[Federal Register Volume 66, Number 77 (Friday, April 20, 2001)]
[Proposed Rules]
[Pages 20214-20217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-9824]


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NUCLEAR REGULATORY COMMISSION

10 CFR Part 35

[Docket No. PRM-35-16]


American College of Nuclear Physicians and the Society of Nuclear 
Medicine; Denial of a Petition for Rulemaking

AGENCY: Nuclear Regulatory Commission.

ACTION: Denial of a petition for rulemaking.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is denying a 
petition for rulemaking submitted by the American College of Nuclear 
Physicians (ACNP) and the Society of Nuclear Medicine (SNM) (PRM-35-
16). The petitioners request that the Commission: rescind its approval 
of the NRC staff's draft final revision of the regulations at 10 CFR 
part 35 ``Medical Use of Byproduct Material'', which was approved by 
the Commission in a Staff Requirements Memorandum dated October 23, 
2000; revoke all of part 35, except for specifically identified 
requirements; and institute a new rulemaking proceeding to adopt a 
regulatory scheme for the use of byproduct material in diagnostic 
nuclear medicine that reflects the discipline's safety record. The NRC 
is denying the petition because: the Commission approved the final rule 
after an extensive rulemaking process that provided an unprecedented 
level of enhanced stakeholder and public participation; the Commission 
believes that the ACNP/SNM had many opportunities to present their 
concerns and suggestions as part of that process; and the petition does 
not appear to present any significant new information or 
recommendations that the Commission has not already considered.

ADDRESSES: Copies of the petition for rulemaking and the NRC's letters 
to the petitioners are available for public inspection or copying in 
the NRC Public Document Room, 11555 Rockville Pike, Room 01-F21, 
Rockville, Maryland.

FOR FURTHER INFORMATION CONTACT: Catherine Haney, Office of Nuclear 
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, telephone (301) 415-6825, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

The Petition

    On January 11, 2001, the NRC docketed a January 3, 2001, letter 
from Donald A. Podoloff, MD, of the American College of Nuclear 
Physicians, and Jonathan M. Links, PhD, of the Society of Nuclear 
Medicine, to the Office of the Secretary, as a petition for rulemaking 
under 10 CFR 2.802 (PRM-35-16). The petitioners request that the 
Commission: rescind its approval of the NRC staff's proposed revision 
to 10 CFR part 35, ``Medical Use of Byproduct Material,'' which was 
approved by the Commission in a Staff Requirements Memorandum dated 
October 23, 2000; revoke all of 10 CFR part 35, except for specifically 
identified requirements; and institute a new rulemaking proceeding to 
adopt a regulatory scheme for the use of byproduct material in 
diagnostic nuclear medicine that reflects the discipline's 
``unparalleled and undisputed safety record.''
    The petitioners provide a history of the Commission's statutory 
authority and nuclear medicine regulation from their perspective. The 
petitioners state that the NRC regulates the medical use of reactor-
generated radioactive materials to protect the public health under 
section 81 of the Atomic Energy Act (AEA) (42 U.S.C. 2111) and that its 
responsibilities include the regulation of radiopharmaceuticals and 
sealed sources. The NRC does not regulate machine-produced x-rays nor 
naturally occurring or accelerator-produced radioisotopes (such as 
those used in positron emission tomography). The petitioners also 
described the relationship between NRC and State regulatory authority 
and the impacts of NRC's program on State regulatory programs.
    The petitioners characterize the use of radioactive material as a 
highly regulated activity. All uses and possession of radioactive 
material are prohibited, except those uses and possessions that are 
authorized by an individual license. The petitioners believe that as 
medical uses of radioactive materials expanded with the development of 
new technologies, the licensure process quickly became complex, often 
involving lengthy documents with little consistency from one license to 
another license. The petitioners state that in the late 1970's, the NRC 
placed all common license conditions into regulations. The petitioners 
believe that this regulatory action was the NRC's attempt to simplify 
the licensing process and to allow greater consistency in uses and 
possession of radioactive materials.
    The petitioners believe that the NRC's regulations applicable to 
diagnostic nuclear medicine eclipse the regulatory controls imposed on 
other dramatically more dangerous medical products and procedures by a 
wide margin. The petitioners state that the goal of this petition is to 
end that unsupportable and extraordinarily expensive program. The 
petitioners also state that their proposed regulatory scheme would 
assure the continued extremely safe use of diagnostic nuclear medicine 
products and procedures while saving the nation millions of dollars a 
year.

