ML23151A568

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PRM-035-011 - 59FR37950 - American Medical Association, Petition for Rulemaking (Therapeutic Uses of Iodine 131 and Home Confinement)
ML23151A568
Person / Time
Issue date: 07/26/1994
From: Hoyle J
NRC/SECY
To:
References
PRM-035-011, 59FR37950
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KEYWORD: ADAMS Template: SECY-067 07/26/1994 PRM-035-011 - 59FR37950 - AMERICAN MEDICAL ASSOCIATION, PETITION FOR RULEMAKING (THERAPEUTIC USES OF IODINE 131 AND HOME CONFINEMENT) PRM-035-011 59FR37950 RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete

DOCKET NO. PRN-035-11 (59FR37950) In the Matter of AMERICAN MEDICAL ASSOCIATION, PETITION FOR RULEMAKING (THERAPEUTIC USES OF IODINE 131 AND HOME CONFINEMENT) DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 04/20/94 04/20/94 03/28/94 04/06/94 PETITION FOR RULEMAKING SUBMITTED BY THE AMERICAN MEDICAL ASSOCIATION LITTER TO THE SECRETARY FROM MICHAEL J. ZARSKI, LEGISLATIVE COUNSEL FOR A. M.A., ADVISING OF PETITION FOR RULEMAKING SENT TO THE CHAIRMAN 07/21/94 07/20/94 FEDERAL REGISTER NOTICE - RECEIPT OF PETITION FOR RULEMAKING 09/29/94 09/26/94 COMMENT OF WESTINGHOUSE ELECTRIC CORPORATION (A. T. SABO) (

1) 10/11/94 10/11/94 COMMENT OF AMERICAN MINING CONGRESS (JAMES E. GILCHRIST) (
2) 10/19/94 10/14/94 COMMENT OF ACNP AND SNM (DR. WILLIAM H. MCCARTNEY) (
3)

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~lKAJ DOC~~ l c.D (202) 429-5120 USNR ax (202) 223-4579 American College of Nuclear Physicians October 14, 1994 John C. Hoyle Acting Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555 Attn: Docketing and Service Branch

  • 94 OCT 19 P 4 :4 0 The Society of Nuclear Medicine RE:

Comments on Petition for Rulemaking filed by the American Medical Association; 59 FR 37950 - July 26, 1994.

Dear Mr. Hoyle:

The American College ofNuclear Physicians (ACNP) and the Society of Nuclear Medicine (SNM) 1 wish to comment on the petition filed by the American Medical Association. We support the petitioners request that NRC amend its regulations to recognize that current medical practice concerning the therapeutic uses of I 131, particularly in outpatient settings, is effective and safe for the public. We also support the petitioner's request that NRC formally recognize that adequate home confinement precautions reduce the hazards associated with radioisotopes sufficiently to eliminate the need for hospitalization following therapeutic administration of radiopharmaceuticals. Finally, we support the petitioner's recommendation that NRC increase the external radiation limit for the public from I 00 mrem/year to 500 mrem/year. The ACNP and SNM refer the NRC to comments filed on the patient release criteria proposed rule (59 FR 30724) which outlines our support for rasing the level from 100 mrem to 500 mrem/year. In addition to our comments filed on this rule we feel that the construct offered by the petitioner attempts to eliminate the burdensome paperwork discussed by NRC in their proposed rule on patient release criteria. ACNP and SNM wholeheartedly support any effort by NRC to reduce the amount of paperwork necessary, lower the level of regulatory compliance costs, and implement sound scientific regulations in conjunction with the medical community. In comments to NRC by ACNP/SNM we recommend alternative language similar to that offered by petitioners. This language would make it possible to have an effective rule without the burden of unnecessary paperwork. ACNP and SNM believe that one major goal for the NRC should be to drastically reduce the amount of paperwork to only that level which is required to protect public health and safety. Currently NRC far exceeds that level placing an unnecessary burden on Nuclear Medicine practitioners and the public. By altering the language in this petition consistent with ACNP/SNM's comments, without any additional paperwork, NRC would move significantly towards this goal. In conclusion, we support the issues and suggestions raised in the petition by the American Medical Association and urge NRC to adopt this language as part of the proposed patient release criteria rule. If you have any questions please feel free to call Mr. David Nichols, Regulatory Affairs Coordinator at (202) 429-5120. 0~~~D~~ President American College of Nuclear Physicians Sincerely, James J. Conway, M.D. President Society of Nuclear Medicine 1 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. FEB 2 4 199 Acknowled ed b card.............................,

