ML20202D386

Seeks Commission Approval of Proposed Policy Statement That Would Identify Future Role of NRC in Regulation of Medical Uses of Byproduct Matl.Page 18 of Incoming Submittal Not Included & Page 48 Was Blurred

ML20202D386
Person / Time
Issue date:	02/01/1978
From:	Minogue R, Casey Smith NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS), NRC OFFICE OF STANDARDS DEVELOPMENT
To:
References
SECY-78-068, SECY-78-068-R, SECY-78-68, SECY-78-68-R, NUDOCS 9902010382
Download: ML20202D386 (103)

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"'" "*"5 SECY-78-68 Feb-uary 1, 1978 NUCLEAR REGilLATORY COMMisslON POLICY SiiS5fDN ITE7d For: The Comissioners . 6 Jin a >

Frum: Robert B. Minogue, Director, Office of Standards Development ([

Clifford V. Smith, Director, Office of Nuclear Materials Safety and Safeguards Thru: Executive Director for Operations b 'h s

Subject:

NRC REGULATION OF THE MEDICAL USES OF BYPRODUCT MATERIAL

Purpose:

To seek Commission approval of a proposed policy statement that would identify the future role of NRC in the regulation of the medical uses of byproduct material.

Issue: (1) To what extent should the protection of patients be con-sidered in NRC's regulation of the medical uses of byproduct material?

(2) Should the policy statement be published in the Federal Register as proposed, effective with post-adoption coment period, or effective without coment period?

Categgy_: This paper covers a major policy question.

D: cision Criteria: Issue 1. (protectionofpatients)

1. Degree of compliance with Congressional mandate to protect health and safety of public.

2. Need for an effective regulatory program to minimize unnecessary or medically unproductive radiation exposure, implementing International Comission on Radiological Protection (ICRP) and National Council on Radiation Protection and Measure-ments (NCRP) guidance.

3. Need to avoid duplicative or unnecessarily burdensome regulatory controls, particularly where there is adequate com-pliance with voluntary guide' lines and professional standards.

4. Need to recognize that physicians have the primary respon-sibility for the protection of their patients.

Contact:

p E. Podolak ,

443-6910 9902010302 780201 i PDR SECY  ;78-068 R PDR g

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4 The Commissioners 2 ,

5. Need to minimize intrusion into physician-patient relationships.

Jgue2. (publishproposedoreffective)

Administrative Conference recommendation that agencies pub-lish statements of general policy in the Federal Register in proposed form inviting written comments (SECY-77-162).

Al ternatives: Issue 1. (protectionofpatients)

1. Regulate, as NRC (and the AEC before) has traditionally done in other areas, only the radiation safety of workers and the general

• public.

2. In addition to Alternative 1, regulate the radiation safety of patients where justified by the risk to patients and where voluntary standards, or compliance with these standards, are inadequate. 2 Issue 2. (publish proposed or effective)

1. Publish the policy statement in proposed form inviting public coment.

2. Publish the policy statement in effective form inviting post-adoption public coninent.

3. Publish the policy statement in effective form without opportunity for comment.

Discussion: Issue 1. (protectionofpatients)

At the November 23, 1976 briefing on SECY 76-529. "The Issues Concerning NRC's Involvement in the Regulation of Nuclear Medicine," the Comission endorsed the staff's recommendation to hold public meetings prior to developing a statement of NRC policy on the subject. The Comission approved (SECY 77-172) the Federal Register notice announcing two meetings, one with the public and a separate public meeting, on the afternoon of the same day, with NRC's Advisory Comittee on the Medical Uses of Isotopes.

"For this paper and the proposed policy statement, patients are not included in the general public.

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! The Comissioners 3 The central issue for both the Commission briefing and F public meetings was, "To what extent should the protr aon of the patient be considered in NRC's regulation of tF. medical use of byproduct material?". Other key issues were: (1)NRC evaluation of physicians' clinical qualifications, (2) NRC restrictions on the use of radioactive drugs and devices, (3)

NRC requirement for misadministration reporting, and (4) NRC evaluation of the qualifications of paramedical personnel, such i as technologists, radiopharmacists and physicists.

The public meetings were held on May 6, 1977, in Silver Spring, Maryland. In addition to the Federal Register announcement and -

a public announcement, the NRC directly contacted over 30 physician groups, professional societies, public interest groups, Federal agencies., 25 NRC Agreement States and several non-Agreement States. The meeting record was held open for the receipt of written comments, first for 30 days and then for an additional 40 days due to public interest in the subject.

Enclosure 3 is a summary of the comments from the public and the Advisory Committee on the Medical Uses of Isotopes. Generally, the States were in favor of increased NRC regulathn to limit i unnecessary patient exposure and the physicians and physician '

groups favored less NRC regulation and proposed that NRC with-draw from areas they considered to be medical judgment. The Advisory Committee steered a middle course, favoring NRC regu-lations where they are justified by the risk to the patient and where compliance with voluntary standards is inadequate.

Based on the background material discussed in SECY 76-529, and the comments and advice of the public and the Advisory Committee, the staff has prepared a draft Federal Register announcement (Enclosure 1) that solicits public comment on the proposed NRC policy on the regulation of the medical use of radioactive material. If affirmed by the Commission, the policy would state that:

(a) 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.

(b) The NRC'will regulate the radiation safety of patients where justified by the risk to patients and where vol-l untary standards, or compliance with these standards, ve j inadequate.

(c) The NRC will minimize intrusion into medical judgments affect-ing patients and into other areas traditionaly considered to be a part of the practice of medicine.

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The Commissioners 4 In general, a distinction can be a between diagnostic and therapeutic procedures, with - . diagnostic radioisotope proce-dures having a low radiati- risk to patients. Diagnostic radio-isotope procedures ordir_.ily deliver no more than a few tenths of a rem to the patient; on the other hand, therapeutic radioisotope procedures can deliver many thousands of rems to localized areas of the patient.

In general, there are no specific national or international standards for limiting patient exposure from the medical uses of radioisotopes. However, most standards-setting bodies have _

recognized the need for limiting patient radiation exposure and have published general statements to that effect. The National Council on Radiation Protection and Measurements (NCRP Report No. 39 Basic Radiation protection Criteria) states:

In the judgment of the NCRP, there can be no rational means to regulate unifonnly or to limit radiation exposure prescribed for patients for necessary and proper diagnostic or therapeutic purposes. On the other hand, steps can be taken to minimize unneces-sary or medically unproductive radiation exposure.

The multiplicity of often overlapping activities of Federal, State and voluntary agencies is described in the briefing paper SECY 76-529 and summarized in the Background Supplement (Enclo-sure 5). The pertinent regulatory authorities and policies of NRC and FDA are also outlined in the proposed Federal Register announcement (Enclosure 1). Essentially, FDA regulates the safety and efficacy of drugs and medical devices with respect to the patient by controlling their manufacture, distribution and investigational use. NRC regulates the radiation safety of workers and the public, including patients.

Regarding the activities of other Fedcral Agencies, States, peer groups and professional societies, there is a clear trend toward increased involvement in protecting patients from unnecessary radiation exposure. Most of these efforts are along the lines of developing voluntary guidelines and professional standards to limit patient exposure.

The NRC staff has participated in, and actively supported the efforts of Federal and State agencies and professional soci-eties in developing guidelines and professional standards for patient protection from unnecessary radiation exposure. Exam-pies are (1) participation with the Social Security Administra-tion in developing proposed requirements for Nuclear Medicine Services, (2) participation an various task forces of the Conference of State Radiation Control Program Directors, particularly those developing Model State Regulations, (3)

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1 The Commissioners 5 msistance to FDA's Bureau of Radiological Health in its l development of quality assurance guidelines for diagnostic nuclear medicine instrumentation and radioactive drug dose calibrators, and (4) participation in American National Stand- l ards Institute working groups developing guides for the cali-bration of radioactive drug dose calibrators and semiconductor detectors. The goal of working closely with other Federal, State and private agencies in designing new voluntary guidance for limiting unnecessary patient radiation exposure is consist-ent with present Comission policy. l Presently, NRC intrudes only minimally in medical judgments. l The staff believes that it is possible to limit patient expo- '

sure and at the same time minimize intrusions into medical l judgments and physician-patient relationships. The physician on the spot has a unique and specific knowledge of his patients and his patients' needs and certain responsibilities for his patients that cannot be transferred to a regulatory agency.

Current NRC regulations recognize that physicians have the primary responsibility for the protection of their patients.

The regulations are predicated on the assumption that properly trained and adequately informed physicians will make decisions in the best interest of their patients. This establishes a practical limit on the exercise of NRC's authority in regulating the medical uses of radioisotopes. The staff believes that the practical limit finds a balance between adequate regulatory controls and avoidance of undue interference in medical judg-ments and physician-patient relationships. A consequence of too much regulation could be poorer health care delivery to patients.

Allowing the physician to make the majority of the decisions concerning the patient, as he does in other areas of medical practice, carries the greater consequent risk that the physician will make mistakes. However, even the strictest regulation by Federal and State agencies and professional societies will not be able to prevent some mistakes from occurring.

As noted, the central issue of this paper and the May 6,1977 public meetings is, "To what extent should the protection of the patient be considered in NRC's regulation of the medical use of byproduct material?". This issue includes the implicit assumption that the traditional AEC-NRC role of regulating to provide for the radiation safety of workers and the general public is the proper point for departure. The recommendations of the regulatory staff, that the Commission: (1) regulate ,

the radiation safety of the patient... and (2) at the same '

time minimize intrusion into medical judgments..., are small departures from the status quo. The first recommendation draws the NRC slightly closer toward the regulation of medical prac-tice; while the second recommendation pulls NRC slightly away

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ine Commissio- 6 l from regulating medical practice. These recommendations essen- l tially ask that the Comission endorse current NRC regulatory l practices with the two mentioned exceptions. The majority of I

the regulatory staff feels comfortable with this level of con-trol. There are, however, some staff that favor still closer regulation of medical practice and others that favor pulling ,

l farther away from regulating medical practice. I i The staff has not explored the alternatives at the extremes, namely: (1) Total NRC withdrawal from regulating the medical uses of radioisotopes; and (2) NRC taking total responsibility '

for regulation of the medical uses of radioisot3?s. Either alternative might call for legislative adjustment of NRC's regulatory authority vis-a-vis other Federal and State agencies.

Enclosure 1 discusses in detail where NRC regulations abridge medical judgment or the practice of medicine. The principal conflict is NRC restrictions on the physician's choice of clinical procedure under the specific medical license.  !

SECY 78 69 discusses the merits of a staff recommendation to resolve this conflict.

1 Enclosure 1 discusses the disposition of a 1973 AEC proposed rule that would have established minimum training requirements for paramedical personnel and required the reporting to NRC and the patient of misadministrations of byproduct material. SECY 78-70 discusses the merits of a staff recommendation to publish a new proposed misadministration rule.

Enclosure 1 also discusses NRC's evaluation of physicians' qualifications and NRC's use of certain medical board certifica-tions.

Enclosure 7 is a proposed Plan of Action to implement NRC policy for regulating the medical uses of radioisotopes.

Alternative 1. Regulate, as NRC (and the AEC before) has tra-ditionally done in other areas, only the radiation safety of workers and the general public.

Pro: (1) This policy can be well defined, minimizing public confusion on roles of various regulatory bodies.

(2) Eliminates NRC intrusions into medical judgments and the physician-patient relationship.

(3) Has a lower cost to NRC and licensees than Alterna-tive 2.

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Th2 Commissioners 7 Con: (1) This policy abandons NRC protection of the health and safety of patients.

(2) No other Federal agency is authorized to regulate routine use of radioisotopes for protection of the patient.

L Alternative 2. In addition to Alternative 1, regulate the radiation safety of patients where justified by the risk to l patients and where voluntary standards, or compliance with these standards, are inadequate.

Pro: (1) This policy allows concentration of NRC's regulatory effort where the risk to patients is greatest (e.g.,

therapy procedures).

(2) Helps protect patients from unnecessary medical radia-tion exposure.

(3) Recognizes that physicians have the primary responsi-bility for protecting their patients and minimizas NRC intrusion into medical judgments and physician-patient relationships.

(4) Provides a balanced approach regarding protection of patients.

Con: (1) This policy has NRC regulating medical judgment in some instances.

(2) Has a greater cost to NRC and licensees than Alterna-tive 1.

Issue 2. (proposedoreffective)

SECY-77-162 outlines a December 30, 1976 recommendation of the Administrative Conference of the United States (41 FR 56767) concerning statements of general policy (and interpretive rules of general applicability). Essentially, the Administra-tive Conference recommends publishing policy statements in the Federal Register in proposed form inviting public coment,-

unless it is impracticable, unnecessary, or contrary to the public interest in which case the policy statement should so state with reasons. The Administrative Conference further recommends that where there is no opportunity for comment the effective policy statement should include a post-adoption comment period, unless it would serve no public interest or

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would be so burdensome as to outweigh any for' ale gain in which case the policy statement should so .e with reasons.

The Comission (SECY-77-162) respon' . to the Administrative Conference by (1) agreeing with t:..: purpose of the recommenda-tions; (2) listing potential cost problems with adopting advanced coment as a general principle (delay in rules and statements, litigation attacking decisions not to await com-ment and premature judicial review); and (3) stating the Com-mission's intention to continue deciding on a case-by-case basis the propriety of holding a particular rule or statement out for coment.

Because the medical policy statement (Enclosure 1) fits neither the Administrative Conference's criteria for publishing effec-tive with post-adoption comment, nor their criteria for pub-lishing effective without post-adoption comment, nor the Com-mission's cost considerations, the regulatory staff is recom-mending publication of the medical policy statement in proposed form inviting public comments. In this particular case public comment may alter and improve the ultimate Commission decision and should offer benefits in possible increased confidence in the acceptability of the ultimate Commission decision as postu-lated by the Administrative Conference.

Recommendation: That the Comission:

1. Regulate the radiation safety of workers and the general public and regulate the radiation safety of patients where justified by the risk to patients and where voluntary ,

standards, or compliance with these standards, are inade-quate (Alternative 2 of Issue 1).

2. Approve publication in the Federal Register of the proposed

' policy statement (Enclosure 1) inviting public comment on NRC's future role in regulating the medical uses of radio-tsotopes (Alternative 1 of Issue 2).

3. Note that:

a. The proposed policy statement would be published in the Federal Register for 60-day public comment. (If approved by the Commission, the proposed rules in SECY 78-69 and SECY 78-70 will be published in the same Federal Register issue with 60-day comment periods.

One public announcement would cover the proposed policy statement and the two proposed rules.)

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! 9 The Comissioners

b. " .ater expiration of the coment period, no sig-l .oficant adverse comments or significant questions have been received and no substantial changes in the text of the policy statement are indicated, the l

Executive Director for Operations will arrangeIffor sig- l i

publication of the statement in final form.nifical changes in the text of the policy statement are indi-  ;

! cated, the revised statement will be submitted to the ~ j Comission for approval. l l

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c. The Subcomittee on Energy and the Environment of l the Comittee on Interior and Insular Affairs of the U.S. House of Representatives and the Subcomittee on

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Nuclear Regulations of' the Committee on Environment and Public Works of the U.S. Senate will be inform (Enclosure 4). I

d. A public announcement, such as Enclosure 2, will be )

issued when the oolicy statement is filed with the '

Office of the Federal Register.

The Offices of Inspection and Enforcement, State Programs, and Coordination:

l' the DivisionThe of Rules Office of and Records the Executive Legalconcur Directorin hasthe recom of this paper.

0GC/0PE coments are responded to at Enclo-no legal objection.The draft public announcement was prepared by the sure 6.

Office of Public Affairs.

