[Federal Register Volume 63, Number 156 (Thursday, August 13, 1998)]
[Proposed Rules]
[Pages 43580-43586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-21460]


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U.S. NUCLEAR REGULATORY COMMISSION

10 CFR Chapter I


Medical Use of Byproduct Material; Draft Policy Statement

AGENCY: Nuclear Regulatory Commission.

ACTION: Draft policy statement.

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

DATES: Submit comments by November 13, 1998. Comments received after 
this date will be considered if it is practical to do so, but the 
Commission is able only to ensure consideration of comments received on 
or before this date.

ADDRESSES: Send comments to: Secretary, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, Attention: Rulemakings and 
Adjudications Staff.
    You may also provide comments via NRC's interactive rulemaking web 
site through the NRC home page (http://www.nrc.gov). From the home 
page, select ``Rulemaking'' from the tool bar. The interactive 
rulemaking website can then be accessed by selecting ``New Rulemaking 
Website.'' This site provides the ability to upload comments as files 
(any format), if your web browser supports that function. For 
information about the interactive rulemaking web site, contact Ms. 
Carol Gallagher, (301) 415-5905; E-mail: cag @nrc.gov.
    Deliver comments to: One White Flint North, 11555 Rockville Pike, 
Rockville, Maryland 20852, between 7:30 am and 4:15 pm Federal 
workdays.
    Copies of comments received may be examined at: NRC Public Document 
Room, 120 L Street, NW. (Lower Level), Washington, DC.

FOR FURTHER INFORMATION CONTACT: Catherine Haney, Office of Nuclear 
Material Safety and Safeguards, Nuclear Regulatory Commission, 
Washington, DC 20555-0001, telephone (301) 415-6825, E-Mail: 
[email protected], or Marjorie U. Rothschild, Office of the General Counsel, 
Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone 
(301) 415-1633, E-Mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In 1979, the Nuclear Regulatory Commission published a policy 
statement, ``Regulation of the Medical Uses of Radioisotopes'' (44 FR 
8242; February 9, 1979), in which it informed NRC licensees, other 
Federal and State agencies, and the general public of the Commission's 
following general intention in regulating the medical use of byproduct 
material:
    1. The NRC will continue to regulate the medical uses of 
radioisotopes as necessary to provide for the radiation safety of 
workers and the general public.
    2. The NRC will regulate the radiation safety of patients where 
justified by the risk to patients and where voluntary standards, or 
compliance with these standards, are inadequate.
    3. The NRC will minimize intrusion into medical judgments affecting 
patients and into other areas traditionally considered to be a part of 
the practice of medicine.
    NRC activities in the medical area, such as promulgation of 
regulations and development of regulatory guidance, as well as 
cooperative relationships with other Federal agencies have been guided 
by this statement.
    A Federal Register notice, ``Medical Use of Byproduct Material: 
Issues and Request for Public Input'' (62 FR 42219-42220; August 6, 
1997), describes (as reflected below) NRC's detailed examination of the 
issues surrounding its medical use program during the last four years. 
This process started with NRC's 1993 internal senior management review; 
continued with the 1996 independent external review by the National 
Academy of Sciences (NAS), Institute of Medicine (IOM); and culminated 
in NRC's Strategic Assessment and Rebaselining Initiative (SA). In 
particular, medical oversight was addressed in the SA Direction-Setting 
Issue Paper Number 7 (DSI 7) (released September 16, 1996). In 
September 1997, the Commission issued its ``Strategic Plan,'' which 
stated that its goal in regulating nuclear materials safety is to 
``prevent radiation-related deaths or illnesses due to civilian use of 
source, byproduct, and special nuclear materials' (NUREG-1614, Vol. 1, 
at 9).

[[Page 43581]]

