ML20198L872
| ML20198L872 | |
| Person / Time | |
|---|---|
| Issue date: | 10/06/1997 |
| From: | Cool D NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | |
| Shared Package | |
| ML20198L846 | List: |
| References | |
| FOIA-97-358, FRN-62FR42219, RULE-PR-35 NUDOCS 9710270201 | |
| Download: ML20198L872 (5) | |
Text
,
J 3 Submitted _on October 6,1997 f or publication in the l'ederal Register. ;
(7590 01 P) !
NUCLEAR REGULATORY COMMISSION ,
1 10 CFR Part 35 Medical Use of Byproduct Material; Workshops AGENCY: U.S. Nuclear Regulatory Commission.
ACTION: Notice of workshops.
SUMMARY
- ' The Nuclear Regulatory Commission has initiated a rulemaking for a comprehensive revision of its regulations governing the medical use of byproduct materialin 10 CFR Part 35. As part of this rulemaking, the Coriimission intends to solicit the active input of i
i the various interests that may be affected by the rulernaking eariy 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 relision of Part 35. The first NRC public workshop i
! 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 worksheps 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 9:00 a.m. to 5:00 p.m.; October 29,1997, from 8:30 a.m. to 5:00 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 9:00 a.m. to 5:00 l p.m.; November 13,1997, from 8:30 a.m. to 5:00 p.m.; and November 14,1997, from 8:30 a.m.
f' to noon.
ADDRESSES: The Philadelphia workshop will be held at the Korman Suites Hotel, 2001 5:
Hamilton Street, Philadelphia, PA 19130,215-569-7000. The Chicago workshop will be held at A
97 02 g 1 971022 h IhJ- __ _7-ase con m e - ._ _ _ _ _ , _
the Ramada Congress Hotel,520 South Michigan Avenue, Chicago, IL 60005, 313-427 3800.
FOR FURTHER INFORMATION CONTACT: Francis X. Cameron, Special Counsel for Public I
Liaison, Office of the General Counsel, Nuclear Regulatory Commission, Washington D.C.
20555, Telephone:301-4151642.
SUPPLEMENTARY INFORMATION: ,
Background
The NRC has examined the issues surrounding its medical use program in great detail I
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 (D017)(released September 16,1996). In its " Staff Requirements Memorandum (SRM) COMSECY 90 057, 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, j of the staffs proposed program in SECY 97131, SupplementalInformation on SECY-97115
" Program for Revision of 10 CFR Part 35, ' Medical Uses of Byproduct Material,' and Associated Federal Beaister Notice," dated June 20,1997.
4 After Commission approval of the staffs program to revise Part 35 and associated guidance documents, the staff initiated the rulemaking process, as announced in 62 FR 42219 ,
a
1 o'
(August 6,1997). The rulemaking is being conducted using a group approach. A Wo king ,
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 afternatives, 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 potentialimpacts 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 matenal. 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 allinterested 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.
i l J
- / .
.~ i 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 un the rulemaking issues, but also to have an oppmiunity to discuss the rulemaking issues with one another and the Agency, l . Accordingly, tb 'ommission is convening two public workshops where the representatives of )
I I
- the interests that may be affected by the rufemaking will have an opportunity to discuss the i rulemaking issues. Although the workshops 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 workshop process to develop a consensus agreement of l
]
l l the participants on the rulemaking issues. ;
i >
5 To have a manageable discussion, the number of participants in each workshop will be f
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
_i_nterests include: nuclear medicine physicians; physician specialists, such as cardiologists and radiologists; medical physicists; medical technologists; nurses; medical education and l _
certification organizations; radiopharmaceuticalinterests; hospital administrators; patients rights advocates; Agreement States; ~ Federal agencies; and experts in risk analysis. Other members 1
[ 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 facihtator, Francis X, Comeron.
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 Groupe
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 i
will be transcribed and made available to the participants and the public.
i i
Copies of the issue papers developed by the staff will be provided to the workshop 1
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, Maryland this f_ th day of S A@ * .1997.
For the Nuclear Regulatory Commission.
'fff f. ,
Donald A. Cool, Director, Division of Industrial and Medical Nuclear Safety, Office of Nuclear Material Safety and Safeguards.
\ _M