[Federal Register Volume 63, Number 142 (Friday, July 24, 1998)]
[Proposed Rules]
[Pages 39763-39765]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19805]


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

NUCLEAR REGULATORY COMMISSION

10 CFR Part 35


Medical Use of Byproduct Material; Public Meetings

AGENCY: U.S. Nuclear Regulatory Commission.

ACTION: Notice of public meetings.

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

SUMMARY: The Nuclear Regulatory Commission has developed a proposed 
rulemaking for a comprehensive revision of its regulations governing 
the medical use of byproduct material in 10 CFR Part 35, ``Medical Use 
of Byproduct Material,'' and a proposed revision of its 1979 Medical 
Use Policy Statement (MPS). Throughout the development of the proposed 
rule and MPS, the Commission solicited input from the various interests 
that may be affected by these proposed revisions. The Commission now 
plans to solicit comments on the proposed rule and MPS through two 
mechanisms--publishing the documents in the Federal Register for public 
comment (scheduled for August 1998); and convening three facilitated 
public meetings, during the public comment period, to discuss the 
Commission's proposed resolution of the major issues. The public 
meetings will be held in San Francisco, California, on August 19-20, 
1998; in Kansas City, Missouri, on September 16-17, 1998; and in 
Rockville, Maryland, on October 21-22, 1998. All meetings will be open 
to the public. Francis X. Cameron, Special

[[Page 39764]]

Counsel for Public Liaison, in the Commission's Office of the General 
Counsel, will be the convener and facilitator for the meetings.

DATES: The first public meeting will be in San Francisco on August 19-
20, 1998, from 8:30 a.m. to 5:00 p.m. each day; the second public 
meeting will be in Kansas City on September 16-17, 1998, from 8:30 a.m. 
to 5:00 p.m. each day; and the third public meeting will be in 
Rockville on October 21-22,1998, from 8:30 a.m. to 5:00 p.m. each day.

ADDRESSES: The San Francisco meeting will be held at the ANA Hotel San 
Francisco, 50 Third Street, San Francisco, California 94103, 415-974-
6400. The Kansas City meeting will be held at the Radisson Suite Hotel 
Kansas City, Kansas City, 106 West 12th Street, Kansas City, MO 64105, 
800-333-3333. The Rockville meeting will be held in the auditorium at 
the U.S. Nuclear Regulatory Commission, 11545 Rockville Pike, 
Rockville, MD 20852-2738.

FOR FURTHER INFORMATION CONTACT: Francis X. Cameron, Special Counsel 
for Public Liaison, Office of the General Counsel, Nuclear Regulatory 
Commission, Washington D.C. 20555-0001, Telephone: 301-415-1642.

SUPPLEMENTARY INFORMATION:

Background

    Following a comprehensive review of its medical use program, the 
Commission directed the NRC staff to revise 10 CFR Part 35, associated 
guidance documents, and, if necessary, the Commission's 1979 Medical 
Policy Statement [Staff Requirements Memorandum (SRM)--COMSECY-96-057, 
Materials/Medical Oversight (DSI 7), dated March 20, 1997]. The 
Commission's SRM specifically directed the restructuring of Part 35 
into a risk-informed, more performance-based regulation. In its SRM 
dated June 30, 1997, ``SECY-97-115, Program for Revision of 10 CFR Part 
35, `Medical Uses of Byproduct Material' and Associated Federal 
Register Notice,'' the Commission approved the NRC staff's proposed 
plan for the revision of Part 35 and the Commission's 1979 Medical Use 
Policy Statement (MPS). The schedule approved by the Commission in SRM-
SECY-97-115 provides for the rulemaking to be completed by June 1999.
    After Commission approval of the NRC staff's program to revise Part 
35 and associated guidance documents, the NRC staff initiated the 
rulemaking process, as announced in 62 FR 42219 (August 6, 1997).
    The proposed rule and MPS were developed using a group approach. A 
Working Group and Steering Group, consisting of representatives of NRC, 
the Organization of Agreement States, and the Conference of Radiation 
Control Program Directors, were established to develop rule text 
alternatives, rule language, and associated guidance documents. State 
participation in the process was intended to enhance development of 
corresponding rules in State regulations, to provide an opportunity for 
early State input, and to allow 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.
    The proposed revision of Part 35 is based on the Commission's 
directions in the SRMs of March 20, 1997, and June 30, 1997. The 
revision is intended to make Part 35 a more risk-informed, performance-
based regulation that will focus the regulations on those medical 
procedures that pose the highest risk, from a radiation safety aspect, 
with a subsequent decrease in the oversight of low-risk activities; 
focus on those requirements that are essential for patient safety; 
initiate improvements in NRC's medical program, by implementing 
recommendations from internal staff audits, other rulemaking 
activities, and results of analyses in medical issues papers; 
incorporate regulatory requirements for new treatment modalities; and 
reference, as appropriate, available industry guidance and standards.
    As part of the rulemaking process, significant issues associated 
with the regulation of the medical use of byproduct material and the 
revision of the MPS were identified, alternatives were developed for 
them, and public input on them was specifically sought. These 
alternatives were developed to stimulate input from members of the 
public in an effort to encourage all interested parties to contribute 
to the development of the revised regulation and were discussed during 
facilitated public workshops and meetings throughout the development of 
the proposed rule and MPS.
    The program for revising Part 35, associated guidance document, and 
MPS has provided more opportunity for input from potentially affected 
parties (the medical community and the public) than is provided by the 
typical notice and comment rulemaking process. Early public input was 
solicited by requesting input through Federal Register notices; holding 
public meetings of the Working and Steering Groups; meeting with 
medical professional societies and boards; putting background 
documents, rulemaking alternatives, and a ``strawman'' draft proposed 
rule on the Internet and in NRC's Public Document Room; and convening 
two facilitated public workshops. Significant regulatory issues were 
also discussed at the Part 35 Workshop that was held in conjunction 
with the All Agreement States Meeting in October 1997, the Advisory 
Committee on the Medical Uses of Isotopes (ACMUI) meetings in September 
1997 and March 1998, and the ACMUI subcommittee meetings in February 
1998. Input received during these interactions and in writing were 
beneficial to the staff in developing the proposed rule and MPS.