    In its Staff Requirements Memorandum (SRM)--COMSECY-96-057,'' 
Materials/Medical Oversight (DSI 7),'' dated March 20, 1997, the 
Commission stated that it supported continuation of the ongoing medical 
use regulatory program with improvements, decreased oversight of low-
risk activities, and continued emphasis on high-risk activities. This 
SRM also directed the NRC staff to revise 10 CFR Part 35, associated 
guidance documents, and, if necessary, the Commission's 1979 ``Medical 
Use Policy Statement.'' The Commission SRM specifically directed the 
restructuring of Part 35 into a risk-informed, more performance-based 
regulation. In addition, the Commission expressed its support for use 
of the Advisory Committee on the Medical Use of Isotopes (ACMUI) and 
professional medical organizations and societies in the revision of 
Part 35 and the medical policy statement. The Commission specifically 
directed the NRC staff to ``consider a rulemaking process that provides 
more opportunity for input from potentially affected parties than is 
provided by the normal notice and comment rulemaking process, but would 
be less consumptive of resources and time than the process recently 
used in the development of NRC's rule on radiological criteria for 
license termination.''
    A June 30, 1997, SRM informed the NRC staff of the Commission's 
approval, with comments, of the NRC staff's proposed program in SECY-
97-131, Supplemental Information on SECY-97-115, ``Program for Revision 
of 10 CFR Part 35, `Medical Uses of Byproduct Material,' and Associated 
Federal Register notice,'' dated June 20, 1997. After Commission 
approval of the NRC staff's program to revise Part 35 and associated 
guidance documents, the NRC staff initiated the rulemaking process, 
which includes revision of the Medical Use Policy Statement, as 
necessary (62 FR 42219). The Commission directed the NRC staff to 
consider certain issues, including recommendations on revising the 
policy statement by focusing regulation of medical use on those 
procedures that are essential to patient safety and that pose the 
highest risk, developing regulatory oversight alternatives for 
diagnostic procedures that are consistent with the lower overall risk 
of these procedures, and considering the viability of using or 
referencing available industry guidance and standards to the extent 
that they meet NRC needs (62 FR at 42219). This notice solicited 
informal and formal public input during the rulemaking process on the 
development of proposed rule language and associated documents (62 FR 
at 42219-4220). At various stages in this process, the Working/Steering 
Group placed options for a revised Medical Use Policy Statement and 
major issues associated with 10 CFR Part 35, and a strawman draft of 
the proposed rule language on the Internet.
    In developing a proposed revision of the policy statement, the 
Commission also has had the benefit of input from the Working/Steering 
Group, which met publicly in August, September, and December 1997 and 
in January, February, and March 1998; the ACMUI, at its meetings on 
September 25-26, 1997, and March 1-2, 1998; ACMUI subcommittee meetings 
in February 1998; ``stakeholders'' and members of the public at 
facilitated workshops in October and November 1997; professional 
medical organization meetings; and State regulators at a publicly 
noticed workshop at the October 1997, ``All Agreement States'' 
1 Meeting. State participants have included representatives 
of the Organization of Agreement States and the Conference of Radiation 
Control Program Directors. State participation in this process is 
intended to further the Commission's strategy to ``work with the 
Agreement States to assure consistent protection of public health and 
safety nationwide'' (NUREG-1614, Vol. 1, at 11). Such State involvement 
also enhances development of corresponding rules in State regulations; 
provides an opportunity for early State input; and allows State staff 
to assess potential impacts of NRC draft language on the regulation of 
non-Atomic Energy Act materials used in medical diagnosis, treatment, 
or research in the States.
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    \1\ An Agreement State is a State that has signed an agreement 
with NRC, pursuant to Section 274 of the Atomic Energy Act, allowing 
the State to regulate the use of radioactive material, other than 
use in reactor facilities, within the State. During the next 5 
years, the total number of Agreement States may increase from 30 to 
33. NRC ``Strategic Plan'' (Fiscal year 1997-Fiscal year 2002), 
NUREG-1614, Vol. 1 (September 1997), at 9.
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    At these meetings and workshops, the NRC staff presented 
alternatives and/or draft text for the Medical Use Policy Statement and 
10 CFR Part 35. Alternatives generated by workshop participants were 
also discussed. To ensure that all interests were represented, to the 
degree possible, invited workshop participants included radiation 
oncologists, nuclear medicine physicians, other physician specialists 
(i.e., clinical endocrinologists and cardiologists), radiopharmacists, 
medical physicists, educators, patient rights advocates, oncology 
nurses, radiation safety officers, medical technologists, hospital 
administrators, State and Federal Government officials, and 
radiopharmaceutical manufacturers. Policy statement alternatives ranged 
from retaining the status quo to various modifications of the current 
medical policy such as statements limiting NRC's role in the regulation 
of medical use to ensuring that the physician's prescription is 
accurately delivered to the correct patient; making clear that NRC will 
not intrude into medical judgments affecting patients; and providing 
for NRC assessment of risks to the radiation safety of patients that 
would reference comparable risks, standards, and modes of regulations 
for other types of medical practice.
    The normal pattern for NRC policy statement proposals is the 
development of a proposed policy statement by the NRC staff for 
Commission consideration, publication of the proposed statement for 
public comment, consideration of the comments by the NRC staff, and 
preparation of a final statement, as appropriate, for Commission 
approval. As directed and approved by the Commission, the NRC staff has 
increased participation in the early stages of this development process 
through meetings and workshops for affected interests and by making 
documents available on the Internet.
    The meetings and workshops elicited informed discussions of options 
and approaches for developing a revised Medical Use Policy Statement, 
and the rationale for such options and approaches. Although these 
meetings and workshops were not designed to seek ``consensus'' in the 
sense that there is agreement on how each issue should be resolved, 
they were conducted at a very early stage of proposed policy statement 
development to increase participation of interested parties and the 
public with the following objectives:
    (a) To ensure that the relevant issues have been identified;
    (b) To exchange information on these issues; and
    (c) To identify underlying concerns and areas of disagreement, and, 
where possible, approaches for resolution.
    The Commission hopes that the interactions among the participants 
in the meetings and workshops also fostered a clearer mutual 
understanding of the positions and concerns of all participants. 
Comments made at these workshops and meetings, and related written and 
electronic comments (as summarized below), were considered by the NRC 
staff in its preparation of a staff draft proposed policy statement, as 
described in the paragraphs below. Comments were also used, as

[[Page 43582]]

appropriate, in developing proposed revisions of 10 CFR Part 35. The 
intent of an informal comment period, in advance of publishing a 
proposed policy statement in the Federal Register, was to provide an 
opportunity for interested parties to provide input during the 
development of the draft proposed medical policy statement.