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~~ AMERICAN MINING CONGRESS FOUNDED 1897 1920 N Street NW, Suite 300 Washington, DC 20036-1662 202/ 861-2800 Fax: 202/ 861-7535 Offlcera Chairman: Richard de J. Osborne Vice Chairman and Chairman, Finance Committee: Douglas C. Yeartey Vice Chairmen: AllenBom

  • MIiton H. Ward Harry M. Conger Gordon R. Par1<er M. Thomas Moore Billie B. Turner arry G. McGrath

. Burgess Winter John M. Piecuch Bob E. Cooper President: John A. Knebel S6ct&t.aty: Michael J. Chakarun Treasurer: Clarence L. Smith Dlrectora CaMn A. Campbell Jr., Chicago Harry M. Conger, San Francisco MIiton H. Ward, Englewood CO Allen Born, Norcross GA A. Gene Dewey, Los Angeles Richard de J. Osborne, New Yori< Gordon R. Par1<er, Denver W. R. Stamler, Paris KY M. Thomas Moore, Cleveland Arthur Brown, Coeur d'Alene ID Wm. G. Mulligan, Woodcliff Lake NJ Billie 8. Turner, Northbrook IL Dana S. Getman, Bangor Ml J. Burgess Winter, Tucson Ian White-Thomson, Los Angeles Aen A.Barton,Peoria W arl E. Elers, Houston Robert M. Smith, Toronto Marc F. Wray, Pittsburgh Robert P. Lar1<1ns, Houston Thomas W. Garges Jr., Indiana PA Anthony G. Fernandes, Denver Barry G. McGrath, Englewood CO Gerard E. Munera, Englewood CO Merle D. Wolfe, Knoxville Jerry K. Ellis, San Francisco Douglas C. Yeartey, Phoenix Bruce E. Grewcock, Omaha John M. Piecuch, Reston VA Robert C. Scharp, Oklahoma City James A. Todd Jr., Birmingham John M. Willson, Vancouver BC Jeffrey L Zelma, St. Louis A. Thomas Green Jr., Cleveland George A. Mealey, New Orleans Bob E. Cooper, Salt Lake City David D. Eckert. Shelton CT J. Brett Harvey, Salt Lake City Werner G. Nennecker, Spokane Richard T. Zltting, Albuquerque John U. Martin, Dallas Sir Ian MacGregor, New York+ N. T. Camlcia, Greenwich + Charles F. Barber, New Yori<+ Ralph E. Balley, Stamford +

  • Immediate Past Chairman

+ Honorary BY HAND DELIVERY Secretary of the Commission U.S. Nuclear Regulatory Commission 11555 Rockville Pike Rockville, Maryland 20850 Attention: Docketing and Service Branch October 11, 1994 Re: American Medical Association's Petition for Rulemaking - Docket No. PRM-35-11

Dear Secretary:

The American Mining Congress (AMC) submits these comments in response to the Nuclear Regulatory Commission's (NRC) notice of receipt of a petition for rulemaking by the American Medical Association (AMA). 59 Fed. Reg. 37950 (July 26, 1994). AMA's petition requests the Commission to amend its regulations to increase the external radiation limit to the public from 100 mrem/yr to 500 mrem/yr for the purpose of medical diagnosis and therapy. AMC supports AMA's petition. AMC is a national trade association representing: (1) producers of most of the United States' metals, uranium, coal, and industrial and agricultural minerals; (2) manufacturers of mining and mineral processing machinery equipment and supplies; and (3) engineering and consulting firms and financial institutions that serve the mining industry. AMA's petition expressed concern that 10 CFR 20.1301, which reduced the radiation exposure limit from 500 mrem/yr to 100 mrem/yr, would have an adverse impact on the availability and cost of treatment with radiopharmaceuticals, which outweighs the advantages of reduced radiation exposure to the public. AMA also argued that the 100 mrem/yr exposure limit is inconsistent with medical experience and not necessary to protect the public from radiation hazards. AMC agrees with AMA that the an increased exposure limit for medical diagnosis and therapy is more than adequately justified in the interest of public health. This is particularly true since AMC believes that in reducing the exposure limit from 500 mrem/yr to 100 mrem/yr, NRC appeared to be making a conservative policy decision rather than a scientific determination based on adverse effects seen at higher exposure levels. FEB 2 4 1995 Acknowledged by card.........................,.......

