[Federal Register Volume 65, Number 150 (Thursday, August 3, 2000)]
[Rules and Regulations]
[Pages 47654-47660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-19573]


=======================================================================
-----------------------------------------------------------------------

NUCLEAR REGULATORY COMMISSION

10 CFR CH. I


Medical Use of Byproduct Material; Policy Statement, Revision

AGENCY: Nuclear Regulatory Commission.

ACTION: Final policy statement; revision.

-----------------------------------------------------------------------

SUMMARY: The Nuclear Regulatory Commission (NRC) is revising its 1979 
policy statement on the medical use of byproduct material. These 
revisions are one component of the Commission's overall program 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 more performance-
based, consistent with NRC's ``Strategic Plan for Fiscal Year 1997-
Fiscal Year 2002.'' The policy informs NRC licensees, other Federal and 
State agencies, and the public of the Commission's general intentions 
in regulating the medical use of byproduct material.

EFFECTIVE DATE: August 3, 2000.

FOR FURTHER INFORMATION CONTACT: Thomas Young, Office of Nuclear 
Material Safety and Safeguards, Nuclear Regulatory Commission, 
Washington, DC 20555-0001, telephone (301) 415-5795, 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 NRC 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 public of the Commission's general intention in regulating the 
medical use of byproduct material. Specifically,
    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 policy.
    On August 6, 1997 (62 FR 42219-42220), NRC published a document in 
the Federal Register, ``Medical Use of Byproduct Material: Issues and 
Request for Public Input,'' describing NRC's detailed, four-year 
examination of the issues surrounding its medical use program. This 
process started with a 1993 internal senior management review; 
continued with a 1996 independent external review by the National 
Academy of Sciences' (NAS) Institute of Medicine (IOM); and culminated 
in NRC's Strategic

[[Page 47655]]

Assessment and Rebaselining Project (SA). Since that Federal Register 
document was issued, NRC conducted an exhaustive and public review of 
the medical use program. Specifically, in 1997 and 1998, NRC's current 
and future role in regulating the medical use of byproduct material was 
discussed at meetings of the Advisory Committee on Medical Uses of 
Radioisotopes \1\ (ACMUI) and the Organization of Agreement States 
(OAS), and with various professional societies and government agencies. 
During this period, the NRC staff also presented four alternative 
proposed revised versions of the 1979 Medical Policy Statement (MPS) to 
participants at NRC sponsored workshops and public meetings. These 
workshops and public meetings also included discussions on the major 
areas that were being considered for revision in 10 CFR Part 35, 
``Medical Use of Byproduct Material.''
---------------------------------------------------------------------------

    \1\ The ACMUI advises the Commission on regulating and licensing 
uses of radionuclides in medicine.
---------------------------------------------------------------------------

    On August 13, 1998 (63 FR 43580), a proposed revision to the MPS 
was published in the Federal Register for a 90 day public comment 
period. This comment period was later extended 30 days, to December 16, 
1998, (63 FR 64829; November 23, 1998) to allow additional time for 
public, stakeholder, and State comments. In addition, to allow for wide 
participation in the process, NRC discussed the proposed revision of 
the MPS with interested individuals and organizations at 3 public 
meetings during the comment period (San Francisco, California, on 
August 19 and 20, 1998; Kansas City, Missouri, on September 16 and 17, 
1998; and Rockville, Maryland, on October 21 and 22, 1998).
    NRC received 42 specific comments on the proposed MPS from various 
organizations and individuals. These comments were extracted from the 
transcripts of the 3 public meetings and the 10 written comment letters 
submitted in response to the Federal Register document. Additional 
details about the comments are provided in Section IV, ``Discussion of 
Public Comments.'' These comments were similar to the comments that 
were discussed in the August 13, 1998 (63 FR 43582-43583), Federal 
Register. Based on NRC's consideration of all the comments, no changes 
to the proposed MPS are being made. (See the final statements that 
appear in Section II, below.)

II. Statement of General Policy

    This NRC policy statement informs NRC licensees, other Federal and 
State agencies, and the public of the Commission's general intentions 
regarding the regulation of the medical use of byproduct material. The 
current revision of 10 CFR part 35 is based on this statement of NRC 
policy. The Commission expects that future NRC rulemaking activities in 
the medical area and future NRC involvement with other Federal and 
State agencies will follow this statement of policy. This NRC policy 
promotes a more risk-informed approach to regulation of byproduct 
material.
    The following is the final Medical Use Policy Statement to guide 
NRC's 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.