ACMUI

    At the ACMUI meetings referenced above, the ACMUI recommended to 
the NRC staff its versions of a revised medical policy statement. At 
its meeting in March 1998, a four-part revision of the current policy 
statement was recommended: the more technically accurate term 
``radionuclides'' in Statement 1 is substituted for ``radioisotopes''; 
the order of Statements 2 and 3 is reversed; former Statement 3 
(Statement 2 in the ACMUI version) is revised to make it clear that NRC 
``will not intrude into the medical judgments affecting patients'' 
(rather than the current policy of minimizing such intrusions) and to 
drop from that statement the phrase ``into other areas traditionally 
considered to be a part of the practice of medicine''; and to modify 
Statement 3 primarily to provide that an assessment of risks justifying 
NRC medical use regulations will reference comparable risks, comparable 
voluntary standards, and modes of regulation for other types of medical 
practice.

``All Agreement States'' Meeting Workshop

    This workshop, which included State participants in the meeting as 
well as members of the public, also discussed the issues associated 
with the revision of 10 CFR Part 35 and the Medical Use Policy 
Statement. Some participants at the workshop stated that NRC's 
regulatory framework had been, and in the future could be, properly 
developed under the existing policy statement. Those participants who 
found fault with the existing medical regulatory framework did so 
primarily on the basis that it is too prescriptive and intrudes into 
the practice of medicine, which they asserted is adequately regulated 
by existing medical practices, including voluntary standards, within 
the medical community. Many comments were made about the proposal for a 
revised policy statement under which NRC assessment of the risks 
justifying its regulations would reference comparable risks and 
comparable modes of regulation for other types of medical practice. 
Some participants questioned the capability of NRC to evaluate those 
risks and noted that such an evaluation would require some mechanism 
for judging appropriate risk.
    Participants favoring a policy statement limiting NRC's role to 
ensuring the accurate delivery of the physician's prescription did so 
mainly on the basis that the statement specified those areas NRC would 
regulate and that it provided a regulatory role for NRC that would not 
intrude into the practice of medicine. Several participants drafted an 
alternative option in addition to those alternatives presented by the 
Working Group. That alternative primarily modified Statements 2 and 3 
of the current policy statement to provide that NRC's role in 
regulating the radiation safety of patients is to ensure that the 
physician's prescription is accurately delivered to the correct 
patient, more strongly state NRC's policy not to intrude into medical 
judgments affecting patients and into other areas traditionally 
considered to be part of the practice of medicine, and commit NRC to 
regulate the radiation safety of patients only where justified by the 
risk to patients and only where voluntary standards or compliance with 
such standards are inadequate. Although no clear preference was 
evident, some States indicated their preference for certain 
alternatives.

Facilitated Public Workshops

    The facilitated workshops considered alternatives for the Medical 
Use Policy Statement presented by the Working Group, as well as 
alternatives generated by the workshop participants (which were mainly 
modeled on the ACMUI or Agreement State recommended statements 
described above). Certain themes emerged in these workshop discussions, 
such as ensuring that NRC follows the policy statement in the future, 
does not interfere in the practice of medicine or medical judgments 
affecting patients, regulates medical use of byproduct material based 
on the risk posed by the medical use and only after determining that 
voluntary medical practice standards are inadequate, and limits its 
role in regulating the radiation safety of patients to ensuring that 
the physician's prescription is followed. At the Philadelphia workshop, 
an alternative with this latter limitation generated the most favorable 
comments.
    Some participants expressed the view that the objectives described 
above could be achieved by revisions to the current statement, whereas 
others asserted that mechanisms such as tort law or ``physician 
practice review procedures'' could substitute for NRC regulatory 
control in certain areas. On the other hand, participants expressed 
concern that certain policy statement alternatives could so limit NRC's 
role that its regulation would not encompass either high-risk 
diagnostic or ``emerging'' medical use technologies. Another concern 
was that NRC regulation of only the administration of the byproduct 
material would not provide an adequate level of protection to the 
patient.
    According to certain participants, there is an absence of data 
supporting the necessity of NRC regulation to ensure that the correct 
patient receives the correct dose. In view of the perception that NRC 
is not qualified to assess the risks associated with medical practice, 
the workshop participants voted in favor of a policy statement 
providing that in any assessment of such risks, NRC, as a matter of 
policy, will rely on the determinations of the ACMUI and 
representatives of major professional medical organizations and 
Government agencies (to include stakeholder participation). Supporters 
of this statement pointed out that one of its advantages is that it 
would provide for stakeholder participation in risk assessment 
decisions. However, other participants expressed concern that certain 
professional organizations might not necessarily have the best 
interests of patients in mind when developing a risk assessment.