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If you have any questions or we can be of further assistance, please call me at (202) 861-2876 or Katie Sweeney, Counsel, at (202) 861-2812. 2 Yours ve~ tru~ James E. Gilchrist /I? Vice President

DOCKET NUMBER J PET\\TION RULE PRMJ 5-JJ (5'1Fl<J1'1So) DOCKETED ustrnc Westinghouse Electric Corporation September 26, 1994 Energy Systems The Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D. C. 20555 ATTN: Docketing and Service Branch

  • 94 SEP 29 P 4 :07 OFFICE OF SECF.ETARY T t"' -,., r,y l"E OOCKE l ~l..1 '-'"
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BPI\\NCH RA 94-059 A TS Box 355 Pittsburgh Pennsylvania 15230-0355

SUBJECT:

Ref. 59FR37950 Petition for Rulemaking - - "American Medical Association." - - (10 CFR Parts 20 and 35) Gentlemen: The Westinghouse Electric Corporation appreciates the opportunity to provide comments on the Petition for Rulemaking referenced above. Westinghouse supports the AMA's petition in general, and particularly in the following areas: To include the reinstatement of Section 20.107 from the regulations in effect before the 1991 amendments to Part 20; The proposed changes in Section 35.75; The provisions of Section 35.310(a); and, The revised introductory paragraph of Section 35.315 These comments are presented for consideration by the Commission in this Petition for Rulemaking proceeding. A T. Sabo, Manager Regulatory Affairs db fE8 2 4 1995 Acknowledged by card................................ ~ ([)

iD,S. NUCLEAR ;:-1:::Ct.Ji..t\\TORY COMMISSION DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics P,ostmarl< Date q /;i..1 {q 'j Copies Received ___,--___ Add'! Copies Reproduced J Special Distribution 12~ 0......;.'.>_ 1_()...,.._,,0__,~..... -- L e.5 t>--r 7

OCKET NUMBER - :.. *-*nr,ON RULE PRM - / J (Sd-J FR 31 CJ 50) NUCLEAR REGULATORY COMMISSION 10 CFR Parts 20 and 35 [Docket No. PRM-35-11] American Medical Association AGENCY: Nuclear Regulatory Commission. '94 JUL 21 A 8 : 1 5 OFFICE OF SECRETARY OOCK r:T1r/f' t. SER'.' rE ACTION: Petition for rulemaking; Notice of receipt.

SUMMARY

The Nuclear Regulatory Commission (NRC} is publishing for public comment a notice of receipt of a petition for rulemaking, dated March 28, 1994, which was filed with the Commission by the American Medical Association (AMA}. The petition was docketed by the NRC on April 20, 1994, and has been assigned Docket No. PRM-35-11. The petitioner requests that the NRC amend its regulations to recognize that current medical practice concerning the therapeutic uses of I 131, particularly in o~tpatient settings, is effective and safe for the public. The petitioner also requests that the NRC formally recognize that adequate home confinement precautions reduce the hazards associated with radioisotopes sufficiently to eliminate the need for hospitalization following therapeutic administration of radiopharmaceuticals. The petitioner also requests that the NRC increase the external radiation limit for the public from 100 mRem/year to 500 mRem/year.

/0/11} 1:/1 DATE: Submit comments by (75 days after publication in the Federal Register). comments received after this date will be considered if it is practical to do so, but the Commission is able to assure consideration only for comments received on or before this date. ADDRESSES: Submit written comments to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention: Docketing and Service Branch. Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland, between 7:45 am and 4:15 pm Federal workdays. For a copy of the petition, write the Rules Review and Directives Branch, Division of Freedom of Information and Publications Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555. The petition and copies of comments received may be inspected and copied for a fee at the NRC Public Document Room, I; 2120 L Street, NW. (Lower Level), Washington, DC. FOR FURTHER INFORMATION CONTACT: Michael T. Lesar, Chief, Rules* Review section, Rules Review and Directives Branch, Division of Freedom of Information and Publications Services, Office of Administration, U.S. Nuclear R-gulatory Commission, Washington, DC 20555, Telephone: 301-415-7163 or Toll Free: 800-368-5642. 2

SUPPLEMENTARY INFORMATION:

