl~. thl 1/ ;J.1/17 a,;f f,2FR. i./1:Jo

ADDRESSES: Copies of Regulatory Guide 8.39, "Release of Patients Administered Radioactive Materials"; the final regulatory analysis, NUREG-1492, "Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material" (1997); Revision 2 of NUREG/BR-0058, "Regulatory Analysis Guidelines of the U. S. Nuclear Regulatory Commission" (1996); and the public comments received on the proposed rule may be examined and copied for a fee in the Commission's Public Document Room at 2120 L Street NW. (Lower Level),

Washington, DC. Single copies of Regulatory Guide 8.39 may be obtained free of charge by writing the Office of Administration, Attn: Distribution and Services Section, USNRC, Washington, DC 20555, or by fax at (301) 415-2260.

Single copies of NUREG-1492 and NUREG/BR-0058 may be purchased at current rates from the U.S. Government Printing Office, P.O. Box 37082, Washington, DC 20402-9328 (telephone (202) 512-1800); or from the National Technical Information Service at 5285 Port Royal Road, Springfield, VA 22161.

FOR FURTHER INFORMATION CONTACT: Stewart Schneider, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 415-6225.

I. Background Each year in the United States, radioactive pharmaceuticals or compounds or radioactive implants are administered to approximately 8 to 9 million individuals for the diagnosis or treatment of disease or for human research.

These individuals to whom radioactive materials have been administered are 2

hereinafter referred to as "patients." These patients can expose others around them to radiation until the radioactive material has been excreted from their bodies or the radioactivity has decayed away.

NRC's current patient release criteria in 10 eFR 35.75, "Release of patients or human research subjects containing radiopharmaceuticals or permanent implants," are as follows:

"(a) A licensee*may not authorize release from confinement for medical

- care any patient or human research subject administered a radiopharmaceutical until either: (I) The measured dose rate from the patient or human research subject is less than 5 millirems per hour at a distance of I meter; or (2) The activity in the patient or human research subject is less than 30 millicuries; (b) A licensee may not authorize release from confinement for medical care of any patient or human research subject administered a permanent implant until the measured dose rate from the patient or human research subject is less than 5 millirems per hour at a distance of I meter."

- On May 21, 1991 {56 FR 23360), the NRC published a final rule that amended 10 CFR Part 20, "Standards for Protection Against Radiation." The rule contained limits on the radiation dose for members of the public in 10 CFR 20.1301. However, when 10 CFR Part 20 was issued, there was no discussion in the supplementary information on whether or how the provisions of 10 CFR 20.1301 were intended to apply to the release of patients.

Some licensees were uncertain about what effect the revised 10 CFR Part 20 would have on patient release criteria, and two petitions for rulemaking were received on the issue. On June 12, 1991 (56 FR 26945), the NRC published in the Federal Register a notice of receipt of, and request for 3

convnent on, a petition for rulemaking {PRM-20-20) from Dr. Carol S. Marcus.

In addition, Dr. Marcus submitted a letter dated June 12, 1992, further characterizing her position.

On March 9, 1992 (57 FR 8282), the NRC published a notice of receipt and request for co11111ent in the Federal Register on another petition for rulemaking (PRM-35-10) on patient release criteria from the American College of Nuclear Medicine (ACNM). On May 18, 1992 (57 FR 21043), the NRC published in the Federal Register notice of an amendment submitted by the ACNM to its original petition (PRM-35-lOA).

In addition, a third petition {PRM-35-11) dealing, in part, with these same issues was submitted by the American Medical Association (AMA). That petition was noticed in the Federal Register on July 26, 1994 (59 FR 37950).

The main point raised in the petition was that the radiation dose limits in 10 CFR Part 20 should not apply to individuals exposed to the patient and that the dose limit to the individuals should be 500 millirems per year. The AMA believed that 10 CFR 20.1301 would have an adverse impact on the availability and the cost of treatment of thyroid disease, which would outweigh the advantages of reduced radiation exposure to the public. The AMA stated that treatment of up to 10,000 cancer patients annually for thyroid carcinoma would require the hospitalization of the patients under the revised regulation

{10 CFR 20.1301), reducing both early release of patients and the treatment of patients at home.

II. Publication of the Proposed Rule 4

On June 15, 1994 (59 FR 30724), in response to the first two petitions, the NRC published a proposed rule on criteria for the release of patients administered radioactive material. The proposed rule discussed the public comment letters received on the first two petitions. Three additional comment letters were received on the third petition (PRM-35-11). These letters each supported the petition but did not contain any additional information not covered by the letters on the first two petitions.

The NRC proposed to amend 10 CFR 20.130l(a}(l) to specifically state that the dose to individual members of the public from a licensed operation does not include doses received by individuals exposed to patients who were released by the licensed operation under the provisions of 10 CFR 35.75. This was to clarify that the Commission's policy is that patient release is governed by IO CFR 35.75, not 10 CFR 20.1301.

The NRC proposed to amend 10 CFR 20.130l(a)(2) to specifically state that the limit on dose in unrestricted areas does not include dose contributions from patients administered radioactive material and released in accordance with 10 CFR 35.75. The purpose was to clarify that licensees would not be required to control areas (such as waiting rooms) simply because of the presence of a patient released pursuant to 10 CFR 35.75. If a patient has been released from licensee control pursuant to 10 CFR 35.75, licensees would not be required to limit the radiation dose from a patient to members of the public (e.g., visitors in a waiting room) to 0.02 millisievert (2 millirems) in any I hour. Patient waiting rooms or hospital rooms would need only be controlled for those patients not meeting the release criteria in 10 CFR Part 35.

5

The NRC proposed to adopt a new 10 CFR .35,.75(a') ~to change the patient release criteria from 1,110 megabecquerels (30 mil1icuri-e£) of activity in a patient or a dose rate of 0.05 millisievert (5 millirems) per hour at 1 meter from a patient to a total effective dose equivalent not to exceed 5 millisieverts (0.5 rem) in any 1 year to an individual from exposure to a released patient. A dose-based limit provides a single limit that could be used to provide an equivalent level of risks from all radionuclides. Also, the proposed changes were supported by the recommendations of the ICRP and the NCRP that an individual could be allowed to receive an annual dose up to 5 millisieverts (0.5 rem) in temporary situations when exposure to radiation is not expected to result in annual doses above I millisievert {0.1 rem) for long periods of time.

The NRC proposed to adopt a new 10 CFR 35.75(b)(l) to require that the licensee provide released patients with written instructions on how to maintain doses to other individuals as low as is reasonably achievable if the total effective dose equivalent to any individual other than the released patient is likely to exceed 1 millisievert (0.1 rem) in any 1 year. A requirement to give instructions to certain patients was already contained in 10 CFR 35.315{a){6} and 35.415(a){5), but the proposed requirement would also require instructions for an additional 50,000 individuals who are administered iodine-131 for the treatment of hyperthyroidism and another 27,000 individuals who are breast-feeding and administered various diagnostic and therapeutic radioactive materials. The purpose of the instructions is to maintain doses to individuals exposed to patients as low as is reasonably achievable.

The NRC proposed to adopt a new 10 CFR 35.75{b){2) to require that licensees maintain, for 3 years, a record of the released patient and the 6

calculated total effective dose equivalent to the individual likely to receive the highest dose if the total effective dose equivalent to any individual other than the released patient is likely to exceed 1 millisievert (0.1 rem) in a year from a single administration. The major purpose was to provide a record to allow licensees to assess the need to limit the dose to individuals exposed to a patient who may receive more than one administration in a year.

Finally, the NRC proposed to amend its requirements on instructions in 10 CFR 35.315(a)(6) and 35.415(a)(5). These regulations already required instructions (not necessarily written) in certain cases, but the phrase "if required by§ 35.75{b)" was added to each. The purpose of this change was to make Part 35 consistent as to when instructions must be given.

In addition, the NRC concurrently issued an associated draft regulatory guide and supporting draft regulatory analysis for public colllllent. The draft regulatory guide, OG-8015, "Release of Patients Administered Radioactive Materials," proposed guidance on determining the potential doses to an individual likely to receive the highest dose from exposure to a patient and

- established appropriate activities and dose rates for release of a patient.

The draft guide also proposed guidelines on instructions for patients on how to maintain doses to other individuals as low as is reasonably achievable and it described recordkeeping requirements. The draft regulatory analysis, NUREG-1492, "Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material" (May 1994), examined the benefits and impacts of the proposed rule considered by the NRC.

7

III. Public Comments on the Proposed Rule A total of 63 co11111ent letters were received on the proposed rule, the draft regulatory guide, and the draft regulatory analysis. A majority of the comment letters were from medical practitioners and medical organizations, but there were also comment letters from priva'te individuals, public-interest groups, and regulatory agencies in Agreement States. Overall, the majority of conrnent letters supported a dose limit of 5 millis1everts (0.5 rem) for individuals exposed to patients released with radioactive material. However, about one-fourth of the comment letters opposed the proposed recordkeeping requirement. The significant conrnents are discussed below, arranged by subject.

EXCLUSION OF PATIENT RELEASE FROM§ 20.130l(a)

All the commenters except one supported governing patient release by the regulations in IO CFR 35.75 and excluding the dose to individuals exposed to a -

released patient from IO CFR 20.130l(a).

Coaent. One commenter, representing a public-interest group, objected to any exposure of a member of the general public who has not consented freely to the dosage. They said that such exposure would lead to widespread morbidity and mortality.

Response.

~

In its revision of 10 CFR Part 20 (56 FR 23360; May 21, 1991), the NRC determined that, while doses should be maintained as 8

low as is reasonably achievable, a dose limit of 1 millisievert (0.1 rem), or a dose limit of 5 millisieverts (0.5 rem) in certain special circumstances, provides adequate protection. The revised Part 20 is based, in part, upon the recommendations of the International Commission on Radiological Protection (ICRP) and the recoR111endations of the National Council on Radiation Protection and Measurements (NCRP). The NCRP reconnnends public dose limits of 1 millisievert (0.1 rem) for continuous or frequent exposure and 5 millisieverts (0.5 rem) for infrequent exposure.

The ICRP reconnnends that the limit for public exposure should be expressed as an eff~ctive dose of 1 millisievert (0.1 rem) in a year, except that, in special circumstances, the dose could be higher in a single year provided the average over 5 years does not exceed 1 millisievert (0.1 rem) per year. In ICRP Publication 60, in defining medical exposure, ICRP stated that medical exposure includes "exposures {other than occupational) incurred knowingly and willingly by individuals helping in the support and comfort of patients undergoing diagnosis or treatment." Furthermore, in explaining, dose

- limits in medical exposure, the ICRP stated in the same publication that "the Commission therefore recoR111ends that dose limits should not be applied to medical exposures. 11 Thus, in ICRP's opinion, family members who are helping in the support and comfort of patients would not be restricted under the dose limit stated above.

The revision of Part 20 incorporated the long-term objective as the dose limit and included a provision(§ 20.130l(c)) to allow for alternative limits on an occasional basis. Section 20.130l(c) provides that an annual dose of up to 5 millisieverts (0.5 rem) is acceptable if there is a need for it and if 9

steps are taken to reduce the dose to as low as is reasonably achievable. The NRC reaffirms that previous determination in this rulemaking.

In the case of released patients, it would be unlikely for a single individual exposed to a patient to receive a dose in a year of over 5 millisieverts (0.5 rem) because large therapeutic doses (greater than 3,700 megabecquerels (100 millicuries)) are usually not administered more than once to the same patient in a given year.

Coaent. One commenter said that the NRC should change the 0.1 rem dose -

limit for the public in 10 CFR 20.130l(a)(l) to 0.5 rem for all licensed activities because a dose limit of 0.5 rem offers adequate protection and is a dose that has no proven effects.

Response. This issue of the general public dose limit is outside the scope of this rulemaking. The issue was dealt with when 10 CFR Part 20 was recently revised (56 FR 23360; May 21, 1991). That rulemaking explained the NRC's rationale for adopting the 1-millisievert (0.1-rem} dose limit in 10 CFR 20.130l(a}(l}.

ACTIVITY-BASED VS. DOSE-BASED RELEASE LIMIT The issue is whether to retain the current patient release ,limit in 10 CFR 35.75, which is expressed as an activity limit together with an alternative but approximately equivalent limit on dose rate at 1 meter, or to express the release limit as a dose to an individual exposed to the patient.

10

The majority of commenters supported the dose-based limit. However, some co11111enters opposed the dose-based approach.

Coaent. A number of commenters said that 10 CFR 35.75 should not be changed and that the 30 millicurie or 5 millirem per hour release criteria should be retained because they are working well. Some corrmenters said that a dose-based release limit as proposed woul~ cause confusion and potential problems. One commenter said that the Part 20 revision was not intended to alter the status quo for patient release. Conunenters objected to the dose-based release limit because they thought the dose estimates to the public would be very inaccurate as these estimates are based on the unreliable method of predicting the anticipated time and proximity to others. Conunenters also said that dose estimation and the subsequent recordkeeping would be time consuming and would add to the cost of treatment without a probable significant decrease in radiation exposure.

Response. The NRC is adopting a dose-based limit rather than an activity-based limit because the dose-based limit better expresses the NRC's primary concern for the public's health and safety. A single activity requirement was not retained because different radionuclides with the same activity can give very different doses under identical exposure conditions.

Likewise, a single dose rate requirement for all radionuclides was not retained because different radionuclides with the same dose rate, at the time of release, can give very different doses depending upon the half-life of the radionuclide. The total dose depends on the effective half-life of the 11

radioactive material in the body of the patient and other factors that vary for different materials. For these reasons, the NRC is establishing a dose limit rather than an activity or dose rate limit.

The NRC is establishing a dose limit of 5 millisieverts (0.5 rem) total effective dose equivalent to an individual from exposure to the released patient for each patient release. This dose limit is consistent with the underlying risk basis of the current 10 CFR 35.75 (50 FR 30627; July 26, 1985), the recommendations of the NCRP and the ICRP, and the provisions in 10 CFR 20.130l(c) pertaining to temporary situations in which there is justification for a dose limit higher than 1 millisievert (0.1 rem).

The NRC believes that the dose-based release limit can and will work well because the associated Regulatory Guide 8.39, RRelease of Patients Administered Radioactive Materials, 11 can be used to relate the dose to the quantity of activity in the patient. The guide provides conservative estimates of activities for commonly used radionuclides and their corresponding dose rates with which a patient may be released in compliance with the dose limits in the final rule. The approach used in the regulatory guide is based on NCRP Report No. 37, nPrecautions in the Management of -

Patients Who Have Received Therapeutic Amounts of Radionuclides.n 1 In the case of iodine-131, the most significant radionuclide, the release quantity based on the standard conservative assumptions is 1.2 gigabecquerels (33 millicuries), which is essentially the same as the current release quantity.

1 National Council on Radiation Protection and Measurements (NCRP),

nPrecautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides," NCRP Report No. 37 (October 1, 1970). (Available for sale from the NCRP, 7910 Woodmont Avenue, Suite 800, Bethesda, MD 20814-3095.)

12

NUREG-1492 contains a detailed examination of the benefits and impacts of the final rule that includes dose estimation, recordkeeping, and radiation exposure. Single copies of the final regulatory analysis and Regulatory Guide 8.39, "Release of Patients Administered Radioactive Materials," are available as indicated in the ADDRESSES heading.

Coaent. A commenter said that the calculational approach in the rule would require the physician to ask many personal questions of the patient.

9 Response. The commenter is incorrect in believing that the dose-based approach will generally require personal information from the patient. The NRC anticipates that nearly all patients will be released based on default assumptions which do not require any personal information from the patient.

A table of release quantities, based on standard conservative assumptions, is provided in Regulatory Guide 8.39, "Release of Patients Administered Radioactive Materials.* However, the rule does allow the physician to cal~ulate patient-specific dose estimates to allow early release of a patient not otherwise subject to release under the default values in Regulatory, Guide 8.39.

Coaaent. One convnenter said that it should continue to be acceptable to release patients based on the dose rate at I meter.

Response. The rule authorizes release of patients based on the dose to an individual for each patient release. However, release quantities based on dose rate and conservative assumptions can be calculated. The table of release quantities in Regulatory Guide 8.39, "Release of Patients Administered 13

Radioactive Materials," specifies the dose rate at 1 meter of convnonly used radionuclides that allow licensees to authorize patient release.

RELEASE QUANTITIES Using a dose-based system based on a dose to the most highly exposed individual of 5 millisieverts (0.5 rem) would, in some circumstances, allow release of a patient with more than 1,110 megabecquerels (30 millicuries) of activity. Some co11!11enters were opposed to allowing releases with higher activities than are now pennitted.

Coaent. Several commenters said that the release of patients with more than 30 millicuri-es of iodine-131 should not be pennitted because of concerns about the risk of internal exposure. One co11111enter said that doses to family members from the patient vomiting were not adequately considered. The same cof'llllenter also said that a study indicated that in-home contamination by patients dosed w,ith I-131 could double family members' risk of developing -

thyroid cancer.

Response. The concern over contamination is not justified by the radiation doses that are likely to be caused by the removal of radionuclides from the patient's body by the pathways of exhaled air, feces, saliva, sweat, urine, and vomit. Measurements from several studies, as discussed in the supporting regulatory analysis, have shown that a relatively small proportion of the radioactive material administered will appear as contamination. Doses to family members exposed to contamination from living in close contact with 14

released patients have been measured in several studies and in every case were less than 10 percent of the 5-millisievert (0.5-rem) total effective dose equivalent limit and were most often less than l percent of the 5-millisievert (0.5-rem) limit. In addition, the internal doses resulting from contamination were always less and generally far less than the external dose, meaning that contamination was the less important source of radiation exposure. These measurements show that even if the family members repeatedly touched household items touched by the patient, contamination does not cause unacceptably high doses. These findings were true even in the case of a British study where eleven patients volunteered to disregard special precautions against contamination and minimizing spousal and family exposure. These measurements are discussed in NUREG-1492. Also, the NCRP recently addressed the risk of intake of radionuclides from patients' secretions and excreta in NCRP Commentary No. 11, "Dose Limits for Individuals Who Receive Exposure from Radionuclide Therapy Patients," and concluded that, " .*. a contamination incident that could lead to a significant intake of radioactive material is

- very unlikely. "2 In general, the physical reactions {e.g., vomiting) that a patient may experience from the administration of any radiopharmaceutical are rare.

Vomiting is seldom an important elimination route for radiopharmaceuticals after the patient has left the medical facility since orally administered radiophannaceuticals such as iodine-131 are rapidly absorbed, within a half hour, by the gastrointestinal system.

2 National Council on Radiation Protection and Measurements, "Dose Limits for Individuals Who Receive Exposure from Radionuclide Therapy Patients," NCRP Co111T1entary No. 11 (February 28, 1995). (Available for sale from the NCRP, 7910 Woodmont Avenue, Suite 800, Bethesda, MD 20814-3095.)

15

Regarding the convnent on the doubling of risk of developing thyroid cancer, there is no scientific consensus by the United Nations Scientific Convnittee on the Effects of Atomic Radiation, ICRP, or NCRP to support the suggested increased risk of thyroid cancer following ingestion of iodine-131.

Based on the information currently available, the Co11111ission continues to conclude that the benefits outweigh the potential of small increased risks associated with this rule.

Co1111ent. One connnenter noted that hospitals now make great efforts to control contamination from patients who are now hospitalized because they contain more than 30 millicuries of iodine-131. This co11111enter stated that it would not be possible to maintain the same level of contamination control at these patients' homes if these patients were released with more than 30 millicuries of iodine-131.

Response. The NRC agrees that, even though released patients are given instructions on how to limit the hazard from contamination, contamination -

control in a hospital can be mo.re effective than contamination control out of the hospital. However, the two situations are not really comparable. In the case of the released patient at home, therapeutic administrations usually occur no more than once in a year and probably no more than once in a lifetime; but in the case of a hospital, large the~apeutic administrations are done repeatedly on many patients. Therefore, areas in hospitals have the potential for contamination from many patients, and people who frequent the hospital (e.g., clergy or a hospital orderly) have the potential to be exposed to contamination from many patients. In addition, the 5-millisievert 16

(O.S~rem) limit that is applied to household members exposed to a patient is a special limit that is appropriate for only occasional use and for use where there is a definite need. This special limit fits the case of doses received by the household members of a released patient, but does not fit the case of people who frequent a hospital on a routine basis. Lastly, in limiting doses, the NRC considers what is reasonably achievable. The mere fact that a home cannot control contamination as well as a hospital does not mean that the contamination control achieved in homes is not adequate. Actual measurements 41 of doses to household members from contamination, as discussed in NUREG-1492, show that the doses from contamination are low, demonstrating that the ?egree of contamination control that was achieved is adequate.

Coaent. One commenter said that the proposed rule did not adequately address the concerns that the Agreement States expressed on the petitions for rulemaking concerning releasing patients with quantities of iodine-131 in excess of 30 millicuries.

Response. In co111T1enting on the petitions, a number of States expressed concerns about releasing patients administered 14.8 gigabecquerels (400 millicuries) of iodine-131, which one of the petitioners had requested.

However, the States that commented were generally favorable to the proposed rule limiting the dose to the most exposed individual to 5 millisieverts (0.5 rem), and none of the States indicated that their concerns were misrepresented. In fact, one Agreement State conunented that it was pleased that the NRC had considered the comments made by the Agreement States at various meetings with the NRC. The dose-based limit would generally permit releases if the dose to another individual would not be likely to exceed 17

5 millisieverts {0.5 rem}. For example, if a "licensee ~ses the default table of release quantities provided in the regulatory gui.de as *the basis for release, a patient administered 1.2 gigabecquerels (33 *m~q1;curies) or less of iodine-131 could be irrnnediately released and no record of release is required.

However, if the licensee wishes to release a patient with an activity that is greater than the value in the default table, the licensee must do a dose calculation using case-specific factors to demonstrate compliance with the release criteria. Furthermore, if the table is used as the basis for release but the administered activity exceeds the value in the table, the licensee must hold the patient until the time at which the retained activity is no greater than the quantity in the table or the dose rate at 1 meter is no greater than the value in the table. When the administered activity is greater than the value in the default table, a record of the basis for the release must be maintained for NRC review during inspection. Regardless of the method used by the licensee to authorize release, the dose limit of 5 millisieverts (0.5 rem) in the revised 10 CFR 35.75 applies. By identifying more than one method for calculating the release of a patient in accordance tit with 10 CFR 35.75, the NRC provides greater flexibility for licensees to achieve compliance with the new requirement while still providing adequate protection of public health and safety.

Coaent. One commenter said that in some cases it should be permissible to authorize the release of a patient even if the dose to a family member might exceed 0.5 rem because the release might be beneficial and acceptable to family members. Another comenter said that a dose of 0.5 rem to an

individual exposed to a p*atient has so 1ittle hazard that the NRC should not be concerned with it.

Response. The NRC does not believe that individuals exposed to a patient should, in general, receive doses in excess of 5 millisieverts (0.5 rem). This is consistent with the recommendations of the ICRP in ICRP Publication 60, 3 "1990 Recommendations of the International Commission on Radio l ogi ca 1 Protection 11

and the reconrnendat ions of the* NCRP in NCRP Rep*ort

• 9 No. 116, 4 "Limitation of Exposure to Ionizing Radiation." Each of these reconrnendations provides a basis for allowing individuals to receive annual doses up to 5 millisieverts (0.5 rem) under certain circumstances. Both the ICRP and the NCRP reconrnend that an individual can receive a dose up to 5 millisieverts (0.5 rem) in a given year in situations when exposure to radiation is not expected to result in doses above 1 millisievert (O.l rem) per year for a long period of time, as would be the case for doses from released patients. In NCRP Conrnentary No. 11, "Dose Limits for Individuals Who Receive Exposure from Radionuclide Therapy Patients," 2 the NCRP recommended a dose limit of 5 millisieverts (0.5 rem) annually for members of the patient's family. However, on the reco111nendation of the treating physician, the NCRP considered it acceptable that members of the patient's family be permitted to receive doses as high as 50 millisieverts (5 rems).

3 International Co111nission on Radiological Protection (ICRP), "1990 Reconrnendations of the International Conrnission on Radiological Protection,"

ICRP Publication No. 60 (November 1990). Available for sale from Pergamon Press, Inc., Elmsford, NY 10523.

4National Council on Radiation Protection and Measurements, "Limitation of Exposure to Ionizing Radiation," NCRP Report No. 116 (March 31, 1993).

Available for sale from the NCRP, 7910 Woodmont Avenue, Suite 800, Bethesda, MD 20814-3095.

19

The NRC does not agree that the latter NCRP recommendation should apply in general. The NRC believes that if the dose to another individual is likely to exceed 5 millisieverts (0.5 rem), the patient should remain under the control -

of the licensee. Licensee control is necessary to provide adequate protection to the individuals exposed to the patient.

RECORDKEEPING The strongest opposition to the proposed rule was to the proposed requirement to maintain a record of the released patient and the calculated total effective dose equivalent to the individual likely to receive the highest dose if the dose to that person is likely to exceed I millisievert (0.1 rem). Under the proposed rule, if a patient had or might have had one or more administrations within the same year, the licensee would use the records to determine the dose from the previous administrations so that the total dose to an individual exposed to a patient from all administrations would not exceed 5 millisieverts (0.5 rem).

Coaent. Many connnenters indicated that this requirement would cause excessive costs in time, effort, and money to track down records of previous administrations, to perfonn calculations, and to keep records of all the work and asked that the requirements to make calculations and keep records be removed. The conunenters believed that the work would not produce an increased level of safety, that the NRC greatly underestimated the cost, and that the recordkeeping would be unnecessary, inappropriate, and impractical.

\

Some conunenters said that multiple administrations that would result in a total 20

effective dose equivalent greater than 1 millisievert {0.1 rem) are not done to the same patient routinely. Other co1T111enters said that there have been decades of experience unencumbered by any paperwork burden at all with no evidence that a lack of paperwork has resulted in any additional problems.

One commenter said that if 0.5 rem is acceptably safe, why have the documentation required at the 0.1 rem level.

Another commenter said.that it cannot be a licensee's responsibility to know the details of a radionuclide therapy performed by another licensee in terms of which members of the public received the most radiation dose from that other licensee's therapy procedure.

One commenter said that the excessive recordkeeping cost would be a nonreimbursable cost, and the burden will cause many physicians to stop offering iodine therapy, which would force patients to travel to large medical facilities in cities and cause problems with patient access in sparsely populated areas.

Response. Upon reconsideration, the NRC has decided to delete the requirement to keep records when the dose to the most highly exposed individual is likely to exceed 1 millisievert (0.1 rem). The requirement was proposed so that it would be possible to account for the dose from multiple administrations in the same year to ensure that the total dose to an individual exposed to the patient did not exceed 5 millisieverts (0.5 rem).

The NRC has an advisory con111ittee, the Advisory Con111ittee on the Medical Uses of Isotopes, or "ACMUI," which advises the NRC on rulemakings and other initiatives related to the medical use of byproduct materials. The NRC also has a visiting medical fellows program that recruits selected physicians or 21

pharmacists to work for the NRC for a period of 1 to 2 y.e.ars. Both the ACMUI and the current Visiting Medical Fellow, Myron Pollycove, M.D., provided advice to the NRC during the development of this rule. 1n addition, Barry A. Siegel, M.D., former Chairman of the ACMUI, reviewed the patient records at his medical facility for the 1-year period from July 1, 1993, to June 30, 1994 (Mallinckrodt Institute of Radiology, St. Louis, Missouri).

Ors. Siegel and Pollycove concluded that no co111110n nuclear medicine practice, be it diagnostic, therapeutic, or a combination of the two, results in multiple large administrations that would be likely to cause the 5-millisievert {0.5-rem) dose limit to be exceeded because of multiple administrations in a year.

While the proposed requirement to maintain a record of the dose to another individual if the dose is likely to exceed 1 millisievert {0.1 rem) has been deleted, a recordkeeping requirement with a reduced impact has been retained as discussed under the heading, "Discussion of Text of Final Rule."

Coaent. Several commenters said that those who pay for health care 9 will put great pressure on physicians to optimize calculations to reduce in-patient days and to justify out-patient treatments.

Response. There is no objection to optimizing calculations to reduce in-patient days as long as the calculations are realistic and the 5-millisievert (0.5-rem) limit in 10 CFR 35.75 is met. Regulatory Guide 8.39, "Release of Patients Administered Radioactive Materials," describes examples of calculations that are acceptable to the NRC.

22

WRITTEN INSTRUCTIONS TO PATIENTS In general, there was little objection to providing *instructions to patients on how to minimize the dose to others, but there was significant opposition to the proposed requirement that the instructions would have to be written.

Co1111ent. One co1T111enter said that the Statement of Considerations for the proposed rule was in error in stating that the existing regulations already required that the instructions to patients be written.

Response. The commenter is correct. The Statement of Considerations was in error on that point. The existing regulations do not specify that instructions have to be in written form.

Coment. A number of co1T111enters said that instructions should not need

• to be written and that oral instructions should be permissible. Some of these commenters said that oral instructions are more effective and that how the instructions should be given is within the province of the doctor-patient relationship and that the NRC and its regulations should not interfere with that relationship. One commenter said that the physical condition of the patient could lessen the patient's ability to follow the instructions.

Another co1T111enter said that the standard written instructions require too much time explaining how each patient varied from the standard instruction sheet.

However, one Agreement State and a major health maintenance organization strongly supported the requirement that the instructions be written.

23

Response. The NRC believes that providing written instructions has a significant value because often patients will not remember all of the instructions given orally. In addition, written instructions can be read by other family members or care-givers. The requirement to provide the instructions in written form was also supported by the ACMUI.

This regulation allows the licensee to detennine the form of the written instructions. The NRC believes that for the majority of releases requiring written instructions, the written instructions can be prepared in a generic form. For example, the Society of Nuclear Medicine has prepared a brief pamphlet, "Guidelines for Patients Receiving Radioiodine Treatment," which can be given to patients at nominal cost (less than $1 per patient). However, oral instructions may al so be provided in a11 cases*.

Coaaent. Several commenters said that dictating to a physidan how and what he or she must tell a patient is not the purview, mandate, or competence of the NRC and interferes with an essential part of medical practice, which is convnunication between physician and patient.

Response. In a policy statement published on February 9, 1979 (44 FR 8242), entitled "Regulation of the Medical Uses of Radioisotopes; Statement of General Policy," the NRC made three specific statements. The third statement of the policy is "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 final rule is consistent with this statement because it does not dictate the choice of medical treatment or diagnosis, does not specify the details of what the physician must say or must 24

include in the contents of the written instructions, and is directed at minimizing the risk to the patient's family who have no doctor-patient relations to the prescribing or administering personnel. However, Regulatory Guide 8.39, "Release of Patients Administered Radioactive Materials,"

recommends contents of the written instructions.

Further discussion of the 1979 Medical Policy Statement is presented under the heading, "VIII. Consistency with 1979 Medical Policy Statement."

Coaent. Several conrnenters asked whether written instructions were appropriate if the patient was blind, illiterate, or did not read English.

Another commenter said that the instructions should be both written and oral and should be in the primary language of the patient.

Response. The NRC believes that written instructions are useful and should be required. If the patient is blind, illiterate, or does not read English, it is likely that someone else will be able to read the instructions for the patient. NRC considers it too much of a burden to require that the instructions be given in the primary language of the patient, although the regulations do not preclude foreign language written instructions if the licensee chooses to provide them. In most situations, it will be possible to find someone who can translate for the patient if necessary. The requirement that written instructions be given to the patient does not preclude additional oral instructions.

Coaaent. Several commenters asked how the NRC would enforce implementation of the instructions given to the patient. Another conrnenter 25

asked how the licensee could verify that the instructions are followed.

Another convnenter said that a sizable fraction of patients may not follow radiation safety instructions to protect spouses and may be even less careful about protecting total strangers. This commenter also asked whether it is reasonable to expect that released patients will alter their behavior and limit their activities for the protection of others.

Response. The NRC does not intend to enforce patient compliance with the instructions nor is it the licensee's responsibility. However, it is the responsibility of licensees to provide instructions to the patients.

Following the instructions is normally the responsibility of the patient.

However, American medical practice routinely depends on patients following instructions, such as instructions on when and how to take medications.

With regard to compliance with the instructions, surveys of patients and their spouses, as discussed in the supporting regulatory analysis, indicate that most will attempt to follow the instructions faithfully, especially"with regard to protecting their children, although some patients and their spouses -

indicated that they might not keep physically distant from their spouse for prolonged periods of time.

Coaent. One coR11tenter said that instructions should be given for all administrations of radioactive material, regardless of the quantity administered.

Response. The NRC does not agree. In some cases, particularly in the large number of diagnostic administrations, the potential doses are so small 26

that the burden of requiring instructions cannot be justified. Under the final rule, if the dose to any individual exposed to the patient is not likely to exceed I millisievert (0.1 rem), instructions are not required but the physician could give any instructions that he or she considers desirable.

CONFINEMENT OF PATIENTS Coaent. Two conrnenters said that patients cannot be confined against their wishes and that the ruJe provides no penalty for the patient who leaves confinement in the hospital "against medical advice." Another commenter said that the rule seems to require that the licensee have control of the patient's activities after release.

Response. The NRC recognizes that patients cannot be held against their will. The rule deals with the conditions under which the licensee may authorize release. The NRC would not penalize a licensee for the actiy,ities of the patient after release or if the patient were to leave "against medical advice."

Coaent. One co11111enter asked whether a patient who was releasable but was still hospitalized for other reasons would still be considered under the licensee's control.

Response. Once the licensee has authorized the release of the patient, there is no need to keep the patient under licensee control for radiation protection purposes if the patient remains hospitalized for other reasons.

27

However, good health physics practice would be to continue to make efforts to maintain doses to people at the facility as low as is reasonably achievable.

Coaent. Coll'lllenters also asked how a patient can be confined to his or her house.

Response. These coD1J1enters misunderstood the concept of confinement.

As explained in the Statement of Considerations for the proposed rule (59 FR 30724), the term "confinement" no longer applies to the revision to 10 CFR 35.75. Instead, the text of the rule uses the phrase 11 licensee control" to more clearly reflect the NRC's intent~

The NRC believes that there is a distinct difference between a patient being under licensee control in a hospital or other licensee facility {e.g., a hospice or nursing home) and being at home. In a hospital or other area or address of use listed on the NRC license, the licensee has control over access to the patient as well as having trained personnel and instrumentation available for making radiation measurements not typically available at the 4lt patient's home. In addition, while under licensee control, a licensee has control over the dose by limiting the amount of time that individuals are in close proximity to the patient. A patient who goes home is released from licensee control.

Coaent. One commenter thought that the rule should define the term 11 release."

28

Response. The term nrelease from licensee control," when read in context, refers to radiation protection considerations and is sufficiently clear that there is no need to define the term.

MISCELLANEOUS COMMENTS ON THE RULE Coaent. Several comrnenters said that the rule should not be a matter of Agreement State compatibility at any level.

Response. The NRC does not agree. The NRC conducts an assessment of each proposed requirement or rule to determine what level of compatibility will be assigned to the rule. These case-by-case assessments are based, for the most part, on protecting public health and safety. NRC has evaluated the final rule and assigned compatibility designations ranging from level 1 {full compatibility required) to level 3 (uniformity not required} as detailed later in this Federal Register notice.

Co1111e11t. Several comrnenters said that a breast-feeding infant should not be considered as an individual exposed to the patient for the purposes of determining whether patient release may be authorized. These colTll!enters said that consideration of the breast-feeding infant should be under the jurisdiction of the physician, that the issue is a medical issue rather than a regulatory issue, and that the NRC should not interfere in medical issues.

Response. The NRC does not agree. The NRC has a responsibility to protect the public health and safety, and that responsibility extends to all individuals exposed to a patient administered licensed radioactive materials, including breast-feeding children. When the release is authorized, it is 29

based on the licensee's determination that the total effective dose equivalent to an individual from the released patient is not likely to exceed 5 millisieverts {0.5 rem). The dose to the breast-feeding child from breast-feeding is a criterion for release but it can be controlled by giving the woman guidance on the interruption or discontinuation of breast-feeding, as required by the new 10 CFR 35.75. However, the release could be based on the default table of release activities in the regulatory guide or a patient-specific calculation, as required by the new 10 CFR 35.75. The issue of the dose to the breast-feeding child is discussed in NUREG-1492 and Regulatory Guide 8.39, *Release of Patients Administered Radioactive Materials."

Co..ent. One convnenter said that the proposed rule did not accurately represent the position of the Advisory Co1J111ittee on Medical Uses of Isotopes.

Response. A review of the transcript for the ACMUI meeting in May 1992 shows that the Federal Register Notice provided an accurate description of the -

ACMUI position. The final rule was discussed with the ACMUI on October 18, 1995, and the ACMUI, in general, supported the rule. {For ACMUI's comments and NRC's respon~es, see Section V. Coordination with the Advisory Committee on Medical Uses of Isotopes.)

C011111ent. One co1J111enter said that its facility treated many foreign patients with therapeutic pharmaceuticals. These patients frequently may leave the hospital and irrmediately board a plane to return home. Thus, there is a limit to the amount of control that a licensee has over the patient.

30

Response. The NRC recognizes that the licensee has no control over the patient after the patient has been released. The quantities for release listed in Table 1 of Regulatory Guide 8.39, "Release of Patients Administered Radioactive Materials, 11 were calculated using conservative assumptions (for example, by using the physical half-life of the radioactive material rather than the more realistic effective half-life). Thus, the NRC considers it unlikely that the dose to an individual in real circumstances would approach 5 millisieverts (0.5 rem).

In special situations, such as when a released patient would immediately board an airplane and would therefore be in close contact with one or more individuals, it may be necessary to base the release on a more realistic cas-specific calculation. Once the patient is released, the responsibility fo~ following the instructions is entirely the patient's, not the licensee's.

COMMENTS ON THE DRAFT REGULATORY GUIDE Comments were also requested on Draft Regulatory Guide, DG-8015, "Release of Patients Administered Radioactive Materials," associated with this rulemaking. Because the guide is associated with the rule, the conrnents received on the draft guide are discussed here. Most of the comments concerned the method and the assumptions used to calculate the dose to the individual likely to receive the highest dose.

Coaaent. Several commenters said that the calculational methodology in the draft guide is too complex and that the assumptions are too conservative.

As an example, several co11111enters said that the assumed 24-hour nonvoiding 31

assumption used in calculating doses is too conservative. As evidence that the calculations are too conservative, several convnenters said that the doses measured using dosimeters were much lower than doses calculated using the models in the draft guide.

Response. The NRC has revised the guide to use a phased approach for determining when release can be authorized. While the calculations can sometimes be complex, the results of calculations that use conservative assumptions are given in a table of release quantities in Regulatory Guide 8.39, "Release of Patients Administered Radioactive Materials." Of the 8 to 9 million administrations performed annually, in all except about 10,000 cases (radioiodine therapy for thyroid cancer), release can be authorized based on conservative assumptions and using Table 1 with no calculational effort on the part of the licensee and no additional recordkeeping beyond what is already required. For permanent implants, the guide provides dose rates at I meter from the patient at which release may be authorized. Thus, for implants, there would be no calculational effort 4II needed. In addition, the guide provides infonnation on iodine therapy for thyroid cancer that can be used for determining release based on retention and elimination. This additional information in the guide will allow the licensee to perfonn the calculation with relatively little effort.

With regard to the co0111ents that the methodology is too conservative and that measured values are lower than calculated by the methodology, the methodology in the table giving default release quantities is intended to be conservative. The NRC believes it is appropriate and prudent to be conservative when providing generally applicable release quantities that may 32

be used with little consideration of the specific details of a particular patient's release. A review of published information, as described in the regulatory analysis, NUREG-1492, "Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material 11 (1997), finds that measured doses are generally well below those predicted by the methodology used to calculate the table of default release quantities. Thus, the default release quantities are conservative as the NRC intended. However, the licensee is given the option of using case-specific calculations that may be less conservative.

Nevertheless, the NRC agrees that the assumption used in the draft guide of 24-hour nonvoiding in the thyroid cancer example was overly conservative.

The revised example uses an excretion half-life of 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> as reconunended by th~ ICRP in ICRP Publication 53, ffRadiation Dose to Patients from Radiopharrnaceuticals. 115 Coment. One co11111enter said that the occupancy factor (generally, assumed to be 0.25 at 1 meter} should not be left to the discretion of the licensee because low occupancy factors could easily be justified by providing stri'ct safety instructions without any verification that the instructions will be followed. Another co11111enter liked the flexibility provided by being able to adjust the occupancy factor, but wanted to know if other considerations are allowed and if it is acceptable to use values lower than 0.125.

5 lnternational Commission on Radiological Protection (ICRP}, "Radiation Dose to Patients from Radiopharrnaceuticals, ICRP Publication No. 53 (March 11 1987}. Available for sale from Pergamon Press, Inc., Elmsford, NY 10523.

33

Response. Draft Regulatory Guide 8.39 discussed situations in which it might be permissible to lower the occupancy factor from 0.25 to 0.125, but did not reconnnend occupancy factors less than 0.125. Occupancy factors less than 0.125 may be difficult to justify because it is generally not realistic to assume that the patient can avoid all contact with others. However, lower values for the occupancy factor are not prohibited by the regulation, but they must be justified in the record of the calculation, as the record will be subject to inspection.

Coatlent. Several commenters said that the iodine-131 retention fraction of 0.3 used in the draft guide for treatment of thyroid cancer is too large and that the correct value should be 0.05 or less. Another commenter said that the biological half-life of extrathyroidal iodine should be 0.5 day for both the euthyroid and hyperthyroid condition. One conunenter said that the biological half-lives from ICRP Publication No. 53 should be used for thyroid cancer.

/

Response. The NRC agrees that the commenters raised valid points. In Regulatory Guide 8.39, the iodine retention fraction for thyroid cancer was changed to 0.05. The biological half-life for the extrathyroidal fraction was changed to 0.33 day. In addition, the biological half-lives from ICRP Publication No. 53 were used for the thyroid cancer case.

Coaent. One commenter said the table of release quantities in the draft guide should be expanded to include beta emitters such as strontium-89 34

and phosphorous-32. Another commenter said that the table should be expanded to include chromium-SI, selenium-75, yttrium-90, tin-II7m, and iridium-I92.

Response. Values for the beta emitters strontium-89 and phosphorous-32 have been added to the table of release quantities in Regulatory Guide 8.39.

The table of release quantities was also expanded to add values for chromium-SI, selenium-75, yttrium-90, tin-117m, and iridium-192.

Co1111ent. The table of release quantities in the draft regulatory guide should be expanded to include accelerator-produced radioactive materials as an ~

aid to Agreement States.

Response. Several accelerator-produced materials were added to Regulatory Guide 8.39 as an aid to the States and to medical facilities. The NRC has no regulatory authority over the release of patients administered accelerator-produced materials and would not inspect the release of patients administered accelerator-produced materials.

Coaent. One conunenter said that the regulatory guide should have a table of release quantities based on biological half-life rather than only the physical half-life.

Response. Regulatory Guide 8.39 now provides more infonnation on release quantities for iodine-131 based on biological half-lives.

35

Coaent. One con111enter said that the factor of 10*0 used in the draft guide to estimate internal dose is not well supported fo.r nonoccupational exposures. Another connnenter said that the calculation of dose to individuals exposed to the patient ignores the potential of radiation dose from the excretion of radioactive material from the patient, and this could present a significant radiological hazard to family members.

Response. It is true that there is not a great deal of information on the use of the factor in nonoccupational settings, but measurements. (described in NUREG-1492) have been made in which iodine uptake was measured in people exposed to a patient. These data suggest that the fractional uptake of the administered activity will be on the order of 10-6

• Since iodine is among the most soluble and volatile radiophannaceuticals, it can be expected that the transfer to others of less soluble and less vol.atile radiophannaceuticals would be less than that of iodine.

In addition, the NCRP recently concluded that, for individuals exposed to radionuclide therapy patients, the risks of external irradiation and potential contamination are minor from a public health viewpoint; therefore a significant intake from a contamination incident is very unlikely. 2 COlllent. A medical organization co11111ented that the draft guide is not complete and does not provide sufficient comprehensive examples to assist licensees in complying with the rule.

Response. The NRC has expanded the guide to tnclude information and further examples on the biological elimination of iodine-131 and on when 36

guidance on the interruption or discontinuation of breast-feeding should be given. Expanded examples are now given in Regulatory Guide 8.39, "Release of Patients Administered Radioactive Materials." The example on thyroid cancer was revised to include more realistic assumptions, and an additional example on hyperthyroidism was added. The NRC believes that the examples provided illustrate the techniques sufficient to perform the whole range of potential calculations.

Coaaent. One co1J111enter said that the draft regulatory guide did not provide enough information on when and for how long breast-feeding of infants should be interrupted.

Response. Regulatory Guide 8.39 has been greatly expanded with respect to information on the breast-feeding child, including a table on reco1J111endations for the interruption or discontinuation of breast-feeding for specific radiopharmaceuticals.

Coaent. One co1J111enter said that the sample instructions in the draft guide concerning implants should include a picture of an implant seed.

Response. The sample instructions were not expanded to include this because of graphics limitations, but licensees may add photos if desired.

Coaent. Several co1J111enters asked whether multiple individual calculations have to be done or if a generally applicable calculation could be done once and used for many patients.

37

Response. The NRC believes that there may be 5nme situations for which a case-specific calculation could be done for a clas*s of patients. The record for a particular patient's release could then reference tne calculation done for the class of patients. However, depending on a patient's individual status (e.g., lower occupancy factor), there may be cases when the calculation will be done for a specific individual.*

COll9ent. One co1T111enter said that the discussion on radiolabeled antibodies in the draft guide was wrong because antibodies labeled with iodine-131 will be deiodinated in the body and the iodine will behave like other iodine. None of the radiolabeled antibodies now being developed or planned for the future should have an internal dose hazard for the general public.

Response. The NRC agrees with this co1T111ent. Statements in Regulatory Guide 8.39 are now modified.

COMMENTS ON THE DRAFT REGULATORY ANALYSIS (DRAFT NUREG-1492)

Coraent. One commenter said that the value of a person-rem should be

$40 rather than $1,000 as used in the draft regulatory analysis for the purpose of evaluating the costs and benefits of the rule. The conunenter cited a 1993 Health Physics Society position paper as a reason that the value should be $40 per person-rem.

38

Response. The Connnission recently adopted a value of $2,000 per person-rem as explained in Revision 2 of NUREG/BR-0058, "Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission (November 1995), 9 Section 4.3.3, "Evaluation of Values and Impacts. 11 (Single copies of NUREG/BR-0058 are available as indicated in*the ADDRESSES heading.) The draft regulatory analysis, which was prepared utilizing $1,000 per person-rem, employed a simple computational model using the physical half-life only ,of

• radiopharmaceuticals. The regulatory analysis has been revised to include use of $2,000 per person-rem, as well as a more realistic dose model based on biological retention and elimination of the radiopharmaceuticals. The more realistic model with a value of $2,000 continues to demonstrate the cost-effectiveness of the dose-based limit. Specifically, the savings in hospital costs under the earlier release time allowed are estimated at

$14 million, whereas the collective dose of 2,740 person-rem (at a value of

$2~000 per person-rem) corresponds to a cost of about $5 million.

NUREG-1492 contains a detailed discussion of the model and the benefits

• and impacts of the dose-based limit. Single copies of the final regulatory analysis are available as indicated in the ADDRESSES heading.

Coaent. One commenter said that the benefits of the rule were overestimated because the length of ~ime that a thyroid patient would have to remain in the hospital was overestimated and the cost of a hospital room was overestimated, being $450 per day rather than $1,000 per day as assumed in the draft regulatory analysis.

Response. The commenter is correct that the benefits of the rule were overestimated. The estimates in the draft regulatory analysis of days of hospitalization required did not include biological elimination of the 39

radioactive material; only radioactive decay was consider~d. As a consequence, the draft regulatory analysis, in some ccrses, overestimated the time that patients would need to be retained under licensee control, and therefore the costs of patient retention were too high. The final regulatory analysis corrects the estimates.

The NRC believes that the current cost of $1,000 per day for a hospital room is not an overestimate. Under 10 CFR 35.315(a)(l), licensees are required to provide a private room with a private sanitary facility for each patient receiving radiopharmaceutical therapy and hospitalized for compliance with 10 CFR 35.75. Considering this NRC requirement and the recent reference -

cited in the final regulatory analysis on the cost of hospitalization, $1,000 per day for a hospital room is a reasonable estimate.

Coment. One commenter said that the description of the measured doses received by family members was not consistent with the reference cited.

Response. The commenter is correct. An incorrect reference was given.

The final regulatory analysis provides the correct reference.

IV. Coordination with NRC Agreement States The NRC staff discussed the status of this rulemaking effort at two public meetings: the Agreement State Managers Workshop held on July 12-14, 1994, and at the All Agreement States Meeting held on October 24-25, 1994.

The Agreement States expressed no objections to the approach in this rule.

V. Coordination with the Advisory Committee on Medical Uses of Isotopes The Advisory Committee on Medical Uses of Isotopes (ACMUI} is an advisory body established to advise the NRC staff on matters that involve the 40

administration of radioactive material and radiation from radioactive material. The NRC staff presented a su111Tiary of the comments on the proposed rule to the ACMUI during a public meeting held in Rockville, Maryland, on November 17 and 18, 1994.

Drafts of the final rule and regulatory guide were discussed with ACMUI in Rockville, Maryland, on October 18 and 19, 1995. The ACMUI supported the approach in this rule but suggested some clarifying changes. The NRC staff made all but one of the suggested changes. The ACMUI suggested using the term "rationale" instead of "consequences" in the requirement under the revised 10 CFR 35.75(b), to provide "guidance on the interruption or discontinuation of breast-feeding, and information on the consequences of failure to follow the guidance~ for cases where failure to follow the instructions could result in a dose to the infant exceeding 1 millisievert {0.1 rem). Since most of the administrations that would be affected by this requirement are technetium-99m administrations, the ACMUI suggested the change because there was concern that the consequences of low doses of radiation cannot always be explained to the patient without causing unjustified alann. Also, there was concern that physicians cannot explain with certainty the effects of low doses of radiation, such as would be caused by diagnostic administrations of technetiurn-99m. The staff did not change the rule in response to the ACMUI comment. The requirement to provide information on the consequences is included primarily to protect the breast-feeding infant from therapeutic administrations of radioiodine, which could cause serious thyroid damage.

Regulatory Guide 8.39 will contain guidance on the types of information, including expected consequences, to be provided to patients to meet this requirement. Transcripts of the meetings have been placed in and are available for examination at the NRC Public Document Room, 2120 L Street NW.

(Lower Level}, Washington, DC.

41

VI. Discussion of Text of Final Rule This section sunvnarizes the final rule. The NRC is amending 10 CFR 20.130l(a)(l) to state specifically that the dose to individual members of the public from a licensed operation does not include doses received by individuals exposed to patients who were released by the licensed operation under the provisions of 10 CFR 35.75. This is not a substantive change. It is a clarifying change to make clear that the CoD111ission's policy is that patient release is governed by 10 CFR 35.75, not 10 CFR 20.1301.

For the sake of consistency and clarity, the same words are used in

§ 20.1002, "Scope"; in§ 20.1003, "Definitions" (in the definitions of both public dose and occupational dose); and in§ 20.1301, "Dose limit~ for individual members of the public." Also for consistency and clarity, the exclusion of dose from background radiation and from voluntary participation in medical research programs that are now included in§§ 20.1002 and 20.1003 are added to§ 20.130l(a). In addition, the definition of "member of the public," as published in 60 FR 36038 on July 13, 1995, is revised by removing the footnote which read, "Except as delineated in other parts of 10 CFR Chapter l." With the publication of this rule that footnote is no longer needed.

The NRC is amending 10 CFR 20.130l(a)(2) to state specifically that the

~

limit on dose in unrestricted areas does not include dose contributions from individuals administered radioactive material and released in accordance with 10 CFR 35.75. The purpose of this change is to clarify that after a patient has been released under 10 CFR 35.75, licensees are no longer required to control radiation from the patient. The regulation uses the term "individual" to refer to the individual to whom the radioactive material has been administered rather than Rpatient" to clarify that the regulation refers to anyone r~ceiving a medical administration.

42

The NRC is amending 10 CFR 20.1903(b) to use the *t~rm "licensee control" rather than 11 confinement" because the latter term no longer applies to 10 CFR 35.75. The conforming change is necessary since the term "licensee control" more clearly reflects the.NRC's intent in 10 CFR 35.75.

The NRC is adopting a new 10 CFR 35.75(a) to change the patient release criteria from 30 millicuries of activity in a patient or a dose rate of 5 millirems per hour at 1 meter from a patient to a dose limit of 5 millisieverts (0.5 rem) total effective dose equivalent to an individual from exposure to a released patient. (The dose from the radionuclide involved is taken to be the dose to total decay.} A dose-based limit provides a single limit that can be used to provide an equivalent level of protection from risks from a11 radionuclides. Also, the changes are supported by the reco11111endations of the ICRP and NCRP that an individual can receive an annual dose up to 5 millisieverts (0.5 rem) in temporary situations where exposure to radiation is not expected to result in annual doses above 1 millisievert (0.1 rem) for many years. Usually, the only individuals likely to exceed a dose of 1 millisievert (0.1 rem) will be those who are aware of the patient's condition such as the primary care-giver, a family member, or any other individual who spends significant time close to the patient.

This dose-based rule would, in some instances, permit the release of patients with activities greater than currently allowed. This is especially true when case-specific factors are evaluated to more accurately assess the dose to other individuals. The individuals exposed to the patient could receive higher doses than if the patient had been hospitalized longer. These higher doses are balanced by shorter hospital stays and thus lower health care costs. In addition, shorter hospital stays may provide emotional benefits to I

patients and their families. Allowing earlier reunion of families can improve I

I the patient's state of mind, which in itself may improve the outcome of the treatment and lead to the delivery of more effective health care.

43

The release criteria in 10 CFR 35.75(a) could prevent a woman from being released because of the potential transmission of radioactive materials in breast milk. The dose to the breast-feeding child is controlled by giving the woman guidance, as required by 10 CFR 35.75(b}, on the interruption or discontinuation of breast-feeding and information on the consequences of failure to follow the guidance. The expectation is that the woman would follow the instruc'tions and would interrupt or discontinue breast-feeding.

Finally, 10 CFR 35.75(a} includes a footnote to inform licensees that the NRC has made available guidance on rule implementation. The footnote states that Regulatory Guide 8.39, "Release of Patients Administered Radioactive Material," contains tables of activities not likely to cause doses exceeding 5 millisieverts {0.5 rem} and describes methods for calculating doses to other individuals.

The NRC is adopting a new 10 CFR 35.75(b) 'to require that the licensee provide released patients with instructions, including written instructions, on how to maintain doses to other individuals as low as is reasonably achievable if the total effective dose equivalent to any individual other than the released patient is likely to exceed 1 millisievert (0.1 rem). This also requires giving instructions to a woman who is breast-feeding a child if the dose to the child could exceed 1 millisievert (0.1 rem} assuming there were no interruption of breast-feeding. The instructions must include guidance on discontinuation or the interruption period for breast-feeding and the consequences of failing to follow the recoR1Dendation. Regulatory Guide 8.39 contains tables that show temporary interruption periods for various radiopharmaceuticals or discontinuation. The temporary interruption periods were calculated based on the determination that the dose to a child from breast-feeding is unlikely to exceed 1 millisievert (0.1 rem}. However, the physician may use discretion in the recommendation, increasing or decreasing the duration of interruption somewhat depending on the woman's concerns about radioactivity or interruption of breast-feeding.

44

The purpose of describing the consequences is so that women will understand that breast-feeding after an administration of certain radionuclides could cause hann {e.g., iodine-131 could harm the child's thyroid). In other cases, the guidance could simply address avoidance of any unnecessary radiation exposure to the child from breast-feeding.

A requirement for instructions for certain patients was already contained in 10 CFR 35.315{a}(6} and 35.415(a)(5), but the modified requirement for written instructions adds approximately (a) 50,000 patients per year who are administered iodine-131 for the treatment of hyperthyroidism and (b} 27,000 patients per year, among about 8 million administerea radiopharmaceuticals, who may be breast-feeding to whom additional written instructions be given. The purpose of the written instructions is to maintain doses to individuals exposed to patients as low as is reasonably achievable.

The instructions may be either written only or written plus oral. The NRC believes that written instructions are necessary so that the patient and the patient's family and friends will have a document to refer to rather than having to rely solely on the patient's memory and understanding of the instructions.

The requirement of 10 CFR 35.75(b), requiring a licensee to provide guidance on discontinuation or the interruption period for breast-feeding and the consequences of failing to follow the recommendation, presumes that the licensee will make appropriate inquiry regarding the breast-feeding status of the patient. For women who are breast-feeding a child where the dose to the child is likely to exceed 1 millisievert (0.1 rem); the NRC requires that the patient be provided with specific instructions, as described in 10 CFR 35.75{b). There is no specific requirement to maintain a record indicating that breast-feeding status was determined prior to the release of the patient.

The NRC is adopting a new 10 CFR 35.75(c) to require that the licensee maintain a record of the basis for authorizing the release for 3 years if the 45

calculation of the total effective dose equivalent to other individuals uses the retained activity rather than the activity administered, an occupancy factor less than 0.25 at 1 meter, the biological or effective half-life of the radionuclide, or shielding of radiation by the patient's tissue. Thus, records of release are required when the default assumptions are not used as discussed in Regulatory Guide 8.39. Measurements made in several studies indicate that the default assumptions should generally overpredict the dose even when instructions are not given or are not strictly followed. If a licensee administers an activity no greater than the value in the default table of release quantities provided in the regulatory guide as the basis for ti release, no record of release is required.

Licensees are already required by 10 CFR 35.53 to retain records of the measurement of the activity of each dosage of radioactive material administered to a patient; these records are typically maintained in a patient dose log. In addition, 10 CFR 35.32 requires licensees to retain a written directive and a record of each administered radiation dose or radiophannaceutical dosage for therapeutic administrations and diagnostic administrations of iodine-125 or iodine-131 sodium iodide greater than 30 microcuries. These records can be used in conjunction with Regulatory Guide 8.39 to demonstrate that patient releases meet the requirements of 10 CFR 35.75(a) when no record is required by 10 CFR 35.75(c). When the licensee determines that the patient must be held to allow the reduction of radioactivity and then released, the licensee will need a record of release time to demonstrate that the release criteria have been met. A licensee may use any existing record to establish the release time. If biological elimination of radioiodine is a basis for release and the licensee uses the information in Regulatory Guide 8.39, a record of the thyroid uptake may be necessary as part of the basis for release because it is one of the nonstandard conservative assumptions listed in IO CFR 35.75(c). If other case-specific factors are used as the basis for patient release that are in 46

addition to, or modify, the standard conservative assumptions, a record of the basis for the release, including the assumptions used for the calculations, must also be maintained.

This recordkeeping requirement is a modification of the proposed rule.

The proposed rule would have required that a record be maintained of the basis for the patient's release, including all calculations performed, if the total effective dose equivalent to any individual other than the released patient is likely to exceed l millisievert (0.1 rem) in a year from a single administration. Under the proposed rule, the major purpose of the record was to provide the basis for limiting the dose to 5 millisieverts (0.5 rem) to individuals exposed to a patient who may receive more than one administration in a year. Upon reconsideration, based on public co1J111ents and consultation with the ACMUI, an NRC medical consultant, and the NRC Visiting Medical Fellow, the NRC has decided to delete this requirement. A review of medical treatment practices revealed no common practice that would result in doses exceeding the 5 millisievert {0.5 rem) limit because of multiple administrations in the same year to the same patient. Without the need to account for the dose from multiple administrations, maintaining records for the many tens of thousands of patients released when their dose to an individual is likely to exceed 1 millisievert (0.1 millisievert} becomes an unnecessary burden. The requirement to retain these records has therefore been deleted. Each patient release is to be treated as a separate event, and licensee knowledge of previous administrations is unnecessary.

The NRC is also adopting a new 10 CFR 35.75(d) to require that the licensee maintain a record that instructions were provided to a woman who is breast-feeding a child if the administered activity could result in a total effective dose equivalent to the breast-feeding child exceeding 5 millisieverts (0.5 rem) if the woman did not interrupt or discontinue breast-feeding. Thus, the NRC is requiring records for certain radiopharmaceutical administrations (e.g., therqpeutic administrations of 47

iodine-131). The activities of radiopharmaceuticals that require this record are described in Regulatory Guide 8.39.

Finally, the NRC is deleting its requirements on written instructions in 10 CFR 35.315(a}(6) and 35.415{a){5) because those paragraphs are redundant now that 10 CFR 35.75 has requirements for instructions. In addition, 10 CFR 35.415(a) and a(l) are reworded to clarify the original intent of the paragraphs, which was to limit the dose rate at 1 meter from the patient. The ambiguity was introduced when Part 20 was revised and a conforming change was made in 10 CFR 35.415. The conforming change that was made was not fully consistent with the original intended meaning of 10 CFR 35.415(a) and (a)(l). It VII. Disposition of the Petitions for Rulemaking The three petitions for rulemaking submitted by Dr. Marcus (PRM-20-20),

the ACNM (PRM-35-10 and PRM-35-lOA), and the AMA (PRM-35-11) requested that the NRC amend the revised 10 CFR Part 20 and 10 CFR Part 35. These requests and their disposition by this rulemaking are discussed below.

The requests made by Dr. Marcus and their disposition may be summarized as follows:

(1) Raise the radiation dose limit in 10 CFR 20.130l{a) for individuals exposed to radiation from patients receiving radiopharmaceuticals for diagnosis or therapy from 1 millisievert (0.1 rem) to 5 millisieverts (0.5 rem). The final rule grants thts request.

{2) Amend 10 CFR 35.75{a){2) to retain the 1,110-megabecquerel (30-millicurie) limit for iodine-131, but provi~e an activity limit for other radionuclides consistent with the calculational methodology employed in the National Council on Radiation Protection and Measurements (NCRP) Report No. 37, "Precautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides." 1 The final rule does not contain activity limits, but Regulatory Guide 8.39 uses a calculational methodology 48

based on NCRP Report No. 37 to relate the dose to the quantity of activity in the patient. Therefore, the wish of the petitioner to have an easy method to determine when the patient may be released is granted in Regulatory Guide 8.39.