Overview of Written and Electronic Comments

    The Commission also received written comments in response to the 
above notice, some of which addressed the Commission's Medical Use 
Policy Statement. Commenters on the policy statement include a State, 
professional medical organizations, an industry trade group, 
universities, and members of the public. The Commission has provided an 
overview of comments below.
    An Agreement State recommended that the Commission continue the 
status quo with respect to the Medical Use Policy Statement, but more 
strictly adhere to that policy. According to that State, any intrusion 
into medical judgments affecting patients should be based solely on 
radiation protection considerations.
    A number of professional societies, e.g., the American 
Brachytherapy Society (ABS), the Society of Nuclear Medicine/American 
College of Nuclear Physicians (SNM/ACNP), and the American Association 
of Physicists in Medicine (AAPM) also provided comments on the Medical 
Use Policy Statement. ABS agrees with current Medical Use Policy 
Statements 1 and 3, but believes that Statement 3 needs revision to 
provide that NRC will regulate the radiation safety of patients

[[Page 43583]]

only where justified by the risk to patients and only where voluntary 
standards or compliance with these standards are inadequate. According 
to ABS, Statement 2 should also make clear that ``[t]he risk threshold 
justifying patient safety risks will be comparable to those of other 
types of medical practice.'' ABS believes that the NRC concept of 
acceptable patient risk is zero.
    The SNM/ACNP asserts that contrary to the clear language in the 
current policy statement, NRC has steadily increased its involvement in 
the regulation of nuclear medicine despite minimal changes in this area 
of medicine over the years and a lack of significant problems with this 
medical modality. The AAPM supports NRC's efforts to revise the Medical 
Use Policy Statement to focus on radiation safety and not on the 
practice of medicine or medical physics. However, the AAPM urged NRC to 
publish its risk data so that the regulated community can understand 
the NRC's actions in regulating the medical uses of radiation. AAPM 
supports the concept of risk-based regulations, although noting that 
the licensees' response to regulatory actions will require the 
expenditure of health care funds.
    A university of health sciences commented that NRC's current 
Medical Use Policy Statement is appropriate. This commenter believes 
that NRC should continue to regulate medical use to provide for the 
radiation safety of workers, patients, and the general public and that 
there is no need for changes to the particular statement of general 
policy. Another university's comments were very similar to those of the 
AAPM, described above.
    Comments were also submitted on behalf of the Council on 
Radionuclides and Radiopharmaceuticals, Inc. (CORAR). According to 
CORAR, any revision of the Medical Use Policy Statement is futile 
unless NRC takes direction from that statement. As to the first 
statement of the medical policy, CORAR believes that 10 CFR Part 35 is 
unnecessary because 10 CFR Part 20 is adequate for regulation of all 
other uses of radioactive material and could be expanded to ensure the 
safety of medical use. CORAR commented on the second and third 
statements of medical policy by asserting that regulation of the 
radiation safety of patients is neither justified nor inadequate. In 
support of this contention, CORAR cited several factors, including 
regulation by other bodies such as the Food and Drug Administration and 
State Boards of Medicine, the responsibility of physicians to adhere to 
standards and codes of medical practice, and the exemplary performance 
record of nuclear medicine. CORAR concludes that the current medical 
policy statement provides argument against perceived prescriptive 
regulation.
    One member of the public questioned what constitutes ``other areas 
traditionally considered to be part of the practice of medicine,'' 
within the meaning of the policy statement. This commenter agreed that 
although the ACMUI should be the primary source of ``risk judgments,'' 
it can't be the only source of such judgments, and consideration should 
be given to other groups and individuals. Another member of the public 
commented that the policy statement should not limit NRC's role to 
protection of workers and the general public. This commenter stated 
that the policy statement assumes there is some entity to ensure that 
clinical nuclear medicine physicians are qualified to protect those 
groups. According to the commenter, it is of considerable concern that 
the policy statement does not account for the fact that many private 
practice offices and outpatient centers are not components of 
hospitals.
    Although the Commission has considered all of the comments 
provided, it is specifically responding to comments that raised major 
issues associated with revision of the Medical Use Policy Statement. At 
the outset, the Commission notes that its nationwide ``performance 
goals'' for measuring results toward meeting NRC's nuclear materials 
safety goal include ``[z]ero radiation-related deaths due to civilian 
use of source, byproduct, and special nuclear materials'' and for ``no 
increase in the number of misadministration events which cause 
significant radiation exposures'' (NUREG-1614, Vol. 1, at 9-
10).2 In response to comments, the Commission is proposing 
revisions of its policy statement (see Section IV., below) that make 
clear its intent to avoid intrusion into medical judgments affecting 
patients, rather than the current policy of minimizing such intrusions. 
The Commission rejects regulation of the medical use of byproduct 
material on the basis of ``comparable risk,'' as the ACMUI and ABS have 
proposed. The Commission doubts that such an approach would meet the 
statutory standard in Section 161b. of the Atomic Energy Act of 1954, 
as amended (AEA), to regulate all uses of byproduct material ``to 
protect health and minimize danger to life.'' The Commission (as well 
as others, such as NAS and the ACMUI) has recognized the lack of 
acceptable data to compare the risks from medical use of byproduct 
material with risks in other medical modalities. In the absence of 
acceptable data, regulation on the basis of ``comparable risk'' would 
be regulation to an inadequately understood level of risk. In addition, 
there is not an expressed authorization in the AEA to regulate any use 
of byproduct material on the basis of an insufficiently known 
``comparable risk.'' Without acceptable data or an express statutory 
authorization, justifying the significant departure from the 
Commission's established policy with respect to risk to patients would 
be, at a minimum, problematic.
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    \2\ The Commission is proposing to amend its regulations to 
substitute the term ``medical event'' for ``misadministration.'' 
However, in historical discussions, the term ``misadministration'' 
is still used.
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II. Rationale