The Requested Actions

    The petitioners request that the NRC amend its regulations to match 
the regulatory scheme to the minimal risks presented. Specifically, 
they request that NRC regulate the use of byproduct material in 
diagnostic nuclear medicine solely by:
    1. Protecting workers, the general public, and the environment 
through

[[Page 20215]]

the radiation protection standards of 10 CFR part 20;
    2. Ensuring the protection for patients, workers, the public, and 
the environment by enforcing comprehensive education, and training and 
experience requirements for the use and possession of byproduct 
materials;
    3. Relying on health care professionals with the required 
education, training, and experience in nuclear medicine, nuclear 
pharmacy, and basic nuclear and radiation science to protect the health 
and safety of their patients under the supervision of their respective 
State Medicine and Pharmacy Boards;
    4. Revoking all of part 35, except for requirements concerning 
comprehensive education, training, and experience of authorized users, 
coupled with a new provision that would require evidence of mastery of 
basic nuclear and radiation sciences by passage of an examination given 
in this field by a board certified by the American Board of Medical 
Specialties or a single alternate examination equivalent in scope and 
depth to that covered in the certified boards and approved by the 
Advisory Committee on the Medical Uses of Isotopes (ACMUI);
    5. Ceasing the subdivision of diagnostic nuclear medicine into 
smaller and smaller fragments. After completing comprehensive 
education, training, and experience in basic nuclear and radiation 
sciences, and passing an appropriate comprehensive examination in these 
areas, as defined in (4) above, an authorized user may subspecialize in 
any portion of diagnostic nuclear medicine he/she wishes without 
further Commission restriction;
    6. Removing all license conditions except for simple 
identification. This includes the name, address, e-mail address, 
telephone, and fax numbers of the institution, the responsible 
administrator, and the Radiation Safety Officer (RSO). The license 
should simply state, ``This license permits the possession, use, 
transport, and disposal of any byproduct material, in any physical or 
chemical form, in any quantity, for diagnostic nuclear medicine use 
including clinical use, research, quality control, teaching, and 
related diagnostic nuclear medicine professional activities.'' In the 
case of presently limited licenses, such as in nuclear cardiology, 
``diagnostic nuclear cardiology'' should replace ``diagnostic nuclear 
medicine.'' The license should also state that, ``This license does not 
cover diagnostic uses of radiopharmaceuticals containing more than 30 
microcuries of I-131.''
    7. Inspecting diagnostic medical licensees only in those rare 
situations of likely over exposures of workers, the general public, or 
the environment. The routine inspections now being conducted are an 
invitation to document meaningless paperwork ``deviations'' and which 
impose substantial unnecessary costs on licensees. As far as patients 
are concerned, cases of possible malpractice will be handled under 
existing State law by the Boards of Medicine and/or Pharmacy and the 
courts, without NRC involvement unless specifically requested by the 
Board or the court.
    8. Decreasing the size of the staff assigned to the medical use 
program to adequately reflect the limited role the Commission plays in 
assuring diagnostic nuclear medicine safety. This staff adjustment has 
been long overdue. As the number of NRC medical licensees decreases 
because of the increase in Agreement States, the number of employees 
assigned to the medical program paradoxically increases. Because 
Congress requires that the NRC recover its costs from licensees, fewer 
and fewer licensees are supporting an increasingly bloated NRC program. 
A properly sized staff alone would dramatically reduce the escalating 
cost of holding an NRC license.