Anticipated Consideration at an open meeting during the Week o Scheduling:

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/ O 6 )%g4 Cliffo . Sm th,' irector fety Robert B. Minogue Director Offi f Nuclear Materials Office of Standards Development and afeguards

Enclosures:

See page 10 DISTRIBUTION _ - --

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. o-i 10 The Commissioners Enc' ,.es: i

• Federal Register _ Notice of Proposed Policy Statement

2. Draft Public Announcement

3. . Summary of Public and Advisory.  ;

Committea Comments  :

4. Draft Congressional t.etter

5. Background Supplement

6. Response to OGC/0PE Comments 7 Proposed Plan of Action (Imple-mentation of Medical Policy) 1 i

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E';CLOSU R S 1 Federal Register !;otice of Proposed Policy Statement

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1 NUCLEAR REGULATORY COMMISSION PROPOSED POLICY STATEMENT REGULATION OF THE MEDICAL USES OF RADI0 ISOTOPES The Nuclear Regulatory Comission (NRC) has under consideration the following proposed policy statement regarding NRC's future role in regu- ].

lating the medical uses of radioisotopes. All interested persons who

! wish to submit written concents or suggestions for consideration in con- ,

l nectic'1 with the proposed policy statement should send them to the Secre-1 l

tary of the Commission, U.S. Nuclear Regulatory Comission, Washington, D.C. 205S5, Attention: Docketing and Service Branch, by -*

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1 Copies of coccents may be examined in the NRC Public Document Room at ]

i 1717 H Street, N.W., Washington, D.C. For further informaticn contact l 1 1 l '

Edward Podolak, Office of Standards Development, U.S. Nuclear Regulatory I l

Connission, Washington, C.C. 20555 (Phone: 301-443-6910).

l In 1976. NRC, with a view to possible changes, began reviewing its regulations regarding the medical uses of radioisotopes, originally pro-l mulgated by the Atomic Energy Comission (AEC). On April 21,1977, NRC published a meeting notice in the FEDERAL REGISTER (42 FR 20691), inviting 1

the public to coment on NRC's regulations c0ncerning edical practices. I 1

Enter date 60 days from publication in FEDERAL REGISTER._

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1 Enclosure 1 1  ;

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The FEDERAL REGISTER notice and rela * . .olic announcerents sta ted that j

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the purpose of the public mee+' , was to receive written and oral comments tha+ the Cocmission could use in deciding future NRC policy in regulating the 1edical uses of radioisotopes and to provide a basis for scssible future rule making. The notice requested cocments on specific issuas as j follows:

To what extent should the protection of the patient be considered in NRC's regulation of the medical use of byproduct material?

Areas of possible regulatory involvement by NRC in tnis area include: l 1 Evaluation of physician's clinical qualifications,

' . Selection of patients for diagnostic or tnerapeutic procedures, I 1

3. Selection of instruments to be used in performing diagnostic o therapeutic procedures,

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4. Selection of radioactive drugs or devices to be used,

5. Selection of procedures to be pcrformed,

6. Selection of dase level (quantity of radioactive materia! or radiation dose) to be used,

7. Proper measurements of the dose the patient receives,

8. Calibration of diagnostic equipment and dose-measuring instrumentation.

l 9. Qualifications of paramedical personnel, such as technologists, l

nurses, radiopharmacists and radiological physicists, and i 10. Reporting to NRC, the patient and/cr the ;2tiint's physiciar, misadministration uf radioactive material or radiation from devices incorporating radicactive raterial.

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In addition to the FEDERAL REGISTER notice and other publit announce-I i

ments, NRC directly contacted more than 30 physician groups, prof?ssional societies, public interest groups, and Federal agencies, the 25 NRC Agree-ment States and several non-Agreement States.

2 Enclosure 1

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l The ungs of NRC staff with the public and the Advisory Comittee

..oical Uses of Isotopes were held on May 6,1977, in Silver Spring, Ma ryland. The meeting record was held open for 70 days following the Teeting for the receipt of written coments. Over 90 people participated in the public meetings and 33 comments were received for the record. 1 Transcripts of the meetings and copies of the coments may be examined in l tne NRC Public Document Room at 1717 H Street, N.W., Washington, D.C. i

1. PROPOSED POLICY STATEMENT This NRC policy statement is intended to infonn NRC licensees, other Federal and Sta*.e agencies and the public of the Ccmission's general intentien regarding the regulation of the medical uses of radioisotopes.

It 15 expected that future NRC activities in the medical area, such as orsmulgation of new regulations and development of cooperative relationships with other Federal agencies, will follow this statement nf NRC policy.

Based on past experience and the comments and advice of the public, other Federal agencies, the States and NRC's Advisory Comittee on the Medical Uses of isotopes, the Comission has developed the following policy l

statement to guide its regulation of the medical uses of radioisotopes:

I The 1?.C licenses radioisotopes in three categories: byproduct, source and special nuclear material. The 'E dces not regulate naturall/ occurring or accelerator prcduced radioisotopes. The term byproduct material means any radioactive material (except special nuclear material) yielded in or made radioactive by exposure to the radiation incident to the process of pro-d;cing or utilizing special nuclear material. .The term source material means (1) uranium thorium or any combination thereof, in any physical or chemical form or (2) ores wnich contain by weight one-twentieth of cte percent (0.05%) or more of (i) uranium, (ii) thorium or (iii) any ccmbination thereof. Source material does not include special nuclear l

material. Special nuclear material means (1) plutonium, uranium 233, uranium enriched in the isotope 233 or in tne isotope 235 or (2) any material artificially enriched by any of the foregoing, but does not include source material.

3 Enclosure 1

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1. The NRC will continue to regulate the medical uses of l

radioisotopes as necessary to provide for the radiatio" i safety of workers and the general public. l

2. The NRC iill regulate the radiation safety of patients l where justified by the risk to patients and where volun-  !

tary stanjards, or compliance with these standards, are l inadequate.

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

1 II. RATIONALE The NRC, and its predecessor the Atomic Energy Commission has regu-lated the medical uses of radioisotopes since 1946. AEC recognized that physicians have the primary responsibility for the protection of their patients and designed its regulations accordingly. The physicians were required to be licensed by the State, and their applicable training and experience were evaluated in consultation with the Advisory Comittee on the Medical Uses of Isotopes. This regulation has been generally oriented toward assisting qualified physicians in discharging their responsibilities to patients. However, regulation by AEC/NRC has at one time or another encompassed nearly every aspect of the delivery of radioisotope medical services to patients. The broadest regulation occurred between 1962 and 1975, when the Food and Drug Administration (FDA) exempted from its require-ments for new drugs all radiopharmaceuticals regulated by AEC. Durini this period AEC regulated the radiation safety of workers and the general

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public a_nd n the safety and efficacy of radio' active' drugs and devices with' respect to patients. AEC regulation included production of the radioisotcpe, manufacture of the final radioactive drug product or device, distribution, 4 Encirsure I

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use and disposal of the products. In 1975, the FDA terminated the exemp-tion for radiopharmaceuticals, stating tha't it would now regulate the safety and efficacy of radioactive drugs with respect to patients. (As noted later in this staterent, FDA does not regulate the physician's routine use of radiopharmaceuticals.) At the same time, NRC withdrew from regulating radioactive drug safety and efficacy, stating that it would regulate the radiation safety of the workers and the public. The 1976 Medical Device .bnendments to the Food, Drug and Cosmetic Act extended FDA's authority over medical devices (including devices containing radioactive materials) in a way similar to its authority over drugs.

NRC's authority to regulate domestically the medical uses of byproduct material is found in the Atomic Energy Act of 1954, as amended. For example, section 81 of that Act authorizes NRC "to issue general or specific licenses tu applicants seeking to use byproduct material for...

medical therapy...." Section 81 directs NRC to regulate the manufacture, production, transfer, receipt in interstate commerce, acquisition, owner-ship, possession, import and export of byproduct material. Finally, _

Section 81 also directs that:

The Commission shall not permit the distribution of any byproduct material to any licensee, and shall recall or order the recall of any distributed material from any licensee, who is not equipped to observe or f ails te cbserve such safety standards to protect health as may be established by the Commission or who uses such material in violation of law or regulation of the Commission or in a manner other than as disclosed in the application

-- therefor or approved by the Connission.

5 Enclosure 1 l

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i Commission regulations, for the most part set '- .n 10 CFR l l

Parts 30 through 36, were promulgated to sar- .c the broad regulatory )

scheme envisaged by section 81. For e ..gle, Part 35 establishes regu-lations specific to human uses of byproduct material. FDA's statutory l authority (Federal Food, Drug and Cosmetic Act, as amended, 21 U.S.C. 301 i

et seg.) does not diminish NRC's authority. Where NRC's and FDA's author-ities overlap, the respective authorities can be harmonized by interagency agreement.

The central question in the April 21, 1977, FEDERAL REGISTER notice is a question of policy not authority, namely:

To what extent INuld the protection of the patient be considered in NRC's regulat.an of the medical use of byproduct material?

From the standpoint of authority, it is clear that NRC can regulate the medical uses of byproduct material to protect the health and safety of users of this material, for instance, patients. In licensing the possession and use of byprcduct material, NRC establishes limits within which physicians exercise professional discretion. From the standpoint of policy, these limits depend upon how NRC views the potential hazard to the patient's health and safety in the uses of the byproduct material.

The greater the potential hazard to a patient from the byproduct material or its use by a physician, the more NRC may elect to circumscribe areas that might otherwise be regarded as within the discretion of the physician.

The first part of NRC's policy statement indicates that NRC will

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continue to regulate the medical uses of radioisotope's as necessiry~to ~

provide for the radiation safety of workers and the general public.

2The term general public in this statement specifically excludes patients.

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Enclosure 1

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i This is the trad .I regulatory function of NRC for all uses of byproduct .cce and special nuclear material. It is a regulatory role that !.a not questioned by any of the commenters but, rather, it was consistently recognized as a necessary role in the medical uses of radioisotopes.

NRC's regulation of the radiation safety of workers and the general public in the medical uses of radicisotopes is relinquished by NRC to l Agreement States; does not overlap with FDA's activities; is in hartnony l

with regulation by the Department of Transportation, Social Security l Administration and the Joint Coninission on Accreditation of Hospitals; I l

and dovetails with Occupational Safety and Health Administration regula- l 1

tion of the work-place for the use of naturally-occurring and accelerator-produced radioactive materials.

The second part of NRC's policy statement indicates treat 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. As noted before. NRC has the authority to regulate tl.a i radiation safety of patients.

3 The NAS-BEIR report discusses limiting the exposure of the popula-tion to medical applications of ionizing radiation. That report, which I includes all medical uses of ionizing radiation, shows in average dose 3

National Academy of Sciences Advisory Comittee on the Biological Effects I of lonizing Radiations (NAS-BEIR) report. . iffects on Populations of l Expcsure to Low Levels of Ionizir.g Radiatien. National Academy of Sciences -

National Research Council, Washington, D.C. , (1972).

7 Enclosure 1 a

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rate from radiopharmaceuticals of 1 mrem / year and an average dose rate from diagnostic radiology of 72 mrem / year in 1970.

The following quotation is from the NAS-BEIR report:

In the foreseeable future, the major centributors to radiation exposure of the population will continue to be natural back-ground with an average whole body dose of about 100 mrem / year, and medical applications which now contribute comparable expo-sures to various tissues of the body. Medical exposures are not under control or guidance by regulation or law at present.

The use of ionizing radiation in medicine is of tremendous value ,

but it is essential to reduce exposures since this can be accomplished without loss of benefit and at relatively low cost. The aim is not only to reduce the radiation exposure to the individual but also to have procedures carried out with maximum efficiency so that there can be a centinuing it. crease in medical benefits accompanied by a minimum radiation exposure.

NRC will act to help ensure that radiation exposure to patients is as low as is reasonably achievable, consistent with competent medical care and with minimal intrusion into medical judgments. NRC will not exercise regulatory control in those areas where, upon careful examina-tion, it determines that there are adequate regulations by other Federal r State agencies or well administered professional standards. Wherever possible, NRC will work closely with Federal and State agencies and pro-fessional groups in designing new voluntary guidance for practitioners to limit unnecessary patient radiation exposure. However, there are specific areas discussed in Section III of this policy statement where NRC will regulate the radiation safety of patients to help minimize unnecessary patient exposure.

The t'hird part of NRC's policy statement indicates that NRC will minimize its intrusion into medical judgments affecting the patient and I

8 Enclosure 1 l

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into other areas traditionally considered to be a part of the practice of medicine. The Commission recognizes tMt physicians have the primary '

responsibility for the protection of their patients. The Comission believes that basic decisions concerning the diagnosis and traat;nent of disease are a part of the physician-patient relationship and are tradi-tionally considered to t,e a part of the practice of medicine. NRC regu-lations are predicated on the assumption that properly trained and ade-quately infonned physicians will make decisions in the best interest of their patients.

The regulations try to find a balance between adequate controls and avoidance of undue interference in medical judgmentt A consequence of too much regulation could be poorer health care delivery to patients. A consequence of le ving to physicians the majority of the decisions con-cerning their patients is that the physicians will make mistakes. The tightest regulation of physicians' decisions by Federal, State and pro-fessional groups will not be able to prevent future incidents in the medical uses of radioisotopes.

The Comission recognizes that FDA regulates the manufacture and interstate distribution of drugs, including those that are radioactive.

FDA also regulates the investigational and research uses of drugs as well as the specific guidance on doses and procedures found in the product labeling. Ilowever, FDA does not have the authority to restrict the routine use of drugs to procedures (described in the product labeling) FDA has approved as safe and effective. Indeed, NRC is the only Federal Agency 9 Enclosure 1 M96+ 9 l

m

a i

6 e . , , i that is currently authorized to regulate the routine use of r sctive drugs from the standpoint of reducing unnecessary radir' .. exposure to patients.

l The Coninission believes that the diagnostic use of radioactive drugs j is, in most cases, clearly an area of low radiation risk to patients.

I Therefore, NRC will not control physician's prerogatives on patient selec-tion, instrument selection, procedure selection, drug selection and dose level for most diagnostic uses of radioisotopes. For all therapeutic uses l l of radioactive drugs, and in certain diagnostic uses-for example, the use of phosphorus-32 for localizatior. tf eye tumors-the risk to patients is not low. The rin of tissue or organ damage (or even death) is inherent in the use of therapeutic levels of radioactive drugs. NRC will continue to restrict the uses of therapeutic and certain diagnostic radioactive drugs to the indicated procedures that have been approved by FDA. The 4

NRC will not control the physicians' prerogatives on patient selection and instrument selection for therapy procedures, because these proce-dures are so specialized and patient specific.

Congress recently gave FDA authority to regulate medical devices, similar to FDA's authority to regulate drugs, but with additional authority l to restrict the routine use of medical devices as may be necessary to provide reasonable anurance of their safety and effectiveness. FDA l has not yet had sufficient time to implement its full authority to regu-late medical devices containing byproduct, source or special nuclear l

l 10 Enclosure 1 l __ .- =.

. material. Therefore, HRC wil' .cinue to restrict physician's uses of these medical device' voth for diagnosis and therapy, to those pro-cedures that NRC has determined (in consultation with its Advisory Committee on the Medical Uses of Isotopes) to be safe and effective.

The Commission does not consider equipment calibration, qualifica-tions of paramedical personnel or reporting to NRC misadministrations sf radioactive material to be exclusively the practice of medicine or a car" of physician-patient relationships. As described in detail in Sec-tion III, the Commission intends to regulate these areas of patient radiation safety where justified by the risk to patients and where voluntary standards, or compliance with these standards, are inadequate.

III. NRC POSITION ON SPECIFIC ISSUES The following represent the Comission's position on the specific issues raised in the April 21, 1977, FEDERAL REGISTER announcement 32 FR 20691):

Evaluation of physicians' clinical qualifications.

NRC has always required that licensees be qualified by training arc experience in the handling of radioactive material from the standpoinc :P radiation safety of workers and the general public. l The Commission believes that it is necessary to continue to ev3'.'An physicians' clinical qualifications prior to issuance of NRC license:.

At this time there is no alternative method of determining if a.physictaa not certified by the American Board of Nuclear Medicine or the America l

11 Enclosure '

_ .._ .__. _ ..,,.,_._.. - -- rrn

}

l ,

l Boarsi cf i diology, is competent to use byr,roduct material. However, the l

...uission also believes that, as this field of medicine continues to mature, other alternatives will replace the NRC evaluation of clinical qualifications.

