[Federal Register Volume 62, Number 153 (Friday, August 8, 1997)]
[Proposed Rules]
[Pages 42707-42708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20974]


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NUCLEAR REGULATORY COMMISSION

10 CFR Part 35


Medical Use of Byproduct Material; Working Group for Revision

AGENCY: U.S. Nuclear Regulatory Commission.

ACTION: Establishment of working group and notice of meeting.

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SUMMARY: A working group consisting of representatives from the U.S. 
Nuclear Regulatory Commission, the Organization of Agreement States 
(OAS), and the Conference of Radiation Control Program Directors 
(CRCPD) has been established in response to Commission approval of the 
staff's proposed plan for revising 10 CFR part 35, associated guidance 
documents, and the Commission's 1979 ``Medical Policy Statement,'' if 
necessary. With this approval, the NRC staff has begun developing draft 
rule language and alternatives, using an entirely modality-based 
approach, to help focus the public input and the discussions during 
facilitated public meetings. During this process, the staff is 
examining the applicability of risk-informed, performance-based 
regulations and less prescriptive approaches to regulation of nuclear 
material used for medical purposes. The working group will meet at NRC 
Headquarters in Rockville, Maryland, on August 19 and August 20, 1997, 
to review the early draft staff documents and to discuss the major 
regulatory issues associated with the medical use of byproduct 
material.

DATES: The Working Group will meet on August 19 and 20, 1997, from 9:00 
a.m. to 5:00 p.m.

ADDRESSES: U.S. Nuclear Regulatory Commission, One White Flint North, 
Auditorium, 11555 Rockville Pike, Rockville, MD, 20852-2738.

FOR FURTHER INFORMATION CONTACT: Cathy Haney, U.S. Nuclear Regulatory 
Commission, Office of Nuclear Material Safety and Safeguards, MS T8F5, 
Washington, DC 20555, telephone (301) 415-6825, e-mail [email protected].

SUPPLEMENTARY INFORMATION: NRC has examined the issues surrounding its 
medical use program in great detail during the last four years. This 
process started with NRC's 1993 internal senior management review 
report; continued with the 1996 independent external review report by 
the National Academy of Sciences, Institute of Medicine; and culminated 
in NRC's Strategic Assessment and Rebaselining Project (SA). In 
particular, medical oversight was addressed in the SA Direction-Setting 
Issue Paper Number 7 (DSI 7) (released September 16, 1996). In its 
``Staff Requirements Memorandum (SRM)--COMSECY-96-057, Materials/
Medical Oversight (DSI 7),'' dated March 20, 1997, the Commission 
directed staff to revise Part 35, associated guidance documents, and, 
if necessary, the Commission's 1979 ``Medical Policy Statement.'' The 
Commission SRM specifically directed the restructuring of Part 35 into 
a risk-informed, more performance-based regulation.
    A June 30, 1997, SRM informed the staff of the Commission's 
approval, with comments, of the 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 this approval, 
the NRC staff initiated development of draft rule language, using an 
entirely modality-based approach. The modality approach places all 
requirements for a given type of treatment into a single section of the 
regulation, including: (a) Who or what organization is licensed; (b) 
what type of license is issued; (c) the necessary technical 
requirements, such as surveys and calibration; (d) the training and 
experience requirements; (e) the event recording and reporting 
requirements; and (f) the quality improvement and management 
objectives.
    Per NRC Management Directive 6.3, ``The Rulemaking Process,'' the 
rulemaking will be conducted using a group approach. A governmental 
working group consisting of representatives of NRC, OAS, and CRCPD has 
been established to develop rule text alternatives, including draft 
guidance documents. State participation in the process will enhance 
development of corresponding rules in State regulations, and provide an 
opportunity for early State input and will allow the 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.
    At the initial meeting of the working group, on August 19-20, 1997, 
the group will review the initial draft input developed by the NRC 
staff, focusing its discussion on the major regulatory issues 
associated with the medical use of byproduct material.

Committee Organization and Operations

    Cathy Haney, NRC, Office of Nuclear Material Safety and Safeguards, 
will serve as chairman. Other members are from the NRC's Office of 
Nuclear Material Safety and Safeguards; Office of Nuclear Regulatory 
Research; Office of the General Counsel, and Office of State Programs; 
and from OAS and CRCPD.

[[Page 42708]]

Committee Meetings

    The working group will meet, as needed, in the Washington, DC, 
area, or at other locations agreed upon by the working group members. 
Meetings will be announced in advance, through the NRC Public Meeting 
Notice System and, with some exceptions, will be open for public 
observation. Persons attending working group meetings will be welcome 
to provide input to the working group for its consideration, either in 
written form or orally, at times specified by the working group chair.

    Dated at Rockville, Maryland, this 4th day of August 1997.
    For the Nuclear Regulatory Commission.
Donald A. Cool,
Director, Division of Industrial and Medical Nuclear Safety, Office of 
Nuclear Material Safety and Safeguards.
[FR Doc. 97-20974 Filed 8-7-97; 8:45 am]
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