[Federal Register Volume 62, Number 198 (Tuesday, October 14, 1997)]
[Proposed Rules]
[Pages 53249-53250]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-27084]
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Proposed Rules
Federal Register
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This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 62, No. 198 / Tuesday, October 14, 1997 /
Proposed Rules
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NUCLEAR REGULATORY COMMISSION
10 CFR Part 35
Medical Use of Byproduct Material; Workshops
AGENCY: U.S. Nuclear Regulatory Commission.
ACTION: Notice of workshops.
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SUMMARY: The Nuclear Regulatory Commission has initiated a rulemaking
for a comprehensive revision of its regulations governing the medical
use of byproduct material in 10 CFR part 35. As part of this
rulemaking, the Commission intends to solicit the active input of the
various interests that may be affected by the rulemaking early in the
rulemaking process. One of the mechanisms that will be used to obtain
the comments and recommendations from affected interests will be the
convening of workshops to discuss the fundamental approaches and issues
that must be addressed in the revision of part 35. The first NRC public
workshop will be held in Philadelphia, Pennsylvania on October 28, 29,
and 30, 1997. The second NRC public workshop will be held in Chicago,
Illinois on November 12, 13, and 14, 1997. Both workshops will be open
to the public. Francis X. Cameron, Special Counsel for Public Liaison,
in the Commission's Office of the General Counsel, will be the convener
and facilitator for the workshops.
DATES: The first workshop will be in Philadelphia on October 28, 1997,
from 9 a.m. to 5 p.m.; October 29, 1997, from 8:30 a.m. to 5 p.m.; and
October 30, 1997, from 8:30 a.m. to noon. The second workshop will be
in Chicago on November 12, 1997, from 9 a.m. to 5 p.m.; November 13,
1997, from 8:30 a.m. to 5 p.m.; and November 14, 1997, from 8:30 a.m.
to noon.
ADDRESSES: The Philadelphia workshop will be held at the Korman Suites
Hotel, 2001 Hamilton Street, Philadelphia, PA 19130, 215-569-7000. The
Chicago workshop will be held at the Ramada Congress Hotel, 520 South
Michigan Avenue, Chicago, IL 60605, 312-427-3800.
FOR FURTHER INFORMATION CONTACT: Francis X. Cameron, Special Counsel
for Public Liaison, Office of the General Counsel, Nuclear Regulatory
Commission, Washington D.C. 20555, Telephone: 301-415-1642.
SUPPLEMENTARY INFORMATION:
Background
The 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 the 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 Commission approval of the staff's program to revise part 35
and associated guidance documents, the staff initiated the rulemaking
process, as announced in 62 FR 42219 (August 6, 1997). The rulemaking
is being conducted 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, have been established to develop rule text alternatives,
rule language, and associated guidance documents. State participation
in the process is 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.
As directed by the Commission, the staff has developed
alternatives, with draft regulatory text, for the more significant
issues associated with the regulation of the medical use of byproduct
material. These alternatives to regulation in specific areas are
intended to help focus the discussion during workshops and meetings
during the Fall of 1997 and to assist the staff in developing the text
of the proposed rule. Alternative regulatory text has been developed
for: (a) The quality management program; (b) training and experience
for authorized users, radiation safety officers, and medical
physicists; (c) radiation safety committee; (d) patient notification of
reportable events; and (e) the threshold for reportable events. In
addition, alternative recommendations for revision of NRC's 1979
Medical Policy Statement have been developed. The alternatives
represent a broad range of possibilities and are being provided 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. The staff has not selected any alternatives at this time
and is open to additional alternatives that might be proposed, which
are consistent with the guidance provided by the Commission.
Workshops
The Commission believes that it is important for interests affected
by the medical use rulemaking to not only have an early opportunity to
comment on the rulemaking issues, but also to have an opportunity to
discuss the rulemaking issues with one another and the Agency.
Accordingly, the Commission is convening two public workshops where the
representatives of the interests that may be affected by the rulemaking
will have an opportunity to discuss the rulemaking issues. Although the
workshops are intended to foster a clearer understanding of the
positions and concerns of the affected interests, as
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well as to identify areas of agreement or disagreement, it is not the
intent of the workshop process to develop a consensus agreement of the
participants on the rulemaking issues.
To have a manageable discussion, the number of participants in each
workshop will be limited. The Commission, through the facilitator for
the workshop, will attempt to ensure participation by the broad
spectrum of interests that may be affected by the rulemaking. 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;
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
rulemaking issues and the workshop discussions at periodic intervals
during the workshops. Questions about participation may be directed to
the facilitator, Francis X. Cameron.
To ensure that each workshop addresses the issues in a consistent
manner, the workshops will have a common pre-defined scope and agenda
focused primarily on the alternatives, with draft regulatory text,
developed by the Part 35 Working and Steering Groups. However, the
workshop format will be sufficiently flexible to allow for the
introduction of additional related issues that the participants may
want to raise. The workshop commentary will be transcribed and made
available to the participants and the public.
Copies of the issue papers developed by the staff will be provided
to the workshop participants. Also, copies will be available for
members of the public in attendance at the workshops, as well as
available through NRC's Public Document Room (U.S. Nuclear Regulatory
Commission, Attention: NRC Public Document Room, Washington, DC 20555-
0001) and on the Internet via NRC's Technical Conference Forum (http://
techconf.llnl.gov/noframe.html).
Public input is solicited during the development of the proposed
rule but, to be most helpful, should be received by March 1, 1998.
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, Md., this 6th day of October 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. 97-27084 Filed 10-10-97; 8:45 am]
BILLING CODE 7590-01-P