III. Rationale

    NRC's principal statutory authority for regulating medical use of 
byproduct material is at sections 81, 161, 182, and 183 of the Atomic 
Energy Act of 1954, as amended (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). Specifically, section 81 of the AEA provides 
in pertinent part 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. 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. 2201(b) (emphasis added)). 
Similarly, section 161.i. 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 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. 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 104.a. of the AEA, 
which is often mistakenly cited for the proposition that, in regulating 
the 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. 
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 104.a., 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 
39. 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 as stated in

[[Page 47656]]

Sec. 20.1002 is 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'' (Sec. 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 (Sec. 30.2). The regulations in part 35 are designed ``to 
provide for the protection of the public health and safety'' and 
reflect the broad statutory standard in the AEA, discussed above 
(Sec. 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).

IV. Discussion of Public Comments

    As previously noted, NRC received 42 comments on the proposed 
revision to the MPS, taken from 10 letters that were submitted and from 
the transcripts of the 3 public meetings. NRC received verbal comments 
on the proposed MPS (63 FR 43580; August 13, 1998) from stakeholders 
(e.g., physicians, medical physicists, nuclear medicine technologists, 
and radiation safety professionals) during the public meetings that 
were held in August, September, and October 1998. Stakeholders also 
submitted written comments to NRC in response to that Federal Register 
document.
    NRC has reviewed all comments, identified the issues raised by the 
commenters, and combined comments where appropriate. The following 
discussion includes these issues, the combined comments, and the NRC 
responses to these combined comments.

General Comments

Issue 1: Absent Harm, What Is the Purpose of NRC Regulation?
    Comment. A commenter stated that only physicians can determine what 
is unnecessary radiation exposure to patients. This commenter cited the 
``Rationale'' portion of the August 13, 1998 (63 FR 43584) document 
about the responsibility of NRC to regulate actual medical use of 
byproduct material from the standpoint of reducing unnecessary 
radiation exposures. According to the commenter, ``If the patient 
exposure is unnecessary and harm is done, then the physician may be 
guilty of malpractice (monetary awards, civil penalties, possible loss 
of medical license, etc.). NRC regulations won't prevent malpractice 
and NRC penalties are the least of the guilty physician's worries. If 
the patient exposure is unnecessary but no harm is done, then the 
physician may be still guilty of fraud (billing for unnecessary 
procedures). But if no harm is done, what is the purpose of NRC 
regulation?''
    Response. The purpose of NRC regulation of the medical use of 
byproduct material is to reduce unnecessary radiation exposure to 
patients, workers, and the public. Protection of patient radiation 
safety is an overall goal in regulating the medical use of byproduct 
material. 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 as they pertain to the administration of the 
radiation or radionuclide, rather than to other, non-radiation related 
aspects of the administration. Although the Commission recognizes that 
physicians have primary responsibility for the protection of their 
patients, NRC also has a necessary role with respect to the radiation 
safety of 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. Moreover, 
there is nothing in the Commission's regulatory approach to medical use 
regulation that would in any way modify the legal rules governing 
malpractice suits arising out of the medical use of byproduct material.
Issue 2: Should the MPS Be Revised More Frequently?
    Comment. A commenter noted that the proposed revision is an 
improvement over the 1979 MPS; however, the commenter recommended that 
the NRC review the MPS more frequently (e.g., every 10 years).
    Response. How often the Commission reviews and/or revises the MPS 
depends on a variety of factors. These factors may be internal, such as 
the need for a change in the focus of NRC's regulations, or external, 
such as technological developments. NRC believes that a set interval to 
review the MPS would not provide the flexibility needed to respond to 
the many factors which may influence a decision to revise this policy. 
For example, this revision of the MPS coincides with the NRC's detailed 
examination of its medical use program which started in 1993 and 
includes issuance of the Commission's 1997 Strategic Plan (NUREG-1614, 
Vol. 1).
Issue 3: Is the MPS Being Revised To Justify the New Part 35?
    Comment. Several commenters noted that the current MPS was adequate 
for effective regulation in safeguarding public health and safety in 
radiation protection and should not be revised, but simply understood 
and implemented as originally intended. Several other opinions were 
stated more strongly. Specifically, one commenter stated that NRC has 
never paid meaningful attention to the MPS because most existing 
provisions of Part 35 do not ``pass muster'' under the MPS, 
particularly as they apply to physicians conducting nuclear medicine 
procedures. Another commenter's opinion was that the proposed MPS was a 
step backward and the MPS is being revised to justify the proposed 
rule.
    Response. The Commission agrees that the 1979 MPS was adequate. 
However, based on the Commission's recent review of its regulatory 
framework for medical use of byproduct material, these revisions are 
being made to emphasize a risk-informed regulatory approach. The 
Commission strongly disagrees with the commenters' opinions that the 
medical use regulations in part 35 were promulgated without considering 
the 1979 MPS. In point of fact, all part 35 rulemaking activities have 
been issued after ensuring compatibility with the 1979 MPS.
    After the Commission initiated the review process in 1993, the 
policy and the rule were revised in parallel in order to achieve a 
consistent regulatory framework for medical use of byproduct material. 
As stated before in response to other comments and explanations of the 
background for this matter, the Commission's Strategic Assessment in 
1997 included a decision to consider developing a more risk-informed, 
performance-based approach. In the process, the three-part 1979 MPS was