Supporting Information

    The petitioners state that they are not asking for a 
``deregulation'' of diagnostic nuclear medicine in the usual meaning of 
the word, which implies a decrease in safety standards; they are 
requesting that NRC remove prescriptive regulations and license 
conditions. The petitioners believe that qualified professional 
authorized users have significantly more training and real-life 
experience than regulators in providing the highest level of protection 
and safety for their patients and others.
    The petitioners believe that the Commission has never adopted a 
regulatory scheme that matches its requirements to the acknowledged 
minimal risks posed by diagnostic nuclear medicine. The petitioners 
characterize the revisions to 10 CFR part 35 approved by the Commission 
on October 23, 2000, as offering little meaningful change from the 
existing regulations. The petitioners believe that, combined with NRC's 
increased use of ``license conditions'' to impose requirements that do 
not appear in its regulations, the new supposedly ``risk-informed'' 
regulations mark a step backward, not forward and that these new 
regulations bear no relationship to the risk sought to be protected 
against, and which will, by its substantial unnecessary costs, 
adversely impact health care.
    The petitioners state that in the 64-year history of nuclear 
medicine in the United States, about one-third of a billion 
radiopharmaceutical doses have been administered. There was one case, 
in the 1950's, of a radiation death due to a diagnostic 
radiopharmaceutical. This event occurred before there was board 
certification in nuclear medicine, nuclear pharmacy, and nuclear 
medicine technology. The petitioner states that this mistake was due to 
human error and would not have been avoided with NRC's current 
regulations and license conditions.
    The petitioners believe that the entire predicate of the NRC's 
regulation of diagnostic nuclear medicine appears to be that radiation 
from byproduct materials poses significant risks to patients, workers 
and the public and that this predicate is demonstrably untrue. The 
petitioners believe that diagnostic nuclear medicine is extremely safe, 
and its use by properly trained health care professionals poses no 
undue risks. The petitioners cite the conclusion of the Institute of 
Medicine of the National Academy of Science that the regulatory 
structure imposed on diagnostic nuclear medicine by the NRC is a costly 
and unnecessary burden that yields no benefit to patients, workers, or 
the public.
    Although this petition deals solely with diagnostic nuclear 
medicine, the petitioners believe that essentially the same arguments 
can be made to reduce the burden on the practice of therapeutic nuclear 
medicine.
    The petitioners state that the NRC should become involved in 
regulating patient safety only when justified by the risk and where 
voluntary standards are inadequate. The petitioners believe that the 
NRC has steadily increased its regulations of nuclear medicine despite 
minimal changes in the materials used, their applications in medicine, 
and the absence of any evidence of significant problems.

Petitioners' Cost Estimate

    On October 21, 1998, the petitioners presented a preliminary cost 
estimate of the impact of the proposed revisions of part 35 to the NRC 
at a public meeting. The analysis, entitled ``Preliminary Estimate of 
the Cost of the Proposed part 35 for a Typical Hospital Nuclear 
Medicine Service; Spread Sheet Analysis,'' was prepared by Mark Rotman, 
a former Visiting Medical Fellow at the NRC. The petitioners state that 
the analysis did not include the cost of most of 10 CFR parts 19 and 
20,

[[Page 20216]]

NUREG-1559 Volume 9 (the new guidance for medical use licensing, 
including nuclear medicine); typical license conditions; radioactive 
waste disposal; user fees; or any costs to any Agreement State nuclear 
medicine licensees. The petitioners state that the total cost of the 
NRC's regulatory scheme alone came to just over $100,000,000/year and 
assuming Agreement States will be forced by NRC to have similar 
programs, which is happening now, the cost, including Agreement State 
licenses, is $500,000,000. The petitioners believe that the total costs 
could easily reach $1 billion per year, even with uncertainties. The 
petitioners request that the NRC discard its own cost analysis, which 
was sent to OMB, and work with the petitioners to produce a realistic 
cost estimate. The petitioners assert that the Commission has refused 
to recognize the existence of the analysis produced by the ACNP/SNM and 
has refused to discuss it, comment on it, or address the issues on it 
in any manner. The petitioners believe that if this petition is 
granted, most of these costs would disappear. The petitioners believe 
that it is likely that nuclear pharmacy costs would also decrease and, 
therefore, radiopharmaceutical costs would decrease as well.

Conclusion

    The petitioners believe that the requested changes would benefit 
the public in two ways. First, substantial requirements for physicians' 
education, training, and experience, and appropriate evidence of 
mastery by testing would improve the knowledge and abilities of 
physicians offering diagnostic nuclear medicine. Second, costs to the 
health care system would decrease without any decrease in safety.