Background

The petitioner states that in order to "provide adequate protection of public health and safety" and to observe "the principle of keeping all radiation exposures 'as low as is reasonably achievable,'" the NRC has revised its standards for protection against radiation. NRC proposed a revision of the regulations governing radiation use and exposure limits in 1976. Modifications of the revised regulation were proposed in 1979, 1980, 1983, 1985, and 1986. Revised regulations were published May 21, 1991 (56 FR 23360), to become effective June 21, 1991, and to be fully implemented by January 1, 1993 (later extended to January 1, 1994, see 57 FR 38588; August 26, 1992). The petitioner states that the section of the final rule relevant to outpatient treatment with ! 131 or other radiopharmaceuticals (S 20.1301) reduces the radiation exposure limit to the public from 500 mRem/year to 100 mRem/year. The petitioner believes that§ 20.1301 will have an adverse impact on the availability and the cost of treatment of thyroid disease, which will outweigh the advantages of reduced radiation exposure to the public. Therefore, the petitioner requests that

this provision be amended to restore the previous external radiation limit of 500 mRem/year.

3

Petition The AMA, following a report of its Council on Scientific Affairs (CSA Report F (A-92)), submitted a petition for rulemaking to the NRC. The petitioner also submitted CSA Report Fin support of the petition. The petitioner states that the medical use of inorganic sodium I 131 has been an effective component of medical practice for over 35 years. The petitioner also states that radioactive biologicals, such as monoclonal antibodies labeled with I 131, have been.added to the physician's armamentarium. The petitioner believes that the ability of the physician to administer I 131 on an outpatient basis has maintained the accessibility and minimized the costs of these treatments. According to the petitioner, patients treated with I 131 must contain no more than 30 mci total body activity before they may be released from the treatment facility. The petitioner states that therapeutic use of ! 131, particularly in the treatment of thyroid carcinoma, often requires doses in excess of 30 mCi, and may require doses as great as 400 mci. The petitioner states that because doses of 30 mci of I 131 are substantially below the doses typically used to treat thyroid carcinoma, treatment of up to 10,000 cancer patients annually with appropriate doses would require the hospitalization of the patients under the revised regulation (10 CFR 20.1301). The petitioner argues that this new radiation exposure limit set by the NRC is inconsistent with medical experience and is not necessary in order to protect the public from radiation hazards. 4

The petitioner states that the new radiation exposure limit will reduce both early release of patients and the treatment of patients at home, thus creating potentially avoidable hospital inpatient costs and burdens on the health care delivery system. Suggested Changes to the Regulations The petitioner requests that the following amendments to the NRC's regulations be made:

1.

Reinstate S 20.107 from the regulations in effect before the 1991 amendments to Part 20. The added section would read as follows: S 20.107 Medical diagnosis and therapy. Nothing in the regulations of this part shall be interpreted as limiting the intentional exposure of patients to radiation for the purpose of medical diagnosis or medical therapy.

2.

Section 35.75 should be revised to read as follows: S 35.75 Release of patients containing radiopharmaceuticals or permanent implants. A licensee may not authorize release from confinement for medical care any patient administered a radiopharmaceutical or a permanent implant until the measured dose rate from the patient is less than 5 millirems per hour at a distance of one meter or the cumulative dose to individual members of the public will be less than 500 millirems per year.

3.

In S 35.310(a), the introductory text of paragraph (a) should be revised to read as follows: 5

S 35.310 Safety instruction. (a) A licensee shall provide reasonable and adequate radiation instruction for all personnel caring for the patient receiving radiopharmaceutical therapy and confined for compliance with S 35.75 of this chapter.

4. In S 35.315(a), the introductory paragraph should be revised to read as follows:

S 35.315 Safety precautions. (a) For each patient receiving radiopharmaceutical therapy and confined for compliance with S 35.75 of this chapter, a licensee shall: The AMA believes that these amendments will have a beneficial impact on the availability and cost of treatment of thyroid disease while maintaining safeguards to the health of the public. Related Petitions and Proposed Rule On December 26, 1990, Carols. Marcus, MD, filed a petition for rulemaking with the NRC (PRM-20-20). Dr. Marcus requested that the NRC restore the radiation dose limit in the amended standards for protection against radiation that can be absorbed by members of the public from patients receiving radiopharma-ceuticals for diagnosis or therapy from roo mRem/year to 500 6