[[Page 47657]]

revised into a four-part MPS with re-arranged statements to clarify 
NRC's policy.
    The revised MPS was published for public comment in the Federal 
Register (63 FR 43580-43586; August 13, 1998) and was discussed at 
meetings with stakeholders and Agreement States. Discussions with 
stakeholders were meaningful and beneficial, and addressed substantive 
issues from the medical community (e.g., patient safety, perceived NRC 
intrusion into the practice of medicine, and regulatory relief for 
diagnostic nuclear medicine). No new issues were identified during the 
public comment period and NRC has not revised the MPS any further.
Issue 4: Should NRC Regulation of the Medical Use of Byproduct Material 
Be Based on Section 104 of the Atomic Energy Act?
    Comment. A commenter disagreed with NRC's interpretation that 
section 104 of the AEA applies only to special nuclear material. In the 
commenter's opinion, NRC's medical use regulations should be based on 
section 104 of the AEA.
    Response. NRC's principal authority for regulating medical use of 
byproduct material is at Sections 81, 161, 182, and 183 of the AEA. As 
previously discussed under Section III, ``Rationale'', NRC regulation 
of byproduct material is not bound by the limitation in section 104.a. 
of the AEA, that refers to minimal regulation of reactor facilities or 
special nuclear material used for medical therapy.

Comments on Statements 1, 2, 3, and 4 of the MPS

    Statement 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.
Issue 1: Should the MPS Refer to ``Radionuclides'' or to ``Byproduct 
Materials?''
    Comment. Several commenters noted that Statement 1 made reference 
to uses of radionuclides in medicine. They indicated that NRC only has 
the statutory authority to regulate byproduct material.
    Response. The Commission believes that the general term 
``radionuclide'' is appropriate for a general statement of policy such 
as the MPS. The latter is intended to inform the public, NRC licensees, 
and other Federal and State agencies of the Commission's general 
intentions regarding the regulation of medical use. The 1979 MPS 
referred to ``medical uses of radioisotopes'' and the term is now being 
changed to ``uses of radionuclides in medicine'' (see 63 FR 43584; 
August 13, 1998). As rephrased, the term ``radionuclide'' is a more 
accurate technical statement of the scope of NRC regulation in this 
area.
Issue 2: Is Statement 1 Needed if Individuals Handling Radioactive 
Material Are Properly Trained?
    Comment. According to one commenter, the goal of this statement is 
adequately served by assuring qualification of professionals involved 
in nuclear medicine. In the commenter's opinion, NRC has no evidence 
that these individuals do not already adequately provide for the 
radiation safety of workers and the public, and nuclear medicine is of 
low risk to workers and members of the public.
    Response. The Commission agrees that one way of meeting the goal is 
to ensure that individuals are adequately trained in radiation safety 
practices and are placed in key positions within a licensee's 
organization to maintain radiation exposures as low as are reasonably 
achievable. Statement 1 sets forth this position. As previously stated, 
the Commission is bound by statute to regulate byproduct material (and 
source and special nuclear materials) to ``protect health and minimize 
danger to life.'' Statement 1 of the MPS continues to provide a 
regulatory approach to maintain an adequate level of safety. The 
Commission expects all medical licensees to provide radiation safety 
for workers and the general public.