(3) Delete 10 CFR 20.130l(d), which requires licensees to comply with provisions of the Environmental Protection Agency's environmental regulations in 40 CFR Part 190 in addition to complying with the requirements of 10 CFR Part 20. The EPA regulations referenced in 10 CFR 20.130l(d) are contained in 40 CFR Part 190, which deals only with doses and airborne

- emissions from uranium fuel cycle facilities. Part 190 of Title 40 of the Code of Federal Regulations does not apply to hospitals or to the release of patients.

Furthermore, 10 CFR 2P.130l{d) does not incorporate the EPA's Clean Air Act standards in 40 CFR Part 61 that applies to hospitals. The NRC is separately pursuing actions with the EPA to minimize the impact of dual regulation under the Clean Air Act and to take agreed upon actions that will lead to EPA recision of 40 CFR Part 61 for NRC and Agreement State licensees.

Because the reference to EPA regulations in 10 CFR 20.l30l{d) has noth.i_ng to do with the patient release issue, and therefore is outside the scope of this rulemaking, the final rule denies this request.

The requests made by the ACNM and their disposition may be summarized as follows:

(1) Adopt a dose limit of 5 millisieverts (0.5 rem) for individuals exposed to patients who have been administered radiopharmaceuticals. The final rule grants this request.

(2) Permit licensees to authorize release from hospitalization any patient administered a radiopharmaceutical regardless of the activity in the patient by defining "confinement" to include not only confinement in a hospital, but also confinement in a private residence. The final rule denies this request for the reasons described in the discussion on this issue.

49

Finally, the requests made by the AMA did not all pertain to the issue of patient release. The final rule grants the request pertaining to patient release, i.e., that the radiation dose limits in 10 CFR 20.1301 should not apply to individuals exposed to the patient and that the dose limit to the individuals should be 5 millisieverts (0.5 rem}. The request to change the term "hospitalized" in 10 CFR 35.310(a) and 35.315(a} to the term "confined" was denied for the reasons discussed above. The request not related to the subject of patient release (that it should be clear in Part 20 that Part 20 does not limit the irttentional exposure of patients to radiation for the purpose of medical diagnosis or therapy) was addressed in another rulemaking, -

"Medical Administration of Radiation and Radioactive Materials," which was published as a final rule on September 20, 1995 (60 FR 48623), and became effective on October 20, 1995.

VIII. Consistency with 1979 Medical Policy Statement On February 9, 1979 (44 FR 8242}, the NRC published a Statement of General Policy on the Regulation of the Medical Uses of Radioisotopes. The first statement of the policy reads "The NRC will conti_nue to regulate the medical uses of radioisotopes as necessary to provide for the radiation safety of workers and the general public." The rule is consistent with this statement because its purpose is to provide for the safety of individual members of the public exposed to patients administered radioactive materials.

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 compliance with these standards, are inadequate. 11 This statement is not relevant to the rule because the rule does not affect the safety of patients themselves. The rule instead affects the safety of individuals exposed to patients.

50

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 rule is consistent with this statement because it places no requirements on the administration of radioactive materials to patients and because the release of patients administered radioactive materials has long been considered a matter of regulatory concern to protect members of the public rather than solely a matter of medical judgment.

Thus, the final rule is considered to be consistent with the 1979

- Medical Policy Statement.

IX. Issue of Compatibility for Agreement States The NRC considers the definitions contained in§ 20.1003 and the text in

§ 20.130l(a) that are modified by this rulemaking are Division 1 levels of compatibility. The definitions and text in these sections must be the same for all NRC and Agreement State licensees so that national consistency can be maintained.

Section 20.1002, "Scope," is a Division 3 level of compatibility because this section by nature is not a regulatory requirement and many States are prohibited by their administrative procedures act from including such sections in their rules. The scope section is a general statement of scope of the rule and does not contain specific requirements that are not presented in other sections of Part 20. Rules at the Division 3 level would be appropriate for Agreement States to adopt, but they do not require any degree of uniformity between NRC and State rules.

Additionally, §§ 35.75(a) and (b) are a Division 2 level of compatibility because the patient release criteria required by the rule are the minimum requirements necessary to ensure adequate protection of the public health and safety. The Agreement States will be allowed to establish 51

requirements that are more stringent than the NRC's requirements, but not less stringent. The recordkeeping requirements in§§ 35.75(c) and (d) are a Division 3 level of compatibility because uniformity in recordkeeping is not considered essential for this rule.

X. Small Business Regulatory Enforcement Fairness Act In accordance with the Small Business Regulatory Enforcement Fairness Act of 1996, the NRC has detennined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs of 0MB.

XI. Finding of No Significant Environmental Impact: Availability The NRC has detennined under the National Environmental Policy Act of 1969, as amended, and the Co111J1ission's regulations in Subpart A of IO CFR Part 51, that the amendments are not a major Federal action significantly affecting the quality of the human environment, and therefore an environmental impact statement is not required. The final amendments clarify the pertinent regulatory language to reflect explicitly the relationship between 10 CFR Part 20 and Part 35 with respect to release of patients, and the amendments revise the release criteria ,for patients receiving radioactive material for medical use from an activity-based standard to a dose basis. It is expected that there will be relatively little change in radiation dose to the public or to the environment as a result of the revised regulation.

The final environmental assessment and finding of no significant impact on which this determination is based is available for inspection at the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. Single copies of the environmental assessment and the finding of no significant 52

impact are available as indicated in the FOR FURTHER INFORMATION CONTACT heading.

XII. Paperwork Reduction Act Statement This final rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

These requirements were approved by the Office of Management and Budget, approval number 3150-0010.

The public reporting burden for this collection of information is estimated to average 13 hours1.50463e-4 days <br />0.00361 hours <br />2.149471e-5 weeks <br />4.9465e-6 months <br /> per licensee per year, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments on any aspect of this collection of information, including suggestions for reducing the burden, to the Information and Records Management Branch (T-6 F33), U.S. Nuclear Regulatory Co11111ission, Washington, DC 20555-0001, or by Internet electronic mail at BJSl@NRC.GOV; and to the Desk Officer, Office of Information and Regulatory Affairs, NEOB-10202, (3150-0010), Office of Management and Budget, Washington, DC 20503.

Public Protection Notification 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.

XIII. Regulatory Analysis The NRC has prepared a final regulatory analysis (NUREG-1492) on this regulation. The analysis examines the benefits and impacts considered by the 53

NRC. The NRC has received public connnents regarding the draft regulatory analysis and has addressed the comments (see Co111T1ents on the Draft Regulatory Analysis in Section III. Public Connnents on the Proposed Rule). The final regulatory analysis is available for inspection at the NRC Public Document Room at 2120 l Street NW. (lower Level), Washington, DC. Single copies are available as indicated in the ADDRESSES heading.

XIV. Regulatory Flexibility Certification As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), -

the NRC certifies that this rule will not have a significant economic impact on a substantial number of small entities. This rule affects medical use of byproduct material licensees. The impact of the final rule will not be significant because the final rule basically represents a continuation of current practice.

XV. Backfit Analysis The NRC has determined that the backfit rule, 10 CFR 50.109, does not apply to this rule, and therefore, that a backfit analysis is not required for this rule, because these amendments do not involve any provisions that impose -

backfits as defined in 10 CFR 50.109(a}(l).

Lists of Subjects in 10 CFR Part 20 Byproduct material, Criminal penalties, Licensed material, Nuclear materials, 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.

54

Lists of Subjects in 10 CFR Part 35 Byproduct material, Criminal penalties, Drugs, Health facilities, Health professions, Incorporation by reference, 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. 552 and 553; the NRC is adopting the following amendments to 10 CFR Parts 20 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, 106 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. Section 20.1002 is revised*to read as follows:

§ 20.1002 Scope.

The regulations in this part apply to persons licensed by the Commission to receive, possess, use, transfer, or dispose of byproduct, source, or special nuclear material or to operate a production or utilization facility under Parts 30 through 35, 39, 40, 50, 60, 61, 70, or 72 of this chapter. The 55

limits in this part do not apply to doses due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, to exposure from individuals administered radioactive material and released in accordance with§ 35.75, or to exposure from voluntary participation in medical research programs.

3. In § 20. I 003, the footnote to the definition of member of the pub 1i c is removed and the definitions of occupational dose and public dose are revised to read as follows:

§ 20.1003 Definitions.

Occupational dose means the dose received by an individual in the course of employment in which the indi-vidual's assigned duties involve exposure to radiation or to radioactive material from licensed and unlicensed sources of radiation, whether in the possession of the licensee or other person.

Occupational dose does not include dose received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with

§ 35.75, from voluntary participation in medical research programs, or as a member of the public.

Public dose means the dose received by a member of the public from exposure to radiation or radioactive material released by a licensee, or to any other source of radiation under the control of a licensee. Public dose does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in 56

accordance with§ 35.75, or from voluntary participation in medical research programs.

4. In§ 20.1301, paragraph (a) is revised to read as follows:

§ 20.1301 Dose limits for individual members of the public.

(a) Each licensee shall conduct operations so that--

(1) The total effective dose equivalent to individual members of the public from the licensed operation does not exceed 0.1 rem (1 millisievert} in a year, exclusive of the dose contributions from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with

§ 35.75, from voluntary participation in medical research programs, and from the licensee's disposal of radioactive material into sanitary sewerage in accordance with§ 20.2003, and (2) The dose in any unrestricted area from external sources, exclusive of the dose contributions from patients administered radioactive matertal and released in accordance with§ 35.75, *does not exceed 0.002 rem (0.02 millisievert) in any one hour.

5. In§ 20.1903, paragraph (b) is revised to read as follows:

§ 20.1903 Exceptions to posting requirements.

(b} Rooms or other areas in hospitals that are occupied by patients are not required to be posted with caution signs pursuant to§ 20.1902 provided that the patient could be released from licensee control pursuant to§ 35.75 of this chapter.

57

PART 35--MEDICAL USE OF BYPRODUCT MATERIAL

6. The authority citation for Part 35 continues to read as follows:

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).

7. In Section 35.8, paragraph (b) is revised to read as follows:

§ 35.8 Information collection requirements: 0MB approval.

(b) The approved information collection requirements contained in this part appear in§§ 35.6, 35.12, 35.13, 35.14, 35.20, 35.21, 35.22, 35.23, 35.29, 35.13, 35.50, 35.51, 35.52, 35.53, 35.59, 35.60, 35.61, 35.70, 35.75, 35.80, 35.92, 35.204, 35.205, 35.310, 35.llS, 35.404, 35.406, 35.410,-35.415, 35.606, 35.610, 35.615, 35.630, 35.632, 35.634, 35.636, 35.641, 35.643, 35.645, 35.647, 35.980 and 35.981.

8. Section 35.75 is revised to read as follows:

§ 35.75 Release of individuals containing rad1ophannaceuticals or permanent implants.

{a) The licensee may authorize the release from its control of any individual who has been administered radiophannaceuticals or permanent implants containing radioactive material if the total effective dose 58

equivalent to any other individual from exposure to the released individual is not likely to exceed 5 millisieverts {0.5 rem). 1

{b) The licensee shall provide the released individual with instructions, including written instructions, on actions reconunended 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 millisievert (0.1 rem). If the dose to a breast-feeding infant or child could exceed 1 millisievert (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) infonnation on the consequences of failure to follow the guidance.

{c) The licensee shall maintain a record of the basis for authorizing the release of an individual, for 3 years after the date of release, 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.

{d) The licensee shall maintain a record, for 3 years after the date of release, that instructions 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 millisieverts (0.5 rem).

§ 35.315 [Amended]

9. In§ 35.315, paragraph (a)(6) is removed and reserved.

1 Regulatory Guide 8.39, "Release of Patients Administered Radioactive Materials, describes methods for calculating doses to other individuals and 11 contains tables of activities not likely to cause doses exceeding 5 millisieverts (0.5 rem).

59

§ 35.315 Safety precautions.

{a) * * *

(6) [Reserved]

10. In§ 35.415, the introductory text to paragraph (a) and paragraph (a)(l) are revised and paragraph (a)(S) is removed.

§ 35.415 Safety precautions.

(a) For each patient or human research subject receiving implant -

therapy and not released from licensee control pursuant to§ 35.75 of this part, 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.

Dated at Rockville, Maryland, thh JJ°day of {).._ .. 7, 1997.

-,- , ~ ..

Forteh Nuc ear Regu atory Co1T1TI1ss1on.

~retary of the Commission.

60

I--

T :\JI\ £RSITY OF CALIFOR:'\I:\, LOS :\:\GELES OOCKE T~f *t.-****** l'CL\

,1 ..... .

..,,,t-it,,c.1,,n \~(; }

1,\ ---------

January 24, 1995 *95 FEB -2*"' --

UCLA SCHOOL OF MEDICINE IC "(:1 ~ r p ~- r. :< HARBOR

• UCLA MEDICAL CENTER 0 FF " FL., ~ 1' r

• r ,. r DEPARTMENT OF RADIO LOCY The Honorable Ivan Selin, Ph.D. OOCn 1 1000 CARSON STREET Chairman 8H/ ~ (

• TORRANCE, CALIFORNIA 90509 us Nuclear Regulatory Commission 11555 Rockville Pike Rockville, MD 20852

Dear Chairman Selin:

The purpose of this letter is to inquire about the reason for the puzzling delay concerning the "Patient Discharge Rule". This is NRC's rule which is supposed to state that the most exposed contact of a patient treated with radionuclide therapy should remain at the soo mrem maximum, and that the methodology published by the National Council for Radiation Protection and Measurements (NCRP) in 1970 (NCRP no. 37) should be employed for estimating such doses. This would end needless and expensive hospitalizations.

As a representative of the Society of Nuclear Medicine (SNM) and the American College of Nuclear Physicians (ACNP), I met with you on the subject of poor performance by NRC on this Proposed Rule

., published in the Federal Register on 15 June 94 (Criteria for the Release of Patients Administered Radioactive Material, RIN 3150-AE41, 59FR 30724-30732, and associated analysis and regulatory guidance). our meeting was held in your office the third week of Sept. 1994, and dealt with the points made in my 18-page letter

• to NRC pointing out its serious scientific, mathematical, and medical mistakes. You agreed with my points, stated that NRC "had not done its homework", and vowed that it would be repaired.

Given the fact that I did all the physics, math, pharmacokin-ethics, and pathophysiology for NRC, and contributed model calculations, model language and the pertinent references, one would assume that it would require no more than about an hour of NRC time to complete the rule. After all, it was NRC that asked me to write a petition on the subject in the first place, in December of 1990.

The reason for pushing for progress on this rulemaking is very simple. NRC is frivolously wasting medical dollars for no good reason at all.

Let us see what NRC's delays are costing those who pay for health care in this country. According to NRC's estimates in the regulatory analysis of this rule, we treat about 50,000 patients a year for hyperthyroidism. In my experience, about 20% require total administered activities of NaI-131 greater than 30 mci, your present outpatient limit. As my experience is skewed by -

working in a public hospita l whose patients often present with advanced disease, let us say that only 10% nationally require greater than 30 mci, or 5000 patients/year. In addition, about --u

S. NUCLEAR REGULATORY COMMISSIO~

DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmark Data ~ c ax.,, _.o~

Copies Received_...__ _ _ _ __

Add'! Copies Reproduced _ _ _ __

Special Distribution :?:t:12,) \16 ,

January 24, 1995 The Honorable Ivan Selin, Ph .D.

Page 10,000 patients a year are treated with NaI-131 for thyroid cancer, virtually all of whom require more than 30 mCi per therapy.

Let us say that the average inpatient hospital cost for the hyperthyroid patient is $3000, and that the average cost for a thyroid cancer patient is $2000. That is (3000) (5000)+(2000)

(10,000)=15,000,000+20,000,000=$35 million per year, of unnecessary expenses.

For 25 years, NRC has failed to understand NCRP no. 37, and these costs, in 1995 dollars, amount to about $675 million (assuming a mean population of 200 million). For 4 years NRC has delayed my petition, at a patient cost of $140 million and a User Fee of perhaps $0.5-1 million. For 6 months, all NRC had to do was copy my comment letter but instead cost patients $17.~ million.

During the 4 months after our meeting, NRC has cost America's patients about $12 million. While many physicians "get around" NRC's "30 mCi" rule, mainly for hyperthyroid patients, by breaking up administered activity into 30 mci chunks or less, no radiation dose is saved by the public, inpatient costs are avoided, but the patient may be ill for several extra months. It is not ethically acceptable that NRC should impose several extra month= of illness on patients who need to avoid costs that result from a scientifically unrespectable and foolish NRC regulation in the first place.

I recommend that you rectify this situation immediately. If your

~taff and management still find it too difficult to accomplish, then perhaps you could either copy my recommendations or those of a~ intelligent Agreement State, such as California.

Tnank ycu for your attention and consideration.

...C' :::.ncere~y, cbu-wtbJ Carols. Marcus, Ph.D., M.D.

Director, Nuclear Med. Outpt. Clinic and Professor of Radiological Sciences UCLA, Vice-President, Society of Nuclear Medicine and President, American College of Nuclear Physicians, California Chapter Phone: (310) 222-2845 FAX: (310) 533-7159 cc: Commissioner E. Gail de Planque Hugh Thompson, Deputy EDO David Nichols, ACNP/SNM Conjo int Office

DOCKET NUMBER PROPOSED RULE...;..;;.;;~ ~ ~ OOC KE r ED (59 f te.~~.;\4-) US HRC rsr,\

4809 Drummond Avenue ~

Chevy Chase, MD 20815 ,- .,

February 23, 1 ~ FEB 24 Ah., *..) 0 Dr. Ivan Selin, Chairman U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Re: Proposed Rule on "Criteria for the Release of Patients Administered Radioactive Material," 59 F.R.

30724 (June 15. 1994)

Dear Chairman Selin:

A recent letter to you, dated January 24, 1995, and now in the Public Document Room, deals with the pending rulemaking on patient release criteria. That letter, a copy of which is appended, raises questions about the integrity of the current rulemaking, and indeed places it under a cloud which only you are in a position to dispel.

To make clear the different interests involved, the letter's author is a petitioner in the rulemaking, whereas I am a commenter, acting in my private capacity as a member of the public, not in my capacity as an NRC employee. (Because in the past I have been treated for thyroid cancer with iodine-131, and might conceivably need to be treated with it again, the radiation doses that my family receives from me, if and when I am treated, could be affected by the outcome of this rulemaking.) As you know, I have not participated in any official capacity in deliberations on this rulemaking, nor do I intend to. 1 This letter, like my 1992 comments on the notice of the petition for rulemaking and my 1994 comments on the proposed rule (also appended), was written at home, on my own time, using my own computer, paper, envelopes, stamps, and so forth.

The gist of my comments, both on the notice of the filing of the petition for rulemaking and on the proposed rule, has been that I-131 is a special case, because of the special dangers it poses to family members and members of the public. Several States made the same point in their comments on the petition, as I described in my comments on the proposed rule.

1 I did, however, recently send an electronic mail message to two of my supervisors, referring to the rulemaking. I do not think it constitutes interference in the deliberative process, but I am attaching it anyway, in the interest of full disclosure.

ty,.R *- 1 1995 Acknowledged by eard ........................""""

U.S. NUCLEA. MMl'.:SIOi~

DOCKf ~ Ci iON Of FIC J:1El ARY 0

Post ar~ Da Ccp".-;i; R c Add1 Cop s Special Cistnbu

2 The January 24 letter makes representations about a private meeting with you in September, 1994. It appears to claim that in that meeting, the petitioner presented you with information bearing on.the rulemaking; that you stated your agreement with her substantive positions; and that you yourself criticized the NRC staff handling of the rulemakin.g, saying that the staff "had not done its homework" and that errors would be corrected.

I do not for a moment mean to suggest that I take these representations at face value. Far from it. Over the past few years, I have probably read several dozen letters from the same source, and have learned to take them all with, to put it kindly, a grain of salt. But unless and until they are refuted, they cast doubt on the rulemaking as a whole, and jeopardize it legally, for they depict a relationship between the regulators and the regulated that is completely at odds with the arm's-length regulation to which NRC is committed.

If new information bearing on this rulemaking was presented to you, it must be placed on the docket for all to see and respond to; if not, the allegation should be refuted. 2 Likewise, if, as the letter appears to claim, you offered assurances as to the further handling of the rulemaking, that fact also should be made known on the rulemaking docket. But if, as seems to me infinitely more likely, no such assurances were given, this allegation too should be denied, on the public docket.

"An inside job from the start" was the petitioner's unforgettable description, in a 1992 letter sent to the docket of this proceeding, of an earlier NRC rulemaking in which she was the petitioner. In various letters to the NRC, the petitioner has complained of the fact that in response to that "inside job" rulemaking, tlle agency adopted a rule requiring the NRC to reveal any staff involvement in procuring or preparing a petition for rulemaking nominally submitted by a member of the public or the regulated industry. The January 24, 1995, letter now claims that the petition for rulemaking in this proceeding was also requested by the NRC staff. This is not a new assertion; previous letters to the NRC have also made this claim about the current rulemaking, and have even identified by name the individual (no longer with NRC) who allegedly requested the petition.

2 If the Commission has decided to consider new information, it might profitably inquire whether this rule comports with the new Basic Safety Standards for radiation protection which are now being adopted by the international community.

3 If this allegation is true, then the NRC is required by its own rules to make this fact known. If it is false, on the other hand, then the NRC owes it to the public and to its own reputation to refute an allegation which could lead the public and a reviewing court to view the NRC rulemaking process as corrupted. If the issue is in doubt, you have an Inspector General to resolve just such questions.

Over the years, the petitioner has sent countless letters that make adverse comments on NRC employees, named and unnamed, with direct and often coarse attacks on their veracity, integrity, competence, and/or sanity. 3 In her letter of January 24, 1995, the petitioner goes one step further, and seeks to associate you personally with her criticisms of the NRC staff.

I frankly doubt that the account of your comments is even remotely accurate. People tend to hear what they want to hear, and strong feelings can cloud perceptions, so I am sure that you were either misunderstood or misrepresented. I hope that you will make this clear on the public docket, and will do so quickly. It is difficult enough for public servants to endure abusive and unprofessional diatribes*, year after year, without 3

Many of these letters, all on UCLA letterhead, and apparently prepared with the aid of a secretary, were written during the petitioner's four years as a member of the NRC' s Advisory Cammi ttee on the Medical Uses of Isotopes. To the obvious question -- whether any public funds, Federal or State, paid for these letters and the photocopied magazine cartoons that rather bizarrely often accompanied them -- I have no answer.

The following extract is from a letter sent to the NRC on January 24, 1992:

And out of that boredom and frustration [of the NRC, over the decline of the nuclear power industry], I suppose, and not a smal 1 degree of personality disorder, arose the desire to practice medicine and pharmacy without a license . . . . The Commission, with its oversimplifications of medical and pharmacy practice, required willing pawns to do its work. A sort of Darwinian evolution took place in which the scientifically unfit, a few individuals with very poor attitudes, and several cowards inherited the duty .... In order to support the Commission's desires, and advance their own power agendas, the present staff uses fraud in any convenient form. Data are misrepresented, omitted, ignored, or manufactured for convenience . * . . The recent humiliation of NRC by staff of 0MB when NRC' s fraudulent version of the "Quality

4 having to wonder even for a fraction of a second whether their own ultimate supervisor, the agency Chairman, views them in the same light.

The petitioner's sense of urgency is understandable, with nominations for new Commissioners now pending before the Senate.

But clearly petitioner wants more than just a rapid approval of her petition. Her ultimate objective, as she has repeatedly made clear, is to end all or virtually all NRC regulation in the medical area. 5 Apparently toward that end, the petitioner now seeks to depict the agency's leadership as having been brought to heel by her superior knowledge and dominating will. Mistaken as the petitioner may be about the degree of her influence on the agency, the NRC cannot remain silent without appearing to give credence to her claims.

I wish to make clear that I am not seeking to silence the petitioner. I believe in the First Amendment and in the free flow of ideas. Accepting the principle of freedom of speech means sometimes having to listen to views expressed unpleasantly.

Management" rule was uncovered is astounding but predictable. Instead of NRC' s upper management retracting the material and apologizing, a delegation of NRC staff and management went into frenzied, paroxysmal "superlying" to cover the original lying, and earned the contempt of all concerned. Some of the statements made in writing by NRC staff to justify the Rule describes actual deaths of patients caused by physicians which in fact did not occur. This would itself constitute a libel suit, but in this case has no point; no damage will be done because no one believes the NRC anyway. Pitiful, isn't it? *** I do not believe that the Medical Use Program is compatible with honesty, integrity, or even simple human decency.

Hard as it may be to believe, this rhetoric is temperate compared with that of more recent letters, the frequency and shrillness of which have been increasing markedly. And what did the NRC do that so enraged the petitioner? It promulgated a modest rule designed to make all medical licensees follow the sensible radiation safety practices that 95 percent of them had already adopted on their own.

Two organizations with which the petitioner is associated challenged the rule in court, and despite the efforts of an able lawyer, Sheldon Trubatch, the D.C. Circuit rejected the challenge, completely and crushingly.

5 Presumably, this would mean NRC' s asking Congress to be relieved of its statutory duty to protect the public from the hazards associated with the medical uses of nuclear materials.

5 Moreover, the NRC cannot do its job properly unless it gets the views of the affected public, including the regulated community, presented with candor and frankness. But there is all the difference in the world between candor, on the one hand, and vituperative personal abuse, on the other, and this petitioner has crossed that line not once but many times.

Purely as a tactical matter, petitioner would help her own cause if she learned that if every letter contains the same overheated rhetoric -- NRC actions are always "diabolical,"

"dastardly," or "venomous," the product of "perversions" and "personality disorders," etc., etc., -- the hyperbolic language loses its power to shock and instead becomes numbingly tedious.

In the end, the reader feels that he or she is reading essentially the same letter for the twentieth or thirtieth time.

Small wonder that the letters are always from petitioner alone, and that more responsible members of the medical community seem in no hurry to associate themselves with petitioner's views.

Furthermore, the reasonable person will ask whether the petitioner's singular mode of expression does not suggest that the substance of the letters also leaves something to be desired.

And indeed, all too often, what the petitioner offers is not balanced, or complete, or accurate. Let me offer just one example, on a subject I happen to know something about, and let the reader extrapolate from it. Petitioner writes, in a docketed letter of January 12, 1995:

As NRC apparently does not understand anything about "radiation risk" in nuclear medicine, let me explain it. In terms of years of life lost, which is the preferred, sophisticated way of describing risk, the number of years of life lost from radiation accidents in nuclear medicine, after 59 years and approximately a quarter of a billion radiopharmaceutical administrations, is probably less than one. [Emphasis in the original.] *.. All the NaI-131 events that NRC crows about have not been associated with any years of life lost. Patients at worst simply take synthetic tetraiodothyronine, and with the exception of certain lawyers, are normal.

Petitioner is correct that I-131 misadministrations (about which the NRC has never "crowed," needless to say) do not cause death. These events can, however, have serious impacts on the quality of life, and anyone who thinks that the sole consequence of being without a thyroid is the need to take a daily pill of

6 synthetic thyroid hormone is grossly misinformed. 8 It is readily understandable that the petitioner wants the Commission to believe that the "preferred, sophisticated" way of describing risk is to look only at years of life lost. In that way, the numerous misadministrations involving inadvertent overdoses of I-131 become a non-problem. But does the petitioner really believe that it will be as simple as taking a pill a day for the newborn Micronesian infant whose thyroid was ablated (i.e., burned out by radiation) because his mother was given a therapeutic dose of I-131 at a Hawaii hospital without first being asked whether she was nursing? What about the mother in Arizona, given a thousand-fold overdose of I-131? Does the petitioner not know that the normal thyroid dose varies from person to person, that patients often have difficulty achieving the correct dose, and that both underdosing and overdosing of thyroid hormone can have adverse consequences? Has petitioner never looked at the Synthroid package insert, which discusses the possibility that long-term use of the drug leads to osteoporosis, and the special problems presented when the patient is diabetic?

On the basis of my personal experience, the experience of friends, and the many Marshallese thyroid patients whom I 8

It is fascinating, incidentally, to see how the petitioner's views have evolved, and become more radical, just since the petition was filed. The original petition asked that the 30-millicurie rule be relaxed for all radiopharmaceuticals except I-131. Petitioner then changed her mind, but still described as 11 ludicrous" ( in a 1992 letter) the idea that patients requiring 400 millicuries of I-131 could be treated as outpatients. The cost calculations in the January 24, 1995, letter appear to imply, however, that all I-131 patients can be treated as outpatients, regardless of dose level.

On the other side of the ledger, it is gratifying that the petitioner appears to have become better ;informed about I-131 therapy in the course of the rulemaking. In the January 1995 letter, the petitioner stresses that the 30-millicurie rule leads physicians to administer therapy in "chunks" of 30 millicuries or below to avoid hospitalizing patients. Yet in October 1992, when I mentioned having received two 29.9 millicurie doses of I-131 as an NIH outpatient, the petitioner's response, in a November 1992 letter to the docket, was to say that if this were true, it would explain why I had had a recurrence of cancer, and it was surprising that I had not filed a malpractice suit -- but that it was more likely that I was making it up. I take the petitioner's January 1995 letter as an implied retraction of the suggestion that I was fabricating my own medical history in my 1992 comments.

7 encountered professionally in my tenure as an administrative judge with the Nuclear Claims Tribunal in the Republic of the Marshall Islands, I would suggest that the petitioner's view of risk is simplistic and tendentious in the extreme. Perhaps the petitioner has never seen, as I have, people whose lives have been blighted (including children permanently retarded) because for one reason or another -- a lack of information, or the deficiency of the health care system -- they did not receive an adequate dose of thyroid hormone. Perhaps the petitioner is unaware of the tragic case of the late Senator John East of North Carolina, who, according to his wife, was driven to take his own life because of psychological effects resulting from his doctors' failure to prescribe the correct dose of synthetic thyroid hormone. Or does the petitioner really know all this, and choose not to share the information with a Commission presumed not to know better'?

It would be understandable if the petitioner's zeal to buffalo the NRC into surrendering its authority over the medical uses of nuclear materials had affected her ability or willingness to provide sound professional advice to NRC. Whatever the cause, however, the result is unfortunate. The petitioner, as a professional with many years of experience in the field of nuclear medicine, could be making a valuable contribution to the Commission's processes. But that is not the case today.

I should add that I am not offended that the petitioner has demanded my dismissal by NRC. Quite the contrary: I am one of those NRC employees who regard an "off-with-his-head" edict from the petitioner as a source both of mirth and even some modest pride that perhaps we have been doing something right. 7 The Commission has probably figured out for itself by now why the petitioner is so violently abusive toward dedicated public servants such as Dr. Donna Beth Howe, Marjorie Rothschild, Dr. Patricia Holahan, Dr. Anthony Tse, James Lieberman, and Dr.

Carl Paperiello -- not because they are giving incorrect or unbalanced information to the Commission, but for precisely the contrary reason. It is just because they are rational, fair, and level-headed that the petitioner is so intent to neutralize them with attacks on their competence and motives calculated to make 7

When the petitioner recently wrote to the NRC demanding that a senior manager be ,ft@fff?J

• sent away for psychiatric treatment, the manager a, Pffllla,taped the fatwa to his wall for tall.

M!ll,, .. . -.. i 'fs l,, v WI Of' O C,(,S V 4U,t C.

• 8 them look like agenda-driven ideologues. 11 As the Commission considers what to do next, I respectfully suggest that it step back for a moment and consider how this rulemaking might appear to an outside observer. For that purpose, it might profitably consult with its Solicitor, John Cordes, who will have the job of defending the Commission's rule in court if any petition for review is filed. He (and any other lawyer) will surely tell you that the Commission's technical judgments are entitled to utmost deference from reviewing courts, but that procedural defects are another story. At this point, the petitioner's letters have raised a host of questions about the procedural regularity of this rulemaking .

Finally, and perhaps unnecessarily, let me assure you that I am not taking part in this rulemaking for my own entertainment.

If there is one thing that all present and former cancer patients share, it is a sense of how precious and irretrievable time is.

Using my evenings and weekends to write letters to the NRC docket is not a busman's holiday for me; I have many things that I would rather be doing with my spare time, including working on history projects, woodworking, and enjoying my family's company. But the issue here is of protecting my own family, families like mine, and the public at large from the risks associated with I-131.

Patients who come home with 150 or more millicuries of I-131 in their systems will inevitably be delivering a larger radiation dose to their families than when they could not leave radioactive isolation until the level in their bodies dropped below 30 millicuries. Nor is the hazard limited to patients' families.

It also affects anyone who travels by airplane 9 or public 11 Although this is not directly relevant to the rulemaking, I cannot help observing that the failure of NRC leadership to speak up in defense of the agency's abused employees, and to make clear that vilification of staff members will not be tolerated, has had the effects that might be predicted: a lowering of staff morale, and incitement of the petitioner to progressively more inappropriate behavior. I should add that I am not looking for any defense of me personally; for the purposes of this rulemaking, I am a member of the public rather than of the NRC, and petitioner is welcome to say whatever she cares to about me.

' We already know, from the comments filed by the National Institutes of Health, that despite being warned of the radiation consequences to others, NIH patients from abroad who have received I-131 as outpatients commonly go directly to the airport and board flights back home. So far, none of these patients has had more than 30 millicuries of I-131 in his or her system. But if you and the other Commissioners do what the petitioner now demands, the

9 transportation (and, as I pointed out in my 1992 comments, anyone who might go to a supermarket and bring home fruits or vegetables contaminated by the touch of a prematurely released I-131 patient). The conscience of the individual patient is not an adequate substitute for long-standing and sensible regulatory measures, where the hazards of I-131 are concerned.

Protecting the health and safety of the public from radiation risks, including those associated with the use of radiopharmaceuticals in medicine, is the NRC's statutory duty.

To yield to the petitioner's demands would be, I respectfully submit, an abdication of that duty. I hope that it will be understood, therefore, that my participation in this rulemaking, and my comments today, are a sign not of disloyalty to the NRC, which I have served since 1975, but rather, on the deepest level, of my loyalty to it.

Sincerely, Peter Crane Attachments: Petitioner's letter, January 24, 1995 Electronic Mail Message, January 10, 1995 Comments on Proposed Rule, August 25, 1994 cc: Docket File Commissioner Rogers Commissioner de Planque next time you take a transoceanic flight, you may unknowingly be spending seven or more hours sitting next to someone who has received 200 or 300 millicuries of I-131 only hours before. (If that happens, let us hope there is no turbulence, since the patient may well be nauseous already. Not only may you and others around you get a much larger dose of radiation, think of the person who handles the airsickness bag.) Once you abolish the rule that keeps people with more than 30 millicuries of I-131 in radiological isolation, your and the public's only protection will be the altruism of the patient. The altruistic patient will spend the money on a hotel room in order to isolate himself or herself while the bulk of the I-131 passes through the system and is eliminated.

The patient who is a little less altruistic, or a little less well-to-do, will get on the plane, knowing that no one can tell that he or she is a walking radioactive source.

10 James M. Taylor, Executive Director for Operations Karen D. Cyr, General Counsel David A. Williams, Inspector General Dr. Shirley A. Jackson Mr. Dan Berkovitz Dr. Donna Beth Howe Marjorie Rothschild, Esq.

Dr. Patricia Holahan Dr. Anthony Tse James Lieberman, Esq.

Dr. Carl Paperiello Dr. Carol Marcus Public Document Room

I

-f l'CL.-\

UCLA SCHOOL OF MEDICINE

• 95 Fff, 15 ~; ijARBOR : UCLA MEDICAL CENTER DEPARTMEr-.1 OF RADIOLOGY The Honorable Ivan Selin, Ph.D. 1000 CARSON STREET Chairman .

• I * ** * ** TORRANCE. CALIFORNIA 90509 us Nuclear Regulatory co:iiiinhfsio-n 11555 Rockville Pike Rockville, MD 20852

Dear Chairman Selin:

The purpose of this letter is to inquire about the reason for the

• puzzling delay concerning the "Patient Discharge Rule". This is NRC's rule which is supposed to state that the most exposed contact of a patient treated with radionuclide therapy should remain at the !:500 mrem maximum, and that the methodc?.ogy published by the National Council for Radiation Protection and Measurements (NCRP) in 1970 (NCRP no. 37) should be employed for estimating such doses. This would end needless and expensive hospitalizations.

As a representative of the Society of Nuclear Medicine (SNM} and the American College of Nuclear Physicians (ACNP), I met with you on the subject of poor performance by NRC on this Proposed Rule published in the Federal Register on 15 June 94 (Criteria for the Release of Patients Administered Radioactive Material, RIN 3150-AE41, 59FR 30724-30732, and associated analysis and regulatory guidance). Our meeting was held in your office the t'hird week of Sept. 1994, and dealt with the points made in my 18-page letter to NRC pointing out its serious scientific, mathematical, anc medical mistakes. You agreed with my points, stated that NRC "had not done its homework", and vowed that it would ::>e repaired.

Given the fact that I did all the physics, math, phar::iacokin-ethics, and pathophysiology for NRC, and contributed model calculations, model language and the pertinent references, one would assume that it would require no more than abou~ an hour of NRC time to complete the rule. After all, it was NRC that asked me to write a petition on the subject in the first place, in December of 1990.

The reason for pushing for progress on this rulemaking is very simple. NRC is frivolously wasting medical dollars for no good reason at all.

Let us see what NRC's delays are costing those who pay for health care in this country. According to NRC's estimates in the regulatory analysis of this rule, we treat about ~0,000 patients a year for hyperthyroidism. In my experience, about 20% require total administered activities of NaI-131 greater than 30 mci, your present outpatient limit. As my experience is skewed by working in a public hospital whose patients often present with advanced disease, let us say that only 10% nationally require areater than 30 mcj, or 5000 patients/year. In addition, about ,'O

~

9502060007 950125 PDR PR

~ cu:tr:'0-::tn"T'"IA a- ,Y

,.

• January 24, 199*J)F' The Honorable Ivan Selin, Ph.D.

Page 10,000 patients a year are treated with NaI-131 for thyroid cancer, virtually all of whom require more than 30 mci per therapy.

Let us say that the average inpatient hospital cost for the hyperthyroid patient is $3000, and that the average cost for a thyroid cancer patient is $2000. That is (3000) (5000)+{2000)

(10,000)=15,ooo,ooo+20,ooo,000=$35 million per year, of unnecessary expenses.

For 25 years, NRC has failed to understand NCRP no. 37, and these costs, in 1995 dollars, amount to about $675 million {assuming a mean population of 200 million). For 4 years NRC has delayed my petition, at a patient cost of $140 million and a User Fee of perhaps $0.5-1 million. For 6 months, all NRC had to do was copy my comment letter but instead cost patients Sl7.~ million.

During the 4 months after our meeting, NRC has cost America's patients about $12 million. While many physicians "get around" NRC's "30 mCi" rule, mainly for hyperthyroid patients, by breaking up administered activity into 30 mci chunks or less, no radiation dose is saved by the public, inpatient costs are avoided, but the patient may be ill for several extra months. It is not ethically acceptable that NRC should impose several extra month= of illness on patients who need to avoid costs that result from a scientifically unrespectable and foolish NRC regulation in the first place.

I recommend that you rectify this situation immediately. If your Dtaff and management still find it too difficult to accomplish, then perhaps you could either copy my recommendations or those of a~ intelligent Agreement State, such as California.

T~ank ycu for your attention and consideration.

...C' :..ncere.:.y, cbu.wtb]

Carol S. Marcus, Ph.D., M.D.

Director, Nuclear Med. outpt. Clinic and Professor of Radiological Sciences UCLA, Vice-President, Society of Nuclear Medicine and President, American College of Nuclear Ptysicians, California Chapter Phone: (310) 222-2845 FAX: (310) 533-7159 cc: Commissioner E. Gail de Planque Hugh Thompson, Deputy EDO David Nichols, ACNP/SNM Conjoint Office

From: Peter G. Crane (PGC)

To: mgm, wjo Date: Wednesday, January 11, 1995 2:34 pm SUbject: Patient release criteria One of the issues raised by comments in the current rulemaking on patient release criteria is the dose that members of the public could receive from sitting next to a patient with I-131 in their systems after a therapy dose. We now have more exact information as to what that dose might be, because of a patient who, after receiving an I-131 treatment at Mass. General in Boston, left the hospital before receiving permission from the Radiation Safety department. The incident is described in PNO-I-94-074 and -074A.

The patient had been tested 22 hours2.546296e-4 days <br />0.00611 hours <br />3.637566e-5 weeks <br />8.371e-6 months <br /> after receiving her treatment

• and, at 7.2 mrem/hr, did not meet the Smrem/hr standard of NRC regulations. (The assumption is that if you are putting out 5 mrem/hr, you have about 30 millicuries of I-131 in your system.)

Rather than wait to be tested again (the next day), she left,

~saying she had a plane to catch that afternoon. In the end, however, she spent the night in a hotel room and did not fly until the following morning.

The hospital estimates that by the time she actually left the hospital, three hours after being tested, she had eliminated enough of the I-131 in her system that she in fact met NRC regulatory standards; they put the level of I-131 in her system at 22 millicuries. If she went from over 30 millicuries to 22 millicuries in three or four hours, we can assume that by the following morning, when she flew to Boca Raton, the level of I-131 in her body was a lot lower than 22 millicuries. Nevertheless, the licensee calculates that the person sitting next to her on her three-hour flight could have received as much as 108 millirem.

That might be a data point worth considering as the Commission decides whether to allow people to get 150 or 200 or 300 millicuries of I-131 as outpatients, with no period of radiological isolation.

To get personal for a moment, the other moral of the story is that if you have to get a 150-millicurie dose of I-131, it's nice if the woman from Radiation Safety who tests you in the early afternoon of the day following treatment is the sort of person to say, "Look, you're not that much above the limits for release now, I get off at 5, by then you' 11 probably be below 5 millirem, why don't I come by then and test you again and see if we can't get you out of here tonight." That happened to me one October 31, and as a result, I got to see my kids in their Halloween costumes.

4809 Drummond Avenue

- -- ~ * -:.:- Chevy Chase, MD 20815 OHlt.i:. >_-*-

,,-1.-

-~::-., *., ,c~ugust 25, 1994 OOCK[Th,._ -

John Hoyle, Acting Secreta:fy:

• r'

• U.S. Nuclear Regulatory Commission Washington, D. C. 20555 Attention: Docketing and Service Branch

Dear Mr. Hoyle:

The following are comments on the proposed rule on "Crtteria for the Release of Patients Administered Radioactive Material," published for comment at 59 F. R. 30724 ( June 15, 1994)

• They are submitted in

• my prtvate capacity as an interested member of the public, not in my offidal capacity as Counsel for Special Projects at the U.S. Nuclear Regulatory Commission. My concerns in this area stem from my own experience as the recipient of a number of therapeutic and diagnostic doses of radioactive iodine-131, totaling some 800 millicurtes. Each of these meant taking precautions to minimize radioactive contamination of family members and members of the public. Knowing the hazards posed by I-131, I am deeply troubled by an NRC staff proposal, taken in the face of strong opposition from the responsible health authorities of many states, that could significantly increase radiation doses to the families of persons treated with this particularly dangerous radiopharmaceutical.

At the outset, however, I should say that the NRC staff has done a conscientious job of attempting to calculate the actual dose that members of the public are likely to receive from patients treated with radiopharmaceuticals. Dr. Patrtcia Holahan, a radiation biologist in the NRC's Office of Nuclear Materials Safety and Safeguards, worked on those calculations, and although, to paraphrase an old song, I don't know much radiation biology, I do know Trtsh Holahan, and I have no doubt that her calculations are flawless.

My concerns are directed to a quite different issue: how the notice of proposed rulemaking dealt with public comments, my own and those of others, regarding the particular hazards of I-131. 1 For as I understand it, the dose calculations in the proposed rule are based on the probable external radiation dose to family members and other members of the public from a patient a given distance away. My comments, on the other hand, in focusing on the special risks posed by I-131, stressed the potential for internal contamination, by skin contact, inhalation, and ingestion. (See my comments of October 31, 1992, hereby incorporated.) In particular, I emphasized the risk of contamination from vomiting if, as not infrequently happens, a therapeutic dose of I-131 induces nausea.

1 These were comments filed in response to the NRC's announcement of the receipt of petitions for rulemaking. 57 F .R. 21043 (May 18, 1992).

2 Numerous other commenters, including health authorities of six states (lllinois, New York, Colorado, Alabama, Texas, and North Carolina) raised the same concern about 1-131, though you would not know this from the notice of proposed rulemaking. The individual states cautioning about I-131 were the following:

- New York.

The New York State Department of Health said of I-131: "At dosages greater than 150 millicuries nausea and the likelihood of vomiting are more likely and present a risk of extensive contamination." (New York was willing to consider outpatient

• -- treatment above 30 millicuries of I-131, but to a maximum of 80 millicuries, and then only under special circumstances.)

- Texas.

The Texas Department of Health observed that I-131 is "the most radiotoxic byproduct material used for medical use," warranting espec1ally close controls.

-- Colorado.

The Colorado Deparment of Health commented that while a relaxation of the current 30-millicurie limit might be appropriate for "certain other isotopes," it did "not feel this is justified for patients receiving iodine-131."

-- Illinois.

The State of Illinois Department of Nuclear Safety likewise expresed concerns, "espec1ally in light of the request to release patients containing up to 400 mCi [millicuries] of I-131."

- Alabama.

The Alabama Department of Public Health expressed support for relaxing current release criteria for some radiopharmaceuticals, but declared itself "opposed to the petition in that it supports release of patients from hospital (institution) confinement whose body burden of iodine exceeds 30 mi111curies, even as high as 400 millicuries. "

- North Carolina.

The North Carolina Department of Environment, Health, and Natural Resources stated that while the "30 rnillicurie limit is indeed arbitrary in that it has been generically applied to all radiopharmaceuticals, 11 patients dosed with I-131 could cause significant radiation doses to "family members, coworkers and other persons they encounter," both from external gamma radiation and internal dose.

3 Two other states, as well as the NRC's own Advisory Committee on the Medical Uses of Isotopes (ACMUI), recommended keeping the 30-millicurie limit for all radiopharm:iceuticals, not just I-131. And as the notice of proposed rulemaking did mention, 21 Agreement States, meeting in 1992, recommended keeping the 30-millicurie limit for I-131 while relaxing 1t for other radiopharmaceuticals.

Finally, it will be recalled that Dr. Carol Marcus, the author of one of the petitions. before the NRC, originally proposed retaining the 30-millicurie standard for I-131, but eliminating it for all other radiopharmaceuticals. 2 In a November 9, 1992, letter to the docket, she used the word "ludicrous" to describe the contention of the American College of Nuclear Medicine that doses of 400 millicur1es of I-131 could safely be administered on an outpatient basis .

In short, the concerns that I was expressing about I-131 in October 1992 turn out to be utterly mainstream: standard conservative practice.

Nor are these concerns about I-131 trifling. As I mentioned 1n my October 1992 comments, the transcript of a 1992 ACMUI meeting shows the Committee's chairman, Dr. Barry Siegel, worrying about the hazard to family members posed by diagnostic doses of as little as 5 millicurles of I-131.

But although one commenter after another, as well as the states mentioned above, pointed to the special hazards associated with I-131, the notice of proposed rulemaking never mentioned th1s, nor did it suggest that one of the key issues in the rulemaking was whether I-131 should be 1n a class by itself for regulatory purposes. Nor 1s the issue of patient vomiting ever mentioned.

In my earlier comments, I also pointed out that anyone who has been treated with a therapeutic dose of I-131 is already severely hypothyroid (by design), and that this condition may impair the person's ability to follow safety guidelines for the protection of family members and other members of the public. (Judith Brown of ACMUI raised essentially the same issue in a 1992 ACMUI discussion of the proposal, when she asked how patients felt after receiving a treatment.) This comment also was not dealt with 1n the notice of proposed rulemaking.

Nor was there any response to my suggestion that although the NRC staff was justifying its proposal on grounds of the supposed psychological benefit to patients and their families, it might be more comforting to patients to know that they were minimizing the radiation z I gather from Dr. Marcus's July 11, 1994, letter to the docket that her position on this point may since have changed. In case I have misunderstood her views, however, I suggest that the NRC and other interested persons read her submissions for themselves.

4 dose to others by remaining in the hospital in radioactive isolation.

Speaking from the experience of five inpatient treatments, radioactive isolation is unpleasant, but worrying that one is putting others at risk may be even less pleasant.

My experience in that regard is not unique. Several months ago, I asked an NRC staff member, recently released from the hospital after 23 hours2.662037e-4 days <br />0.00639 hours <br />3.80291e-5 weeks <br />8.7515e-6 months <br /> confinement to receive a 100-millicurie dose of I-131, the following question: "If you had been given a choice between getting the treatment as an outpatient and as an inpatient, which would you have chosen, do you think?" She replied:

I personally would have preferred to stay in the hospital for the full three days [ originally projected] until the thyroid was well below 29. 9

[millicuries] vice getting out with thyroid at 50 rnlllicuries. If I had lived alone it might not have been a significant issue.

I think, especially with children at home, the argument to bring patients home is ridiculous, too risky, too hard to keep isolated. I think my kids were more frightened that 1*was home, in a sequestered state, locked away upstairs as it were, ta.king my meals alone on paper plates, not being able to kiss them good night than they would have been had I stayed in the hospital for three days.

We had a chair in the living room with masking tape marking a large X as well as one in the kitchen.

Those were the only two place I could sit when I did come downstairs briefly. My husband slept on the couch for five days and used the boys' bathroom downstairs, etc ....

That such concerns are not frivolous is confirmed by the American Journal of Public Health article ( "Contamination of the Home Environment by Patients Treated with I-131: Initial Results"), placed in the docket by a commenter. It suggested that in-home contamination by patients dosed with I-131 could double family members' risk of developing thyroid cancer. The same study found that of 12 adults studied, none was "willing to adjust living habits with their spouses because of the radiation therapy." (By contrast, they were willing to take steps to protect their children. )

I suspect that with a larger sample, this finding would not hold up -- all the thyroid cancer patients I have known have been, like the NRC staff member just quoted, careful to protect their spouses from radiation - but this is nevertheless a data point that needs to be considered. If even a sizable fraction of patients will not follow radiation safety guidance to protect their own spouses, what reason is their to think that they will be rigorous about protecting total strangers, such as fellow passengers on public transportation, or the

5 shoppers in the grocery store? ( For example, a person dosed with I-131 who handles a piece of fruit and then does not buy it may leave behind a residue of contamination that may wind up in the thyroid gland of whoever later eats that piece of fruit. )

Consider also the observation of the North Carolina Department of Environment, Health, and Natural Resources that many thyroid cancer patients treated with I-131 are otherwise healthy, and "[r]eleasing such patients with the expectation that they will go home and lock themselves in a room for two or three days with lim:l.ted contact with family and friends is not realistic."

To be sure, the notice of proposed rulemaking acknowledges North Carolina 1s comment, 1n the context of concluding - sensibly -- that rema1n1ng at home does not constitute "confinement" for regulatory purposes. But that is not enough. The whole point of the proposed rule is to make it possible for the licensee to dispense with confinement altogether 1f the calculated dose to any member of the public falls below certain lim:l.ts. If a patient is single and lives alone, and is given instructions for minimizing radiation dose to others, it may be easy to demonstrate that the criteria are met, but whether the public is actually protected will then depend entirely on whether the patient abides by the restrictions. The key issue, then, is whether it is reasonable to expect that released patients will alter their behavior and limit their activities for the protection of others, and on this point the proposed rule is silent, despite the comments of states and others.

Why has the NRC embarked on this novel course, 1n the face of such strong and unified opposition from health authorities in so many states, as well as its own ACMUI? Dr. Marcus has explained that the im:mediate occasion for her petition was a change in 10 CFR Part 20, "Standards for Protection Against Radiation," that reduced allowable doses to members of the public from NRC-licensed activities by a factor of five. It appears that at the time that rule change was put into place, the issue of its applicability to the release of patients with radioactivity in their systems had not been thought through. As a result, the new rule, by dropping the maximum allowable dose to members of the public from .5 rem to .1 rem, could theoretically have been read to require many procedures that are normally performed on an outpatient basis to become inpatient procedures.

If this was the problem, there could have been a quick and easy fix. It would have been a relatively simple and non-controversial matter to propose a rule to make clear that the new Part 20 was not intended to alter the status quo for the release of patients. ( The comments make clear that there is a consensus 1n favor of the

• 5 rem standard.) But what the NRC has done is go much further, and propose a rule under which procedures that fonnerly were handled only on an inpatient basis could become outpatient procedures. Thus having first lurched (unintentionally) in the direction of imposing new and unnecessary controls, the NRC has reacted by lurching in the opposite direction, to el1m1nate valuable, time-tested radiation

6 protection measures, over the objection of individual states, the Agreement States as a group, and other comrnenters.

No one should have the illusion that this rule change would simply give patients and doctors a choice between inpatient and outpatient treatment. In practice, the pressure to contain costs would probably mean that :Insurance companies would pay only for the cheapest possible optl.on, creating pressure on practitioners to find a way to justify out-patient treatments. In such cases, patients will not realistically have a choice, unless they are able to pay for hospitalization out of their own pockets. Most, whether they like it or not, will be outpatients, living at home, and their families will be

• getting unnecessary radiatl.on doses, so long as it is possible to calculate, on paper, a set of restrictions by which doses can be kept to .5 rem.

In conclusion, I will frankly admit that as a commenter, I am disappointed that the notice of proposed rulemak1ng has not done more to come to grips with the issues raised in the public comments. If commenters are not to be discouraged from participating in NRC processes, the NRC owes it to the public (which in this case includes state health authorities) to offer more evidence that it has so far given that it reads and thinks openm:lndedly about the comments that are filed. Whenever an agency fails to respond to major concerns raised in public comments on a rulemaking, there is a risk that members of the public and others will view the notice-and-comment process as no more than a Pf9 forma exercise, in which the conclusion is foreordained: Moreover, agencies cannot expect reviewing courts to accord them the deference they normally receive on technical issues when there is no articulated technical judgment to which to point.

In sum, the proposed rule is ill-advised, at least with regard to I-131. The consensus of responsible health authorities on this point is clear, and the NRC should heed it.

Sincerely,

, The need to demonstrate that the agency has not prejudged the outcome, and is openminded with respect to views submitted by public commenters, is especially strong in the present case, given Dr. Marcus's repeated assertions, in letters filed in the public docket(~, the letter of November 9, 1992), that her petition for rulemaking was filed at the request -- indeed, the insistence - of a then member of the staff. As I suggested in my earlier comments, I believe that the NRC should clear the air and indicate one way or the other whether this rulema1d.ng has been, in Dr. Marcus's own phrase (in the November 1992 letter, in reference to an earlier rulemaking 1n which she was a petitl.oner}, "an inside job from the start. 11

L'C.G'{ET NUMBERP 20 35 PHOPOSED RULE  ; *

( S1FR:3o7:J-'f) . Q 881em --11 111111-=1111Hosp1*tsl oot?tEJt N:~y\t::ti~:~.D. ~

Arnella C. Hennig, M.D.

= Margare.t J. Thompson, M.D.

RADIATION ONCOLOGY . OC1 24 ~eoElb~ J. Williamson, M.D.

94 October 19, 1994 _,. CPt. fAR Y OFt~f 00 T\~GSi SfR BRl\.~CH ICE Secretary, U.S. Nuclear Regulatory Commission Attn: Docketing and Service Branch Washington, D.C. 20555 Dear Sir or Madam; I recently received a copy of the Federal Register pp. 30724 to 30732 describing the NRC's proposed rules governing the release of patients containing radioactive materials from hospitals. Although the date for accepting comments from the general public on these regulations has passed, I wish to express my concern regarding these newly proposed regulations.

In these pages of the FR, there are rules which would require estimations of the radiation dose received by the general public who may be exposed to patients containing radioactivi!)'. These rules should be deleted from the proposed regulations for at least two reasons. First, the amount of clerical and administrative effort to collect data and the amount of effort required to perform these calculations seems to be prohibitive. The proposed rules are inconsistent with the health care community's efforts to reduce costs.

The proposed regulations would increase the costs of these nuclear medicine procedures with very little gain in safety for the general public.

Second, the assumptions require to make these calculations are nebulous, at best. The results of these calculations can change dramatically depending on patient and general public behavior assumptions which can vary widely. To permit calculations to be performed in a reasonable time, some generalization of assumptions (e.g. rate of radioactive decay in the patient, how long household members will be in proximity to the patient, age of household members, etc.) is probably required. To generalize the assumptions to a point where they encompass most of the situations likely to be encountered by nuclear medicine patients, conservative assumptions will probably be used.

Conservative assumptions require that precautions must be observed longer than normally required, and the costs (e.g. additional complexity of instructions to patients, longer hospital confinements) will be increased accordingly.

In summary, I suggest that these proposed regulations are too complex, too restrictive, and too costly for the amount of benefit obtained from them. I suggest that they be eliminated from the final regulations.

Thank you for the opportunity to comment on these proposed regulations.

Yours truly, Robert Cacak, Ph.D.

Medical Physicist and Radiation Safety Officer Acknowledged by card .....M~R...::.1...J~ ...

POST OFFICE BOX 14001 , SALEM, OREGON 97309-5014 PHONE (503) 370-5294 FAX (503) 370-5748

f S NUCLt:. **.. . __, . ...,,,\ C01i'i MiSSION

'. DOCI,d i~G l SE1 'iCE SECTION OFFIC[ OF THE SECRETARY OF THE COMMISSION Document S!atstics

OOCKETEO Michael J. Bailey, M.S.

USHRC Kari Cann, M.S.

COLORADO Gregory L. Gibbs, M.S.

Gerald A. White, M.S.

ASSOCIATES in *94 OCl - 3 p 3 :36 Diplomates American Board of Radiology Trevor Fitzgerald, M.Sc.

MEDICAL Member Canadian College of Medical Physics PHYSICS OF Fa ICE Of SECREJ~~;

tff f\ If' ~ ct. R ' 1 . ~

Gary W. Douglas, M.Sc.

Comments regarding NRC proposed amendments to 10 CFR Parts 20 and 35 relating to "CRITERIA FOR THE RELEASE OF PATIENTS ADMINISTERED RADIOACTIVE MATERIAL."

Gerald A White, M .S. DOCKET NUMBER Colorado Associates in Medical Physics PROPOSED RULE Pl ,;200 115 330 a. W. Uintal Ste 288 ( ;-q FR 3o71.'t)

Colorado Springs CO 80905 119-636-0556 A

~ C? - ~

The comments relate to the NRC discussion in FR vol. 59 no. 114, to the proposed changes to the CFR and to the associated Draft Regulatory Guide DG 8015.

The NRC proposed rule change, although brief, will lead to substantial changes in the handling of patients containing significant amounts of radioisotopes as radiopharmaceuticals. In general these changes are to the benefit of patients seeking medical care and to their families. The adoption of methodology similar to NCRP 37 is a welcome step. The values in table 2 of the reg guide may differ somewhat form the NCRP 37 values, but the inherent uncertainty in the underlying assumptions makes the differences insignificant. The proposed change to 35 .75 , supported by the interpretation in the regulatory guide Table 2 should be supported.

It is essential to obtain from the NRC a commitment that the release language in 35 .75 does in fact apply to situation where an individual's exposure is LIKELY to be less than 5 mSv per year. This is distinct from an individual's ACTUAL exposure That is, according to the propose rule, the NRC interest in an individual containing radiopharmaceuticais ends when the likelihood of an exposure to others is less than 5 mSv and the licensee is not subject to action if at some later time an individual does in fact receive greater than 5 mSv. The NRC cannot expect licensees to be responsible for the actions of patients who have been released in accordance with the reg guide tables or calculation methods. This should be made explicit by the NRC.

The modifications to 20.1301 are in accordance with current NRC policy and are also welcome.

WR *-1 199&~

Acknowledged by card ......................-.--

330 AW. Uintah

• Suite 288

• Colorado Springs, Colorado 80905 * (719) 636-0556

• JUCLl I ! *.:.1-. fCYlY COMMISSION DOCKCTl'~G <le St:RVICE SECTION orr:cc.: o.: TL:E SECRETARY F THE COMMISSION Document Statistics

There are several problems of interpretation, application and implementation that should be addressed by the NRC, either in a revision to the regulatory guide or as a policy statement in connection with the adoption of the rule changes. Those are as follows:

-FR notice page 30729 NRC response to Issue 4 describes the NRC interpretation of "licensee control" The NRC raises the possibility of the licensee controlling a patient in a location other than a hospital provided the license prop,_erly listed the location as a place of use or was otherwise described in an amendment. This will raise some practical problems in the current (and foreseeable) healthcare delivery systems that can be minimized by an appropriate NRC statement. Under present reimbursement schemes there will be great pressure on licensees (who are mostly hospitals) by third party payers (HMO's, Managed Care Providers, etc.) to place patients in these lower cost locations for radiation isolation if hospitalization is not required for medical reasons. It is important to explicitly state that these locations must also comply with all license conditions (training of personnel, policy an procedure creation and implementation, radiation monitoring including surveys for ambient radiation level and contamination, etc. The management of these third party systems have no experience with NRC compliance and may well interpret the NRC FR statement in a narrow sense that nothing more than inclusion in the place of use listing or a license amendment is required. The management of these third party system often have a significant personal and institutional financial incentive to minimize costs, including cost associated with radiation safety. The liability for license compliance, however, remains with the licensee( usually the hospital). A clarification of this issue by the NRC is warranted.

A second problem relates to the proposed regulatory guide language regarding patients who may be lactating. The proposed change to part 35 .75 taken together with the reg guide produces a situation that is unacceptable from both a medical and regulatory standpoint and creates a substantial departure from previous NRC policy.

Heretofore when a patient was released from licensee control ( or confinement) the NRC interest in the patient ceased. The language relating to lactating women implies that the licensee is responsible for judging the behavior of the patient and for nursing that might result in a dose to the child in excess of 5 mSv. The reg guide language coupled with the proposed change to 35.75 might require the confinement of lactating women subsequent to diagnostic tests with various radiopharmaceuticals. The decision to nurse is best left to the lactating woman and her physician. The risk benefit relationship is not the same as that for a member of the general public and should not be an item of regulatory compliance. The NRC should do no more that require an informed decision by the woman

and physician, perhaps mandating a dose calculation. An absolute dose limit is not warranted, nor should the NRC hold licensees in violation for women who continue to nurse despite recommendation to the contrary.

11:36 DOCKETED US RC :*

• 94 OCT - 3 *P3 :38

. Ollie~ of thi Prisidant i 'Ravuider Nath, Ph. 0.