mRem/year. Dr. Marcus opposed the newly effective radiation dose limit in 10 CFR 20.1301 because of the impact of this lower limit on outpatient medical procedures. She believed that therapeutically effective doses of I 131 may result in exposure to the public within the immediate surroundings of greater than 100 but less than 500 mRem/year. She stated that some procedures utilizing radioisotopic materials that have routinely been performed on an outpatient basis would require hospitalization for regulatory rather than medical reasons. She also believed that enforced hospitalization would significantly increase the cost of medical care and possibly result in the patient's inability to receive that care. On October 5, 1991, the American College of Nuclear Medicine (ACNM) filed a petition for rulemaking with the NRC (PRM-35-10). On April 14, 1992, the ACNM filed an amendment to its original petition (PRM-35-l0A). The ACNM requested that the NRC adopt a dose limit of 500 mRem/year for nonpatients and 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 ACNM stated that their request is in the best interest of patients who require access to affordable quality care while allowing them to be diagnosed and treated on an outpatient basis instead of being confined to a hospital. The ACNM believed that temporary home confinement should be allowed 7

instead of mandating hospitalization. The ACNM stated that published scientific papers attest to the safety of outpatient radiopharmaceutical therapy in doses of up to 400 millicuries of !131 NaI. On June 15, 1994 (59 FR 30724), the Commission published a proposed rule addressing the issues raised in PRM-20-20 and PRM-35-10. The petitioner and commenters are advised to review and comment on this proposed rule. It provides the Commission's position on the fundamental concern underlying the current petition. In the proposed rule, the Commission states that the provisions of 10 CFR 35.75 govern the release of patients, not the provisions in 10 CFR 20.1301. consequently, commenters should comment on PRM-35-11 in this context because most of the issues raised in this petition are addressed in the proposed rule. The NRC staff also issued NRC Information Notice No. 94-09, dated February 3, 1994, entitled "Release of Patients with Residual Radioactivity from Medical Treatment and Control of Areas Due to Presence of Patients Containing Radioactivity Follo'v(ing Implementation of Revised 10 CFR Part 20, 11 which provided the NRC staff's interim guidance governed by 10 CFR 35.75. Dated at Rockville, Maryland, this ~ ~ day of July 1994.

-.:>r the Nuclear Regulatory Commission.

the Commission. 8

American Medical Association Physicians dedicated to the health of America Michael J. Zarski, JD 515 North State Street 312 464-4763 DOCKETED USNRC /1.- 1.0 1/:J't? Legislative Counsel Chicago, Illinois 60610 Division of Federal Legislation 312 464-4961 Fax '94 APR.-Wr Pf2 :21 DOCKET NUMBER r-*- *' rio, J RULE PRM '!,'5-*/ / (51 FR )1o/5 oj April 6, 1994 Samuel J. Chilk Secretary of the Commission United States Nuclear Regulatory Commission Washington, D.C. 20555 OFFICE OF SECRETARY DOCKET! 'G & SERVICE BRANCH RE: Petition for Modification of Regulations Affecting Outpatient Treatment with Racliophannaceuticals

Dear Mr. Chilk:

Attached for your information is a copy of a recent letter to the Chainnan of the Nuclear Regulatory Commission requesting several regulatory modifications. Sincerely, IJJIJvJp~* Michael J. Zarski ,.,vi t) Attachment Chilk.let )

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American Medical Association Physicians dedicated to the health of America DOCKETE us.me James S. Todd, MD Executive Vice President 515 North State Street Chicago, Illinois 60610 312 464-5000 312 464-4184 Fax )..0

  • 94 APR ~

P4 :22 DOCKET NUMBER --:- ~':;:*! March 28, 1994 PETITION RULE PRM

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{__SC/ Fl<-J1'1S f)j Ivan Selin, Chairman United States Nuclear Regulatory Commission Washington, D.C. 20555 RE: Petition for Modification of Regulations Affecting Outpatient Treatment with Radiopharmaceutical.

Dear Mr. Selin:

Pursuant to policy adopted by American Medical Association (AMA) House of Delegates, the AMA petitions the Nuclear Regulatory Commission (NRC) to adopt the following changes to its regulations:

1.

Reinstate (from the regulations as published prior to the 1991 revision of Part 20):

2.

"Section 20.107 Medical diagnosis and therapy. "Nothing in the regulations of this part shall be interpreted as limiting the intentional exposure of patients to radiation for the purpose of medical diagnosis or medical therapy." Amend Section 33.75 to read as follows: "Section 35.75 Release of patients containing radiopharmaceutical or permanent implants." A License may not authorize release from confinement for medical care of any patient administered a radiopharmaceutical or permanent implant unit the measured dose rate from the patient is less than 5 millirems per hour at a distance of one meter or the cumulative dose to individual members of the public will be less than 500 millirems per year."

3.