NRC has fcr several years accepted certification by the American Board of Nuclear Medicine and the American Board of Radiology as suffi-cient evidence of clinical competence in the fields of nuclear medicine and radiation therapy, respectively. It has recently determined that certification by the American Board of Radiology in Diagnostic Radiology, with Special Competence 11. Nuclear Radiology, is sufficient evidence of clinical competence in nuclear imaging procedures.

Based on specific assessments in consultation with its Advisory Com-mittee en the Medical Uses of Isotopes, NRC will continue to expand its use of the various board '.ertifications as satisfactory evidence of adequate elinical training and experience for the medical uses of radioisotopes. ]

NRC will also work closely with the professional societies to assist them l

in developing suitable pennanent alternatives to NRC's evaluation of physicians'  !

clinical qualifications.

2. Selection of patients for diagnostic or therapeutic procedures.

NRC currently evaluates a physician's clinical qualifiu ' ..s to use l radioisotopes on humans. One NRC requirement is that the phys ian's training include " supervised examination of patients to detennine the suitability for radioisotope diagnosis and recomendation on dosage to be prescribed."

l 12 Enciosure 1

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4 V A ..

1 The Comission recognizes that the selection of patients for diag-nostic or therapeutic procedures is basically a matter of medical judg-ment. Diagnostic procedures have a low patient risk and therapeutic procedures are specialized and patient specific. Radioactive drug manu-facturers provide guidance on patient selection and contraindications in ,

the product labeling. Supplemental voluntary guidelines on limiting patient radiation exposure, including the standpoint of patient selection, are available in the literature. The contribution to unnecessary patient exoosure from improper selection of patients is believed to be small. 1 i

I Therefore the Commission does not anticipate the need to limit, to any major extent, the physician's discretion in selection of patients.

Because the NRC does not evaluate physician qualifications for the general I license, the Comission will continue its minor restriction in the general medical license [10 CFR 5 35.31(c)(4)] prohibiting administrations of radiopharmaceuticals to a woman with confirmed pregnancy or to persons l

under 18 years of age. This restriction does not affect specific licensees.

3. Selection of instruments to be used in cerforming diagnostic or I therapeutic procedures.

NRC evaluation of a physician's qualifications includes an evalua-tion of training in radiation physics and instrumentation.

The selection of instruments for perfoming diagnostic or therapeutic

~

procedures is, like patient selection, basically a matter of edical l

l 13 Enclosure 1

- um-ar:er.=r.::2rr i

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.. i Judgment. There are also voluntary guidelines available on the selecti calibration and maintenance of instrumentation. Again, diagnosti gro-cedures have icw patient risk ano therapeutic procedures are speciali:ed and patient specific. NRC does not currently restrict selection of instru- i ments and does not anticipate the need for doing so in the future. The Commission recognizes that FDA will r:gulate the investigational and research uses of medical devices under its new legislation, the Medical Device Amendments of 1976 (P.L.94-295). The Commission also recognizes  !

that these amendments give FDA new authority to restrict she routine use of medical devices ur. der such ccnditions as may be necessary to provide reasonable assurance of their safety and effectiveness. i

4. Selection of radioactive druos or devices to be used.

Presently the NRC generally restricts a physician's selection of radioactive drugs by limiting the distribution of the radioactive drugs to those products meeting FDA requirements. The physician is thus restricted to using radioactive drugs subject to an FDA-approved " Notice of Claimed Investigational Exemption for a New Drug" (IND) or an FDA-approved New Drug Application (NDA). NRC regrlates the manufacture and installation of teletberapy devices as well as the integrity testing of these and other radioactive medical devices during use. However, NRC does not presently require that medical devices containing radioactive material meet FDA requirements. . _

The Commission believes that it is necessary to continue its restric-tions on the availability of radioactive drugs to those that meet FDA i

14 Enclosure 1

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l i requirements. NRC will study and assess rDA the necessity for a similar NRC requirement for radicar ,e medical devices.

In those cases where several radiopharmaceuticals have been approved by FDA for the same procedure, the Como:ission does not plan to restrict a physician's decision regarding which agent to use. The Commission con-siders the basic decision on drug or device selection to be a traditional part of medical practice.

The Food, Drug and Cosmetic Act differentiates between pharmacy and manufacture. However, no clean line has been established .o determine l

when a nuclear pharracy has gone beyond the ordinary practice of pharmacy (compounding and dispensing) and has become a manufacturer. The FDA is drafting guidelines that will define all of those operations (of nuclear phannacies) connected with the preparation of radioactive drugs which will l

be regarded as manufacture (and, therefore, subject to FDA new drug requirements) and not part of the practice of pharmacy. In the absence of FDA guidelines, the NRC is licensing the distribution of only those products from nuclear pharmacies prepared from FDA-approved radiopharma-ceuticals or reagent kits.

l 5. Selection of crocedures to be performed.

NRC evaluates a physician's clinical qualifications. His training j includes studies, under a preceptor, of case histeries to establish the most appropriate diagnostic or therapeutic procedures, limitations, i contraindications, and so forth.

l l

l 15 Eqclosure 1 l

l

_ ~

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The Cr . ion recognizes that tne selection of procedures is basically a ma+ of medical judgment. The Connission does not anticipate the need to limit, to any major extent, the physician's di..cretion in the selection of clinical procedures.

The Commission recognizes that FDA does not restrict tne routine use of NOA-approved drugs to those procedures for which there is substantial evidence of safety and ef fectiveness, that is, to those procedures approved in the drug labeling. According to FDA's regulations on drug labeling:

The FDA Connissioner clearly recognizes that the labeling of a marketed drug does not always contain all the most cuirent ir.fr-nation available to physicians relating to the proper use of tra drug in good ceJical practice. Advances in nedical kn0wledge and practice inevitably precede labeling revision by the manufacturer and formal labeling approval by the Food and Drug Administration.

Gcod medical practice and patient interests thus require that physicians be free to use drugs according to their best knowl-edge and judgment. Certainly, when a physician uses a drug for a use not in the approved labeling, he has the responsibility to be well-informed about the drug and to base such use on firm scientific rationale or sound medical evidence, and to maintain adequate medical records of the rugs use and effects, but such usage in the practice of medicine is not in violation of. the Federal Food, Drug and Cosmetic Act.

Basically, NRC issues two types of licenses to medical institutions for the human uses of byproduct material, the medical license of broad scope and the medical license of limited scope.

Broad medical licenses authorize multiple quantities and types of byproduct material for unspecified uses and are issued to institutions that (1) have had previous experience operating under a limited medical license and (2) are engaged in medical research as well as routine l

16 Enclosure 1 l-

i l s ,

l

'~ mummum M .

l diagnosis and therapy using radioisotopes. The programs under the broad medical license operate under the supervision of a medical iso-topes comittee. No physicians are naced as individual users on the I

license, nor are radioisotopes limited to specific clinical procedures.

Limited medical licenses specify the radioisotopes and the clinical procedures that may be performed by physicians named on the license.

Under limited medical licenses the institutional licensee must have a medical isotopes comittee and the physicians named on the institution's licensa conduct their programs with the approval of that committee. Under limited medical license the authorized diagnostic ar.d therapeutic radio-dctive drugs and the authorized clinical procedures are listed in the NRC regulation 10 CFR i 35.100, " Schedule A - Groups of medical uses of byproduct material".0 The authorized clinical procedures listed in the groups are proce-dures approved by FDA in the drug labeling. Since FCA does not restrict the physician to clinical procedures listed in the labeling, NRC regu'.a-tions are more restrictive than FDA regulations.

Elsewhere in this issue of the FEDERAL REGISTER is a proposed rule that would delete the specification of the clinical procedure from the lists of the diagnostic radicactive drugs in 5 35.100. However, this proposed rule would place limitations on a drug's use for procedures not

_ _ specifi.ed in the package insert.

6 Radioactive materials in 6 35.100 are divided into six groups, each group having similar requirements for user training and experience, facilities and equipment, and radiation safety procedures.

17 Encic;ure i

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. l As noted in Section II of this policy statement, the radiation risk to the patient from most diagnostic nuclear medicine procedures is low, while the risk is significant from misuse of therapeutic levels of radioactive l drugs. Those few diagnostic procedures where the risk to the patient is high are not listed in 5 35.100 but are the subject of specific license authorizations and will continue to have the clinical procedure specified.

6. Selection of dose level (quartity of radioactive material or radiation dose) to be used.

As noted in Item 2, selection of patients, the physician's training must ir.rlude supervised experience in recomending proper dosages for specif' patients.

Th Comission recognizes the selection of dose level is basically a

,nter of medical judgment. The package inserts for radioactive drugs include the recommended usual dose and usual dosage range. Because of the

. many variables that determine the most effective dosage for both the diagnostic and therapeutic use of radioisotopes, the NRC does not presently regulate these, nor does it anticipate the necessity of restricting in the future the physician's selection of dose level.

7. Proper measurement of the dose the patient receives.

The Commission believes that proper measurement of the radioactive drug dosage, or radiation dose in the case of therapy, helps to ensure that the patient receives what the physician has prescribed and thus helps minimize unnecessary radiation exposure. to-patients. NRC now requires--

most licensees, particularly those who prepare radioactive drugs from 7

The risk to a patient from a false positive or a false negative diagnosis through the use of a drug for a purpose not fully investigated and specified on the label would be expected to be greater than it is for a labeled use but this risk is difficult to quantify.

18 Enclosure 1

• • g y, radioisotope generators or reagent kits, to measure the doe- ..rior to administration. This requirement is now imposed thre a license condi-tion. NRC will study the merits of amending it; regulations to require measurement of all diagnc; tic and therapeutic doses of radiopharmaceu-ticals, regardless of origin.

NRC currently has under consideration a proposed rule (42 FR 25743) that would require annual calibration and monthly checks of teletherapy units. This rule has received many public connents, the comments will be analyzed arid the rule modified, if warranted. Based on the dicoosition of this prcposed rule on teletherary calibration, NRC may propose a similar rule for the ;eriodic calibration of brachytherapy sources.

8. Calibration of diagnostic equipment and dose measuring instrumentation.

The Commission believes that the calibration of diagnostic equipment and dosage measuring devises helps ensure that the patient receives what the physician prescribes and thus helps minimize unnecessary radiation exposure to patients. NRC presently requires licensees who prepare radio-active, drugs from radioisotope generators and reagent kits to describe in the license applications a method for calibration of their dose measuring devices. NRC also provides an acceptable method for calibrating dose calibrators in "A Guide for Preparation of Applications for Medical Programs" (NUREG-0338 Rev.1 Novetter 1977) that can be cbtained by writing to the Radioisotopes Licensing Branch, Division of Fuel Cycle and Material Safety,

'Nuclesr Re'gul'atory Commission Washington, D.C. 20555.

19 Enclosure 1

_ _ _ _ - _ _ _ _- m

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1 l-l l NRC presently dr ,6 have any requirements concerning the calibra-l tion of diagnot*' . equiptent. Because of'the extensive experience of FDA's Bureau of Radiological Hea'th and the new authcrity of FDA's Sureau of Medical Devices NRC will collaborate with them in their devel.opment of voluntary guidelines for the routine calibration of diagnostic equipment.

At the same time, NRC . vill study the merits of proposing mandatory requirements.

9. Qualifications of paramedical personnel, such as technologists, nurses, radiopharmacists and radiological pFysici P s.

On March 9, 1973, i.EC Dublished (38 FR 6399) a proposed amendment to its regulations in 10 CFR Part 35 that would (1) define the activities that may be delegated by physicians and those that may not, (2) require physicians to determine that para:redical personnel have been properly trained, and (3) require medical licensees to report to the Comission and to the patient misadministrations of radioactive material.

The Commission recognizes thct there are several organizations currently involved in developing or providing minimum standards, guide-lines or certification for technician training. These programs are administered by State, Federal and private agencies including: the Health Services Administration (Medicare and Medicaid DHEW), the Bureau of Radio-logical Health (FDA/DHEW), the Joint Ccmission on Accreditation of Hospi-tais (JCAH), the American Registry of Radiological Technologists (ARRT),

the Registry of Medical Technologist; (RMT) and the new certification board by the Technologists Section of the Scciety of Nuclear Medicine.

20 Enclosure 1

l l

l l The Commission also recognizes that the majority of paramedical 1

(allied health) personnel using radioactive material are not covered by l l

these programs. Rather they are trained on-the-job, are not certified; and many do not have their training documented. However, the introduction of a relatively less comprehensive NRC program, such as that in the 1973 AEC proposal, could undemine the efforts of voluntary organizations or l l

those Federal or State agencies relying on more coeprehensive guidelines. l Elsewhere in this issue of the FEDERAL REGISTER is an announcement wi9 drawing the 1973 AEC proposal and substituting an NRC proposed mis-administration reporting requirerent. The announcement and Item 10 discuss more thoroughly the reasons for withdrawal of the AEC proposal and substitution of the NRC proposal. NRC is presently studying the various allied health certification programs currer.tly in effect and currently being drafted by other Federal, State and professional groups.

If the coverage provided by these programs is not adequate to protect the patient from unnecessary radiation exposure, NRC will work with these groups 'to develop a new NRC proposed rule for the training of allied health personnel.

10. Reporting of misadministration of radioactive material or radiation frca devices incorpo ating radioactive material.

As described in Item 9, in 1973 AEC published a proposed rule that would require. - - -

licensees to report misadministrations of radiopharmaceu-ticals or radiation from byproduct material to the Corrnission and to the 21 Enclosure 1

_ . . _ _ .... .-- .= a-x = 1:-

+ -

l patient or a rc:ponsible relative whenever the misadministration could l

cause a " demonstrably adverse effect on the patient." Ninety-eight

! coninent letters were received, most objecting to the proposal for reporting l

l to the patient. Reasons given for objection to the requirement for reporting misadministrations to the patient were: (1) such reports would constitute self-incrimination, (2) such reports would invite or increase unwarranted malpractice suits. (3) this would place the government as a third party in the physician-patient relationship, (4) this is a matter of medical ethics, and (5) there are no comparable requirements for any other drug or physicians in any otner field of medicine.

The purpose of a misadministration reporting requirement is to allow NRC to investigate the incident; evaluate the corrective action taken by the licensee to minimize the chance for recurrence; and, if there is a possibility of other licensees making the same errors, to allow NRC to begin generic corrective action which would, as a minimum, inform other licensees of the potential problem.

As also noted in Item 9, elsewhere in this issue of the FEDERAL _

REGISTER is a new NRC proposed rule for misadministration reporting. This proposed rule is different from the 1973 AEC proposed rule in that the NRC proposal requires reporting to NRC and the referring physician of all therapy misadministrations and only those diagnostic misadministrations that could cauw a clinically detectable adverse effect on the patient.

' ~

~

A'e i other inisadministrations will be subject to a record-keeping require-ment and a requirement that these records be made available for NRC inspection.

22 Enclosure 1

1 l

l IV. PUBLIC AND ADVISORY COMMITTEE COMMENTS The NRC staff met with the public on the morning of May .977, and with its Advisory Committee on the Medical Uses of Isotopes in an af ter-noon public meeting on the same day. The members of the Advisory Committee were the chairman, Mr. Richard E. Cunningham, Deputy Director for the Division of Fuel Cycle and Material Safety of NRC's Office of Nuclear Materials Safety and Safeguards; Dr. James Quinn from Northwestern Memo-rial Hospital; Dr. Joseph Workman from Duke University Medical Center; Dr. David Kuhl from the University of California, Los Angeles; Dr. Henry Wagner from Johns Hopkins Medical Institution; Dr. Edward Webster from Massachusetts General Hospital; and Dr. Frank DeLand from the University of Kentucky. Two consultants to NRC, Captain William Briner from Duke University Hospital and Dr. Peter Almond from the M. D. Anderson Hospital, 4

also attended.

The comments from mecbers of the public can be classified broadly in two categories. In the first category, the physicians, physicians' groups, pharmacists' groups and industry ccaments range from statements that "present regulations are sufficient" to "the NRC should not regulate the use of radioisotopes in medicine at all." Many of the cont.ents in this category stated that FCA regulates the safety and efficacy of drugs and that NRC should withdraw from this area and regulate only the radia-tion safety of workers and the general public.