I *

'Yale University Sc:hool of Medicine

l)ept; of Therapeutic; Radiology

:m Cedar Street

'. New :i-tavet\, C.'T 06510

(203) :785-2971

-PAX::(203) 737-42:12 September .30, 1994

\

L iI

_; e  :.US Nuclear Regulatory Commi$aion

• Attn: Larry Camper

'Mail Stop T8 P5

11545 Rockville Pike, OWFN Roc:kwille, MD 20852*2738 Re: : NRC Proposed Rule: "Criteria for the Radioactive Materials."'

Dear Dr. Camper

: .'.H*>

• ' On behalf of the American Association of Pl~icists in Medicine (AAPM) and its nearly 4000 membtm1, I would like to provide t~::- following comments on the NRC proposed rule on "Criteria for the Release of1f~tients Ad ministered Radioactive Materials": j:,;, * .

J :~:'.i** . *.

' The AAPM endorses the NRC's efforts to re'~ fye differences between Part 20:.

and J>art 35 by decwing that Part 35 takes precedert~: .,.... *.over Part 20.

.ri**+

We agree with the NRC that the dose limit ,~ i\~e family .member should be .,

tlaise'd from 100 mrem per year to 500 m:cm per ye*\ We Uk~ that the Paragraph 35.75 of the proposed rules states explici.tlf that "a licensee may authorize release ... if the total efiectlv~ uotfe equivalent to an {Nlividual. .. is not likely to exceed 5 millisieverts (0.5 rem) in any one year." It is our _! i,rtterpretation that the whole point of this proposed rule is to raise the annual li_~ t '.to exposed individuals from t-00 millirem to 500 milirem. i': .

• . :tr*. ..

TI\Q AAPM is concerned about the ability oflt.(, licensee to control a patient in a location other than the hospital or licensed fa~ty. Toe AAPM b9lieves releasing patients administered radioactive material$.*

to a location other than the hospital is fraught with problems and needs furthe.t:'guidance from the NRC either through a policy statement or a revision of the regulatory guide. It is not dear also whsT'e lillbillty lies u a l'<llcnsed patient 1*efu~s to to~~~ directions. MAR ._ 1. 19951

.:-t ..

t*

• Acknowledged by card ................~:....:::::

YJ. -~~\

>f; :*

f' TM P.saoclaUon*: scientific Journal i~ MEOl~~j P1*1VSICS, Membtr Sociaty cf the American tnatilulll of Pl'lyeiQs iiod 11111 1nternal~i1arOrgaf\lZalion of Medical Ptly&ic1.

t.

'* . N'u * .. ,,J:y COMMISSION CCC1 J. SLJW ,CE SECTION I.; , L ry: ThE SECRETARY OF HE COMMISSION Oocume t Statistics Pcstrnark Date _ r=='--'~--'J:.....=._ _ _ __

11:37 r

I (1 *~

~~~ .. ].:* *.

• r* *.

• -I; ~:

The AAPM is also concerned that there is a ~ -_possibility of radionuclide contamination by released individuals. Neither tl'\*tprpposed rule nor the regula-tory guide addtQ~Ui th~ iAA11~ of contamination. Thi~)is *a deficiency which must be

~dressed. ~'.:.:t' *.

~ j:\,/ . **'

be 1 *

• : It is AAPM's position that the decision regai_\~g nursing _an infant should tj:tad by the informec mother and her physician. i~ NRC should not interfere with ' this decision. -*;~;'* *:::::-

-~;; ./  :.

* : Finolly, the AAPM believes that the requireilti.nt of dose calcuU1tiom rather ;

than leither calculation of remaining activity or a ~ l.$~rement of dose rate at one *:

meter may significantly increase the time and papefy?<?tk required for each release~

The proposed calculations are complex and open ~il ijcensee's interpreta~on, and it is too likely that the NRC may interpret the ~stances in a specific case differently. In addition, it should be made clear t ~*thc calculations should be used a& advice, but the ultimate decision to release a patiijt -~hould be made by the physfclan and physicist working together. An exp~ lOn of the regulatory guide to iilclude additional guidance with more examples is::~4tquested.

: ~i '

. ; Thank you for allowing us to comment on ~ '. important regulation. We look forward to working with you in the future. i j 't .

sm;ely, .

,~~

iiN $

Ravinder N~~:.~.D.

President, A:'-M

• • • ),,:.,

tq:*::..

RN/tm :i*;i:? .

sent via FAX 301-415-5369  :: ~:f ,: .

cc MPM EXCOM Geoff Ibbott i

• Charles Kelsey Jim Purdy Melissa Martin

{* I UMBER Pennsylvania F OPOSED RULE Pl 2 O 3S Hofpital (__ 5 ~ F fl ~071-'j) DOCKETED USHRC September 23 . l *~"'7llll S£P 30 800 4il:~ for Sick and Injured Spruce Street Phil adelphi a. Pennsylvania 19107-6 192

- ~ r- c~c-~~ttl Secretary OF FICE CL~,.:.,~ c:tp\\1'.[

U.S. Nuclear Regulatory Commission QOCKE TIT,-.:i ~ :'*-

cD J_; !..i[.1-\

di\ ~f~

Washington. DC 20555

Dear Sir:

This letter is in support of the proposed rule change in 10 CFR Parts 20 and 35 (RIN 3150-AE41) entitled Criteria for Release of Patients Administered The Nation f*nt Hmpi(, Radioactive Materials. I support the rule change so that rule would conform t ,wuled I I to NCRP Report No. 37. Our institution has a limited number of isolation re ,,.,11 of Radiology rooms. Retaining patients for longer periods of time would deny to use of Rohen E C 1mpbell. M [)

these rooms to other patients would may require them (such as patients with C' aonnJn infectious diseases). The human factor of needlessly isolating a patient for Diagno.wc Imo ~111 ~

an extended period of time for a minimal reduction in the potential radiation Carolyn E Parrv. 1\1 D exposure to family members should also be considered.

Mane C, "1 alo~r M D Richard B Keohane. M.D.

C arnl A Doi nsk.. M.D The major reason I am writing is to express my concern regarding possible

'-co '-un, Han, \1 D.

Wi'liam G. M. R1tch1e 1\1. pressure for insurance companies to release patients as early as possible. In Mark M \1aslack. M.D. the past year we have had two instances where insurance companies have stated

'-tevc M Kaplan. M.D.

C r stme D. Emery M D that they were unwilling to pay for more than one or two days of Lew*ence C Wang, M.D. hospitalization for patients treated with high doses of iodine 131. Although Loma Blum. M.D.

Richard A Vim. 1\1.D. two days of hospitalization is often an adequate length of time for the C A ) Wilson. 1\1.D. residual activity to be below the quantities where the patient may be Edw~,~ A D Ora,10. M I released, I have experienced situations where we have treated an older patient I-\

Radiation Oncol ~" who is unable to drink as much as a younger patient who subsequently had to Jo~n R. Gl2ssburt, M D.

Je'frey G Rosenstock M.D. remain in the hospital for as long as five days.

l ll[, t.ll,1111 B,adv J* MI:' I would also like to address the situation of where it may be desirable to retain the patient for longer periods of time even when the patient "s residual Rud,atum Phwu, Leonard '>~at- son "h D.

activity may be below regulatory limits. The type of situation I am referring to is when the physician and radiation safety staff may have serious doubts about the willingness or ability of the patient to comply with the recommended home precautions and where the patient ., s household includes young children and/or pregnant women. I would request that the regulations make some mention of this type of situation so that insurance companies are not able to apply undo pressure on hospitals to release patients before the activity is below the regulatory limit or when the relevant professionals believe that release of the patient would put other individuals at risk.

Thank you for the opportunity to comment on this matter.

and The Institute of Pennsylvania Hospital Vl+J\ 111 North Forty-ninth Street Philadelphia, Pennsylvania 19139

.::. f* **_1~* . . . :;*,-:-ORY COMMISSION ff._, ' : .- .,;_ ,-;VJCE SECTION Orr.: -* .::,r l i E SECRETARY

\.:t~ !HE COM1 1'.SS10N

~~g~5~END~~E: Pl 2- 9

~

DEPARTMENT OF HEALTH &. HUMAN SERVICES(fC/ FR ~3-==o=:.-;72J

~ * ~P:i!

ub 1ic Health Service6 OOCKETEO National Institutes of Health Bethesda, Maryland 20892 SEP - I 1994 *94 EP 12 P2 :51 The Secretary of the Commission r F c ; ,t. T~RY

u. s . Nuclear Regulatory Commissio FF~fT ,~~ ~~R- IC[

Washington, DC 20555 OOC ~ LH\3t Attention: Docketing and Service Branch

Dear Sir:

The National Institutes of Health (NIH) wishes to provide comments regarding the Draft Regulatory Guide DG-8015 "Release of Patients Administered Radioactive Materials" dated June 1994. The NIH is a large facility conducting biomedical research and medical diagnosis and treatment. The proposed rulemaking would impact the NIH because the NIH frequently administers I-131 for the treatment of hyperthyroidism and thyroid cancer. In addition, the NIH has an active monoclonal antibody therapy program involving a variety of radionuclides such as I-131, Lu-177, and Y-90/In-lll.

The NIH agrees with the request to permit individuals to receive up to 5 millisieverts (0.5 rem) in a year from patients administered radioactive materials. Both the patient and the hospital benefit from this proposed change. The patient will not have to remain in isolation for an additional time period to maintain compliance with the 1 millisievert (0.1 rem) limit. By not requiring extended hospital stays, hospital resources can also be saved thereby benefitting the NIH.

However, the NRC is placing additional regulatory requirements on the licensee in the event that the total effective dose equivalent (TEDE) to any individual, other than the patient, is likely to exceed 1 millisievert (0.1 rem) in a year from a single administration. These additional regulatory requirements, such as the written instructions and add i t ional re*cordkeeping on the released patient, do not provide added health and safety benefit to the general public.

Maintaining a record of the released patient and ~he calculated TEDE to an individual likely to receive the highest dose is impractical. It appears that the NRC expects the licensee to maintain control over the patient's activities once they are released from isolation. This is not possible.

In order to calculate the TEDE for an individual likely to receive the highest dose, the patient would have to give an outline of their proposed activities over the f i r st few days post-release from isolation. It is possible that a patient, containing radioactive material when released from the hospital will not know or will not follow their proposed activities once released. A scenario quite common to the NIH involves administering therapeutic

' w; **

-* . ;! _;,i. *w ...,..,~:.JIJHORYCOMM~~,c,,v.

0O'.:t~L r1r1G & SERVICE SECTION Off ,CE OF THE SECRETARY OF THE COMMISSION Document Statistics tmarlc Date ff ~ j z 72,o: 5&1>U-/4~

Copies Received /

Add'I Copie Reproduced _ _ 3____

• oecial Distribution /tTcf}5_; YlfY'4 chn,.LL

radiopharmaceuticals to foreign patients. Once these patients are released from isolation, they frequently return to their native country. Even though the licensee may instruct the patient not to use public transportation, the patient may leave the hospital and immediately board a plane to return home. There exists a limit as to the amount of control that a licensee has over the patient.

The expectation for the licensee to sum "the doses from all administrations of all radionuclides to the patient in the year for which the record is maintained" to prevent doses in excess of 5 millisieverts (0.5 rem) is not practical. First, it requires significant amounts of time and effort for staff to compile this data. Second, unless the patient provides an accurate patient history including the dates of administration, the types and amounts of the radionuclides administered, it will be extremely difficult to sum the doses. For example, some patients undergoing cancer treatments are subjected to a combination of outpatient diagnostic and inpatient therapeutic amounts of radiopharmaceuticals. The NIH treats patients from a l l over the world and it may not be possible to obtain the data necessary to sum the doses from all outpatient and inpatient administrations.

The licensee should not be held accountable for the management of information provided by the patient.

We hope that these comments are useful for your review of this topic. Please feel free to contact Ms. Kelly Austin at (301) 496-5774 if you have any questions regarding these comments.

Robert A. Zoon, M.E., M.S.

Deputy Radiation Safety Officer, NIH

AUG-30-1994 09 : 00 FROM ALABAMA RADIAT ION CONTROL TO 83014155385 P.03

. .,., DOCKET NUMBERPI OPOSED RULE...:..::_.....~

(5qFR3tJ11't) DOC KETED US, RC

'94 SEP 12 P2 :50 STAT E OF ALABAMA DEPARTM ENT OF P UBLIC HEALTH OF Flf"E OF ~-r, ~E-~P'(

eee!t t: ~,,1 tr,a C rr:1*.

• j. ..._~,__ _

t A. ..,, __

DONALi~ E. W11,1,1.\Mso;-.:, M. D.

• S*1'ATK H l':J\l,TH On*1c1-: R BR h t' _,r,.

August 11, 1994 MEMORANDUM TO: Terry Frazee, Chairman, SR-6 FROM: David WalterQ6v *

SUBJECT:

Comments on Draft Reg Guide DG-8015

1. The sheer number of different release activities for all the various isotopes will lead to confusion. Some of our licensees use many of the listed nuclides on humans.

If this is the format to be used, consider having 2 or 3 groups of radiopharmaceuticals with the.most restrictive radionuclide in each group used to determine the group release activity.

2. Case by case calculation of maximum *doses to individuals would only be used to allow a p~tient early release. These case by case incidents will become standardized over a short period of time, but will have to be approved because an inspec tor cannot prove the licensee wrong. Even assuming that the Agency could prove that an individual received a dose in excess of 100 mrem/yr from a patient, we could not necessarily fault the l icensee. They can rightly claim that their calculations were from best estimate criteria which they based on patient information and exposure data.

3. Licensees cannot be accurate in their assessment of multiple administration exposures. A great deal of cancer patients and members of their f amilies are members of support groups.

How do you estimate the exposure to a family member over a year when they most likely will be exposed to numerous cancer patients who have received radiopharmaceutical therapy? Since it can't be guaranteed

• that all patient sources of exposure will be accounted for when aetermining the exposure to an individual, what is the sense of doing it at all? This does not seem to be good science, and it fuels the fires of fear and paranoia to the general public or newly educated patient or family member.

i\dmini~trntivc,?fficc~: Norm,ndalc Mall. sn I~. Patton A.venue. Mont~()m1:"Y, Alabama 361 ll Ma1hnl! Addrc~s: 434 Monroe Strccl. Montw,mcry, Alaham:r 36 1-'0-30 17

• ;_~ ,.

,.,. N 1 108 bV card...... ISEP- 2 8 1994~

u. U~lJCL ~ ;., : F::.: JJ~ lOtl';, tOMMl$'S10N

'.;KEW G & ::,ERVICE SECTION Cfflt-E Of THE SECRETARY OF THE COMMISSION Document Statistics Postmar1< Date r?rtrvufJ. &y SJ,-e,t ~

0,~es Reo::!ved _ _ _~ - - - -

Md'I Co *es Reproduced _ __ } _ _ __

~ecial Dis!ribuuon . i1Lt25i -'j fJ{JIL; C tl W-

AUG-30-1994 09 :00 FROM ALABAMA RADIAT ION CONTROL TO 83014155385 P.02

• - ,. Terry Frazee, Chairman, SR-6 Page 2 August 11, 1994

4. The requirements for records are a paper chase. For years our licensees have handed out the 1987 Society of Nuclear Medicine pamphlet to all persons receiving radiopharmaceutical therapy. Making the licensees document the TEDE from the chart in the rule and then saying they did so in my opinion is a waste of time. How does this help us accomplish our primar~ goai - to protect the public health and safety? If it doesn the pus do that, don't reguire itl

5. The statement that a licensee must keep a record of doses to patients only if they are administered an amount of radionuclide in which the dose to another individual is considered likely to exceed 100 mrem is redundant. Licensees are already required to record all doses administered. Will this require a licensee to havetwo dosage records for each radionuclide therapy patient to satisfy the rule?

In summary, any change in the rules should be done to help our Agencies protect the public health and safety, and protect the environment. If an inspector cannot determine that a licensee is endangering the public health and safety by violating a rule or if the licensee ultimately cannot control all aspects encompassed by the rule because of circumstances outside their legal control, such a rule is unreasonable and unnecessary. Let us concentrate on reasonable, logical rules which have a positive impact on public health and safety, and which can be positively linked to a licensee's legal control.

DW/jsm

i:u3-30-1994 09:57 FR01 ALA~ RADIATICJ,I aJ-lTRCl.. TO 83014155385 P.01 ALABAMA DEPARTMENT OF PUBLIC HEALTH Division of Radiation Control Montgomery, Alabama IS SENDING TO: ....N,&..,;R;.,_.;..t!._ _ _ _ _ _ _ _ __

FACSIMILE NUMBER: {lo 1) o/tS- S3&>S-DATE: 'i/'3o)t:t'f THE FOLLOWING~ PAGES ARE FOR: $ke.J: S ~

~ : T~ .D($-~o JS-FROM:~ lv,a/4 RETURN FAX NUMBER: (205) 613-5387 VERIFICATION NUMBER: (205) 613-5391 tttiiiP§. Silk@ 22 aa z st gaaanss a  ;

sources of exposure will be accounted for when determin~g the exposure to an individual, what i$ the sense of doing it at all? This does not seem to be good science, and it fuels the fires of fear and paranoia to the general public or newly educated patient or family member.

Admlnl,rr.livc Office., Normandalc M,11, ~72 K l*urton Avcn11c, Mon1,:omc'1', Alab<<n>a ,l61 t t Mallin11 Add.,, .., .C3.C Monroe Street. Mon1,11omc'1', Al*h*m* M,t l0-3017 STOPPED

AUG-30-1994 08:59 FROM ALABAMA RADIATION CONTROL TO 83014155385 P.01 ALABAMA DEPARTMENT OF PUBLIC HEALTH Division of Radiation Control Montgomery, Alabama IS SENDING TO: _,._A},L.:.R_t!..;;;,___ _ _ _ _ _ _ __

FACSIMILE NUMBER: QO 1) 'f 1S- S3fr1..S-THE FOLLOWING b PAGES ARE FOR: ~ S~

J?& : T~ bci-~o JS-FROM: ~ 0.J4 RETURN FAX NUMBER: (205) 613-5387 VERIFICATION NUMBER: (205) 613-5391

~ROPO, E~H~~~; PR 2 o 35 5qfR3011.'-/ DOCXE. TtD Kootenai Medical Center US J~C

• 94 SEP 12 P 2 :S 1 July 7, 1994 OFFIC E CF StCRETARY DOCKETING \ Si:J,:vicr BRANC:f' -

COMMENT REGARDING DRAFT REPORT -

REGULATORY ANALYSIS ON CRITERIA FOR THE RELEASE OF PATIENTS ADMINISTERED RADIOACTIVE MATERIAL I strongly support, and would urge you to adopt alternative #3 which would amend the patient release criteria in 10 CFR 35.75 to specify a dose limit of 5 millisieverts (0.5 rem) for patient release after hospitalization for I-131 therapy . This would signi f icantly reduce patient/third party expense for I-131 therapy (including the significant expense incurred by the federal and state governments), while at the same time reducing hospital costs for the treatment.

I do not believe there is a significant danger to the public from this amendment, with appropriate patient instruction regarding safety measures .

Sincerely,

• jfr-~

Larry K. Hatch , MD Director Department of Nuclear Medicine Kootenai Medical Center LKH:eh 2003 Lincoln Way Coeur d'Alene, Idaho 83814 208/666-2000 Vl+J\.

Membef d~Hosp,lalsd Ame<ica, Inc. SEP 2 8 1994 0

Acknowledged by card ... .....................,...,H,.

.... NUCL;::,..;:;. r.E:GULATORY COMMISSION DOCKEl ING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Fostmarl( 0a1e & o v (_ ,/er}- by s J-.n ~ (J e_-r-0 Copies Rer,eived _ _---'.____ _ __

Add'I Copies Repro-1uced ---,3  ;:-----,,---.....

Special D1st~i"' *; - _IU __J:J~'f.,_._........._.,___

-..4f-.L..LJ4-j:-4 1_GIJ:"""__ - - - - - -

DOCKET NUMBER PROPOSED RULE Pl ..2.~, 'J ~-

ra EXECUTIVE COMMITTEE

{5q Ff<. 3"1:Z.'1)

Amer1can A ssoc1at1on . .

DOCKETED of c1*us,1ntca RC 1 E d

• 94 SEP l 2 P2 *5 1 n ocrinologists AACE '95 Stanley Feld, 11.D., F.A.C.E.

OFFICL rt- vE . I=' r; RY ANNUAL MEfflNG Dallas, Texas President July 28, 1994 DOC Kt rmG & ~lR,,. r:f APRIL 5-9 Sheraton Chicago Stephen F. Hodgson, 11.D., F.A.C.E.

Rochester, Mrmesota BRANCH President*Elact Mr. S. Schneider John A. Seibel, 11.D, F.A.C.E. Division of Regulatory Applications Albuquerque, New Mexico Vice President Office of Nuclear Regulatory Research H. Jack Bukfn, IID, F.A.C.E. U.S. Nuclear Regulatory Commission Ort;mo, Florida Vice President Washington, DC 20555-0001 Helena W. Rocllard, 11.D., F.A.C.E.

Rockville, Maryland Secretary*Treasurer

Dear Mr. Schneider:

Eugene T. Davidson, 11.D., F.A.C.E.

, Florida e Past President The American Association of Clinical Endocrinologists (AACE) would like to BOARD OF DIRECTORS comment regarding the draft report on "Regulatory Analysis on Criteria for the TERMS EXPIRE 1995 Release of Patients Administered Radioactive Material" published May 1994.

Doris G. Bartuska, 11.D., F.A.C.E.

Philadelphia, Pennsylvania Rhoda H. Cobln, 11.D., F.A.C.E. We support the proposal to amend release criteria in 10 CFR part 35 "medical use Mi<land Park, New Jersey JuM A. Davidson, 11.D., F.A.C.E.

by-product material." The proposed section 35.75 will amend the criteria for release Oalas, Texas of patients if the total effective dose equivalent to an individual for exposure to the Wllll1111 W. Fore, 11.D., F.A.C.E.

Philadelphia, Pennsylvania released patient is not likely to exceed .5 rem in any one year. If the total effective Paul S. Jelllnglr, 11.D., F.A.C.E. dose to any other individual is likely to exceed .1 rem in a single year from single Hollywood, Florida administration, the licensee will provide the patient with written instructions on how C. Conrad Johnston Jr., 11.D., F.A.C.E.

Indianapolis, Indiana to maintain doses to other individuals as low as reasonably achievable and maintain Wllll1111 F. Price, 11.D, F.A.C.E. for three years a record of the released patient and the calculated total effective dose SpartMbtlrg, Sou1h Carolna TERMS EXPIRE 1996 equivalent to the individual likely to receive the dose.

Gllbetl H. Daniels, 11.D., F.A.C.E.

Boston, Massachusetts We believe that this proposal will, in fact, permit the release from confinement of A. Dickey, 11.D., F.A.C.E.

Nor1h Caroina patients who have received 1-131 up to a dose of 100 millicuries. This will result in

• Garcia, 11.D., F.A.C.E. substantial hospital cost savings as well as savings to the individual and society in West Bloomlield, Michigan John J. Janb, 11.D, F.A.C.E.

socioeconomic and psychosocial tenns. We believe that if properly administered, the Po<t Charlotte, Florida amended regulations will not allow undue hazard' to patients or to their contacts.

AM II. Lawrence, 11.D., Ph.D., F.A.C.E.

Hines, lllroois Howanl R. Nankln, 11.D., F.A.C.E. As advocates for patients who have thyroid carcinoma, as well as other thyroid Columbia. South Carolna disorders, the members of AACE believe that this ruling will considerably facilitate Pasquale J. Palumbo, 11.D., F.A.C.E.

Scottsdale, Arizona the ease of their care and we strongly recommend the adoption of the proposed TERMS EXPIRE 1997 amendment.

Donald A. Bergman, 11.D., F.A.C.E.

New Yori(, New York Geo,ge A. Bray, 11.D., F.A.C.E. Sincerely, Baton Rouge, Louisiaia

~~~

C. Wayne Callaway, 11.0., F.A.C.E.

Washngton, D.C.

Yank D. Coble Jr., M.D., F.A.C.E.

Jacksonville, Florida Edward Paloyan, M.D., F.A.C.E.

Hines, Illinois H. Jack Baskin, M.D.

Victor E. SIiverman, 11.D., F.A.C.E.

Atlanta, Georgia Chairman, AACE Regulatory Committee Richard L Weinstein, U.D, F.A.C.E.

Wuiii Creek, Califomia Staff:

cc: AACE Executive Committee Robert J. Harvey, Executive D*ector Wanda Callahan Linda Kepner Marilyn Smith 2589 Park Street / Jacksonville, FL 32204-4554 / (904) 384-9490 / FAX (904) 384-8124 ea o* car .....-..... .

• ns. NUCL::A, . i.:~-.. . _,J..T(J,W COMMISSION OOCKEllNG & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics

NUC L EAR ENERGY I NS T ITUTE

• 94 SEP -9 P 1 :15 Felix M. Killar, Jr.

/;;o)

~

DIRECTOR , MATERIAL LICENSEES PROGRAMS OFF IC-:: OF SEC-RE \;~Y DOC K Tl '.G g_ c,t"- /1r-*

September 1, 1 * .ANf'H Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 ATTENTION: Docketing and Service Branch

SUBJECT:

Criteria for the Release of Patients Administered Radioactive Material; Proposed Rule 59 Fed. Reg. 30724 (June 15, 1994)

Dear Mr. Secretary:

On behalf of the nuclear industry, the Nuclear Energy Institute (NEI)1 submits the following comments on the proposed rule for the release of patients administered radioactive materials.

On June 15, 1994, the NRC published in the Federal Register (59 Fed. Reg.

3 0724) a notice that it was requesting comments on a proposed rule concerning revising the criteria for the release of patients who have been administered radioactive materials. The new criteria will be dose-based rather than the cunent rule's activity-based criteria. The new rule will also be consistent with national and international recommendations on the release of patients who have been administered radioactive materials. The proposed rule will require the licensee to maintain a record for three years if the quantity of radioactive material from a single administration is likely to have a result such that an individual who is exposed to the patient could receive an annual total effective dose equivalent to 1 millisievert (0.1 rem).

1 NEI is the organization responsible for establishing unified nuclear industry policy on matters affecting the nuclear energy industry, including the regulatory aspects of generic operational and technical issues.

NEI's members include all utilities licensed to operate commercial nuclear power plants in the United States, nuclear plant designers, major architect/engineering firms, fuel fabrication facilities, materials licensees, and other organizations and individuals involved in the nuclear energy industry.

1776 I STREET , NW SUITE 400 WASHINGTON , DC 20006-3708 PHONE 202 739 8000 FAX 202 785 4019

j **

September 1, 1994 Page2 NEI has reviewed the proposed rule and the supporting basis for the change. Based on this review we support the proposed rule with a few exceptions as noted below. We support the proposed rule because it is consistent with national and international recommendations on patient exposure and other individuals' exposure to patients who have been administered radioactive materials. In addition to the technical reasons, we support this rulemaking as it is morally correct. In medical care, the patients well-being is fundamental to patient recove:ry. Laws and regulations that are detrimental to the patient's well-being inhibit the possibility of full recove:ry for the patient. Most patients want to go home, to familiar surroundings, as soon as they feel well enough to do so. The existing NRC regulation prevents the patient from being released from the hospital even though the patient feels well enough to go home and the doctor would release him. We believe this revision will help reduce the time between administration of radioactive materials and the patient returning home. This revision should also contribute to improving the well-being of the patient's family. The patient will be home and the strain on the family of going to the hospital would be gone. At the same time these changes will not adversely affect the health and safety of the family members. Finally, the proposed rule also has the effect of reducing medical costs. While costs are not the prima:ry issue for the NRC in protecting the public's health and safety, it is an issue in this count:ry. To continue to improve medical care and at the same time reduce medical costs are prime concerns throughout the nation.

While we support the rule, we do have the following concerns. The record keeping can lead to implementation problems. To create a record on the patient's radiation administration and the dose effect to people coming in contact with the patient beyond the recommendations ofNCRP 37 is a problem. The state of California has successfully used the guidance ofNCRP 37 for a number of years, we believe the NRC should be able to as well. The rule as proposed by the NRC with the increased paper work will increase cost which does not provide any off setting health and safety benefit for the patient or the people that the patient comes in contact with. As an experiment, a nuclear medicine physician followed the proposed rule to determine the impact. This doctor found that by following the proposed rule with the paper work requirement it would add about $571 per patient treated. If it is assumed that 62,000 patients per year are treated (this is the NRC's assumption) this equates to over $35.4 million in additional health care costs that must be paid by the patient and/or his medical insurance carrier. This does not include the extra nonmedical costs to the patient or the lost opportunity for other patients and the hospital/medical institution. Therefore, besides unnecessa:ry paper work, the rule also imposes unnecessa:ry medical costs of over

September 1, 1994 Page 3 of over $35.4 million. Therefore, we strongly recommend that the NRC's rule limit the paper requirements to those used by the state of California.

We are also concerned that the NRC does not have a good understanding of the medical aspects of the draft regulatory guidance for the calculation of the dose to people who come in contact with the patient. The guide assumes the organ receiving the radiation is fully intact and fully uptakes the radionuclide. In most cases, the organ is not intact and the excess radionuclide passes and is excreted.

Using the NRC's overly conservative assumptions results in removing the benefit that the rule change is attempting to provide. The NRC needs to provide better medical reviews of its proposed guidance in order to fully comprehend the medical aspects of the rule.

In summary, we support the NRC's proposed rule because it is technically as well as morally correct. We object to the unnecessary regulatory overburden in record keeping that the NRC is attempting to impose.

If you have any questions, please do not hesitate to contact me at 202 739-8126.

Sincerely,

!J-4r ~

Felix M. Killar, Jr.

Director Material Licensees Program c: Carl J. Paperiello - NRC

KAISER PERMANENTE DOCKET ED us m Executive Offices, Ordway Building DOCrET _ *94 SEP -6 P 3 :25 f -...:...;;.::..--".J.

(S Cf FY?_ 30724)

September 2, 1994 By Federal Express Secretary U_. S. Nuclear Regulatory Commission Washington, D. C. 20555 Attn : Docketing and Service Bran~h Re : Comments on Proposed Rule -- Criteria for the Release of Patients Administered Radioactive Material

Dear Sir or Madam :

On behalf of Kaiser Permanente, we appreciate the opportunity to comment on the above-referenced proposed rule, which was published in the Federal Register on June 15, 1994 . I understand from my conversation with Stewart Schneider, Office of Nuclear Regulatory Research, that you are considering comments received after the close of the comment period.

Kaiser Permanente is the largest health maintenance organization in the United States. Kaiser Permanente owns and operates hospitals in four states and medical offices in 16 states and the District of Columbia.

We wish t o comment on two aspects of the proposed rule:

(1) whether released patients should receive written instructions on h ow to maintain doses of radioactive materials to other individuals as low as reasonably achievable; and (2) whether, under the proposed rule 's recordkeeping requirement, it is effective to calculate the total effective dose equivalent to the individual likely to receive the highest dose from exposure to the released patient.

J:\COH ENMI\NRC.S01 Kaiser Foundation Health Plan, Inc.

One Kaiser Plai.a Oakland, California 94612 510-271-5910

~;:p 2 s* 1994 -

A,., IV I dged by car~:....................."......_

{)oi'1' e"'t St *i('tics I. Written Instructions Requirement /section 35,75/b} 11 We agree that released patients who may expose other individuals to a total effective dose equivalent greater than 1 millisievert (0 . 1 rem ) shou l d be provided with written guidance on how to maintain possible exposures to others as low as r e as onably achievable . In our opinion , however , the proposed rule could be strengthened . First , the rule should require , where appropriate , wri t ten i n structions that specifically address possible exposures by high risk populations , such as newborns , children , and pregnant women . I f the released patient is likely to have contact with any high risk individua l s , the written guidance should provide specific instructions on how to limit exposures to those individuals . Second , in our experience , whether a released patient is receptive to receiving written instructions depends on the patient ' s physical and menta l condition at the time of discharge . We , therefore , suggest that the rule state that where the individual(s) taking primary responsibility for the released patient can be readily identified , the physician has the option of providing that person(s) also with written instructions on how to maintain possible exposures as low as reasonably achievable . II . Calculation of Total Effective Dose Equivalent of Individual Likel y to Receive the Highest Dose <section 35 . 75/b} <2}} Kaiser Permanente supports the proposed rule ' s requirement that licensees maintain patient records for three years . However , the requirement to calculate , and maintain a record of , the total effective dose equivalent of the individual likely to receive the highest dose from the released patient is not practical and should not be adopted . The proposed calculation would require the licensee to know the patient ' s activities for approximately 60 days after release , the di s tances the patient will maintain from other individuals during that period of time, and with whom the patient will have contact . Gathering this information would be difficult , and the resulting calculation would likely not provide a reliable or useful measure of possible exposures . A better way to meet the rule ' s objective of limiting exposures to radioactive materials from a released patient is to estimat e the total effective dose rate equivalent from measurements of the patient and reference to a regulatory guide that sets forth which diagnostic procedures and radioactive materials are likely to expose individuals to a total effective dose equivalent exceeding 0.1 rem . J:\COH ENMI\NRC.S0 1

Kaiser Permanente supports the NRC's effo r t to clarify the rules regulating release of patients administered radioactive materials. We hope that our comments assist in that effort. Sinc e r ely, KAISER FOUNDATION HEALTH PLAN, INC. By : *~ Ai ~ Mitchell S.Y. Cohen Counsel J:\COHENMI\NRC.S01

cc: Ken Ayers Doug Bonacum Charles Finney J:\COHENMI\NRC.S01

PR 1 0 3S DOCt~ETEO l)OC-KET NUMBER PROPOSED RULE ~ 1 (sq Ff<_ 3 07 2i--J \"' (ii)

                                                                                                                               '-f 6 ORAR - - - - - - - -                                            C: , 1RC                              ~

Council on Radionuclides and Radiopharmace.uticals, Inc.

                                                                *94 SEP -6 P J :27 3911 Campolindo Drive MoC3g2, CA 9 556-1551 510/283-1850 F2x: 510/283-1850

'Henty EL ~;Ph:.D;, FACNP E~Dircaor Secretary 8/26/94 U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Attn: Docketing and Service Branch Subjects: 1. Proposed Rule, Criteria for the Release of Patients Administered Radioactive Material. Federal Register Vol 59, No 114, Wednesday, June 15, 1994, Page 30724.

2. Draft Regulatory Guide DG-8015, Release of Patients Administered Radioactive Material, June, 1994.

3. Draft NUREG-1492, Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Materials, May, 1994.

These comments on the above referenced subjects are submitted on behalf of the Council on Radionuclides and Radiophannaceuticals, Inc. (CORAR). CORAR is comprised of representatives of the major manufacturers and distributors of radiopharmaceuticals, radioactive sources and research radionuclides used in the USA for therapeutic and diagnostic medical applications, and for industrial, environmental and biomedical quality control and research. CORAR members manufacture and distribute the radionuclides that are administered to patients and are keen to promote practices and regulations that benefit the patient and provide adequate protection of the public. We believe that the NRC proposed rule will provide a workable regulatory framework for optimizing the well being of nuclear medicine patients and persons in support. We applaud the NRC rationale which considers the unnecessary healthcare costs and adverse impact on patient recovery that result from current regulations. The proposed rule reflects the recommendations of the NCRP and ICRP and is more understandable than current regulations. In the attached comments we have identified opportunities for reducing the regulatory burden for licensees. We appreciate the opportunity to comment on this proposed rule and would be glad to assist if you need clarification or further information. Sincerely yours, Leonard R. Smith, CHP Mark A. Doroff, CHP CORAR Working Committee on Patient Release Criteria Acknowledged by card :,~~.. !"8...2!!. .=:;..

U.S. l\.Jl-t ,* -..* : . .*.. :, J-. iORY COMMISSION 01;C:{*; .... ,,,:**~ .-:;rnv,cE SECTION Off:(;f: OF THE SECRETARY OF THE COMMISSION Document Statistics Postman< Date _ _ _ __ _ _ __ Copie~ 0 eceived _ _ __ _ _ __ AMI Cor,es Reproducoo _ _ _ _ __ Spec,a, D.slributior _ _ __ _ _ __

COMMENTS ON CRITERIA FOR THE RELEASE OF PATIENTS ADMINISTERED RADIOACTIVE MATERIAL. L COMMENTS ON PROPOSED RULE. ISSUE 1: Should limits in 10 CFR 20.1301 (a) or 35. 75 govern patient release? We agree with the NRC that the appropriate limit for patient release should be 5 millisievert (500 mrem) per year for individuals exposed to released patients. IO CFR 3 5.7 5 is the appropriate part for specifying this limit. We also agree that 10 CFR 20.1301 should be modified to explicitly exclude exposure for patients in the I millisievert (100 mrem) per year public dose limit. The NRC proposal is effective in clarifying this issue. These criteria are fully compatible with recommendations of the National Council on Radiation Protection and Measurements and the International Commission on Radiological Protection. ISSUE 2: Should an activity limit or dose rate limit be used to permit patient release? The use of activity limits or a dose rate criteria for patient release have the advantage in providing simple methods for deciding on when to release a patient. The provision of a Regulatory Guide with tables of values for typical patient conditions will also satisfy the need for simplicity. We support the regulatory position in the Draft Regulatory Guide which includes activity levels as well as the methodology to perform calculations based on case-specific factors as means of demonstrating compliance. ISSUE 3: Should the calculation methodology in NCRP Report No. 37 be an acceptable means of demonstrating compliance? We agree that the methodology in NCRP Report No. 37 is acceptable and that the Regulatory Guide is a suitably updated application of this methodology. ISSUE 4: Should confinement be defined to include a private residence? We agree that confinement should not be used to mean only hospitalization. The proposed rule appears to adequately address this issue and provide suitable protection to individual members of the public.

ISSUE 5: Should 10 CFR 20.1301 (d) require compliance with Environmental Protection Agency regulations? We appreciate the NRC clarifying that the EPA regulations are not relevant to nuclear medicine patients. However, it is conspicuous that many commentators are confused by the regulations in this case. It is also interesting that NRC staff perceive that current regulations permit a 500 mrem dose limit for patient release. M~y lic~ns~es do not perceive this. It appea,rs.tha,t the style adopted in :writing regulations is sometimes confusing for licensees. In the interest of promoting comprehension and compliance we recommend that the NRC consider means to improve their internal review process and response to licensee comments to avoid creating regulations that may confuse the licensee. In this case it would be helpful to mention that the EPA regulation applies to uranium fuel cycle facilities. That would prevent thousands of licensees from having to consult these EPA regulations. The NRC should be aware that most licensees will not possess copies of the EPA regulations. By cross referencing a redundant regulation, without explanation, the NRC is inadvertently committing the conscientious licensee to unnecessary expense and trouble that can detract from their radiation protection program. ISSUE 6: Should licensees be required to provide patients with written instructions on how to maintain dose to other individuals ALARA? The NCR's proposal for providing written instructions appear appropriate particularly since the licensee has recourse to writing their own instructions or using instructions presented in the draft Regulatory Guide. However physicians should be allowed to provide oral instructions as an alternative. ISSUE 7: Should records of patients released, containing radioactive materials, be required? This question can be addressed by determining the value of these records. Of first concern should be the well being of the patient and the protection of the. public. Since it is unlikely that such records will substantially improve the well being of the patient or the protection of the public it is clear that any record keeping requirements must be of minimal burden. Since any such records will necessarily be medical documents the NRC should automatically ensure that regulatory inspections protect them from inadvertent public disclosure. This should be specified in the regulation. This is necessary to avoid the need for licensees to frequently provide affidavits to protect individual's privacy. 2

II. COMMENTS ON DRAFT REGULATORY GUIDE DG-8015. A. General Comments. We believe the Guide provides the necessary guidance to licensees who will need to revise their current procedures to meet the requirements of the Prop9sed Rule ..... W.~ agree with the,NRC decisi9~ to. µse ,the method described in NCRP Report No. 37 for the purpose of calculating the dose to the individual likely to receive the highest dose from exposure to the patient. The Guide provides the flexibility of using activities or calculations to determine which patients may be released and when patients must be provided instructions and the determination documented. This Guide provides practical means by which a license can authorize release and demonstrate compliance. B. Specific Comments.

1. Discussion.

a. We support the use of Equation 1 from NCRP Report No. 37 as the means of calculating the activities at which patients may be released which are used in Table 2.

b. Although the effective half-life is not used in Equations 1,2, and 3, we are pleased to see that it can be used as discussed in Appendix A when calculating doses based on case-specific factors.

C. We agree with the assumption that the dose to other individuals from intake is expected to be small relative to the external gamma dose.

d. Table 2 needs to be expanded to include other radionuclides which are administered to patients for diagnosis or therapy.

These include Cr-51 , Se-75, Y-90, Sn-117m, and Ir-192.

2. Regulatory Position.

a. The provision to calculate the maximum dose likely to be received by an individual exposed to a patient based on case-specific factors is needed and the guidance given in the Guide is practical and realistic. This is particularly important in situations when it can be demonstrated that the maximum dose will not exceed the limits even though the activity administered may exceed the activity level in Table 2.

3

b. The requirement to provide instructions to patients when the dose to an individual is expected to exceed 100 mrem is consistent with ALARA and provides an added measure of protection of the public. We agree with the NRC's position to accept the pamphlet currently available from the Society of Nuclear Medicine. Oral instruction should also be an acceptable alternative particularly when the patient is illiterate.

c. There should be instruction in the Guide for licensees to include a statement in the release record, required for doses between 100 and 500 mrem, that will ensure these medical records will not be available to the public. If this is not possible, then the regulation must specify that these records are protected from public exposure.

m. COMMENTS ON DRAFT NUREG-1492.

General Comments:

a. The analysis perfonned as a basis for the Proposed Rule is comprehensive, as it accurately identified the current scope of use of radionuclides in diagnosis and therapy, assessed the doses to exposed individuals using calculations with practical and reasonable assumptions, and considered other factors including the relative cost of health care and patient well being. In addition, we approve of the NRC position that the release limit (500 mrem) be consistent with the recommendations of the NCRP.

b. We agree that the proposed rule should promote a dose-based limit consistent with NCRP recommendations.

A dose-based limit does provide a consistent, scientific basis that can be applied to all radionuclides, including those which have yet to be used in medical diagnosis and therapy.

c. We agree that, although selection of Alternative 3 would permit the release of patients with activities that are greater than currently allowed, selecting this option will result in a reduction of exposure to health care personnel and significant benefit to patients and their families with reduced financial burden on the health care system.

We agree that Alternative 3 was the best choice for establishing a patient release dose limit and the decision was based upon a sound regulatory analysis.

d. It is conspicuous that the NRC has not justified the proposal to require written instruction to patients and to document calculations in cases where public doses could exceed 100 mrem. This is not current practice. The NRC has not indicated that current practice is inadequate. The NRC proposal for these additional admnistrative requirements appear unecessary and of no benefit to patients or the public.

4

_,,,,:,....--s,;;.,~,'\";_>,. i.. .JriiBER PROPOSED RULE Pl 'J-_ 0 35 J - DEPARTME---, 10 Ji~~; 30~/r1o @

,;. E

                                                                                              , SHR ,
                                                                                                        ~

SPRI : 162704 *94 SEP -2 A11 :40

                                   \~

Jim Edgar Thomas W. Ortciger Governor OF FI-.[ c_D4"e-ctor, - I\ -~

                                        .. , ~ ~~ ~::r;~:&.~~~*;/:;=,               OOCKE rl G            ,. :c BR /i r*

August 29, 1994 Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Attention: Docketing and Service Branch Re: 10 CFR Parts 20 and 35. Proposed Rule, "Criteria for the Release of Patients Administered Radioactive Material" Gentlemen: The Illinois Department of Nuclear Safety {Department) hereby submits its comments on the referenced proposed rulemaking. We are very pleased to see the NRC publishing a companion Draft Regulatory Guide {DG-8015, "Release of Patients Administered Radioactive Materials") and a companion draft NUREG {NUREG-1492, "Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material") for comment at the same time as the proposed rule. This allows licensees and Agreement States the opportunity to understand the NRC's views on the development and proposed implementation of the proposed rule and comment accordingly. We agree with the idea of modifying 10 CFR 20.130l(a)(l) and (2) to exclude doses to individuals from patients administered radioactive material and released. We also agree with your decision to allow facilities the flexibility to release patients based upon calculated doses rather than a quantity of material used (such as 30 mCi). This approach is consistent with other changes to 10 CFR Part 20 where each facility is responsible for evaluating the total effective dose equivalent to workers and members of the public. We strongly agree with the idea of requiring written instructions be provided to patients on how to maintain doses as low as reasonably achievable. By establishing a cut-off level for this requirement, the paperwork burden for licensees is greatly reduced. @ recyclable

   . ~\.,:                    .. * *. '. *. < -CMf'-1iSSi0N c,-::- **.::-          *.~:r,\Ji(,E SECTION c t*;*, -..-,,: ! hE 3ECRETARY OF THE COMMISSION Document Statistics Postmark Date           rhl l1L,1 Copies Received _ _ __,_/_ _ _ __

Adcfl Copies Reproduced :1 Special Distribution /!$ tJt, flJ/s Utf1~  :.L, ir _ _ _ __

Page 2 The Department commented on the "Working Draft" of this proposed rule to the Office of State Programs in a letter dated September 2, 1993. We are pleased that NRC has considered the comments in that letter as well as comments made by Agreement States at various meetings with NRC. If you have any questions regarding these comments, please contact me or Kathy Allen at (217) 785-9947. Sincerely, f~e.~

                            ~~en C. Collins, Chief Division of Radioactive Materials cc:   Jim Lynch, State Agreements Officer

OOC E.1EO US ~RC UNIVERSITY OF *94 I\UG 31 p 4 :35 WISCONSIN-MADISON MEDICAL SCHOOL August 29, 1994 ATTN: Docketing and Service Branch Secretary U.S. Nuclear Regulatory Commission Washington DC 20555 Mr. Secretary: I am providing this in response to the request for written testimony of the criteria for welfare of patients administered radioactive material. ( 10 CFR Parts 20 and 35; RIN3150-AE41)

1) The use of a single-action level for dose limits to individuals is simpler than several action levels different for various situations.

The reduction of the level to 0.1 rem seems unnecessary given a) the fact that the 0.5 rem level is close to that of natural back-ground radiation a US citizen receives, and b) 0.5 rem is considered safe for other situations. To those of us who teach this material to future practitioners, this fragmentation of action levels imparts an unnecessary complication , and to the patient may well impart the reasonable impression that radiation from therapeutic applications is more dangerous than from natural sources.

2) I strongly urge that the requirements for written instructions be deleted. While it is probable that some patients currently receive inadequate instructions, I believe they will

• do so after this require-ment is implemented, as the deficiency is more likely related to the familiarity and knowledge of the medical practitioner rather than any other factor. As a direct result of this directive, patients will receive a) less information than prior and b) the information they receive will be less applicable.

Department of Radiology E3/311 Clinical Science Center 600 Highland Avenue Madison, WI 53792-3252 608/263-5306 FAX 608/262-0907 Michael A. Wilson, M.B., Ch.B., F.R.A.C.P. Professor, Radiology & Medicine Chief, Nuclear Medicine Section

• s. I JCLE,A C * ,._; vRY COMMISSION DOC
• r.. S-R 'CE SECTION Fi-irl.. 'i ,t-1E-::.. CRETARY OF- TfiE COMMISSION Document Sta+;stics

US Nuclear Regulatory Commission August 29, 1994 One might argue that this written requirement will be in addition to the current verbal instruction, but this is not what happens practi-cally. I formerly used a written instruction sheet with therapy, but found I was spending too much time explaining how each patient varied from the sheet rather than the most appropriate instruction for that patient and their family. I believe this argument is supported by ethicists and lawyers who now acknowledge that the consent form has detracted from informed consent whenever these forms are used. More and more procedures that used consent forms are withdrawing them and going to acknow-

  ,  ledging that consent was discussed with the patient. If this is occurring for a uniform procedure performed on a patient, consider how different the instructions should be for an elderly patient who lives essentially alone except for daily family support and those for a mother of several young children. For every family situation there is a different instruction sheet, and this depends on number of toilet facilities, household density, patient occupation and numerous other individual arrangements that cannot be covered in one or several instruction sheets.

Sincerely, Michael A. Wilson, MD Chief of Nuclear Medicine Professor of Radiology and Medicine University of Wisconsin Medical School MAW/kl

                                  ~ DEPARTMENT Of)'t'M\rrff 4815 WEST MARKHAM STREET* LITTLE ROCK, ARKANSAS 72205-3867 TELEPHONE AC 501 661-2000
                                                                              *94 AUG 31           A9 :08 JIM GUY TUCKER                                       SANDRA B. NICHOLS, M.D.

GOVERNOR DIRECTOR ., ET NUMBER

                                 -o RULE PR   ;)_

O 135, Of f 1Cl LF S~Cfff TAR~- DOCK[ i I 'G i.. ~ P' :CE. Secretary (51F'R...3tJ72'--I)' Augus  :~G~§94 U.S. Nuclear Regulatory Commission Washington D.C. 20555 RE: Cri t eria for the Release The Division of Radiation Control & Emergency Management of the Arkansas Depctrtmcn t of Health has reviewed the proposed rule "Criteria for the Release of Patients Administered Radioactive Material" and provides the following comments regarding the proposed rule. We are supportive of the concept of using a dose based limit for a decision on release limits for patients; not defining "confinement" in the regulation; using the calculation methodology in NCRP Report# 37 for dose calculations to a member of the public from a released patient; and removing the 30mCi limit from the regulations . If exposure calculations are performed using the methodology in NCRP Report# 37, individual mCi limits are not necessary. A m~asured exposure limit has merit if only for a check of the calculations and should be considered for re-inclusion in the regulation but only as a adjunct to a calculat~d exposure . There is some concern about a release limit of 500 mRem/yr to the exposed individual. The justifications for the release limit override our concern so we are generally supportive of it, but suggest the following: (1) the written instructions to the patient become extremely important and must be in easily understood, lay terms; (2) judgment may need to be applied dependent upon the home environment, i.e . , presence of small children, individuals already medically challenged etc . ; (3 ) the patient should have an option of deciding if he/she wishes to leave the hospital. Insurance companies and special plans may con s ider the 500 mRem/y,* a "must" release limit and not a "may" release limit. Patients should not ha ve to be released if that may cause more stress than the hospital stay. There is some concern also that this limit adds yet another radiation exposure lim i t t o an in creasing large range of limits the public is asked to accept. Unde r standably , the public may require an in-depth explana t ion. Th e Reg Guide appe ar s useful. We ha ve no comments about NUREG- 1492. Si n1.: ere Iy ,

   ~ - l}~

Greta J . Dicus, Director Divis ion of Radiation Centro l ".,Ui, ~ ~ 8~ " Emergency Management SEP 2 8 1994 -- y card ................ .* *HI ,,,n

• rlJ.S. NUC'....: . : _,;. *1 :.;(;;,",,,,, SSiON DOC:' ~ , *-flViU:: SEC f!ON Offll, .... o-- I r<E $ECF1ETARY oF rhE cm", ss:,..N Docunert s*atisf cs

                                                      . ,Ash:eviile -O:ffice:'. 29* 1,/2 Page Ave . .- _      Ashevill~. *Ne ?8801 ~ 704-251-0518 Raleigh ~-ffice: _P.O .Box ._1008

• Raleigh ,. NC 27-602
• 919-8,32-749_1 _.. _

                                                            . . .                  . , .. . . . oo
                                                            * *COMMENT . ON . .                         . -* .

• o..,., '° CRITERIA FOR RELEASE -oF PATIENTS .. ADMIN ESnRE1" . _- . _ o RADIO,ACTIVE MATE.RIAL * . . . . ~ r"' . . . ~~ : c::-g ..

(-PROPOSED RU:µE 59 . FR 30724ff) -- ~~; ~ - ~~ **

                     .** SUBMITTED BY FAX .WITH FOLLOW~UP                                     COPY**

BY- MA

                                                                                                                         . §;~ m
                                                                                                                                   *J,£'
                                                                                                                                                       ~w
                                                                                                                                                           -~

_n~c::, *

                                                                                    '         .           .           *_        **. ~~                 ~ --
                                                                                                      .                            :.--a .......,      '-..      . .*
                                                                                                                             .        -:::-;;, .. - Ll 29_ August .1994 . *'

DOCKET NUMBER,-.1 -*2 *Al - ... *_ 'Pi~-- N . Secretar*y USNRC .'._ PROPOSED RULE...=..=.... * -......,. cvpWi,11:_ Washington DC . 2.0 555

                                                                *. * (Stt PR. 3Cl72..'1). .
                              .* Tbe . Clean W~t~r . Fun'ct .- of North* :ca*rolin; . [tWFNC] .

Qppos-e_~- the proposal to amend J.,O *C.FR *20 and 10

• CFR 35 to allow higrier .doses: t6- m_e mber$* of the genera:l *public from
• radicipha-rr(laceutic;::a.ls .iD r *eleased p~tierits, -*

                      . because .-.the * *propqsa*1 *unnecess-arily . inc-reas-es the

r adiatio_n burdeh

• of members .o-f the- *geritfral .pub°iic w_ithout consideririg - all *. so_u rces of *. radiation burden *

                        .inc:r_ec;ise,

• s*ince
• expbs_ures due* *to r .a dionuclide$ in

         .- **

• _sewer.a ge '. are inappropl'.'ia.tely -exclud~d from ~~gulatory * *

          . * . coverage; .' :therefo're, the :ov~rall *. impact *. *o f

• th_e _

- *. . prop*o sed :increase*s . cannot

• be con$e_r vati vely assessed . .

           * . * * * : * !n -_ addition, . CWFNC- opposes -the * .proposal to amend
     ***:***. lb CFR =2'0 arid ib CFR *35, because' *the amendinents would
 * *. : * * *. * * *. expose uninformed members* ,-of _the

• generai pop:ulation to

                 - an unrtec~is~ry radiative bur~en witho~t : any betiefi t :

and (rnor:e

• _.'importantly) :witnou_t -* their : *cons~nt ~ .. CWFNC does .. _not. object if -patients fr:ee1y choose "to' 1.u;1dertake themselves the excess morbidity or *rn_o .rtality r~sks ass_h ciated .with .radioiogi~al treatment. or tj.i"agi:iosis,*

                       *p*rovided that competant professional$ ' have_. e -x p_lain.e d cle~i°rly to .those . pati'e nts the . p6s.s*: Lbilities fo*r
                 . * -_iatrog~n"i_c* damage -'tr.om radioisotope * *exp9s.ures *. _N or
                 . *. do~s *CW:FNC object it' cornpe_t ant

• health .professional s

                . ** fr~ely ** c _o nsent_ to. the e*xcess morbidity or mortality_

ri .s ks *associated with their

• own involvement in
• such

              *.. potentially ther-a p.eut;:i_c -t.ech~iques -. Howe*v er; CWFNC_

_ _d oes object to . the

• exp.O sure -of ~embers *-of the gen~r?,l

               .. * *_ public who have. no~ thems_e lves* consented freely *to . the
                     -* dosage*.                          *                                              * . *' . . .                             * , (more).
                          .* .       *                                      . A .-         .. ed. b d SFP *1. 8'. 1994 . .
                                                                            * . ~K'.'lo~-1.crug . . . y ar ...., . *** * . * **                        .,.
                                                                                    .                           Hnted on* l'11, J>>at~-:r r ~ ~toOMd papa, with IOV Int.

s. :DOCKETING NUCLEAR' REGULATORY Co'MMISSION . .... **

                                                                                           .t g*SERVtCE SECTION ...

OFFICE OF THE SECRETARY . OfTHE*COMMlSSION * .

                                                                                          . a * ..

.-.Dorument Statistics . ~

fosm,arl( 0a1e . ~

                                'it ( ;_q /fZLj *.*.                                ...

Copies Received- * *. 1 *

          .Add'I Copies Reproduced . : 2. . . .

Special Distribution ~ iZJ;.'4 !JfJfl

           . 'S.?)t ~ t d_pv-w .

                                     .          . __ . _ _   ."CWFNc. *u .: .* PATIENT t0i:"LEAS2  2/3    **

__ *_rn.. add~t~pji , _.CWE;N,C ..oppo.se_s- th~ prqp_osal_ -t_C? *. amend

• 10 C:FR 2<l *and- ld :CFR. >3*5~- , because the amendments

               *c_ont~:1:-ri peither: ¢_on~_id~ra:t;ion of .the 'total p9pu4,at-:i;oh _

dose from . the pat'i.:ent *, .- no*r* c_c,nsider*ation-.* o:f the

               'ijl,crei:neptal populat::J*o n dos e . from, the re-gu:J.a,tor.y

_.r- evls._ion.-:- P~pui a t_i_or1 . *dos-~ i6"onslderi:~ti.on's __ are*.

             . ~sse.nt~c;tl,* b¢cau~e *p opulation dos*e Js *an _appropri:qt~

me*asu-t.'e* *:of tot.al S:o-cial *':aost, ana fallu*r e to conside:r° ',* populati.<Jil dos*e could ~e s*u:i t in anai ytical .bia~es ,

• producing
• a _misl~adihg sop1al_ .cost_;;tb.-benefit *r -a t.(o
• by . displaci.ng cer:ta'in health..;. care - :c*:ost$ from :.t'he pat:i~nt ,: ?OC~.or, _or _hpsp_ltal _ t,.o . ~-oc~e~y_ ~t: ?c.irg~ ~- .,
• In acidit1;on, CW-FNC. opposes the propo_s al t:o amena - .. *

                 ;t'b CFR ::20: :a:pd 10 _.CFR * ~5 , because. the. ~endments. w'ill result lri wicle~fpr~a:d 'mo:ri;fidity *a:nd moita.lity. as: -~
       . .       result* *o";f a_dc;ii:t:iona): .radiative;_ ,expos:qre*s of t~e                             . *-* .

genet~l --* pu.b.l::i.. c .. *As e*s_t1m~t ed

• oy .the . USN-RC; the "treatment* - - of . hyp¢rthyroidi_sm an,d thyr~id. cari'c:el also

              )~i.th -i. 3    -Ji                               o'o J nvo1v~s.. so~e'* 6 0; O pa~ient~ : an)1'1al:li -*
             . .These *patients may expose *a n~er o.f *fridi,vH;h~ais: tc:t th~_ max_im~ ".likeiy"

• 0 _;.5: ;rem dose , . ~hci° ~:n* fact (as . t *he

               -~111.e ~s wr:itten). exposure s may *wel,l: e?{ceed O. 5 .rem.-

Asswni-rig th?_ f

• each*- patient- *proyide s a total' p<;>pulatiori

              *: b.:u:t:-cien

• o:-f. ,o !'-S petson.- rem. -- w.h:tch' *may : be an.

ti-nde*r est*imate but a*ssume*s that *-tn,e pat-fent:' expo,se*s e~a*c tly bne.: pers_o n, '<s.uc*h as . a* ,.610s*e* fami),y mernberY to th~ '.maxiITiuin a:Ilo'.Wat?le dose b\it. exposes n"6 *o n~ e-1$e ~~-

                 ~_he* ~l- 3}::t dir~¢t' ~x~o~ure*s * .a-lo~~ :w9µ1d ptov.ide iQ , '0'00

..*. per_s_p11---rems e~posur,e. antni~lly~ ---*which c9r~e$pond$ to 23

                 - 24

• additional fatal ca.n cer.s caused- annually to' non..:

pa_ti"~nJ:s* from *_rad:ioibdirte* th_y.roid :~r*eatment=s .ai:"o~e *

                 -(ust*ng the estimate o.f 770 - SfO ex_Ct=SS cancer_S' .pe:r.

m_i11:ion person* tern _iri Table 4~2 *: at 172, 6£ BEIR VJ. or to 77 -8 0 ao~it1onai. -f~tal_ *cancers cp,u~~d *_.anQ.U~liy to non-'patie.n ts .from . radi oiodin~ treatments alorie -: Jus.ing . t he estfmatt= of 255-6~2664 ~xcess cancer*.s . p:er: million person ;r em 4"n Tab :ie* 1 ~9 .~t-: 1 72 cif Johij Goffman ***s 19~0 Radiation-Induced Ca~c~r from Low~Dose Exp6sure )~ *

• Th~se figui'es do not consid~r. :f!Ori~thyro i _ d treatment;s -,

do . not coris.ide*r sewe*rage* expostire."s i .

• ifnd d9 no~:.

consider nonfatal cancers oi; *.other mortalit*y*

           * **m9rbidi ~ y_ ~.                          .

or ..

                                                                                               . °(mor_e}
                                                                                                \  . .

l *

                                                                          ~ C ~: PA'l'IE~ RELEASE 3/3
                      * . As* . the* :*.p_ropQsed *rule * .. ~.ppe.ars ** to .* ;_iolate ...

fu'i'~dalllehtal *principa l s. of- * :justice , by unrecoveraQly- * * *

            .:exter.riali_z*ing the '. costs** ot-.. a speclal* *-irite-re-st_ .-,.gro1;ip * * *

• without the: corisenf- .of* the newly *_af"fl,icted ,poptila-fton, some n¢ntr-iy.i:a"l -nu.mber *of .wh*om :wouid *
• be . seriously .

I * * ** injure*d , pnys*Jc.a.I-ly* *: and also

• in. co:i 1_sequence financia l ly*, the Cl~an Water Fund -of North *carQlina opposes the abo*ve-t:eferenced. a.m.en(:lmen_t s ~ .. . .

                  *. * ,.- *e arl    Rupert,

• Ph . D;. * * *

                     . . Ral'e igh *Res*eaJ;"Ch Di'rec:t or                     .             .
              * . * ,

• The -Clean Water- Fund of No"rth -Caroli.na PO . Box- 1-0 o8 .* . : *. .

                .< .*       *Raieigh :*.NC*** 276.02           ** *
                                                                                      .  **t*
                                                                                                            ** * *

• I I
• DOCKET NUMBER PROPOSED RULE I

p :2 0 35 oocKETfO (sq FR 3071'/) USNRC BeaDDOllf William Beaumont Hospital Royal Oak *94 I\UG 30 p 4 :43 August 22, 1994 Secretary, U.S. Nuclear Regulatory Commission Washington, DC 20555 ATTN: Docketing and Service Branch

SUBJECT:

Comments on Proposed Rule 10 CFR Parts 20 and 35: Criteria for the Release of Patients Administered Radioactive Material A. I disagree with the proposed change in 10 CFR 3& to permit release of patients containing radioactive materials based on 500 millirem exposure to an individual from exposure to a released patient. The best way to resolve the conflict between 10 CFR 20 and 10 CFR 35 is to: (1) exclude 35.75 from 20.1301 and (2) leave

35. 75 unchanged. This is how the NRC handled the conflict in regulations initially after the revision of 10 CFR 20. This is the proper approach to balancing the needs of the patient, health costs, and regulatory concern for household members of radiation risk.

