Byproduct material; medical use: Regulatory revision— Workshop,

[Federal Register: October 16, 1998 (Volume 63, Number 200)]

[Proposed Rules]

[Page 55559-55560]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr16oc98-27]

NUCLEAR REGULATORY COMMISSION

10 CFR Part 35

Medical Use of Byproduct Material; Workshop

AGENCY: U.S. Nuclear Regulatory Commission.

ACTION: Notice of workshop.

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 is now soliciting comments on the proposed rule and MPS through

[[Page 55560]]

two mechanisms--publishing the documents in the Federal Register for a 90-day public comment period (63 FR 43516 and 63 FR 43580, August 13, 1998); and convening facilitated public meetings and a workshop, during the public comment period, to discuss the Commission's proposed resolution of the major issues. The workshop on NRC's medical rulemaking initiative will be held during the Organization of Agreement States' (OAS) 1998 All Agreement States Meeting, in Bedford, New Hampshire.

DATES: The workshop will be held on October 31, 1998, from 9 a.m. to 12 noon.

ADDRESSES: The Wayfarer Inn, 121 South River Road, Bedford, NH 03110, telephone 603-622-3766.

FOR FURTHER INFORMATION CONTACT: Cathy Haney, U.S. Nuclear Regulatory Commission, Office of Nuclear Material Safety and Safeguards, telephone 301-415-6825, e-mail cxh@nrc.gov.

SUPPLEMENTARY INFORMATION: After a comprehensive review of its medical use program, the Commission directed the staff to revise 10 CFR part 35, associated guidance documents, and, if necessary, the Commission's 1979 MPS (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 staff's proposed plan for the revision of Part 35 and the Commission's 1979 MPS. The schedule the Commission approved in SRM-SECY-97-115 provides for the rulemaking to be completed by June 1999. 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 proposed rule and MPS were developed using a group approach. A Working Group and Steering Group, consisting of representatives from NRC, OAS, and the Conference of Radiation Control Program Directors, Inc., 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: (1) 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; (2) focus on those requirements that are essential for patient safety; (3) 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; (4) incorporate regulatory requirements for new treatment modalities; (5) reference, as appropriate, available industry guidance and standards; and (6) provide for capturing relevant safety-significant events.

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. Based on the worthwhile public input received during the early rulemaking process, the Commission believes that it is important for interests affected by the proposed revisions not only to have an opportunity to comment on the proposed rulemaking and MPS, but also to have an opportunity to discuss the proposed revisions with one another and the Commission. Accordingly, the Commission is convening three public meetings (63 FR 39763, July 24, 1998) and a workshop, 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.

The workshop will be open to the public, on a space available basis. The agenda for the workshop will focus on discussion of: (1) The proposed revision of part 35 and the MPS; (2) proposed changes in licensing, inspection and enforcement philosophy; (3) implementation costs; (4) resolution of cross-cutting issues; and (5) Agreement State issues. However, the workshop will also provide enough flexibility for the public to have an opportunity to comment on related rulemaking issues.

Members of the public who are unable to attend the workshop can send comments to Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff, or provide comments via NRC's interactive rulemaking website through the NRC home page (http://www.nrc.gov). The comment periods for the proposed rule and the MPS end on November 12 and November 13 ,1998, respectively. Comments received after these dates will be considered if it is practical to do so, but the Commission is only able to ensure consideration of comments received on or before these dates.

Dated at Rockville, Maryland this 9th day of October, 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. 98-27809Filed10-15-98; 8:45 am]

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