Workshops

    Based on the substantive public input received during the early 
rulemaking process, the Commission believes that it is important for 
interests affected by the proposed revisions to have an opportunity to 
comment on the proposed rulemaking and MPS, as well as have an 
opportunity to discuss the proposed revisions with one another and the 
Commission. Accordingly, the Commission is convening three public 
meetings, during the public comment period, where representatives of 
the interests that may be affected by the proposed rulemaking and MPS 
will have an opportunity to discuss the proposed revisions. Although 
the meetings are intended to foster a clearer understanding of the 
positions and concerns of the affected interests, as well as to 
identify areas of agreement or disagreement, it is not the intent of 
the meetings to develop a consensus agreement of the participants on 
the rulemaking issues.
    To have a manageable discussion, the number of participants in each 
meeting will be limited. The Commission, through the facilitator for 
the meeting, will attempt to ensure participation by the broad spectrum 
of interests that may be affected by the proposed rulemaking and MPS. 
These interests include: nuclear medicine physicians; physician 
specialists, such as cardiologists and radiologists; medical 
physicists; medical technologists; nurses; medical education and 
certification organizations; radiopharmaceutical interests; hospital 
administrators; radiation safety officers; patients' rights advocates; 
Agreement States; Federal agencies; and experts in risk analysis. Other 
members of the public are welcome to attend, and the public will have 
the opportunity to comment on the proposed rulemaking and MPS and to 
participate in the meeting discussions at periodic intervals. Questions 
about participation

[[Page 39765]]

may be directed to the facilitator, Francis X. Cameron.
    The meetings will have a pre-defined scope and agenda focused on 
the Commission's resolution of the major issues addressed during the 
development of the proposed rule and MPS. However, the meeting format 
will be sufficiently flexible to allow for the introduction of 
additional related issues that the participants may want to raise. The 
meeting commentary will be transcribed and made available to the 
participants and the public.
    Copies of the proposed revision of Part 35 and the MPS will be 
provided to the meeting participants. Also, copies will be available 
for members of the public in attendance at the meetings. The 
availability of the proposed rule, and associated documents, and the 
MPS for individuals who are unable to attend any of the public meetings 
will be noted in the Federal Register notices for these documents.
    Public comments on the proposed rule and MPS are solicited but, to 
be most helpful, should be received by the date that will be announced 
in the Federal Register notices on the proposed rule and MPS. Comments 
received after this date will be considered if it is practical to do 
so, but the Commission only is able to ensure consideration of comments 
received on or before this date. Written input and suggestions can be 
sent to Secretary, Nuclear Regulatory Commission, Washington, DC 20555-
0001, Attention: Rulemakings and Adjudications Staff. Hand-deliver 
comments to 11555 Rockville Pike, Rockville, MD, between 7:30 a.m. and 
4:15 p.m. on Federal workdays.

    Dated at Rockville, Maryland this 17th day of July, 1998.
    For the Nuclear Regulatory Commission.
Frederick C. Combs,
Acting Director, Division of Industrial and Medical Nuclear Safety, 
Office of Nuclear Material Safety and Safeguards.
[FR Doc. 98-19805 Filed 7-23-98; 8:45 am]
BILLING CODE 7590-01-P