B. I strongly disagree with the proposed rule requiring that individual calculations be made and records maintained for NRC review for two reasons. ( 1) The burden of making multiple individual calculations and record keeping would increase heal th care costs. The NRC estimates the burden for this requirement will be 0.42 hour per patient. This estimate does not factor in additional time spent counselling patients and family members about their social calendars and engagements after discharge. The best suggestion for reducing this paperwork burden and associated health care cost is to remove this requirement entirely from the proposed rule. (2) The method suggested for determi ning the total effective dose equivalent is not scientifically valid on an individual to individual basis. This has been demonstrated in peer reviewed articles published in the medical journals. Actual patient measurements of dose equivalent have been reported in the literature that disagree with the calculations suggested by the NRC. That proves that the calculation method is not appropriate on a case by case basis. Furthermore, the calculation method served as the basis for the standard used for release of patients in 10 CFR Part 35. It is both unnecessary and unscientific to require a calculation of total dose equivalent to persons who come into contact with the released patient. 3601 West Thirteen Mile Road Royal Oak, Michigan 48073-6769 (313) 551-5000 Vt+I\ _Member ol Volunlary Hosp,1a1s 11 AmeriLa inc .

                                                                                                          .SEP , S 1994 eJ by carci ..........................." .....

S. 1 1 _.. v , *1 .ur,,r~110.;JiON D()_ * .;. ~ t:i ICE SECTION C *., c:- : ;f:. SECRETARY OF Tht. COMMISSlON Docurient ~tattstics

Comments on Proposed Rule 10 CFR Parts 20 and 35: Criteria for the Release of Patients Administered Radioactive Material Page 2

c. I disagree with the requirement that "written instructions" be provided to the patient. This is unnecessarily prescriptive and is not as effective as a performance based rule. The regulations in 35.315 (6) currently require that the patient be "provided radiation safety guidance that will help to keep radiation dose to household members and the public as low as reasonably achievable before authorizing release of t he patient". The proposed requirement in 35. 75 for "written instructions" is, therefore, redundant.

D. I strongly recommend that this proposed rule be abandoned for the simpler, more beneficial and cost effective approach mentioned above in this letter. Simply amend 10 CFR 20.1301 to exempt patients administered radioactive materials and released in accordance with 35.75. Sincerely, j I ;J,1---

~ ~ /~~

CHERYL CULVER SCHULTZ, M.S. 'b Radiation Safety Officer

DOCKET NUMBER Pl PROPOSED RULE ~ 3f HERBERT C . ALLEN . JR ., M D .. FACNM ( S o/FR :; 07 2 :..;I) 9269 KIRBY DRIV E HOUSTON, TEXAS 77 054 @

                                                                                                                                  ~

CONSULTATION BY APPOINTMENT

                                                                   ~~ 17                                            NUCLEA R MEDICINE 171 3 1 790 - 0540 August 29, 199 4 /___~/'*                         4 John Hoyle, Acting Secretary, US Nuclear Regulatory Commission
                                                              *-_;_*_r_._*

A;:c::994 DOCKETING & Washington, DC 20555 srnvteE BRANCH ,r-.......

                                                            ~                        secv-1-mc       ,.~,
                                                                                                  , ~. ":.. >

ATTN: Docketing and Service Branch '

                                                                           - ~. ....~-=~~
                                                                                        -{_; .:.~'/
                                                                   \
                                                                     ",._                          \, /

RE: Criteria for the release of patients administered radioactive material, Nuclear Regulatory Commission, Proposed Rule We thank NRC for providing us an opportunity to comment on the Proposed Rule, Federal Register/Vol 59, No.114/Wednesday, 6/15/94. As background for these comments, we would like to state that my group have been in the private practice of nuclear medicine since 1954. From September 1960 until 1987, we have practiced nuclear medicine on an outpatient basis funded from fees-for-services by private patients. There was no subsidy from medical schools, hospitals or governmental entities. During this period of time, we operated outpatient therapy for the treatment of thyroid cancer among other nuclear medical diagnostic studies and therapy, but primarily thyroid cancer. During this period of time, we treated over 450 thyroid cancer patients on an outpatient basis in a private office with confinement to the patient's home, in which the restricted area was designated the patient's bedroom and adjoining bathroom. These studies were done with the approval and authorization of the AEC in the early 1960's and renewed approval by the Texas Department of Health. We are in the process of preparing several publications of our experience on the outpatient treatment of thyroid cancer using greater than 30 mCi. We are making these comments with regard to 10CFR Parts 20 and 35. Our activity range has been from 50 to 400 mCi. Our average total integrated effective dose equivalent for 400 mCi using film badge dosimetry in the Exposure Model was 0.210 rem (see attachment). On the theoretical activity dose mathematical exposure model submitted both by NRC and TRCA, was 6.25 rem compared to actual measured patient/family exposure model of 0.210 rem which is 2.38 times less than the maximum permissible allowed for one year, 0.5 rem (see attachment). SEP 2 8 1994 k,'t.r10W eoged oy card ....... ...--~~*""'

     .NUCLEAR FE '*JLATORY COMMISSION DOCKETr~G & SERVICE SECTION OFF lCf: OF THE SECRETARY OF THE COMMISSION Document Statistics ark Date    f-L t_Cf fqL/

O>pies Received _ ___;/_ _ __ Arld'I (;on:es Reoroduced 3 Epec:2! D:stnbutio. fl.:r,'{)~ fJO!Z; ,

   ~ULl'\e..t   r!--4r

Page 2 U. S. Regulatory Commission Using the same mathematical exposure model with the actual measured patient data of 169 mCi (activity) with average thyroid uptake and effective half life, of 39 patients the total effective dose equivalent was 0.088 rem. Using exclusively the film badge dosimetry technique model with 169 mCi the total effective dose equivalent was 0.022 rem. It is our contention that this data probably indicates that 35.75 release of patients containing radiopharmaceuticals should be re-examined before the proposed rule changes are finalized. This would certainly reduce the increased burden on the licensee as well as reduce the paper load in accordance with the Paperwork Reduction Act of 1980. The data acquired over 3 decades on outpatient therapy of thyroid cancer with activity greater than 30 mCi (up to 400 mCi) is certainly in agreement and consistent with the NRC 1970 MEDICAL POLICY STATEMENT, particularly the third policy statement also supported by the first and second statements that this new scientific data indicates that NRC will have less pressure to attempt to regulate the medical uses of radioisotopes as long as the radiation safety of workers and the general public is at stake. It appears that the film badge dosimetry data supports this policy. With respect to the issues of compatibility for agreement states, radiation therapy using radiopharmaceuticals should not be a matter of compatibility concerning therapy. We do not believe that more governmental control is necessary. We are of the opinion that it is important for medicine to preserve the doctor/patient relationship and not have outside interference with the management and care of radioisotope patients and should be free of intrusion, just as long as the health and safety of the occupational worker (health care staff) or the public are safe from radiation and the regulations are not exceeded. Because of the time constraints of the private practice of nuclear medicine, we hope we can make further comments on the proposed changes. We are hoping the Regulatory Flexibility Act of 1980 will permit us to do so. Sincerely, ~~'~r~o Herbert C. Allen, Jr., M.D., FACNM Member-American College of Nuclear Medicine HCA:mb enc.

Page 3 U. S. Regulatory Cbnmi.ssion RE: Criteria for release of pa.tients adrn,inistered radioactive material , NRC , Proposed Rule Comparison TBRC/NRC Theoretic Exposure Model Versus Actual Patient/Family Exposure TBRC/NRC Theoretical Actual Patient/Family "Exposure Model" "Exposure Model"

                                                       = 1.44(E.R.)(%
         *400 mCi

• 400 mCi

        **33% uptake

• 6.2% uptake 88 mrem/hr 88 mrem/hr

       **6.25 d

• 1.1 d

                   *** 6.25 rem                        .. 0.210 rem

• Texas Board Health letter 10/21/1993

         ** NCRP Report #37
        *** TBRC/USNRC 30 X's greater than actual Patient Family "Exposure Model" (0.21 O rem)

• Mean values 73 patients

         ** 2.38 X's less than maximum permissible allowed for 1 year (0.5 rem)

Herbert C. Allen, Jr . , M. DJ. 9269 Kirby Drive lbuston, Texas 77054

Page 4

u. S. Regulatory Cbrnnission RE : Criteria for release of patients administered radioactive material, NRC Proposed Rule Patient's Family/Public Outpatient Radiation Exposure From Greater Tan 30 mCi lodine-131 E.R. = mCi X r

{d)2 TBRC/N RC Theoretical Actual Patient/Family "Exposure Model" "Exposure Model"

                      = 1.44(E.R.)(%                       .44(E.R.)(%

• 400 mCi 169 mCi

           ** 33% uptake                                               6.2% uptake ilmBad 88 mrem/hr                   osimet                      37.2 mrem/hr
           ** 6.25 d                       "Model"                     1.1 d
                    *** 6.25 rem               169 mCi       0.088 rem
                                       .. 0.022 rem (0-0.130 rem) range

• Texas Board Health letter 10/21/1993

             ** NCRP Report #37
            *** TBRC/USNRC 284 X's greater than actual Patient Family "Exposure Film Badge Model" (0.022 rem)

• Mean values 73 patients

            ** 22.7 X's less than maximum permissible allowed for 1 year (0.5 rem)

Gold Standard lntergrated Dose Herbert C. Allen, Jr. , M. D. 9269 Kirby Dr. l:buston. Texas 77054

HERBERT C ALLEN JR M D FACNM 9269 KIRBY DRIVE HOUSTON, TEXAS 77054 CONSULTATION BY APPOINTMENT (7131 790 05 0 NUCLEAR Mco,c,Nc Fax Transmittal sheet DATE: 8-29-94 l-bnday, 7 PM CDT TO: John C. Hoyle, Acting Secretary, NRC FAX # 301-504-1672 FROM: Herbert C. Allen, Jr, M.D. 713 PHONE# 790-0540 FAXi 13 790-0542 NUMBER OF PAGES 5 (including cove_r_s'h_e_e---,t.- .--)____ 8-30-94 A'ITN: Kris Cater: In accordance with my conversation with Kris Cater today, enclosed is original copy that was faxed 8-29-94. Kris asked rre to . note that the FAX was sent 8-29-94 so that she v.Duld not redocket

• it.

                                                 '!hank you.

Marge

DOCKET NUMBER 2 .-- PROPOSED RULE PR cJ_t)1*0 j oo cr, ETE ( H Fl!. 3 01.:2 ~ US RL Mayo Clinic Rochester, Minnesota 55905 Radiation Safety Telephone 507 284-3332 August 23, 1994 Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, DC 20555 Attn. : Docketing and Service Branch

Reference:

Proposed Rule, Criteria for the Release of Patients Administered Radioactive Material We appreciate this opportunity to comment on the proposed rule regarding the criteria for release of patients who have been administered radioactive material. Mayo Foundation does not support the proposed rule on the criteria for release of patients, changing the current 5 mR/h@ 1 meter or 30 millicuries (10CFR35.75) to a calculational methodology determining the total exposure to the maximally exposed individual. A review of the literature will reveal that current practice for release of patients do not result in individual members of the public receiving more than 100 mrem from exposure to a single patient. The additional requirements will not decrease doses further, but only adds to the cost of treatment. The assumption that dose to members of the population from a patient containing radioactive materials can be calculated with any accuracy or precision is false considering the uncertainty associated with the movement of treated patients and the time they spend near members of the public including family members. This rule increases regulatory requirements without a concomitant increase in safety; therefore, the costs outweigh any benefit, perceived or real. We suggest that the current rule is adequate and that the proposed rule be withdrawn. Sincerely, Claire E . Bend r, MD Chair, Radiation Safety Committee SEP 2 8 1994 Aunov llldged by card ...- "... ... _..

U.S. NUCLEAR REGULATORY COMMISSION DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION DoCllnent Statistics Postmffl Date --.a<i'___-__,2_

                              . ~-_ q--'--4....__
                                            =

Coples Received _ _...L..-::=--- - - Add'I Copies Reproduced ~ ,c__-.---_ __,_,_ Special Oislrtt>ution-=~=====-.5-

DOCKET NUMBER PROPOSED RULE PR ~ lJ I DOC ETE~ us ~ C51 r::e -3o 1--2 1) I

                                                                                   *94 ~UG 29 p 4 :10 August 29, 1994 Secretary Samuel Chilk Attention: Docketing and Service Branch U.S. Nuclear Regulatory Commission Washington, DC 20555

Dear Secretary Chilk:

On behalf of the over 29,000 physician and physicist members which comprise the American College of Radiology, I respectfully submit the following comments on the NRC's proposed rule on the Criteria and Release of Patients Administered Radioactive Material (59 CFR 30724). The ACR commends the efforts of the NRC to make the release standard both more logical and reasonable. The proposed changes make more sense in basing the release of patients on the dose that might be received rather than the activity remaining in the patient. In addition, the ACR commends the NRC for declaring that patient release criteria be governed under 10 CFR 35.75 rather than 10 CFR 20.1301(a). The ACR is concerned, however, that the draft regulatory guide (DG-8015) is not complete and does not provide sufficient comprehensive examples to assist licensees in complying with the rule. Some questions have arisen as a result of the wording in the regulatory guide which may deviate from what is currently being practiced. Questions involving length and immediacy of possible confinement need to be more fully addressed. The ACR would like to have the opportunity to further comment and improve the regulatory guide and assist the NRC, where appropriate, in helping licensees receive information pertinent to implementation of the regulations . While the ACR applauds this new approach and clarification of the governing regulation, the proposed rule does raise other concerns. For instance, the calculations required by changes in the proposed rule are often complex, and a licensee's interpretation may result in calculation errors or calculation discrepancies which could lead to violations of the rule. The ACR hopes that further clarification will be made to assist licensees with these calculations. In addition, the ACR hopes that inspectors will be sensitive to calculation discrepancies which may occur as a result of the proposed rule. Conscientious attempts by licensees to comply with this rule should not be considered a violation if an inspector holds to another method of calculation. AMERICAN COLLEGE 0 F RADIOLOGY 1891 Preston White Drive, Reston, Virginia 22091 (703) 648-8900

U.S. NUCLEAR EGULATC, ,::: DOCKETING & C I OFFICE OFT  ; 0 THE ,S

 = - -- - - - --=- -

The ACR is also concerned that the NRC's quest to provide uniform regulations in this area may take away discretion from physicians and may lead to cases where patients are either improperly held too long or released too early. Because of the implications of retaining patients that may otherwise, in the judgment of the physician, benefit from leaving the hospital (e.g. cost of confinement, care and convenience to the patient, etc.) and the inherent harm of not retaining patients that institutions may have otherwise retained but for the result of the calculation, it is critical that the NRC not hold too strictly to methods of calculation. The decision as to whether the patient should be confined is ultimately a physician-based decision and should not be solely based on a method of calculation. Physicians must be able to maintain discretion on decisions which ultimately affect their patients. - The ACR appreciates the NRC's efforts to clarify and improve this rule and hopes that the NRC will address the ACR's concerns to improve the rule further . Sincerely, f&_JJ,gtisf Bradley W. Short Assistant Director Government Relations

DOCKET NUMBER PR ;z_o 1 3 ~ PROPOSED RULE _ (_ sq F/2 3 () 1.:z.V 111 ., August 29, 1994 AMERICAN SOCIETY OF HOSPITAL PHARMACISTS Pharmacists in health systems helping people make the best use of medications

                                                                                                         *94 AUG 29 P 3 :18 OF FICE C: ~ - v;{[T:, 2 Y DO CKET\\*: : - ~r *:* ,_

John C. Hoyle Deliver to: 8k: t ,'I Acting Secretary U.S. Nuclear Regulatory Commission 11555 Rockville Pike Washington, DC 20555 Rockville, MD Attn: Docketing and Service Branch RE: 10 CFR Parts 20 and 35: RIN 3150-AE41: Proposed Rule. Criteria for the Release of Patients Administered Radioactive Material. Mr. Secretary: The American Society of Hospital Pharmacists (ASHP) is pleased to submit comments on the Nuclear Regulatory Commission's proposed rule, Criteria for the Release of Patients Administered Radioactive Material. ASHP is the 30,000-member national professional association that represents pharmacists who practice in health-systems, including hospitals, HMOs, long-term-care facilities, and home care agencies. Included in our membership is a significant representation of those individuals involved in nuclear pharmacy practice; and, it is on comments received from those individuals, that ASHP has based this submission. ASHP concurs with the opinion of the Commission, as well as the majority of other interested parties, in supporting the proposed revisions to 10 CFR 20.130l(a)(l) and (a)(2)to place them in accordance with 10 CFR 35.75 as related to the criteria for patient release (i.e., a dose limit of 5 millisieverts (0.5 rem) total effective dose equivalent in a year). Further, ASHP supports the Commission's view that written instructions should be provided to the patient by the licensee on how to maintain doses to other individuals "as low as reasonably achievable" (10 CFR 35.75 (b)(l); proposed). However, ASHP members commented that current requirements under 10 CFR 35.3 l 5(a)(6) and 35.415(a)(5) seem adequate in most situations. Therefore, while ASHP supports the Commission's intent to help patients follow appropriate safety measures for themselves and those with whom they may come in contact, we believe that such regulations regarding patient instruction should, in the end, defer to the professional judgment of the physician, nuclear pharmacist and/or other qualified provider. As acknowledged in the Federal Register notice, "not all [precautions] are necessary for every patient; therefore patients should be given specific instructions that are applicable to their situation." ASHP believes this approach should prevail in any subsequent Commission deliberations on this subject. ASHP appreciates the opportunity to provide these comments, and we look forward to future opportunities to work cooperatively with the Commission. If you have any questions regarding our comments, or if we can be of further assistance, please do not hesitate to contact us. Sincerely, ([J_~~~ D. Lance King, R.Ph. Government Affairs Associate N:\WP\NRC\CMT0829.0l \dlk 7272 WISCONSIN AVENUE BETHESDA, MD 20814 301-657-3000 FAX : 301 - 652- 8278

s. , 2 1994 AcKnowledged by card ...................................

U.S. NUCLEAR REGULATORY COMMISSION DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION DoaJment Statistics Postmar1< Date H-J)  ?- ::A-4Lj Co~es Rece*ved ~ ---- Add'I Cornes H - *rvl~ Special O1st;ibut10, _ __ _

DOCKET NUMBER PROPOSED RULE PR m, 3 o Richard J. Hammes, MS, RPh, BCNP CS-9 F/(_,301;c~OCKETED Chairman, Section on Nuclear Pharmacy American Pharmaceutical Association

                                  . US C             Senior Clinical Nuclear Pharmacist Assoc. Clin. Professor of Pharmacy

• AUG 29 p 4 :13 University of Wisconsin Hospital 94 Radiology Dept. Rm. E3/311 600 Highland A venue OfFICt. OF SECRETAR'Madison, WI 53792-3252 oocKETI 'G & SERVICE Secretary RAH CH U.S. Nuclear Regulatory Commission Washington, DC 20555 Attention: Docketing and Service Branch Mr. Secretary:

This is in response to the proposed rule changes of 10 CFR Parts 20 and 35; RIN3150-AE41, Criteria for the Release of Patients Administered Radioactive Material. My initial reaction to the proposed rule changes was very negative. However, after receiving and reviewing the associated Reg. Guide and NUREG, I find the proposal much more reasonable. The latter documents are very well done and useful and will facilitate the implementation of the proposed changes. I still wonder if the gain in overall safety is worth the cost of implementing these changes. The proposed two action levels (0.5 Rem and 0.1 Rem) make the whole process unnecessarily confusing. If 0.5 Rem is acceptably safe, why have the 0.1 Rem level with all of the associated documentation required? I also do not believe that the requirement for 'written' instructions should be carved in stone. For some patients written instructions would be meaningless (blind or illiterate) or medically contraindicated (psychotic or paranoid). Some discretion should be left to the physician in terms of the appropriate level and format of ALARA instruction. I recommend discarding the 0.1 Rem action level and the requirement for 'written' instructions. Appropriate radiation safety instruction of some format should be provided in all cases of radiation therapy, hence the regs would be simplified considerably with a corresponding decrease in paperwork, if the 0.1 Rem level was eliminated and the format unspecified. RichardJ.Ifammes August 25, 1994 SEP 2 8 1994 A *no l d ed by card .........................-

U.S. NUCLEAR REGULATORY COMMISSION DOCKETING & SERVICE SECTION OFFICE Of THE SECRETARY OF THE COMMISSION Document Statistics PostmmDate g1-;;;_i - 1+ Coples eceived _ _ _ r _ _ __ Add'I Co . s Flei, :Jet'O -<--- - - Speci Dis .bulioo: 5 ~ ; \ J

J.~. NUCLEAR REGULATORY COMMISSION DOCKETING & SERVICE SECTION OFFICE OF THE SECRET ARY OF THE COMMISSION Document Statistics Postmarl< Date  ? ~ .?- Copies Received _ __;_/_ _ _ __ 7- - q + Add'I Copies Reprod! ~ . ' _ Special Distribution ~ --

DOC <~T NUMBER PROPOSED RULE PR e::l.O} '3~ DOCKETED C_5 9 A2_ .:3iJ 1-.2. 1) us~ PC

                                                                             *94 AUG 29 P3 :20 26 August, 1994                                                            OFFICE Cr .:t.* R~ 1/\RY OOCKE- - Tm*JG* u.V "- f '"r-

{'["f' 1, BRA 'Crl Secretary United States Nuclear Regulatory Commission Washington, DC 20555. Attention: Docketing and Service Branch. Regarding: Criteria for Release of Patients following the administration of radioactive materials.

Dear Secretary:

We are writing regarding the proposed change in the rules for patients leaving the hospital following the administration of radioisotopes for medical therapy (10 CFR Part 20 and 35). We strongly recommend that the proposed rule mandating estimating the doses to the patient's family members and other exposed persons prior to discharge not be implemented as it is stated. Currently we discuss radiation safety precautions extensively with therapy patients prior to discharge to educate them regarding the radiation exposure others will receive and recommend procedures to keep the dose to others as low as possible. These recommendations are made for each patient individually and take into account such domestic items as the age and pregnancy status of possible exposed individuals, their travel arrangements, employment and living situation post discharge. We feel it is better to recommend methods to decrease the radiation exposure to others rather than to propose dose estimations. The dose estimates to the public would be very inaccurate as they are based on the unreliable method of predicting the anticipated time and proximity to others. In addition the estimates and subsequent record keeping will be time consuming and add to the costs of treatments with probably no significant decrease in radiation exposure. The only definite consequence will be heightened public concern and paranoia. To require dose calculation and written instructions to each patient of the likely exposure to others will cause more anxiety and be detrimental to the public good by impeding the use of Iodine-131 in the treatment of thyroid overactivity and thyroid cancer. Radioiodine therapy for thyroid diseases has spared patients the hazard of surgical thyroidectomy with it~ incidence of approximately 1% vocal cord paralysis, 1% hypoparathyroidism and 0.01 % mortality. Any action which reduces the use of radioiodine in favor of surgery by generating unnecessary anxiety can be confidently expected to be harmful to the public health. We feel that the radiation dose to family members and the general population is low and below the level of any significant risk particularly when patients and family members are SEP 2 8 1994. Ackno card *******-***--***..........H.,1n

U.S. NUCLEAR REGULATORY COMMISSION DOCKETING & SERVICE SECTION OFFICE Of THE SECRETARY OF THE COMMISSION Document Statistics J'-C:Z{p-9'¥-

Secretary 8/26/94 Page - 2 educated appropriately. Studies in the literature confirm that the families and the general public have low radiation exposures following therapy. Discussions with patients at follow-up visits also confirm that they are able to carry out the recommendations to decrease exposure to others. It is more important to individualize the recommendations to the patient to be followed after discharge than to have inflexible rules applying to everyone. If any change is needed at all it is to encourage consistent and accurate discussion with the patient and family members in an effort to reduce the family's exposure rather than to use inaccurate dose prediction models. The authorized user physician should be able to conduct his/her practice regarding the release of therapy patients in such a way as to confidently assure the public and family of patients that they are not exposed to more than 500 mrem from an administration of a radiopharmaceutical procedure. The use of the 30 mCi (1-131) or 5 mrem/hr at one meter rule regarding discharge of patients after radioisotope therapy is working well and the proposal to require dosimetry for each patient will not provide any additional safety benefit to the public but would rather increase the cost of treating these patients. Sincerely, ~llJi~ ~rego{y "1. Wiseman M.D. Division of Nuclear Medicine Mayo Clinic

~~

Brian P. ullan M.D. Division of Nuclear Medicine ~ t~

• Colum A. Gorm M.D.

Division of End crinology Mayo Clinic

'*. OCKET NUMBF.R PR ,,:l..D 1 J.:; 90POSED RUU: - BIALLINCKRODT (St?~ '301-5l-'+)

   -        Nuclear Medicine                    DOUc;,r.~~~D
                                             '94 AUG 29 P3 :18 Mallinckrodt Medical, Inc.

August 26, 1994 OFF,C. Cf =. q[T/ RY NMA Medical Physics Consultation DOCKETl~1G & _ 1 ... E 9457 Midv.rest Avenue 8RANCI Garfield Heights, Ohio 44125 Telephone (216) 663-7000 Secretary Facsimile (216) 663-6234 U.S.Nuclear Regulatory Commission Washington, DC 20555 Attn: Docketing and Service Branch Re: Comments on Criteria for the release of patients administered radioactive material - CFR Vol. 59, No.114, pp. 30724.

Dear Secretary,

We view the proposed regulations favorably for the following reasons: I. A dose-based regulation is more applicable with a greater degree of accuracy than an activity-based regulation. While an activity-based regulation is easier to use, it does not apply to all radiopharmaceuticals. Hospital stays with some radiopharmaceuticals will be extended. However, most would be reduced. Even 1-131 is slightly relaxed with these new calculations. It will also address some of the new therapies in a more appropriate manner. All of this will ultimately result in reduced costs of medical care.

2. A change from an exposure limit to members of the general public of 100 mrems to 500 mrems is appropriate in these cases, because these exposures are calculated at 1 meter distance, and the likelihood of anyone maintaining this distance, or less, is remote. Therefore, a 500 mrem limit calculated at 1 meter will be no greater than 100 mrems in actuality. Further, the exposure will be primarily to "members of the family" which take on a little different set of circumstances than "members of the general public". Members of the patients family should be more aware, and perhaps be more willing to accept a greater radiation burden than should members of the general public, for the sake of the psychological improvement of the patient which may be equally as important as their medical improvement.

SUGGESTION: In the case of multiple administrations, clarify if the licensee must track and keep records of all administrations, or just administrations resulting in exposures greater than 100 mrems. See Item 1.4 of DG-8015 . SEP 2 8 1994 Acknowleaged by card ..................'"..."'"""'

                                    ,e U.S. NUCLEAR REGULATORY C0MMISSIO1"'

DOCKETING & SERVICE SECTION OFFICE Of THE SECRETARY OF THE COMMISSION Document Statistics Postmm Date .(J;

            ; . _t25

_~- - - -

3. The ability to incorporate into the calculations some flexibility regarding the issue of "confinement" is a welcome concept. This allows for case-specific situations such as the elderly, the person who lives alone, etc. In practical terms, it allows the definition of "confinement" to extend to the concept of confinement in a private residence. This will also result in reduced costs of medical care. Further, it will reduce exposures to hospital personnel who are likely to be closer to child- bearing age than members of the patient's family.

SUGGESTION: Program should be flexible enough to allow for a greater fraction reduction than from 0.25 to 0.125 in the event of total isolation at home. It isn't clear in the regulatio n if other considerations are allowed.

4. The publication of a Regulatory Guide is mandatory. This guide should include:

standardized calculation, tables of acceptable release activities that are radiopharmaceutical specific, and examples of written instructions. SUGGESTION: Tables of acceptable release activities as seen in Table 2 of the Draft Regulatory Guide (DG-8015) should be expanded to include common beta-emitters (P-32 and Sr-89) and, in order to assist Agreement States, accelerator/cyclotron-prod uced radiopharmaceuticals. Further, the examples of written instructions should include parameters to be used in calculating times of the various instructions (how long to stop breast-feeding and how to calculate it, days to avoid public transportation, etc .) as well as examples. In summary,while 10CFR35.75 as we currently know it, is an easier regulation to apply and enforce, the changes introduced in this proposed change wou ld be more universally applicable and more accurately applied to all radionuclides. We feel that the suggestions described above would make the new regulation more under-standable by licensees and easier to apply. Sincerely, ~7 NMA Medical Physics Consultation P/Convnenta.NRC

                  .                      DOCKET NUMBER                             *-,                                     ~

_ _ 1_2_00_1_9t_h -~_!_e{_~;-~:_3_.~_1!_f_il _~_Lo_E*-p~-

                                                                      ' tri
                                                                         ~-~cc                                                                                ,q-+c-~++-flD
                                                                                          '__.c_. 2

_0_03_6-_ 24_0_ 1 _@rn~ American (202) 429-5120 US. °C Fax (202) 223-4579 The Society College of of Nuclear Nuclear *94 AUG 29 PS :17 Medicine Physicians August 25, 1994 Samuel J. Chilk, Secretary Attn: Docketing and Service Branch U.S. Nuclear Regulatory Commission Washington, DC 20555 RE: Criteria for the Release of Patients Administered Radioactive Material, R1N 3150-AE41, 59 FR 30724-30732, June 15, 1994, and attached analysis and regulatory guidance.

Dear Secretary Chilk:

The American College of Nuclear Physicians (ACNP) and the Society of Nuclear Medicine (SNM) 1 are pleased to provide comments on the proposed rule that would change the current criteria from activity based to absorbed dose based levels. We agree with this change but disagree strongly with the additional requirements NRC feels are necessary to achieve this goal. We would like to take this opportunity to provide information that we feel would strengthen this rulemaking. The enclosed comments include both the proposed rule and accompanying regulatory guide and analysis. Since its publication in 1970, the Nuclear Medicine community in many Agreement State programs has relied on National Council on Radiation Protection and Measurements report (NCRP) no. 37 to evaluate appropriate action necessary for the release of a patient being exposed to radioactive material. We thus have decades of experience using the guidance ofNCRP no. 37, unencumbered by any paperwork burden at all, with no evidence that a lack of paperwork has resulted in any additional problems. Since 1936, when Nuclear Medicine began performing therapy, there is no documented evidence of problems involving members of the public in this area. We are pleased to see that NRC is willing to change its regulation in this area based on the principles of NCRP no.37. Unfortunately, NRC has added extra calculations that are not medically sound, additional paperwork, and an extra requirement for estimated anticipated exposures in the 100-500 mrem range. This is inconsistent with NCRP no. 37, other NCRP, International Commission on Radiological Protetion (ICRP) and International Atomic Energy Agency (IAEA) guidance, and even the intent of the current 10 CFRpart 20. This extra requirement is not scientifically valid and needs to be removed along with the majority of paperwork and calculation burdens. The following comments detail other concerns we have regarding this rule. I. Patient Confinement ACNP and SNM are concerned about restrictions that are placed on the licensee regarding patient confinement. The requirement that "although licensee control does not necessarily restrict a patient to a hospital, the location of the patient must be listed as a place of use on the license or a license amendment must be issued pursuant to ACNP and SNM are composed of over 15,000 nuclear medicine physicians, nuclear pharmacists, nuclear medicine scientists, and nuclear medicine technologists involved in the delivery of essential health care.

                                                                               ._ . ,                       SEP 2 8 1994 Ach'1uW ged by card ...............- ...

U.S. NUCLEAR REGULATORY COMMISSION DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmark Datg /+ l---"'~-1,/-30

               --~J)
                                --+,-/91 copies Reef , __ _

Add'! Co,.. 1

r. : ,-c -¥

                          - --"-I-- - , - -

Patient Release Criteria Comments August 25, 1994 Page2 10 CFR 35.32 (e)," is impractical in a medical setting. This should be removed. A patient can walk out of the hospital any time he/she wants even with several hundred mCi ofNaI-131 still inside his/her body because the risk to a member of the general public is not significant. In fact, it is illegal in all states to forcibly prevent such a patient from leaving if he/she wishes to. It is impossible for the physician to predict or confine the patient's whereabouts. The physician has the responsibility to advise the patient of steps necessary to prevent unnecessary exposures to members of the public. It is inherent in the practice of medicine that a physician evaluates how to approach recommendations for hospital confinement vs. confinement at another place. This is physician judgment and not within NRC's jurisdiction. Clearly this NRC intrusion goes beyond the mandate of the Atomic Energy Act, Section I 04, and would appear to allow the NRC to evaluate a medical decision made by a qualified physician, despite the fact that no significant harm exists for members of the general public. This part of the rulemaking should be removed. II. Scientific and Medical Errors ACNP and SNM are also concerned that calculations and radiopharmacokinetic analysis in the regulatory guide are incorrect and do not represent the mathematics of biexponential biological functions. This material needs to be corrected in the regulatory guide. These errors appear to have occurred because of inadequate review of this rule by management competent in mathematics and health physics with help from qualified physicians. As we understand it, the idea of using the methodology ofNCRP no. 37 for a 500-mrem limit is wholly supported by the ACMUI, but the advisory committee never reviewed any other portions of this rule before it was published in the Federal Register. We would recommend that closer consultation with the ACMUI on the final language of this rule would help to rectify some of the scientific and medical errors in the rule and accompanying regulatory guide. Members of ACNP and SNM have also found miscalculations in the regulatory guide. We would like to refer you to comments submitted by Carol S. Marcus, M.D., Ph.D. who is currently the Vice President of the Society of Nuclear Medicine and the American College of Nuclear Physicians Government Affairs Chair for regulatory issues. Based upon Dr. Marcus' comments and asswning most conservatively that the effective half life of 1-131 for hyperthyroid patients is as long as that assumed for thyroid cancer patients (normal effective half life), we would like to add the following calculation for the treatment with 1-1 31 of patients with hyperthyroidism: D1(..)* 0.25 tpom = [13.9(F) + 0.73(1-F)] (mCi admin.) mrad F= Fraction Thyroid Uptake Example: F= 0.55 D1(..>* 0.25 tpom = (7.63 + 0.33)(mCi admin.) mrad

                             = 8.0 (mCi admin.) mrad

Patient Release Criteria Comments August 25, 1994 Page 3 III. Interference with the Practice of Medicine The NRC in this Federal Register notice points out that the Proposed Rule is consistent with the Medical Policy Statement of 1979. We believe this Proposed Rule is not consistent with the third statement of the Policy; this rule very much interferes with the practice of medicine. We are also concerned about the implications of NRC's definition of a member of the general public. It is our opinion that a member of the patient's family or an individual with whom the patient shares a domicile is not a "member of the general public. 11 He/she is a "member of a specific public, 11 and part of the medical entity that has the patient as its focus but includes certain others. For example, a father who holds down his screaming child for an x-ray of the child's broken leg and in doing so receives some radiation from the x-ray machine, is different from a member of the general public, or a radiation worker. We strongly recommend that NRC make this distinction similar to that in 10 CFR 35.315 (a)(6) and 10 CFR 35.415 (a)(5). Here it clearly states "household members and the public. 11 Dictating to a physician how and what he/she must tell a patient is not the purview, mandate, or competence of NRC, and interferes with an essential portion of medical practice, which is communication between physician and patient. This is different for every patient and every physician. The NRC is incorrect when it states that "In fact, written instructions are already required under 10 CFR 35.315 (a)(6) and 35.415 (a) (5)." Written instructions to patients were not required by these rules, which require the licensee "to provide the patient with radiation safety guidance that will help keep radiation doses to household members and the public as low as reasonably achievable.11 These rules were written precisely to include the choice of verbal instructions, in part for patients who do not read English or who are illiterate. IV. Paperwork burdens and costs e This rulemaking appears to have an inordinately large and burdensome paperwork requirement accompanying it It would require detailed calculations and explanations by the physician on the release of every patient. The current requirements under the practice of medicine sufficiently cover this area. Additional paperwork with no medical value should not be added to this rule. This additional paperwork will interfere with the physician's interaction with patients and increase the inspection fees charged by the NRC. V. Economic Impact In the Regulatory Analysis the NRC has chosen "$33" for the cost per patient for these requirements. Once the uptake and effective half-life are known, NRC appears to have assumed a 15-minute calculation at NRC's

 $133/hr rate. NRC should have included what it costs to obtain uptake and effective half-life numbers to begin with, especially since they are not done in cancer therapy patients and often done only occasionally in hyperthyroid patients. These measurements, generally not being medically necessary, are all extra costs of this rule. We have not added costs of searching for and documenting previous doses to the same patient that year, or to the same member of the public from a different patient. We have included the cost of inspecting these calculations in APPENDIX 1.

Patient Release Criteria Comments August 25, 1994 Page4 Another compelling reason to remove this paperwork is the huge unreimbursable cost. As the physician and technologist would often be present when the inspector inspects the calculations, we have to consider adding at minimum, another $173 for many individual cases. Those who pay for healthcare will put great pressure on physicians to optimize calculations and reduce inpatient days. This burden will cause many physicians to stop offering Nal-131 therapy procedures and force patients to travel to large medical centers in cities, for the most part. In addition, this will cause problems with patient access, especially in sparsely populated areas and does not promote health and safety. VI. Agreement State Compatibility ACNP and SNM support the Agreement State request that this rule should not be listed as a matter of compatibility. Many Agreement States already have superior programs in place that maintain an adequate level of safety for members of the public, without generating additional expenses for Nuclear Medicine facilities. VII. CONCLUSIONS AND RECOMMENDATIONS Although ACNP and SNM agree in principle with a portion of this rule, and appreciate that NRC recognized the benefit a dose-based level will provide, there are still many flaws with this rulemaking. Additional paperwork and costs only hinder the ability of a physician to practice Nuclear Medicine. We would like to suggest alternative regulatory language that will achieve the same result and lower the burden on all concerned parties. In addition, there will be no compromise of the level of safety to either the patient, a member of the household, or the general public. Alternative regulatory language: Authorized user physicians should conduct their practices in such a way as to give a high level ofassurance that uninvolved members of the general public cannot receive more than 500 mrem from a radiopharmaceutical procedure or a brachytherapy implant. Involved members ofthe public, such as those who share a household with the patient and those who help care for the patient, should not receive more than 500 mrem, either. The licensee should provide the patient or other responsible party with radiation safety guidance that will help to keep radiation dose to involved and uninvolved members ofthe public as low as reasonably achievable. " 10 CFR Parts 35.75, 35.315, and 35.415 would be rescinded. We would thus have a medical practice performance standard, without additional and unnecessary prescriptive regulation. A Regulatory Guide containing useful information for calculation of likely radiation absorbed doses would be of value. There would not be any requirement for individual calculations, or complex paper trails. We will decrease the cost of these procedures by decreasing inpatient costs. We will not increase healthcare costs.

Patient Release Criteria Comments August 25, 1994 Page 5 ACNP and SNM would like to offer its medical expertise to the NRC in revising this rule. If you have any additional questions feel free to contact Mr. David Nichols in our Washington Office at (202) 429-5120. Thank you for your consideration of these comments. W:ot._~- ~81 William H. McCartney, M.D. Sincerely, James J. Conway, M.D. President President American College of Nuclear Physicians Society of Nuclear Medicine

APPENDIX 1 For Each Patient: Secretary/receptionist: 4 visits, 7 1/2 min/visit for checking identification, financial/insurance status and forms, checking old records, lining up charts. Scheduling of patients for 4 visits, typing results for computer report, copying and filing, 30 min/pt. Technologist: RAJU day 0, 1,2,3, 30 min. each. Semilogarithmic plot of data, 30 min. Calculations from graph, check them, 30 min. Physician: Checks technologist calculations, 15 min. Makes member of the public dosimetry calculations, checks them, makes patient-specific paper trail which includes the technologist's work as input data, sees to it that copies are made for inspection purposes; 45 min. (This is too complex for technologists to perform.) Patient: If lives nearby, 1 day and 3 half days off work. If lives far away, 5 days off work (1 to treat, 4 days for measurements.) I have not included hotel or meals if out of town. Inspector: 1 hr. per calculation. COSTS Secretary/receptionist: 1 hr x $20/hr (incl. overhead) = $ 20 Technologist: 3 hrs x $40/hr (incl. overhead) = 120 Physician: 1 hr x $133/hr (underestimate) = 133 Patient: @ $60/day, $150-$300; use 10% for the 5 days and 90% for 2 1/2 days Inspector: 1 hr@ $133/hr = 133

                                                                                   $556-706; with weighted patient day cost this comes to:                                  $571 For NRC's number of 62,000 pts/y, this is $35.4 million, not $2.1 million. Considering the fact that many Agreement States cite NCRP no. 37 and have no extra paperwork and no problems, this is $35.4 million that is not currently present in Nuclear Medicine facilities. NRC's actual costs will approximately double the cost of the procedure, not counting hospital inpatient days.

DOCKET NUMBER IJROPOSEO RULE ft ;:!_{J I ~ OOtfif;f {Sq ;-;l 36 po 3-1-~~ityofCincinnati 20 N\ University of Cincinnati Radiation Safety Office

                         *94 ~UG 29 P3 :17                                       Radiation Safety Lab 231 Bethesda Avenue Cincinnati, Ohio 45267-0591 Phone: (513) 558-4110 Fax:    (513) 558-9905 August 25, 1994 Samuel Chilk, Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555 Attn: Docketing and Service Branch Re:        Criteria for the Release of Patients Administered Radioactive Material, RIN 3150-AE41, FR59(114) :30724-30732, 1994 (15 June)

Mr. Chilk: On Wednesday June 15, 1994, the NRC published (Federal Register, Vol 59., no. 114) a proposed rule entitled "Criteria for the Release of Patients Administered Radioactive Material". In conjunction with the proposed rule, the NRC also has published the following two draft reports for comment: 1) Task DG-8015, "Release of Patients Administered Radioactive Materials" and 2) NUREG -1492, "Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material 11

• The University of Cincinnati is deeply concerned with the adverse effects the proposed rule will have on health care practices and costs. Cost effectiveness and cost reduction in health care is a national mandate. Yet the NRC rule, without reducing overall radiation exposure to the U.S. population, proposes to increase the cost of health care through increased documentation and record keep ing requirements.

In NUREG -1492, the U.S. NRC concluded the proposed rule will result in a 11 decrease in national health care cost of $30,000,000 per year". The NRC indicated the cost saving is mainly from the decrease in hospitalization time for thyroid cancer patients who are being treated with I-131. The University of Cincinnati agrees that increased hospitalization results in increased health care cost and that the cost includes both direct health care costs, due to the costs associated with the housing the patient in a hospital room, and indirect costs, due to loss of work by the patient. However, the data used by the NRC to conclude that the proposed rule will result in decreased hospitalization time i s inaccurate. The current regulation, 10 CFR 35.75, allows for patients to be Patient Care

• Education
• Research
• Community Service An affirmative action/equal opportunity institution SEP 2 8 1994

             ~    :_ )_ ,OH'r COMMISSION
     ~ _1CK ETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmarl( Date Fe-cL      Y: - , f ' :Z. (;,

• 1L/

Copies Received / Add'I Copies Reproduced --=

                           ..3:;...__ __

Special Distribution :5uAd. I d £.h )

released if the "measured dose rate from the patient is less than 5 millirem per hour at a distance of one meter; or the activity in the patient's body is less than 30 millicuries". In Task DG-8015, the NRC indicates under the proposed rule that an I-131 patient would be able to be released if the activity in the patient's body is less than 33 millicuries or the measured dose rate is less than 7 millirem per hour at a distance of one meter". In NUREG-1492 the NRC based their cost saving conclusions on the following data: under current regulations a patient receiving a midpoint dosage of 175 millicuries for thyroid cancer needs to be hospitalized for 6 days and under the proposed rule this same patient would only have to be hospitalized for 3 days. These data is inaccurate. First, a thyroid cancer patient receiving a midpoint dose of 175 millicuries under the current regulation is not hospitalized for 6 days. These patients are routinely released after 1 or 2 days under the current regulations. In addition within a few hours (not 3 days) a patient's body burden can easily decrease from 33 millicuries to 30 millicuries and a patient's exposure rate will decrease from 7 mrem/hr to 5 mrem/hr. Contrary to the NRC's conclusion, the change in regulations will not significantly affect the "average" patient's hospital stay. The similarity between release numbers for I-131 under both the current and the proposed regulation is not a surprise since both release limits are based upon the maximum dose to a member of the public being 500 millirem. In performing the calculations for the cost of hospital retention, the NRC used a value of $1000.00 per day (NUREG-1492). The NRC arrived at this estimate by starting with a 1990 daily room rate average for a community hospital of $687 and adjusting for inflation and then adjusting for cost of a priyate room. We challenge the resulting estimate of $1,000 per day as being grossly inflated for a patient retained in today's hospital because of radiation emitting from his/her body. The cost per day for housing radiation therapy patient does not include the cost for specialized care or specialized equipment and therefore would not be the same as for an "average hospitalized" patient. The cost for housing a radiation therapy patients is only the cost for a private room (~$350.00 per day) plus the cost for a physician's visit (-$80.00); thus, a better estimation of the cost per day for a radiation therapy patient's hospital stay would be ~$450. Instead of reducing health care costs, the proposed rule will increase health care cost. The biggest additional cost is from the increased recording-keeping required under the proposed regulations. The NRC acknowledged the rule would increase record keeping. The NRC indicated that the increased record keeping will cost an estimated "$33.00 per patient" and would "result in an Page 2

annual estimated cost of approximately $2.1 million dollars per year". As the University of Cincinnati reviewed the NRC's proposed rules and related publication it was quickly apparent that the majority of patients who will require the increased documentation are patients who can under current regulations be released immediately after the administration or implantation of the radioactive material with only minor documentation (i.e., an administered activity of less than 30 millicuries or dose rate less than 5 mrem/hr at 1 meter). The University of Cincinnati asks, What risk is being prevented or decreased by the regulations? The proposed regulation does not appear to have any significant i mpact on decreasing overall radiation exposure to the general pub lic. The proposed regulation continues to allow individual members of the public to receive 500 millirem radiation exposure from a "released" radiation therapy patient and this "individual" will continue to be a member(s) of the patient's family. Therefore, without decreasing radiation exposure the NRC is increasing documentation requirements for physicians who, in accordance with NRC approval ( i . e. , an NRC license), administer radioactive materials to humans. In addition to increasing the dollar cost of health care. The regulations will have an impact on the quality and psychological cost of health care. The patient is a person and needs to be treated as such. One of the most important factors of a patient's treatment is their mental health. In NUREG-1492, the NRC indicated that the psychological cost for the current regulations was moderate and the psychological cost for the proposed regulation was low. The NRC's conclusion was based on the effect on a patient's psychological state from time spent in a hospital. As noted above there is no significant difference in hospital stay between the current regulation and the proposed regulation for the average patient. Therefore, using the NRC's basis for psychological cost, there is no difference between the current regulation and the proposed regulation. However, the regulations, as proposed, may adversely effect the patient's mental health and thereby may increase the psychological cost to the patient. The proposed regulation increases psychological cost by increasing fear and the attitude that the treatment is "haza rdous". The University of Cincinnati agrees that the dose limit for individual members of the public from patients who have been administered radioactive materials should be 500 millirem and that 10 CFR 20.1301(a) should be amended to exempt patients administered radioactive material. The University of Cincinnati does not object to, but sees no particular advantage amending 10 CFR 35.75 from an activity/dose rate release criterion to an exposure criterion of 500 millirem (i.e., modify 10 CFR 35. 75 as proposed in 10 CFR 35.75(a)). However, the University of Cincinnati strongly objects to the NRC requiring the licensee to compile and maintain Page 3

4 *

• C' documentation for imaginary people who may receive a total effective dose equivalent of 100 rnrern ( i . e * , NRC' s proposed regulation 10 CFR 35.?S(b}}.

For the University of Cincinnati, Bernard Aron, M.D. (reviewed a nd agreed} Director, Radiation Oncology

             ~~

John B\.eneman, M.D. Associate Professor, Radiation Oncology Representative, Radiation Safety Committee

    ~ i~ftio~             Vi    President Associate Dan, College of Medicine Administrative Representative, Radiation Safety Committee

( Michae~ )~~ f\M Chief, Nuclear Medicine, Children's Hospital Medical Center Representative, Radiation Safety Committee

          ~
                      /! /Y1'--7"'_,-

Harry Maxo, M.D. Dire ctor , uclear Medicine, University Hospital Representative, Radiation Safety Cornrnittee Safety Committee Victoria Morris, CHP Radiation Safety Officer Page 4

~,.,

 ~

Q{;Jii'

           .J John U. Hidalgo Consulting Physicist 0 CKET NUMBER POSED RULE PR C5o/F I<. 3 0/J;;.'j) 1.0,  s                 DOCKETED us me
                                                                                      *94 AUG 28 A11 :30 OFFIC - OF .:ECHf 1/ r< Y OOC KE....
                                                                                           ! lho  ,, ,...c-R'"rt
                                                                                               ~ '--  ~L            i BRANCH Secretary, U.S. Nuclear Regulatory Commission Washington, DC 20555 attn.: Docketing and Service Branch

Dear Sir:

I appreciate the opportunity to comment on Draft Regulatory Guide DG 8015. This is a well considered document and will contribute to the improved handling of release of therapy patients. There are two areas in the Guide that i feel need further attention:

1. Release of Patients Treated for Thyrotoxicosis, Dosage Range: 4 to 16 mCi.

In the Guide, Table 2, page 4: it is indicated that records must be kept for any patient who receives more than 6. 5 rnCi ofI 131. By my calculations (attached), the exposure from these patients \-Vill be 10 to 50 mrem. This is overkill and will generate unnecessary papenvork.

2. Release of Patients Treated for Thyroid Cancer, Dosage Range: 100 to 300 mCi.

In treatment, the first step is Thyroid ablation. Sometimes I 131 is the agent of choice. More often, this effect is achieved by Surgery. In either case, subsequent therapies will result in exposures that are significantly different from the "Guide" calculations. Usually, these patients will present with a Thyroid Uptake of less than S % . The attached table shows that for 100 mCi and uptake of 5 %, the first day exposure is 130 1mem and the subsequent exposure is SO 1mem for a total of 180 mrem as compared to the Guide value of 499 mrem . . The above calculations assumed a minimum distance of one meter. If two meters are used on the first day and two meters is employed on subsequent days, the calculated (attached table) exposure is 30 + 50 or 80 mrem. With this regime, 1209 Lai r Avenue, Metairie, Louisiana 70003/504

• 733-0063 SEP , 8 1994 _

ckro !edged by card ... u ... . , . . . __ _ __

 . NUCLE..:.,; . 1.--.iv1..A I vh 1.,uh : ... :~1--- >:

OOCKET!Nl-, & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Receiv,-d / op:es Aepr I is!ri~u~ '1 121>2.f; f lJR., - s.~f'io:..= ~~LJ_ "-.iij--

                        ---=------

200 mCi would expose to 160 mrem and 300 mCi would expose to 320 mrem. These are significantly lower yet conservative exposure levels and are realistic As a Certified Medical Nuclear Physicist it will be my responsibility to make these estimates. I urge your serious consideration of these changes. Sincerely, ~4.fA!../y John U. Hidalgo, C:MNP, FACNM.

Room G-7 Parran Hall Radiation Safety Office Pittsburgh , Pennsylvania 15261

                                                   *94 AUG 28 A11 :29           412-624-2728, 2729 Fax : 412-624-3562 Secretary U.S. Nuclear Regulatory Commission Washington, De 20555 Attention:      Docketing and Service Branch Re :            Comments on Proposed Rule "Criteria for the Release of Patients Administered Radioactive Material" The following comments are provided on the proposed rulemaking for 10 CFR Parts 20 and 35 ,

"Criteria for the Release of Patients Administered Radioactive Material ", which was published in the Federal Register / Vol. 59, No. 114 / Wednesday, June 15 , 1994 I Proposed Rules. I am in support of the proposed change in 10 CFR 20.1301(a) to exclude the dose contribution from patients administered radioactive material , and released in accordance with 10 CFR 35.75 , from the 0.1 rem annual dose limit to the public . I am also in support of the proposed provision in 10 CFR 35.75 to allow an annual dose limit of 0.5 rem per year for individuals exposed to a patient administered radioactive material and released from licensee control. The numerous benefits from allowing the earlier release of a patient administered radioactive material, as stated in previous regulatory comments, far outweigh the negligible risk to the small group of people who may receive an annual dose up to 0.5 rem. This is consistent with both ICRP and NCRP recommendations , which provides allowances for a maximum annual dose of 0.5 rem to members of the public on an infrequent basis. I am in support of establishing a dose based limit (as opposed to an activity or exposure rate limit) for the release of patients containing radiopharmaceuticals or permanent implants in order to provide for an equivalent level of risk from all nuclides. However, I do not believe that the proposed changes in 10 CFR 35.75 provide enough specific regulatory guidance for a license to make a determination when it may authorize the release of a patient. The calculational methodology for determining the potential doses to an individual from exposure to a patient administered radioactive material, proposed in Draft Regulatory Guide DG-8015 , is simplistic in its assumptions and ignores the potential for radiation dose from excretion of radioactive material from the patient. The following comments are specific to the calculational methodology and procedures contained in the Draft Regulatory Guide:

1. The determination of an exposure factor , that accounts for the different occupancy times and distances when an individual is around a patient, is completely subjective and should not be left to the intuition of the licensee. Low exposure factors (0.125 or less) could easily be justified by providing strict safety instructions, and allowing the patient to be released at relatively high activity levels, without any verification that the instructions will be followed .

SEP 2 8 1994 A 10w e ged by card ..... - - - * - -

tJ.S. t, . ~: ... DOCKt: 11' G ,:;. SER 11 CE ~ECTION OFFICE OF fHE SECRETARY OF THE COMMISSION Document StatistiCS Postmarl( Date '-/ ~pies Received _ _ _..,___ _ __ Add'I Copies Reproc icr>d ~----=---

  ~ial D1stri::, ;on.JZI   Y4 PIJ/4

- ~Gh J\. h ::.z.r-. _ _ _ __

              .fl_

Page 2.

2. In the model for calculating doses based on case-specific factors, the values for the average biological half-lives of extrathyroidal iodine in both euthyroid and hyperthyroid patients of 0.21 days and 0.063 days respectively, (referenced from NUREG-1492) are not consistent with the measurement data from our institution.

Our survey measurements indicate an average biological half-life of 0.5 days for extrathyroidal iodine in patients administered therapeutic quantities of iodine for both hyperthyroidism and thyroid cancer. Also, the assumption of thyroidal uptake of iodine of 30 percent for a thyroid cancer patient is erroneous. Typical iodine uptake in the residual thyroid tissue for these patients would be in the range of 1 to 5 percent.

3. The internal dose contribution from patients administered radiopharmaceuticals has been discounted on the basis of a few studies involving household members of patients administered therapeutic quantities of 1-131, and the assumption that the I-millionth rule of thumb for estimating the intake from an accidental release is applicable to exposures from a patient. I do not believe that the current research data is sufficient to support the assumption that the internal doses to a person exposed to a patient administered radiopharmaceuticals will be negligible and may therefore be ignored. For example, following the procedures presented in Draft Regulatory Guide DG-8015 for calculating doses to an individual using case-specific factors, a licensee could justify the immediate release of a patient administered 200 mCi of 1-131 sodium iodide for the treatment of thyroid cancer.

The dose for the first 24 hours assumes no loss of iodine from voiding of the bladder and is given by:

34. 6(2. 2R -cm2/ mCi *h)(200mCi)(8d)(0. 25)( l -e-0* 693<1d>t<8d))

D(l day) = (100cm)2 D(l day) = 0.253 rem Since it may be assumed (according to the Regulatory Guide) that the extrathyroidal iodine has been totally voided after 24 hours and will not contribute to the dose, it is only necessary to determine how much thyroidal iodine will be present at the end of the first day and calculate the dose from that point to total decay. Assuming a typical thyroid uptake fraction (F2) of 5 percent: Q(l day) = 200 mCi(0.05)(0.91)

                     =   9.1 mCi

Page 3.

34. 6(2. 2R -cm2/mCi *h)(9. lmCi)(7. 2d)(0. 25)

D(ld-oo) = (100cm)2 D(ld-oo) = 0.125rem D(total) = 0.378 rem Clearly, the 190 mCi of 1-131 that is going to be excreted through urine, sweat, and breath from this patient over the first few days would likely present a significant radiation exposure hazard to family members and the public through the spread of contamination. This represents the uncontrolled release of over 6300 ALi's of radioactive material into the public domain. A patient, once released, can take public transportation, dine at a restaurant, or stay overnight at a hotel. Even though it would be required for a licensee to provide the patient with written radiation safety guidance, to minimize radiation exposure to others, there is absolutely no control or assurance that the patient will fully understand or follow the precautions. Also, both ICRP and NCRP recommend an annual dose limit of 5 rem to the skin and extremities, based on deterministic effects, for members of the public. This dose could be reached with as little as 0.8 uCi of 1-131 spread over 1 cm2 of skin for a period of 24 hours. The number of studies and associated data regarding the potential for contamination by patients administered radioiodine is severely limited, and cannot support discounting the potential skin, extremity and internal dose to other individuals under the circumstances outlined above. In summary, while I support the proposed changes in 10 CFR 20.1301(a) and 35.75 with respect to the allowable dose limits and the establishment of a dose based criteria for the release of patients administered radioactive material, I do not agree with the calculational model proposed in Draft Regulatory Guide DG-8015 for determining doses to exposed individuals. This model contains an "exposure factor" parameter which is completely subjective and without any lower limit. It also assumes that for patients administered 1-131 for hyperthyroidism and thyroid cancer, the extrathyroidal iodine is rapidly eliminated from the body within 24 hours and will not contribute significantly to an exposed individual's dose. The use of this model would allow a licensee to release a patient containing hundreds of millicuries of a radiopharmaceutical which could result in levels of contamination and radiation exposure that would be of concern to public health and safety. Until additional studies have been conducted to better demonstrate the exposure and internal dose potential from patients containing radioiodine, the release at these high levels cannot be justified.

Page 4. I recommend the following specific changes to proposed 10 CFR 35.75:

1. Include in the regulation, the specific calculational model (or nuclide specific exposure rate) to be followed in determining the total effective dose equivalent to the individual likely to receive the highest dose. External exposures could be calculated using Equations 2 and 3 from Draft Regulatory Guide DG-8015, without any allowances for the use of II case specific factors 11 *

2. In addition to the above, there should be a limit on the total amount of radioactivity that will likely be excreted from the patient after being released from licensee control. This limit should be established at some multiple of ALI' s to provide an equivalent level of risk from all radionuclides. I would recommend a limit of 1000 ALi's, which is equal to 30 mCi for 1-131.

3. The requirement to maintain a record of the release which includes a calculation of the highest dose to an individual is unnecessary and burdensome. It should only be required to maintain a record of the exposure rate measurement which is made to demonstrate compliance with the release criteria.

4. There should be no intent of the regulation to require a licensee to track multiple administrations of a patient for the purpose of controlling total annual exposures to the public. This would be impractical and provide no real increased level of safety.

Michael Sheetz, M.S., C.H.P. Senior Health Physicist University of Pittsburgh

15:51 001

 .                                     TI-E lNNERSilY OF TEXAS MDAN)~N5~                             DOCKET NUMBER PROPOSED RULE _ __ , _

PR ~ 35 CANCER CENTER c~ ~ r R. JOrli. t..l)

                                                      *94 AUG 28 A1 1 :30 OFFIC[ OF SECRET~RY                      E. Edmund Khn, M.D.

DOCKETING " SER IC[ Pro(ceeor o( Radiology & Medicine Chief, Experimental Nuclear Medicine BR~r CH Director, Center for Mctaoollc Imaging (713) 794-.1052 August _26, 1994 John C,_ Hoyle, Acting Secretary U, S. Nuclear Regulatory Commission Washin:ton, D.C. 20555 ATTN: Docketing ar.d Service Branch

Dear Se.cretary Chi1k:

I write to express tlu:*. 01>inion of our American College of Nuclear Medicine about the proposed regulatory change8 from the Federnl Register (Vol. 59, No. J4 on June 15, 1994), DG 8015 deaiing with criteria for release of patients to whom radio-pharmaceuticals or other appropiiate ia.dioactive material has been administered . We are very pjeased to support the ab_andonmoot of the so-called 30 mCi Rule" since our College has oeen the primary petition~r to aet.:-0mplish this. Your propose.cl document is a major step iu the directlQn ~:,f practical regul&don on behalf of pubJic health and safety for America. V/e wou]d lixe to ta.ke this opportunity to provide the following comments which e we feel would strengthen this mandate:

1. Relea~ of patients treated tor th)rotoxicosis: The 30 mCi :rule was designed to address the release of cancer patients. Extension of this condition to the treatment of thyrotoxicosis was not a pan of the purpose of the present rule change, NCRP 37 did not indicate that exposure to the public would he of any significance from doses in the range of 4 to 20 mCi. Calculations, by one of our members, physicist John Hidalgo, show the exposure from these cases wiJl range from 10 to .50 mr~m. Table 4 in the accompanying RcguJatory Guide shows a dose rate for record preparation of l mrem per hour, This is an invocation of the public limit of l 00 mrem whkh is not part of NCRP 37 and is not a realistic value. The origin of this number is not based on data available in scientific literature, The premise that these low doses can cause some kind of harm is neither logical nor provable.

2. Release of patients treated for thyroid cancer: Cancer patients usually present with a thyroid uptake of less than 5 %* Calculations, again by John Hidalgo, show that for 100 mCi and an uptake of 5 %, the first day exposure is l 30 mrem and the subsequent exposure is SO mrem for a total of 180 mrem with Jm distance as compared to the 1515 HOLOOMBE nou1.EVARD

• 110usTON, TEXAS 1*1030
• rm, 1~z-1. 11. 1 SEP 2 8 199'
• Acknow1 dged oy card.... ""'"'"'"-'""",,...,.

v. ~ . . _ . . , ...,, , I 1,.,UMMISSION DOCt'..C 1::** !i St:RVICE SECTION OFFICE Of THE SECRETARY OF THE COMMISSION Document Statistics Postmark Date _ _ __ _ _ _ __

Copies Received _ _ _.....__ _ __ Add'! Copies Reproduced _J__ _ _ __ Special Distribut:on~ ~ ~ 4.J-...;.::_..:::.,..._ c_. hn e..,

15:51 002 100 mrem. With this regime~ 200 mCi would expose to 160 mrem and 300 mCi would expose to 320 mrem. These are significantly lower yet conservative exposure levels.