    Statement 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.
Issue 1: Does This Statement Provide Justification for NRC To Interfere 
in the Treatment of Patients?
    Comment. One commenter was concerned that Statement 2 continues to 
justify NRC interference in the treatment of patients. According to the 
comment, there is no supporting data that clearly demonstrates that 
unsealed byproduct material, when used by qualified authorized users to 
treat patients, has harmed workers or the public.
    Response. Statement 2 does not provide justification for NRC to 
``interfere'' in the medical treatment of patients. The modifications 
to this statement express the Commission's policy not to intrude 
(rather than ``minimizing'' intrusion as set forth in the 1979 MPS) 
into judgments affecting patients except to provide for the radiation 
safety of workers and the general public. Providing for the radiation 
safety of the public and workers is essential for the Commission to 
carry out its statutory mandate. When this protection involves a degree 
of regulation of medical judgments affecting patients, the NRC may find 
it necessary to intrude, to a certain extent, into medical judgments 
affecting patients.
    For example, the release from a hospital of a patient to whom 
radioactive materials have been administered 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). 
From a medical point of view, it may be appropriate for a physician to 
release from a hospital a patient to whom radioactive materials have 
been administered. However, the patient release criteria in NRC 
regulations may require hospital confinement of that patient if his or 
her release could result in a dose to other individuals that exceeds 
the dose-based limit stated in 10 CFR 35.75(a).
    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; February 9, 1979). Commission regulations no longer prohibit 
authorized user physicians from using diagnostic or therapeutic 
radioactive drugs containing byproduct material for indications or 
methods of administration that are not listed in the FDA-approved 
package insert. In addition, Commission 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. The recent amendment of 10 
CFR 35.75, cited above, substitutes a dose-based limit for patient 
release (rather than an activity-based limit) that may provide medical 
use licensees greater flexibility in determining when patients may be 
released from their control.
    Finally, Statement 2 of the MPS 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

[[Page 47658]]