Amend Section 35.310(a) to read as follows: "(a) A License shall provide reasonable and adequate radiation instruction for all personnel caring for the patient receiving radiopharmaceutical therapy and confined for compliance with Section 35.75 of this chapter... "

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4.

Amend Section 35315(A) to read as follows: "(a) For each patient receiving radiopharmaceutical therapy and confined for compliance with Section 35.75 of this chapter... " The reasons for these changes and information supporting this petition are set out in the attached report of the AMA Council on Scientific Affairs, CSA Report F (A-92). The AMA believes that the regulatory changes* requested in this petition would have a beneficial impact on the availability and cost of treatment of thyroid disease while maintaining safeguards to the health of the public.

  • J=A J,:o.; )I<~

James S. Todd, MD

REPORT OF THE COUNCIL ON SCIENTIFIC AFFAIRS U.S. Nuclear Regulatory Regulations* Affecting Outpatient Treatment.with Radiopharmaceuticals (Resolutions 22 and 23, A-91)_

  • presented by:

E. Harvey Estes, Jr., MD, Chairman Referred to:_ Reference Committee E (Doris G. Bartuska, MD, Chair) Report: F (A-92) 1 Resoiutions 22 and 23 (A-91) were referred to the Board of 2 Trustees. Resolution 22 calls fo~ the American Medical Associ~tion-3 (AMA) to petition the U.S. Nuclear Regulatory _ColllJilission_ (NRG..) __ to_ 4- -.r.ecogri.ize that" current. medicai p~actice co~cerning' the therap~utic 5 :uses of 1131, -particularly in outpatient settings; is effective, 6 safe_to the public and without hazard to the health of America.* 7 This resolution also~instructs the Association to petition the NRC 8 to *.formally *recognize that adequate home confinement precautions 9 r~duce.the hazards associated with radioisotopes sufficiently to * ,:10*.' elipiinate the need for hospitalization following therapeutic 11--ad.ministration 'of radiopharmaceuticals, and that such treatment of

  • 12, patients on an outpatient basis is not in violation of NRC

-:.-13 regulations. Resolution 23 calls for the American Medical

  • 14 Association to petition the NRC to revise regulation 10 CFR 20.1301, 15 'restoring the 'previous external radiation limit of 500 mRem/year.

16 17 INTRODUCTION 1s* ._--,,1 I *;

  • .,..~ *

~ ~ 1 19, The.medical use of inorg~ic sodium 1131 has b~eri. an* eff~~tive W ,

  • 20 - component"-of*medica-1 :practice.-*for *over* 35 ~years~ -: Moie-~rece:ntly;*~- *-,~--:

21. radioactive biologicals -sucli:,aa **monoclonal antibodi~s '- labelect'-*wi th : -_ ~- * ..* *:::,. :- ~ 22- -r13~.--haye_'been'.-added*.to'*the-pliysician's *armamentadum:" The '-'::".::-_*-'*-- ~r \\' 23* 'ab'ility:of "the phys1c'ian*to~ad.minister*Il3l':ciii'.an_-outpatient~basis __,_ 24.: *has.-maintained the *accessibility and minimized :the. costs of. such>- '._-

  • 25 trea~e~ts\\\\* -Patien_ts*"_tre~ted :wi~h~ 113~ )1~~s_t ;~~~ta~~ ::rio_ ~m~r-E{;t~~ _ -*:=-:~

. 26+=30-mCi-total*-body '-'radiatfon 'before' they-may oe :*released fromvthe,.. *- -~.c 0 ~~ <:;.. '°_. -_, 27r_ ~treatment. facility; 1 r;:_,'Howev~"r /'tlierape,ftic* '.u~e;~of,:I131*;1"f_.f;:~t};/,;\\ *;:~~-:..:. ~,_ '. 28 particularly in the treatment of thyroid carcinoma, -often requires:-~' 29 * -doses in excess of 30 mCi, and may require doses as, great. as :.400 *:*. '-':" :* +' -----,.; -* 30

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  • 4 5

6 7 8 9 10 11 12 13 CSA Rep. F - page 2 exposures 'as low as is reasonably achievable'," the NRG has revised its Standards for Protection Against Radiation.4 A wide-sweeping revision of the regulations governing radiation use and exposure limits was proposed in 1976 and ~odifications of the revised regulations were proposed in 1979, 1980, 1983, 1985 and 1986. Following the closing of the open comment period.in 1986, revised regulations were announced May 21, 1991, to become effective June 21, 1991, and to be fully implemented 'by January 1, 1993.4 The section of the final rule relevant to outpatient treatment with 1131 or other radiopharmaceuticals (10 CFR 20.1301, page 23398 of reference 4) reduces the radiation exposure limit to the public from 500 mRem/year to*100 rnRem/year. 14 On December 26, 1990, a petition was filed by Carol S. Marcus, MD, 15 of California requesting that the NRC restore the radiation exposure 16 limit of nonpatients to 500 rnRem/year.5 Her opposition to the 17 newly *effective radiation exposure limit of 100 mRem/year was based 18 ** on*the *impact of *this lower limit: on outpatient *mearc*ar-proc*edures.