3. Paper work: The estimates of time required to prepare records in the proposal seem much too low. The preparation of the proposed records wm significantly increase

       *medical care costs involved. Any case where the possible exposure is less than 500
        ~rem should not need this burdensome paperwork.

4. Calc~lations: 1'he calculation methodology in the proposed Regulatory Guide is overdone for the real world. Exposure to total decay is overkill. The decay shouJd

       ,i>e formed from initial dm,e to some acceptable level at which the patienl could be released without ooncern. This has bten a safe and acceptable procedure for many years Md there is no need to alter those rules,

5. Instructions: All of the instructions to the patient are a responsibility of the

       *physician. These will be different for each patient and good management of the patient requires the physician to tailor the instructions to flt each individual patient's needs. We feel that a member of the patient's family is not a member of the general public but yet a dedicated or specific public.

6. Compactbmty: we believe that levei 3 .is the appropriate compatibility level for agreement states but prefer that deirees of compatibility have no place in therapy -

the doctor/patient relationship should be pl'eserved. In closing, thank you very mur-h for your efforts towards clarification and modification of the 30 mCi rule which has unnecessarily plague.(!* and befuddled practJtioners for decades. Our College alsv agrees with comments co-jointly made by the Society of Nuclear Medicine and the American College of Nucl~ l>hysicians. We greatly appreciate your consideration of these comments. sm~~~/.~ E. Edmund Kim, M.D. I President, American College of Nuclear Medicine /tt

Department of MEMORANDUM Veterans Affairs *94 AUG 28 Al l :JO OFFICE OF SECRETARY DATE: July 13, 1994 DOCKET! 'G & SE:.RV1CE BRANCH TO: Secretary, U.S. Nuclear Regulatory Commission FROM: Lynn McGuire, Chair, DVA National Advisory Group on Radiation Safety ~ Radiation Safety Officer John L. McClellan Memorial Veterans Hospital Little Rock, Arkansas SUBJ: Comments regarding proposed rule, 10CFR 20&35, Criteria for the Release of Patients Administered Radioactive Material, FR59#114, pp30724-32.

1. Comments and remarks below pertain to the proposed rule and both associated documents - DG-8015 and NUREG-1492.

a. General (1) The NRC is to be commended on their cost-benefit approach employed in the analysis of options presented in NUREG-1492.

(2) The cost estimate of $1000/person-rem (p. 26 NUREG-1492) is not appropriate for medical procedures in which the benefit derived by the patient is great. The figure of $40/person-rem given by the Health Physics Society Position Statement is more appropriate.

b. Radiation Doses to the Public (1) The proposed regulation attempts to clarify the situation regarding exposures to members of the public from patients administered radioactive materials. These regulations do not completely address many more vexing situations caused by such patients. For example, it is not clear that the following real situations are addressed:

• Patients who have been administered RAM, and otherwise meet the release criteria, but remain hospitalized for other reasons. Are they still under the licensee's control? Do other radiation safety considerations apply such as training, contamination control, etc.?
• Waste disposal issues, such as associated contaminated items (dressings, catheters, etc.),

especially with regard to receipt by a landfill. SEP 28 1 ~ Acknowledged by card ...-- *

 -~- "'UL L .... '  ,_ - - J \ 1vH Y COMMISSION DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics ark Date ~ J..            /1 pies Received _ _ ---=:/,--_ _ __

Add'I Copies Reproduced ~ -..,.-- -

     . .. .                        !RO.is

,i

• Radiation doses to the public in an area bounded by both a waiting room and an imaging room.

It would be difficult to separate the dose caused in this area from patients who are "released" and those who are apparently still under the licensee's control, i.e. those who are being imaged. Because of issues of these types, and since the nature of nuclear medicine is that patients are essentially uncontained sources of radiation, and that society derives great benefit from the practice of radiation medicine, the following more general exemption is proposed: Licensees are exempt from the requirements of J0CFR19, 20 and 35 as they pertain to radiation emitted or radioactive material excretedfrom patients who have been administered radioactive material in such a manner as they are not likely to cause doses to a member of the general public in excess of 0.5 rem TEDE.

c. Specific Comments Reiardini Methodolo~y in NUREG-1492 and DG-8015, (1) Table 2, DG-8015, is confusing in that it only assumes physical decay and 1/4 exposure time. A more appropriate calculation is by Appendix A methodology. This Appendix is supposed to apply to patient-specific cases, but actually uses ICRP models, which may be treated as generally applicable in the absence of specific patient data. Therefore, as shown in the example on p.A-3, the actual exempt activity would be 100 mCi for 1-131, not 33 mCi as shown in Table 2.

(2) Suggest that the method employed for 131 I should be simply to apply the retention functions given in Eqs. 12 and 13, p. 17 NUREG-1492, as the models to be employed for all general cases and all times. These take into account the first 24-hour voiding period which is handled clumsily in these documents. (3) Example p.A-5 for 10 mCi 1311 is not case-specific. It does not consider patient uptake and retention and simply uses the 10 mCi administered and physical decay. It would be more illustrative to either Eq. 13 or the 24-hour uptake value and a Tetrof7.2 days. (4) What is the basis for a Teff of 5.7 days given on p. 17, NUREG-1492?

f oocKETEO USHRC

                                                                                 *94 ~UG 26 p 2 :4:

US Nuclear Regulatory Commission Washington, DC 20555 Attn: Docketing and Service Branch Re: 10 CFR Parts 20 and 35 RIN 3150-AE41

                                                                                                @ 2b Criteria for the Release of Patients Administered Radioactive Material Comments from:

David E. Cunningham, Ph.D., 211 Cocoa Avenue V Hershey, Pennsylvania 1703 Comment 1. Section 35.415 Radiation safety guidance should be in the form of a written document and this document shou ld include a picture of the source. See for example the attached picture of I - 125 seed. Comment 2. Appendix B. Sample Instructions for Patients Receiving Permanent Implants. Attach picture. See Comment 1. Include the following in the Sample:

            "Show this document to all physicians providing your care in the future."
            " If you have questions, or you are hospitalized or in the event of any medical emergency,               contact the following ... "

Comment 3. Section 20.1301(2). The term "released" as used in this document must be defined as it applies to licensed operations as opposed to the medical discharge of the patient. Comment 4. It appears the implementation of this Proposed Ru l e may create the possibility of two wings of the same floor with different dose equivalent restr i ctions. For example, a Cesium-137 patient hospitalized for brachytherapy is subject to 2 mrem/hr and 100 mrem/yr limitations. However, an I-125 patient hospitalized for medical reasons is excluded from part 20.1301 considerations. Please confirm this possibility. SEP 2 8 1994 Acknowledged by card .............................."**

 ~ "'    ,.                      *       - - h,,, , u ..J...,h,; ti OOCK1.: i *;*'..., 1 SErlVICE SECT ION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics

Fostmarl< Date -p-Jq'-J

~pies Rece,ved _ _ _.,...,/_ _ __

er: C-:> ~ie5 Repr*.-:Juced ___..,..__ ____ ec,:21[

• s"t~.:ti 1 ~ 0 5J fJl)ll1

_-5::lL ~ ~ --

OOCl i~ r~o DOCKET NUMBER u ( PROPOSED RULE Pl -2° rJ-..

                          *94 mJG 26 f-\ ~ :08 (Sq  r ll J O  -;.."'/

4809 Drummond Avenue _ *  ::n 1AR Chevy Chase, MD 20815 OFFILt Or~...;- c~c IC~ugust 25, 1994 OOCK[Tlt Li ,J i-, John Hoyle, Acting Secreta ht , 1 U.S. Nuclear Regulatory Commission Washington, D. C. 20555 Attention: Docketing and Service Branch

Dear Mr. Hoyle:

The following are comments on the proposed rule on "Criteria for the Release of Patients Administered Radioactive Material," published for comment at 59 F.R. 30724 (June 15, 1994). They are submitted in my private capacity as an interested member of the public, not in my official capacity as Counsel for Special Projects at the U.S. Nuclear Regulatory Commission. My concerns in this area stem from my own experience as the recipient of a number of therapeutic and diagnostic doses of radioactive iodine-131, totaling some 800 millicuries. Each of these meant taking precautions to minimize radioactive contamination of family members and members of the public. Knowing the hazards posed by I-131, I am deeply troubled by an NRC staff proposal, taken in the face of strong opposition from the responsible health authorities of many states, that could significantly increase radiation doses to the families of persons treated with this particularly dangerous radiopharmaceutical. At the outset, however, I should say that the NRC staff has done a conscientious job of attempting to calculate the actual dose that members of the public are likely to receive from patients treated with radiopharmaceu ticals. Dr. Patricia Holahan, a radiation biologist in the NRC's Office of Nuclear Materials Safety and Safeguards, worked on those calculations, and although, to paraphrase an old song, I don't know much radiation biology, I do know Trish Holahan, and I have no doubt that her calculations are flawless. My concerns are directed to a quite different issue: how the notice of proposed rulemaking dealt with public comments, my own and those of others, regarding the particular hazards of I-131. 1 For as I understand it, the dose calculations in the proposed rule are based on the probable external radiation dose to fpmily members and other members of the public from a patient a given distance away. My comments, on the other hand, in focusing on the special risks posed by I-131, stressed the potential for internal contamination, by skin contact, inhalation, and ingestion. (See my comments of October 31, 1992, hereby incorporated. ) In particular, I emphasized the risk of contamination from vomiting if, as not infrequently happens, a therapeutic dose of I- 131 induces nausea. 1 These were comments filed in response to the NRC's announcement of the receipt of petitions for rulernaking. 57 F.R. 21043 (May 18, 1992).

lJ.:., . I I I (.(JMMISSION u , , .:~G 6 :;ERVICE SECTION vt l: iCE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmark Date _ _ _ _ _ _ _ __ Coptes Received _ _ _-'-- - - - "dd"I Copies f1eproduced _ .,c...__ _ __

,pP.c~ ; * ,r                  LPJ    ~
   -    c..,                  

2 Numerous other commenters, including health authorities of six states (Illinois, New York, Colorado, Alabama, Texas, and North Carolina) raised the same concern about I-131, though you would not know this from the notice of proposed rulemaking. The individual states cautioning about I- 131 were the following:

  -- New York.

The New York State Department of Health said of I-131: "At dosages greater than 150 millicuries nausea and the likelihood of vomiting are more likely and present a risk of extensive contamination. 11 (New York was willing to consider outpatient treatment above 30 millicuries of I-131, but to a maximum of 80 millicuries, and then only under special circumstances. )

  -- Texas.

The Texas Department of Health observed that I-131 is "the most radiotoxic byproduct material used for medical use," warranting especially close controls.

  -- Colorado.

The Colorado Deparment of Health commented that while a relaxation of the current 30-millicurie limit might be appropriate for "certain other isotopes," it did "not feel this is justified for patients receiving iodine-131. 11

  -- Illinois.

The State of Illinois Department of Nuclear Safety likewise expresed concerns, "especially in light of the request to release patients containing up to 400 mCi [millicuries] of I-131."

  -- Alabama.

The Alabama Department of Public Health expressed support for relaxing current release criteria for some radiopharmaceuticals, but declared itself "opposed to the petition in that it supports release of patients from hospital (institution) confinement whose body burden of iodine exceeds 30 millicuries, even as high as 400 millicuries."

  -- North Carolina.

The North Carolina Department of Environment, Health, and Natural Resources stated that while the 11 30 millicurie limit is indeed arbitrary in that it has been generically applied to all radiopharmaceuticals, 11 patients dosed with I-131 could cause significant radiation doses to "family members, coworkers and other persons they encounter," both from external gamma radiation and internal dose.

3 Two other states, as well as the NRC's own Advisory Committee on the Medical Uses of Isotopes (ACMUI), recommended keeping the 30-millicurie limit for all radiopharmaceuticals, not just I-131. And as the notice of proposed rulemaking did mention, 21 Agreement States, meeting in 1992, recommended keeping the 30-millicurie limit for I-131 while relaxing it for other radiopharmaceuticals. Finally, it will be recalled that Dr. Carol Marcus, the author of one of the petitions before the NRC, originally proposed retaining the 30-millicurie standard for I-131, but eliminating it for all other radiopharmaceuticals. 2 In a November 9, 1992, letter to the docket, she used the word "ludicrous" to describe the contention of the American College of Nuclear Medicine that doses of 400 millicuries of I-131 could safely be administered on an outpatient basis. In short, the concerns that I was expressing about 1-131 in October 1992 turn out to be utterly mainstream: standard conservative practice. Nor are these concerns about 1-131 trifling. As I mentioned in my October 1992 comments, the transcript of a 1992 ACMUI meeting shows the Committee's chairman, Dr. Barry Siegel, worrying about the hazard to family members posed by diagnostic doses of as little as 5 millicuries of 1-131. But although one commenter after another, as well as the states mentioned above, pointed to the special hazards associated with I-131, the notice of proposed rulemaking never mentioned this, nor did it suggest that one of the key issues in the rulemaking was whether I-131 should be in a class by itself for regulatory purposes. Nor is the issue of patient vomiting ever mentioned. In my earlier comments, I also pointed out that anyone who has been treated with a therapeutic dose of I-131 is already severely hypothyroid ( by design) , and that this condition may impair the person's ability to follow safety guidelines for the protection of family members and other members of the public. ( Judith Brown of ACMUI raised essentially the same issue in a 1992 ACMUI discussion of the proposal, when she asked how patients felt after receiving a treatment.) This comment also was not dealt with in the notice of proposed rulemaking. Nor was there any response to my suggestion that although the NRC staff was justifying its proposal on grounds of the supposed psychological benefit to patients and their families, it might be more comforting to patients to know that they were minimizing the radiation 2 I gather from Dr. Marcus's July 11, 1994, letter to the docket that her position on this point may since have changed. In case I have misunderstood her views, however, I suggest that the NRC and other interested persons read her submissions for themselves.

4 dose to others by remaining in the hospital in radioactive isolation. Speaking from the experience of five inpatient treatments, radioactive isolation is unpleasant, but worrying that one is putting others at risk may be even less pleasant. My experience in that regard is not unique. Several months ago, I asked an NRC staff member, recently released from the hospital after 23 hours confinement to receive a 100-millicurie dose of I-131, the following question: "If you had been given a choice between getting the treatment as an outpatient and as an inpatient, which would you have chosen, do you think?" She replied: I personally would have preferred to stay in the hospital for the full three days [ originally projected] until the thyroid was well below 29.9 [millicuries] vice getting out with thyroid at 50 millicuries. If I had lived alone it might not have been a significant issue. I think, especially with children at home, the argument to bring patients home is ridiculous, too risky, too hard to keep isolated. I think my kids were more frightened that I was home, in a sequestered state, locked away upstairs as it were, taking my meals alone on paper plates, not being able to kiss them good night than they would have been had I stayed in the hospital for three days. We had a chair in the living room with masking tape marking a large X as well as one in the kitchen. Those were the only two place I could sit when I did come downstairs briefly. My husband slept on the couch for five days and used the boys' bathroom downstairs, etc .... That such concerns are not frivolous is confirmed by the American Journal of Public Health article ( "Contamination of the Home Environment by Patients Treated with I-131: Initial Results"), placed in the docket by a commenter. It suggested that in-home contamination by patients dosed with I-131 could double family members' risk of developing thyroid cancer. The same study found that of 12 adults studied, none was "willing to adjust living habits with their spouses because of the radiation therapy." (By contrast, they were willing to take steps to protect their children. ) I suspect that with a larger sample, this finding would not hold up -- all the thyroid cancer patients I have known have been, like the NRC staff member just quoted, careful to protect their spouses from radiation -- but this is nevertheless a data point that needs to be considered. If even a sizable fraction of patients will not follow radiation safety guidance to protect their own spouses, what reason is their to think that they will be rigorous about protecting total strangers, such as fellow passengers on public transportation, or the

5 shoppers in the grocery store? (For example, a person dosed with I-131 who handles a piece of fruit and then does not buy it may leave behind a residue of contamination that may wind up in the thyroid gland of whoever later eats that piece of fruit.) Consider also the observation of the North Carolina Department of Environment, Health, and Natural Resources that many thyroid cancer patients treated with I-131 are otherwise healthy, and "[r]eleasing such patients with the expectation that they will go home and lock themselves in a room for two or three days with limited contact with family and friends is not realistic." To be sure, the notice of proposed rulemaking acknowledges North Carolina's comment, in the context of concluding -- sensibly -- that remaining at home does not constitute "confinement" for regulatory purposes. But that is not enough. The whole point of the proposed rule is to make it possible for the licensee to dispense with confinement altogether if the calculated dose to any member of the public falls below certain limits. If a patient is single and lives alone, and is given instructions for minimizing radiation dose to others, it may be easy to demonstrate that the criteria are met, but whether the public is actually protected will then depend entirely on whether the patient abides by the restrictions. The key issue, then, is whether it is reasonable to expect that released patients will alter their behavior and limit their activities for the protection of others, and on this point the proposed rule is silent, despite the comments of states and others. Why has the NRC embarked on this novel course, in the face of such strong and unified opposition from health authorities in so many states, as well as its own ACMUI? Dr. Marcus has explained that the immediate occasion for her petition was a change in 10 CFR Part 20, "Standards for Protection Against Radiation," that reduced allowable doses to members of the public from NRC-licensed activities by a factor of five. It appears that at the time that rule change was put into place, the issue of its applicability to the release of patients with radioactivity in their systems had not been thought through. As a result, the new rule, by dropping the maximum allowable dose to members of the public from .5 rem to .1 rem, could theoretically have been read to require many procedures that are normally performed on an outpatient basis to become inpatient procedures. If this was the problem, there could have been a quick and easy fix. It would have been a relatively simple and non-controversial matter to propose a rule to make clear that the new Part 20 was not intended to alter the status quo for the release of patients. ( The comments make clear that there is a consensus in favor of the . 5 rem standard.) But what the NRC has done is go much further, and propose a rule under which procedures that formerly were handled only on an inpatient basis could become outpatient procedures. Thus having first lurched (unintentionally) in the direction of imposing new and unnecessary controls, the NRC has reacted by lurching in the opposite direction, to eliminate valuable, time-tested radiation

6 protection measures, over the objection of individual states, the Agreement States as a group, and other commenters. No one should have the illusion that this rule change would simply give patients and doctors a choice between inpatient and outpatient treatment. In practice, the pressure to contain costs would probably mean that insurance companies would pay only for the cheapest possible option, creating pressure on practitioners to find a way to justify out-patient treatments. In such cases, patients will not realistically have a choice, unless they are able to pay for hospitalization out of their own pockets. Most, whether they like it or not, will be outpatients, living at home, and their families will be getting unnecessary radiation doses, so long as it is possible to calculate, on paper, a set of restrictions by which doses can be kept to .5 rem. In conclusion, I will frankly admit that as a commenter, I am disappointed that the notice of proposed rulemaking has not done more to come to grips with the issues raised in the public comments. If commenters are not to be discouraged from participating in NRC processes, the NRC owes it to the public (which in this case includes state health authorities) to offer more evidence that it has so far given that it reads and thinks openmindedly about the comments that are filed. Whenever an agency fails to respond to major concerns raised in public comments on a rulemaking, there is a risk that members of the public and others will view the notice-and-comment process as no more than a pro forma exercise, in which the conclusion is foreordained. 3 Moreover, agencies cannot expect reviewing courts to accord them the deference they normally receive on technical issues when there is no articulated technical judgment to which to point. In sum, the proposed rule is ill-advised, at least with regard to 1-131. The consensus of responsible health authorities on this point is clear, and the NRC should heed it. Sincerely, 3 The need to demonstrate that the agency has not prejudged the outcome, and is openminded with respect to views submitted by public commenters, is especially strong in the present case, given Dr. Marcus's repeated assertions, in letters filed in the public docket ( ~ , the letter of November 9, 1992), that her petition for rulemaking was filed at the request -- indeed, the insistence -- of a then member of the staff. As I suggested in my earlier comments, I believe that the NR C should clear the air and indicate one way or the other whether this rulemaking has been, in Dr. Marcus's own phrase (in the November 1992 letter, in reference to an earlier rulemaking in which she was a petitioner), "an inside job from the start. 11

CAUTION RADIOACTIVE MATERIAL

RADIOLOGY ASSOCIA TE~t,l~f fffVILLE, P.C. 115Nq *: MEDICAL IMAGING PRACTICE LIMITED TO C LIFTON E. GREER,Jr1 M.D. MEDICAL IMAGING AND RONALD E. OV ERFIELD, M.D. SAMUEL B. RUTLEDGE, M.D. *94 AUC 26 A8 :27 RADIATION ONCOLOGY HENRY C. HOWERTON, M.D. BUSINESS omcr. A, KNOX PATTERSON, M.D. 21125TH AVE. N1 SUITE 611 MICHA EL B. SESHUL, M.D. NASHVILLE, TN 372t3 GREC".ORY R. WEA VER, M.D. WEBB J. EARTHMAN, M .D. Phone: ('15) 329-9707 MARK P. FREEMAN, M.D. Fu: ('15) 327-1162 J ACK R. BAKER, M.D. JOHN G . HUFF, M.D. DAVID N. BOLUS, M.D. BAPTIST HOSPITAL BRENT T. LA VTON, M.D. NASHVI LLE, TN 37203 LISA A. ALTI ERI, M .D. DEPT. OF MEDICAL IMAGING RADIATION ONCOLOGY KENNETH M. LLOYD, M.D. DIRECTOR DEPT. OF RADIATION ONCOLOGY JULIAN C. HEITZ. M.D. August 19, 1994 Secretary of Commission U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Attn : Docketing and Se rvice Branch

Dear Sirs:

I n r e cent review of the Federal Register dated Wednesday, July 15, 1994, the propose d changes concerning CFR 35.75(b)(I), 10 CFR 35 . 75(b)(II), a nd a me ndme nts to 10 CFR 35.315(a)(VI) and 35.415(a) (V) , I wa s plea sed with the intent and support the changes proposed. The a bove propo sed cha nges, if implemented, would continue to gua rante e publ ic safety and a t the same time reduce the cost of health care delivery. Thank you for your favorable consideration and proposal of the s e changes . Sincerely,

          ~~.                              M.D.

REO: lw cc: Herbert C. Allen, Jr., M.D. E. Edmund Kim, M.D. Gregory R. Weaver, M.D. Mr. Thomas Johnson, Jr. SEP 2 8 i994 Acknowledged by card .*-- -

U.~- 1*1 ~ .... _ . . ' ":... 1v1:. 1S!:iiuN DOCr< '.: i ;; ,G 6. SERVICE SECTION OFF1CE OF THE SECRETARY OF THE COMMISSION Document Statistics

~stmanc Date            !J    t t:>J  /1l--/

Copies ReCl;i'JCd _ _ __,7____ lidd'I C~;:;ies Reprod~ --=--,3- -=---= - 'G~ec:al Dis'ribution tcr/J0 Pf)l21 _Scbne tel-RT

University of Pittsburgh DOCKET ED ~ USNRC ~

            ,        .          DOCKET NUMBER
          !:>chool ~f Ph,n11111nPROPOSED RULE PR   ~

O s Qfjice rftb, De,111 (G q f RJO7 2 'i, August 10, 1994 Mr. John E. Glenn, Chief Medical, Academic, and Commercial Use Safety Branch Division of industrial and Medical Nuclear Safety, NMSS U.S. Nuclear Regulatory Commission Washington, DC 20555-0001

Dear Mr. Glenn:

In response to your memorandum of July 25, 1994, I have the following concerns with regard to the proposed rule, "Criteria for the Release of Patients Administered Radioactive Material":

1. The Proposed Rule and the Regulatory Guide both address the issue of breast-feeding; that the 5 millisievert (0.5 rem) limit applies to the infant as the individual likely to receive the highest exposure. However neither document provides much in the way of guidance on this topic. While it is fairly obvious that patients undergoing 1-131 sodium iodide therapy procedures should discontinue breast feeding, what about patients who receive dosages of 1-131 sodium iodide below the 500 mrem/year release and/or 100 mrem/year record-keeping levels? Are there minimum dosages of other radiopharmaceuticals wherein known or assumed percent excretion in breast mi lk would result in an infant receiving an exposure in excess of 100 mrem/year (for recording) or 500 mrem/year (for release). Such information (and associated calculation assumptions) should be provided in a table in the Regulatory Guide. I feel that this would avoid considerable individual licensee effort, confusion and controversy in the future.

2. The Proposed Rule states that in the case of beta emitters, "which do not pose a large external dose hazard, (sic) dose through inhalation or ingestion of contamination could be significant pathways and must be accounted for in a calculation for compliance." The Regulatory Guide states that (p 7) "if a radionuclide is a beta emitter, other pathways of exposure may need to be considered" and (p A-9) "internal doses may be ignored in the calculations if they are likely to be less than 10 percent of the external dose since they would be significantly less than the uncertainty in the external dose." These SEP 2 8 1994 -.

J-\(.1\flOWledged by card .........- .......- .......

If...,. ; . . , r , v'-' fv,tv::iiv, DOCl\t ilNG & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmar1< Date - - -- -- - - f,o pies Received _ _ _/ _ _ _ __ Add'I Copies Reproduced ~ - -~ - Special Distribution ~ f)(J/l n Ltl..e,,11'-' 7

Mr. John E. Glenn August 10, 1994 statements imply that for beta emitters (e.g., Sr-89, P- 32) the licensee must perform calculations to ensure that the release and reporting criteria have not been exceeded for beta emitters based on certain assumptions re. internal contamination. Again, considerable individual licensee effort, confusion and controversy could be avoided if the NRC would address (within Table 2 or a separate table of the Regulatory Guide) activities of commonly used beta emitters below which patients may be released and above which records are required. Associated calculations and assumptions should also be included in the Regulatory Guide.

3. My major problem with the Proposed Rule deals with the 1 millisievert (0.1 rem) record-keeping requirement (15.75 (b), (2)) and the reason (see Proposed Rule, p 30730, Issue 7.) given for its inclusion: "This record would provide a basis for assuring that the maximum dose to an individual exposed to the patient is below 5 millisieverts (0.5 rem) for any single administration.

This record also provides a basis for ensuring that doses from multiple administrations greater than 1 millisievert (0.1 rem) each do not total more than 5 millisieverts (0.5 rem) in any year." While I don't have a major problem re. documentation of the basis upon which the patient was released, I question whether it is practical or possible to utilize this record to prevent exposures of > 500 mrem/year from multiple administrations to the same patient. This clearly appears to be the intention of the NRC as stated in the Regulatory Guide (p 8-9), "To prevent a dose in excess of 5 millisieverts (0.5 rem) in any 1 year to an individual as a result of exposure to a patient containing radioactive material, licensees should sum the doses from all administrations of all radionuclides to the patient in the year for which the record is maintained." One can envision situations wherein a patient receiving 1-131 sodium iodide therapy and re leased at the 500 mrem/year limit may require a second therapy with 1-131 sodium iodide or a radioactive implant within the same year. Would the 500 mrem/year limit for multiple administrations prevent the second therapy from being performed as indicated? (Note: in this situation the Proposed Rule, as written, would intrude into medical judgements and interfere with the practice of medicine.) The basis for this reporting requirement assumes that all areas of the hospital in which patients are administered applicable radioactive materials will maintain a single, combined record for review prior to a subsequent administration. This is not reality! Moreover, how does the basis for this reporting requirement apply in situations wherein a given patient may receive multiple administrations of radioactivity within the same year at different institutions?

Mr. John E. Glenn August 10, 1994 To ensure that the 500 mrem/year limit for multiple administrations is, f in fact, not exceeded would require that the licensee calculate the specific (exact) exposure rate for each radionuclide administration expected to result in an exposure rate > 100 mrern/year. I.e., one could not establish the final total exposure rate based simply on the data given in Table 2 of the Regu latory Guide. If it is truly the intention of the NRC to li mit exposure from multiple radioactive administrations to the same patient to less than 500 mrem/year, then I guess I would have to question (based on the above considerations) the appropriateness of a release criteria for a single administration based on an exposure of 500 mrern/year.

4. The Background section of the Proposed Rule implies that patients may be released based simply on reference to the Tables included in the Draft Regulatory Guide. However, with regard to the 1 millisievert (0.1 rem) record-keeping requirement, Proposed Rule 35.75 (b), (2) states: "Maintain, for th ree years, a record of the released patient and the calculated effective dose equivalent to the individual li kely to receive the highest dose." The statement suggests that a patient-specific calculation of the actual effective dose equivalent to the individual likely to receive the highest dose must be performed and documented for each re leased patient; that simple reference to the Tab les in the Regulatory Guide will not be adequate. Such a requirement will be extremely burdensome to nuclear medicine facilities and, in my opinion, is not warranted or justified by the risk associated with a 500 mrern/year or lower exposure.

[As a related question, can the memorandum from Robert M. Bernero included in our packet be interpreted that it would not be permissable to refer to the Tables in the Regulatory Guide as a method to address the regulations proposed under Part 35.75?]

5. Proposed Rule 35.75 (b), (1) requires that the licensee "provide the patient with written instructions on how to maintain doses to other individuals as low as reasonably achievable." My personal experience is that verbal instructions are, in fact, more effective than written instructions, especially taking into account the varying levels of literacy, familiarity with the English language, and other problems (e.g., eyesight) associated with reading and understanding written material encountered in routine practice. Moreover, providing verbal instructions gives the patient the opportunity to ask questions. (I assume that a problem wi th verbal instructions, from an NRC perspective, is the inability to document that they were in fact provided to the patient.)

Mr. John E. Glenn August 10, 1994

• In my opinion, the provision of appropriate medical care instructions (including instructions to minimize radiation exposure to family members) is an aspect of the practice of medicine. Unless the NRC can document problems associated with current practice, the provision of such instructions should not be required by regulation.

In summary, I have no major problem with the sections of the Proposed Rule that exempt patients administered radioactive materials from the requirements of Part 20, or with defining specific release criteria (i.e., 35.75 (a)). (Provided, however, that it wi ll be permissable for the licensee to reference the Tables in the Regulatory Guide as the basis for release and not be required to perform patient-specific calculations.) I feel that the requirements included under 35.75 (b), (1) and (2) will result in substantial interpretation and enforcement problems, are unecessarily burdensome to the licensee, and should be eliminated from the final rule. The considerations related to th is latter recommendation are extensive and should be discussed and a consensus opinion formed by the ACMUI. It is my assumption that similar and additional comments and concerns will be forthcoming in response to the Federal Register publication of this Proposed Rule, and suggest that they be considered in total by the ACMU I at its scheduled November 1994 meeting. Sincerely,

    "               -~ (
   /~-* .1t1J/i.' /     . , <'. ~ /' ."'* ... ,:

Dennis P. Swanson, R.Ph., M.S. Member, Advisory Committee for the Medical Use of Isotopes

DOCKET NUMBER PR p OPOSED RULE 2-A (~°!FR 3rr72'-I) DOCKETED USi PC 8816 Deer Valley Drive Huber Heights, OH 45424 July 27, 1994 *94 AUG 26 AS :27 Division of Regulatory Applications Office of Nuclear Regulatory Research U.S .. Nuclear Regulatory Commission Washington, DC 20555-0001

Dear Sir or Madam:

1. I have recently reviewed NUREG-1492 and while I appreciate the concern addressed and the need to reconcile the requirements of 10CFR parts 20 and 35, I have

 ~ome serious concerns about the conclusions reached, the methodology and the accuracy.

2. The regulatory changes will affect no procedures commonly performed other than 1-131 therapies. Therefore I am particularly concerned by the fact that some of the primary data on 1-131 supporting the calculational method appears to be in error and possibly fabricated.

3. The primary determinant of the estimated dose to the member of the general public is the assumed distance from the patient and the fraction of time a member of the general public spends at that distance. For the purpose of calculation the authors selected a reference distance of 1 meter and assumed that an individual is exposed to the individual at that reference distance 25 percent of the time. The only justification for those assumptions is quoted below:

         "The selection of 25 percent of the "Reference dose " for estimating maximal likely exposure is an intuitive judgment based on the authors' judgment of time-distance combinations that are believed likely to occur when instructions to spend as little time as possible to the patient are given. The value is also supported by empirical data. Harbert and Wells (HA74) monitored family exposures of three patients for external exposure. Table 4.9 summarizes key parameters of patient treatments and associated measured doses to family members. The last column of Table 4.9 provides dose estimates that would have been predicted based on the 25 percent Reference Dose Model adopted in this report."

4. Because my own "intuitive judgment" ran counter to the authors', I obtained the 1974 Harbert and Wells article which is attached. In so doing, I found that not one piece of the data in table 4.9 came from the reference article. The changes are summarized below.

5. The Harbert and Wells article reviewed not 3, but 11 patient family summaries.

The three patients with the highest family exposures had been selected and the measured exposures on all family members were changed. The data from the table in NUREG-1492 and the original Harbert and Wells article are: SEP 2 8 1994 AcKnow1a ged by card .........- ..............._..

~. Nui..,L *. *       * ,.. - :~, en* 1ssin

• DOCK::Tl:'1G & SERVICE SECTION OFFiCE OF THE SECRET ARY OF THE COMMISSION Document Statistics stmark Date P/ /o/'-/

                       'f pies Received _ ____,__ _ _ __

d'I Copies Reproduced _3_ __,,--_ _ J;i$i~

Measured Family Harbert &Wells Patient Body Burden Doses (mrem) as Measured

                     ,., nic;,-h!lrOP(mri)            in NlJR~n- 1492      Familv nnc;e (nir .. .,., )

1. 25.2 146 128 55 80 70 30

2. 42.5 20

3. 26.4 91. 36 36 50 20 20

4. 18 .4 146 , 73 80 40 ,0,0

5. 29.7 40

6. 24 .8 40

7. 25 0

8. 29.9 50,30

9. 36.4 30 0 0,0

10. 30 0

11. 22. 3 20

6. Review of the original article as compared to the NUREG table 4.9 data reveals two serious deviations from acceptable scientific procedure. First, data from the source was selected, not reported in toto and there was no evidence in the text that the data was only a partial set. Second and most serious, the data ascribed to the referenced source had been dramatically changed.

7. At best. it would appear that the data was "corrected." This.if it is the case, is still a serious faux pas since the data in the NUREG was incorrectly presented as measured data and a complete data set. If "corrected" this data does little to validate the time and distance assumptions used in the calculational method since then, in essence, calculated data is shown to agree well with calculated data.

8. The alteration of the data was extreme. In the original article, the average measured family member dose was approximately 1.25 mrem for each mCi of body burden.

In the NUREG set of data the average measured family member dose was presented as 3.15 mrem/mCi, a factor of 2.5 change.

9. In many ways, the data contained in this article was the keystone by which the calculational method was supported. The original data supports an estimate of closer to 10 percent of the time at the reference distance of 1 meter; it does not as the quoted paragraph above states, support the author's intuitive judgment of 25 percent.

10. The calculational method with its assumptions about time family members spend ,at the reference distance is the foundation for table 2 in Draft Regulatory Guide DG-8015, which determines which patients must receive instruction and the dosage at which record keeping is required, so changes in the time and distance assuptions have far-reaching effects on the implementation of the program.

1 1. The point of this letter is not to suggest an alternate limit or procedure, but to point out that a scientific document which uses manipulated data is suspect in its entirety. The manipulation of data has undercut the validity of much of NUREG-1492 and Draft Regulatory Guide DG-8015. These documents need to be revised and reviewed by parties who played no part in the misrepresentation of facts in NUREG 1492. RM J r

,'l-,. L<..bo-;..,__

SUSAN POTEAT

jD.Jll/ CONCISE COMMUNICAT ION RADIATION EXPOSURE TO TH E FAMILY OF RADIOACTIVE PATIENTS John C. Harbert and Sister Nola Wells Georgetown University Hospital, Washington, D.C. Eleven patients treated with 131 1 for thyroitl tine personnel monitoring at our hospital. Control

• carcinoma or thyroid ablation anti their imme,li- films from the same lots gave negative readings in all ale family members were monitored by film cases. Known exposure controls were not used. All badge for racliation exposure. The results indi- badges were transported to and from the laboratory caterl that the current AEC regulation permitting to the patients' homes in lead containers which also a patient bod,* burden of 30 mCi at time of hos- contained the control film.

pital discharge is conservative. RESULTS Patients treated with large doses of 131 1 for thyroid AEC licensing regulations generally require that cancer (Table 1) were hospitalized until body re-patients who receive therapeutic 131 1 be hospitalized tention was Jess than 30 mCi except for Patient No. 2 until the radionuclide burden falls below 30 mCi. who lived alone with an elderly wife where a burden The National Council on Radiation Protection and of 42.5 mCi was not considered a public hazard. Measurements (NCRP) has set forth many recom- The highest absorb.~d dose readings among 11 rela-mendations for the behavior of visitors and relatives tives was 80 mrad. Patients who underwent thyroid or temporarily radioactive patients. NCRP Report ablation for a variety of causes, usually intractable

o. 37 (]) contains a detailed and complex set of angina (Table 2), were given doses under 30 mCi conditions pertaining to patients discharged from to avoid hospitalization. These patients would ex-hospital with burdens greater than 8 mCi of 1 " 11. crete most of the administered activity in the first We are frequently asked by patients, particularly 24 hr and relatives' film readings were, therefore, those hospitalized with large doses of 131 1, what risks generally lower. Patients were asked to judge the they may cause family and friends. Because we know faithfulness with which relatives wore their badges.

of no report bearing practically on this subject and An attempt was made to determine the extent of the AEC has considered iowering permissible bur- contact between the patient and each family member dens (2), we undertook the following study. but this was too uncertain to be reported. Estimates of total do,e (0 00) to relatives was ex-METHOD trapolated from the known absorbed dose (0") re-Patients treated with moderate-to-large quantities ceived by each relative for a duration of n days of Na 181 l for thyroid ablation or cancer were according to the equation given film badges for themselves and members of their immediate family. Patients and family 0oo = 0,./(1 - e-n~) members were instructed to wear their badges on where >.. is the effective decay constant, 0.693/T,.rr their waist belts at all times during the day for 8 and T,.r, = 7.6 days. days. They were asked to relate to the patient as Using this equation the highest exposure of 80 normally as possible. The patients were instructed mrad to a family member would extrapolate to a to sleep alone and to keep contact with infants at a minimum during the 8 days but no other precau-J tions were advised. Received Feb. 13, 1974; revision accepted April 29, 1974.

• The film badges were a commercial multiwindow, For reprints contact: John C. Harbert, Dept. of Nuclear I tnultifilter. automatic orocessed tvoe used for rou-Medicine, Georgetown University Hospital, 3800 Reservoir Rd .. NW Wnshinl!ton T) .C. 20007

HARBERT AND WELLS TABLE 1. FAMILY EXPOSURE FROM PATIENTS TABLE 2. FAMILY EXPOSURES FROM PATIENTS TREATED FOR THYROID CARCINOMA TREATED FOR THYROID ABLATION Body Total 2-'*hr Exposure Family Total burden ol Exposure Family Po. dose uptake Time dose, Po* dose discharge time dose, lienl (mCi) 1%) (doy1) (mrod) tient (mCi) (mCi) (days) (mrod) 5 29.7 10 7 -40 1 210 25.2 8 80,70,30 6 2,.8 9 6 ,o 2 219 ,2.5 2* 20 7 25.0 10 8 0 3 311 26 ..C 8 50, 20, 20 8 29.9 55 8 50,30 80, ,o, 0, 0

                "         209          18.-4        8 10 9       36 ..C 30.0          '*"

10 7 8 30,0, 0, 0 0

• Died ofter 2 doy1 from unrelated cau1e1. 11 22.3 12 8 20 maximum of 130 mrad, well below the permissible It may be prudent for therapists treating patients yearly exposure of 500 mrad. with large doses of radioiodine to monitor family members having the greatest exposure to the patient.

DISCUSSION If cumulative film-badge readings for 8-day periods

'J. -

• The National Council on Radiation Protection and Measurements (I) has stated that patients may be discharged with a burden of 8 mCi mi I without restrictions. This burden is based on an exposure rate of 1.8 mRhr at 1 meter, which would result in 500 mrad if exposed to infinity. Clearly the likeli-approach 260 mrad ( which yields D co =

mrads ), additional precautions for the patient's fam-ily may be necessary. Our findings indicate that there

• is insufficient reason from a public health standpoint to lower currently allowed burdens of 1 ~ 1 I at time of discharge from the hospital. Such a step would in-500 hood of such prolonged close proximity is remote. crease health care costs unnecessarily.

If no household member is under 45 years of age, the permissible discharge burden is 80 mCi which ACKNOWLEDGMENTS would conceivably result in 5 rads if exposed for The authors wish to thank Kenneth Mossman and Gregg the effective life of the radionuclide. The AEC has Becker for valuable assistance in the preparation of this selected a burden between these two figures of 30 communication. mCi, but is currently considering lowering the per-missible patient burden at time of discharge from REFERENCES the hospital (2). On the basis of this study we feel that current AEC regulations are conservative and J. Precautions in the management of patients who have received therapeutic amounts of radionuclides. NCRP Report family members are unlikely to receive the per- No. 37 : Washington, DC, NCRP Publications, October, missible dose of 500 mrad/year as a result of asso- 1970 ciation with patients discharged with currently al- 2. Personal communication: John Boyer, Division of lowed radionuclide burdens. Material Licensing, USAEC 888 JOURNAL OF NUCLEAR MEDICINE

Table 4.9 Family Doses from Patients Treated for Thyroid Carcinoma Predicted Measured Dose Based on Total Body Burden Doses to 25% of Activity at Time of Family Reference Administered Discharge Member Dose Patient (mCi) (mCi) (mrem) (mrem) 1 210 25.2 146, 128, 55 176 2 311 26.4 91, 36, 36 184 3 209 18.4 146, 73 128 Source: HA74. may reach levels as high as 75 to 80 percent

                                                                                       -0.693t            -0.6931 (ST88).                                                                               T. 1                           (8)

R(t) = F 1 e * +F.e--r;- 2

• Since elemental iodine is heavily concentrated in the thyroid gland, iodine-131, a beta-gamma where F 1 + F 2 = 1.0 ; and where F 1 and F 2 emitter, has found extensive applications in represent the extrathyroidal and diagnostic and therapeutic procedures involving thyroidal fraction of iodide, the thyroid. Owing to its physical, chemical, and respectively, biological characteristics, iodine-131 is the most frequently used therapeutic radiopharmaceutical Tb1 = biological half-life of and thus of primary concern in a discussion of extrathyroidal iodide, regulatory release criteria.

Tb2 = biological half-life of iodide Biological Half-Life following uptake by the thyroid, The biological half-life of elemental iodide is t = time after administration of primarily governed by metabolic utilization and iodide. retention of organified iodide. For euthyroid conditions, the thyroid releases approximately 60 Because radioactive nuclides of iodine are also to 100 µg of hormonal iodide daily. Empirical lost by radioactive decay, the retention equation studies by Dunning and Schwarz (DU81) show Eq. (8) must be modified accordingly: that the elimination of iodide from the thyroid

                                                                                       -0.693 I           -0.693 I among individuals may vary with biological half-                                                                     (9) lives of 21 days to over 300 days. Under condi-                        R(t) = F1 e    T14       + F2e    Ti4 tions of extreme hyperthyroidism ( e.g., Graves' disease), enhanced elimination of iodide may               where reach biological half-life values as short as 7 days (ST88).                                                                                    T1,1XTP                  (10)

Tlqf = T,, 1 + TP' The Quantitative Assessment of the Uptake, Retention, and Excretion of Iodine-131 T,.2 :xTP (11) There is general agreement that retention of .~ Tz4 = T,, + TP' 2 stable iodide introduced into the blood stream declines with time according to a two-term exponential equation (ICRP79): and T,, = the physical half-life of iodine-131. NUREG-1492 16

TIE lNNER.5I1Y OF TEXA.5 MDANJERSON DOC :ETED ~ USNRC ~ CANCER CENTER

                                                                                                   *94 AUG 25 P5 :42 DOCKET NUMBER PROPOSED RULE        PR   '2-0 3                                      OFF ICE OF SE:.:RE. TARY E. Edmund Kim, M.LUOCKE TWG & :'t.R',* 1CE August 16, 1994              (~qf:R'3072s)                           Professor of Radiology & Medi
                                                                                                                      "-lv,..M Chief, Experimental Nuclear Medicine Director, Center for Metabolic Imaging 1515 Holcombe Boulevard Houston, Texas 77030 Tel: 713/794-1052 Fax: 713/794-5456 Secretary, U.S. Regulatory Commission Attn: Docketing and Service Branch Washington, D .C. 20555

Dear Sir/Madame:

This letter is in support of the Nuclear Regulatory Commission's proposed regulatory guidelines from the Federal Register Volume 59, Number 114, dated June 15, 1994. I have reviewed the proposed rules and summary and support them fully . Should you require further information, please do not hesitate to contact me. e Respectfully , l,;µlf~,~ E. Edmund Kun , M.D . ~

 /dpo TEXAS MEDICAL CENTER 1515 HOLCOMBE BOULEVARD

• HOUSTON, TEXAS 77030 * (713) 792-2121 5t:p 2 8 1994, A ",v, I uu~

                                                                                  .;;;I
                                                                                          \,

1 card ................................

  ,.,_,,...,"-'*                    . -'-*>Mi:5::ilON

[)QC'\£: ilf\G j ~E.rMCE SECTiON OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics ,CS1ma11t Date Y 9-'/C, L-/ /J Copies Received _ __ _ _ __ Add'I Copies Reproduced ~ - - - - 6Pecial Distribution fl.:{,tJS. pril! . sc.hn.&i~ ~

DOCKETED USURC American Medical Laboratories, Inc.* 14225 Newbrook Drive P.O. Box 10841

                                                                         *94 AUG 24 P4 :25 Chantilly, Virginia 22021 -0841 703-802-6900 OFFI C'":. r_l~ .3ECPE lt RY OOCKE TI HG 3 c-,t R ICE August 16, 19~ /.i.HCH Secretary U.S. Regulatory Commission Attn: Docketing and Service Branch Washington, DC 20555

Dear Sir:

As a nuclear medicine physician, I wish to congratulate the NRC on the proposed regulations regarding the criteria for the release of patients administered radioactive materials which appeared in Federal Register Volume 59 Number 114 dated June 15, 1994. The portion that I refer to begins on page 30729. These regulations, when implemented, will help in the providing of nuclear medicine services to patients. Again, thank you. Sincerely, lr~oi.1~ President and CEO IDG:klp SEP 2 ~ i9M I Acknowledged by card ................................,a

  ., ** I                           .

00(.;l\c. , "'"' - v - . . ,vc ~t:Cl ION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics l'astmark Date P / 11-/ 11./ Coples Received _ ___,__ _ _ __

Add'I Copies Reproduced _J.__--.-.-:.-r- -

'Specfal Dis ri i ~ f.JiJk

DEPARTMENT OF VETERANS AFFAIRS OOC XETfO Medical Center Hampton VA 23667 US NRC @) DOCKET NUMBER p *94 AUG 22 PS :53 PROPOSED RULE 2 0J5 ( Sqrf. 301 J..LJ) August 18, 19 94 Secretary, u. s. Nuclear Regulatory Commis s i on Attention: Docketing and Service Branch Washington, D.C. 20555

Subject:

Federal Register Volume 59, Number 114, Dated June 15, 1994 Please accept this letter as my "yes ** vote to express my support to the proposed rules published in Federal Register volume 59, number 114, dated June 15, 1994 regarding "Criteria for the Release of - Patients Administered Radioactive Material." Thank you. Sincerely, 1\<-lkj\__ T. K. CHAUDHURI, M.D. Professor and Chief, Nuclear Medicine Service

                                                                            \

SEP 2 8 1994 Ackn~wl dged by ~rd ...................--,, .,.

                                                        * - *  ::q -

\f,~. h..... * , ,.,,* OOCKE "I ,,. - .- , ~- ..,L(, I ,ON Off 1;:,t o- WE SECRETARY 0 THE CO ISSION Docume t StatistiCS fostmark Date ~--I J..- / Cf t.,J

                             -,-a---'-----

0>pies Recei~ _ _ _/ _ _ _ __ Md'I Cop,es Rcpr uced _____,_ _ _ ~ ia! * * * /!i:JIZ.,

 'Sc_

DOCKETED THE UNIVERSITY OF TEXAS us.me

• _;._ HOUSTON I: :J HEALTH SCIENCE CENTER AUG 22 p SMJdical School Department of Radiology OF FICE Cf :: :..CRET/~ RY DO Ctff f!I , ~ & ~-~-.R'1 1r;f BRJ~NCH August 16, 1994 DOCKET NUMBER PROPOSED RULE PR 2. O ' S Secretary U.S. Nuclear Regulatory Commission (SCf FR :J D7.2-'-/)

Washington, D.C. 20555 ATTN: Docketing a11d Service Branch RE: 10 CFR Parts 20 and 35 Proposed Rule on Criteria for the Release of Patients Adminivtered Radioactive Material a11d Draft Regulatory Guide DG-8015 e11titled Release of Patients Administered Radioactive J}faterials.

Dear Secretary:

• In general, I support the adoption of this rule. However, I would like the NRC to pursue all means of reducing unnecessary documentation and paper work. I have the following proposals to help meet that goal:

1) The NRC proposes to require an additive rule to determine the release of patients who receive multiple adn1inistrations of radioactive material. That is, if an individual receives multiple administrations at separate times, then the physician must add the potential exposures to individuals from these multiple administrations to assure compliance with the 0.5 rem lim_it. This .is unnecessary. The additive rule is an attempt to guarantee 100% compiianc.;e with criteria ihat are already conservatively safe for the general public. The costs in time, effort, and money to track down records on previous administrations, to perform calculations and to docwnent all work is wholly unnecessary, not appropriate, and grossly underestimated by the NRC.

If there were multiple releases of the san1e patient who had received radioactive material, then there would be a very rare incidence wherein a member of the public might receive more than 0.5 rem per year from this individual. Even if there were 10 administrations that theoretically might result in a one time 5 rem dose to someone, why is this rare event so terrible when occupational employees can receive that type of dose as an acceptable limit? The main concern for the NRC is whether or not multiple administrations ar~ done roulinely, since this might represent a dose in excess of 500 mrem to a substantial number of individuals. They are not UT-Houston Medical School

• 6431 Fannin
• Room 2.132 M.S.M.B.
• Houston, Texas 77030 * (713) 792-5231 Located in the Texas Medical Center SEP 2 8 1994 I Acknowledged by card .............."'.................

0Ol,I',_' I,'-:.,¢.;

                                               . ........... i-........
                          ...... tiJl(;t SECTION OFFICE Of THE SECRETARY OF THE COMMISSION Document Statistics "M>stmar1< Date  __,~--=--=-,,..,'--'-....:-.-,..:;._,

Copies Received _ _ __.,___ _ __ Add'I Copies Reproduced ~ - - -- Special Distribution fl ;t Y) (,)Ofl..t S c1'. n .e.., tA .,",--, 1

Secretary U.S. Nuclear Regulatory Com RE: 10 CFRParts 20 & 35 August 16, 1994 Page done routinely. As it stands it appears to be an unnecessary burden to try to guarantee I 00% compliance with an already very safe rule. One concern of the NRC might be that, if the additive rule were eliminated, some practitioners might want to bypass the release rule by breaking up a single administration into multiple administrations. Although this is not likely to occur, it can be easily eliminated by making the additive rule apply only to planned multiple administrations rather than incidental multiple administrations.

2) The regulatory guide proposes to provide guidance regarding activities below which patients may be released but does not take into account the biological half-lives of pharmaceuticals. I believe it would be more helpful to establish release criteria based upon the biological as well as the physical half-lives of the radiopharmaceuticals. A committee should be drawn up to establish a more complete table for release criteria with a wide range of radiopharmacy materials so that it will not be likely that individual users will have to perform lengthy calculations in order to ascertain on an individual basis whether or not a patient may be released. For individuals to have to repeat calculations on others and repeat work of others is unnecessary.

3) It is not appropriate to require that individuals keep a record of the calculated total effective dose equivalent to an individual likely to receive the highest dose and to maintain this record for three years. If the table in my recommendation #2 is developed, then there would be no need for anyone to keep a record of these calculations on an individual basis. If there are planned multiple administrations, then the physicians responsibility might be to verify that the planned multiple administration would net exceed' the 500 mrem limit 1'ut, since this would be a simple addition function, given my recommendation in item 2, then there should be no real need to provide any record of calculations for later inspection.

4) There are major difficulties when one considers the potential for exposure to a nursing infant or a conceptus of a pregnant patient. These are special circumstances that should be considered by the medical practitioner when providing care for such patients. An analogy with prescription drugs is appropriate. Just as a physician should discuss with a patient the appropriate risks, precautions and recommendations regarding the use of certain drugs while pregnant or while nursing, so to the physician has the responsibility to discuss the analogous matters regarding radioactive materials. Just as the patient is advised to keep drugs away from children, so to there may be advice to avoid certain activities that may unnecessarily expose the child to radiation. However, these are medical issues for the immediate

Secretary

• U.S. Nuclear Regulatory Com RE: JO CFR Parts 20 & 35 August 16, I 994 Page family, not regulatory issues for protection of the public. The physician's medical responsibility is to work with the patient and provide appropriate advice. There is no need for the NRC to interfere in these medically oriented issues. All sections relating to these issues are unnecessary and should be abandoned.

Very sincerely yours,

 ~~

Professor (713) 792-5235 ex 670 (FAX) 792-5023 (E-MAIL) I:lwagner@image30.med.uth.trnc.edu LKW/mkp (c:\wpwin60\docs\lettenlnrcdraft.ltr)

State of North Carolina Department of Environment, Health and Natural Resources Division of Radiation Protection James 8 . Hunt, Jr., Governor Jonathan 8. Howes, Secretary Dayne H. Brown, Director August 10, 1994 DOCKET N BEA PROPOSED RULE...:...;;.;;._ _ p :;. _ 0 35 i.il

                                                                                                                         .I:,:,

Secretary ( 5q FR 30~2. '-i) U .S. Nuclear Regulatory Commission Washington, DC 20555 Attn: Docketing and Service Branch PrOJ)osed Rule-Criteria for the Release of Patients Administered Radioactive Material I support the first recommendation stated in section IV (Coordination with NRC Agreement States). This recommendation is for revising 10 CFR part 20 to exclude doses to individuals exposed to patients released under 10 CFR 35.75 .

• I do not see how the NRC plans to regulate a patient once they have left the hospital. Also, I do not believe you can confine a patient to their home. I think giving instructions to the patient is a good idea. I don't agree with changing the dose limits to 500mRem in 1 year for individuals exposed to patients, because this is dependent upon whether the patient follows the directions given. How can the NRC enforce dose limits without an enforcement policy? Is the NRC planning on going home with each patient and monitoring his/her activities to insure the people who spend significant time around this patient do not exceed the 500mRem?

SCENARIO: Bob's elderly mother has a Thallium Stress test in February 1995. She lives with Bob and is sent home after the test is completed. Bob's 14 year-old adopted daughter has bone pain and has a bone scan (Tc-99m) in June 1995. Bob's 42 year-old wife has hyperthyroidism and receives 150mCi of 1-131 in September 1995. Once she is down to 30 mCi the hospital releases her and gives her instructions. She gets home and realizes after 3 years of therapy to help her ovulate, she is finally ovulating. I realize this is a strange scenario, but if you do not know the surrounding individuals history, how can you implement this 500mRem/year. How are you going to stop Bob from trying to get his wife pregnant, since they have spent thousands of dollars in therapy and they are both getting older and may not be able to have their own kids? Bob has already been exposed earlier in the year to his mom and daughter. How is the NRC planning to accumulate these doses to assure Bob does not exceed the 500mRem/year. P.O . Box 27687, Raleigh , North Carolina 27611 -7687 Telephone 919-571-4141 FAX 919-571-4148 An Equ a l Oppo rtunity Affirmative Ac ti o n Emp loye r 50 % re c yc led/ 10% post consumer pa er '2. \S9' A "' I

NUCU:.AFi 11~ . :_,_;,. I Oi-i V COMMISSION OOCKETi ~G & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Docvrnent Statistics Postmark Date --1.L--->----L-.1"--!.....- - - Co pies ReceiV('d _ _ _~ - - - - dd'l Copie Rep p icir\l Dis I iJ :o, _Yl]:: );7~ ft21z 1 _ _5V'\n.ll.. l ti_t,,~

page 2 8/10/94 NRC My recommendations agree with but are limited to:

1) Revise 10 CFR part 20 to exclude doses to individuals exposed to patients released under 10 CFR 35.75.

2) Retain the current 30mCi activity limit for iodine-131 and the maximum dose rate of 5mRem/hour for patient release.

3) \\'hether the NRC defines the word confinement or not, I do not see how you plan to confine a patient to his/her house unless you plan on enforcing this rule (which I would like to know how, if you plan to do this). To define confinement, it must only be addressed to those areas we have regulatory authority over.

4) Written instructions should be given to the patient. H these instructions were to be given to everyone who will be spending time around or in the close proximity of the patient, this could be a long list and a time consuming job. H you educate the patient, he/she can take care of the surrounding people by not being around them.

The patient is the controlling factor in this matter. Thank you for reviewing these comments. Sincerely,

 ~ W>>3/4P~,A,

- Wendy B. Tingle, Health Physicist Radioactive Materials Section Division of Radiation Protection State of North Carolina

ONE HUNDRED 100 Medical Plaza Imaging Medical Corp.

 *******************                                                                       100 UCLA Medical Plaza, Suite 100 F~MPIP                                             oocKE1EO USHRC Los Ange les, CA 90024-6970 310-824-3933 FAX 310-824- 1000

• *94 ~UG 22 1\11 :Sll OfFICl Of~

oocKETiwANCH

                                                              .)f cilJ~rcl DOCKET NUMBER PROPOSED RULE              PB 20 35 (Sif/(307~'1)

August 17, 1994 Secr etary U.S. Regulatory Commission Attn: Docketing and Service Branch Washington, DC 20555

Dear Secreta ry:

I received a copy of the federal reg i ster, volume 59, No. 1 14, dated J u n e 15, 1994, relating to the Nuc l ear Regul atory Commission 10 CFR parts 20 and 35, RIN 3150-AE4 1 , criteria for release of patients administered radioactive material. I would like to congratulate the NRC on the proposed regulations; t h ey are e x ce l lent and I support them wholeh earted l y. Thank much for a job we l l done. Darwood B. Hance, M.D. Di plomate, American Board of Radiology Fel l ow, American College of Radio l ogy Assoc i ate Clinical Professor of Radiology, UCLA DBH:rj Michael M. Edelstein, MD, DABR, DABNM A full service radiology group located on the UCLA campus Darwood B. Hance, MD, DABR, DABNM M RI

• CT
• SPECT
• Nuclear Medicine
• Ultrasound
• Color Doppler Marvin Weiner, MD, DABR Mammography
• Radiography
• Fluoroscopy
• Intervention
• Needle Biopsy 8 1994 A by ea. ......~""'""""""

NUCLt.A, 1 r. _..... ...A I ORY COMMISSION DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistia! Fostnar1< Date JJ-/ J ~I '--/ Copies Received / -Add'I Copies Rep-rod-.,u-coo_ 1___ __ Special D:stribiJf.on }2;r; 5c,,bn-e, d:L ~

                                 ~t fJo.'4

DOCKET NUMBER oo c:~ETEO PROPOSED RULE ;2 0 lJS~RC August 17, 1994 (rq FR 30,2'-/J

                                                       *94         22 All :5 3

• COMMENTS OF OHIO CITIZENS FOR RESPONSIBLE ENERGY , INC.

ON PROPOSED RULE, "CRITERIA FOR RELEASE OF PA'llfENT6 =A-Dt1_-!ttlf ~# ED RADIOACTIVE MATERIAL," 59 FED. REG. 30724 (JUtOO 16 )J.t~ ~4 ~' */re[ I);(/ While not taking a position on other parts of the proposed rule, I .:, ("OCRE") OCRE would address proposed 10 CFR 35.75(b)(l), which requires that written instructions be given to patients who are likely to expose another individual to a TEDE greater than 0.1 rem in a year from a single administration. To the extent applicable, these comments should also be considered as comments on Draft Regulatory Guide DG-8015. OCRE believes that, to promote the ALARA principle, instruc-tions, both oral and written, should be given to all patients who have been administered radioactive materials, regardless of the dose which they are likely to give to others. Limiting patient education to only those persons likely to expose others to great-er than 0.1 rem is a retreat from the ALARA principle. Educating all nuclear medicine patients would reduce the exposure of oth-ers, thereby preventing radiation-induced disease and thus lower-ing health care costs. In addition to providing written instructions, licensees should also explain the instructions orally. This is necessary for patients who may have poor eyesight, or who may be illiterate or who may have difficulty reading English because a foreign lan-guage is their primary language. Adult illiteracy is a problem in the United States, and a growing percentage of the population has another language as the primary language. People who have trou-ble reading English are not likely to admit this to licensee personnel. Also, oral, in addition to written, instructions, would give the patient the opportunity to ask questions of licensee personnel in person, and would allow licensee personnel to assess the patient's degree of understanding of the instruc-tions. Oral explanation would also reinforce the importance of the instructions. Patients may not bother to read the written instructions, may lose the instructions, may hesitate to call the licensee if they have questions, or may not be able to reach licensee personnel by phone in a timely manner. For patients for whom English is not their primary language, the written instructions should be provided both in English and in the primary language of the patient. Respectfully submitted,

        ~;L~

Susan L. Hiatt, Director, OCRE

• 8275 Munson Road Mentor, OH 44060-2406 216-255-3158 SEP 2 8 1994 ~

Acknowledged by card .............."........""'"'

