[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:
cxh@nrc.gov, or Marjorie U. Rothschild, Office of the General Counsel,
Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone
(301) 415-1633, E-Mail: mur@nrc.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In 1979, the Nuclear Regulatory Commission published a policy
statement, ``Regulation of the Medical Uses of Radioisotopes'' (44 FR
8242; February 9, 1979), in which it informed 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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