  • 19 Because therapeutically effective doses of 1131 may result in 20 exposure_'to the public within the immediate surroundings greater 21 than 100 but less than 500 mRem/year, some procedures utilizing 22 radioisotopic materials that have routinely been performed on an 23 'Outpatient basis-will now require hospitalization, not for medical 24 but for regulatory reasons.

Enforced hospitalization will 25 significantly increase the cost of medical care and possibly result 26 in patients not being,able to receive that care. -.This petition has 27 * -received the support of the American C'ollege of Nuclear Medicine 28

  • (ACNM); Resolution 23 was submitted by ~he AGNM and calls for the 29 filing of a petition very similar to that.filed by.Dr. Marcus.'

30 31 A* resolution (28X)* similar to combined Resolutions 22 :and -23* was* 32 adopted by the Texas Medical Association (TMA) in May 1991, calling,- 33 on the TMA to petition the Texas Department of Health (which has*

  • .... 34 authoi:i,~Y.- t~,~~mt1;9l,.,radiat!on _expos'i.1r~ 4 ],im~ts.within,Texas)... toc:__~

. *_ * -~-." 35, -,.~ffirm-,_~d a_~o'lfledg~ t1:,a~ ~h~ _11_sl!:, ot:_:;.;-~diop_:q.~rm~ceutice,ls

  • on~ an
  • .:~,;*:::. **.. "36 outpatient basis.with subsequent. temporary. hom~:..con(:1,nement:_:of -the ~-,
    • --,*... *.37-patient.'does-not-com.promise_t;he health an<! safety'of*.the general,a*

. ~'1. ~

  • ~ *

~ 38 public *. This. TMA. resolution and Resolutions. 22. and 23.represent;, the*.

  • , ::..:. *: _...:*.;~. 3,9 contfnuip.g.. eft:Qrts ~-.of' members.of:_.the: ACNM,.to ;:-preserve. their-~:2-*-

_ * '40 ab!li~J.-~~ ;_o"--~-17.B:C:;i,s~ ~_u~lE:_~_!':~meqi<;ine,J:q. :tP.~..,J~e~_t::a::meq_i~al, interests'k

*. 41 of. their pati~ts,}ll'~-~-"il!:. ~e., ~~~t; _ ec;(!n(?J!!~~Li~ter,.,ests :.9.f l;IQc;,ietY-:*as a*~-

>:* !;,~~~~:e*~*:.-: D -;~*< *~?~::!;~"*t/:::~-:;'!\\.,~ -;.-:.;. : ;;~;\\~.;~,,~~ ;,,~:~-~.!Ll~t;:~.~,i ~~ -*.: *_ 44.. IMPLICATIONS -OF THE, lll;DUCTION :.IN*. RADIATION.EXPOSURE LIMIT **t7 i. I-Dm ,:~i:-. : *1 45

I
.,
  • .**~ \\.:.. A6 Because doses -of 30,tnCi of rl3l_ ~re substantially below th~*~dos~s~

47 typically used to treat.thyroid carcinoma,.treatment of up to ., -i -t -~. ~ -* -~ ~:-{1..--:'.,~:":1~** nj ~7i'\\_ ')*,11 rl'f ~~r ~ t

  • *~1 J ~
  • t:

~ ~ ;;.*~:* ,,' {,' ~... ..1:.,*. "'_;~ ~ ** ':ti-' '", \\. ~,'"T .,,,'... :.... ~-- - ' *:.J':;i"'; .,..::-,tS-t{ ~ ~*...... -. _).. - "{ i"~ ; _,, ~ Tw ~., '°'!'.. , S -j ,....... ~,,' J

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~ -.. _..: ~ CSA Rep. F - page 3 1

  • 10,000 cancev patients annually will require.the hospitalization of 2

the patients under the revised regulation. 2,3,6,7

  • The ACNM argues that the new radia.tion* exposure,limit is* inconsistent with medical experience and is not necessary in order to *protect -the public from radiation hazards.