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

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

    Id. (emphasis added).
    By virtue of section 161 of the Act, the Commission is authorized 
to undertake a variety of measures ``[in] the performance of its 
functions'' (42 U.S.C. Sec. 2201). As stated in subsection b, the 
Commission may ``establish by rule, regulation, or order, such 
standards and instructions to govern the possession and use of special 
nuclear material, source material, and byproduct material as the 
Commission may deem necessary or desirable * * * to protect health or 
to minimize danger to life or property'' [42 U.S.C. Sec. 2201(b) 
(emphasis added)]. Similarly, section 161i. authorizes the Commission 
to ``prescribe such regulations or orders as it may deem necessary'' to 
``(3) govern any activity authorized pursuant to this Act, including 
standards and restrictions governing the design, location, and

[[Page 43584]]

operation of facilities used in the conduct of such activities, in 
order to protect health and minimize danger to life or property'' [42 
U.S.C. Sec. 2201(I) (emphasis added)].
    The Commission is bound by statute to regulate byproduct material 
(as well as source and special nuclear material) to ``protect health 
and minimize danger to life.'' This statutory standard applies to the 
myriad of uses of byproduct material, including, not only medical use, 
but also, for example, radiography and irradiators. However, the 
Commission is not bound by the limitation in section 104a, of the AEA, 
which is often mistakenly cited for the proposition that, in regulating 
medical use of byproduct material, the AEA requires that the Commission 
``impose the minimum amount of regulation consistent with its 
obligations under this Act to promote the common defense and security 
and to protect health and safety of the public'' [(42 U.S.C 
Sec. 2134(a)]. This ``minimum regulation'' limitation does not apply to 
the medical use of byproduct material which falls within NRC's broad 
standard-setting authority in sections 81 and 161. Section 104a, on its 
face, applies only to medical therapy licenses for ``utilization 
facilities'' (e.g., reactors) and ``special nuclear material.'' This 
``minimum regulation'' directive does not govern the Commission's 
regulation of the medical use of byproduct material.
    For the most part, the regulations to carry out the broad statutory 
scheme for byproduct materials are set forth in 10 CFR Parts 30 through 
36. In addition, the public and occupational dose limits in 10 CFR Part 
20, ``Standards for Protection Against Radiation,'' apply whether the 
use of byproduct material is for medical or other purposes. However, 
the scope of Part 20 in Sec. 20.1002 states that, ``[t]he limits in 
this part do not apply to doses due * * * to any medical administration 
the individual has received or due to voluntary participation in 
medical research programs.'' The Commission has clarified that ``the 
medical administration of radiation or radioactive materials to any 
individual, even an individual not supposed to receive a medical 
administration, is regulated by the NRC's provisions governing the 
medical use of byproduct material rather than by the dose limits in the 
NRC's regulations concerning standards for protection against 
radiation'' (``Medical Administration of Radiation and Radioactive 
Materials,'' 60 FR 48623; September 20, 1995). Thus, the Commission 
believes that ``an administration to any individual is and should be 
subject to the regulations in Part 35'' (60 FR 48623).
    The provisions of Part 30, ``Rules of General Applicability to 
Domestic Licensing of Byproduct Material'' ``are in addition to * * * 
other requirements in this chapter'' (Section 30.2). This section 
requires that ``any conflict between the general requirements in Part 
30 and the specific requirements in another part'' are governed by 
those specific requirements (Section 30.2). The regulations in Part 35 
that are designed ``to provide for the protection of the public health 
and safety'' reflect the broad statutory standard in the AEA, discussed 
above (Section 35.1). The Commission has determined that, as a matter 
of policy, ``the patient * * * as well as the general public * * * are 
all members of the public to be protected by NRC'' (44 FR 8242, at 
8244). (See discussion following.)
    The NRC and the Food and Drug Administration (FDA) have regulatory 
responsibilities concerning medical devices, drugs, and biological 
products utilizing byproduct, source, and special nuclear material. NRC 
has responsibility, as described above, for regulating the actual 
medical use of byproduct material from the standpoint of reducing 
unnecessary radiation exposures to the public, patients, and 
occupational workers. In general, the FDA is responsible for assuring 
the safety, effectiveness, and proper labeling of medical products, 
i.e., drugs, devices, and biologics. NRC routinely relies on prior FDA 
approval of medical devices as an essential component of NRC's sealed 
source and device safety evaluations. In a ``Memorandum of 
Understanding'' (MOU), effective August 26, 1993, NRC and FDA 
coordinated existing NRC and FDA regulatory programs for these devices, 
drugs, and products (58 FR 47300; September 8, 1993). These regulatory 
programs include activities for evaluating and authorizing the 
manufacture, sale, distribution, licensing, and labeled intended use of 
these products. The specific ``elements of coordination'' cover 
notification of product complaints, medical events, and emergency 
situations; coordination of investigations; investigation information 
exchange; NRC and Agreement State notifications; product pre-marketing 
and pre-licensing information exchange, and sharing of other 
information such as special notifications to manufacturers, operators, 
licensees, or patients (58 FR at 47302).