~

In the second category, NRC Agreement and non-Agreement State radia-tion control agencies' comments range from statements that "present 23 Enclosure 1

1

{

m regulations are sufficient" to "much 3er regulation is~necessary." I Many of the consents in this c- ,vry note that FDA does not regulate the routine uses of drugs and sevices and, therefore, NRC should regulate to ensure that the patient is protected from unnecessary radiation exposure.

In the area of NRC's evaluation of a physician's clinical qualifi-cations, both categories of commenters recommend greater use by NRC of board certifications. Physicians and the industry in general appear to be interested in maintaining NRC evaluation as a means of entry into the field. They feel that if NRC withdrew from evaluating physician's clini-cal qualifications, the institutions or States would require specialty board certificaticn. They state that there are not enough board certified physicians to fill the demand for services and that board certification 's not necessary for many of the radioisotope procedures. The State radia-tion control agencies believe that NRC's evaluation of physician clinical qualifications is necessary to protect the patient. They feel that if .'iRC withdraws there will be a regulatory gap. Some States suggest that a physician's qualifications should be reviewed periodically, for example, every five years, to determine that he is keeping abreast of this rapidly changing field.

The general sense of NRC's Advisory Cocnittee on the Medical Uses of Isotopes w3s that NEC should continue, at least for the inmediate future, to examine physicians' clinical qualifications and should make

~ ~ ~

greater us'e of the various types of bo'ard certification or registration,  ;

i l 24 Enclosure 1 ]'

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as evide .. adequate qualifications to practice in the areas of r- .ar medicine and radiation therapy.

On the question of selection of patients, instruments, radioactive 1

drugs or devices, procedures and dose level, the State radiation control agencies believe that NRC should not regulate the selection of patients or instruments. However, the States believe that licenses should specify the l

permitted radioactive materials and procedures and should require adher- (

ence to instructions and dose schedules in FDA-approved package inserts.

The physicians and the industry believe that decisions on selection of patients, instrur.ents, radioactive drugs or devices, procedures and dose levels are medical decisions and traditionally a part of the practice of medicine. They commented that NRC should not regulate these areas. Some argued that NRC has no authority to regulate in these areas since Congress gave FDA the authority to regulate the safety and efficacy of all drugs and medical devices.

The Advisory Committee on the Medical Uses of Isotopes does not have a consensus on this issue. The majority of the committee feels that NRC should not restrict the physician to those diagnostic procedures that have been approved by FDA in the labeling. One member believes that NRC should continue this restriction or that some arrangement should be e7de similar to the in-house institution committee review under an NRC Broad Medical License.

~

Regarding proper measurement of the dose the patient receives, the States urge NRC to expand the present licensing requirement 25 Enclosure 1

l

+ .

C M" . .

for measurement of doses of radioactive drugs prepared from rudionuclide generators, to cover all doses of radioactive drugs regardless of how they are prepared. On the related question of the calibration of diagnostic equipnent and dose measuring instrumentation, the States favor NRC activity aimed at limiting patient exposures but recommend that NRC coordinate its activities with FDA's Bureau of Radiological Health and other professional and scientific groups.

The category of physicians, physician groups, and so on, varies in its comments regarding measurement of dose and calibration of diagnostic

~

instrumentation and dose-measuring instrumentation. Several commenters state emphatically that NRC has no business regulating in this area.

Many of them state as their reason the new authority af FDA's Bureau of Medical Devices and the recent activities of FDA's Bareau of Radio-logical Health in developing voluntary quality control guioelines.

Several other cenmenters state that NRC acti/ities in this area are both welcome and necessary to limit unnecessary patient exposures. Simi-lar to.the States' cuanents, some of these latter commenters recommend _

NRC cooperation with FDA's Bureau of Radiological Health and other pro-fessional and scientific groups active in developing guidelines for en<e measurement and instrument calibration.

The consensus of the Advisory Committee on the Medical Uses of

_ lo_stopes on this subject is that NRC would do well to concentrate its activities on assurances that the patient receives the proper dose prescribed by the physician. The Advisory Cornittee can see no reascn 25 Enclosure 1

.,i . . .

4 why radioactive drug doses should not be measured by well-calibrated instrumentation prior to administration to the patient. On the other hand, the Advisory Committee is not enthusiastic about the idea of NRC requiring the calibration of diagnostic instrumentation. The existence of guidelines in this area and the market pressures on manufacturers to provide quality instrumentation are two examples that it discussed.

On the question of the qualifications of paramedical personnel, the physician-industry category is virtually unanimous in its opposition to  ;

1 NRC requirements. The pharmacy, radiopharmacist and technologist groups are particularly against NRC granting credentials to paramedical person-nel citing the numerous certifications and activities of other Federal and State agencies, as well as claiming lack of NRC authority to regulate in j this area. The physician groups cite the fear that the number of certi-fied technologists will fall far short of the need for these personnel.

The sense of the Advisory Committee is that existing certifications cover paramedical qualifications and hospitals look rather carefully at these. They feel that, in the final analysis, physicians are respon- -

sible for their patients and, therefore, are responsible for the qualifica-tions of paramedical personnel working under their direction in caring for l

patients. With the exception of physicist's qualifications for calibra-tion of radiation therapy, the Advisory Committee does not recommend that I

NRC become involved in regulating the qualifications of paramedical _

personnel.

1 l

27 Enclosure 1

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The States consider misadministration repo ' necessary in order to limit unnecessary radiation exposure to p>~ .ats. They point out that with reports of misadministrations of oyproduct material or radiation from byproduct material, NRC will be able to investigate the incident, deter-mine if the corrective action is adequate and, if the problem could occur at other institutions, notify other licensees.

Physicians and physician groups are, in general, opposec to NRC l

requiring reports of misadministrations. They cite the low number of I misadministrations of radioactive material to date comt 'ned with the fear of malpractice suits and the already high insurance pren.lums as the principal reasons for opposing misadministration reporting. They point out that most misadministrations of diagnostic levels of radiopharmaceu-ticals do not harm the patient and are similar to misadministrations of other drugs. They state that medical institutions and the medical pro-fession have procedures for dealing with misadministrations. Several commenters question NRC's authority to require such reports, stating that this is within the traditional practice of medicine and such a reporting requirement would be unique in all of nedical practice. Several com-menters do not object to keeping records of misadministrations for on-site examination by NRC inspectors, but these commenters feel that more harm than good would result from caking such reports directly to NRC, where they would become a part of the public record.

The Advisory Comaittee on the Medical Uses of Isotopes does not have a consensus on the issue of misadministration reporting. The members wra 28 Enclosure 1 9

1

+ i_

1 cocinented are aga' .equiring rep.rts of those misadministrations having no demonstr-t'.e health effects on the patient. 1 One general coment occurred several times during the morning and l l

l af ternoon meeting; and in many of the public contrents. It concerns the need for uniformity in Federal, State and private regulation of the medical uses of radioisotopes. Several cocinenters call for uniformity between NPC and State regulations, but most focus on the discrepancy between the regulation of byproduct material and the regulation of nJ.urally-occurring, accelerator-produced radioactive material and accel-erator therapy. One ccamenter discusses this discrepancy with regard to t nerapy. This corrnenter expresses his concern that regulatory considera-tions have come to play an important part in decision making, particularly in matters where the decision is for a choice among near equals. Specifi-cally, he is concerned that the competition between cobalt-60 and electron accelerator tele nerapy may be infli/enced not from differences in hazards, but because NRC regulates cobalt-60 teletherapy units and does not regu-late electron accelerator units. He feels that physicians may choose the -

least regulated alternative in order to have more time available for the patient-oriented demands of their practice. He suggests that NRC should cooperate with those agencies that can regulate accelerator teletberapy, so that these cccpeting alternatives receive r. ore uniform regulation. He further suggests that any increase in the regulation of one alternative would be counterproductive to public health and safety.

29 Enclosure 1

'A V. CONCLUSION This proposed policy statement on NRC's regulation of the medical uses of radioisotopes is published with the expectation that public com-ment will improve the ultimate Carnission decision. To that end, it l would be helpful if responses include the reasons for a particular point l of view or recomendation.

Dated at Washington, D.C. this day of 197_.

For the Nuclear Regulate y Comission.

Samuel J. Chilk Secretary of the Comission l

l I

30 Enclosure 1

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DRAFT PUBLIC ANNOUNCEMENT NRC PROPOSES POLICY STATEMENT AND R'JLE CHANGES IN REGULATION OF MEDICAL USES OF RADIOIS0TOPF#

l The Nuclear Regulatory Comission is publishing for cement a prc.

posed statement of policy on the' role of NRC in future regulation of the medical uses of radioisotopes. At the same time, two rule changes are proposed which are consistent with the proposed policy. f The proposed policy is based on past regulatory experience, comments and advice of the public, the States and NRC's Advisory Comittee on the Medical Uses of Radioisotopes, and is designed to guide the 'IRC in its regulation of the medical uses of radioisotopes. Under its provision.. ]

(

l. The NRC would continue to regulate the medical uses of radio-isotopes as necessary to provide for the radiation safety of workers and the general public;

• 2. The NRC would regulate the radiation safety of patients where justified by the risk to patients and where voluntary standards, or com-pliance with these standards, are inadequate;

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

The proposed policy statement and the rationale for it are being published in the Federal Register on . Interested persons are invited to submit corrrnents or suggestions by (60 days)_to.the Secretary of the Comission, Nuclear Regulatory Comission, Washington.

0.C. 20555, Attention: Docketing and Service Branch.

1 Enclosure 2 I

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Comments also are invited on two proposed changes to Part 35 of NRC regulations being published simultaneously with the policy statement.

One proposed rule change relates to reporting requirements for the misadministration of radioisotopes. In 1973, the former Atomic Energy Commission (AEC) published a proposed rule which, among other things, would require all misadministrations to be reported to the AEC (now NRC) and to the patient. The NRC is withdrawing the complete 1973 proposal and proposing a different reporting requirenent under which misadministrations would have to be reported to the NRC and to the referring physici3n only

.vren they involved a therapy procedure or could cause a clinically detectacle adverse effect on the patient. However, records would have to be maintained on all misadministrations and would have to be available for NRC inspection.

Under the other proposed change to Part 35, the Commission would t

provide greater latitude to physicians by no longer designating specific diagnostic procedures to be followed in using most low risk radiopharma-ceuticals. However, because of the higher risk to patients, the Com-mission would continue to restrict clinical procedures for the use of therIpeutic drugs and radioactive medical devices.

2 Enclosure 2 F

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4 ENCLOSL'RE 3

- Sum:nsry of Public and Advisory Committee Comments

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- 2 ENCLOSURE 3

SUMMARY

OF PUBLIC* .., ADVISORY l COMMITTEc COMMENTS l

The April 21, 1977, FEDERAL REGISTER announcement asked:

"To what extent should the protection of the patient be considered l in NRC's regulation of the medical use of byproduct material? Areas of possible regulatory involvement by NRC in this area include:

1. Evaluation of the physician's clinical qualifications, Selection of patients ftr diagnostic or therapeutic procedures, I

2.

3. Selection of instruments to be used in performing diagnostic or therapeutic procedures,

4. Selection of radioactive drugs or devices to be used,

5. Selection of procedures to be performed,

6. Selection of dose level (quantity of radioactive material or radiation dose) to be used,

7. Proper measurements of the dose the patient receives,

8. Calibration of diagnostic equipment and dose-measuring instru-mentation,

9. Qualifications uf paramedical personnel, such as technologists, nurses, radiopharmacists and radiological physicists, and "The groups that are asterisked made presentations at the public meeting.

Several were amplified by subsequent written submissions which were included in this summary.

1 Enclosure 3 l

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10. Repe- aJ to NRC, the patient and/or the patient's physician,

.asadminstration of radioactive material or radiation from devices incorporating radioactive material." l The following is a summary of the comments received in response to I the FEDERAL REGISTER request. Multiple submissions from the same groups l were combined where possible.

1. Food end Drug Administration Bureau of Drugs" l l

The FDA's Bureau of Drugs confined its comments to the in vivo (within the body) use of radioisotopes. It explaineG the purposes of j "New Drug Applications" (NOA) and " Investigational New Drug Applications" ,

I (IN0). The FDA statement discussed the former " exemption" for AEC regu-lated drugs and stated that radioactive drugs are now regulated by the FDA to the same extent that FDA regulates other dregs. This statement defined "research" uses of radioactive drugs as uses intended to obtain basic information regarding the metabolism of a radioactively labeled drug or regarding human physiology, pathophysiolcgy, or biochemistry, but not intended for irre.ediate therapeutic, diagnostic, or similar purposes or to determine the safety and effectiveness of the drug in humans (i.e.,

to carry out a clinical trial). FDA noted that there are currently 123 NOA approved radiopharmaceutical drug products and 500 active IND's for radiopharmaceutical drugs.

The Bureau of Drugs stated that FDA regulations permit a radio-pharmaceutical drug that is the subject of an approved NDA to be distrib-uted to any physician licensed to practice medicine. However, they also noted that the package inserts for these products contains a statement 2 Enclosure 3

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g g that radiopharmaceuticals should be used only by physicians qualified by training and experience in the safe use and handling of radionuclides and whose training and experience have been approved by the appropriate The government agency authorized to license the use of radionuclides.

Bureau of Drugs said, "We believe that the NRC should continue to be responsible for the evaluation of physician's qualifications to receive, possess and use radioactive materials."

The Bureau of Drugs stated that selection of patients and instru-mants is a part of the practice of medicine and should not be regulated by NRC. Further, it believes that the selection of drugs and procedures is the responsibility of the nuclear physician and should not be regulated by NRC.

With regard to selection of dose level, the Bureau of Drugs stated:

i I

"The Bureau of Drugs is responsible for the establishment of the amount of radioactive material to be administered to a patient which has been shown to be safe and effective for the intended use. Suggested or recommended amounts of radioactivity to be administered are included in the l' package interts for NDA approved radiopharmaceuticals.

However, the FDA recognizes that a physician must be free to use a drug for an indication or at a dosage j j

not specified in the insert when such usage appears to '

be rational and for the best interest of the patient.

This was the clear intent of Congress when it wrote the Food, Drug, and Cosmetic Act and its amendments and has been repeatedly stated as FDA policy. We believe that the NRC should not regulate the selection of dose levels."

Finally, the Bureau of Drugs noted with regard to the proper

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measureme'nt of the dose the patient' receives, the package inserts ?or radiopharmaceutical drugs include a statement that each dose should be l 3 Enclosure 3 l

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l measur *o by a statable radioactivity calibration system immediately prior

?.o av.nin'stration.

2. NRC Agreement States

• The following NRC Agreement States submitted a joint statement: The Alabama State Department of Public Health, the California, Colorado, New York and Nebraska State Departments of Health, the Kansas State Department of Health and Environment, the Mississippi State Board of Health, the Oregon State Department of Human Resources, and the Texas Department of Health Resources.

The expressed concern of these State agencies is that the NRC should carefully evaluate the impact of relinquishing any of its current controls over nuclear medicine. In their view it is all too easy for the NRC to bow to the statement that a specific area falls under the aegis of the

" practice of medicine" or " medical judgment" and does not relate to radiation health and safety. They believe that because of the escalation of nuclear medicine, regulatory agencies must begin to take into account this significant contribution to the total population dose.

These agencies state that NRC should place equal importance on patient protection, worker protection and protection of the gereral public. They point out that the weakness in the NRC's program is the lack of regulatory control over patient exposure and the use of naturally occurring and accelerator produced radioactive materiai (NARH). They argue that' regulatory agencies responsible-for the control of radiation should be intimately involved in reducing unnecessary radiation exposure in the practice of medicine regardless of the source. They reccmmend l

4 Enclosure 3

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,.r- a that protection of patients against unnecessary radiation exr- . should be enhanced through the following:

1. Periodic evaluation of physicians' quali.ications (e.g., 5 year intervals).

2. Specification in licenses of the permitted radioactive materials and procedures and a requirement for adherence to instructions and dose schedules in the FDA-approved package inserts.