Furthermore,, it will reduce both, early release of patients and the treatment of patients at home, which will in turn impose potentially avoidable hospital inpatient costs and burdens on the h~alth care delivery system *. 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17.. 18 19 20 21 22 23* 24 25 26 ,~27 28 29 30 31 32 33 34 -- 35 36 37 38 39* 40 .. 41 - 42 43 "'44 The* existence of a petition to the NRG in opposition to the revised .regulation offered the AMA the opporttm.ity to comment in support of that petition, rather *than initiating a separate petition as would be required by Resolution 23. On behalf of*the existing petition,* the AMA urged the NRG to reconsider the revised regulation (10 CFR 20.1301) in the* context of its potential negative impact on medical practice, cost containment and the accessibility of health care. These comments.were submitted.in a. sufficiently timely.fashion to. meet an August 12, 1991, deadline. Resolution 22 calls for the filing of a new petition of such and _general scope that-it would amount to.a request to exempt medical therapeutic use of radiopharmaceuticals from existing relevant regulations. broad RECOMMENDATIONS The Council on Scientific Affairs recommends that the following statement be adopted in lieu of Resolutions 22 and 23 (A-91) and that the remainder of_ this. report be filed:*:* : * :.

1.

\\ a That. the American MedicaLAssociation~elieves.that recently-revised regulation 10. CFR20.1301 will have*. an adverse.impact on availability and cost~ of*, treatment of thyroid disease; which will outweigh the advantages of* r,.,;:c:--:.~,_reduced,:radiation.~exposure_. to':- the1,public*. -1riH*'" ;::~~<: -\\ --:.~~~~~-:-~~ *~*;*,~~~~~~~i,1.~;;;;;;;;~L~-ft~J**:... i:--; \\.:ti* )-_c-~* 1111,~ -.=1..1.~,,~*~*)!f*~~c~C~*-:;, ~-~::.r.~*::s.

2.
    • That the: American Medical Association urge the U.S.

'Nuclear Regulatory Commlssion to meet--with official

    • representatives of' the 'American College of* Nuclear *

. Medlcine, the Society for Nuclear Medicine, and the American College of Nuclear Physicians, to *further -. *,

    • evaluate the potential impact of-revised regulation 10.,

CFR20.139l_on the outpatient use of* radionuclide therapies-in the treatment of cancer.**:**,' '., I I' ', /

1 2 3

  • 4 5

CSA Rep. F - ~age 4

3.

That the American Medical Association urge the U.S. Nuclear Regulatory Commission to exempt medical therapeutic use of radiopharmaceutirials from existing._- relevant regulations under conditions that will safeguard the health of the public. Fiscal Note: No significant financial impact.

1.
2.
  • REFERENCES Title 10, Chapter 1, Code of Federal Regulations - Energy.

35, Section 35. 71, October 31, 1986.* Harbert JC, Wells N. radioactive_patients. Radiation exposure*to the family of J Nuclear Med. 1974;15:887-888. Part

3. Allen HC Jr, Zielinski JD.

Non-hospitalized thyroid cancer patients treated with single doses 50 - 400 mCi. J Nuclear* ~- 1990;31:784. Nuclear Regulatory Commission. radiation. Federal Register. Standards for prote.ction *against 1991;56:23360-23474.

5. Nuclear Regulatory Commission.

Filing of petition for rulemaking. Federar -Register.:. 1991; 56: ?6945-26946*~

6.

Culver.CM, Dworkin HJ.*:.. Radiatfon~safety}considerations for post-:-iodine-131.hyperthyroid* therapy*., J. Nuclear Med. 1991;32:169:-17~.} ~r.::;. t;-1 ~\\:i*~\\-.:.--~-,~,,:~ ~,!.!'., T_:"(:;~*.::*1 *~~** ,:~

i. ~; -# :,,.. :"~~~,.,. \\

~H~,.' ;11,! ' J :.:,_;1 i:)V..,. -

  • __.*.~~

~ { - "r* :~:,' "'_.r..... ~" ;. t *'i'":..{~:~ 1~ z. "f ~l-~l,r:;..;

i
7.

Drugs used in* thyroid disease~z-q In:*': Drtlg~-Evali.iatlo'hs Annual** c,~-- lfil. Chicago, Ill: American Medical Association;. 1990: 851-868*~:- .. ".,..,~1 -!".,:,.~p'";

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