., * . . _ * , , ' I .... , . ~.JN DOCKETiNG & SERVICE SECTION '

OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics tPostmar1< Date _£. f-. qLf Qipies Received ___ _.__ ____ Add'I Copies Reproduced 3 Special Distribution fJ-. - )-~ -. P Y -,,,--,n,--~-.-.- t;'.,;:..,h V\ L v

DOCKET NUMBER PROPOSED RULE I 2 OJ 35 Cf°! FR 3o7,s-J DOC KETED American Association of Physicists in Medicine US RC Office of the President *94 AUG 22 A1 1 :40 Ravinder Nath, Ph.D. Yale University School of Medicine Dept. of Therapeutic Radiology OFFI CE OF SECRE rARY 333 Cedar Street OO CKETl l;G & SERVICE New Haven, CT 06510 August 9, 1994 BR AHCH (203) 785-2971 FAX: (203) 737-4252 Secretary US Nuclear Regulatory Commission Washington DC 20555 e ATTN: Docketing and Service Branch FE: Proposed rul e on criteria for the release of patients administered radioactive material.

Dear NRC:

• The American Association of Physicists in Medicine is an association of over 3,000 medical physicists dedicated to the application of physics in medicine. The AAPM Radiation Protection Committee has asked me to request an extension of the deadline for comments on the proposed rule on criteria for the release of patients administered radioactive material. Conflict between part 20 and part 35 of 10CFR is complex and the AAPM believes additional time should be allowed for comments .

If you have any questions, please contact me. Sincerely, RN/dj Ravinder Nath, Ph.D. AAPM President c: EXOOM, C Kelsey, J Purdy. SEP 2 8 1994. aapm\lets-94 Acknowledged by card ... --**IAI*=::::::. The Association's Scientific Journal is MEDICAL PHYSICS. Member Society of the American Institute of Physics and the International Organization of Medical Physics.

1 S,. Lt:1-\n : ,;_ \_._ ~ ",..,n ~ vV1\/11v11.:i::i10N 000<:ETING & SERVICE SECTION OfFICE OF THE SECRETARY OF THE COMMISSION Document Statistics m oate pies Received _ _-= e-h 2 /9V / ,--_ _ __ Mrl Copies Reproduced .....___ _ __

          *a1 Distribution

_ <?c<hb.e 12IY2f.

                             ~h~              1 f!Jn(), .

I

ONE HUNDRED 100 Medical Plaza Imaging Medical Corp.