3. Definition and enforcement of the duties and responsibilities of a physician authorized to use radionuclides.

4. Collaboration among NRC, Agreement States and the Bureau of Radiological Health (FDA) in the developtent and implementatien of quality control guidelines for diagnostic equipment and dose-measuring instrumenta-tion.

5. Collaboration among the NRC, Agreement States, nuclear medicine physicians and nuclear technological societies in the develcpment of Federal standards for mandatory State licensing of radiologic technolo gists (diagnostic X-ray, therapy and nuclear medicine). _

6. Collaboration among the NRC, Agreement States and the Society of Nuclear Medicine in the development of a workable definition of

" reportable misadministrations."

7. Collaboration among the NRC, Agreement States and the Society of Nuclear Medicine in the development of a national repository of infor-

- niation' on' the latent effects, if any, of internal therapy doses.

8. More public education about the benefits and risks associated with the use of radiation.

5 Enclosure 3

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In conclusion, thesa _ement States feel that the regulatory scheme for nuclear - .. cine should have as its goals:

I. To cssist the physician in delivering optimum medical care.

II. To assure the patient that he/she is receiving competent medical care.

III. To minimally interfere with the delivery of health care; but without hesitatation to impose cort ective action when minimum l standards are not met.

3. Neutron Products

• Neutron Products, Inc. expressed its concern that regulatory considera-tions hive come to play an important part in decision making, particularly in matters where the decision is for a choice among near equals. Specifi-cally it is concerned that the competition between cobalt-60 and electron accelerator teletherapy may be influenced by differences in regulatory status deriving, not from a difference in hazard, but from NRC regulation of cobalt-60 teletherapy units. Neutron Products argues that physicians

sy choose the least regulated alternative in order to have more time available for the patient-oriented' demands of their practice. It suggests that NRC should cooperate with those agencies that can regulate accelerator teletherapy so that competing alternatives receive more uniform regulation. 1 It further suggests that any increase in the regulation of ccbalt-60 teletherapy units would be counterproductive to public health and safety. )

1

4. ' Society of Nuclear Medicine" - -- - - - -

The Society of Nuclear Medicine states that the NRC should con-tinue to carry out its responsibilities for the radiation safety of i  !

6 Enclosure 3

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.' 1 occupationally exposed individuals and the environment in which byproduct  !

material is stored and utilized; however, the Commission should avoid involvement in the clinical aspects of nuclear medicine. Such involve- 1 ment, it feels, is contrary to the best interests of patients who are the  ;

beneficiaries of nuclear medicine procedures. l The Society of Nuclear Medicine objects to continuing involvement or

)

i new involvement of HRC in those 10 areas of interest listed in the Federal Register meeting announcement.

In objecting to NRC's continuing to evaluate a physician's clinical qualifications the Society notes that it could find nothing in NRC's or AEC's enabling legislation that either mandates or permits such control i over the practice of medicine. Rather it argues that since the health and safety of the public has been improved by nuclear medicine and nuclear medicine poses no threat to the common defense and security of the U.S.,

an exemption from restrictive controls over the clinical aspects of

.uclear medicine is warranted by the provisions of Section 81 of the Atomic Energy Act of 1954, as amended (42 U.S.C. Section 2111). It notes ,

that the control of the practice of medicine is now, and always has been, vested in the States. It also notes that certifications are granted to qualified practitioners by the American Board of Radiology, the American Board of Pathology and the American Board of Nuclear Medicine. The Society concludes that it is no longer appropriate for the NRC to continue to evalua'te the clinical qualifications of physicians.

7 Enclosure 3 l

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The Society states that selection of patients clearly involves medical judgment which must be made by qualified medical practitioners

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and does not rest within the Federal government.

The Society states that selection of a specific instrument is depend-ent on so many variables that rigid regulatory control is contrary to the best interests of patients. Again it feels that tnis area is also a part 1

of the practice of medicine.

The Society states that there are no provisions in the enabling legislation that allows the Commission to mandate a choice in the selection of drugs or procedure. In fact, it argues that the Federal laws that do regulate drugs and devices in no way require a physician to use drugs or devices for specific ourposes. The Society believes that it was the intent of Congress, as well as the interpretation of the drug and device laws by the courts, for these decisions to be the prerogative of the physician. The Society states that NRC should not restrict the u;e for which radioactive drugs and devices may be employed by qualified nuclear medicine physicians and such restrictions are an unwarranted intrusion into the practice of this specialty. It recommends, "in the strongest i of such controls in 10 CFR 35.100, as wall terms possible," the delet on as reference to these controls in 10 CFR 32.74.

The Society believes that NRC should not regulate of the quantity of radioactive material or radiation dose because they, too, are medical judgments, such regulation is not imposed in any other area of medical l .

practice, and there are many variables that nust be considered in pre-scribing for individual patients.

3 Enclosure 3 l

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i The Society believes that proper measurements of the dose a patie-receives, is not an appropriate area of NRC regulatory concern. ,s I

responsibility, it feels, is one that is imposed by law on .icensed l health care practitioners, such as physicians and pharmacists, who are j l

legally responsible for their individual professional acts in the use of j any drug substance, including radioactive drugs.

l The Society believes that the quality assurance programs now offered or under development by a number of professional and scientific groups  !

I provide a better mechanism for control than Federal regulation. l l

The Society believes that the area of qualifications of paramedical personnel is inappropriate for NRC involvement for a nurber of reasons.

Radiopharmacists and nurses are licensed by the States. Tecanologists and radiological physicists also have a number of certifying groups, f These would include the American Board of Radiology, and the American Board of Science in Nuclear Medicine for physicists, and the American Society of Radiological Technologists and American Society of Clinical Pathologists examinations in nuclear technology for the technologists. _

Also, the newly formed Nuclear Medicine Technology Certification Board will offer its first examination in 1978.

Finally, the Society of Nuclear Medicine recommends that NRC not require reports of misadministrations because the Freedom of Information l Act precludes maintenance of the confidentiality of the reporter of a mis-administration, and th'is additional' requirement wili re~sult in increased cost without benefit to the public. It argues that medical care costs have already increased due to the increased frequency of malpractice litigation.

9 Enclosure 3 l

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5. Atomic Industrial Forum

• l The Atomic Industrial Forum / j urges the NRC to camplete its withdrawal f rom control of t!w manuf acture and use of radiopharmaceu-ticals. It feels that this recommendation takes cognizance of FDA's role in regulating the production of safe and efficacious radiopharmaceuticals and NRC's role in regulating the safety of the medical staff, the patients and the public in the hospitals' that use radiopharmaceuticals. The AIF l

does not see a clear need for either NRC or FDA to control the physician who ad;.dnisters the radioactive drugs or.the patient who receives them.  ;

It states t.7at in general, the Ccngress, the FDA and the pub'.ic have accepted the position that the regulation of physicians and patients is counter productive to good medical practice.

The AIR argues that duplicative regulations by Federal and State agencies provide no demonstrable benefit and impose an unnecessary cost to the patient. It feels that NRC regulation 10 CFR Part 32.74, "Manu-facture and distribution of sources or devices containing byproduct material for medical use," is a duplication of the Good Manufacturing Practices required under FDA regulations. It also feels that NRC regula-tions in 10 CFR Part 35.100, " Schedule A - Groups of medical uses of byprodu:t material," are redundant since they require hospitals to possess license; to use FDA approved drugs. The AIF feels that the FOA, NRC and Agreement States should direct their energies toward regula:ing the

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nuc1 ear pharmacies.

The AIF believes that radioactive drugs, properly evaluated and approved by the FDA, should be treated similar to non-radioactive drugs 10 Enclosure 3

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in that "' 4egulatory control should focus on the manufacturer and not th- aer. It proposes that an NRC license should not be required for l radioactive drug use and the provisions of 10 CFR 35.100 should be dropped. I It 3rgues that the licensing of hospitals for the medical use of radio-isotopes should be based on 10 CFR Parts 20, 30 and 33; that is, hospitals should establish their capability to handle radioisotopes by describing l

l their qualifications as to medical staf f, technologists, instrumentation, radioisotope committee, medical use committee, and physical facilities

...d procedures for protection of the staff, patients and public.

6. American Pharmaceutical Associaticn*

The Nuclear Pharmaceutical Section of the Academy of Pharmacy Prac-tices of the American Pharmaceutical Association (APHA) comments on Item 9 in the Federal Register announct.nent concerning the qualifications of nuclear pharmacists. The APHA believes that the function of the NRC should be limited to development of standards and criteria for the safe use of all radioactive materials and the evaluation of users' radiation safety program. The APHA notes that it is FDA's responsibility to evaluate _

the safety and efficacy of radiopharmaceuticals the same way it evaluates non-radioactive pharmaceutical agents. It argues that while the Federal government is responsible for public health and safety, the individual States under the U.S. Constitution have reserved the power granted to the Federal government necessary to protect the health, safety and welfare of their citizens. Under the police power reserved, the States regulate the practice of pharmacy, medicine, nursing and other professions serving the 11 Enclosure 3

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public. By limiting these professional practices to licenses, a State can assure a certain level of confidence in quality of service. l The APHA believes that while pharmacy and all medical professions are best regulated by State agencies, competency is best assured by professional organizations and peer group reviews. It notes that pro-grams for colleges of pharmacy are accredited by the American Council of Pharmaceutical Education with the National Association of Boards o' Pharmacy developing a standard examination in pharmaceutical sciences to be used by the individual States. The American Pharmau utical Associa-tion has also recently petitioned the Boards of Pharmaceutical Specialty to recognize nuclear pharmacy as a specialty area of practice in pharmacy.

In summary, the American Pharmaceutical Association believes that mechanisms are available or are currently being developed whereby the competency and quality of training for nuclear pharmacists is assured.

It feels that professional organizations, in conjunction with State legislative regulations, are better prepared and equipped to provide direction, guidance, and enforcement in areas of professional conduct and practice than is the NRC. It cercludes that NRC is and should be respon-sible for the assurance of public safety in the use of radioactive material, but should not, as a Federal ager.cy, set itself up to evaluate and regulate the qualifications of professions, including nuclear pharmacy.

7. Conference of Radiation Control Program Directors and Non-Agreement States

• The Conference of Radiation Control Program Directors and some non' Agreement States, specifically the States of Illinois, Oklahoma and i

12 Enclosure 3

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e Massachusetts, presented joint comments. These groups believe that the selection of instruments, radioactive drugs and devices, procedures and the selection of the dose level need not be regulated by NRC. They feel however, that further regulation of a physician's clinical qualifications and the allied health personnel qualifications is necessary. As an example, they note that only board-certified therapists are allowed to practice radiation therapy in Massachusetts. They also believe that regulatory agencies have a role to play in the calibration of diagnostic equt pment and dose measuring instrumentation and that cJ ibrations should not be performed by people who do not have proper training. The Conference recmmends that misadministrations be reported so that they can be studied and, if possible, prevented from rer1rring,

8. American College of Nuclear Physicians" With regard to Item 1, evaluation of physician's clinical qualifica-

r. ions, the American College of Nuclear Physicians (ACNP) notes that

• orically this role has been fulfilled by the NRC. With the develop-

... tat. oi recognized certifications by the American Board of Nuclear Medicine, ,

American Board of Radiology, and the American Board of Pathology, it no longer appears essential to the ACNP for the NRC, or any Federal agency, to review these clinical qualifications, especially in view of the extensive and well-developed programs in continuing education offered by the profes-sional societies supporting these certifying bodies. The ACNP believes the only~ role for NRC is the licensing of those physicians who might require specific radiopharmaceuticals for research or other medical pur-poses, but whose field of specialization and training would not fulfill 13 Enclosure 3 s < . - - - - - - - - - -

i the requirements of the above certifying boards, f- .emple, dermatology, otolaryngology, and occupational medicine.

With regard to the selection of patients for diagnostic or thera-peutic procedures, the ACNP argues that diagnosis and therapy are the responsibility and prerogative of the licensed and certified physician, and there are no laws prescribing in what ranner, or for wnat reason, a qualified physician is to prefer or to prescribe one method of care over another. According to it, the NRC does not have legal responsibility for individual acts of physicians and lacks expertise in medical practice and in the evaluation of new methods in nuclear medicine.

Regarding the selection of instruments to be used in performing diagnostic or therapeutic procedures, again the ACNP feels tnat this is not of appropriate concern for the NRC. Review by the FDA of medical devices in nuclear medicine to determine whether these effectively perform according to a reasonable standard is acceptable to the Coll (;?. It argues that NRC's proposal to influence a nuclear physician's selection of a device or instrument would detract from the effectiveness of the physician's care.

The ACNP believes that the selection of radioactive drugs and devices is not of appropriate concern to NRC. The ACNP argues that the physician's judgment both medically and legally should determine the drug; or devices used on a patient.

The ACNP believes that the selection of procedures to be performed is not an area of appropriate concern for the NRC. It argues that the nuclear physician's State license and specialty board certification and 14 Erclosure 3

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continuing educatin- ..aot be supplanted by the NRC. The ACNP states that the NRC ' .id itstlf incur liability were:.it to deny or restrict ,

procedures that would have benefited the patient.

The ACHP believes that selection of the dose level is not an appro-priate area of concern for the NRC. It argues that only tb5 nuclear I

medicine physician can determine the amount of radiation to give a patient for an appropriate diagnosis. It notes that the appropriate administered activity will be determined by the sensitivity and resolving power of the imaging device or other detector and how the radiopharmaceutical is metabolized. It further notes that the age, size, shape and particular illness of the patient are also imporcant facters requiring the physician's Judgment.

Rega-ding the proper measurement of the dose that the patient receives, the American College of Nuclear Physicians encourages the development of general guidelines for measurement of the activity of radiopharmacetticals used in nuclear medicine. Furthermore, it believes that some duplication may exist between the responsibility of FDA and NRC, and such overlap .

should be carefully reviewed to detemine the appropriate jurisdiction and to simplify the regulations for the practicing physician, and ulti-mately for the patient. The ACNP proposes that, if the radiopharmaceutical is prepared by the physician, the NRC should require appropriate assay methods. It recommends that such requirements be developed in close cooperation with FDA and peer groups to assure patient safety and to minimize duplication of record keeping.

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The ACNP believes the calibration of diagnostic equipment and dose measuring instrumentation is an area within the scope of the practice of nuclear medicine The College is currently addressing this problem by develcping a quality assurance program, It suggests that scientific and professional societies and the concerned Federal agencies, such as the NRC and FDA, should collaborate with it in these efforts.

The ACNP believes that the qualifications of paramedical personnel such as technologists, nurses, radiopharmacists, and radiological physi-cists are not an appropriate concern to the NRC. Such regulation, they i argue, would create an unnecessary burden on the medical health system ar.d increase the cost of health care delivery to the patient. It states )

l that at the present time there are certifying bodies in each area where controls are needed.

The ACNP believes that misadministrations of radioactive material )

should be reported to the patient or his representative, his physician, and the institution holding the license. If the NRC were to receive such information without releasing it publicly, the ACNP feels that such notification would be appropriate. It cautions that a single instance of misadministration requires careful evaluation by peer greeps of physi-cians, and by investigators of the NRC, because basic to the appropriate handling of alleged or actual incidents of misadministraticn is the fact that physicians are not and cannot ever be guarantors of successful results.

16 Enclosure 3

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9. National Council on Radiation Protection" The National Council on Radiation Protection (NCRP) does not make specific recomendations concerning patient care in the practice of medicine, as outlined in the several questions set forth by the NRC. It is, however, active through its scientific committees and NCRP reports in protecting both the patient and general public from radiation. NCRP will continue the active study of radiation problems concerned with nuclear medicine in the preparation of scientific reports useful to the medical community for the protection of patients and the public in this area, as well as in the wider areas for the use of radiation. The NCRP suggests that its review process for the preparation of scientific committee reports might serve as a model for the preparation of NRC documents.

