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SECY-98-263

November 9, 1998

PURPOSE:

To provide the Commission with early feedback on significant concerns raised at the public meetings on the proposed revision of 10 CFR Part 35, "Medical Uses of Byproduct Material;" to obtain Commission direction on performing a risk assessment on the medical uses of byproduct material and extending the public comment period; and to request a "point of contact" from each Commission office for this rulemaking.

BACKGROUND:

In its Staff Requirements Memorandum (SRM) - COMSECY-96-057, "Materials/Medical Oversight (DSI 7)," dated March 20, 1997 (Attachment 1), the Commission directed the revision and restructuring of Part 35 into a risk-informed, more performance-based regulation, (i.e., focus Part 35 on those procedures that pose the highest risk, from a radiation safety standpoint). Therefore, during the development of the regulation, the staff considered information on risk provided by members of the public and professional societies, professional medical standards of practice, and event databases maintained by NRC, to determine where oversight of low-risk activities could be decreased and where there needed to be continuation, or even broadening, of the regulations governing high-risk activities. As a result of these considerations, staff believes that the proposed rule is risk-informed and in accordance with both the Commission's direction and the strategy and goals for nuclear materials safety outlined in Strategic Plan: Fiscal Year 1997-Fiscal Year 2002 (pp.9-12, September 1997)..

Throughout the development of the proposed rule and associated guidance, public workshops were held and opportunities for comment from potentially affected parties were provided, which are not provided by the typical notice and comment rulemaking process. The Federal Register notice for the proposed rulemaking summarized comments received during the developmental stages and noted that there would be a 90-day public comment period that closes on November 12,1998 (63 FR 43515, August 13, 1998).

During the public comment period on the proposed rule, significant regulatory issues have been discussed at facilitated public workshops in San Francisco, Kansas City, and Rockville, between August and October 1998. In addition, these issues were discussed at a Part 35 workshop held in conjunction with the All Agreement States Meeting in October 1998. Summaries of the comments made at the facilitated public meetings have been prepared for the meetings held in San Francisco and Kansas City (Attachment 2). The summary of the Rockville meeting is being prepared and will be forwarded under separate cover. Transcripts of the facilitated public meetings and the workshop are available on the NRC rulemaking website. At the Rockville meeting, the participants specifically requested that two of their concerns -- the need for a risk assessment and extension of the public comment period -- be forwarded to the Commission before the end of the comment period.

On October 30, 1998, a formal request for an extension of the comment period, to allow for the development of the risk analysis and rule accordingly, was submitted to Chairman Jackson by eight professional organizations (Attachment 3). The letter indicates that the 90-day comment period provides ". . . insufficient time to offer meaningful comments on the proposal. . . ." It also states that "Concern was raised that the current activity surrounding risk analysis (the uncompleted report from the Nuclear Byproduct Material Risk Review Group) is not adequate." These organizations offer to ". . . present to the Commission a proposal that describes in detail the type of risk analysis that [they] believe must be performed along with an estimate of the time involved." Finally, the request states that ". . . operating under the existing rules on a temporary basis, in order to develop an appropriate replacement, is preferable to an incomplete and unsupported proposed regulation." The Agreement States endorsed this letter at the recent All Agreement States Meeting.

DISCUSSION:

SIGNIFICANT CONCERNS STATED DURING THE MEETINGS INCLUDED:

• Risk assessment: Some participants believed that NRC has not adequately assessed the risk of the various modalities for medical use because a formal risk assessment was not done. Three major comments were made on the need for a risk assessment: (1) NRC has not fully accounted for the low risk in diagnostic nuclear medicine; (2) relative risk must be considered because risk can occur from both action and inaction in medicine; and (3) NRC should perform a risk assessment, with stakeholders involved in the selection of the methodology, and publish the results for comment before it proceeds with any revision of its medical use program.
  
  
• Comment period: The majority of the participants at the public meeting believed that: (1) the 2-year period for revising the rule and associated guidance did not provide enough opportunity for them to provide input and work with the staff in developing the rulemaking; and (2) the 90-day public comment period was too short to review, thoroughly understand, and comment on such a major rulemaking. Although the comment period is longer than the minimum 75-day comment period, the participants noted that the comment period for Part 35 is no longer than for less significant rulemakings. In addition, some participants stated that the schedule for the rulemaking should include re-publication of the proposed rule after it has been revised to incorporate the public comments.
  
  
• Training and experience: Issues ranged from the broad issue of whether NRC should specify the number of hours of training for various individuals, to modality-specific issues presented by medical specialists (e.g., endocrinologists and cardiologists).
  
  
• Board certification: Issues include the proposed criteria to review medical specialty boards that want to be examining organizations, and the current process used by boards to approve individuals.
  
  
• Radiation Safety Committee: Concerns were raised over the proposed deletion of the requirement for a Radiation Safety Committee (RSC), because some participants believe the RSC is imperative for effective implementation of a licensee's radiation safety program.

OPTIONS FOR COMMISSION DIRECTION ON THE NEED TO PERFORM A RISK ASSESSMENT AND TO ADJUST THE SCHEDULE FOR THE RULEMAKING:

OBTAIN "POINT OF CONTACT" FROM EACH COMMISSION OFFICE

The staff requests that each Commissioner designate a member of his/her office to serve as a point of contact with the staff for this rulemaking. This would be especially useful if the current schedule for the rulemaking, to be completed in June 1999, were retained. Having a point of contact would enable: (1) the Commission to be promptly informed of any significant issues raised by the stakeholders and to be provided with options for resolution of these issues; and (2) the staff to receive timely Commission direction on resolution of these issues and to continue with development of a final rule within the approved schedule.

RESOURCES:

Option 1 (status quo) would have no resource impact. Option 2 (extend the comment period) would result in at least a 0.5 FTE increase in the resources identified in the FY 2000 budget submission for the rulemaking. Option 3 (perform some type of risk assessment) would require different level of resources, depending on which sub-option is approved. Option 3A would require the most resources because it includes a formal risk assessment on the entire rule; estimated resources for this sub-option are up to 10 FTE over a 5-year period plus several million dollars for an outside contract to perform the risk assessment. None of these resources are included in the present budget submission or in the Operating Plan.

RECOMMENDATION:

The staff recommends Option 2B which is responsive to the unanimous request of the participants at the Rockville workshop for extension of the comment period and will not unduly delay the final rule.

COORDINATION:

The Office of the General Counsel has reviewed this paper and has no legal objection. The Office of the Chief Financial Officer has reviewed this Commission Paper for resource implications and has no objections. The Office of the Chief Information Officer has reviewed the proposed rule for information technology and information management implications and concurs in it.