III. The Proposed Commission Policy

    Based on the comments and advice of all the participants in the 
process described previously, as well as members of the public on the 
``Internet'' (via the NRC ``s Technical Conference Forum), the 
Commission is proposing the following as a revised Medical Use Policy 
Statement to guide its future regulation of the medical use of 
byproduct material:
    1. NRC will continue to regulate the uses of radionuclides in 
medicine as necessary to provide for the radiation safety of workers 
and the general public.
    2. NRC will not intrude into medical judgments affecting patients, 
except as necessary to provide for the radiation safety of workers and 
the general public.
    3. NRC will, when justified by the risk to patients, regulate the 
radiation safety of patients primarily to assure the use of 
radionuclides is in accordance with the physician's directions.
    4. NRC, in developing a specific regulatory approach, will consider 
industry and professional standards that define acceptable approaches 
of achieving radiation safety.

Statement 1

    The first portion of the proposed policy statement restates the 
first part of the current policy statement with the substitution of the 
phrase ``uses of radionuclides in medicine'' for the phrase ``medical 
uses of radioisotopes.'' As rephrased, this is a more accurate 
technical statement of the scope of NRC regulation in this area. 
Statement 1 conveys the traditional regulatory function of NRC for all 
uses of byproduct, source, and special nuclear material. Protection of 
the radiation safety of members of the public and workers is central to 
fulfillment of the Commission's statutory mandate to ``protect health 
and minimize danger to life.'' This protection is provided for, in 
part, in the public and occupational dose limits in 10 CFR Part 20 
cited previously. Those limits apply whether the use of byproduct 
material is for medical use or other purposes. The Commission has 
determined to retain its long-standing regulatory framework as 
necessary in the medical uses of byproduct material. As stated in the 
Federal Register notice initiating the Commission's request for public 
comment, the Commission ``was not persuaded by the National Academy of 
Sciences (NAS), Institute of Medicine (IOM) report that recommends that 
the NRC should not be the Federal agency involved in the regulation of 
ionizing radiation in medicine'' [62 FR at 42219 (quoting SRM of March 
20, 1997)].

[[Page 43585]]