 *******************                                                                 100 UCLA Medical Plaza, Suite 100 DOCKiTED
 ~~~M:PI                 ~~

Los Angeles, CA 90024 -6970 USNRC 310-824-3933 FAX 310-824- 1000

                                               *94 Aur:; 19 P4 :48 OFFICE CF SECRETARY DOCKETING & SERVICE BRANCH DOCKET NUMBER              PR               5 PROPOSED RULE                    ;LO August 15, 1994

( 5CJ FR 3012S) Secretary, U.S. Regulatory Commission Attn: Docketing and Service Branch Washington, D.C. 20555

Dear Sir:

Please accept this letter as my full support for the Nuclear Regulatory Commission, 10 CFR Parts 20 and 35, RIN 3150-AE41, Criteria for the Release of Patients Administered Radioactive Material proposed rule. Please note that I am strongly in support of the Nuclear Regulatory commission's proposed rule to amend its regulations concerning the Criteria for Release of Patients Administered Radioactive Material. New criteria will be dose based rather than activity based, and will be consistent with the recommendations to the International Commission on Radiological Protection. Again, please accept my support for this proposed rule. Thank you. Michael M. Edelstein, M.D., FACR, FACNM

• Michael M. Edelstein, MD, DABR, DABNM Darwood B. Hance, MD, DABR, DABNM MaNin Weiner, MD, DABR A fu ll service radiology group located on the UCLA campus MRI
• CT
• SPECT
• Nuclear M edici ne
• Ultrasound
• Color Doppler Mammography
• Radiography
• Fluoroscopy
• Intervention
• Needle Biopsy SEP 2 8 1994 ~

Acknowledged by card ......"--*--**--

' ~* I , - W1,, I\~ '

                    ~ ~t    I
                                'I '* (

OFFICE Ot- iHf:. .:,t. FIETARV OF THE COMMISSION Document Statfslics

                                     ~(  I
                                            * ,:,jt.,."1 foslmarl( Dale             I 6 / 9 '-/

O,ples Received- - -:3.:--- / --- Add'I Copies Reproduced 3 Special Distributi9n J2I.-P-i ~ -: ~

                                        ----,~~

5din£1Jer:~ - --~

• ONE H U NDRE D 100 Medical Plaza Imaging Medical Corp.

100 UCLA Medical Plaza, Suite 100 InMPln Los Angeles, CA 90024-6970 DOCKE1ED 310-824-3933 FAX / US NRC 310-824-1000

• '94 AUG 19 P4 :49

                                                ,- ~ ' ' -                 DOCKET NUMBER OF fl Ct Or SEC RE iARY PROPOSED RULE DOCKE TING & SERVICE                   /J PR    :J.._ e,

_) BRANCH lS'o/ FR 30725 August 15, 1994 Secretary, U.S. Regulatory commission Attn: Docketing and Service Branch Washington, D.C. 20555

Dear Sir:

Please accept this letter as my full support for the Nuclear Regulatory Commission, 10 CFR Parts 20 and 35, RIN 3150-AE41, Criteria for the Release of Patients Administered Radioactive Material proposed rule. Please note that I am strongly in support of the Nuclear Regulatory Commission's proposed rule to amend its regulations concerning the Criteria for Release of Patients Administered Radioactive Material. New criteria will be dose based rather than activity based, and will be consistent with the recommendations to the International Commission on Radiological Protection. Again, please accept my support for this proposed rule. Thank you. Respectfully yours,

          ~ JM.D.,                         FACR, FACNM Michael M. Edelstein, MD, DABR, DABNM            A full service radiology group located on the UCLA campus Dorwood B. Hance, MD, DABR, DABNM                MRI

• CT
• SPECT
• Nuclear Medicine
• Ultrasound
• Color Doppler Marvin Weiner, MD, DABR Mammography
• Radiography
• Fluoroscopy
• Intervention
• Needle Biopsy
• Ackn !edged by card ... ~.1.!..1J!.i..-:::
• h .., \., _ _ ~ .

DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY

                                  ., , ~ """°' i1l:*, a\ol~t ,'4 OF THE COMMISSION Document Statistics 1Poslmat1t ~le            1-I l b I c; '1 fA>pies Received                         /

Add'I Copies Reproduced - ~- - - 6pecial Distribu *on /J..:t.f.h. Y!fJ[s. - ~cl~ /

ONE HUNDRED 100 Medico! Plozo Imaging Medico! Corp. n~MPln DOCKETED Los Angeles, CA 90024 -6970 310-824-3933 FAX 100 UCLA Medico! Plaza, Suite 100 j/ US~IRC 310-824- 1000

• *94 AUG 19 P4 OFFICE OF SE(~Rr.:-TARY DOCKETING.~ SERVICE

so DOCKET NUMBERPB PROPOSED RULE

( 5q f R Jo 7.25j

                                                                                                             ;LO ,

J 3S BRANCH August 15, 1994 Secre tary, U.S. Regulatory Commission Attn: Docketing and Service Branch Washington, D.C. 20555

Dear Sir:

Please accept this letter as my full support for the Nuclear Regulatory Commission, 10 CFR Parts 20 and 35, RIN 3150-AE41, Criteria for the Release of Patients Administered Radioactive Material proposed rule .

• Please note that I am strongly in support of the Nuclear Regulatory Commission's proposed rule to amend its regulations concerning the Criteria for Release of Patients Administered Radioactive Material.

than activity based, New criteria will be dose based rather and will be consistent with the recommendations to the International Commission on Radiological Protection. Again, please accept my support for this proposed rule. Thank you. r!h, fJ Marvin Weiner, M.D., Di BR M ichael M. Edelstein, MD, DABR, DABNM A full service rad iology g roup located on the UCLA campus Dorwood B. Hance, MD, DABR, DABNM MRI

• CT
• SPECT
• N uclear Medici ne
• Ultrasound
• Color Doppler Marvin Weiner, MD, DABR Mammography
• Radiogra phy
• Fluoroscopy
• Intervention
• Needle Biopsy Ac now! dged by card ** ~~~!..!!..~
• L-~ * *

                                   .  *. ( .Jt.'li,, .
               ~ .* :.: 'i .' 1:..:. .$E:t. 1ION OH';,. t :) l hE SECRfTAAV OF THE COMMISSION
                                                       .,~;j. *:*. *

/

ONE HUNDRED 100 Medical Plaza Imaging Medical Carp.

 *******************                                                                      100 UCLA Medical Plaza, Suite 100
 ~~;M:PI~~

O0Ct<ETED uSNFC Las Angeles, CA 90024-6970 310-824-3933 FAX 310-824-1000

                                                                                                                       ~//J
                                                                                                                       \:_o/
                                                    *94 AUG 19 P4              :so Or    ,_ - ?.:.l RETA RY O0Cl~t ';"'. <. ,;_ St.RVICE DOCKET NUMBER t~RANCH                 PAoPosEo RULE             PR 2a

(.f&f F-P. '30125) August 15, 1994 Secretary, U.S. Regulatory Commission Attn: Docketing and Service Branch Washington, o.c. 20555

Dear Sir:

Please accept this letter as my full support for the Nuclear Regulatory Commission, 10 CFR Parts 20 and 35, RIN 3150-AE41, Criteria for the Release of Patients Administered Radioactive Material proposed rule .

• Please note that I am strongly in support of the Nuclear Regulatory Commission's proposed rule to amend its regulations concerning the Criteria for Release of Patients Administered Radioactive Material.

than activity based, New criteria will be dose based rather and will be consistent with the recommendations to the International Commission on Radiological Protection. Again, please accept my support for this proposed rule. Thank you. Res/~ fully~ ours

         ~tall.                          . ,,~~

J. Leonard D vis, M.D., DABR Michael M. Edelstein, MD, DABR, DABNM A full service radiology group located on the UCLA campus Darwaod B. Hance, MD, DABR, DABNM MRI

• CT
• SPECT
• Nuclear Medicine
• Ultrasound
• Color Doppler Marvin Weiner, MD, DABR Mammography
• Radiography
• Fluoroscopy
• Intervention
• Needle Biopsy SEP 2" _

Ackncw,edged by card ............ 8 19~__

i UUlA\t: I NUMt;t:H p PROPOSED RULE~ - ~ ~ (SCJ FR 3 RICHARD D. LIN DGREN 6006 GREEN TREE ROAD MADISON. WISCONSIN 53711 DOCKETED USNRC TELEPHONE 271 -4494 August 14, 1994

                                                                        *94 AU 19 P4 :51 Secretary , U. S . Regulatory Commission                         OFFI CE OF SECRETARY Att n : Docketing and Service Branch                             DOCK ETING & SERVICE Washington , D. C. 20555                                                        BRANCH

Dear sirs :

(j) I have reviewed the proposed regulatory guidlines from the Federal Register, Volume 59 , number 114, which is dated June 15, 1994 . I am a Nuclear Medicine Physician and Radiati on Safety Offi ce r for sev e r al hos pitals in this area. I support this new ru l es . There is a need t o revise the current thirty millicurie rule , and these new rules should result in better patient care at less c ost . There should be very little problems with dose to non-medical personel. I would hope that the new rul e s will be approved . Yours truly,

      ,/J
   ~             Li ndgr-  , M. D.

• SEP 2 8 1994 Acknowledged by card ..................................

_ . ,.. ..J-1v, ~ OOCr<.t: 1,hG o. vui '1"'E SECTION OFFICE OF THE SECRET ARY OF THE COMMISSION Document Statistics

   ~art( Date - ~ ~ ~ - - - - - - -

Copies Received _ _ __ _ _ __ ltdd'I Copies Reproduced ____ _ _ __ lpecial Distribution YJJ:,. 11~ ffJR., , JLq"

                       ~d.~~~?2.

4Sod'JY~ JYk/~~ DOCK *1 E[ 1 S R (j)

                     / j g ~ ~ . ~ 4'd'.flJ/-//4'IJ-g4 AUG 18 PS :14 August 15, 1994              OFF ICE Or )r.W.r ;t,~f~o.tltloJ' OOCKE flNG & ~,t H IC E ANCH Secretary of the Commission, U. S. Nuclear Regulatory Commission Washington, D. C. 20555                              OOCKE T NUMBER D ,i O '":>,:

PROPOSED RULE..:....:.::...::,;._,,_-J,-i}-,' Attn: Docketing and Service Branch ( S"I F f<3072f)

Dear Sirs:

I write to support the proposed changes in 10 CFR Parts 20 & 35, dealing with criteria for release of patients to whom radiopharmaceutials or other appropriate radioactive material has been administered. Those changes noted in the Federal Register Vol 59 # 114 of 6-15-94 appear to be a major step in the direction of practical regulation in behalf of public health and safety for America. Although terminology is precise, format is reversed when it comes to threshold limits (pg 30730, last paragraph, column 1, 1st sentence) 11 The 1-millisievert (0.1-rem) threshold .. . should be contrasted with page 30732 column 2 under par 20.1301 paragraph (2) 11 * *

• does not exceed 0.002 rem (0.02 mSv) in any one hour." That is sieverts before rem versus rem prior to sieverts!

Abandonment of the so-called 30 millicurie rule is jointly in the best interests of medicine including nuclear medicine and the public health at large. Thank you for your efforts at clarification, and modification of the 30 mCi 11 rule 11 which has befuddled and plagued unnecessarily practitioners for decades. Sincerely Yours,

   /4q/tM 4         -~..,.,./::!O Richard A. Wetzel, . D. rAc-; r~ #"/'1 Member Board of Representatives, ACNM & Past President, ACNM lSEP 2 8 1994 .

Ackn wledged by card "---***NNN*n* *N-N

DOCK t I'! J .StRVICE SECTION OFFICE OF l HE SECRETARY OF THE COMMISSION Document Statistics Postfflar1< Date .1 {CJ'-/ t.oples Received _ _---"/~ - - - Ad<fl Copies Reproduced ~.3.

                           -__,.,:--,r---

6pecial Distribut;on fl.:L ~ P/)P Schl'l:et;u;~ 1

DOCKETED DOCKET NUMBER

                 , ,or seo RULE PR   'J-0    3i 1 -

B. Scott Davidson, CHP 207 Avon Road US~RC Narberth, PA 19072 ( ;q FR 301:l'i) (610) 664-2141 *94 AUG 12 Al 1 :23 July 26, 1994 OF F,Ci_ C,* ~ ~*~-ETAR J Secretary, nnct<.El IHG (;.; s- ;' '*rf U. S. Nuclear Regulat.ory Commission re:10CFR 20.1301, 35:'75 BRANCH Washington, DC 20555 Comments on Proposed rule (59 FR 30724), Criteria for the Release of Patients Administered Radioactive Material

                                                                                                     <J)

Mr. Secretary: Please accept the following comments regarding the above captioned matter: I believe that the proposed rule making is an important step in clarifying the release of patients with radioactive materials in them and how this affects dose t.o members of the public particularly, family members. I believe that the dose family members (or individuals with whom the released patients live) are likely t.o receive is justified by the comfort they can get by being with their family, satisfying the benefit aspect of ALARA, and that instructions given t.o patients t.o minimize dose at the 0.1 millisievert limit is also appropriate. However, I believe that the use of a dose limit will cause more confusion and potential problems for both the licensee and the inspect.or who must demonstrate and inspect compliance at this value, respectively, than is necessary. I believe that release quantities serve this purpose better. It is easier for the licensee t.o demonstrate, for phot.on-emitters, a dose rate at one meter, and show the calibration of his instrument, than t.o show the dose calculation and assumptions which can be challenged regarding occupancy; or t.o obviate the need t.o split a calculation between two yeas. For beta-emitters, this exercise is moot. In addition t.o being easier t.o demonstrate compliance, the licensee is not required t.o ask personal questions of the patient t.o determine the length of time they spend with a member of the public, or how they spend this time.

• In the absence of better information regarding how much radioactivity is exchanged between persons engaging in sexual relations, of any variety, the assuthptions used regarding internal dose using the Brodsky Fact.or of 10-6 are best applied t.o the occupational exposure circumstances that he studied t.o arrive at this fact.or.

llrlL~ B. Scott Davidson, CHP

                                                                                        ,SEP 2 8 1994 ~

Acknowledg by card***-*'"" _,. * ,..

... - DOCK-         ~

• OFFICE Of THE SECRETARY

                              *..,. ~-C 1,ON OF THE COMMISSION Document Statistics lostmm Date ---/ '1     /1- I '-

Copies Received _ __ _ _ _ __ Add'I Copies Reproduced ____ _ __ Special Distribution- t:J;tJS . PfJJl 1,

  ~c t, n £ I           /
                , et ~* t:::'

Pascack PR (i) Valley Hospital William J. Woods DOCKET NUMBER R OSFD RULE (51Ff2 3D12l/j Louis R. Vere, Jr.

                                                                    ~([)                 DOCKETED US RC
                                                                                     *94 AUG -9 P2 :52 Chairman, Board of Directors      President OFFICE  or  SECRETAR Y DOCKETING & SERVICE BRANCH July 21, 1994 Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555 RE:      Proposed Rule Amendments to 10CFR 20 and 10CFR 35 RIN 3150-AE41 FR Vol. 59 #114 - June 15, 1994 Pg. 30724

Dear Sir or Madam:

1. With reference to the proposed amendment to 10 CFR 20.1301, we agree with and support this change.

2. With reference to the proposed amendment to 10 CFR 35.75, we disagree with this proposed revision and do not support the change since we believe the added cost incurred by the hospital

• with respect to record-keeping requirements outweighs the assumed benefit to the patient.

We feel that 35.75 should remain as currently written. Thank you for your consideration in this regard. Sincerely, (v}~k~ Carrie Niler Chief Nuclear Medicine Technologist PN Old Hook Road, Westwood, New Jersey 07675-3181 (201) 358-3000 LSEP 2 8 1994 d........... , I ""'

.s. N1.,,_                                         -~ l OOCK!:                ..... __ * {   I r-.. r, OFFICt v . c t1.,kt:TARV OF THE CO MISSION Document Statistics Foslmm Date _."--~

Copes Received _ _ _ - J . ._ _ __ opies Repr

          'sb1Mlon__;..-=~ ~ ~ ~ ~-

_..~4ku. .

@ Pascack Valley Hospital DOCKETED USNRC (fJ

                                                                                                *94 AUG -9 p 2 :52 William J. Woods                    Louis R. Ycre, Jr.

Chairman , Board of Directors President OFFICE OF SECRETARY DOCK ETING & SfRVlCE BRANCH July 21, 1994 Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555 RE: Proposed Rule Amendments to 10CFR 20 and 10CFR 35 RIN 3150-AE41 FR Vol. 59 #114 - June 15, 1994 Pg. 30724

Dear Sir or Madam:

1. With reference to the proposed amendment to 10 CFR 20.1301, we agree with and support this change.

2. With reference to the proposed amendment to 10 CFR 35.75, we disagree with this proposed revision and do not support the change since we believe the added cost incurred by the hospital with respect to record-keeping requirements outweighs the assumed benefit to the patient.

We feel that 35.75 should remain as currently written. Thank you for your consideration in this regard. St ephen Kau ~ a.i::J,-r-..flll-:-+/-r.- - - - Radiation Safety Officer PN Old Hook Road , Westwood, New Jersey 07675-3181 (201 ) 358 -3000 SEP '8 1994 _

                                                                                                   , . card .......,.Hut* fHHlffHUIHftf

OOCKE11, ,. OFF ICE O . i hr: c: RET ARY OF THE COMMISSION Document Statistics Fos1mar1t Date -'""--L..,___,---.:.....,:__ __ Rer.eived _ _ _ -1&-- - ---

        *es Reprod

@ Pascack Valley Hospital DOCKET NUMBER PROPOSED RULE {sq FR 3012~) p :lO I SS DOCKETED USHRC

                                                                                       *94 JUL 28 P 4 :22 William J. Woods                  Louis R. Vere, Jr.

Chairman, Board of Directors President OF FICE OF SECRETAR Y DOCKETI NG & SERVICE BRANCH July 21, 1994 Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555 RE: Proposed Rule Amendments to 10CFR 20 a n d 10 CFR 35 RIN 3150 - AE41 FR Vol. 59 #114 - June 15, 1994 Pg. 30724

Dear Sir or Madam:

1. With reference to the proposed amendment to 10 CFR 20.1301, we agree with and support this change.

2. With reference to the proposed amendment to 10 CFR 35.75, we disagree with this proposed revision a n d do not support the change since we believe the added cost incurred by the hospital with respect to record-keeping requirements outweighs the assumed benefit to the patient.

We feel that 35.75 should remain as currently written. Thank you for your consideration ip. this regard _. Craig Koster, B.S., R.T. Administrative Director of Radiology PN Old Hook Road, Westwood, New Jersey 07675-3181 (201) 358-3000

• SEP 2 8 1994 -~

t\1,;Knowleoged by c.ard ..........""'....""""n*

                                                                  ,         (
.,.....                                           . ' **.... ..,::.hJN DOCKETING ~ ;,i:. nv 1vt: SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document S1ati1tic8 artc Dale --s...;....;;....a..-.J..11-"""- - - -

CoFies Received _ __ .,..__ _ __ Adf!I Copies Re

UNIVERSITY OF CALIFORNIA, LOS ANGELES UCLA BERKELEY

• DAVIS
• IRVINE
• LOS ANGELES
• RIVERSIDE
• SAN DIEGO
• SAN FRANCISCO

                                                                                                 }    SANTA BARBARA

• SANTA CRUZ

                                                                   *94 JUL 25 P4""":66 July 11, 1994                                                                                UCLA SCHOOL OF MEDICINE OFFI CE OF SECRETAR Y            HARBOR - UCLA MEDICAL CENTER DEPARTMENT OF RADIOLOGY DOCKE T!~ G & SERVI CE                        1000 CARSON STREET BRANCH                    TORRANCE, CALIFORNIA 90509 Samuel Chilk, Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555 DOCKET NUMBER PROPOSED RULE Pl      2 0 JS Attention:                Docketing and Service Bra nch                      (sq FT< 3~0_7_2_L/,_,__

Reference:

Criteria for the Release of Patients Administered Radioactive Material, RIN 3150-AE41, FR59(114):30724-30732, 1994 (15 June).

Dear Mr. Chilk:

As the physician and scientist who wrote the Petition you are answering in the above Proposed Rule, I would like to make a number of comments about it, and will also comment on mat e r i a l in Draft Regulatory Guide DG-8015 and Regulatory Analysis NUREG-1492. NCRP no. 37 was published in 1970, and numerous Agreement states adopted it because it is scientifically sensible. We thus have decades of experience using the guidance of NCRP no. 37, unencumbered by any paperwork burden at all, showing no problems whatsoever. I am pleased to see that NRC is willing to change its regulation in this area, which, if it originally was based on any science at all, at present has no apparent scientific basis. Unfortunately, in adopting NCRP no. 37, NRC adds a bizarre calculation expectation, an astonishing and inappropriate paperwork burden, and an extra requirement for estimated anticipated exposures in the 100-500 mrem range that is inconsistent with NCRP no. 37, other NCRP, ICRP, and IAEA guidance, and even the intent of the "new" 10 CFR Part 20 itself. This extra requirement is not scientifically valid and needs to be removed along with the entire paperwork and calculational burdens that have been conjured up by NRC while trying to repair its present regulations. The demonstration calculations and radiopharmacokinetic analysis show that NRC does not understand the mathematics of biexponential biological functions. This material needs to be removed completely because it is wrong. NRC has no comprehension of the medical aspects either, and its modeling must be discarded. NRC lacks adequate understanding of the lactation process, and needs to remove this misleading material from its documents. The arbitrary designation of $33 per patient as the cost of this rule underestimates true cost by a factor of at SEP 2 8 1994 A ru,owledged by card ...."..,, , ~

Duv ,_.. ~C*"*, ~.:. ..,..:(,11uN OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics

 ~art< Date         7 /;i..o ('JLJ fApies Received _ _ _.,,..l_ _ _ __

Md'I Copies Reproduced _.J _____ Special Distribution fl.J;:YJ.L /11/Jll, S c bt>£id.ed...

July 11, 1994 Samuel Chilk, Secretary Page least 1700%, not even counting the costs of record-searching and record-obtaining for patients who.receive more than one therapy dose in one year or the huge cost of medical manpower and legal fees to deal with the obvious onslaught of "violations" as NRC inspectors begin inspecting things they never inspected before, never understood before, and certainly do not understand now. I am pleased that NRC chose to retain my concept of a 25% occupancy factor for a tandem person at 1 meter. I would like to use this, as well as NRC's 1 x 10~ value for internal contamination, to demonstrate how calculations should be done, and have chosen to use the example of thyroid cancer patients. For this purpose, I assume that the thyroid remnants or functioning thyroid cancer tissue contains no more than 5% administered activity (conservative), and a T~ for non-thyroidal iodine of 0.5 (very conservative; for elderly patients). The methodology of NCRP no. 37 for 500 mrem maximum permits administered activity of 350 mci for patients with adults only in the home and 275 mci for homes with 1 yr. old children (worst case). This calculation takes into account the 1 ppm internal uptake assumption given by NRC but uses more precise calculations of thyroid dose and effective dose equivalent using ICRP no. 53 (1987) than the estimate used by NRC, because now the internal dosimetry cannot be automatically discarded. The remainder of my letter is divided up into General Comments, Specific Comments and Calculations (validating the summary statements made above), and Conclusions and Recommendations.

GENERAL COMMENT

S (1) How This Petition came To Be Written The medical community was unable to obtain the final draft of the "new" 10 CFR Part 20 before it was voted on by the Commission in December of 1990. Even the NRC's Advisory Committee on Medical Uses of Isotopes (ACMUI), of which I was then a member, was not given a copy to review. It happened that I was asked to be on a panel with Admiral Carr (he was then Chairman), the Director of the Radiologic Health Branch of California, Edgar Bailey, Don Cool of NRC, and several other individuals to discuss the impact of the "new" 10 CFR Part 20 on licensees. I agreed to do so as long as I received a copy of it, and it was sent to me two days

July 11, 1994 Samuel Chilk, Secretary Page before the meeting. A cursory review showed some obvious problems, and these were discussed at the California Radioactive Materials Management Forum meeting. When I found out that the Commission had voted on the new Part 20, I called Hal Peterson to find out if the appropriate changes had been made. They had not, and when we discussed what to do, he insisted that I write a petition "yesterday" to apply for an exemption to the 100 mrem limit for radionuclide therapy and to change language referring to EPA. At the same time, two new diagnostic radiopharmaceuticals were wending their way through FDA, and NRC's 11 30 mci rule", or 11 5 mrem/hr max" could force anticipated outpatient procedures to become inpatient procedures for no scientifically sensible safety reason. On Christmas Eve I therefore sat down and hurriedly wrote the Petition to save our diagnostic procedures and fix some of the mischief implied in Part 20. Much later, after discussion with NRC, I wrote an addendum that more thoroughly covered radionuclide therapy. contained many needed calculations, and removed I-131 from the 11 30 mci rule" as well. The portion of my Petition that dealt with EPA was so important to NRC that it was quietly granted between the time the Petition was received and.the time 10 CFR Part 20 went to the printer. By the time my Petition was published in the Federal Register, the EPA issue was moot. I can understand NRC's confusion, as Hal Peterson had left NRC and gone to work for DOE, but NRC cannot "deny the petitioner's request" because it was already granted in the final language of 10 CFR Part 20. Due to the unanticipated delay in printing the new Part 20, (because the numbering system had to be redone), my Petition had to lie around for months because no action could begin until the rule was actually available. The Office of General Counsel (OGC) decided during this period "in limbo" to deny my entire petition because it had been lying around too long. I argued that this was preposterous, and threatened to loudly expose their pettiness. After all, NRC had requested that I, a member of their ACMUI, write the Petition in the first place. The Petition was then permitted to sit in the file cabinet until Part 20 was published. Then OGC immediately made it a "conflict of interest" for me to discuss it as a member of the ACMUI. I denied that there was any conflict, but OGC would not agree. OGC has still not been able to articulate what the conflict of interest i.§,. I sincerely doubt they can. Three and a half years later, after supporting a number of NRC personnel, two NCRP contracts, and a contract with Sanford Cohen

July 11, 1994 Samuel Chilk, Secretary Page and Associates, Inc. the NRC published* this Proposed Rule to in part answer my Peti~ion. The Federal Register article clearly implied that the ACMUI agreed with it, and states also that the ACMUI wanted to retain the 30 mci limit and the 5 mrem/hr maximum exposure rate. This is not true. Some physicians wanted to retain those as a default option, not a condition, because they were leery of possible killer paperwork. (How right they were!) None of the members of the ACMUI, including me, ever saw the final wording, and for that reason do not necessarily agree with any of it at all. The idea of using the methodology of NCRP no; 37 for a 500 mrem limit is wholly supported by the ACMUI, but the pointless paperwork, documentation, inspection nightmare, and license amendment efforts and costs are absolutely unpalatable, and I believe the ACMUI intends to convene a telephone meeting to address the problems of this Proposed Rule shortly. (2) 100 mrem vs. soo mrem One hundred mrem/y is not a hazardous level. Neither is 500 mrem/y. Nor is 5000 mrem/y, for that matter. NRC is confusing hazardous levels with idealistically low levels believed to be advantageous based on an unproven theory of radiation carcinogenesis known as the Linear Hypothesis. (Roughly translated, this is the theory that says any little bit can kill you. It is very popular with regulators, lawyers, and "antinukes".) These mrem levels are so low as to be ludicrous. Remember that ordinary background levels average 300 mrem a year in the United States, with exposures over 500 mrem/y in Denver, and even higher in ski areas. One old copper mining town in Colorado has a background of 890 mrem/y. (Colorado is tied for the third lowest cancer mortality rate in the United States. The highest cancer death rate is in a relatively low background area, Washington, D.C.). Flying in an airplane results in 1 mrem/1000 miles. If you fly 100,000 miles a year you get an extra 100 mrem. Should all the airlines keep track of all travelers and when someone hits 100,000 miles from all flights combined should the airlines send him a letter warning him about radiation damage? Instead of free air trips with Mileage Plus should we get a Greyhound Bus pass? If Ivan Selin is so panicked about minuscule doses of radiation, maybe he should go to Moscow by boat next time. Shall we deny lift passes to "ski bums" once they acquired an extra 100 mrem? By what possible scientific logic can NRC now plan to require all

June 11, 1994 Samuel Chilk, Secretary Page this nonsense paperwork for family members of patients who receive radioactive material because they might get between 100 and 500 mrem in a year? This is not the petition condition in the new Part 20, and this senseless concept should be buried as quickly as possible. It is simply a trap for increasing inspection fees and concocting vicious "violations". It is much like NRC's venomous "Quality Management" Rule, which has nothing to do with "quality" or "management", but everything to do with increased inspection fees, vicious "violations", and NRC propaganda. It cannot be the licensee's responsibility to know the details of a radionuclide therapy performed by another licensee in terms of which members of the public received the most irradiation with that other licensee's therapy procedure. Yet NRC will gear up for violations, then demand "disclosure of dangerous radiation" letters, like the purposely misleading and alarming ones NRC sent out after the incident at Indiana, PA in 1992. This whole concept is flagrantly inappropriate. (3) Agreement State Compatibility Intelligent Agreement States are way ahead of NRC, some by a quarter of a century in matters regarding this Proposed Rule, and none of it should be an Item of Compatibility at any level. The Agreement States have no use for the NRC's foolish, expensive protracted efforts in this area. Given the pathetic fact that the NRC, as usual, has no idea of what it is doing in the medicine area, why should any knowledgeable state regulator want any part of this? We have done very well without any of the paperwork nightmare conjured up by an ignorant NRC staff and management. Why use it now, especially when NRC is egregiously in error about cost, just as it was about the cost of the "Quality Management" Rule? (4) Interference With The Practice Of Medicine The NRC claims in this Federal Register notice that the Proposed Rule is consistent with the Medical Policy Statement of 1979, as though that is supposed tq mean something. In the first place, this Proposed Rule is nQ.t consistent with the third statement of the Policy; this Rule very much interferes with the practice of medicine. Second, the Consumer-Patient Radiation Health and Safety Act of 1981 gave responsibility for all matters regarding patient radiation safety to the Dept. of Health and Human Services. If NRC ever had this responsibility, and I don't think

July 11, 1994 Samuel Chilk, Secretary Page it ever really did, it lost it in 1981. Third, the ACMUI has met with the Commissioners and recommended that they change the Policy, omitting statement no. 3, changing or omitting statement no. 2, and keeping only statement no.1. And fourth, I do not regard a member of the patient's family or an individual with whom the patient shares a domicile as a "member of the general public". He/she is a "member of a specific public", if you will, and part of the medical entity that has the patient as its focus but includes certain others. A father who holds down his screaming child for an x-ray of the child's broken leg and in doing so receives some radiation from the x-ray machine is different from a member of the general public, or a radiation worker. There is no NRC category for this type of situation, but I view it as an extension of the patient and a responsibility of the physician. Dictating to a physician how and what he/she must tell a patient is not the purview, mandate, or competence of NRC, and interferes with an essential portion of medical practice, which i's communication between physician and patient. This is different for every patient and every physician. The NRC is incorrect when it states that "In fact, written instructions are already required under 10 CFR 35.315 (a) (6) and 35.415 (a) (5) 11

• Written instructions to patients were not required by these rules, which require the licensee "to provide the patient with radiation safety guidance that will help keep radiation dose to household members and the public as low as reasonably achievable ..* ".

(Notice that "household members" are considered separately from the "public".) These rules were written precisely to include the choice of verbal instructions because in part of patients who do not read English or who are illiterate in every language. This is according to Norman McElroy, who wrote 35.315 (a) (6) and 35.415 (a) (5) and kindly reinterpreted them for me on 6/24/94 at 10:30 AM by telephone. I do not believe any sort of communication requirement belongs in any rule, however, because as long as NRC restricts its licensing of authorized user physicians to those with highly specialized education, training, and experience, appropriate communication is part of the professional behavior of that physician and NRC's jurisdiction in my mipd ends with the designation of physician competence to handle radioactive material. The physician's practice of medicine may be reviewed by the State Medical Board, but NRC has no jurisdiction and certainly has no competence. The NRC's attempt to imagine the effect of having written guidance so as to " .*. relieve apprehensions of the patient, primary care-giver, and family", is ludicrous, not validated by any data base, and the pure construct of naive dilettantes at NRC trying to practice medicine without a license.

July 11, 1994 Samuel Chilk, Secretary Page It is also nonsensical to tell the patient to stop breast-feeding in the instructional material NRC thinks it can force physicians to give to their patients. The patient would have to have stopp~d breastfeeding for some weeks before the administration of NaI-131 (does NRC know why?), and couldn't start again if she wanted to. Does NRC think that turning on breast-feeding is like turning a valve in a submarine? NRC had best not tell authorized user physicians what to tell their patients or how to tell their patients anything. If on the other hand, NRC does not feel that the authorized user physicians know what they are doing, then NRC is committing dangerous negligence in licensing them in the first place and needs to change its criteria for competence. NRC is also appearing to preclude a physician from ever having the right to give NaI-131 to a mother whose nursing infant might get over 500 mrem. If, in the opinion of the physician, the radiation dose that might be incurred by the baby is less hazardous than the consequences*of stopping breast-feeding, the physician must have the option of deciding to impose greater than 500 mrem on the infant. One can do interesting things with synthroid, tapazole, propylthiouracil, and supersaturated potassium iodide, and it is dangerous for NRC to try to oppose a physician's medical judgment. What if an impoverished patient is taking her baby back to a developing country harboring *a cholera epidemic? The risk of a baby dying of cholera from contaminated water used to dilute or dissolve infant formula may be far greater than some small theoretical probability of developing a papillary thyroid cancer some day. Thi~ is not a far-fetched possibility. This was the situation I faced at Tripler, when NRC sent me out to investigate an incident in which a breastfeeding infant received a very high dose of radiation to her thyroid because her mother hid her pregnancy and lactation from her physicians. The mother was later instructed to stop breastfeeding, even though she was heading back to Truk which had a cholera epidemic ongoing. CDC and WHO were sending in medical teams to control the outbreak of the disease. I asked four physicians at Tripler why they stopped the patient's lactation after the initial event. They all gave me the same answer. They thought she should have continued but they thought that NRC could never understand that. I agree with them. NRC cannot understand that. More important, NRC should never be in the loop to judge it or even try to render an opinion. I suppose I could always thwart this rule by writing a prescription for the baby for "Radioactive mother's milk containing unknown quantities of I-- 131, in unknown volumes, at ad li.12 frequency, for any time duration, p.o.". This is all pretty silly, don't you think?

July 11, 1994 Samuel Chilk, Secretary Page (5) one Year Petition Resolution On, 21 Mar 91, James M. Taylor, EDO, published Announcement no. 26 to all NRC employees. This announcement was entitled "Staff Assistance to Prospective Petitioners". On p. 3 it says, "A petition must be resolved within 12 months from the date of publication of the notice of receipt in the Federal Register. The office assigned action to address the petition must establish a milestone schedule. Any extension of the schedule to resolve a petition beyond 12 months must be approved by the EDO." It is now over three years since notice of my Petition was published. On what basis did the EDO approve an extension? What was the milestone schedule of the office? I never saw any memos approving extension. Was this policy honored at all? Did it ever occur to the EDO that the reason for the delay was that the staff and management were not competent to understand the medical issues or to do the math? Even the contractors did not appear to help. Did they review NRC's work? I cannot believe that the Visiting Medical Fellow, Myron Pollycove, ever had the opportunity to carefully review the whole document. Did he? If not, why not? Isn't that what he's there for? Why didn't you get help from your ACMUI? Isn't that why you have medical advisors? How much did all NRC's delays and contracts cost? A million dollars? Probably something like this, but why did NRC management permit its staff to waste our money with wild abandon when a competent individual could have done this in half a day? This is a good example for Congress to study. That's why User Fees are exorbitant. My first Petition, to permit nuclear medicine physicians and nuclear pharmacists to practice medicine and pharmacy in accordance with State law, was submitted over 5 years ago. This was the petition that prompted Announcement no. 26. Why has it not been resolved? How many millions will this cost? That petition was won in California after 1 telephone call and 6 beers with 3 folks in a bar in Sacramento over a 2 hour period. {The bar bill was not charged to the State.) We have been living happily ever after with it. What are the EDO's excuses for NRC delays? What are the User Fees going to look like? Certainly more than a 6-pack of beer and 6 person-hours of time!

July 11, 1994 Samuel Chilk, Secretary Page SPECIPIC COMMENTS AND CALCULATIONS (1) Place ot Patient confinement The notion that "although licensee control does not necessarily restrict a patient to a hospital, the location of the patient must be listed as a place of use on the license or a license amendment must be issued pursuant to 10 CFR 35.32 (e) ." is foolish, very expensive, and belies a lack of understanding of medical practice. This should be removed. In the first place, NRC has to understand patient "control". A patient can walk out of the hospital any time he wants to with several hundred mci of NaI-131 in him. It is illegal to forcibly prevent such a patient from leaving if he wishes to. Likewise, a patient may leave the hospital, not take his prescribed medicine, and pass his disease on to a member of his family or behave in a psychiatrically unstable manner and injure someone. The difference is that in the last two cases, laws exist to protect others from patients with a likelihood of passing on contagious diseases or patients who are psychiatrically dangerous. This is not the case with radiopharmaceuticals because the hazard level is not particularly significant. NRC's evaluation of hazard is way out of proportion to the true hazard. Part of this error is due to the fact that NRC does not have the competence to perform dosimetry and evaluate the hazard from a valid scientific assessment of absorbed doses. The other reason for the error is purposeful. NRC gravely exaggerates hazards to fool the public and make NRC look important. This is inappropriate and needs to be stopped. It is the "culture" of the NRC, and is not respectable. For NRC to try to extort more undeserved fees for emergency license amendments is disgusting. To require some erroneous concept of "control" at other locations is foolish. In practice, the authorized user physician makes an assessment of the probable level of patient compliance with instructions which includes patient intelligence, education, attitude, resources and general home situation, finances, etc. The physician then decides how to approach recommendations for hospital confinement vs. confinement at another place. The NRC cannot possibly be of any usefulness here. This is physician judgment, and must not be documented for inspectors to "second guess". In any case, what counts is patient behavior, not paper trails. Is NRC going to go home with every patient and make sure he sleeps alone and flushes twice? This is all a bizarre NRC intrusion into medical practice and needs to be thwarted immediately.

July 11, 1994 Samuel Chilk, Secretary Page (2) Economic Impact The NRC, which does not understand how to make the necessary calculations, has picked "$33 11 out of the air (there is no documentation) for the cost per patient of these requirements. Once the uptake and effective halflife is known, NRC appears to have assumed a 15-minute calculation at NRC's $133/hr rate. NRC "forgot" to add what it costs to obtain uptake and effective halflife numbers to begin with, especially since they are generally not done in cancer therapy patients and only uptakes are often done in hyperthyroid patients. These measurements, generally not being medically indicated, are all extra costs of this rule. I have not added costs of searching for and documenting previous doses to the same patient that year because I am hoping NRC will drop this nightmare~ Due to extensive patient confidentiality laws, documenting precisely what was done at another medical institution can take many weeks. In a medical emergency, physicians will discuss a case with each other on the telephone, but NRC's bureaucratic, arbitrary, and capricious desires are not going to be respected as medical emergencies. Patients may suffer severe consequences from prolonging NaI-131 treatment for lack of nonsense paperwork to amuse NRC, but I don't think it will amuse the patients, the physicians, or the courts, and this must be dropped. I have included the cost of inspecting these calculations, although the fact that the inspectors won't be able to understand them makes the exercise moot. (I have not included the costs of the trumped up "violations" or the long distance telephone calls from White Flint to Cleveland.) For each patient: Secretary/receptionist: 4 visits, 7 1/2 min/visit for checking identification, financial/insurance status and forms, checking old records, lining up charts. Scheduling of patients for 4 visits, typing results for computer report, copying and filing, 30 min/pt. Technologist: RAIU day 0,1,2,3, 30 min. each. Semilogarithmic plo~ of data, 30 min. Calculations from graph, check them, 30 min. Physician: Checks technologist calculations, 15 min. Makes member of the public dosimetry calculations, checks them, makes patient-specific paper trail which includes the technologist's work as input data, sees to it that copies are made for inspection purposes; 45 min. (This is too complex for technologists to perform.)

July 11, 1994 Samuel Chilk, Secretary Page Patient: If lives nearby, 1 day and 3 half days off work. If lives far away, 5 days off work (1 to treat, 4 days for measurements.) I have not included hotel or meals if out of town. Inspector: 1 hr. per calculation. COSTS Secretary/receptionist: 1 hr x $20/hr (incl. overhead) = $ 20 Technologist: 3 hrs x $40/hr (incl. overhead) = 120 Physician: 1 hr x $133/hr (underestimate) = 133 Patient: @ $60/day, $150-$300; use 10% for the 5 days and 90% for 2 1/2 days Inspector: 1 hr@ $133/hr = llJ.

                                                         $556-706; with weighted patient day cost this comes to:                       $571 For NRC's number of 62,000 pts/y, this is $35.4 million, not $2.1 million. Considering the fact that intelligent Agreement states cite NCRP no. 37 and have no extra paperwork and no problems, this is $35.4 million unnecessary dollars plus extra costs for violations.

NRC's actual costs will approximately double the cost of the procedure, not counting hospital inpatient days. Who will pay for this? Certainly not HMO's, insurance companies, or HCFA. The patient will probably not wish to pay out of pocket for the glory of White Flint, either. The most compelling reason to kill this paperwork is the huge unreimbursable cost and the NRC mischief that would ensue. As the physician and technologist would often be present when the inspector pretends to inspect the calculations, we have to consider adding another $173 for many individual cases. Those who pay for healthcare will put great pressure on physicians to optimize calculations and minimize inpatient days. This will cause many physicians to stop offering NaI-131 therapy procedures and force patients to travel to large medical centers in cities, for the most part. This will cause problems with patient access, especially in sparsely populated areas. This does not promote health and safety. This promotes disease.

July 11, 1994 Samuel Chilk, Secretary Page (3) Biexponental Radiopharmacokinetics The recognition that the biological halflife of thyroidal iodine is different from the biological halflife of non-thyroidal iodine is correct. However, NRC does not understand how one handles this mathematically. You simply add them.* For the NCRP no. 37 formalism, one therefore has 2 sets of terms:

                                                        - 0.693t T

34. 6 (ri) (Oo) (thyroidal fraction) (T 1etr) ( 1-e tetr) /r2 +

                                                            -0.693t
                                                             -T-

34. 6 (r2 ) (Oo) (nonthyroidal fraction) (T2eff) ( 1-e 2eff ) /r2 (34.6 = 24hrs/day x 1 = 24 (1.44); if 0.693 Teff is expressed in hours, you drop the 11 24 11

• The 1.44 converts the halflife to the mean life.)

r 1 = 2.2, but r 2 is less because of significant absorption by the body; 11 measurements on 11 patients in my hospital showed r 2=1. 7. The exponential functions will not be zero if individuals are present for a day or several days instead of infinite time. Assuming that a patient does not void for 24 hours is not mathematically necessary, radiopharmacokinetically correct, or particularly comfortable for the patient. As a matter of fact thyroid cancer patients will void 3/4 to 7/8 of the administered activity over the first 24 hours. The NRC does not understand that thyroid cancer patients are athyreotic when they receive therapy doses. This significantly changes the dosimetry, because almost all the iodine is non-thyroidal. Another problem is that the blood clearance halftime is not the same as an excretory halftime. The I-131 may clear the blood quickly but may reside elsewhere in the body before excretion. A nonthyroidal Ta of 0.21 days is probably too short. The halftime

July 11, 1994 Samuel Chilk, Secretary Page of renal clearance from MIRO and used in ICRP no. 53 is 8 hrs. or 0.33 days. In elderly patients, this may be longer due to diminished but still normal renal function. I performed 20 calculations of renal clearance halflife in 11 thyroid cancer patients and calculated an average of 11 hours. This of course includes the very small percent of I-131 in the thyroid remnant or in cancer tissue as well as the non-thyroidal iodine. In my conservative calculations for thyroid cancer patients I allowed 5% thyroidal uptake (conservative) and a nonthyroidal T~ of 0.5 (very conservative). Internal dose estimates were made using ICRP no. 53. Average uptakes for normal thyroids in my practice are 10-25%, with very rare outliers as low as 5% or as high as 30%. This may vary throughout the country; I use 25% as a conservative uptake percentage. Hyperthyroid% uptakes may vary from normal to up to twice normal (approximately) for toxic nodules and from about 35%-95% for Graves' disease patients. Effective halflives for thyroidal iodine in hyperthyroid patients fall generally into 2 groups, very rapid and close to normal. The close to normal group may actually represent extremely rapid thyroid turnover, reuse, and reabsorption. However, this does not really affect the external dosimetry equation except that sometimes the r 2 of 1.7 may apply instead of 2.2. For conservative purposes, and because I don't know offhand how to account for this, I use 2.2. The Stabin et al. reference has data on uptakes, effective halflives, and fetal dosimetry. (See part (6), References). The TB for normal glands I take to be 80 days with shorter times for children {ICRP no. 53 plus its citations). (4) Calculations Of Administered Activity For Thyroid Cancer Patients This calculation assumes that adults only are the most highly irradiated members of the patient-associated public, and that they will be present until total disappearance of the I-131 as 25% occupancy tandem persons at 1 meter {0.25 tpom): For 350 mci: Dt(co) = 34.6(2.2) (350) (0.05) (7.3)+34.6(1.7) (350) (0.95) (0.5) 4(10,000)

      = 9720 + 9780                                               0 40,000
      = 0.488 rad.

July 11, 1994 Samuel Chilk, Secretary Page Internal dose, 0.00035 mCi: 466 mrad to thyroid and 14.2 mrem ede. 0.488 + 0.0142 = 0.50 mrad This next calculation assumes that a 1 yr old child is the most highly irradiated member of the patient-associated public, and that this child will be present until total disappearance of the I-131 as a 25% occupancy tandem person at 1 meter. For 275 mci: Dt<..,> = 34.6(2.2) (275) (0.05) (7.3) + 34.6 (1.7) (275) (0.95) (0.5) 4(10,000}

       = 7640 + 7683 40,000
       = 0.383 rad Internal dose, 0.000275 mci: 3460 mrad to thyroid and 102 mrem ede.

0.383 + 0.102 = 0.48 mrad Simplifying The Equation For Thyroid Therapy: So long as we keep the above assumptions, the general equation for the external dose component becomes: ( mCi} (mci} Dt<..,> = 34.6(2.2) (0.05} (7.3) (admin) + 34.6(1.7) (0.95) (0.5} (admin} 40,000 40,000

       = 6.94 x 10 4 (mCi admin} + 6.98 x 10 4           (mCi admin}
       = 1. 4 x 10-3 (mCi admin}

Therefore, Dt(O>), 0. 2 5tpom = 1. 4 x 10-3 (mCi admin}

July 11, 1994 Samuel Chilk, Secretary Page On the other hand, if our patient is a young adult with normal kidneys, we should substitute 0.33 for 0.5 for the T~ of non-thyroidal iodine. If we know his% uptake, we can change the 5% assumption as well. Solving The Equation For A Temporary Tandem Person: Let us assume that a thyroid cancer patient received 300 mCi NaI-131, ignores his physicians instructions and advice, and gets right on a bus, sitting next to an unsuspecting member of the "true" general public for 1 hour. Assuming that the patient does not void until he gets home, what is the radiation absorbed dose to the unwary member of the public? (1 hr= 0.0417d}

                                                    -0.693(0.0417) 8.04  )

D = 34.6(1.7) (8.04) (300) (1-e 1hr,tp at 0.5m ( 50} 2

 =   5 6 ( 1-e-0*00364 }
 =   56(1-0.996}
 =   56(0.004}
 =   0.22 rad' 220 mrad

- This is not Chernobyl. One cannot justify hospitalizing this patient because he might lie to his physician and do a mildly unsociable thing. It's not enough radiation to worry about. (I'd rather sit next to him than to someone with active tuberculosis. } If this were a hyperthyroid patient who received 30 mci, one tenth as much, the absorbed dose to the member of the public would be only 22 mrad, an insignificant quantity. I hope that NRC is starting to calm down. Once calculated, these absorbed doses are not as scary as NRC has always assumed and has led the public to believe. (5) Antibodies In section 3.2 of the draft Regulatory Guide, p. A-8, "Internal Dose", NRC states: "Internal dose may be a consideration with certain radiopharmaceuticals now being developed, such as radiolabeled antibodies, or those that are developed in the future."

July 11, 1994 Samuel Chilk, Secretary Page This is wrong. I-131-labeled antibodies will be deiodinated in the body and the iodine will be handled like any other iodine, such as NaI or metabolic products of tri-and tetra-iodothyronine. There is no extra threat to a member of the public from internal dose. The hazard from external dose will depend upon the effective halflife of the radioiodine in the body in any form. The NRC should not concern itself with this. The Center for Biologics Evaluation and Research (CBER) is very cognizant of this issue and has the services of experts to advise it. FDA considers this its problem and its responsibility because of the need to have appropriate package labeling. It is not acceptable for NRC to pretend it has a function here when FDA has it as a definite responsibility and is doing just fine. This in fact has been FDA's complete responsibility ever since it took regulation of radioactive drugs away from AEC/NRC in 1975. NRC's refusal to quit dual-regulating drugs, which NRC has botched miserably for the past two decades, is supposed to end very shortly. It would be appropriate for NRC to stop wasting staff time and our User Fees on such pointless dual regulation, and should not even hint at it in this Regulatory Guide. I believe I am aware of all groups of radiopharmaceuticals being developed now and some being planned for the future. None should have an internal dose problem for the general public, and if they could, FDA will take care of it, and so will knowledgeable professional organizations. NRC has no role at all here. (6) References The references listed in the Regulatory Analysis contain a random assortment of mostly unhelpful citations, and have missed almost all the ones I find really useful in this area. MIRD Dose Estimate Report no. 5 (1975) is essential, and so is ICRP no. 53 (1987). Of the 20 references cited in ICRP no. 53 pertaining to iodine radiopharmacokinetics in adults and children, none are listed in the Regulatory Analysis. On the other hand, I don't believe that Kohler and Milstein's 1975 groundbreaking paper on monoclonal antibody synthesis has any usefulness whatsoever for the issues at hand. I suggest that you add Stabin MG, Watson EE, Marcus CS, and Salk RD: Radiation dosimetry for the adult female and fetus from I-131 administration.in hyperthyroidism. J.Nucl.Med.32:808-813,1991.

July 11, 1994 Samuel Chilk, Secretary Page (7) Regulatory Analysis In General I found the Regulatory Analysis to be generally useless, with mistakes and omissions in the radiopharmacokinetics of iodine and the pathophysiology of thyroid disease. The cost estimates were grossly incorrect and misleading. The analysis had little relevance; setting up straw men to knock down is a waste of time for the presumed informed readership of this document. The Regulatory Analysis missed relevant considerations and calculations, which I have tried to contribute using this letter. In my opinion, this work performed by Sanford Cohen and Associates, Inc., is unacceptably poor and should not be released. CONCLUSIONS AND RECOMMENDATIONS It is evident after careful review of this Proposed Rulemaking that NRC. after forty years. does not comprehend the use of byproduct material in medicine. I recommend removing all activities surrounding this Rulemaking from the present staff, management, and contractor involved, as they are incapable of competent performance and have wasted years and much User Fee funding in the production of this unusable result. I recommend that Commissioner de Planque work with her staff and with the following members and recent members of the ACMUI to do this right: Barry Siegel, M.D., Edward Webster, Ph.D., Peter Almond, Ph.D., Melvin Griem, M.D., and me. A new Proposed Rule can then go out for public comment that makes scientific and medical sense. I envision final regulatory language such as the following:

 "Authorized user physicians should conduct their practices in such a way as to give a high level of assurance that uninvolved members of the general public cannot receive more than 500 mrem from a radiopharmaceutical procedure or a brachytherapy implant.

Involved members of the public, such as those who share a household with the patient and those who help care for the patient, should not receive more than 500 mrem, either. The licensee should provide the patient or other responsible party with radiation safety guidance that will help to keep radiation dose to involved and uninvolved members of the public as low as reasonably achievable". 10 CFR Parts 35.75, 35.315, and 35.415 would be rescinded. We would thus have a medical practice performance standard, without additional and unnecessary

July 11, 1994 Samuel Chilk, Secretary Page prescriptive regulation, that qualified physicians will honor. A Regulatory Guide containing useful information for calculation of likely radiation absorbed doses would be of value. Commissioner de Planque and her Committee would write it. There would not be any requirement for individual calculations, complex paper trails, or any nitpicking nonsense for an inspector to inspect. We will decrease the cost of these procedures by decreasing inpatient costs. We will not increase healthcare costs. Thank you for your attention and consideration .

• Sincerely,

 ~

Carols. Marcus, Ph.D., M.D. Director, Nuclear Med. Outpt. Clinic and Professor of Radiological Sciences, UCLA also Immediate Past Member of ACMUI Chair, Radiologic Devices Panel, FDA Chair, Radiopharmaceutical D.I. Panel, USP Vice President, Society of Nuclear Medicine Telephone: (310) 222-2845 FAX: (310) 533-7159 cc: Interested parties CSM:sfd nrccmb.csm

The University of Texas Medical Branch at Galveston School of Medicine Marine Biomedical Institute Graduate School of Biomedical Sciences Institute for the Medical Humanities School of Allied Health Sciences UTMB Hospitals School of Nursing *94 JUL 15 p ~ePl!Jment of Radiology 8 July 1994 OFFICE OF S::cRETARY DOCK ETING ,x SE1~VICE BRAH:::H Secretary US Nuclear Regulatory Commission ATTN: Docketing and Service Branch Washington, DC 20555

SUBJECT:

Proposed Rule, Criteria for the Release of Patients Administered Radioactive Material, 15 June 1994, 59 FR 30724 The purpose of this letter is to provide a strong statement of support for the subject Proposed Rule. I am a medical physicist with 21+ years of experience as a medical health physicist and a nuclear medicine physicist. I have been the RSO of a broad-scope licensed academic medical center and have been personally involved in the radiation protection aspects of radiopharmaceutical therapy treatments of more than 200 patients. I also am chairperson of NCRP Scientific Committee 90, which is preparing an NCRP Commentary that addresses issues covered in this Proposed Rule. This letter is my personal opinion and does not necessarily reflect the opinions of my employer or the NCRP. NCRP Scientific Committee 90 has been preparing an NCRP Commentary tentatively titled "Dose Limits for Individual Members of the Public from Radiation Exposure from Patients who have Received Radionuclide The r apy". A draft of the Commentary (Enclosure 1) that is currently being circulated within the NCRP Board of Directors contains the essence of my comments on this Proposed Rule. I have been authorized by the NCRP to release the draft as supporting documentation to my comment, with the caveat that the draft represents only the opinion of the Scientific Committee and does not represent the official position of the NCRP. The final Commentary will be a useful resource for your deliberations, but I cannot at t his time give a realistic estimate of its availability in its final official form. In summary of the draft Commentary, I enthusiastically support all aspects of the Proposed Rule and encourage adopt i on as a Final Rule at the earliest possible effective date. I would like to call your attention to two elements of the draft Commentary that address potentially controversial aspects of the Proposed Rule. SEP 2 8 1994 Ackno ledged b} card ~ ................ . NUCLEAR MEDICINE SECTION 301 UNIVERSITY BOULEVARD GALVESTON, TEXAS 77555-0793 (409) 772-2921

1. Should a dose limit greater than 5 mSv be permitted for certain family members in certain circumstances? Please see Appendix A, Section A.2.2.2, pp. 25-27 and Appendix B, Section B.4.2.2, pp. 41-43. These sections argue (persuasively, I hope) that the benefit gained hiY certain family members (and by the patient) in certain circumstances is so great that a dose of 50 mSv would still yield a benefit:risk ratio that would be considered acceptable by those family members.

2. I agree with your decision to leave "confinement" largely undefined, except that I disagree with your interpretation of its meaning. Further, your statement about "licensee control" in this Proposed Rule preamble will remain a part of the record and will be used by NRC and others to interpret the intended meaning of "confinement". See Appendix B, Section B. 4. 3 .1.1 and Section B.4.3.1.2, pp. 46-50. In reality, the treating physician has no control over the patient's movements after administration of the radioactive material. Patients cannot be held in the medical facility against their wishes, and the Proposed Rule provides no penalty for the patient who decides to leave the facility "against medical advice". Confinement of the patient in any venue is based on the voluntary cooperation of the patient, supported by vigorous urgings from the treating physician and the facility RSO about NRC rules and the moral requirement to avoid contact with family members and the public. I would argue that most patients have the ability to realize the reasons for our exhortations and they will cooperate to the best of their abilities, whether the confinement is in a hospital, in a hotel, or in their own home. The Texas experience with outpatient thyroid cancer therapy supports this point of view. Of course, there will always be certain patients who cannot reasonably be expected to comprehend and cooperate, so the regulations should provide that the treating physician should treat only if the patient agrees to confinement in a facility under the licensee's control.

Thank you for the opportunity to comment on this excellent Proposed Rule. 1:::::t ~:::::::::. Professor D., FACNP, FACR Enclosure Draft NCRP Commentary

" NCRP Commentary No. _ bRAFl DOSE LIMITS FOR INDIVIDUAL MEMBERS OF THE PUBLIC FROM RADIATION EXPOSURE FROM PATIENTS WHO HAVE RECEIVED RADIONUCLIDE THERAPY

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld Contents

1. S11mma:cy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

2. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

3. Radiation Risk :Estimates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 3.1 Risk Models . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 3.2 Application of Risk Models to Radionuclide Therapy . . . . . . . . . . . . . . . . . 7

4. Radiation Risks and Detriment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 -

4.1 Risk Coofficien.t:5: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 4.2 &ti.mated Risks for Members of the Public . . . . . . . . . . . . . . . . . . . . . . . 8

5. Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 5.1 Acceptable Dose Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 5.1.1 As Low as Reasonably Achievable Considerations . . . . . . . . . . . . . . 11 5.1.2 Consideration of Other Patients . . . . . . . . . . . . . . . . . . . . . . . . . . 11 5.1.3 Considerations of Patient's Family . . . . . . . . . . . . . . . . . . . . . . . . 11 5.1.3.1 Children, Pregnant and Potentially Pregnant Women . . . . . . . 12 5.1.3.2 Adults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 5.1.3.3 Coworkers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 5.1.3.4 Members of the General Public . . . . . . . . . . . . . . . . . . . . 12 5.2 Medical Confinement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 5.2.1 Need for Confinement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 -

5.2.2 Health Insurance Providers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 5.2.3 Restrictions on Patient Contact with Other Persons . . . . . . . . . . . . . . 15 5.2.4 Patient Instructions . . . . . . . . . * . . . . . . . . . . . . . . . . . . . . . . . 15 5 .3 Identification of Radioactive Condition of Patient . . . . . . . . . . . . . . . . . . . 16 5.3.1 Radionuclide Therapy Treatments . . . . . . . . . . . . . . . . . . . . . . . . 16 5.3.2 Patient Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 5.3.3 Patient Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Appendix A. Characterization of the Detriments ~ t e d with Radionuclide Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 A.1 Description of Radionuclide Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 A.1.1 Radiopharmaceutical Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 A.1.2 Brachytherapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 A.2 Characterization of Detriment to Society . . . . . . . . . . . . . . . . . . . . . . . . 21 1

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld A.2.1 Nature of Exposures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

         ,,    A.2.1.1 External Irradiation . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 A.2.1.2 Internal Intake . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 A.2.2 Exposed Populations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 A..2.2.1 Medical Facility Patients . . . . . . . . . . . . . . . . . . . . . . . . 24 A.2.2.2 Family Members . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 A.2.2.3 Coworkers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 A..2.2.4 General Public . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 A..2.3 Detriment Suffered by Patient . . . . . . . . . . . . . . . . . . . . . . . . . . 28 A.2.3.1 Financial . . . . . . . . . . . . ~ . . . . . . . . . . . . . . . . . . . . . 28 A.2.3.2 SC>Ci.al. * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * *

• 29 A.2.4 Detriment Suffered by Society . . . . . . . . . . . . . . . . . . . . . . . . . . 30 A.2.4.1 Financial. . . . . . . . . * . . . . . . * . . . . . . . . . . . . . . . . . . 30 A.2.4.2 Job-Related Skills . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 Appendix B. Radiation Protection Philosophy for Exposure of Members of the Public to Radionuclide Therapy Patients . . . . . . . . . . . . . . . . . . . . . . . . . . 32 B.1 Basic Radiation Protection Philosophy . . . . . . . . . . . . . . . . . . . . . . . . . . 32 B.2 Justification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 B.3 As Low as Reasonably Achievable . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 B.3.1 Patient Radiation Doses and Effects . . . . . . . . . . . . . . . . . . . . . . . 34 B.3.2 Patient Nonradiation Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 B.3.3 Societal Benefits and Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 B.4 Limitation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 B.4.1 Dose Limits for Members of the Public * . . . . . . . . . . . . . . . . . . . . 39 B.4.2 Special Dose Limits for Certain Members of the Public . . . . . . . . . . . 40 B.4.2.1 Other Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 B.4.2.2 Family Members . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 B.4.2.3 Persons in the Workplace . . . . . . . . . . . . . . . . . . . . . . . . 43 B.4.2.4 General Public . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 B.4.3 Administrative Restrictions on Access of Public to Patient . . . . . . . . . 44 B.4.3.1 Reduction of the Source Term . . . . . . . . . . . . . . . . . . . . . 46 B.4.3.1.1 Controlling Movement of the Patient . . . . . . . . . . 47 B.4.3.1.1.1 Confinement for Medical Care . . . . . . . . . . . . . 47 B.4.3.1.1.2 Minimizing Patient Contact with Public . . . . . . . 49 B.4.3.1.2 Controlling Members of the Public . . . . . . . . . . . 49 B.4.3.1.3 Justification of Intervention . . . . . . . . . . . . . . . . 50 Appendix C. Application for Criteria for Release from Medical Conimement in Common Types of Radionuclide Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . 52 11

J' NCRP SC90 Draft of May 1994 a:\NCRP.com/sld C.1 Brachytherapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 C.1.1 Permanent Implants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

         '    C.1.1.1 Exrunple . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .        52 C.1.1.2 Child . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .       52 c.1.1.~. s ~ . . . . ..* . . . . . . . . . . . . . . . . . . . .. . . . . . . . . .         53 C.1.2 Temporary Implants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .          53 C.2 Radiopharmaceutical Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .          54 C.2.1 Intracavitary Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .       54 C.2.2 Systemic Radiopharmaceutical Therapy . . . . . . . . . . . . . . . . . . . . .              54 C.2.2.1 Immediate Release Following Administration . . . . . . . . . . . .                  55 C.2.2.2 Confinement after Administration . . . . . . . . . . . . . . . . . . .              60 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 111

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1

• 1. Snmmacy 2

3 Most patients who receive radionuclide therapy (radiopharmaceutical therapy, temporary 4 implant outpatient brachytherapy and permanent implant brachytherapy) can depart the 5 medical facility in which the therapy procedure was conducted within 24 h, and frequently in

• -6 less than one hour. *Tue sealed and unsealed sources used for many of these therapy 7 procedures emit x rays and gamma rays in quantities sufficient to deliver radiation doses to 8 individual members of the public, including family members, in excess of the 1 mSv average 9 annual dose limit recommended by ICRP (1991) and NCRP (1993) and legislated by the U.S.

10 Nuclear Regulatory Commission (NRC, 1991a) and the Agreement States. 11 12 This Commentary addresses the risks to members of the public exposed to these patients, discusses the societal costs and benefits of controlling these risks, and recommends methods ti14 by which the risks can be controlled in a manner that is as low as reasonably achievable 15 (ALARA) from a radiation safety viewpoint and acceptable from the viewpoint of patient 16 access to efficacious medical care. It is concluded that the internationally-recommended dose 17 limit of 1 mSv for individual members of the public, other than members of the patient's 18 family, can be achieved without significant negative impact on radionuclide therapy. 19 20 Major recommendations presented in this Commentary include: 1

NCRP SC 90 Draft of May 1994 a;\NCRP.com/sld 1 ' Dose limits. A dose limit of 5 mSv for members of the patient's family is recommended, 2 due to the.infrequent nature of the exposure and because of the substantial benefits that 3 accrue to the family from the patient's therapy treatment. In exceptional circumstances and 4 upon advice of the treating physician, a member of the patient's family may be permitted to 5 receive up to 50 mSv. 6 7 Patient confinement. Confinement in a hospital or other skilled-care medical facility should 8 be used to minimize the radiation dose to members of the p4blic, including the patient's 9 family, only if confinement within the patient's home or other facility is impractical or if 10 compliance with confinement-at-home instructions cannot be assured. 11 12 Need for patient confinement. The treating physician, in consultation with the radiation 13 safety officer of the medical facility, is best qualified to determine the necessity for 14 confinement after treatment and the restrictions to be imposed on the patient upon *discharge 15 from the medical facility, including the appropriate waiting time before returning to work. 16 17 Inpatient records. The radionuclide burden of the patient should be clearly identified in 18 "inpatient" records during confinement and in a written description of the radionuclide 19 therapy procedure (radionuclide, activity, physical/chemical form, treating physician's name 20 and telephone number) which the patient should keep with them until their remaining 2

NCRP SC 90 Draft of May 1994 a: \NCRP .com/sld 1 radioactivity is less than the levels given in Table 4.1 of this Commentary, i&.., for 1311, 60 2 MBq with a dose rate at 1 m of 4 µ.Sv h-1; for an 1 25J prostate implant, (j(){) MBq with a dose 3 rate at 1 *m of 0.5 µ.Sv h-1 ; for a 1'.ZSJ: eye plaque, 60 MBq with a dose rate at 1 m of 0.5 µ.Sv 198 4 h* 1; and for Au seeds, 20 MBq with a dose rate at 1 m of 10 µ.Sv h*1

• 5

- Lifetime risk, The NCRP recommends that for radiation protection purposes, a dose rate 7 effectiveness factor of two be applied and a lifetime risk of fatal cancer of 5 x 10-5 mSv-1 be 8 . used for the general population. 3

NCRP SC 90 Draft of May 1994 a; \NCRP .com/sld 1 2. Introduction 2 3 The U.S. Nuclear Regulatory Commission (NRC) recently revised Part 20, Title 10 of 4 the Code of Federal Regulations (10 CFR Part 20), "Standards for Protection Against 5 Radiation* (NRC, 1991a). Paragraph 20.1301 establishes a dose limit for individual 6 *. members of the public of 1 mSv per y, consistent with recent recommendations of the 7 International Commission on Radiological Protection (ICRP) and of the National Council on 8 Radiation Protection and Measurements (NCRP) (ICRP, 1991; NCRP, 1993b). 9 10 The nuclear medicine and radiation oncology communities have expressed their concern 11 that this fivefold reduction of the dose limit for the public might ultimately lead to a fivefold 12 reduction in the exposure rate and activity provisions of 10 CPR Part 35.75 (NRC, 1991b) 13 and to consequent increases in the costs of providing radionuclide therapy. Hospital 14 administrators and physicians are concerned that therapy patient rooms might need lead 15 shielding in the walls; that additional adjacent rooms might have to be kept vacant; that the 16 patient might have to remain in the hospital for a longer period of time; and, that patients 17 previously treated on an outpatient basis would have to be hospitalized for treatment. There 18 is some question as to whether such actions are consistent with the ALARA philosophy, 19 inasmuch as the small decrease of detriment associated with a reduction of the dose limit for 4

NCRP SC 90 Draft of May 1994 a:\NCRP .com/sld 1 members of the public, excluding family members, from 5 mSv to 1 mSv may require an 2 unreasonably high cost. 3 4 The following issues will be addressed in this Commentary: 5 e6

• What are the risks borne by members of the public exposed to radionuclide therapy 7 patients (Appendix A)?

8 ~ What are the societal costs and benefits of various methods of controlling these risks 9 (Appendix B)? 10

• How should the risks be controlled (Section 4 and Appendix C)?

5

NCRP SC 90 Draft of May 1994 a:\NCRP.corn/sld 1, 3. Radiation Risk Estimates 2 ,. 3 3.1 Risk.Models 4 5 NCRP Report No. 115 (NCRP, 1993) has examined all available studies and data about 6 the estimation of the risk of radiation-induced cancer. The Report shows particular concern 7 for (1) the choice of the most appropriate risk projection model, (2) the duration of excess 8

• risk that is assumed in the risk-projection model, (3) the estimates of the risks for persons 9 exposed to low total doses over a considerable fraction of their lifespan and (4) the fact that 10 the estimates of risk of fatal cancer by the UNSCEAR (1988), BEIR V (NAS/NRC, .1990) 11 and ICRP (1991) Committees are based on those for a Japanese population exposed in 12 wartime and a reference Japanese population in 1982 rather than a current United States 13 population. There are significant differences between the two populations and the correct 14 method of transferring radiation risk estimates is not known.

15 16 The traditional approach to radiation protection recommendations is to be conservative 17 and to extrapolate high-dose data to the low-dose region in a linear fashion with no 18 threshold, but with a dose rate reduction factor, i&.., the curve of risk versus dose terminates 19 at zero risk and zero dose. This implies that any dose of radiation has an associated risk. 6

NCRP SC 90 Draft of May 1994 a:\NCRP .com/sld 1 Current radiation risk estimates for radiation protection are based on the linear model with a 2 dose rate reduction factor of two (NCRP, 1993b; ICRP, 1991). 3 4 3.2 Application of Risk Models to Radionuclide Therapy 5 -67 Risk estimates derived from any mathematical model are associated with many uncertainties (NCRP, 1993b), most or which are not well-characterized or accurately known. 8 At the low doses associated with exposure of members of the public from radionuclide 9 therapy patients (usually a single exposure of 5 mSv or less), the risks for any individual are 10 low and could be zero. 1 1 11 For radiation protection of large numbers of individuals it is prudent to assume that there 12 is a risk of the induction of a cancer in those exposed to even the smallest doses. However, 13 when only a limited number of individuals are involved, it must be recognized that the risks at 14 small doses to that small number of individuals could be zero. The assumption of no effect at 15 small doses is not supported by current molecular radiobiology theory. 7

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1

• 4. Radiation Risks and Detriment 2

3 4.1 Risk Coefficients 4 5 NCRP Report No. 115 recommends a lifetime risk of fatal cancer for the general 6 population of 3.3 to 5 x 10-5 mSV-1 using a dose rate effectiveness factor of from two to 7 three (NCRP, 1993a). For radiation protection purposes a dose rate effectiveness factor of 8 two should be applied and a lifetime risk of fatal cancer of 5 X 10-5 mSv*1 should be used for 9 the general population. 10 11 4.2 Estimated Risks for Members of the Public 12 13 Table 4.1 summarizes the theoretical estimated fatal cancer rates for an individual who 14 receives effective doses between 1 mSv and 50 mSv. 15 16 17 18 19 20 8

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1 L Table 4.1 - Attributable lifetime probability of cancer death due to a 2

               ,.        single, acute ex;posure to a radionuclide therapy patient.

j 6 Effective dose Attributable lifetime Increased lifetime 7 (mSv) probability of cancer probability of 8 death (%)a cancer death (%)b l~ -~ 14 15 16 1 5 50 0.005 0.026 0.26 0.03 0.14 1.4 ij 20 -Basect on a risk of 5 x 10-5 mSv-1 (NCRP, 1993a). 21 22 1Defined as: Attributable lifetime probability of cancer death, natural United States 23 24 cancer death rate (17 percent, ACS, 1990). 9

NCRP SC 90 Draft of May 1994 a: \NCRP .com/sld 1 5. Recommendations 2 3 5.1 Acceptable Dose Limits 4 5 Radionuclide therapy is administered to a patient only when the therapy offers a net 6 benefit compared to the various costs, such as medical side effects, restrictions on the 7 patient's movements after release from medical confinement and the short- and long-term 8 monetary costs of the treatment. The patient will realize the most benefit from the treatment, 9 since the patient will be cured, stabilized or released from severe suffering. However, 10 various segments of society will realize some benefit and cost from the patient's treatment. 11 Determination of acceptable risk levels is not straightforward, since the benefits accruing to 12 the exposed populations at any specified risk level (and, thus, the benefit:cost ratios) may 13 vary widely (Morgan, 1993); additionally, one person's acceptable risk may be unacceptable 14 to another person ~ ' skydiving, motorcycle riding). Radiation protection 15 recommendations and regulations for individuals should be flexible enough to allow 16 consideration of specific situations as exceptions that might warrant dose limits less stringent 17 than those that apply to the general member of the public. 18 19 20

NCRP SC 90 Draft of May 1994 a: \NCRP .com/sld 1 5.1.1 As Low as Reasonably Achievable Considerations 2 3 Radionuclide therapy should be performed in a manner that keeps the detriment to 4 society ALARA, economic and social factors being taken into account. 5 e6 s.1.2 Consideration of Other Patients 7 8 Patients who are not undergoing radiation treatments should not normally receive 9 radiation doses greater than 1 mSv annually from radionuclide therapy patients. In rare 10 instances, such a patient should be permitted to receive up to 5 mSv because the exposure is 11 infrequent and the cost to do otherwise may be considered excessive. The medical facility's 12 radiation safety officer should periodically review all decisions to permit a dose greater than 1 mSv. fj 14 15 5.1.3 Considerations of Patient's Family 16 17 Members of a radionuclide therapy patient's family are likely to perceive that they 18 will benefit from the family member's treatment, and they are likely to be willing to bear 19 greater risks in order to achieve that benefit. Because of the infrequent nature of this 20 exposure, it is recommended that family members be permitted to receive annual doses not 11

NCRP SC 90 Draft of May 1994 a: \NCRP .com/sld 1 exceeding 5 mSv. Higher dose limits may be considered provided the treating physician 2 determines them to be medically justified for the physical and mental well-being of the 3 patient and the family members. 4 5 5.1.3.1 Children, Pregnant and Potentially Pregnant Women, The doses to children, 6 pregnant and potentially pregnant women should not exceed 1 mSv. 7 8 5.1.3.2 Adults, The dose limit for adults exposed to 'a radionuclide therapy patient should 9 not exceed 50 mSv annually. 10 11 5.1.3.3 Coworkers, Coworkers who come into contact with a radionuclide therapy patient 12 should not receive a radiation dose in excess of 1 mSv. A limited number of coworkers may 13 be permitted to receive no more than 5 mSv annually if the average dose to all exposed co-14 workers is 1 mSv or less. 15 16 5.1.3.4 Members of the General Public. No member of the general public should receive a 17 radiation dose in excess of 1 mSv annually from a radionuclide therapy patient. 18 19 20 12

NCRP SC 90 Draft of May 1994 a:\NCRP .com/sld 1 5.2 Medical Confinement 2 3 Radionuclide therapy administrations may range from oral ingestion of a pill in an 4 outpatient setting to placement of sealed sources during a surgical procedure. The immediate 5 medical care of the patient will similarly vary widely, from a 10 min observation time and 96' unconditional release, to protracted periods in inpatient and skilled-care facilities. Medical 7 confinement consists of the physical ~ ' hospitalization) and administrative ~ ' delayed 8 return to work) controls placed on the contact of a radionuclide therapy patient with members 9 of the public. 10 11 S.2.1 Need for Confinement 12 tj The treating physician shall determine the need for confinement for medical care, and 14 shall specify the conditions of confinement and of release from confinement; Table 5.1 15 provides recommendations on activity levels and external dose rates for some of the common 16 forms of radionuclide therapy. If the treating physician is not confident that the patient will 17 comply with the administrative restrictions in these recommendations, the patient should be 18 admitted for inpatient treatment. 19 20 13

NCRP SC 90 Draft of May 1994 a: \NCRP .com/sld

1. Table 5 .1 - Guidelines for unconditional release of patients (" no restrictions")

2 from medical confinement for some common types or radionuclide therapy,* j 6 Radiopharmaceutical Activity Dose rate at 1 m 7 or brachytherapy (MBq) (pSv h-1) 1~ 131 11 1 sodium iodide 60 4.0 12 125 13 1 prostate implant 600 0.5 14 125 15 1 eye plaque 60 0.5 16 198 17 Au seeds 20 10.0 !~ 21 *Patients whose activity or dose rate fall below these levels and who avoid close 22 contact with members of the public are not likely to cause doses in excess of 1 mSv to 23 members of the public. Table values may be multiplied by any alternative dose limit being 24 considered, ~ , multiply table values by five if 5 mSv is the dose limit under consideration 25 (see Appendix C for examples of how to apply Table 1.2). Values in this Table were 26 derived from Table 1.2 of NCRP Report No. 37 (NCRP, 1973) and represent a dose of 1 27 mSv from continuous exposure at 1 m to total decay. 28 29 30 31 14

NCRP SC 90 Draft of May 1994 a:\NCRP .com/sld 1 5.2.2 Health Insurance Providers r 2 3 Insofar as employers, health insurance providers and providers of long-term disability 4 insurance are concerned, medical confinement is an integral component of radionuclide 5 therapy. 7 5.2.3 Restrictions on Patient Contact with Other Persons 8 9 Prior to treatment, the treating physician should obtain a description of the patient's 10 family and household, the patient's job and their usual degree of contact with members of the 11 general public. The treating physician shol).}d not release a patient who has had a 12 radiqnuclide therapy procedure that could result in unacceptable doses to members of the

• public unless the physician is confident that the patient will comply with the necessary 14 restrictions to limit their exposure to members of the public.

15 16 5.2.4 Patient Instructions 17 18 The treating physician should instruct the patient to mioimire contact with members of 19 the public, especially children and pregnant and potentially pregnant women, and to observe 20 all precautions prescribed by the physician. All such instructions should be delivered orally, 15

NCRP SC 90 Draft of May 1994 a: \NCRP .com/sld 1 and a written copy of the instructions should be given to the patient. The treating physician 2 shall determine when the patient can return to work with no radiation restrictions. 3 4 5.3 Identific.ation of Radioactive Condition of Patient 5 6 The radionuclide, therapy patient may present an external irradiation risk, a 7 contamination risk, or both, for a protracted period following treatment. Persons who 8 subsequently provide medical care, or who handle the patient's corpse following death should 9 be alerted to the patient's radioactive status so that they can take appropriate precautions. 11 S.3.1 Radionuclide Therapy Treatments 12 13 If the radionuclide therapy treatment requires the patient to be confined in a hospital 14 or other nonhome location, the patient should be identified as containing radioactive material 15 by use of a special wristband, by posting a sign on the patient's door and by J?Osting of a 16 distinctive label in the patient's "inpatient" chart. These identifications should include the 17 radionuclide, physical or chemical form of the radiopharmaceutical, activity administered, 18 and the name and telephone number of the treating physician and of the radiation safety 19 officer; appropriate radiation safety precautions should be noted in the patient's chart and on 20 the patient's door. 16

NCRP SC 90 Draft of May 1994 a: \NCRP .com/sld 1 ' 5.3.2 Patient Instructions 2 " 3 The radionuclide therapy patient should be instructed as to the radionuclide, its 4 physical or chemical form, the activity administefe4 and any other information that the 5 treating physician feels would be important for the patient to relate to a medical emergency - responder~' paramedic). This information also should be provided in written form, in

, 7     language that the patient and the patient's family can understand.

8 9 5.3.3 Patient Identification 10 11 The patient should be given a wallet-sized card listing the radionuclide, the physical 12 or chemical form, the activity administered, the name and telephone number of the treating 4' physician, and any important radiation safety precautions. The treating physician should 14 state to the patient that they are to keep this card in their possession when they are outside 15 their home. 16

      /

17 18 17

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld Appendix A. Characterization of the Detriments Associated with Radionuclide Therapy 2 3 A.1 Description of Radionuclide Therapy

• 4 5 Many types of cancer (and certain other diseases) can be treated with the radiations 6 emitted by radionuclides. The three general treatment modalities are teletherapy, 7 radiophannaceutical therapy and brachytherapy. The teletherapy patient does not present a 8 radiation hazard to the public. Radiopharmaceutical therapy (unsealed radioactive materials) 9 and brachytherapy (sealed radioactive sources) are collectively identified in this Commentary 10 as radionuclide therapy. The NRC estimates that about 30,000 radiopharmaceutical therapy 11 procedures and 50,000 brachytherapy procedures are performed each year in the United 12 States. Roughly 10 percent of all radiopharmaceutical therapy treatments currently require 13 some hospitalization, as do about 10 percent of all brachytherapy treatments involving 14 permanent or long-duration temporary implants.

15 16 A.1.1 RadiQpharmaceutical Therapy 17 18 In radiopharmaceutical therapy, a radionuclide is bound to a chemical or biological 19 moiety that has locafuation properties suitable for protracted irradiation of a particular cancer 20 site. The radionuclides used at the present time are relatively short-lived beta emitters, but 18

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1 alpha emitters are under active investigation. Most of these radionuclides also emit photons, 2 which usually contribute minimally to the tumoricidal dose, but which produce an 3 undesirable radiation field around the patient. 4 5 The radiopharmaceutical may be completely retained within the patient's body until - the radionuclide has decayed to background. In this case, the only risk to an individual 7 member of the public is the photon field surrounding the patient's body; radioactive 8 contamination does not occur. However, most therapeutic radiopharmaceuticals are taken up 9 with less than 100 percent efficiency or are altered by biological processes, and some of the 10 administered activity appears in mucous secretions, sweat, feces or urine. Thus, the patient 11 poses both an external irradiation risk and a potential contamination risk. These risks are 12 minor from a public health viewpoint. 14 The most common types of radiopharmaceutical therapy are oral or intravascular 15 administration of liquids or capsules (systemic therapy) and instillation of colloidal 16 suspensions into closed body cavities (intracavitary therapy). Examples of systemic therapy 131 17 include 1 sodium iodide for hyperthyroidism and thyroid cancer, 89Sr chloride for bone pain 18 and 32p sodium phosphate for polycythemia vera. The only intracavitary therapy commonly 19 performed is 32p chromic phosphate for malignant effusions. 20 19

NCRP SC 90 Draft of May 1994 a: \NCRP .com/sld 1 ' A.1.2 Brachytherapy 2 3 In brachytherapy, sealed sources are placed into or near a tumor, frequently in a 4 surgical setting. The sources may be allowed to remain in the patient's body permanently or 5 for a week or so, or they may be removed after a period of irradiation that may range from a 6 few minutes to a few days. The patient does not remain radioactive after removal of 7 temporary implants. 8 9 Radionuclides used for permanent implants and for extended-duration outpatient 10 brachytherapy are relatively long-lived x-ray and gamma emitters durably contained in sturdy 11 needles or seeds. When the photons are of low energy and the sources are deep within the 12 patient's body, the external radiation field is of little concern. However, the sources may be 13 placed near or on the surface of the body, in which case even low-energy photons can create 14 a measurable radiation field. Implants using sources that emit high energy gamma .rays are 15 of concern regardless of the treatment site. 16 17 Seeds for brachytherapy are of the general size and shape of a grain of rice. They 18 may be perm~ently implanted directly into a tumor~' prostate cancer), or they may be 19 arranged in an array on a plaque that is placed on the surface of the eye or skin, secured by 20 suture or tape, and allowed to remain in place for several days, ~ , for treatment of ocular 20

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1 melanoma. Although the sturdy construction of the seeds prevents dispersal of the 2 radioactive material in normal handling, a seed may work its way out of the tumor and 3 appear in excreta, or it may fall out of a plaque into clothing, onto bedding or onto the floor. 4 A dislodged source may irradiate members of the public, especially members of the patient's 5 family, and a small child might swallow one. Thus, in a manner similar to the - radiopharmaceutical therapy patient, the brachytherapy patient may pose external and internal 7 irradiation concerns. 8 9 A.2 Characterization of Detriment to Society 10 11 A.2.1 Nature of E;wosures 12 9 A.2.1.1 External Irradiation. Radionuclide therapy produces radiation fields that are usually 14 detectable outside the patient's body. The magnitudes of these fields vary dramatically, 15 depending on the activity administered, the abundance of photon emissions and the spatial 16 distribution of the radionuclide within or upon the patient's body. 17 18 For brachytherapy, the sealed source distribution is well-defined and is confined to a 19 small area, so that sources with low-energy photon emissions can sometimes be shielded by a 20 small external lead shield secured to the skin or worn as an item of clothing; shielding of 21

NCRP SC 90 Draft of May 1994 a: \NCRP .com/sld 1 ' high energy photons is not practical. Radiopharmaceutical therapy is ill-suited to external 2 shielding, since the radionuclide tends to be distributed throughout a large volume of the 3 patient's body. Additionally, many of the radionuclides used for radiopharmaceutical therapy 4 emit gamma rays of sufficiently high energy that a shield would be prohibitively heavy and 5 patients would not wear it. The only practical approach to minimizing the dose to a member 6 of the public from the external radiation field of most radionuclide therapy patients is 7 minimizing the contact time and maximizing the separation distance. 8 9 The dose rate near a single brachytherapy seed which has become dislodged from a 10 patient will be small, but its small size may allow it to lie undetected and cause protracted 11 exposure of unsuspecting persons. Further, a member of the public might not recognize a 12 seed as being radioactive and might pick it up and take it home as a curiosity, or discard it in 13 a trash container, which could lead to it being recycled, incinerated or buried in a landfill. 14 15 Radioactive contamination, in general, does not cause significant external dose rates. 16 large urine spills will be quickly noticed and cleaned up, so external irradiation from 17 radioactive contamination can be regarded as a negligible contributor to public radiation 18 dose. 19 22

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1 A.2.1.2 Internal Intake. Most radiopharmaceutical therapy patients understand that 2 secretions and excreta from their bodies contain radioactive material. Patients who are not 3 mentally competent are under intensive supervision. Thus, a contamination incident that 4 could lead to a significant intake of radioactive material is very unlikely. 5 e Brachytherapy sources are durably encapsulated and are not likely to rupture. A 7 person could swallow an intact brachytherapy source and consequently receive a considerable 8 dose to the gastrointestinal tract. However, the intact source would probably be passed out 9 in the feces within a few days. 10 11 Radionuclide therapy patients may be present in every imaginable state between 12 nonnally active to moribund, and their therapies may range from curative to rninimally 9 palliative. Many can be expected to reappear in the medical environment, whether for 14 continuing attention to the disease for which they received their therapy treatment, *or for 15 traumatic or medical misfortunes completely unconnected to that disease. Some will die soon 16 after treatment and will be of concern to pathologists conducting autopsies and to mortuary 17 personnel who must prepare the body for burial or cremation. In all of these instances, the 18 skin of the patient's body is likely to be breached. The possibility of contamination from a 19 therapeutic radiopharmaceutical and for dislodging of permanent implants is nontrivial, since 20 emergency, medical and mortuary personnel may not be aware of the radioactivity. 23

NCRP SC 90 Draft of May 1994 a;\NCRP.com/sld 1' Fortunately, because the number of persons undergoing these particular types of radionuclide 2 therapy is"very small (estimated to be 10,000 per y), the number of these incidents is also 3 small. Also, the exposed population is primarily the medical community, and many of the 4 protective measures against exposure to blood-borne pathogens used routinely ("universal 5 precautions") provide excellent protection against radioactive contamination. 6 7 A.2.2 Exposed PQPulations 8 9 A.2.2.1 Medical Facility Patients. Many radionuclide therapy patients must be confined for 10 medical care following administration of the radioactive material. A "medical facility" is a 11 hospital or any other type of facility that might be employed for medical confinement, other 12 than the patient's own home. When the radiation field is appreciable, the patient must be 13 isolated from other patients, usually by requiring the patient to not leave a private room until 14 radiation safety precautions have been discontinued. If the walls of the room are constructed 15 of gypsum wallboard ("drywall") or similar low-attenuation materials, adjacent rooms may 16 have to be kept vacant to prevent overexposure of other patients. Some hospitals with heavy 17 radionuclide therapy workloads and limited private rooms have constructed specially-shielded 18 rooms. These expensive measures are made necessary by the need to assume that the 19 radionuclide therapy patient will irradiate patients in adjacent rooms 24 h per day. 20 24

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1 In some hospitals the radionuclide therapy workload may be great enough to permit 2 the dedication of an entire ward, or at least a suite of rooms, for exclusive radionuclide 3 therapy use. All of the patients in these rooms will be radionuclide therapy patients 4 undergoing treatments that deliver tumor doses in the tens of grays, and doses in the 5 hundreds of milligrays to major portions of their bodies. Although Patient A receives no 4I direct benefit from radiation emanating from Patient B's room, and vice versa, these doses 7 (typically less than S mGy) are negligible compared to the treatment dose each patient 8 receives. 9 10 The more problematic instance is the medical facility with a low radionuclide therapy 11 workload in which patients in the adjacent rooms are likely to be non-radionuclide therapy 12 patients,~, a pediatric thyroid cancer patient housed on a pediatric ward, or a e gynecological cancer patient housed on a general gynecology ward. These other patients 14 accrue no benefit from the radiation they receive from the radionuclide therapy patient. 15 16 A.2.2.2 Family Members. A "family member" is any person who spends a substantial 17 amount of time in the company of the patient on a regular basis, providing support and 18 comfort, and who the patient considers a member of their "family," whether by birth, by 19 marriage or by virtue of a close, caring relationship. 20 25

NCRP SC 90 Draft of May 1994 a: \NCRP. com/ sld 1

• When a patient is diagnosed as having cancer, every member of the patient's family is 2 deeply afrected. Can the patient return to work promptly, or will an extended medical 3 absence lead to loss of a job? Are the side effects of the various types of treatment so severe 4 and the chances of success so uncertain that rejection of treatment provides a better quality of 5 remaining life? Will the patient die? Will death be protracted and painful? These questions
• ~ create enormous anxiety and stress within the family, and this emotional distress is a 7 significant detriment to the family.

8 9 A family in distress will draw together, both emotionally and physically. Family 10 members will want to spend extra time with the patient, especially if treatment is palliative 11 rather than curative. Attempts to restrict access of family members to a radionuclide therapy 12 patient are met with resistance from both the patient and the family. Experience over the

• 14 15 many decades in which radionuclide therapy has been available has shown that this resistance can be successfully addressed when the restrictions are imposed for only a few days.

Resistance stiffens, however, if the restrictions are severe or if they are imposed for an 16 extended period of time. In these situations compliance will soon decline. 17 18 The members of a radionuclide therapy patient's family are significantly affected by 19 the patient's disease and treatment. The family members endure a great cost in the hope that 20 the patient will be cured or, at least, made more comfortable in the journey toward death. 26

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1 ~ Given the magnitude of the other costs, family members are likely to perceive as negligible 2 the very small additional cost of being exposed to radiation from the patient. 3 4 A.2.2.3 Coworkers. A radionuclide therapy patient may have any imaginable occupation. 5 Their job may require them to work in very close proximity to their coworkers U, 6 surgeon, assembly line worker), or they may work essentially alone~' cropduster pilot, 7 chimney sweep). A therapy patient may be one of many employees with similar skills in a 8 large company or the only person with a critical skill in a small company. The combinations 9 are endless, as are the exposure conditions and consequent radiation risks. Coworkers 10 receive no direct benefit from the radiation emitted from the patient's body; there may be 11 some indirect benefit if the coworkers would suffer temporary or permanent loss of 12 employment due to absence of the patient. 13 14 A.2.2.4 General Public, The categorization "general public" applies to any person who is 15 not a patient in a medical facility, who is not a member of the patient's family or who is not 16 exposed to the patient as a coworker. A radionuclide therapy patient may have virtually no 17 contact with members of the general public~' a bedridden patient in a long-term nursing 18 care facility), or there may be considerable contact u, airline flight attendant). Depending 19 on the occupation of the patient, the ages of members of the public exposed may range from 20 very young ~ ' elementary school teacher) to very old ~ ' retirement home activities 27

NCRP SC 90 Draft of May 1994 a;\NCRP.com/sld 1 director). Pregnant women and children may be exposed during casual public contact or 2 during the,.course of the patienes employment ~ ' patient is an obstetrician or 3 pediatrician). Administrative restrictions on access of the radionuclide therapy patient to 4 members of the general public are capable of assuring acceptably low radiation doses, but 5 they may be onerous economically and practically. A.2.3 Detriment Suffered by Patient 8 9 A.2.3.1 Financial. Radionuclide therapy may impose two types of financial costs on the patient money paid to healthcare providers for the treatment and loss of income if the 11 patient cannot return to work promptly. While the payment to healthcare providers is not 12 trivial, at least it is constrained and usually of a one-time nature (some patients may be 13 required to take special medications for the rest of their lives, u.._, thyroid hormone 15 replacement). Insurance or public funding is likely to be available to defray most or all of this expense. 16 17 The loss of income due to inability to return promptly to work is a much more serious 18 problem for the patient, and the loss of skilled labor is a problem for society as a whole. 19 While from a public health viewpoint it is desirable to minimize the radiation doses to the 20 general public and co-workers, it is desirable from an economic and social viewpoint that the 28

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1 ' patient be returned as quickly as possible to the work force. Limited absence is usually 2 tolerated By .the employer, and sick leave benefits may provide financial relief during the 3 time of absence. However, extended absences lead to exhaustion of sick leave benefits, after 4 which the employee-patient may be placed on a leave-without-pay status. At some point, the 5 employer may be justified in suspending (without benefits) or terminating the patient's 6 employment Such action may occur very quickly if the employee possesses a critical skill 7 or is easily replaced and the absence places a significant economic burden on the employer. 8 9 A decision to impose stringent radiation safety restrictions on the patient's access to 10 the workplace and to the community may have major negative consequences on the patient's 11 future income. Since quality of life may suffer significantly if income is disrupted, the cost 12 to the patient of receiving the radionuclide therapy will be much higher and may reduce the 13 benefit:cost ratio to a point where the patient might decide to forego the otherwise desirable 14 treatment. Thus, stringent radiation safety restrictions can effectively deny the patient access 15 to care. 16 17 A.2.3.2 Social, In American society today, many people gain their sense of being a 18 valuable member of society from their employment. Radionuclide therapy patients are 19 usually in improved health following the treatment and are eager to return to their normal 20 lifestyle. Unnecessarily stringent radiation safety restrictions will frustrate this desire and 29

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1 ' may lead to anger, depression and withdrawal as the patient's perception of their self-worth 2 deteriorates. If the patient is the family's sole breadwinner, the pressure will be even greater 3 since the spouse and the children will also suffer. 4 5 A.2.4 Detriment Suffered by Sociecy 7 A.2.4.1 Financial. If a radionuclide therapy patient bears the financial responsibility for 8 family members, temporary or permanent loss of a regular paycheck due to administrative 9 restrictions on returning to work can cause financial difficulties for family members, as well 10 as the patient Loss of income can be more devastating to a family than the medical bills 11 associated with a catastrophic illness or injury. A family could lose their home and their 12 ability to feed and clothe themselves . 14 15 Some radionuclide therapy patients will be so important to their employer's business that significant business income will be lost, either temporarily or permanently. If the 16 patient is a key worker in a small business, the business could fail. 17 18 A.2.4.2 Job-Related Skills. Radionuclide therapy patients may be employed in occupations 19 suffering from critical shortages of workers, or they may hold positions of high public or 20 corporate trust and responsibility. Temporary or permanent loss of the patient's skill may 30