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,'' Public Law 105-115, sec. 
906, 111 Stat. 2296 (1997).
Issue 2: Is the NRC the Appropriate Body To Be Involved in Medical 
Judgments Affecting Patients?
    Comment. According to one commenter, the NRC is not the right body 
to intrude into medical judgments affecting patients because NRC's 
experience in this area is extremely limited.
    Response. As discussed above and noted in Statement 2, the 
Commission's policy is not to intrude into medical judgments affecting 
patients, except as necessary to provide for the radiation safety of 
workers and the general public.
    This comment does not account for the principle that ``[t]he 
substantive area in which an agency is deemed to be expert is 
determined by statute.'' Massachusetts v. United States, 856 F.2d 378, 
382 (1st Cir. 1988). See also, Commonwealth of Massachusetts v. NRC, 
924 F.2d 311, 324 (D.C. Cir.), cert. denied, 112 S. Ct. 275 (1991). The 
AEA commits to the NRC the duty of regulating the use of radioactive 
byproduct materials, including radiopharmaceuticals, to protect public 
health and safety.
Issue 3: Should This Statement Include Reference To Providing for the 
Radiation Safety of Workers and the General Public?
    Comment. Several commenters requested that Statement 2 be revised 
to read, as follows, ``NRC will not intrude into medical judgments.'' 
They believed that the last phrase, ``* * * except as necessary to 
provide for the radiation safety of workers and the general public,'' 
should be deleted.
    Response. The Commission does not agree that this statement should 
be revised as indicated by the commenters because providing for the 
radiation safety of the public and workers is essential for the 
Commission to carry out its statutory mandate. The final MPS explicitly 
states that the Commission's intention is not to intrude into medical 
judgments affecting patients except to provide for the radiation safety 
of workers and the general public. When this protection necessitates a 
degree of regulation of medical judgments affecting patients, the NRC 
may find it necessary, as previously explained, to intrude, to a 
certain extent, into medical judgments to protect the public and 
workers.
    Statement 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.
Issue 1: Does This Statement Conflict With Statement 2?
    Comment. One commenter believed that, as written, Statement 3 
conflicted with Statement 2, unless the word ``primarily'' was deleted 
from Statement 3. Without this change, the commenter believed NRC would 
intrude into medical judgments affecting patients.
    Response. The Commission does not agree that, as written, Statement 
3 conflicts with Statement 2. 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. 
Statement 2 emphasizes the intent of NRC to avoid intrusion into 
medical judgments affecting patients, except where necessary to provide 
for the radiation safety of workers and the public. NRC's goal in this 
aspect of medical use regulation is focused on the physician's 
directions as they pertain to the administration of radiation or a 
radionuclide, rather than to other, non-radiation-related aspects of 
the administration. Consistent with its statutory authority, if a 
situation should arise in the future that identifies an additional risk 
to a patient's health and safety, the Commission will consider adopting 
an additional limitation or control on a particular radiation or 
radionuclide modality, as necessary.
Issue 2: Does the Commission Have Any Useful Role in Assuring the 
Accurate Delivery of Byproduct Material to Patients? Should References 
to Patient Radiation Safety Be Deleted?
    Comment. Several commenters indicated that NRC has no useful role 
in assuring the accurate delivery of byproduct material to patients. 
They believe that all references to patient radiation safety should be 
removed, and that NRC should simply state that it will make regulatory 
efforts to ensure the physician's orders are followed.
    Response. The Commission has a role in assuring accurate delivery 
of radiation doses and dosages to patients and has rejected the notion 
that NRC should not regulate patient radiation safety (44 FR 8243, 
February 9, 1979). NRC will continue to regulate the radiation safety 
of patients when justified by the risk to patients, primarily to ensure 
that the authorized user physician's directions are followed. The 
Commission recognizes that physicians have primary responsibility for 
the protection of their patients. However, NRC's role is also necessary 
to ensure radiation safety of patients.
Issue 3: Does NRC Regulation of the Medical Use of Byproduct Material 
Duplicate FDA Regulation?
    Comment. One commenter noted that any attempt by NRC to regulate 
the radiation safety of patients would duplicate the efforts of the FDA 
and state boards of pharmacy and medicine and, as such, would be an 
unwarranted intrusion into the practice of medicine.
    Response. The Commission disagrees with this comment. NRC is 
responsible 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).
    NRC regulation of the medical use of byproduct material does not 
duplicate licensing by State boards of pharmacy and medicine of 
pharmacists and physicians, respectively, to practice pharmacy or 
medicine within their borders. NRC regulations rely on the licensure of 
these professionals by a State (or Territory of the U.S., the District 
of Columbia, or Puerto Rico) to practice their respective professions 
as a prerequisite to NRC authorizing them to use byproduct material in 
pharmacy or medicine.
Issue 4: Should NRC Regulation Be Risk-Based and, If So, Should NRC 
Share Such an Approach With the Medical Community?
    Comment. A commenter insisted that NRC regulation should be ``risk-
based'' (i.e., justified by risk analysis), and if NRC adopts such an 
approach, the risk analysis should be shared with the medical 
community.
    Response. The Commission believes the regulations for use of 
byproduct material in medicine should be ``risk-informed'' rather than 
``risk-based.'' In March 1997, the Commission directed the revision and 
restructuring of part 35 into a risk-informed and, where appropriate, 
more performance-based

[[Page 47659]]

regulation. The Commission is attempting to make its medical use 
regulatory framework more ``risk-informed'' and agreeable with its 
regulatory strategy of regulating ``material uses consistent with the 
level 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.\2\'' In addition, this portion of the MPS 
reflects the Commission's strategy of identifying those regulations and 
processes that are now or can be made risk-informed.\3\
---------------------------------------------------------------------------

    \2\ Page 11, NUREG-1614, Vol. 1, ``Strategic Plan, Fiscal Year 
1997-Fiscal Year 2002''.
    \3\ Id.; and SRM dated March 20, 1997, COMSECY-96-057, 
``Materials/Medical Oversight (DSI 7) at 2.
---------------------------------------------------------------------------