Reason for Denial

    NRC is denying the petition because:
    (1) The Commission approved the final rule addressing the issues 
raised in the petition after an extensive rulemaking process that 
provided an unprecedented level of enhanced stakeholder and public 
participation;
    (2) The Commission believes that the ACNP/SNM had many 
opportunities to present their concerns and suggestions as part of that 
process and did so; and
    (3) The petition does not appear to present any significant new 
information or recommendations that the Commission has not already 
considered.
    In general, the proposed rule amendments, comments, and supporting 
information presented by the petitioners were previously submitted by 
the ACNP/SNM in the following documents that provided comments on the 
rulemaking to revise part 35:
     Document entitled ``A Framework for the Regulation of 
Nuclear Medicine'' ACNP/SNM Government Relations Office, dated December 
18, 1997 (docketed by the NRC on January 13, 1998, as comment number 
239). This document presents information on the important and 
challenging issues that face the NRC as it reviews and revises 10 CFR 
part 35.
     Letter dated November 10, 1998, to James Smith, NRC, 
jointly signed by David C. Nichols, ACNP/SNM; Roy Brown, Council on 
Radionuclides and Radiopharmaceuticals; Felix Killar, Nuclear Energy 
Institute; and Rich White, Council on Radionuclides and 
Radiopharmaceuticals (docketed by the NRC as comment number 498 on 
December 4, 1998). The signatories raise the matter of regulating 
diagnostic nuclear medicine through part 35, combined with training and 
experience requirements.
     Letter dated December 16, 1998, from Robert L. 
Meckelnburg, M.D., President, ACNP and James W. Fletcher, M.D. 
President, SNM, to the Secretary, U.S. Nuclear Regulatory Commission 
(docketed by the NRC on December 16, 1998, as comment number 505). This 
letter discusses limiting the requirements for diagnostic nuclear 
medicine to the provisions of part 20, combined with specific training 
and experience requirements.
     Letter dated September 3, 1999, to Greta Joy Dicus, then 
Chairman, NRC, from Robert F. Carretta, M.D., President, SNM, and James 
M. Woolfenden, M.D., President, ACNP (docketed by the NRC on November 
8, 1999, as comment number 604). This letter discusses limiting the 
requirements for diagnostic nuclear medicine to the provisions of part 
20, combined with specific training and experience requirements.
    The NRC has already responded to comments similar to those 
presented by the petitioners in their January 11, 2001, petition for 
rulemaking. Responses to these comments are provided in SECY-00-0118, 
``Final Rules--10 CFR part 35, `Medical Use of Byproduct Material' and 
10 CFR part 20, `Standards for Protection Against Radiation','' dated 
May 31, 2000. In this document, the NRC staff presented the Commission 
with a draft final rule that would revise the regulations governing the 
medical use of byproduct material as well as related supporting and 
guidance documents. This document contains an exhaustive analysis of 
the comments received on the proposed revision to part 35 that was 
noticed for public comment on August 13, 1998 (63 FR 43516); the NRC's 
response to these comments; and the changes made to the proposed rule 
in response to these comments. The Commission subsequently approved the 
draft final rule in a Staff Requirements Memorandum, dated October 23, 
2000.
    The following addresses Requested Actions 1-5, as listed under the 
heading ``The Requested Actions'' as well as cost figures, discussed 
under the heading, ``Petitioner's Cost Estimate'' of this notice. 
Requested Actions 6 through 8, as listed under the heading ``The 
Requested Actions,'' raise issues not amenable to rulemaking such as 
removal of conditions from NRC diagnostic nuclear medicine licenses, 
inspection, and NRC personnel levels. As such, these issues are not 
further addressed here. However, the NRC staff has responded to 
comments on related issues such as licensing and inspection of 
diagnostic nuclear medicine in SECY-00-0118, Attachment 6, 
SUPPLEMENTARY INFORMATION, III. Summary of Public Comments and 
Responses to Comments, Part II--General Issues, B. Licensing (Issue 1) 
and C. Inspection (Issues 2 and 3).
    The NRC staff has already responded to Requested Action 1 regarding 
the approach of regulating diagnostic nuclear medicine solely under 
part 20 by explaining the need for certain specific provisions in part 
35 in SECY-00-0118, Attachment 6, SUPPLEMENTARY INFORMATION, III. 
Summary of Public Comments and Responses to Comments, Part II--General 
Issues, A. Risk, Issue 4, as follows:

    The final rule includes requirements that are needed to protect 
occupationally exposed individuals, patients, and the public. 
Certain radiation protection-related requirements unique to medical 
use are needed in part 35 because of their contribution to risk 
reduction. For example, the final rule retains requirements to 
calibrate instrumentation used to measure the radioactivity of 
patient dosages before they are administered (Sec. 35.60). For this 
reason and because the NRC believes that these requirements are 
essential to the safe handling of byproduct material * * *