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1 ' seriously compromise the ability of the employer to accomplish certain important tasks. 2 Examples include public school teachers, corporate executives and key government leaders. 31

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1 AppendixB. Radiation Protection Philosophy for Exposure of Members of the Public 2 p to Radionuclide Therapy Patients 3 4 B.1 Basic Radiation Protection Philosophy 5 6 Current NCRP guidance regarding basic radiation protection dose limits is contained in

• 8 NCRP Report No. 116 (NCRP, 1993b). The recommendations in NCRP Report No. 116 regarding exposure of members of the public are identical to those of ICRP Publication 60 9 (ICRP, 1991).

10 11 When a practice that uses ionizing radiation is being considered, NCRP recommends the 12 following course of action (NCRP, 1993b): 13 tit "(l) ... justify any activity which involves radiation exposure on the basis that the 15 expected benefits to society exceed the overall societal cost Gustification), (2) ... 16 ensure that the total societal detriment from such justifiable activities or practices is 17 maintained ALARA, economic and social factors being taken into account and (3) 18 ... apply individual dose limits to ensure that the procedures of justification and 19 AI.ARA do not result in individuals or groups of individuals exceeding levels of 20 acceptable risk Q,imitation)." 32

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1 ALARA, as used in Report No. 116, is equivalent to optimization (ICRP, 1991). 2 3 B.2 Justification 4 5 Radionuclide therapy is administered for certain serious thyroid disorders and for the 6 curative or palliative treatment of cancers and their sequelae. Surgical and medical 7 alternative therapies may or may not exist for a particular patient's clinical situation. Failure 8 to undergo some form of treatment may lead to increased pain, further spread of the disease, 9 increased medical complications and premature death. Thus, the benefits of undergoing an 10 efficacious radionuclide therapy treatment, such as decreased suffering, longer life and better 11 quality of life, are very great for the individual patient. These benefits are gained at the 12 expense of moderate financial cost and minimal morbidity (low frequency, delayed 13 complications) associated with side effects of the treatment. The patient w~o agrees to 14 undergo radionuclide therapy perceives that the benefits exceed the costs, i.&.., that the 15 procedure is justified. 16 17 From society's viewpoint, though, other persons must be considered, since patients 18 may irradiate other patients, family members, various persons in the patient's workplace and 19 members of the general public who come into casual contact with the patient in various 20 public and private circumstances. These other groups of people may have very diverse views 33

NCRP SC 90 Draft of May 1994 a:\NCRP .com/sld 1 ' regarding the benefits and costs to them of receiving a radiation dose consequent to the 2 patient's treatment. They may, in fact, consider alternative therapies preferable in order to 3 avoid any exposure to radiation. 4 5 "... the conduct of a practice should be adjusted to maximise the net benefit to

• 7 8

the individual or to society. This is not a simple process because the objectives of the individual and society may not coincide. When the benefits and detriments do not have the same distribution through the population, there 9 is bound to be some inequity.* (ICRP, 1991) 10 11 The challenge for radiation protection is to balance the inequities in a scientifically defensible 12 and politically acceptable manner. 14 15 B.3 As Low as Reasonably Achievable 16 B.3.1 Patient Radiation Doses and Effects 17 18 The objective of radionuclide therapy is cure of target tissues ~ ' deliver a lethal 19 radiation dose to a tumor) or palliation of pain, with minimal damage to normal tissues. 34

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1 Target tissue doses are in the general range of 10 to 200 Gy, while normal tissues can be 2 adversely affected by doses as low as 5 to 15 Gy. 3 4 In brachytherapy, irradiation of normal tissues sometimes can be minimized by 5 careful placement of radionuclides that emit only low-energy photons. Low-energy photons 6 may be practical in small tumors, but large treatment volumes demand more energetic 7 radiations. Radiation doses to nearby normal tissues are frequently a limiting factor in 8 brachytherapy. The challenge in brachytherapy is to rapidly deliver a large radiation dose to 9 the target tissue, with the least damage to nearby normal tissues, i&, large target tissue 10 doses are delivered in a manner that is ALARA for the nontarget tissues. 11 12 In contrast, most radiopharmaceutical therapy treatments (except intracavitary) rely on 13 biological mechanisms in the patient's target tissues to remove the radiopharmaceutical from 14 the bloodstream. Since radiopharmaceuticals are not extracted from the bloodstream into the 15 target tissues with 100 percent efficiency, nontarget tissues will also extract the 16 radiopbarmaceutical, sometimes leading to high, limiting doses to critical nontarget tissues, 17 ~ , marrow. Delivery of radiopharmaceuticals Ym the bloodstream causes the nontarget 18 tissue doses to be distributed throughout the patient's body. This global rather than regional 19 nontarget dose distribution raises special medical concerns because of the assumed greater 20 detriment associated with irradiation of large tissue volumes compared to small volumes. As 35

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1 with brachytherapy, the goal in radiopharmaceutical therapy is to deliver large target tissue 2 doses in a ..manner that minimizes side effects, i&.., ALARA. 3 4 A radionuclide therapy protocol that is not ALARA would lead to suboptimal target 5 tissue doses (too little irradiation) or deleterious nontarget tissue doses (too much irradiation). - Thus, brachytherapy and radiopharmaceutical therapy are inherently performed in a manner 7 that is ALARA for the patient, insofar as radiation doses and effects are concerned. 8 9 B.3.2 Patient Nonradiation Costs 11 "The detriment to be considered is not confined to that associated with the 12 radiation - it includes other detriments and the costs of the practice. Often,

• 14 15 the radiation detriment will be a small part of the total." (ICRP, 1991)

The major elements of nonradiation detriment associated with radionuclide therapy 16 include financial payments to healthcare providers and temporary or permanent loss of 17 income (and consequent psychological stress) due to restrictions on returning to work. The 18 financial cost of obtaining the radionuclide therapy is constrained to the fees paid to 19 physicians, hospitals and other healthcare providers; some therapy procedures may require 20 the patient to take medications for protracted times, but these costs are relatively minor 36

NCRP SC 90 Draft of May 1994 a: \NCRP .com/sld 1' compared to the primary procedure fees. The financial costs associated with temporary or 2 permanent loss of employment income may range from negligible to great, and the 3 consequent psychological stress experienced by the patient and the patient's family may 4 similarly range from readily acceptable to severe. While the fees paid to healthcare 5 providers are not trivial, they may pale in comparison to the costs associated with the loss of 6 employment income. 7 8 The costs associated with temporary or permanent loss of employment income may be 9 divided into the costs associated with confinement for medical and surgical recovery and with 10 confinement for reduction of radiation doses to members of the public. If the confinement is 11 for the purpose of medical or surgical recovery, the costs are clearly justified. If, on the 12 other hand, the confinement is for the purpose of reducing the radiation doses to members of 13 the public, the confinement becomes an intervention whose justification may be far less clear 14 and highly dependent on the relationship between the member of the public and the patient. 15 16 B.3.3 Societal Benefits and Costs 17 18 Radionuclide therapy is performed in order to forestall premature death and improve 19 the quality of the patient's life (curative), or only to improve the quality of the patient's life 20 (palliative). A successful treatment will allow the patient to return partially or totally to their 37

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld

  ~

1 former role as a productive, contributing member of society, with accrual of all of the p 2 consequent tangible and intangible advantages, ~ , contribution to the work force, 3 employment income for support of self and family, interpersonal relationships with family 4 and frien.ds. If radionuclide therapy is less expensive and produces less morbidity than other 5 possible therapeutic options, and if the patient exerts reduced demand on the healthcare -7 system due to improved health, the financial burden imposed on the healthcare system will be eased. The benefit of returning the person from "patient1' to "member of society" is clear, 8 moral and unquestionably justified. 9 10 The costs to society of radionuclide therapy are the loss of prpductivity and income 11 due to temporary or permanent absence of the patient from the workplace and the 12 theoretically increased risks of stochastic effects due to irradiation of members of the public 14 15 by the patient. As discussed earlier in this Appendix (Section B.3.2), absence from the workplace due to confinement for medical care may be justified (medical or surgical recovery) or of questionable value (reduction of small doses to members of the public versus 16 negative financial and psychological effects on patient and family). These two categories of 17 costs are inextricably and inversely related, since reduced radiation doses to members of the 18 public can be achieved only by restricting the access of members of the public to the patient, 19 i&.., by imposing administrative restrictions on the patient's return to the workplace and the 20 community. Fortunately, the number of radionuclide therapy procedures per year, the actual 38

NCRP SC 90 Draft of May 1994 a;\NCRP.com/sld 1 number of persons in the exposed populations and the collective public dose are all very 2 small. 3 4 B.4 Llmitation 5 6 "Once a practice has been justified and adopted, it is necessary to consider 7 how best to use resources in reducing the radiation risks to individuals and the 8 population. If the* next step of reducing the detriment can be achieved only 9 with a deployment of resources that is seriously out of line with the consequent 10 reduction, it is not in society's interest to take that step, provided that 11 individuals have been adequately protected .... " (ICRP, 1991) 12 13 B.4.1 Dose Limits for Members of the Public 14 15 "For continuous (or frequent) exposure, it is recommended that the annual 16 effective dose not exceed 1 mSv. Furthermore, a maximum annual effective 17 dose limit of 5 mSv is recommended to provide for infrequent annual 18 exposures. An annual effective dose limit recommendation of 5 mSv is made 19 because annual exposures in excess of the 1 mSv recommendation, usually to a 20 small group of people, need not be regarded as especially hazardous, provided 39

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1 , it does not occur often to the same groups and that the average exposure to 2 individuals in these groups does not exceed an average annual effective dose of 3 about 1 mSv." (NCRP, 1993b) 4 5 6 The recommendations for dose limits for members of the public (other than family It members) in this Commentary are based on the desire to limit individual doses to 1 mSv, 8 except in exceptional circumstances. Exceptions that would permit higher dose limits for 9 children and for pregnant and potentially pregnant women are strongly discouraged. 10 11 B.4.2 Special Dose Limits for Certain Members of the Public 12 13 B.4.2.1 Other Patients. Radionuclide therapy patients may be confined in a medical facility. - The other patients in the medical facility are likely to be ordinary patients who are not 15 receiving any type of radiation-based therapy. These patients should be considered members 16 of the public. 17 18 Patients undergoing radiation-based therapy should also be considered members of the 19 public. This position is based on the premise that these other patients could be children or 20 young adults with an excellent prognosis for a long remaining lifetime. However, in 21 extenuating circumstances, a higher dose limit may be permitted after careful consultation 40

NCRP SC 90 Draft of May 1994 a:\NCRP .com/sld 1 between the respective treating physicians and the facility's radiation safety officer. Such 2 exceptions"' should be rare. 3 4 B.4.2.2 Family Members. A person should be exposed to the radiation emanating from a 5 radionuclide therapy patient only when there is a net benefit to the exposed person or to 6 society. Further, the radiation dose should be allowed to increase only if the benefits also 7 increase. 8 11 9 Medical exposure is confined to exposures incurred by individuals as part of 10 their own medical diagnosis or treatment and to exposures (other than 11 occupational) incurred knowingly and willingly by individuals helping in the 12 support and comfort of patients undergoing diagnosis or treatment. The 13 Commission ... recommends that dose limits should not be applied to medical 14 exposures.* (ICRP, 1991) 15 16 Other than the patients themselves, the families of radionuclide therapy patients gain 17 the greatest benefit from radionuclide therapy. A successful treatment will give the patient 18 increased length of life, increased quality of life, or both. The family gains a healthier, 19 happier family member. If the patient is a family breadwinner, the family also gains peace 20 of mind insofar as income is concerned. Thus, the benefits to family members are great. 41

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1 Neglecting for the moment temporary or permanent loss of income due to confinement 2 for medical care (see Section B.4.3) and the direct financial costs of the treatment, the cost 3 to family members is the risk associated with the radiation doses they receive. For a 1 to 50 4 mSv range of effective doses (Table B.1), the theoretical incremental lifetime probabilities of 5 radiation-induced cancer death are 0.03 to 1.4 percent above the natural United States cancer - death rate of 17 percent. The linear no-threshold model used to develop these probabilities 7 cannot exclude zero probability of death, even at the upper end of the contemplated dose 8 range. Most members of the immediate family of a radionuclide therapy patient are likely to 9 conclude that these small, theoretical risks are acceptable compared to the benefits they 10 actually receive. 11 12 The "family," though, is not a monolithic structure. The radionuclide therapy patient fJ may be a child, parent, sibling, grandparent, grandchild, spouse or significant other. 14 Women members of the family may be pregnant. Therefore, the benefit:cost ratio for each 15 family member may be different. For example, the ratio may be quite high for the spouse, 16 but relatively much lower for the pregnant daughter who lives elsewhere and visits the 17 patient frequently. Since the benefit:cost ratio for each family member is different, it is 18 reasonable to establish different dose limits, especially for persons assumed for radiation 19 protection purposes to be more radiosensitive, ~ , children, pregnant and potentially 20 pregnant women. These persons usually will not be primary caregivers for the patient and 42

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1 can restrict their contact with the patient more e.a.sily than can other family members. I' 2 Therefore, a dose limit of 1 mSv is recommended for children or pregnant or potentially 3 pregnant women. A dose limit of 5 mSv is recommended for the infrequent exposure of all 4 other family members, but doses up to 50 mSv may be permitted if the treating physician 5 determines such exposures to be medically desirable for the physical and mental well-being 6 of the patient. If a family member is pregnant, the dose to the embryo or fetus should be 7 constrained to 0.5 mSv per month (NCRP, 1993b). 8 9 B.4.2.3 Persons in the Workplace. The radionuclide therapy patient who is a family 10 breadwinner will wish to resume work as soon as possible. There are significant financial 11 and psychosocial benefits associated with prompt return. The other persons in the 12 workplace, however, accrue little benefit from the patient's early return, and they endure the 13 theoretical risks associated with exposure to radiation from the patient's body. Given the 14 marginal benefit/cost ratio, a dose limit of 1 mSv is recommended for persons in the 15 workplace. 16 17 Scenarios are readily drawn that enhance the benefit/cost ratio to the point where a 18 highex dose limit might be acceptable. For example, the patient could be the President of the 19 United States, or the owner and most highly-skilled employee of a small machine shop that 20 would have to close its doors if the patient could not work. In these scenarios, the benefits 43

NCRP SC 90 Draft of May 1994 a: \NCRP .com/sld and radiation doses would both be higher while still maintaining an acceptable balance 2 between them. H the patient and the employer would like the patient to return to work while 3 other persons in the workplace could receive doses in excess of 1 mSv, a dose limit of 4 5 mSv may be applied to a small number of these persons if the average dose to all 5 significantly exposed co-workers is less than 1 mSv. B.4.2.4 General Public. The radionuclide therapy patient's contact with members of the 8 general public is fully under the control of the patient and can be minimized with only minor 9 impact on the patient's lifestyle. The recommended annual dose limit for members of the 10 public is 1 mSv, and there should be virtually no circumstances in which a higher dose limit 11 is justified. 12 13 Every effort should be made to have a family member transport the patient in a private 15 car from the medical facility to the patient's home. Mass transit should not be usep so long as the patient could cause a dose of more than 1 mSv to any passenger. 16 17 B.4.3 Administrative Restrictions on Access of Public to Patient 18 19 .Radionuclide therapy has been an important element of the practice of medicine for 20 more than 40 y, and it is a justified use of radiation. Similarly, the humane benefits of 44

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1 radionuclide therapy are so great and the societal costs are so modest that the modern 2 practice of radionuclide therapy is judged to be performed in a manner that is ALARA. The 3 remaining question is whether any individuals or groups of individuals are exposed to 4 unacceptable radiation risks and, if so, are there any practical interventions that can be 5 imposed that would reduce these risks to acceptable levels without compromising a potential 6 patient's access to the benefits of radionuclide therapy? 7 8 "The steps needed to restrict the exposure of individuals, either in the control of a 9 practice or by intervention, can be taken by applying action at any point in the 10 network linking the sources to the individuals. The action may be applied to the 11 source, to the environment or to the individual. Actions that can be applied at the 12 source will be the least disruptive. . .. actions applied to the environment or to 13 individuals are more obtrusive and may have social disadvantages, not all of which 14 are foreseeable. Their effectiveness will be limited because they apply only to 15 some of the pathways and individuals." (ICRP, 1991) 16 17 In Section A.2, the radiation risks associated with contamination following 18 racliopharmaceutical therapy and with exposure to or contamination from the sealed sources 19 used in brachytherapy were shown to be negligible compared to those associated with 20 external irradiation by x rays and gamma rays emitted from the patient's body. Thus, the 45

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1 "source" in the quotation introducing this Section is the radioactivity contained in the 2 patient's bpdy. The "individuals" are members of the public and medical radiation workers 3 who participate in the administration of the radionuclide therapy procedure. The radiation 4 protection challenge is to reduce the source term, to reduce the exposure of individuals, or 5 both, without compromising the quality of the patient's medical care. B.4.3.1 Reduction of the Source Tenn. Reduction of the source term could be achieved by 8 using radi~nuclides whose radiations would not pose an external irradiation problem, by 9 using lower activities, or by controlling the movement of the patient. The radionuclides 10 suitable for radionuclide therapy are limited in number. At the current state of the art, the 11 balance between the external irradiation hazard and the need for sufficiently penetrating 12 radiations to achieve the desired clinical effect is optimized. Likewise, the activities 13 prescribed in radionuclide therapy are the smallest consistent with maximal clinical 15 effectiveness and minima] side effects. Advances in the state of the art in radionuclide therapy will incorporate careful scrutiny of the external irradiation hazard, since the medical 16 community is acutely aware of the need to maintain the medical contribution to the public's 17 doseALARA. 18 19 B.4.3.1.1 Controlling Movement of the Patient. The first two aspects of the source term 20 (the nature and amount of radioactivity used) are amenable to scientific inquiry and future 46

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1 ' improvements in medical technology. Controlling the movement of the patient, however, is 2 a far more difficult question, since the American legal system is founded on the primacy of 3 the rights of the individual and on the premise that those rights should be encumbered only 4 when there is an identifiable harm to other persons or to society at large. Except for the 5 medical quarantine of patients with a very limited number of virulent contagious diseases, 6 state and federal laws do not (and should not) provide any mechanism to compel a patient to 7 undergo medical treatment or to comply with a physician's recommendations for follow-up 8 medical care, medications or modification of behavior. At the present time, movement of the 9 patient is controlled by "confinement for medical care, 11 by encouraging the patient to 10 minimize contact with members of the public, or both. 11 12 B.4.3.1.1.1 Confinement for Medical Care. Confinement for medical care may be for 13 medical or surgical recovery, for reduction of dose to members of the public, or both. For 14 most radiophannaceutical therapy procedures, the confinement is for reduction of dose to the 15 public, while confinement after a brachytherapy procedure is more likely to be for surgical 16 recovery. In either type of radionuclide therapy, the period of time necessary for medical or 17 surgical recovery is on the order of one day* or less. Confinement beyond this short recovery 18 period is accomplished for public health reasons and only with the cooperation of the patient. 19 The treating physician has no legal power to compel the patient to remain .confined. Indeed, 47

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1 one of the frustrations of medical practice is the patient who leaves the medical facility 2

• against medical advice."

3 4 Confinement for medical or surgical recovery is an integral component of the 5 radionuclide therapy procedure and, as such, is justified. Physicians are under intense pressure to reduce the period of time that a patient is in the hospital, so the medical or ti7 surgical recovery time is kept to a minimum. The costs associated with confinement for 8 reduction of dose to members of the public are more numerous, less constrained and 9 questionably justified or minimized. 10 11 Confinement for public health purposes imposes financial costs on the patient in the 12 form of room charges and lost income, and on the medical facility in the form of 13 unavailability of the patient's room for a medical or surgical patient with real need for '15 16 hospitalization and of lost income from adjacent rooms that_ must be kept vacant to ,minimize radiation doses to other patients. Confinement for public health purposes imposes higher individual and collective doses on employees of the medical facility compared to doses 17 avoided in members of the public. Confinement for public health purposes imposes 18 psychosocial costs on the patient and the patient's family by interfering with the familial 19 bond-of care and compassion. Finally, confinement for public health purposes imposes 20 financial costs on the nation's healthcare system at a time when these costs arguably could be 48

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1 directed to other individual and public health problems of far greater societal priority. Thus, 2 confinement for public health purposes is an intervention that has numerous substantial costs, 3 is obtrusive and has many social disadvantages. 4 5 B.4.3.1.1.2 Minimizing Patient Contact with Public. Physicians have recognized for many 6 years that a key component of radionuclide therapy is protection of the public after the 7 patient has been treated and released from the medical facility. Considerable effort is 8 expended to educate the patient about the need to carefully control their excreta (following 9 systemic radiopharmaceutical therapy) and to minimize their contact with family members 10 and other members of the public for an appropriate time after returning to their home. When 11 patients are educable and cooperative, these recommendations about responsible behavior are 12 heeded and are effective in minimizing dose to the public. The patient's behavior concerning 13 these matters is more problematic when there are language barriers, when the family is 14 multigenerational and crowded into cramped quarters, or when the patient simply chooses to 15 ignore the physician's advice. Admission for hospital-based inpatient treatment will be 16 necessary in these situations. 17 18 B.4.3.1.2 Controlling Members of the Public, The treating physician's control over the 19 behavior of members of the public in their interactions with the radionuclide therapy patient 49

NCRP SC 90 Draft of May 1994 a: \NCRP .com/sld

1. is nonexistent. Indeed, it is difficult to imagine any societally acceptable mechanism by 2 which the,behavior of the public or the patient could be affirmatively controlled.

3 11 4 B.4.3.1.3 Justification of Intervention. Justification is the process of deciding that the 5 disadvantages of each component of intervention, i.e., of each protective action, are more 6 than offset by the reductions in the dose likely to be achieved. The cost of intervention is e, not just the monetary cost. Some protective or remedial actions may involve non-8 radiological risks or serious social impacts. The proposed intervention should do more good 9 than harm, i&., the reduction in detriment resulting from the reduction in dose should be 10 sufficient to justify the harm and the costs, including social costs, of the intervention." 11 (ICRP, 1991) 12 13 Some radionuclide therapy patients could be released after medical or surgical recovery -15 with external radiation fields that could cause unacceptable radiation doses to members of the public if no intervention were performed. Many years of experience with radionuclide 16 therapy have demonstrated that patients generally are cooperative in minimizing their contact 17 with members of the public, but that they are only reluctantly cooperative about supervised 18 confinement for the purpose of reducing radiation doses to members of the public. As 19 suggested in the quotation introducing this Sectio9,, interventions are less well-accepted and 20 enjoy less compliance as they become more obtrusive and as they intrude between the patient 50

NCRP SC 90 Draft of May 1994 a: \NCRP .com/ sld 1 and the patient's family. Interventions become unpopular with both the patient and the

            ~

2 healthcare system when the financial costs are high. If the interventions become so 3 expensive and burdensome that patients decline radionuclide therapy in favor of a less 4 desirable, but less intrusive, treatment, the patient effectively has been denied access to 5 appropriate medical care, and the patient and society are ill-served as a consequence. 51

NCRP SC 90 Draft of May 1994 a:\NCRP .com/sld 1 , Appendix C. Application for Criteria for Release from Medical Commement in 2 ,. Common Types of Radionuclide Therapy 3 4 C.1 Brachytherapy 5 6 c.1.1 Permanent Implants ~ 8 The activity and the dose rate will decrease according to the physical half-life of the 9 radionuclide. Administrative restrictions on the patient's contact with family members and 10 members of the public should be imposed until radioactive decay has reduced the activity and 11 the dose rate below the values in Table C.2. 12 13 C.1.1.1 Example. A patient is treated with 150 MBq of 198Au seeds. The patient has a 15 five-year-old child, and the spouse must change surgical dressings frequently. Assuming a 1 mSv limit for the child and a 5 mSv limit for the spouse, for what lengths of time would 16 administrative restrictions be necessary? (The physical half-life of 198Au is 2. 7 days.) 17 18 C.1.1.2 Child, From Table C.2, administrative restrictions would need to be imposed until 19 the patient's activity is less than 20 MBq (assuming no appreciable dose during the time 20 restrictions are imposed), or eight days. Restrictions might include prohibitions against 52

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1 sitting in the patient's lap to read a book or listen to a story, or sleeping in the same bed 2 with the patient. 3 4 C.1.1.3 Spouse. Since the dose limit for the spouse was chosen to be 5 mSv, the activity 5 value in Table C.2 is multiplied by five, i&,_, 100 MBq, and the restrictions would be 6 imposed for 1. 7 days. The spouse should sleep in a separate bed, should not sit with the 7 patient on a sofa, and should avoid long automobile trips. Separation distances of 2 to 3 m 8 should be maintained as much as practicable. 9 10 c.1.2 Temporary Implants 11 12 Most "outpatienta temporary implants exhibit no appreciable radioactive decay during 13 the course of the therapy. Administrative restrictions would need to be imposed throughout 14 the irradiation time if the activity or dose rate at implantation exceeds the values iri 15 Table C.1. Common restrictions would be the same as for permanent implants (see Section 16 C.1.1). 17 18 19 20 53

NCRP SC 90 Draft of May 1994 a: \NCRP .corn/sld 1 . C.2 Radiopharmaceutical Therapy 2 3 C.2.1 Intracavitar_y Therapy 4 5 Colloidal 32p (half-life 14 d) may be administered for treatment of malignant effusions.

• 7 8

Since the radiopharmaceutical will not leave the treatment site~' peritoneal cavity), the activity and dose rate will decrease according to the physical half-life. Administrative restrictions on the patient's contact with family members and members of the public should 9 be imposed until radioactive decay has reduced the activity and dose rate below the values in 10 Table C.2. In addition to the restrictions suggested for brachytherapy in Section C.1, 11 surgical dressings with visible signs of radiopharmaceutical leakage should be placed in a 12 trash receptacle located away from the family's living quarters and should be discarded in the 14 15 next available trash collection . c.2.2 Systemic Radiqphannaceutical Therapy 16 17 Oral or intravascular radiopharmaceutical therapy poses a much more difficult problem 18 than brachytherapy and intracavitary therapy, since the activity and dose rate decrease due to 19 both' radioactive decay and biological elimination. Further, the same radiopharmaceutical 20 may disappear at quite different rates in different disease states. Administration of 1311 54

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1 sodium iodide is an important clinical instance of this situation, so it will be used to illustrate 2 the general procedure for incorporating biological elimination into the process for f' 3 establishing administrative restrictions. 4 5 C.2.2.1 Immediate Release Followin2 Administration. The most common therapy of this 131 6 type is 1 sodium iodide administered orally for treatment of hyperthyroidism. The 7 radiop~tical may be liquid or in capsule form, and activities are in the general range 8 100 to 1,000 MBq; 10 CPR Part 35. 75 places a de facto cap of 29.9 mCi (1,100 MBq) on 9 ,this type of treatment because of its 30 mCi release limit. Patients' thyroids are usually 10 intact and exhibit uptakes of 35 percent and greater. 11 12 Culver and Dworkin (1991) measured exposure rates at various distances at times up to 13 11 d post-administration of 1311 sodium iodide for treatment of Graves' disease and 14 Plummer's disease. The data in their Table 1 have been recast in units of exposure rate per 15 unit administered activity and are presented in Table C.1.2 16 17 Table 2 of NCRP Report No. 37 (NCRP, 1970) presented results of a calculation of 18 initial activity and exposure rates that would deliver 5 mSv to total decay for a person 131 19 exposed at a distance of 1 m, 24 h per d; Table C.2 presents these data for 1, for doses of 2 20 Private communication from Dworkin, H.J., M.D., Wtlliam Beaumont Gen~ Hospital, 21 Royal Oak, Michigan. 55

NCRP SC 90 Draft of May 1994 a: \NCRP .com/sld 1 1, 5 and 50 mSv, and with activities expressed in MBq. Table 4 of NCRP Report No. 37 2 recommended the 5 mSv values as "no restrictions" hospital discharge criteria. 3 4 The impact of reducing the dose limit from 5 mSv to 1 mSv may be seen by comparing 5 the very conservative "no restrictions" criteria of Table C.2 to the calculated values in Table 6 C.3, which was derived by using the normalized exposure rate data from Table C.l to e estimate the expected exposure rates from arbitrary low and high treatment dosages. At the 8 lower dosage (300 MBq), restrictions could be completely removed after one week for the 1 9 mSv limit For the higher dosage (1,000 MBq), restrictions would be needed for one week 10 for the 5 mSv limit and roughly two weeks for the 1 mSv limit. 11 12 Because of the large variability of the effective half-life and the lack of correlation of 13 measured exposure rate with administered activity, initial administrative restrictions (If 9 needed) should be imposed for a period of about one week and should be based on the initial 15 measured exposure rate at 1 meter. Administered activity should not be used as the basis 16 because of the widely varying attenuation of patients' bodies while the 1311 is still 17 predominantly in the stomach. The restrictions should be revised after one week based on 18 the actual exposure rate measured during a brief revisit. If a revisit is not feasible, 19 restrictions should be imposed for two weeks. 20 21 In addition to the common administrative restrictions described for brachytherapy 22 (Section C.1), family members should be cautioned about the likely presence of 1311 on items 56

NCRP SC 90 Draft of May 1994 a: \NCRP .com/sld 1 Table C. l - Activity-normalized average external exposure rates 2

            ,.                 around hyperthyroidism patients.*

3 4 5 6 7 8 Time after administration 9 Distance 0 day 2-4 d 5-7 d 8-11 d 10 11 12 1.0m 4.6 +/- 1.6 2.2 + 1.1 1.4 +/- 0.8 13 0.6m 5.9 +/- 2.7 3.4 1.6 2.4 +/- 1.1 14 N 59 41 33 15 15 16 17 -Mean + 1 s.d. 18 19 20 21 22 23 24 25 26 57

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1 Table C.2 - Initial exposure rates and activities of 1311 leading to indicated 4 2

                 ,. integrated dose at 1 m (adopted from NCRP Re,port No. 37).

3

~

7 Integrated Initial Corresponding Normalized 8 dose exposure rate activity exposure rate 9 (mSv) (mR h-1) (MBq) (µ.R h*l MBq-1) ~ 15 16 17 1 5 50 0.36 1.8 18 60 300 3,000 1.2 6 60 !~ 21 22 23 24 25 26 27 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 58

tJ NCRP SC 90 Draft of May 1994 a: \NCRP .com/sld 1 Table C.3 - Expected exposure rates following low- and high-activity 2 3 ,. hyperthyroid therapy with oral 1311 sodium iodide 4 5 (calculated from Table C.1). 9 10 11 Distance Od 5-7 d 8-11 d l~ 15 Dosage = 300 MBq 16 17 1.0m 1.4 0.7 0.4 18 19 0.6m 1.8 1.0 0.7 20 21 Dosage = 1,000 MBq 22 23 1.0m 4.6 2.2 1.4 24 25 0.6m 5.9 3.5 2.4 ~i29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 59

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1 contaminated by the patient's sweat, urine and mucous secretions. Since 1311 can appear in

   ~

131 2 breast milk, breastfeeding should be discontinued until the treating physician measures no 1 3 " in a freshly-expressed milk sample (Culver and Dworkin; 1991). 4 131 5 C.2.2.2 Confinement after Administration. The most common therapy of this type is 1 6 sodium iodide administered orally for treatment of thyroid carcinoma. The -'8 9 radiopbarmaceutical may be liquid or in capsule form, and activities are in the general range 3,000 to 10,000 MBq. Patients have usually undergone surgical thyroidectomy, so that only minimal thyroid tissue remains and uptake values are on the order of a few percent or less. 131 10 The vast majority of the administered 1 is excreted in urine during the first day or two, 11 dramatically decreasing the exposure rates around the patient. 12 13 Culver and Dworkin (1992) measured exposure rates at various distances at times up to 15 16 one week post-administration of 1311 sodium iodide for treatment of thyroid cancer. The data in their Table 1 have been recast in units of exposure rate per unit administered activity and are presented in Table C.4. 17 18 A comparison of the hyperthyroid patient data (Table C.1) and the thyroid cancer 19 patient data (Table C.4) demonstrates the much more rapid decrease and lower final values 20 of exposure rate in thyroid cancer patients. Referring to Table C.2, thyroid <;ancer patients 21 can be released from administrative restrictions two to four d after release from confinement 22 60

NCRP SC 90 Draft of May 1994 a: \NCRP .com/sld 1 Table C.4 - Activity-normalized average external exposure rates around 2 thyroid carcinoma patients.* 3 4 5 6 Time after hospital dischargeb 7 8 9 Distance 0-1 d 2-4 d 5-7 d 10 11 12 1.0m 7.2 +/- 1.6 0.7 +/- 0.7 0.7 + 1.3 13 0.6 m 12.2 +/- 4.9 1.8 +/- 1.4 1.4 + 2.5 14 15 16 -Mean +/-1 s.d.; activity range 4620-8140 MBq, mean = 5850 MBq 17 bHospital stay was 1 d (J/27), 2 d (18/27) and 3 d (2/27), with length of stay 18 determined by activity below 1,110 MBq or exposure rate below 5 mR h-1* 19 20 21 22 23 24 25 61

NCRP SC 90 Draft of May 1994 a: \NCRP .com/sld 1 in a medical facility under the 1 mSv dose limit, and almost immediately under a 5 mSv dose 2 limit; a special return visit for exposure rate measurement is not necessary. 62

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1 References 2-3 ACS (1990). American Cancer Society. Cancer Statistics 1990 (American Cancer Society, 4 Atlanta, Georgia). 5 ALLEN, H.C., JR. and ZIBLTNSKI, J.D. (1990). 11 430 non-hospitalized thyroid cancer 6 patients treated with single doses 50-400 mCi, 11 J. Nucl. Med 31, 784 (abstract). 7 BEIBRWALTE.S, W.H. and WIDMAN, J. (1992). "How harmful to others are iodine-131 8 treated patients, 11 J. Nucl. Med. 33, 2116-2117 (editorial). 9 CULVER, C.M. and DWORKIN, H.J. (1991). "Radiation safety considerations for post-10 iodine-131 hyperthyroid therapy," J. Nucl. Med. 32, 169-173. 11 CULVER, C.M. and DWORKIN, H.J. (l992). "Radiation safety considerations for post-12 iodine-131 thyroid cancer therapy," J. Nucl. Med. 33, 1402-1405. 13 GLASGOW, G.P. (1992). "Radiation safety program for radiation oncology, 11 pages 596 to 14 622 in Advances in Radiation Oncology Physics: Dosimetry, Treatment Planning and 15 Brachytherapy, Purdy, J.A., Ed. (American Institute of Physics for the American 16 Association of Physicists in Medicine, New York). 17 ICRP (1991). International Commission on Radiological Protection. 1990 Recommendations 18 of the International Commission on Radiological Protection, ICRP Publication 60, 19 Annals of the ICRP (Pergamon Press, Elmsford, New York). 20 MORGAN, M.G. (1993). "Risk analysis and management, 11 Sci. Amer. 269, 32-41. 21 NAS/NRC (1990). National Academy of Sciences/National Research Council. Health 22 Effects of Exposure to Low Levels of Ionizing Radiation, Report of the Committee on 63

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1 the Biological Effects of Ionizing Radiations, BEIR V (National Academy Press, 2 Washington). 3 NCRP (1970). National Council on Radiation Protection and Measurements. Precautions in 4 the Management of Patients Who Have Received Therapeutic Amounts of 5 Radionuclides, NCRP Report No. 37 (National Council on Radiation Protection and 6 Measurements, Bethesda, Maryland). -8 NCRP (1972). National Council on Radiation Protection and Measurements. Protection Against Radiation From Brachytherapy Sources, NCRP Report No. 40 (National 9 Council on Radiation Protection and Measurements, Bethesda, Maryland). 10 NCRP (1987). National Council on Radiation Protection and Measurements. 11 Recommendations on Limits for Exposure to Ionizing Radiation, NCRP Report No.-91 12 (National Council on Radiation Protection and Measurements, Bethesda, Maryland) 13 (superseded by NCRP Report No. 116, 1993). 15 NCRP (1989). National Council on Radiation Protection and Measurements. Radiation Protection for Medical and Allied Health Personnel, NCRP Report No. 105 (National 16 Council on Radiation Protection and Measurements, Bethesda, Maryland). 17 NCRP (1990). National Council on Radiation Protection and Measurements. 18 Implementation of the Principle of As Low As Reasonably Achievable (ALARA) for 19 Medical and Dental Personnel, NCRP Report No. 107 (National Council on Radiation 20 Protection and Measurements, Bethesda, Maryland).

• 64

NCRP SC 90 Draft of May 1994 a:\NCRP.com/sld 1 NCRP (1993a). National Council on Radiation Protection and Measurements. ~ 2 Estimates for Radiation Protection Pui:poses, NCRP Report No. 115 (National Council 3 on Radiation Protection and Measurements, Bethesda, Maryland). 4 NCRP (1993b). National Council on Radiation Protection and Measurements. Limitation of 5 Exposure to IoniZini: Radiation, NCRP Report No. 116 (National Council on Radiation 6 Protection and Measurements, Bethesda, Maryland). 7 NRC (1991a). Nuclear Regulatory Commission. Standards for Protection Against 8 Radiation, Title 10, Code of Federal Regulations, Part 20 (U.S. Government Printing 9 Office, Washington). 10 NRC (1991b). Nuclear Regulatory Commission. Medical Use of Byproduct Material, Title 11 10, Code of Federal Regulations, Part 35 (U.S. Government Printing Office, 12 Washington). 13 UNSCEAR (1988). United Nations Scientific Committee on the Effects of Atomic 14 15 Radiation. Sources, Effects and Risks of Ionizing Radiation, Report to the General Assembly with Annexes (United Nations Publications, New York). 16 65

DOCKETED (!) THE UNIVERSITY OF IOWA Department of Radiology us*mc HOSPITALS AND CLINICS 319/356-2188 If no answer, 319/356-1616 I200 Hawkins Dr. Iowa City, Iowa 52242-1077

                                                           *94 JUL -6 P 1 :32                            I FAX 3 I 9/356-2220 OF FICE Of 0QC KET,!f\J     , (* , nTt\~'_C
                                                                  , ,.-.SECf{~        /

• 1-t.

                                                                         ):. ;_i;:.',. : , -

June 29, 1994 oRA, CH 1 Secretary DOCKET NUMSE:Ff PR :2 o ,5 U.S. Nuclear Regulatory Commission PROPOSED RULE..!..!!..:---,..- Washington, DC 20555 ATTN: Docketing and Service Branch ( >CJ f (< :JD 12 LI) RE: FR Doc. 94-14544. 10 CPR Parts 20 and 35 Criteria for the Release of Patients Administered Radioactive Material

Dear sirs:

I would like to take this opportunity to comment on the proposed rule cited above.

    § 20 .13 01 I maintain that NRC should re-instate the previous limit to individual members of the public of 0.5 rem per year. I believe that this value offers adequate radiation protection. I base my belief on the absence of scientific evidence demonstrating a causal adverse effect (e.g., cancer induction) at this level of irradiation. Furthermore, although 0.5 rem/year is somewhat higher than the average effective dose from background sources, it is still within the range of effective doses from background sources. There is a long history of experience at the 0.5 rem/yr limit without any documented problems whatsoever.

Reduction of the limit to 0.1 rem/yr, without effecting a change that is demonstrable and measurable, gives the perception that NRC is conceding to public radiation hysteria. If the new limit to individual members of the public of 0.1 rem per year is maintained, then I support the proposed exclusion of dose contributions from patients containing radioactive materials.

    §35.75 I disagree with the proposed rule. While it is true that the release criteria of <30 mCi or <5 mrem/hr @ 1 m were developed with 1-131 Nal specifically in mind and therefore may not be applicable for other
                                                                                             ~L 2 1 1994 Acknowledg         by card ..,"_ ,_...~'"'""'ii'&

                                      .      ,_,~,I\J '

l.ivv... , ... .. ~~1 . . ,1.Jt 6ECTION OFFIC:t OF THE SECRETARY Of lHE COMMISSlON Oocument Statistics Postmark Date 6/2 0 /9-LJ Coples Received _ ___.__ _ _ __ Add'I Copies Reproduced ->----,--- lz. Special Distrib'JtiOfl J:/2 ~ /J[)/21 _f°c,,6 tlR 1 M.1t: .

• radiopharmaceuticals or radioimplants, I do not believe that the proposed rule is the best overall approach.

The current release criteria for 1-131 Nal are well established. In particular, the criterion of <5 mrem/hr @ 1 m is practical, convenient, fast, reproducible, easy to perform, and results in minimal radiation exposure to the individual performing the survey. Furthermore, this measurement is routinely performed anyway as part of required surveys (10 CFR 35.3 15(a)(4)] and in order to obtain exposure-rate values used to determine recommended length of time visitors may be in the room [10 CFR 35.315(a)(2)]. This method works well and should continue to be an acceptable criteron for release of patients containing 1-131 Nal. In the case of permanent implants, a release criterion could be developed based on a similar approach as was done for 1-131 Nal. For example, the criterion could be a numerical value which is the product of the exposure-rate measurement at one meter and the physical half-life of the radionuclide. Or, with algebraic rearrangement, the criterion could be the exposure-rate measurement which is equal to a specified number divided by the physical half-life of the radionuclide. To illustrate, the current release criterion for Au-198 is <5 mrem/hr @ 1 m. With a physical half-life of 2.7 days, the product of exposure-rate @ 1 m and the physical half-life is 13.5 [i.e., 5 X 2.7 = 13.5]. Thus, a general (non-radionuclide-specific) release criterion could be stated as the exposure-rate @ 1 meter that is equal to 13.5 divided by the physical half-life [in the case of Au-198, 13.5/2.7 = 5 mrem/hr @ 1 m]. In the case of unsealed sources of therapeutic radiopharmaceuticals (e.g., 1-131 antibodies), a release criterion could be established analogous to that described in the previous paragraph for permanent implants with the modification that the effective half-life be used instead of the physical half-life. In this setting, the effective half-life could be readily determined from one or a combination of the following: serial measurements of a previous diagnostic administration of the same radiopharmaceutical; serial monitoring of the patient following administration of the therapeutic radiopharmaceutical prior to release; values established in the literature; measured initial biological excretion (fraction 1) followed by assumed physical decay only of the remainder (fraction 2). This is somewhat more complicated but is still practical. I also suggest deletion of proposed paragraph (b )( 1) Provide the patient with written instructions.... I suggest that, depending on the circumstances, other mechanisms, including oral instructions, are appropriate [for example, blindness]. I believe that existing 10 CFR 35.315(a)(6) and 35.415(a)(5), which require that the licensee provide

the patient with radiation safety guidance ... , are adequate as they exist and do not require modification. Thank you for your consideration of these comments. Sincerely, James Ponto, S, RPh, BCNP Chief Nuclear Pharmacist and Clinical Professor University of Iowa Hospitals and Clinics, and College of Pharmacy Iowa City, IA 52242

DOCKET NUMBER PROPOSED RULE PR 2~ (sq FR '3072f} DOCKETED [7590 ~]SHRC NUCLEAR REG ULATORY COMMISSION

                                                                     '94 JUN 10 P4 :13 10 CFR Parts 20 and 35 RIN 315O-AE41                  OFFICE OF SECRETARY DOCK ETING & SERVICE Criteria for the Release of Patients                 BRANCH Admi nistered Radioactive Material AGENCY:   Nuclear Regulatory Commission.

ACTION: Proposed rule.

SUMMARY

The Nuclear Regulatory Commissi on (NRC) is proposing to amend its regulations concerning the criteria for the release of patients administered radioactive material. The new criteria for patient release would be dose-based rather than activity-based and would be consistent with the recommendations of the International Commission on Radiological Protection (ICRP). The proposed rule would require th e licensee to maintain a record for 3 years if the quantity of radioactive material is likely to result in an annual total effective dose equivalent to an individual exposed to the patient that exceeds I mi l lisievert (0.1 rem) from a single administration. The proposed rule responds to two petitions for rulemaking regarding the criteria for release of patients administered radioactive material.

DATES: The comment period expires f-)1-q/1:{ days following publication in the Federal Register). Comments received after this date will be considered if it is practicable to do so, but the Commission is able to assure consideration only for comments received on or before this date. 1

ADDRESSES: Send comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555. ATTN: Docketing and Service Branch. Hand deliver comments to 11555 Rockville Pike, Rockville, Maryland between 7:45 a.m. and 4:15 p.m. Federal workdays. Examine comments received, the environmental assessment and finding of no significant impact, and the regulatory analysis at: The NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. Obtain single copies of the environmental assessment and finding of no significant impact and the regulatory analysis (NUREG-1492) from: Jayne - McCausland, Offi~e of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone: (301) 415-6219. Obtain single copies of the dr'aft regulatory guide, "Release of Patients Administered Radioactive Material," which is related to this rulemaking, by writing to: Distribution and Mail Services Section, Office of Administration, U. S. Nuclear Regulatory Commission, Washington, DC 20555. FOR FURTHER INFORMATION CONTACT: Stewart Schneider, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 415-6225. SUPPLEMENTARY INFORMATION: Table of Contents I. Background II. Petitions for Rulemaking III. Public Comments Received on the Petitions IV. Coordination with NRC Agreement States 2

V. Coordination with the Advisory Committee on Medical Uses of Isotopes VI. Issues and Their Resolution VII. Summary of the Proposed Changes VIII. Consistency with 1979 Medical Policy Statement IX. Issue of Compatibility for Agreement States X. Finding of No Significant Environmental Impact: Availability XI. Paperwork Reduction Act Statement XII. Regulatory Analysis I,, XIII. Regulatory Flexibility Certification XIV. Backfit Analysis I. Background Each year in the United States, radioactive pharmaceuticals or radioactive implants are administered to approximately 8 to 9 million patients for the diagnosis or treatment of disease (hereinafter this group will be referred to as patient(s)). These patients can expose others around them to radiation until the radioactive material has been excreted from their bodies or has decayed away. As discussed below, most of these exposures would be much less than 1 millisievert (0.1 rem) total effective dose equivalent per year. NRC's current patient release criteria in 10 CFR 35.75, "Release of patients containing radiopharmaceuticals or permanent implants," are as follows: "(a) A licensee may not authorize release from confinement for medical care any patient administered a radiopharmaceutical until either: (1) The measured dose rate from the patient is less than 5 millirems per hour 3

at a distance of one meter; or (2) The activity in the patient is less than 30 millicuries; (b) A licensee may not authorize release from confinement for medical care of any patient administered a permanent implant until the measured dose rate is less than 5 millirems per hour at a distance of one meter." On May 21, 1991 (56 FR 23360}, the NRC published a final rule that amended 10 CFR part 20, "Standards for Protection Against Radiation. 11 The rule contained limits on the radiation dose for members of the public in 10 CFR 20.1301. However, when 10 CFR part 20 was issued, there was no discussion in the supplementary information on whether or how the provisions of 10 CFR 20.1301 were intended to apply to the release of patients, thereby creating the need to address this issue. To determine the potential number of patients that could be affected by this 1ssue, the NRC performed a screening analysis to determine how many patients administered radioactive materials could cause the exposure of an individual to a dose exceeding 1 millisievert (0.1 rem) total effective dose equivalent in a year if there were no restrictions on patient release. The screening analysis indicated that none of the diagnostic administrations were likely to result in a dose to an individual exposed to the patient exceeding 1 millisievert (0.1 rem), except for a few diagnostic procedures using iodine-131. The therapeutic administrations that the screening analysis indicated needed consideration were: (1) the treatment of hyperthyroidism with iodine-131 {50,000 per year); (2) the treatment of thyroid cancer with iodine-131 (10,000 per year); and (3) the treatment of a variety of cancers (e.g., prostate cancer) with thi permanent implantation of iodine-125 seeds (2,000 per year). Other radionuclides may also warrant consideration. For 4

example, doses to individuals exposed to a patient administered ytterbium-169 and gold-198 for therapy might result in radiation exposures exceeding 1 millisievert (0.1 rem) to individuals exposed to the patient. However, these radionuclides are seldom used. In addition, procedures involving radiolabeled antibodies might result in doses exceeding 1 millisievert {0.1 rem), although no such procedures using byproduct material are yet approved for routine use. {For further information see the regulatory analysis for the proposed rule. Single copies of the draft regulatory analysis are available as indicated in the ADDRESSES heading.) II. Petitions for Rulemaking Because some licensees were uncertain about what effect the revised 10 CFR part 20 would have on patient release criteria, two petitions were received on the issue. On June 12, 1991 (56 FR 26945), the NRC published in the Federal Register a notice of receipt of, and request for comment on, a petition for rulemaking (PRM-20-20) from Dr. Carol S. Marcus. In addition, Dr. Marcus submitted a letter dated June 12, 1992, further characterizing her position. Dr. Marcus requested that the NRC amend the revised 10 CFR part 20 and 10 CFR part 35 to-(1) Raise the annual radiation dose limit in 10 CFR 20.130l(a) for individuals exposed to radiation from patients receiving radiopharmaceuticals for diagnosis or therapy from 1 millisievert (0.1 rem) to 5 millisieverts {0.5 rem). (2) Amend 10 CFR 35.75(a)(2) to retain the 1,110-megabecquerel 5

(30-millicurie) limit for iodine-131, but provide an activity limit for other radionuclides consistent with the calculational methodology employed in the National Council on Radiation Protection and Measurements (NCRP) Report No. 37, "Preca4tions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides." 1 (3) Delete 10 CFR 20.130l(d) which requires licensees to comply with provisions of Environmental Protection Agency's environmental regulations in 40 CFR part 190 in addition to complying with the requirements of 10 CFR part 20 .

• On March 9, 1992 (57 FR 8282), the NRC published a notice of receipt and request for comment in the Federal Register on another petition for rulemaking (PRM-35-10} on patient release criteria from the American College of Nuclear Medicine (ACNM). On May 18, 1992 (57 FR 21043), the NRC published in the Federal Register notice of an amendment submitted by the ACNM to its original petition (PRM-35-lOA). In addition, the ACNM submitted two letters dated September 24, 1991, and October 8, 1991, on the issues in their petition. The ACNM requested (considering the contents of all four letters) that the NRC

- revise 10 CFR part 35 to-(1) Adopt a dose limit of 5 millisieverts (0.5 rem) for individuals exposed to patients who have been administered radiopharmaceuticals. (2) Permit licensees to authorize release from hospitalization any patient administered a radiopharmaceutical regardless of the activity in the patient by defining confinement to include not only confinement in a 11 11 1 National Council on Radiation Protection and Measurements (NCRP),

  "Precautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides, NCRP Report No. 37 (October 1, 1970). {Available for sale 11 from the NCRP, 7910 Woodmont Avenue, Suite 800, Bethesda, MD 20814-3095.)

6

hospital, but also confinement in a private residence. Because the petitions submitted by Dr. Marcus and the ACNM both address the patient release criteria set forth in 10 CFR 35.75, the NRC has decided to resolve both petitions with this single rulemaking. The proposed actions, if adopted in final form, would constitute the partial granting of these petitions as set forth in this notice. All other portions of petitions PRM-20-20 and PRM-35-10 would be denied. III. Public Comments Received on the Petitions There were 140 comment letters received on PRM-20-20 and 88 comment letters on PRM-35-10 and PRM-35-IOA. Commenters represented hospitals and clinics, professional associations, citizens' groups, Agreement States and Government agencies, State radiation advisory boards, universities, consulting firms, public utilities, a utility association, and a labor union. The majority of the commenters were physicians who expressed concerns primarily related to the cost of hospitalization. Other commenters included health and medical physicists, pharmacists, nuclear medicine technicians, professors, and one former nuclear medicine patient. Overall, the majority of all comments supported a dose limit of 5 millisieverts (0.5 rem) for individuals exposed to patients released with radioactive material. IV. Coordination with NRC Agreement States The NRC conducted a publi~ workshop with representatives of the Agreement States on July 15 and 16, 1992, to discuss a variety of medical 7

issues, including the proposals for amending 10 CFR parts 20 and 35. The workshop was held in Atlanta, Georgia. Twenty-one of the Agreement States were represented, as well as a representative from the City of New York. The major recon111endations on ~he rule provided by the representatives may be summarized as follows: (1) Revise 10 CFR part 20 to exclude doses to individuals exposed to patients released under 10 CFR 35.75. (2) In 10 CFR 35.~5, retain the dose rate limit of 0.05 millisievert (5 millirems) per hour at a distance of 1 meter and add a dose Jimit of 5 fuillisieverts (0.5 rem) in 1 year for individuals exposed to patients. (3) Retain the current 1,110-megabecquerel (30-millicurie) activity limit for iodine-131 but provide activity- limits for other radionuclides based on the recommendations of NCRP Report No. 37, "Precautions in the Management 1 of Patients Who Have Received Therapeutic Amounts of Radionuclides." (4) I Do not define "confinement" in 10 CFR part 35 because the present wording gives regulatory agencies the prerogative to confine patients by means other than hospitalization. (5) Require that written instructions on how to maintain doses to other individuals as low as reasonably achievable be given to the released patient and any individual likely to spend significant time in close proximity with the patient. The NRC staff presented a status report on the requirements of the proposed rule to the Agreement States at another public meeting in October 1993, in Tempe, Arizona. The Agreem~nt States were generally supportive of the approach in this proposed rule. T-ranscripts of both meetings have been placed in and are available for examination at the NRC 8

Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. In addition, in July 1993, the NRC requested the Agreement States to provide comments on a previous version of the proposed rule. Of those responding, 14 Agreement States were generally supportive of the approach in this proposed rule, one was in opposition, and one was uncertain of its support without further study. The Agreement State that opposed the annual dose limit of 5 millisieverts (0.5 rem) {total effective dose equivalent} believed that instructions on how to maintain doses as low as reasonably I achievable to household members and other individuals would not be followed, radioactive contamination would be a problem, and permanent implants could dislodge. V. Coordination with the Advisory Committee on Medical Uses of Isotopes The NRC staff presented their suggestions for a proposed rule to the Advisory Committee on Medical Uses of Isotopes {ACMUI) during a public meeting held in Rockville, Maryland, on October 22 and 23, 1992. The 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. The major ACMUI recorrmendations on the proposed rule were to-(1) Add a dose limit of 5 millisieverts (0.5 rem) in 1 year for individuals exposed to a patient released with radionuclides. (2) Retain both the 1,110-megabecquerel (30-millicurie) activity limit and the maximum dose rate of 0.05 millisieverts (5 millirems) per hour for patient release in 10 CFR 35.75 because they are a simple means to show compliance without assumptions or calculations. 9

(3) Develop a regulatory guide that includes a set of standardized calculations with factors (e.g., occupancy factor) for licensees to determine compliance with patient release criteria on an individual basis. Provide tables of acceptable release activities that are radionuclide specific, based on exposure at 1 meter for routine patient releases, with built-in safety factors to avoid doses to individuals near the 5-millisievert (0.5-rem) limit. (4) Require that written instructions on how to maintain doses to other individuals as low as reasonably achievable be provided to the patient upon release from confinement. The NRC staff presented status reports on the requirements of the proposed rule to the ACMUI at two other public meetings in May 1993, in Bethesda, Maryland, and in November 1993, in Reston, Virginia. The ACMUI was generally supportive of the approach in this proposed rule. Transcripts of all meetings have been placed in and are available for examination at the NRC* Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. VI. Issues and Their Resolution There are seven issues that arise in responding to the two petitions. These issues and their resolution are discussed below. Issue 1: Should the limits in 10 CFR 35.75 or in 20.130l(a) govern patient release? The petitioners requested an annual dose limit of 5 millisieverts (0.5 rem) for individuals exposed to radiation from a released patient. 10

Supporting Comments The majority of corrnnenters favored a dose limit of 5 millisieverts (0.5 rem) per year for individuals exposed to released patients rather than the 1 millisievert (0.1 rem) in 10 CFR 20.130l(a). The representatives from Agreement States who attended the public meeting held in Atlanta, Georgia, on July 15 and 16, 1992, and the ACMUI public workshop held in October 1992 in Rockville, Maryland, also favored the 5-millisievert (0.5-rem) limit. Some commenters stated that a dose limit of 5 millisieverts (0.5 rem) per year for individuals exposed to a patient is in line with the recommendations of the ICRP and the NCRP. Some commenters believed that the 5-millisievert (0.5-rem) limit is beneficial to both the patient and the family because patients are able to return home earlier than would be permitted if a 1-millisievert (0.1-rem) limit were used. One commenter believed that the case could be made that no limit should be applied to the patient's family, just maintain doses as low as reasonably achievable, because there is a benefit to the family from the patient's being home. A physician commented that many patients come from homes in which no member of the family is under the age of 30, and therefore, contended that there was less risk from radiation exposure. Other comments in favor included: (1) hospitalization can be a distressing experience for many cancer patients; (2) patients can develop hospital acquired infections if kept in the hospital too long; and (3) confining patients in a hospital until the release criteria are met increases the dose to hospital personnel and other patients. Controlling the cost of medical care was one of the most cited reasons 11

in favor of the 5-millisievert (0.5-rem) limit. Concern was expressed that the costs to all parties involved (i.e., patients, hospitals, insurance companies, etc.) would dramatically rise if a 1-millisievert (0.1-rem) limit were used. Convnenters said a 1-millisievert (0.1-rem) limit would require longer periods of hospitalization, that many outpatients would become inpatients, and that this would be extremely expensive. Comments from nuclear power utilities supported the 5-millisievert (0.5-rem) limit requested by PRM-20-20. These commenters stated further that if the limit for annual dose to the public exposed to patients were 5 millisieverts (0.5 rem), then the dose limit should be 5 millisieverts (0.5 rem) for all exposures to the public, including those- from nuclear power plants, because no demonstrable health effects have been observed at chronic exposure levels of 5 millisieverts (0.5 rem). Opposing Comments A citizens' group comment.ed that any amount of radiation, no matter how small, carries a risk to the recipient. Thus, decisions that affect the public health should be made strictly on the basis of health, not economic considerations. A second citizens' group expressed similar concerns. A few commenters stated that the licensee already has the requested relief because the Corrvnission has made provision in 10 CFR 20.130l(c) for approval of a licensee's request to increase the annual dose limit to 5 millisieverts (0.5 rem) for individuals exposed to a patient. 12

Response

The NRC has determined that patient release should be governed by 10 CFR 35.75, not 10 CFR 20.130l(a). 10 CFR 35.75 of the NRC's regulations adopted in 1986 (51 FR 36932; October 16, 1986) prohibits an NRC licensee from authorizing patient release until the measured dose rate from the patient is less than 0.05 millisievert (5 millirems) per hour at 1 meter or the activity in the patient is less than 1,110 megabecquerels (30 millicuries). 10 CFR 20.130l(a) of the revised standards for protection against radiation, adopted in 1991 (56 FR 23360; May 21, 1991), requires a licensee to limit the radiation dose of any individual member of the public from licensed activities to less than 0.1 rem (1 millisievert) (total effective dose equivalent) in a I year. The NRC's view that 10 CFR 35.75 governs patient release represents a reasonable interpretation of the Commission's regulations on this subject. As a general rule, requirements in 10 CFR ~art 35 are "in addition to, rather than "in substitution for," compliance with other NRC requirements including - 10 CFR part 20. However, in this case, the dose limit of 10 CFR 20.130l(a), if it were interpreted to apply to patient release, could require a license to continue confinement of a patient whose release would be permitted under 10 CFR 35.75. The NRC will not adopt this interpretation because that would make 10 CFR 35.75 essentially meaningless. When the NRC proposed 10 CFR 35.75 (50 FR 30627; July 25, 1985), it said, "The Commission believes that either limit (i.e., 30 millicuries of activity or the 6 milliroentgen per hour exposure rate at 1 meter) provides an adequate measure of safety for the general public and that further reductions 13

in public exposure are not reasonably achievable considering the cost and potential for detrimental effect from an unnecessarily long hospital confinement." Further, when it approved 10 CFR 35.75 in final form, the NRC again said, "The NRC believes that a 30-millicurie release limit provides an adequate measure of public health and safety." See 51 FR 36932. The NRC's conclusion was based on an independent NRC public health and safety judgement that is specific to patient release. This conclusion was neither tied to nor designed to implement the more general considerations in the 10 CFR part 20 dose limits that had already been proposed when the conclusion of adequacy was reached. The NRC maintains that the public health and safety judgement specific to patient release in 10 CFR part 35 should prevail over the more general 10 CFR part 20. The criterion in the proposed 10 CFR part 35, 5 millisieverts (0.5 rem) total effective dose equivalent per year, excluding background or any occupational exposure, is consistent with: the Commission's provision in 10 CFR 20.1301(c) for authorizing a licensee to operate up to this limit for limited periods of time; the recommendations of the International Commission - on Radiological Protection (ICRP) in ICRP Publication 602, "1990 Recommendations of the International Commission on Radiological Protection;" and the recommendations of the National Council on Radiation Protection and Measurements (NCRP} in NCRP Report No. 116 3 , "Limitation of Exposure to 2 International Commission on Radiological Protection (ICRP), "1990 Recommendations of the International Commission on Radiological Protection," ICRP Publication No. 60 (November 1990). Available for sale from Pergamon Press, Inc., Elmsford, NY 10523. 3 National Council on Radiation Protection and Measurements, "Limitation of Exposure to Ionizing Radiation," NCRP Report No. 116 (March 31, 1993). Available for sale from the NCRP, 7910 Woodmont Avenue, Suite 800, Bethesda, MD 20814-3095. 14

Ionizing Radiation." Each of these provides a basis for allowing individuals to receive annual doses up to 5 millisieverts (0.5 rem) under certain circumstances. Both the ICRP and NCRP recommend that an individual be allowed to receive a dose up to 5 millisieverts (0.5 rem) in a given year in situations where exposure to radiation is not expected to result in doses above 1 millisievert (0.1 rem) per year for long periods of time, as would be the case for doses from released patients. The recommendations of the ICRP and NCRP are based on their findings that annual exposures in excess of 1,, 1 millisievert (0.1 rem) to a small group of people, provi~ed _that they do not occur often to the same group, need not be regarded as especially hazardous. Therapeutic treatments with radioactive materials are limited to a relatively small proportion of the population and are not often repeated for the same patient. Although the NRC adopted 10 CFR 20.1301(a) after 10 CFR 35.75, it did not intend to supersede 10 CFR 35.75. There is no indication in the associated statements of consideration or response to comments that NRC intended to supersede 10 CFR 35.75 criteria when 10 CFR part 20 was amended. - Because the NRC finalized 10 CFR 35.75 after proposing revisions to 10 CFR part 20 in 1986, the NRC's silence should indicate that it did not intend the revised standards for protection against radiation to supersede either 10 CFR 35.75 or the NRC's underlying adequacy judgement. As reflected in the above discussion, the NRC's finding of adequacy with respect to patient release criteria does not apply to or set a precedent for the operations of nuclear power plants. The basis for the limit for patient release is justified by the considerations that specifically apply to patient release. 15

To codify the policy regarding the issue of the applicabjlity of 10 CFR 20.1301 to patient release, the NRC is proposing to amend 10 CFR 20.1301(a)(l) to explicitly exclude doses to individuals exposed to released patients. In addition, 10 CFR 20.130l(a)(2) would be amended by adding the words "exclusive of the dose contributions from patients administered radioactive material and released in accordance with § 35.75" to make it clear that the limit on dose in unrestricted areas does not include dose contributions from patients administered radioactive material and released in accordance with 10 CFR 35.75. Issue 2: Should the patient release criteria in 10 CFR 35.75 be expressed as a dose-based limit instead of being expressed in terms of activity retained in the patient and dose rate at 1 meter from the patient? Supporting Comments While the choice of a dose-based vs. an activity-based limit was not presented as an issue in the petitions, many commenters supported a dose-based limit of 5 millisieverts (0.5 rem), although those same commenters also generally supported retaining an activity limit. Some colll11enters and the ACNM discussed the inadequacy of the current activity-based limit in 10 CFR part 35 to deal with new techniques such as the use of radiolabeled antibodies. 16

Opposing Conments Several cormienters, as well as representatives from the Agreement States and the ACMUI, noted that the 1,110-megabecquerel (30-millicurie) activity limit is a simple method to demonstrate compliance with NRC regula~ions and should be retained. PRM-20-20 requested that the NRC specify an activity for each specific radionuclide consistent with the calculational methodology of NCRP Report No. 37, "Precautions in the Mana~ement of Patients Who Have Received Therapeutic Amounts of Radionuclides."

Response

The NRC's primary concern is the public's health and safety. Doses are a measure of degree of protection, whereas activity of different radionuclides is not related in any consistent way to the level of ,protection. For this reason, the NRC proposes to establish a dose limit as the only patient release criterion in 10 CFR 35.75. The proposed dose limit is 5 millisieverts (0.5 rem) total effective dose equivalent in a year. This dose limit is consistent with the underlying risk basis of the current 10 CFR 35.75 (50 FR 30627), the recormiendations of the ICRP, and the provisions in 10 CFR 20.1301(c), pertaining to temporary situations in which there is requisite justification for a dose limit higher than 1 millisievert (0.1 rem). Unlike the current 10 CFR 35.75, the proposed 10 CFR 35.75 does not specify an activity or dose rate for authorizing patient release. The 1,110-megabecquerel {30-millicurie) requirement was not retained because the 17

doses from a released patient are different for different radionuclides that have the same activity. Likewise, a release criterion based on dose rate from the patient is not a uniform indicator of dose because the total dose depends on the effective half-life of the radioactive material in the body of the patient and other factors, which will differ for different materials. In most cases, the dose received by an individual exposed to the ~atient will be from external exposure. However, in the case of a breast-feeding mother, the infant could be exposed following ingestion of breast milk. In this case, the 5-millisievert (0.5-rem) limit applies to the infant as the individual likely to receive the highest exposure. To help licensees easily determine if they may authorize the release of a patient, a draft regulatory guide, published concurrently with this proposed rule, contains a table that specifies the activity of commonly used radionuclides with which a patient can be released in compliance with the proposed dose limit. The table in the draft guide provides a simple method to demonstrate compliance that assumes no biological elimination of the radioactive material. For example, 'in the case of iodine-131, the value specified is 1,200 megabecquerels (33-millicuries). The draft regulatory guide also offers guidance for the licensee who chooses to calculate activities at which patient release may be authorized based upon case specific information. Single copies of the draft regulatory guide are available as indicated in the ADDRESSES heading. The 0.05 millisievert (5 millirems) per hour at 1 meter dose rate limit was not retained in the regulation because, in essence, consideration of the I dose rate is included in calculating the activity for each of the radionuclides specified in the draft regulatory guide. In addition, the draft 18

regulatory guide now relates the dose rate with the release criteria in the proposed 10 CFR 35.75. Newer techniques, such as the therapeutic use of radiolabeled antibodies, involve the administration of perhaps as much as several gigabecquerels (hundreds of millicuries). These newer techniques require that a patient remain under the control of the licensee for a much longer period of time before the current release criteria can be met. By changing the basis for the release of patients in the proposed rule to an annual dose limit, the activity or resulting dose rate are.no longer the only limiting factors upon which a patient release is based. Under the proposed rule, the dose would be the determining criteria, irrespective.of the amount of radioactive material administered or the potential pathways of exposure of individuals as a result of contact with the patient. This is particularly important for proper control of some types of materials, such as strong beta emitters, which do not pose a large external dose hazard. In these cases, dose through inhalation or ingestion of contamination could be significant pathways and must be accounted for in a calculation for compliance. To demonstrate compliance with the proposed rule in this situation, the optional calculational method described in the draft regulatory guide could be used, potentially resulting in an earlier patient release than would otherwise have been allowed, while still providing the specified level of protection. Issue 3. Should the calculational methodology in NCRP Report No. 37, "Precautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides," be an acceptable means to demonstrate compliance with the proposed rule? 19

Supporting Connnents PRM-20-20 requested that patients given 1,110 megabecquerels (30 millicuries) of iodine-131, or more, be hospitalized and released in accordance with the guidelines of NCRP Report No. 37, and that the maximum activity that a patient can be released with for a specific nuclide be CODSistent with the calculational methodology of NCRP Report No. 37. Many commenters and representatives from the Agreement States that attended the public workshop held in Atlanta, Georgia, on July 15 and 16, 1992, also agreed

• with this request.

Opposing Convnents No comments opposing the methodology in NCRP Report No. 37 were received.

Response

The NRC agrees that the calculational methodology of NCRP Report No. 37 can be used to calculate external doses from patients. Although NCRP Report No. 37 is dated, it still contains an appropriate method to calculate the integrated dose at 1 meter from a patient following administration of certain radionuclides. This methodology is modified in the draft regulatory guide to calculate activities to meet the 5-millisievert (0.5-rem) (total effective dose equivalent) limit. 20

Issue 4. Should, as the ACNM requested, the word "confinement" be defined to include confinement in a private residence? Supporting Comments The ACNM petitions stated that 10 CFR 35.75 seems to mandate hospitalization as the only place of confinement for patients receiving radiopharmaceutical therapy for compliance with 10 CFR 35.75. The ACNM I,, petitions also stated that 10 CFR 35.75 overlooks the merits of a necessary

• option, temporary home confinement, for outpatient radiopharmaceutical therapy at levels exceeding 1,110 megabecquerels (30 millicuries). This petition further stated that patients containing quantities up to 14,800 megabecquerels (400 millicuries) of iodine-131 could be confined in a private residence, as justified by published scientific papers that contend that home confinement of such patients would not adversely affect public health and safety.

Another commenter supported home confinement because it would greatly improve patient comfort while reducing medical expenditures by a considerable amount, and that this can be accomplished without any significant risk to the public. Some commenters believed that patients confined at home with as much as 14,800 megabecquerels (400 millicuries) of iodine-131 would not create a safety hazard to the public if simple precautions were followed. Several commenters believed that they had been told by the NRC that the use of the term confinement in 10 CFR 35.75 provided for a nonhospital option. A couple of commenters suggested that if a patient is medically capable of self-care, informed and cooperative, release in amounts greater than 1,110 megabecquerels .(30 millicuries) is sensible. 21

Opposing Comments The Conference of Radiation Control Program Directors {CRCPD) commented that confinement should not be defined *1n 10 CFR part 35 because the present wording alre~dy provides the option to confine patients by means other than hospitalization. An Agreement State representative remarked that it is not realistic to believe that a person will go home and lock themselves in a room for two to three days with limited contact with family and friends. Another Agreement

• State representative maintained it is difficult to control actions of an ambulatory patient and difficult to ensure that the patient has remained in confinement. This commenter also noted that the ACNM definition does not address transportation to a confined area in a pri~ate residence ,that would prohibit a patient from using public transportation.

A former radiopharmaceutical therapy patient opposed the changing of the existing requirements. He said that cutting hospital costs by releasing highly radioactive patients may afford short-term economic benefits for health care providers but it carries serious health and safety risks to the family an~ the public. He also indicated that some people would have a difficult time following the extensive advice that is given as to the precautions to be taken on returning home. Some commenters expressed the belief that release from a hospital with

• activities as high as 14,800 megabecquerels (400 millicuries) of iodine-131 is dangerous to public health and safety.

22

Response

The NRC has decided that the term nconfinement" should be deleted from the proposed revision to 10 CFR 35.75. Instead, the proposed rule language now uses the phrase "licensee control." The NRC believes that the phrase "licensee contro1" more clearly reflects the NRC's intent. The phrase "licensee control" refers to the ability of the licensee to demonstrate that it can control doses to other individuals from the patient, as well as the spread of radioactive materi~l.- The licensee maintains control

• both from the location of patients and by the actions the licensee takes to control doses. Although licensee control does not necessarily restrict a patient to a-hospital~ the location of the patient must be listed as a place of ase on the license or a license amendment must be issued pursuant to 10 CFR 35.13(e). Additional choices would be avaiiable (e.g., hospices -or nursing homes) as long as the licensee can demonstrate that it can control doses to other individuals as well as the *spread of radioactive material.

The NRC believes that there is a distinct difference between a patient being "confined" in a hospital and "confined" in a home. In hospital confinement, the licensee has control over access to the patient as well as having trained personnel and instrumentation available for making radiation measurements not typically available at the patient's home. In addition, while under licensee control, a licensee has control over the dose by limiting the amount of time that individuals are in close proximity to the patient. Therefore, as a general practi~e, the NRC does not want licensees to use a patient's home for the purpose of confining the patient. 23

Issue 5. Should 10 CFR 20.130l(d) require compliance with Environmental Protection Agency (EPA) regulations? PRM-20-20 stated that compliance with the EPA's Clean Air Act air effluent standards would cost medical facilities

 $100,000,000 per year, which would be added to national health care costs.

Supporting Comments Most comments from physicians and medical associations expressed concern over redundant NRC and EPA regulations contained in 40 CFR 61 resulting from

• the EPA's limitation on air effluent from NRC-licensed facilities.

Opposing Comments No opposing comments were received.

Response

The EPA regulations referenced in 10 CFR 20.130l(d} are contained in 40 CFR part 190, which deals only with doses and airborne emissions from uranium fuel cycle facilities. 40 CFR 190 does not apply to hospitals or to the release of patients. Furthermore, 10 CFR 20.130l(d) does not incorporate the EPA's Clean Air Act standards in 40 CFR part 61 that apply to hospitals. The NRC is separately pursuing actions with the EPA to minimize the impact of dual regulation under the Clean Air Act. Because the reference to EPA regulations in 10 CFR 20.130l(d) has nothing to do with the patient release issue and has no impact on the 24

petitioner, the NRC will not grant this request of the petitioner. Issue 6. Should the regulations require that patients, upon release, receive written instructions on how to maintain doses to other individuals as low as reasonably achievable? Supporting Comments PRM-2O-2O recommended education of the patient and the care provider. Some commenters supported written instructions for the patient upon release. Representatives from the Agreement States who attended the public workshop held in Atlanta, Georgia, on July 15 and 16, 1992, and the ACMUI public workshop held in October 1992 in Rockville, Maryland, also agreed with this concept. Opposing Comments

• A physician stated that instructions regarding patient activities significantly increase apprehension needlessly.

Response. The NRC agrees that written instructions on how to maintain doses as low as reasonably achievable to people exposed to released patients should be provided. These written instructions would specify what actions should or I should not be taken by the released patients and by the individuals 25

potentially exposed. In fact, written instructions are already required under 10 CFR 35.31S(a)(6) and 35.41S(a)(S). Under the proposed 10 CFR 35.7S(b), when the total effective dose equivalent to any individual other than the released patient is likely to exceed 1 millisi-evert (0.1 rem) from a single administration, the licensee would be required to provide written instructions to the patient on how to maintain doses as low as reasonably achievable to household members and other individuals. If the dose to any individual exposed to the patient is not likely to exceed 1 millisievert (0.1 rem), instructions are not required but the physician could give any instructions that he or she considers desirable. Written instructions provide an available reference after the patient's release, if questions regarding patient c~re arise. Written instructions reduce the chance of misunderstanding the licensee's instructions as verbal instructions may not be properly conveyed to persons not present at the time of release. The NRC also believes that providing written instructions will help relieve apprehensions of the patient, primary care-giver, and family. The draft regulatory guide published concurrently with this proposed - rule includes recommended contents of the written instructions. The instructions should be specific to the type of treatment given, such as I radioiodine for hyperthyroidism or thyroid carcinoma, or permanent implants; and may include additional information regarding individual situations. The instructions should include a contact and phone number in case the patient has any questions. Written instructions should include, as appropriate: (1) maintaining distance from individuals, including sleeping arrangements and the need to avoid public transportation; (2) the need to stop breast-feeding if appropriate; (3) avoidance of public places (such as grocery stores, 26

_shopping centers, theaters, restaurants, and sporting events); (4) hygiene; and (5) the length of time precautions should be taken. Not all of these precautions are necessary for every patient; therefore, patients should be given specific instructions that are applicable to their situation. Issue 7. Should records of patients released containing radioactive materials be required? I,, Although the issue of records did not arise in the petitions or the - comments on the petitions, proposed 10 CFR 35.75(b) would require the licensee to maintain a record of the basis for the patient's release and the calculations performed to determine the total effective dose equivalent if an individual is likely to receive a dose in excess of 1 millisievert (0.1 rem) in a year from a single administration. It is anticipated that this requirement will be met by either a notation, such as a reference to the Regulatory Guide, or calculation(s) to be retained in the patient's file. This record would provide a basis for assurirg that the maxjmum dose to an individual exposed to the patient is below 5 millisieverts (0.5 rem) for any single administration. This record also provides the basis for ensuring that doses from multiple administrations greater than 1 millisievert (0.1 rem) each do not total more than 5 millisieverts (0.5 rem) in any year. The 1-millisievert (0.1-rem) threshold for recordkeeping is based on the public dose limit of 1 millisievert (0.1 rem) specified in 10 CFR part 20. This threshold would not result in an undue recordkeeping burden for the majority of diagnostic administrations because these administrations are well below 1-millisievert (0.1-rem). Based on the regulatory analysis, the 27

majority of administrations requiring records involve iodine-131 therapeutic administrations and a few diagnostic procedures using iodine-131. Recordkeeping would affect less than one percent of all administrations. (For further information, see the regulatory analysis for the proposed rule. Single copies of the draft regulatory analysis are available as indicated in the ADDRESSES heading.) The proposed record retention period of 3 years is consistent with similar recordkeepin~ requirements in 10 CFR parts 20 and 35. VII. Summary of the Proposed Changes This section summarizes the regulation changes that are being proposed. The NRC proposes to amend 10 CFR 20.130l(a)(l) to specifically state that the dose to individual members of the public from a licensed operation does not include doses received by individuals exposed to patients who were released by the licensed operation under the provisions of 10 CFR 35.75. This is not a substantive change but clarifies the NRC policy that patient release is governed by 10 CFR 35.75, not 10 CFR 20.1301, as discussed above under Issue 1. The NRC proposes to amend 10 CFR 20.130l(a){2) to specifically state that the limit on dose in unrestricted areas does not include dose contributions from patients administered radioactive material and released in accordance with 10 CFR 35.75. The purpose of this change is to clarify that l'icensees are not required to control areas, such as a waiting room, simply because of the presence of a patient released pursuant to 10 CFR 35.75. If a patient is not required to be confined pursuant to 10 CFR 35.75, licensees are 28

not required to limit the radiation dose to members of the public (e.g., visitor in a waiting room) from a patient to 0.02 millisievert (2 millirems) in any one hour. Patient waiting rooms or hospital rooms need only be controlled for those patients not meeting the release criteria in 10 CFR 35.75. The NRC proposes to adopt a new 10 CFR 35.75(a) to change the patient release criteri~ from 30 millicuries of activity in a patient or a dose rate of 5 millirems per hour at 1 meter from a patient to a dose limit of 5 millisieverts (0.5 rem) in any one year, excluding background or any - occupational exposure, to an individual from exposure to a released patient. The reasons for this change were discussed above under Issue 2. In brief, a dose-based limit provides a single limit that can be used to provide an equivalent level of risks from all radionuclides. Also, the proposed changes are supported by the recommendations of the ICRP and NCRP that an individual can be allowed to receive an annual dose up to 5 millisieverts (0.5 rem) in temporary situations where exposure to radiation is not expected to result in doses above 1 millisievert (0.1 rem) for long periods of time. Doses among individuals who may come in contact with a released patient are highly variable and.reflect the crucial, but difficult to define, parameters of time, distance, and shielding. Although all members of society have the potential for exposure to a released patient, based on time and

\

distance considerations, it is reasonable to conclude that for the overwhelming majority of reieased patients, the maximally exposed individual is likely to be one who is aware of the patient's condition such as the primary care-giver, a family member, or any other individual who spends significant time close to the patient. 29

The NRC proposes to adopt a new 10 CFR 35.75(b)(l) to require that the licensee provide released patients with written instructions on how to maintain as low as reasonably ach1evable doses to other individuals if the total effective dose equivalent to any individual other than the released patient is likely to exceed 1 millisievert (0.1 rem) in any one year. A requirement for written instructions for certain patients was already contained in 10 CFR 35.315(a)(6) and'35.415(a)(5). The proposed requirement would add approximately 50,000 patients per year who are administered iodine-131 for the treatment of hyperthyroidism. The purpose of the written instructions is to maintain as low as reasonably achievable doses to individuals exposed to patients, as discussed in more detail under Issue 6. The NRC proposes to revise 10 CFR 35.75(b)(2) to require that licensees maintain a record of the basis for the patient's release for three years. These records must include the calculations performed to determine the total effective dose equivalent of the individual likely to receive the highest dose if the total effective dose equivalent to any individual other than the released patient is likely to exceed 1 millisievert (0.1 rem) in a year from a single administration. It is anticipated that this requirement will be met by either a notation, such as a reference to the applicable regulatory guide or calculation(s) to be retained in the patient's file. The major purpose of the change is to provide the basis for controlling the do$e to individuals exposed to a patient who may receive more than one administration in a year, as discussed above under Issue 7. Finally, the NRC proposes to amend its requirements on written instructions in 10 CFR 35.315(a)(6) and 35.415(a)(5). These regulations already required written instructions in certain cases, but the phrase 11 if 30

required by § 35.75(b)" was added. The purpose of this change was to ensure internal consistency within 10 CFR part 35 on when written instructions must be provided. VIII. Consistency with 1979 Medical Policy Statement On February 9, 1979 (44 FR 8242), the NRC published a Statement of General Policy on the Regulation of the Medical Uses of Radiois9topes. The first statement of this policy states that, "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." The proposed rule is consistent with this statement because its purpose is to provide for the safety of individuals exposed to patients who are administered radioactive materials. The second statement of the policy states that, "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." This statement is not relevant to the proposed rule because the proposed rule does not affect the safety of patients themselves but affects the safety of individuals exposed to patients. The third statement of the policy states that, "The NRC will minimize intrusion into medical judgements 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 places no requirements on the administration of radioactive materials to patients and because the release of patients administered -radioactive materials has long been considered a matter of regulatory concern rather than solely a matter of 31

medical judgement. Thus, the proposed rule is considered to be consistent with the 1979 medical policy statement. IX. Issue of Compatibility for Agreement States The NRC believes that the proposed modifications to 10 CFR 20.1301(a) and 10 CFR 35.75 should be Division 1 and 2 items of compatibility, respectively, because the patient release criteria required by the rule are - the minimum requirements necessary to ensure adequate protection of public health and safety. However, representatives of the Agreement States who attended the public workshop held in Atlanta, Georgia, on July 15 and 16, 1992, have recommended that the proposed changes to 10 CFR part 35 should not be a matter of compatibility (i~e., Division 3) for the Agreement States. In addition, two Agreement States in their written comments on the draft rule reviewed in July 1993 addressed the issue of patient release under 10 CFR part 35 as a Division 3 matter. Under Division 2 status, the Agreement States must address the changes and may adopt more stringent requirements, but may not adopt less stringent provisions. X. Finding of No Significant Environmental lmpact: Availability The NRC has determined under the National Environmental Policy Act of 1969, as amended, and the Convnission's regulations in Subpart A of 10 CFR part 51, that the proposed amendments, if adopted, would not be a major Federal action significantly affecting the quality of the human environment 32

and therefore, an environmental impact statement is not ~equired. The proposed amendment would clarify the pertinent regulatory language to reflect explicitly the relationship between 10 CFR part 20 and part 35 with respect to . release of patients, and revise the release criteria for patients receiving radioactive material for medical use from an activity-based standard to a dose basis. Because the risk basis of the current regulation remains unchanged, it is expected that there would be* no significant change in radiation dose to the public as a result of the revised regulation. { ,, The draft environmental assessment and finding of no significant impact on which this determination is based is available for inspection at the NRC Public Document Room, 2120 L Street NW. {Lower level), Washington, DC. Single copies of the draft environmental assessment and the finding of no significant impact are available as indicated in the FOR FURTHER INFORMATION CONTACT heading. XI. Paperwork Reduction Act Statement This proposed rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1980 (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 information collection requirements. The public reporting burden for this collection of information is estimated to average 0.42 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection 33

of information, including suggestions for reducing this burden, to the Information and Records Management Branch (MNBB-7714), U.S. Nuclear Regulatory Convnission, Washington, DC 20555-0001; and to the Desk Officer, Office of Information and Regulatory Affairs, NEOB-3019 (3150-0010), Office of Management and Budget, Washington, DC 20503. XII. Regulatory Analysis The NRC has prepared a regulatory analysis (NUREG-1492) for the* proposed - amendment. The analysis examines the benefits and impacts considered by the NRC. The regulatory analysis is available for inspection at the NRC Public Document Room at 2120 L Street NW. (Lower Level), Washington, DC. Single copies are available as indicated under the FOR FURTHER INFORMATION CONTACT heading. XIII. Regulatory Flexibility Certification As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), the NRC certifies that, if adopted, this proposed rule would not have a significant economic impact on a substantial number of small entities. As a result of the revised regulation, the impact would not be significant because the revised regulation basically represents a continuation of current practice. The NRC is seeking public comment on the initial regulatory flexibility certification. The NRC is particularly seeking convnent from small entities as defined under the NRC's size standards published on November 6, 1991 34

(56 FR 56672), as to how the regulations will affect them and how the regulations may be tiered or otherwise modified to impose less stringent requirements on small entities while still adequately protecting the public health and safety. Any small entity subject to this regulation who determines that, because of its size, it is likely to bear a disproportionate adverse economic impact should offer comments that specifically discuss the following items: (a) The licensee's size and how the proposed regulation would result in a significant economic burden or whether the resources necessary to implement - this amendment could be more effectively used in other ways to optimize public health and safety, as compared to the economic burden on a larger licensee; (b) How the proposed regulation 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 regulation were modified as suggested by the licensee; (d) How the proposed regulation, as modified, could more closely equalize the impact of NRC regulations or create more equal access to the benefits of Federal programs as opposed to providing special advantages to any individual or group; and (e) How the proposed regulation, as modified, would still adequately protect the public health and safety. The comments should be sent to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555. ATTN: Docketing and Service Branch. Hand deliver comments to 11555 Rockville Pike, Rockville, Maryland, between 7:45 a.m. and 4:15 p.m. Federal workdays. 35

XIV. Backfit Analysis The NRC has determined that the ba~kfit rule, 10 CFR 50.109, does not apply to this proposed rule and, therefore, that a backfit analysis is not required for this proposed rule, because these amendments do not involve any provisions which would impose backfits as defined in 10 CFR 50.109(a)(l). XV. List of Subjects 10 CFR part 20 Byproduct material, Licensed material, Nuclear materials, Nuclear power plants and reactors, Occupational safety and health, Packaging and containers, Penalty, Radiation protection, Reporting and recording requirements, Special nuclear material, Source material, Waste treatment and disposal. 10 CFR part 35 Byproduct material, Criminal penalty, Drugs, Health facilities, Health professions, Incorporation by reference, Medical devices, Nuclear materials, Occupational safety and health, Penalty, 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. 551; the NRC is proposing to adopt the following 36

amendments to 10 CFR parts 20 and 35. PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION

1. The authority citation for part 20 is revised 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 (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236), secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (U.S.C. 5841, 5842, 5846).

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

§ 20.1301 Dose limits for individual members of the public. (a) Each licensee shall conduct operations so that-- ( 1) The total effective dose equivalent to individual members of the public from the licensed operation does not exceed 0.1 rem (1 mSv) in a year, exclusive of the dose contributions from the licensee's disposal of radioactive material into sanitary sewerage in accordance with § 20.2003 and from patients administered radioactive material and released in accordance with § 35. 75, and (2) The dose in any unrestricted area from external sources, exclusive of the dose contributions from patients administered radioactive material and released in accordance with § 35.75, does not exceed 0.002 rem (0.02 mSv) in any one hour. 37

PART 35--MEDICAL USE OF BYPRODUCT MATERIAL

3. The authority citation for part 35 continues to read as follows:

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).

4. In Section 35.8, paragraph (b) is revised to read as-follows:

 § 35.8    Information collection requirements:   0MB approval.

(b) The approved information collection requirements contained in this part appear in §§ 35.12, 35.13, 35.14, 35.21, 35.22, 3~.23, 35.27, 35.29, 35.13, 35.50, 35.51, 35.53, 35.59, 35.60, 35:61, 35.70, 35.75, 35.80, 35.92, 35.204, 35.205, 35.310, 35.315, 35.404, 35.406, 35.410, 35.415, 35.606, 35.610, 35.615, 35.630, 35.632, 35.634, 35.636, 35.641, 35.643, 35.645, and

• 35.647 .

5. Section 35.75 is revised to read as follows:

 § 35.75    Release of patients containing radiopharmaceuticals or permanent implants.

(a) A licensee may authorize release from licensee control any patient administered radiopharmaceuticals or permanent implants containing radioactive 38

material if the total effective dose equivalent to an individual from exposure to the released patient is not likely to exceed 5 millisieverts (0.5 rem) in any one year. (b) If the total effective dose equivalent to any individual other than the released patient is likely to exceed 1 millisievert (0.1 rem) in a year from a single administration, upon release the licensee shall: (1) Provide the patient with written instructions on how to maintain doses to other individuals as low as reasonably achievable; and I., (2) Maintain, for three years, a record of the released patient and the e calculated total effective dose equivalent to the individual likely to receive the highest dose.

6. In Section 35.315, paragraph (a)(6) is revised to read as follows:

 §  35.315 Safety precautions.

(a) * * * (6) Provide the patient with radiation safety guidance, if required by

• § 35.75(b), that will help to keep radiation dose to household members and the public as low~as reasonably achievable before authorizing release of the patient.

39

7. In Section 35.415, paragraph {a)(5) is revised to read as follows:

 § 35.415 Safety precautions.

(a) * * * (5) Provide the patient with radiation safety guidance, if required by

 § 35.75{b), that will help to keep radiation dose to household members and the public as low as reasonably achievable before releasing the patient if the patient was administered a permanent implant.

• Dated at Rockville, Maryland, this tj'! day of June, 1994 .

For the Nuclear Regulatory Commission.

                                                     /4__
                                             . oy '

ng Secretary of the Commission . 40}}