10. American College of Radioloay*

The American College of Radiology (ACR) states:

"We have serious reservations that the (NRC's) respon-sibility for safety extends to the broader area of medical judgment and efficacy which would be enccmpassed by affirm-ative decisions on all of the ten questions in your notice.

In our opinion, the evaluation of physician qualifications to practice medicine, the determination of patient selec-tion for given procedures and the choice of procedures are not prope areas of involvement of any Federal agency."

The ACR believes that NR: can appropriately rely upon the voluntary credentialling mechanisms and State licensure requirements for physicians to provide proper protection for the public in medical uses of radionuclides.

The ACR n'otes that voluntary credentialling programs for paramedical person-nel exist and are working well, 17 Enclosure 3

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a licensed physician can use these drugs for other than the spr a purposes this should cause no concern to the NRC." Acco- ..w to the ACR the diagnostic radionuclide proven safe and ef fective for one purpose will always be safe for another, regardless of whether it is or is not effective for that unapproved use.

The ACR believes that the selection of procedures is the practice of medicine. It argues that the certification and recertification process, along with the yearly reviews of hospital staff privileges by peers,

uarantees the physician's ability to make decisions far better than could any regulation.

The ACR is convinced that the NRC no longer needs to be concerned with the selection of dose levels. According to it, this area of concern has been assumed by FDA, which advises physicians about recommended dose levels through drug package inserts.

The ACR believes that metheds to insure proper measurement of patient josage should be the responsibility of the FDA's Bureau of Radiological Health and of the medical and scientific community and not of HRC. It believes that methods of calibration of diagnostic equipment and dose measuring instruments is also the responsibility of the Bureau of Radio-logical Health and the medical and scientific community, and need not be l

the concern of NRC.

The ACR believes that the qualifications of paramedical personnel

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are not a'n appropriate area of conce'rn for the NRC, since mechanisms already exist to measure the qualifications of these individuals.

Physicists are certified by the American Board of Radiology upon the 19 Enclosure 3

• AM satisfactory completion of both- .en and oral examination. Pharmacists are licensed by State phar .y boards and are presently organizing a certification board for radiopharmacists. Techrologists are presently certified in nuclear medicine technology by the American Registry of Radiological Technicians and the American Society of Clinical Patholo-gists. A third registry is being formed by the technologist section of the Society for Nuclear Medicine. The ACR argues that the pool of certi-fied technologists is small and any Federal regulations that would reduce the short supply of non-certified tec* N logists would '.a seriously infla-ticnary and wculd solve nothing.

The ACR suggests that it is important to define the term "misad- (

ministration." If the term " misadministration" means a dose administra-tion that would seriously affect the health and safety of the patient and represent a significant breakdown in radiation safety technique, it feels the NRC should be informed so that N?,C's investigation could correct the reasons for this breakdown and perhaps be useful to other institutions.

J.', however, the term " misadministration" refers to unimportant misadminis-trations, the ACR believes that they should not be reported to the NRC.

11. Equipment Committee ACR*

The Equipment Connittee of the American College of Radiology reccmmends that the NRC support and participate in orgoing activities to improve the quality, safety and efficiency of medical services rather than to begin an independent effort in this area. It notes that patient protection is a central theme of a wide variety of ongoing activities by (1) professional organizations such as the American College of Radiology and American 20 Enclosure 3

Asse uon of Physicists in Medicine, (2) voluntary standards setting s coups such as committees of the National' Council on Radiation Protection and Measurements International Comission on Radiation Protection, International Commission on Radiation Units and Measurements, Interna-tional Electrotechnical Institute, and American National Standards Insti-tute, and (3) State and Federal agencies such as the National Institutes of Health, Food and Drug Administration, Health Resources Administration, and State radiation control agencies. The Equipment Committee feels that the NRC has expertise and experience in areas concerning the regulation of the ex;,osure of the general population and workers to ioni:ing radia-tion, and NRC has the resources to collect data related to the need for medical irradiation controls. Therefore, NRC could participate in a coordinated effort to provide apprepriate controls for medical irradia-tion. However, the Equipment Committee believes that NRC's mandate, experience and expertise do not provide sufficiently uniform or complete i

coverage of the medical irradiation field to warrant NRC taking a central j i

role in patient protection. l

12. College of American Pathologists The College of American Pathologists comments that it is strongly opposed to increased regulations by the NRC in the area of the medical l

use of isotopes, which it feels is the practice of medicine and is more than adequately monitored for the safety of the patient. Such menitoring activitie's, it notes, are carried out by appropriate government agencies,

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peer review committees within institutions, Professional Standards Review l l

i 21 Enclosure 3

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i Organizations and other responsible entities, such as State Boards of l

Medical Examiners. I

13. Arkansas Department of Health The Arkansas Division of Radiological Health and its Advisory Committee on the Human use of Radiopharmaceuticals noted that exposure to medically-oriented sources of radiation is the largest contributor to the total man-made fracticn of the radiation dose to the general population. The Division feels that while the use of ionizing radiation as a diagnostic tool is and snall continue to be mandatory to quality medica'l care, it cust be applied in a safe and effective manner. To that end, it believes t9at regulatory practices must be devised and implemented that will assure quality care and patient safety, and yet, will not hinder or impede the physician's judgment in the management of medical care.

The Division recommends tnat the initial evaluation of the physi-cian's qualifications to use radioactive material for human purposes be continued and tre evaluation criteria be periodically reviewed as a joint affort of NRC's Advisory Connittee and the professional certifying organi-zations.

The Arkansas Medical Advisory Committee believes that a regulatory agency does not have a place in the selection of patients for diagnostic or therapeutic procedures unless the procedures are experimental or provide a public health risk. It believes that a regulatory agercy may develop c~riteria as guidance to the patient selection but they should be l

applied as guidance only, f.

f 22 Enclosure 3

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4 The Arkansas Division of Radiological Health believes that the regulatory procedures now in effect, which evaluate and, as approprir ,

approve radiopharmaceutical use or therapy precedures, must be continued and expanded to include all medically-oriented sources of radiation (naturally-occurring and accelerator produced). It argues that the li:ensees must be required to use the radioactive material in accordance with the approved package insert, manufacturer's directions for use or other approved procedure. It believes that within this framework the physician must be given the latitude, within logical counds, to exercise professicnal judgment.

The Divisien reccmmends that regulations requiring routine calibra-tion of diagnostic equipment and dose measuring instrumentation be devel-oped and implemente6. It argues that equipment calibration and routine equipment inspections are required of industrial radiographers, while nothing comparable is required of licensees responsible for human exposure.

It believes that efforts to train and credential paramedical personnel

hould be pursued because these people actually perform hands-on duties that are critical to the efficient and safe use of radiation. Again it compares NRC regulations requiring specific training for radiographers and their assistants to the lack of requirements for personnel (excluding physicians) applying radiation to humans.

Finaly, the Division states that patients have an inherent right to

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knew when' they are the subject of a case o'f misadministration of a dose 1

of radioactive material, radiation, or any pharmaceutical that may cause deleterious effects. It believes that logical regulations, developed by 23 Enclosure 3

O -.

regulatory agencies, crofessional organizatior a other interested

,.itroversial issue and must parties must address all aspects of thi-consider the physician patient relationship and the area of medical judgment.

14. Ralph G. Robinson, M.D.

Ralph G. Robinson, M.D. is Head of the Division of Nuclear Medicine at the Kansas University School of Medicine, Kansas City, Kansas, and is currently serving on FDA's Radiopharmaceuticals Advisory Cornmittee.

Dr. Robinson states his belief that the NRC's reguletary concerns pro-perly encompass the licensing of physicians and facilities for the safe handling and use of byproduct material but should not invade the judg-mental areas that must remain with the physician in his practice of medicine. Specifically he states that the NRC would properly be involved in Item #1, evaluation of physician's qualifications, Item #7, assuring )

proper measurement of the dose the patient is to receive, Item #8, assuring 1 1

that dose-measuring equipment (not diagnostic equipment) is properly l calibrated, and Item #10, requiring reporting to the NRC or the patient's physician (not the patient) misadministration of radioactive material. ]

Dr. Robinson states that selection of patients, instruments, radio- )

)

active drug, procedure and the selection of the dose level should all be the physician's perogative since the physician is in fact already held responsible for proper performance of the practice of nuclear medicine in

~

these areas. 'He says, "As long as the NRC is satisfied that a physician i

has the minimum standards of training in areas which would qualify him to The make those decisions, NRC's responsibility and interest ceases.

24 Enclosure 3 l

l

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e l

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s nuclear physb es then on his own to do the best for each patient under b' care, making those decisions for himself."

Dr. Robinson recommends that NRC not be involved in any attempt to determine the qualifications of any paramedical personnel, including technologists, nurses,'radiopharmacists, and nuclear medicine physicists since the physician who supervises them is ultimately responsible, both I

professionally and legally, for their performance. He argues that various certifying boards e'ist for nuclear medicine technology or science, phar-macists are controlled by State Boards of Pharmacy, and that there is a clear move toaard the development of national standards for certifica-tion and credentialling of all allied health personnel. For example, he notes a report called "A Proposal for Credentialling Health Manpower" prepared by the Public Health Service Manpower Coordinating Committee,  ;

i June 19, 1976, at HEW. He believes that the addition of NRC requirements to the accreditation methods available to the nuclear medicine technolo-  ;

ist and the proposed development of national standards for credentialling, c': example, a nuclear medicine technologist, would be a duplication of _

Federal effort and overlapping jurisdiction and regulations.

Dr. Robins:n concludec:

"So, in summary, let me say that I would support the 1 1

continued involvement of the Nuclear Regulatory Comission l in areas which are traditionally their province. That does

~

not and never has included the regulation of ra'dioactive drugs, something that the AEC did only on a lend-lease basis for the Food and Drug Administratien for a period of 25 Enclosure 3 l I

. i d

4 some years. I believe it is NRC's responsibility to license and certify as to safety and to accountability of radioactive materials received and utilized, it is the Food and Drug Administration's responsibility to see that drugs are properly labeled and supplied for appropriate use in the practice of Nuclear Medicine, and it is the j nuclear physician's responsibility to see that the 1

patient is then served best in each case by the appro- I priate examination, determined on an '7dividual basis, ir.cluding the choice of radiopharmaceutical, dosage,  !

I route of administration and equipment utilized."

]

15. American College of Nuclear Medicine  :

I.

I The governing body of the American College of Nuclear Medicine (ACNM) states that the evaluation of physicians' clinical qualifications should be maintained and regulated by the NRC or its Agreement States.

The ACNM believes that there should also be apprcpriate calibrction of diagnostic equipment and dose measuring instrumentation. Howver, the ACNM believes that'the other issues in the Federal Register announ:ement fall within the prerogative of the practicing physician and actually are I his responsibility. The ACNN concludes its statement as follows: "It is our position and feeling that without the appropriate regulation as we have proposed we would see a significant reduction in the quality of nuclear medicine practice in this nation." j l

l 26 Enclosure 3 .

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16. Franklin D. Cur 1, M.D.

Franklin D. Curl, M.D., is the Director of Nuclear Medicine at Providence Medical Center. Dr. Curl questions why nuclear medicine, with ,

probably the best patient safety record of all the medical specialties, should come under additional scrutiny at this time by another regulatory body. He notes that nuclear medicine physicians' clinical qualifications are evaluated and certified by the American Board of Nuclear Medicine.

He also notes that the selection of patients for diagnostic or therapeutic procedures has characteristically been carried out by physician', under general guidelines specified in their radioactive materials licenses. He feels that further involvement of the NRC in the practice of medicine j would not result in any better protection of patients or improvement in medical care. He cautions that the potential exists for unnecessary delay in adoptir.g new diagnostic or therapeutic procedures and for inter-ference with medical care in general through an excess of regulatory activity.

Dr. Curl believes that State regulatory bodies are adequate to ~

l protect public and patients against unnecessary medical radiation under current procedural arrangements. He argues it is unlikely that either State or Federal regulatory bodies can contribute much to the improvement of medical care above and beyond the traditional efforts of medical organizations and their practitioners. Additionally, he suggests that

' ~

the po'ssibilit'y for substantial damage to medical practice exis'st through misguided regulatory interference or solution of imaginary problems.

27 Enclosure 3

~

1

17. Mississippi State Board of Health The Division of Radio'ogical l Health of the Mississf state Board of Health points out that the major concern by NRC, cne Agreement States and non-Agreement States regulatory personnel is the role that is to be exercised regarding patient safety. It is the Division's opinion that enabling legislation, rules and regulations do not specifically address radiological safety of the patient. However it believes the safety of workers and the general public is addressed sufficiently well so that the State Board of Health has no other choice but to identify those factors i in a nuclear medicine program that could affect the safety of the involved workers and the general public and regulate accordingly. It feels that the most effective means by which a regulatory agency can assure the 1 health and safety of the involved workers and general public is to assure that the physical facilities meet certain minimal criteria. Such facili-ties might include isotope storage, disposal, area shielding, materials i handling and the adequacy of counting and surveillance instrumentation, i.,cluding personnel monitoring devices. In its opinion any other involve-ment by NRC or State regulatory programs would have overtones of infringe-ment on the practice of medicine. It proposes that one or more of the peer groups should establish minimal clinical qualifications of practi-tieners and associated paramedical personnel.

The Division states that the Food and Drug Administration bears

~

~ ~

regulatory responsibility for the utilization of drugs and 'dev' ices ,and l 1

l the user physician bears professional and/or moral responsibility for administration of the drugs or for radiation from the devices. So far as l

2E Enclosure 3 l l

the NRC and its State countero- .re concerned, the only responsibility to be exercised regardin- .c users qualifications is to examine them and determine if the pre established minimum has been met. It feels that the user / physician or institution has the responsibility and prerogative of choosing his own paramedical persor.nel.

The Division believes that the oost controversial subject in regula-tory responsibility is that of choice and administration of drugs and devices themselves in concert with the associated dose levels and specific procedures. Someone should be looking at these items, the division suggests, but it should not be a radiation regulatory agency.

18. American Association of Colleges o' Pharmacy The Subcommittee on Nuclear Pharmacy of the American Association of Colleges of Pharmacy proposes that pharmacy educators in cooperation with professional organizations and State Boards of Pharmacy are assuring the quality of education and training for nuclear pharmacists. It believes the NRC need not consider possible regulatory involvement concerning the qualifications of nuclear pharmacists; the pharmacy profession has accepted this responsibility and will continue to do 50 in order to develop and maintain the highest standards of pharmacy practice.

19. Radiation Theracy Committee AAPM The American Association of Physicists in Medicine (AAPM) Radiation Therapy Committee, whose concern is primarily with the therapeutic use of radioactive materials, proposes that any regulation promulgated by the

~

~ ~

NRC should deal primarily with the radiaticn sources: calibration, safety of brachytherapy sources, and overall safety of teletherapy units.

29 Enclosure 3

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l

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9 i

It asks for consist- and minimum overlap among State, peer group, .

1 advisory gror ,,xC and other Federal agency standards. It believes that 1 the practice of medicine and the determination of the patient dose should remain with trained on-site personnel. It argues that NRC should not be i l

expected to be responsible for the radiation dose to the individual patient but should exercise broader control to minimize the total dose to the population at large from sources of ionizing radiation.

Regarding the specific questions in the Federal Register the Radiation Therapy Committee coments: for Item (1), NRC minimum standards of physician training and experience should be consistent with the standards l of other interested groups; Items (2) through (6) are basically concerned with the practice of medicine and should not be regulated by NRC, Item (7),

for teletherapy units, is the subject of a May 19, 1977, NRC proposed rule (42 FR 25743) and the calibration of brachytherapy sources should be provided 'uy the supplier and checked by the user; Item (8) is not a therapy enestion; for Item (9), training and experience should be consis-cent with State, peer group, advisory group and other Federal agency standards; finally, for Item (10), unless there are gross errors in calibration, as would be covered by other NRC regulations such as the May 19, 1977, proposed teletherapy rule, there does not appear to be a need in therapy to report misadministration of radiation doses to NRC.

The Comittee recomends that the NRC include a full-time radio-therapist on its Advisory Comittee on the Medical Uses of Isotopes.