    The NRC staff has already responded to Requested Actions 2-4 
regarding training and experience requirements for the medical use and 
possession of byproduct material. See SECY-00-0118, Attachment 6, 
SUPPLEMENTARY INFORMATION, III. Summary of Public Comments and 
Responses to Comments, Part II--General Issues, E. Training and 
Experience, Issue 7, as follows:

    The NRC believes that the training and experience requirements 
in the final rule for authorized medical physicists (AMP), 
authorized nuclear pharmacists (ANP),

[[Page 20217]]

authorized users (AU), and Radiation Safety Officers (RSO) are 
sufficient to assure that the radiation safety of the public, 
patients, human research subjects, and workers is maintained. 
Therefore, we deleted the requirement for an examination from all 
the training and experience sections. Instead of an examination, we 
will rely on the preceptor's certification that an individual has 
completed the required training and experience and has achieved a 
level of competency sufficient to function independently as an AMP, 
ANP, AU, or RSO.

    Further, under the revised 10 CFR part 35, NRC will continue to 
rely on health care professionals who are required to meet certain NRC 
training and experience criteria to protect the health and safety of 
the public and patients.
    The NRC staff has already responded to Requested Action 5 regarding 
the structure of regulations for the medical use of byproduct material 
in nuclear medicine (i.e., there are different requirements for 
training of AU's under Secs. 35.100, 35.200 and 35.300) in SECY-00-
0118, Attachment 6, SUPPLEMENTARY INFORMATION, III. Summary of Public 
Comments and Responses to Comments, Part II--General Issues, E. 
Training and experience, 2. Training and experience--unsealed byproduct 
material, Issue 5, as follows:

    The NRC recognizes that there is a certain degree of basic 
radiation safety knowledge that is common among all the types of 
use, e.g., use of the decay formula and decontamination techniques. 
However, we also believe that there are some basic differences 
between the uses of byproduct material under Secs. 35.100, 35.200, 
and 35.300 that warrant additional training and experience, e.g., 
increased potential for exposures in excess of part 20 limits and 
the potential for adverse biological effects. For example, AUs 
[authorized users] handling byproduct material for imaging and 
localization studies, as compared to uptake, dilution, and excretion 
studies, are generally handling larger quantities and many different 
radionuclides. Also, AUs meeting the training and experience 
requirements in Sec. 35.190 are not authorized to prepare 
radioactive drugs using generators and reagent kits, but AUs under 
Sec. 35.290 are authorized to prepare drugs using generators and 
reagent kits. Finally, AUs under Sec. 35.390 are handling material 
in quantities that can cause deterministic effects.

    The NRC staff has already addressed the cost figures (i.e., over 
$100,000,000/ year to $1 billion/year) presented by the petitioners in 
SECY-00-0118, Attachment 6, SUPPLEMENTARY INFORMATION, III. Summary of 
Public Comments and Responses to Comments, Part II--General Issues, G. 
Costs of the revision, Issue 5, as follows:

    In evaluating the costs of regulatory compliance and 
implementation, the NRC has used detailed information whenever it is 
available. We have sought data from a number of sources, including 
medical speciality groups, manufacturers, members of the ACMUI, the 
National Institutes of Health, and various published sources. 
However, certain necessary data are treated as proprietary. Other 
data are not collected or are available only in a disaggregated 
form. Many of the compliance costs will vary substantially from 
licensee to licensee, depending on the number and type of modalities 
and procedures that they use and perform. Other compliance costs 
will be dependent on numerous interrelated variables. We believe 
that an effort to collect the necessary data and/or develop 
necessary models to provide substitutes for missing or unavailable 
data would require very considerable time and expense. We are 
concerned that at the conclusion of such an effort, because of many 
remaining gaps and uncertainties in the underlying data, an estimate 
of the total cost of the regulations would still fall within such 
broad confidence bounds that it would be fundamentally flawed.

    In addition, the NRC has prepared a regulatory analysis for the 
final rule which shows a net decrease in the cost to licensees of 
implementing the final rule as compared to the current rule. NRC has 
also submitted an estimate of the cost associated with the 
recordkeeping and reporting to OMB for its approval. This document, 
currently under review by OMB, shows a decrease of approximately 30 
percent in costs associated with the recordkeeping and reporting 
requirements as compared to the current part 35.
    For the reasons cited in this document, the NRC denies the petition 
in its entirety.

    Dated at Rockville, Maryland, this 16th day of April, 2001.

    For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
[FR Doc. 01-9824 Filed 4-19-01; 8:45 am]
BILLING CODE 7590-01-P