    The Commission's efforts to make the regulations more risk-informed 
are evidenced in its recent actions to revise part 35. Before 
initiating the rulemaking and the associated revision of the MPS, the 
Commission thoroughly reviewed several extensive assessments, as 
previously noted. In developing the overall revision of part 35 and the 
MPS, the Commission considered information on risk provided by members 
of the public and professional societies, professional medical 
standards of practice, and event databases maintained by NRC to 
determine where oversight of lower-risk activities could be decreased. 
The Commission also examined whether continuation, or even broadening, 
of the regulations governing higher-risk activities was needed. In 
addition, throughout the development of the proposed rule and 
associated MPS, NRC held public workshops with early opportunities for 
comment from potentially affected parties. These interactions included 
significant discussions on the risk associated with medical uses of 
byproduct material.
    Although a formal risk assessment was not performed, the Commission 
believes that the risks associated with use of byproduct material in 
medicine have been adequately evaluated and considered. Based on these 
considerations, the revised regulatory approach is more risk-informed 
and more performance-based and significantly reduces regulatory burden 
in many areas. The Commission has retained prescriptive regulatory 
requirements (e.g., in part 35) only where it believes they are 
necessary to ensure adequate protection of workers, patients, and the 
public. However, there is nothing in the NRC's regulations that 
prohibits the medical community or other stakeholders from conducting 
an independent formal risk assessment of the medical use of byproduct 
material and forwarding its analysis and recommendations for Commission 
consideration.
Issue 5: Should NRC Be Involved With Prescriptions for the Medical Use 
of Byproduct Material?
    Comment. A commenter pointed out that NRC should not be involved 
with prescriptions because the requirements for accurate delivery of 
prescriptions are covered under state medical and pharmacy law. The 
commenter believes that written directives are not necessary to ensure 
high confidence that the actual administration of radiation to the 
patient was intended by the authorized user.
    Response. The Commission's statutory authority to regulate the 
medical use of byproduct material provides for NRC to have a role with 
respect to patient radiation safety. Statement 3 narrows the primary 
focus of NRC regulation of the radiation safety of patients to whether 
the physician's directions for the administration of byproduct material 
are followed. This regulatory role is in contrast to the broad 
regulation by a State board of pharmacy or medicine of the general 
practice of those disciplines within its borders.
    The Commission is not using the term ``prescription'' because it 
might typically include aspects of the administration that are outside 
NRC's purview. Instead, the term ``written directive'' (as defined in 
part 35) is used to specify the physician's directions (i.e., the 
procedure to be performed and the dose or dosage). This regulatory 
objective is currently reflected in provisions of part 35 requiring 
``high confidence'' that byproduct material will be administered as 
directed by an authorized user physician.

    Statement 4: NRC, in developing a specific regulatory approach, 
will consider industry and professional standards that define 
acceptable approaches of achieving radiation safety.
Issue 1: How Should Industry Standards Be Used in Regulating the 
Medical Use of Byproduct Material?
    Comment. According to several commenters, the NRC ignores 
professional standards and regulates as it pleases. In the commenters' 
opinions, NRC should accord industry and professional standards the 
respect they deserve. They believe that if NRC in fact endorses 
standards developed by private, consensus organizations, the revised 
MPS would be improved.
    Response. The Commission believes that Statement 4 commits NRC to 
an approach for regulation of medical use that considers both industry 
and professional standards that define acceptable levels of achieving 
radiation safety. NRC reviewed industry and professional standards in 
developing and implementing part 35 and the guidance document (NUREG 
1556, Volume 9). For example, some provisions in 10 CFR part 35 allow 
medical licensees the flexibility to use standards from nationally 
recognized organizations to meet the performance standards reflected in 
the rule.
    Consideration of industry and professional standards as part of 
NRC's policy to achieve radiation safety in medical use of byproduct 
material conforms to the Commission's Strategic Plan \4\ that 
encourages ``industry to develop codes, standards, and guides that can 
be endorsed by the NRC and carried out by industry.'' The NRC's 
intention is to consider industry and professional standards in 
developing regulations and guidance for the medical use program, 
consistent with the concepts in the ``National Technology Transfer and 
Advancement Act of 1995'' (the NTTAA), Public Law 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.''
---------------------------------------------------------------------------

    \4\ Page 10, NUREG-1614, Vol. 1, ``Strategic Plan, Fiscal Year 
1997-Fiscal Year 2002''.
---------------------------------------------------------------------------

    Not 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, in regulating medical use of byproduct material, the Commission 
endorses the concept in section 12 (a) of the NTTAA, of ``emphasizing, 
where possible, the use of standards developed by private, consensus 
organizations.''
Issue 2: Should NRC Consider Task Group Reports of the American 
Association of Physicists in Medicine (AAPM) for Developing Approaches 
for Achieving Radiation Safety?
    Comment. A commenter pointed out that, in defining acceptable 
approaches for achieving radiation safety, NRC should consider the task 
group reports of the AAPM, which are the latest