Statement 2

    The second portion of the proposed policy statement is based on the 
third part of the current statement. The modifications explicitly state 
the Commission's proposed policy not to intrude into medical judgments 
affecting patients except to provide for the radiation safety of 
workers and the general public. Given the significance of this change, 
the Commission is soliciting specific public comment on whether the 
wording in the current statement should be revised to read ``not 
intrude into medical judgments,'' rather than ``to minimize intrusion 
into medical judgments.'' These comments will be especially useful in 
evaluating the consistency between the proposed MPS and the 
Commission's preliminary intent to continue to require patient 
notification following medical events (the proposed revision to 10 CFR 
Part 35 would replace the term ``misadministration'' with ``medical 
event''). Specifically, some would argue that continued regulatory 
requirements for patient notification would be inconsistent with the 
proposed revision to Statement 2 of the MPS. Others would argue that 
notification requirements would be consistent with Statement 3 of the 
proposed policy statement since a medical event represents a situation 
where the physician's directions for the administration of byproduct 
material were not followed and, thus, patient notification should be 
made.
    As set forth above, providing for the radiation safety of the 
public and workers is essential for the Commission to carry out its 
statutory mandate. When this protection necessitates a degree of 
regulation of medical judgments affecting patients, the Commission may 
find it necessary to intrude, to a certain extent, into medical 
judgments to protect the public and workers. For example, release of 
patients administered radioactive materials has long been considered a 
matter of regulatory concern to protect members of the public, not just 
a matter of medical judgment (``Criteria for the Release of Individuals 
Administered Radioactive Material,'' 62 FR 4120; January 29, 1997). 
Thus, from a strictly medical point of view, it may be appropriate for 
a physician to release a patient administered radioactive materials 
from the hospital. However, patient release criteria in NRC regulations 
(10 CFR 35.75) may require confinement of that patient if release of 
that patient could result in a dose to other individuals that exceeds 
the dose-based limit stated in 10 CFR 35.75(a).
    In the current policy statement, the Commission stated its intent 
to ``minimize intrusions into medical judgments affecting patients and 
into other areas traditionally considered to be part of the practice of 
medicine.'' The modifications in this part of the proposed policy 
statement more strongly reflect the Commission's long-standing 
recognition that physicians have the primary responsibility for the 
diagnosis and treatment of their patients. NRC regulations are 
predicated on the assumption that properly trained and adequately 
informed physicians will make decisions that are in the best interests 
of their patients. Therefore, in recent years, the Commission has moved 
away from a more rigid scheme of medical use regulation, which at one 
time, for example, restricted the uses of therapeutic and certain 
diagnostic radioactive drugs to the indicated procedures that had been 
approved by the FDA (44 FR 8242, at 8243).
    NRC regulations no longer prohibit authorized user physicians from 
using diagnostic or therapeutic radioactive drugs containing byproduct 
material for indications or methods of administration not listed in the 
FDA-approved package insert. Further, NRC regulations now permit 
medical use licensees and commercial nuclear pharmacies to depart from 
the manufacturer's instructions for preparing radioactive drugs using 
radionuclide generators and reagent kits. In addition, the recent 
amendment of 10 CFR 35.75, cited above, substituting a dose-based limit 
for patient release (rather than an activity-based limit), may provide 
medical use licensees greater flexibility in determining when such 
patients may be released from their control.
    The Commission's proposed policy to avoid (rather than minimize) 
intrusion into medical judgments affecting patients is consistent with 
recent Federal legislation (specifically applicable to FDA), which is 
to be construed so as not to ``limit or interfere with the authority of 
a health care practitioner to prescribe or administer any legally 
marketed device to a patient for any condition or disease within a 
legitimate health care practitioner-patient relationship.'' (There are 
certain exceptions to this mandate, which do not change any existing 
prohibition on the promotion of unapproved uses of legally marketed 
devices.) ``Food and Drug Administration Modernization Act of 1997,'' 
Pub. L. No. 105-115, Sec. 906, 111 Stat. 2296 (1997).

Statement 3

    Neither the AEA sections cited above nor the regulations in 10 CFR 
Part 35 use the term ``risk.'' The Commission's current policy 
statement on medical use, quoted above, makes specific reference to 
``risk'' to patients. As there stated and reaffirmed here, the 
Commission specifically rejects the notion that it should not regulate 
patient radiation safety (44 FR at 8243). The Commission will continue 
to regulate radiation safety of patients where justified by the risk to 
patients. However, proposed Statement 3 makes clear that the focus of 
NRC regulation to protect the patient's health and safety is primarily 
to ensure that the authorized user physician's directions are followed. 
The NRC goal in this aspect of medical use regulation is tied to the 
physician's directions as they pertain to the application of the 
radiation or radionuclide, rather than to other, non-radiation related 
aspects of the administration. Consistent with the Commission's 
statutory authority, if a situation should arise in the future which 
identifies an additional risk to the patient's health and safety, the 
Commission will consider adopting an additional limitation or control 
on a particular radiation or radionuclide modality as necessary. 
``Prescription'' is not being used for this purpose because it might 
typically include aspects of the administration that are outside NRC's 
purview. Either the ``written directive'' or ``clinical procedures 
manual'' (as those terms are defined in Part 35) would contain the 
physician's directions (i.e., the procedure to be performed and the 
dose) . This regulatory objective is currently reflected in certain 
provisions of Part 35 (e.g., 10 CFR 35.32(a) (requiring ``high 
confidence'' that byproduct material or radiation therefrom will be 
administered as directed by an authorized user physician) and as part 
of the rationale of the current policy statement. In the proposed 
revision of 10 CFR Part 35 and as explicitly stated above, NRC is 
emphasizing that protection of patient radiation safety is an overall 
NRC goal in regulating the medical use of byproduct material. Although 
the Commission recognizes that physicians have primary responsibility 
for the protection of their patients, NRC has a secondary, but 
necessary, role with respect to the radiation safety of patients.
    The Commission is attempting to make its medical use regulatory 
framework more ``risk-informed,'' based on its regulatory strategy of 
regulating ``material uses consistent with the level

[[Page 43586]]

of risk involved, by decreasing oversight of those materials that pose 
the lowest radiological risk to the public and continuing emphasis on 
high-risk activities' (NUREG-1614, Vol. 1, at 11). In addition, this 
portion of the proposed policy statement reflects the Commission 
strategy of identifying those regulations and processes that are now or 
can be made risk-informed (NUREG-1614, Vol. 1, at 11. SRM of March 20, 
1997, at 2).