30 Enclosure 3

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m

20. Nuclear Medicine Committee AAPM The American Association of Physicists in Medicine (AAPM) Nuclear Medicine Committee states that the NRC bears the responsibility for ,

l I

regulating the safe use of radioactive materials for the health and safety of the worker and the public. This activity, it believes should include receipt and disposal records, laboratory surveys records, person-nel monitoring procedures, etc., as well as assurance that no releases are made to the environment. The Committee suggests it would be reasonable for the NRC to take responsibility for the release of radionuclides from patients receiving therapy quantities of internally-administered radio-nuclide therapy and to assure the proper measurement of the dose that the patient receives.

However, the Committee feels strongly that NRC responsibility does not and should not extend into areas that are clearly within the realm of the professional practice of nuclear medicine or radiation therapy, including: (1) evaluation of the physician's clinical qualifications, (2) selection of patients for diagnostic procedures, (3) selection of .

instruments for performing diagnostic or therapeutic procedures, (4) selection of radioactive drugs or devices, (5) selection of procedures and (6) qualifications of paramedical personnel such as technologists, nurses, radiopharmacists and radiological physicists.

In its opinion there is a clear line between the health and safety of occupational workers and the public and the clinical judgment of a physician in treating a patient. The Committee feels that the NRC shoald continue to assure that physicians are well trained in the safe handlir.g 31 Enclosure 3

. l

.. j a

I 1

. l and use of radiopharmaceuticals, in the proper operation of laboratories f dealing with radioactive material and the proper disposal of radioactive waste. It feels that FDA should continue its responsibility in the area of drug effectiveness, safety and manufacture.

21. G. D. Adams, Ph.D. .

1 Dr. Adams is the Radiation Safety Officer for the University of Oklahoma Health Sciences Center and a consultant physicist for several community hospitals. Dr. Adams feels that the NRC can and should estab-lish minimum standards of training and experience (Item. (1) and (9)) for physicians and paramedical personnel. He proposes a further area that needs to be addressed is standards and quality assurance for the programs l

whereby such training and experience may be acquired. He feels medical diagnosis and therapy have received attention but medical research areas have not.

Dr. Adams believes that Items (2) thrcugh (6) (selection of patients, instruments, drugs or devices, procedures and dose level) appear to infringe on the practice of nedicine.

He feels that quality assurance on all procedural aspects and equipment capabilities deserve emphatis, even beyond the gains made in the revised NRC licensng guides that now exist in draft form. He argues that no one presently has a sufficient data base from which to construct a wholly appropriate quality a'ssurance program and NRC could be helpful in the collection of a data base and in the identification and enunciation cf guidelines.

32 Enclosure 3

d y , y* d'

- - - With regard to misadministrations of radioactive material Adams I

feels that a record of the facts, an eval'uation, and the ocedures implemented to deter recurrence, should be maintained for NRC inspection.

22. American Society of Hosoital Pharmacists The American Society of Hospital Pharmacists states that, in the light of existing patterns of ret.lations and the professional practice and training of radiopharmacists, intervention by NRC in delivery of health care involving radiopharmaceuticals is both unnecessary and unjusti-fied. The Society feels that the regulation of radiaticc. safety by NRC remains a valid and important activity.

It believes that the statutory and administrative background of the I

regulation of radiopharmaceuticals demonstrates limits on NRC's authority for regulating radiopharmaceutical usa to factors affecting occupational and environmental safety, it states, for instance, the Atomic Energy Act i

of 1954 does not provide for any extensive regulation of drugs that have radioactive characteristics. It believes that from the statutory missions and expertise of both FDA and NRC, it is evident that Congress intended .

FDA to retain authority over all drug regulation. The Society states that it is questionable whether Congress ever intended to grant NRC greater powers than it granted FDA under the Food, Drug and Cosmetic Act.

It feels that the FDA is in a far better position to evaluate both the safety and efficacy of raciopharmaceuticals as part of an entire system

~

of drug regulation than is NRC whose expertise and authority is limited.

It believes that the present regulatory scheme has evolved slowly and 1

1 l

33 Enclosure 3

deliberately and is a reason ' opproach to dealing with radiophar-maceuticals, it sugge?' the FDA, not NRC, is the expert on drugs in the government and its expertise should remain undisturoed so that a single policy of drug regulation exists in this country.

The Society believes the education, training and practice environment I

of a nuclear pharmacist is such that he, and members of the nuclear j medicine team, are fully qualified to exercise professional judgments of 1

the highest standard to protect and serve their catients. To assure that l l

cn b appropriately trained and qualified pharmacists provide radiopharaa-ceutical services, the States have exercised their police power to regulate this profession within their borders. The sophistication of radiopharma-ceutical formulation and expense involved in establishing a central nuclear pharmacy generally iinits these facilities to large medical centers affiliated with various health professions' schools. This, in itself, the Society argues may bt evidence that practitioners will be competent and the practice environment will be superior. It proposes that the States and the Joint Comission on Accreditation of Hospitals should establish standards sufficier.t to protect the public and the patient, while guaranteeing nuclear medicine and radiopharmaceutical services of the highest quality. Tr.erefore, it concludes, no further regulation by NRC is necessary.

The Society feels that tne selection of an appropriate radiopharma-ceutical'and an appropriate dose is a professional decision made by pharmacists and physicians which is unique to each patient. It argues 3.'. Enclosure 3

l .

O 4 L

- f

.. these decisions entail considerations indistinguishable from deci-sions relating to other kinds of drug therapy and, therefore, should not be interfered with by NRC. "

Indeed, to bind the revolution in medical care to the speed of Federal regulation would seriously and unnecessarily ,

inhibit continued improvement in the high quality of medical care we i enjoy today," the Society contends.

In summary, the Society believes that regulation of radiopharmaceu-ticals by the NRC is both undesirable and legally impermissible. This conclusion, it argues, is evidenced by: (1) questionable statutory authority for NRC to enga,e in such regulation, (2) existing education and training of nuclear pharmacists ard State Boards of Pharmacy require-ments, (3) adequately safe environment in which radiopharmaceuticals are prepared ano used is regulated by the Joint Comnission on Accreditation of Hospitals, and contains adequate equipment to assure proper preparation of radiopnarmaceuticals with r.v danger to the patient, and (4) medical pharmaceutical decisions about preparing and using radiopharmaceuticals are patient-specific and cannot be governed by a general or specific .

regulation.

23. Walter Wolf, Ph.D.

Dr. Wolf is a professor of radiopharmacy and director of the radio-pharmacy program at the University of Southern California. He is also Director of Radiopharmacy Services for the U.S.C. Medical Center. Dr. Wolf

~

confines his comments to Item (4), selection of radioactive drugs to be ~

used, and item (9), cualification of paramedical personnel such as technol-ogists, nurses, radiopharmacists and radiological physicists. Dr. Wolf 35 Enclosure 3

4 e - - , _

i

~e-- . nn .. . .-

believes that the control of radiopharmaceuticals should be the responsi-

- bility of the Food and Drug Administration and State Boards of Pharmacy I

in their drug aspects, and that the regulation of the personnel prescribing j and dispensing drugs is adequately covered by existing State statutes.

He believes that the area of responsibility of the Nuclear Regulatcry J Commission should and must be limited to assuring and providing guidance in radiological safety of any agent, device or material used. His funda-mental point is that regulation of the practice of phar-macy and the practice of medicine is a function that is vested in the States.

24. National , Bureau cf Standards The Nat1onal Bureau of Standards (NBS) limited its comments to the area that is its priEJry concern, the assurance of adequate quality in measurements. This includes the reference standards, calibration of equipment and instruments, and testing of measurement performance that are essential elements in assurance of measurement quality. Acccrding to NBS the measurements made by manufacturers, distributors, and users of radiopharmaceuticals should be tract 1 to NSS through a specified procedure. The NBS has arrangements .ith the Atomic Industrial Forum and the Food and Drug Administration to provide traceability to national measurement standards. NBS has worked closely with the manufacturers of dose calibrators over the years to evaluate their performan:e and improve tne general quality of their performance. In addition reference sources

~

have been developed and distributed fo'r measurement assurance purposes.'

~

In the past two years NBS has conducted, under the spcnsorship of the Bureau of Radiological Health of FDA, a program which tests the 36 Enclosure 3

. 1

.e 4

t l

1 i

ability of therapy departments to deliver a prescribed absorbed dose of cobalt-60 gamma rays to water. Thermal l'usinescence dosimeters and plastic phantom blocks are mailed on a prearranged schedule to partici-pants on a priority list established by BRH. fhe blocks are irradiated  ;

under prescribed conditions and returned to NBS for evaluation. Each participant is informed of his performance and, where appropriate, sug-gestions are made for improving performance and dates for future retesting l

are arranged.

The NB5 feels that without measurement assurance programs, it will be impossible to determine whether radioisotcpes are being administered in the amounts prescribed with sufficient accuracy. fhe result of inac-curate measurements will be either an ineffective use of radioisotopes or excessive dose to the patient. In either case there would be unnecessary radiation exposure.

4 Since participation in the measurement assurance activity conducted

y NBS is voluntary, only a small fraction of the user cr.mmunity is reached. Thus, NBS is unaware of the performance of those who make the _

majority of measurements in the field. Although there are many additional factors that murt be considered in using radioisotopes to achieve maximum public benefit with minimum risk, measurement quality assurance is a primary f actor. It is its hope that NRC will give this subject adequate attention in any future regulations that may be issued.

37 Enclosure 3

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• h.M

25. Food and Drug Administration's Pr . of Radiological Health and Bureau of Medical Devices and _01 .sstic Products The Food and Drug Administration's Bureau of Radiological Health (BRH) and Bureau of Medical Devices and Diagnostic Products (EM00P) offered joint comments. They note the Food and Drug Administration has specific authority to regulate certain aspects of radiation medical devices and radiopharmaceuticals under the " Radiation Control for Health j and Safety Act of 1968" (P.L.90-602) and the Food, Drug and Cosmetics Act, as amended by the Medical Device Amendment > of 1 7 5 (P.L.94-295).

These acts provide FDA with the authority for pre-market approval of new ,

drugs; the establishment of performance standards or general controls for medical devices; and the establishment of performance standards for electronic products. Authority is also provided to take action against misbranded or adulterated devices and electronic products having defects.

They note that control over the specific use of drugs and medical

,:evices has been properly reserved to the practice of medicine under the cognizance of State Licensir.g Boards. The FDA is working closely with the concerned professional organizations to provide guidance in the safe use of medical radiation sources. FDA recognizes that NRC is also active in the development of guidance and believes that such efforts should be expanded rather than adopting further regulations on the medical use of radioisotopes.

On the question of physicians' clinical qualifications, the BRH and BMDDP believe that NRC should continue to exercise its responsibility in detennining that physicians possess appropriate training and experience 38 Enclosure 3

-~

1

• .~ a_-

4 prior to grak , a license to receive, possess and use radioactive materir' They Delieve that the evaluation of clinical qualifications should be examined in recognition of nuclear medicine specialty board  ;

certification, and guidelines for non-certified individuals should be established with *ne assistance of professional associations as well as 1

State and Federal agencies involved in credentialling. ]

l The BRH and BM00P believe that patient selection for diagnostic or j l

therapeutic procedures belongs within the purview of medical practice.

"are should also be a place for the development of voluntary guidelines l oy concerred agencies and professional organizations. )

l They believe that instrument selection for diagnostic or therapeutic I procedures is an integral part of the practice of nuclear medicine and should not be regulated by NRC. They note that the appropriateness, safety and performance of the instruments are subject to regulatory authority of the food and Drug Administration. They also note that criteria adopted by the Joint Commission on Accreditation of Hospitals and criteria under development by the Bureau of Quality Assurance of the Social Security Administration require that appropriate instrumentation be available for the scope of procedures performed by the nuclear medicine department.

The BRM and EM00P believe that the selection of radioactive drugs for specific clinical procedures is also part of medical practice and should be an individual decision by the clinician bas *d en the condition of the patient. They ncte that FDA approves new dr'gs, including the 39 Enclosure 3

i 1 l l  ;

1 labeling of those indications for which the safety and effectiveness has i l

been proven, and investigational new drugs for utilization in research.

The BRH and BMODP believe that the selection of procedures for the' specific examination or treatment of a patient is the responsibility of the physician and should not be regulated by NRC. They argue that the physician's training and experience should be appropriate for the proce-dures used. They propose that NRC collaborate (1) in scientific efforts with concerned groups to evaluate the comparative effectiveness of several procedures utilized for a specific condition and (2) in the development of ~ volt.otary guidelines.

With regard to the selection of dosage level, the BRH and BMDDP note that FDA is responsible for the establishment of dosage ranges for those drugs shown to be safe and effective for the intended use. They point out such levels are recomended for administration to achieve quality diagnostic information and NRC should not regulate the selection of dose levels.

They recommend that NRC require, through a license condition, that each diagnostic dose be checked by a suitable radioactivity measurement system immediately prior to acheinistration. They note that the FDA has incorporated this stipulation as a recommendation that appears in all radiopharmaceutical package inserts. They also believe tr.at therapeuti:

sources used for brachytherapy and teletherapy also be subject to periodic calibration.

With regard to the calibration of diagnostic equipment an dose seasaring instrumentation, the BRH and BM00P note that the Food, Drug and 40 Enclosure 3

l i

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• l l ,

l.

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Cosmetic Act as amended by the Medical Device Anendments of 1976, has j empowered the FDA with the authority to regulate the manufacture and l l

marketing of such devices. They state that the FDA will proceed actively I with the development of regulatory performance standards for those medical ,

1 devices classified as Class II. At this time, they add, the BRH is l developing quality assurance recommendations and guidelines for nuclear medicine eouipment which will be promulgated after review by concerned individuals and organizations. They feel that separate activities by the NRC in this area would be duplicative, but a collaborati.: effort in the develcpment of guidance would be welcomed.

With regard to the qualificaticn of paramedical personnel, the BRH and BM00P note that the General Accounting Office has urged that the NRC l

require physicians to determine that technol; gists have been properly trained for their duties. They also note that each of the listed profes-I sionals has certifying examinations to test knowledge and competency, and moreover, the physicians must bear full responsibility for the actions of their staffs. They feel that new NRC requirements in this area would be _

vuplicative. They point out that the technologists' group has been the subject of increasing pressure from legislative bodies, both at the Federal and State level. Several States now have enabling legislation to license technologists practicing within the State. The National Conference of Radiation Control Program Directors has established a committee of radiation allied health' operators to formulate recommendations for qualifi-cations cf allied health personnel using radiation sources. The BRH and l

41 Enclosure 3 l

l

. . 1 BM00P propose that action by the NRC should be confine cooperation and support in this area to prevent duplicatier efforts.

With regard to tne reporting of misadministrations, they feel that misadministrations should be reported to a responsible Federal and/or State agency in order to obtain assistance. They believe that evaluation of reports also leads to identification of problems and more effective control measures and imp.oved patient care. They propose that there should be a ccoperative effort between FDA, NRC, and other agencies to droit guidelines which better define misadministration. Thay also propose that consideration be gi/en to closer cocperation with the radiopharma-ceuticals' at trse reaction voluntary reporting system which has been set up between the FDA, the Society of Nuclear Medicine, and the United States Pharmacopoeia. They point out that the FDA has also initiated a medical device and laboratory product problem reporting program. The basic objectives of this program are the improvement of product quality and the communication of health hazards in industry and the government.

.2. American National Standards Institute The American National Standards Institute (ANSI) Committee N-44 comments that, in view of the overlapping responsibilities with agencies already effectively involved in regulating medical radioisotooes, the NRC is not well-advised to expand into any of the areas outlined in the Federal Register announcement. Specifically, the comments of the chair-man of ANSI N-44 are as follows:

1. In the early development of radioactive isotopes in medicine the AEC reviewed physicians' qualifications. Now that the 42 Enclosure 3

American Bor si Nuclear Medicine, Radiology, and Pathology certife ..oysicians' qualifications in these areas, it is no longer necessary nor is it appropriate for NRC or any other Federal agency to review physician clinical qualifications.