[[Page 47660]]

standards of practice for medical physicists.
    Response. The Commission agrees that AAPM standards of practice for 
professionals involved in the use of certain byproduct material 
modalities and for radiation safety equipment should be considered as 
part of NRC's risk-informed and performance-based approaches to 
regulating the medical use of byproduct material. The Commission 
acknowledges that these and other standards of practice are often 
voluntary and, as such, medical professionals are not required to 
follow them. Therefore, where appropriate, the NRC focused part 35 on 
performance objectives to be achieved by licensees and is allowing 
licensees to select among the various performance standards to meet the 
objective of the regulation. This provides a licensee significant 
flexibility in designing its radiation protection program.
    For example, in developing the final rule for the therapeutic uses 
of sealed sources, the NRC consulted several AAPM Radiation Therapy 
Committee Reports, including: Task Group 40 (Comprehensive QA for 
Radiation Oncology, 1994); Task Group 56 (Code of Practice for 
Brachytherapy Physics, 1998); Task Group 59 (HDR Treatment Delivery 
Safety, 1997 Draft); and AAPM Report No. 54 (Stereotactic Radiosurgery, 
1995).
    In addition to the AAPM, other groups and societies set 
professional radiation safety and practice standards for medical use. 
NRC plans to review such standards for possible use in developing 
regulatory positions (e.g., National Council on Radiation Protection 
and Measurements, Health Physics Society, and Society of Nuclear 
Medicine).
Issue 3: Does the Existence of Professional Standards Mean That NRC 
Regulation Is Unnecessary?
    Comment. Several commenters expressed the opinion that NRC 
regulations were unnecessary. They believe that NRC should not make 
regulations or license conditions out of industry or professional 
standards, because that reduces flexibility (i.e., regulations cannot 
evolve as quickly and easily as professional standards). In their 
opinion, NRC should recognize that these standards are implemented by 
other appropriate oversight bodies and that the existence of 
professional standards should signal to the NRC that regulation is 
unnecessary. Finally, these commenters indicated that a mechanism is 
needed to require the NRC to justify why an implemented industry 
standard is not acceptable.
    Response. The Commission disagrees with the comment about 
professional standards necessarily replacing NRC's radiation safety 
requirements. Many of the professional standards are voluntary in 
nature, do not have the force of law, and may not meet the definition 
of a consensus standard under the NTTAA. As such, not all professional 
standards are adequate to meet the Commission's objectives for the 
regulation of medical use of byproduct material.
    The Commission must consider industry consensus standards before a 
``government-unique standard'' is promulgated. The process is described 
in NRC Management Directive 6.5, ``NRC Participation in the Development 
and Use of Consensus Standards.'' Further information on this topic is 
available on the NRC's web site, www.nrc.gov/reference__library/
standards program/reference documents, e.g., Public Law 104-113, 
``National Technology Transfer Advancement Act of 1995'' (NTTAA), OMB 
Circular on implementation of the NTTAA, NRC Annual Standards Reports 
(listings of consensus standards endorsed by NRC).
    For example, NRC reviewed the technical literature to identify 
consensus standards and protocols that could be used or referenced in 
the rule and guidance document, thereby avoiding promulgation of 
``government-unique standards'' when revising the MPS, 10 CFR part 35, 
and NUREG 1556 (Volume 9). Part 35, subparts C, F, and H, describe 
various performance objectives to be achieved (e.g., calibration of 
survey instruments, calibration of radiation sources used for manual 
brachytherapy and used in radiation therapy devices, and acceptance 
testing of treatment planning computers). A licensee may use 
measurements provided by the source manufacturer or by a calibration 
laboratory accredited by the AAPM. Alternatively, a licensee may select 
and implement an appropriate voluntary performance standard from a 
published protocol that was accepted by a nationally recognized body in 
order to meet the performance objectives of these regulations. This 
approach is consistent with the Commission's goal to develop 
regulations that are more performance-based. The Commission believes 
this approach provides significant flexibility for medical use 
licensees to design radiation protection programs that, when fully 
implemented, maintain radiation exposures to workers, patients, and the 
public to levels that are as low as are reasonably achievable.

    Dated at Rockville, Maryland, this 27th day of July, 2000.

For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 00-19573 Filed 8-2-00; 8:45 am]
BILLING CODE 7590-01-U