Statement 4

    According to Statement 2 of the current policy statement, NRC will 
regulate the radiation safety of patients where justified by the risk 
to patients and where voluntary standards, or compliance with these 
standards, are inadequate. In its SRM of March 20, 1997, the Commission 
repeated its continued support of professional medical organizations 
and societies (as well as the ACMUI) in developing regulatory guides 
and standards (SRM, at 1). Proposed Statement 4 commits NRC to an 
approach for regulation of medical use which ``will consider industry 
and professional standards that define acceptable levels of achieving 
radiation safety.'' Such consideration, however, does not involve, as a 
prerequisite for regulation, the problematic determination of licensee 
compliance with a voluntary standard (as implied in current Statement 
2). At a minimum, such an undertaking leaves NRC with the dilemma of 
how to deal with licensees that may not comply with voluntary 
standards. For this reason, the Commission's proposed policy statement 
does not retain that aspect of the current policy statement.
    The Statement of Consideration for the proposed 10 CFR Part 35 
rulemakings specifically addresses NRC's current policy of 
consideration of ``voluntary standards and compliance with such 
standards.'' Affirming consideration of industry and professional 
standards as part of the NRC policy in achieving radiation safety in 
medical use conforms to the Commission's Strategic Plan. The relevant 
strategy there stated is to increase the involvement of licensees and 
others in the NRC regulatory development process, based on the concepts 
in the ``National Technology Transfer and Advancement Act of 1995'' 
(the NTTAA), Pub. L. No. 104-113, 110 Stat. 775 (1995). Section 12(d) 
of the NTTAA requires ``all Federal agencies and departments to use 
technical standards that are developed or adopted by voluntary 
consensus bodies * * * as a means to carry out policy objectives or 
activities,'' except when use of such standards ``is inconsistent with 
applicable law or otherwise impractical.''
    It is not clear that all ``medical industry and professional 
standards'' would meet the definition of ``technical standards'' in 
Section 12(d)(4) of the NTTAA ( ``performance-based or design-specific 
technical specifications and related management systems practices).'' 
Nevertheless, as indicated above, the Commission endorses, in 
regulating medical use of byproduct material, the concept in Section 
12(a) of the NTTAA, of ``emphasizing, where possible, the use of 
standards developed by private, consensus organizations.'' As also 
stated in the Strategic Plan, the Commission encourages ``industry to 
develop codes, standards, and guides that can be endorsed by the NRC 
and carried out by industry.''

IV. Policy Implications

    This proposed policy statement affirms the Commission determination 
that it shall continue its role in regulating the medical use of 
byproduct material, but with emphasis on the goal of protecting the 
radiation safety of occupational workers, the public, and patients, 
while avoiding intrusion into medical judgments affecting patients. 
Ensuring that the authorized user physician's directions for the 
administration of byproduct material are followed is the primary means 
of achieving this regulatory goal. Moreover, the Commission is renewing 
the objective of utilizing industry and professional standards that 
define acceptable levels of achieving radiation safety.

Reference Information

    1. Strategic Assessment Direction-Setting Issues Paper Number 7 
is available by writing to the U.S. Nuclear Regulatory Commission, 
Attention: NRC Public Document Room, Washington, DC 20555-0001, 
telephone: (202) 634-3273; fax: (202) 634-3343.
    2. The memorandum ``Management Review of Existing Medical Use 
Regulatory Program (COMIS-92-026)'' (dated June 16, 1993) is 
available by writing to the U.S. Nuclear Regulatory Commission, 
Attention: NRC Public Document Room, Washington, DC 20555-0001, 
telephone: (202) 634-3273; fax: (202) 634-3343.
    3. ``Radiation in Medicine: A Need for Regulatory Reform'' 
(1996) is available from the National Academy Press at 2101 
Constitution Avenue, NW, Box 285, Washington, DC 20555.
    4. Summary minutes and transcripts of the ACMUI March 1998 
meeting or transcripts of the May 8, 1997, Commission briefing are 
available by writing to the U.S. Nuclear Regulatory Commission, 
Attention: NRC Public Document Room, Washington, DC 20555-0001, 
telephone: (202) 634-3273; fax: (202) 634-3343. Transcripts of the 
May 8, 1997, briefing are also available by Internet at http://
www.nrc.gov.
    5. The NRC Medical Policy Act Statement of 1979 was published in 
the Federal Register, Volume 44, page 8242, on February 9, 1979.
    6. SECY-97-115, Program for Revision of 10 CFR Part 35, 
``Medical Uses of Byproduct Material'' and Associated Federal 
Register notice; SECY-97-131, Supplemental Information on SECY-97-
131, Supplemental Information on SECY-97-115, ``Program for Revision 
of 10 CFR Part 35, ``Medical Uses of Byproduct Material,'' and 
Associated Federal Register notice; and the associated SRM (dated 
June 30, 1997) are available by writing to the U.S. Nuclear 
Regulatory Commission, Attention: NRC Public Document Room, 
Washington, DC 20555-0001, telephone: (202) 634-3273; fax: (202) 
634-3343. Copies are also available on the NRC Technical Conference 
Forum at http://techconf.llnl.gov/noframe.html.

    Dated at Rockville, Maryland, this 5th day of August, 1998.

    For the Nuclear Regulatory Commission.
John C. Hoyle,
Secretary of the Commission.
[FR Doc. 98-21460 Filed 8-12-98; 8:45 am]
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