2. With regard to the selection of patients for diagnostic or therapeutic procedures this function does not appear to be within the province of the NRC. The NRC does not have legal responsibility for individual acts of physicians and lacks expertise in medical practice. Nuclear medicine is no way different than other branches of medicine and does not require this attention.

I. With regard to selection of instruments to be used in performing diagnostic or therapeutic procedures, regulation of medical devices is within the province of the Food and Drug Administration.  !

i This does not appear to be an area of appropriate concern for l the NRC and would confuse the development of regulations which are just now being enacted.

4, With regard to selection of radioactive drugs or devices to be i used, this also is not an area appropriate for NRC activities.

Physician's judgment based upon the patient's condition and the drugs and devices available must determine his course of action.

Traditional medical and legal liability channels exist.

~ ~ ~ ~ ~

5. With regard'to selection of procedures to be performed, respon-sibility lies with the physician. State license and specialty board certification and continuing education requirements a3 Enclosure 3

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= .

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t provide him with the necessary information upon which to base a selection of procedures in a particular patient depending upon I

that patient's condition. When he errs, the patient has legal i 4

channels for recourse, i

6. With regard to selection of the dose level to be used, this i depends on the patient's Caadition, available radiotracers and equipment. Again, if the physician errs he is legally liable.

The insertion of NRC into this decision cannot be justified.

7. With regard to proper measurement of the dose the patient receives, the surveillance of users of radioactive materiab is acccmplished at the State and local level by Bureaus of Radio-logical Health under the State health departments It wee ?nst appropriate that the practices at '.ne Ic.es of the laboratory discer. pag mated als be inspected oy agencies closest to the

cene. The intsuc on or the NRC at that level would overlap

=!th e.usting jurisdictions already accomplishing that task.

t i

Quality assurance programs for isotope measurement instruments already in conunon use have been developed by the Bureau of Radiological Health, the National Bureau of Standards, and "151 Committees. Sufficient guidelines exist and the x nitoring of facilities and performance is carried out at the State level.

Therefore, no need is seen for the NRC to participate in this i - . ..

activity.

8. With regard to the calibration of Dagnostic equipment and dose measurir.g instrumentation, the same comments apply as to item #7.

44 Enc'esure 3

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l

9. With regard to qualifications of paramedical personnel, at the present time there are certifying bodies in each area where such controls are needed. For physicists there is the American Board of Radiology, the American Board of Health Physics, and the American Association of Physicists in Medicine. For pharma-cists and radiological physicists involved in nuclear medicine, professional certification is being accomplished by the newly formed American Board of Nuclear Medical Scientists. Technologists are certified either by the American Registry of Radiological Technicians or the American Society of Clinical Pathologists.

These training programs are reviewed by the Joint Review Comittee on Educational Programs in Nuclear Medicine Technology of the American Medical Association. The Joint Comittee on Accredita-tion of Hospital reviews qualifications of paramedical personnel.

These certifications should be adequate. Additional organizations entering into this proces would only cause further escalation in the administrative overhead that applies to medicine and would result in further increases in the cost of medical care.

10. With cegard to reporting to the NRC, the patient and the patient's physician a misadministration of radioactive material or radiation from devices incorporating radioactive material, this question can more appropriately be responded to by the professional societiesassociatedwkththeusesofradioactivematerialsin patient diagnosis and therapy. Our comittee does not coment on this proposed activity.

45 Enclosure 3

r .r l

In summary, the ANSI N-44 Committee believes there is no new rear-for the NRC to develop legislative responsibility with respect + .sie use of radiation in medicine as was suggested in their Federal Register j announcement. NRC's attention should be focused on the large areas of  ;

responsibility outside of medicine to which its main program efforts and funds are directed.

27. The Health Physics Society The Health Physics Society complained about receiving the meeting notice after the meeting. (The president of the SociE'j was informed three days before the meeting that the notice mailed to the Society had been returned because of an address change. The $cciety was informed that the meeting record was open for 30 days for comment.) The Health Physics Society did not suomit any subs ~;;uent coments.

28. Advisory Committee on the Medical Uses of Isotopes NRC's Advisory Committee en Medical Uses of Isotopes met on t.5e j

afternoon of May 6, 1977, to discuss the NRC's role in regulating the l

rwdical use of radioisotopes. The members of the advisory committee were l

I the chairman, Mr. Richard E. Cunningham, who is the Deputy Director for the Division of Fuel Cycle and Material Safety of NRC's Office of Nuclear Materials Safety and Ssfeguards, Dr. James Quinn frca Northwestern Memorial Hospital, Dr. Joseph Worbaan frem Duke University Medical Center, Dr. Dasid Kuhl from the University of California, Les Angeles, Dr. Henry Wagner from

! Johns Hopkins Medical Institution, Ur'. E6ard Webster f rem Massachusetts l

General Hospital, and Dr. Frank DeLand f r:m the 'Jniversity of Kentucky.

Two consultants to NRC, Captain William B-iner from Duke University

" 46 Enclosure 3

Hospital and Dr. Peter Almond from M. " ..aerson Hospital, were also in attendance. The purpose of the .ernoon meeting was to discuss the same issues that were discussed in the morning meeting namely, the 10 items published in the Federal Register of April 21, 1977. Since the members of the Advisory Committee were present at the morning meeting they were able to consider the arguments presented at that earlier meeting.

To begin this discussion, the chairman, Mr. Cunningham, observed that the persons providing ::tatements at the morning meeting seemed to be c . <ided rough!-j into two groups. One group, representing the medical

ccmunity and industry, in general, indicated that NRC's proper rule is to regulate public health and safety and not to become involved in the regulation of the physician's relationship with his patient. Mr. Cu..ningham noted that a second group included both the Agreement States and the non-Agreement States representatives, who indicated that certainly the present level of regulation is appropriate and perhaps, in some instances, a greater level of regulation is needed. Mr. Cunningham stated that an exception to his general observations was the question of NRC evaluating physicians' qualifications. On that issue there was a spectrum of opinion.

The Advisory Committee's discussions inwnediately focused on the question of NRC's continued evaluation of physicians' clinica) qualifica-tions. These discussions brought out the following points:

1. There are presently certification boards, State licensing agencies and scientific organizations to evaluate competence in nuclear medicine and radiation therapy; 47 Enclosure 3

2 .e pool of board-cer c i - - -

---~wesicians is not adequate to ft ;i11 the need;

3. The NRC's ro5e in evaGar: . . _ ysicians' qualifications is unique in the Federal governmen c.

4. It is desirable for ee instm=c--,2c r unnecessary Federal regula-tions;

5. There is wide accepte :- Asts current method for assessing physician clinical qualificatforrat =m= :

6. There is a need for aar as h- miwe to board certification.

The general sense of the W z: Ic .~.;:nstittee was that NRC, at least for the immediate future, shcuic:. _.- a to examine physicians' clinica?

qualifications and should sats & _:.;se of the various types of board certification or registration, m w - me of qualifications to practice in the areas of nuclear medicirme , =- --iation therapy. In their opinion if NRC were to withdraw precis r --= - m regulation in this area, the-e would be a gap that could possit:59y. .

,. 2.e- the delivery of these services With regard to the questiant u '~ Z m ;ulation of the qualifications of paramedical personnel, it w = m-. mense of the Advisory Cocmittee that there are existing paramedicar -

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-1 ions that cover this area at least to some extent and that _---_T.:1 ~:ook rather care'ully at these certifications. In the final w4p+n. 2. ney feel that it is the physicir.

who is responsible for his p 4 .=wer as such he is responsible for tne qualifications of those pars ===r + *F - annel that work under his direc-tion. The Advisory Committee w w ._.._. --erommend that NRC become involved cine Enclosure 3

e in regulating the qualifications of paramedical personnel, with the exception of physicists' qualifications for calibration of teletherapy e;uipment,

27. American Medical Association in June 1977, the House of Delegates of the AMA aoopted Resolution 118 that called on the AMA to recognize the adequacy of regulation of medical

,se of nuclear materials by the Nuclear Regulatory Commission over the past 25 years and to urge tnat the responsibilities of the NRC be neitner evaanced ao- :u-tai'ed.

25. A;-eement States At the Annual Meeting of the Agreement 5tates, October 4-6, 1977, the Agreement States representatives acknowledged the proposed policy statement and COncende j the statement, "The NRC will take step 5 to help insure that unnecessary radiation exposure of the patient is minimized," However, iney .T. ace a general comment of their " reservations" concerning the policy paper as a whole. They said that the States would submit comments individ-ually. (The Office of State Programs expects the States to respond .

during the 60 day public comment period.)

I 43 Enclosure 3

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Dear Enclosed for the infor1 nation of the are copies of a Nuclear Regulatory Comission proposed statement regarding its regulation of the medical uses of radioisotopes. It will be pub-lished in the Federal Register inviting public coninent.

The proposed policy statement was developed from past regulatory experi-ence and the corrents and advice of the public, the States and NRC's Advisory Comittee on the Medical Uses of Isotopes. The following principles are being proposed to guide NRC in its regulation of the medical uses of radioisotopes:

i. The NRC will continue to regulate the medical uses of radioisotopes as necessary to provide for the radia+. ion safety of workers and the general public;

2. The NRC will regulate radiation safety of patients where justified by the risk to patients and where voluntary standards, or con.pliance with.these standards,are-inadequate; and Enclosure 4

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3. The NRC will minimize intrusion into medical judgments affecting i

patients and into other areas traditionally considered to be a l

part of the practice of medicine. ,

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In addition to the proposed policy statement, the NRC is publishing, in the same edition of the Federal Reaister, two proposed rules related to the medical policy. One rule would allow physicians greater leeway in tneir use of racioac-ive drugs. The other rule would require the reporting to NRC of serious misad'ainistrations of radioactive material.

Enclosed also are copies of a public announcement to be released by the Commission on this matter in the next few days.

Sincerely, Robert B. Minogue, Director _

Office of Standards Development

Enclosures:

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1. Proposed Policy Statement

2. Proposed Rules

3. Public Announcement Enclosure 4

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ENCLOSURE 3 Background Supple.ent e l

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BACKGROUND SUPPLEMENT l

l The Atomic Energy Commission (now Nuclear Regulatory Commission) has l regulated the medical use of byproduct, source and nuclear material since 1946. This regulation at one time or another has encompassed every aspect-of the delivery of radioisotope medical services to the patient. The AEC ,

regulated the production of the radioisotope, the manufacture, distribu-tion and use of tne final dosage form and the disposal of associated radioactive waste.

At the outset, the AEC recognized the physician's underlying respor-sibility for the patient. The AEC regulations were oriented toward assist-ing the physician in carrying out this responsibility. Essertially, the regulations were predicated on the assumption that a properly trained and adequately iaformed physician would choose the best alternative for the patient, provided, of course, that the tools were both safe and effective.

The principal features of the AEC regulation of the medical uses of radio-isoto;es were:

1. An evaluation of the physician's clinical qualifications, as well as his qualifications for the safe handling of radioactive material;

2. An evaluation of the applicant's facilities, equipment and radiation safety program;

.. _ ._ 3. Establishment of institutional medical isotopes committees to evaluate all proposals for research, diagnostic and therapeutic uses of radioisotopes within the institution; and j 1 Enclosure 5 l

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4. Regulation of the safety and efficacy of radioactive dr -

and devices.

The broadest AEC regulation occurred between 1962 .ad 1975, when the Food and Drug Administration (FDA) e, s;jt - '*e requirements for new drugs all radiopharmaceuticals regt.nec, oy the AEC. In 1975, the FDA terminated the exemption for radioactive drugs, stating that it would now regulate the safety and efficacy of radioactive drugs with respect to the patient. Simultaneously, the AEC withdrew from regulating radioactive drug safety and efficacy, stating that it would regulat t.be radiation safety of the workers and the public.

The Food, Drug and Cosmetic Act of 1938 (FDCA) established the authority for FDA to regulate the safety of drugs offered for interstate connerce by controlling ;;rsduct labeling. Legislative amendments in 1962 gave the FDA tighter control over drug safety and introduced controls over the efficacy of drugs. The FDCA, as amended, gave FCA the authority to

ontrol the manufacture and distribution of drugs, including radioactive Yugs, but did not provide authority for FDA to centrol the routine u_se_ of thesedrugs. Specifically, FDA has-no authority to regulate the way in which a prescription drug is used by a licensed physician (including uses not approved in the labeling). The FDA can and does require the manu-facturer to carry out investigational programs to establish the safety and efficacy of new drugs. The 1976 Medical Device Amendments to the FDCA extended the FDA'-s authority over medical-devices, including radioactive ~

devices, in a way similar to its authority over drugs.

2 Enclosure 5

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The individual states have polir . ers to protect the health and l safety of their citizens. Eac* . ate licenses individual physicians for the practice of medicine within its borders. Each State has phar-macy laws and licenses phar acists and nurses; at least two states license nuclear medicine technologists. NRC Agreement States have similar authority to NRC in the medical area and these States and most non-Agreement States regulate naturally occurring and accelerator-produced radioactive material.

There are several professional societies provide services for their membership, such as education, certification, comunication and lobbying.

Many of these groups have be:ome involved in FDA's (Bureau of Radiological Health) efforts to develop voluntary guidelines for the rnedical uses of radioisotopes. To date, the most significant contributions to the regu-lation of the medical uses of radioisotopes from these societies are the physician certification programs of the American Board of Radiology and ne American Board of fluclear Medicine and the Joint Commission en Accreditation of Hospitals' Accreditation of fluclear Medicine and Radi-ology programs.

Other Federal Agencies exercising limited controls over the medical uses of radioisotopes are the Socia'. Security Administration (Medicare and Medicaid reimbursement), thc. Environmental Protection Agency (Drinking Water Standards, Clean Air Act, Atomic Energy Act) and the Occupational Safety and Health Administration.

3 Enclosure 5

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I l A .gn FDA is the principal Federal Agency regulating the medical a of radioisotopes, the FDA's somewhat limited autho ity contrasts with the NRC's more general mandate "...to protect the her.lth and safety of the public." Thus, the NRC and the Agreement States regulate the clinical qualifications of the physician-user, a situatior that is unique in medi-cine. As noted, the regulations of AEC and now NRC recognize that the physician has the primary responsibility for tSe care of patients and these regulations are predicated on the assumption that a properly trained and adequately informed physician will cnoose from among "ternatives in l

the patient's best interest. This establishes a cractical limit on the exercise of NRC's regulat:ry authority. The NRC must maintain adequate regulatory controls while avoiding undue interference in medical judgments and in the physician-patient relationship.

The staff believes tnat a consequence of too much regulation could be poorer health care delivery to patients. Allcwing the physician to make

he most important decisions concerning the patient carries the risk that the physician will make mistakes. Although additional regulations may

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sometimes be an appropriate response to mistakes by physicians, additional 1

regulations c.ay not be the response of choice in most cases. The strictest regulation by Federal, State and private agencies will not be able to l

l prevent future mistakes in the medical uses of radioisotopes.

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Office of General Counsel and Office of f Policy Evaluation Comments f

I. Office of General Counsel A. Comment: OGC stated (i) that it is in accord with the tone and content of the proposed policy statement, (2) that the proposed i

statement is a very thorough treatment of the subject, and (3) that the proposed policy statement merits release. OGC recommended that some analys4s be made of the Clean Air Act Amendments of 1977 for the final '

policy statement, and that for the proposed policy statement, a foot-note referencing the potential effects of the Amendments and the uncer-tainty surrounding them would be sufficient.

B. Response: As suggested by OGC, CELD will analyze the effect of the Clean Air Act Amendments of 1977 for the final policy statement.

OSD and NMSS prefer not to introduce the issue of the Clean Air Act Amendments of 1977 into the proposed policy statement because this may draw attention away from the central issue of protection of the patient.

II. Office of Policy Evaluation A. Comment: OPE stated, "While the proposed policy statement pulls together NRC's role in the regulation of nuclear medicine to date, it fails to address what I feel is the most fundamental question of all:

what should be NRC's future role in the regulation of nuclear medicine 1 Enclosure 6

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