03-10010. Announcement of Pubic Meeting

AGENCY:

Nuclear Regulatory Commission.

ACTION:

Announcement of a meeting.

SUMMARY:

The Nuclear Regulatory Commission (NRC) is conducting a rulemaking to amend its regulations for medical use of byproduct material to address issues related to training and experience associated with recognition of Specialty Boards by the NRC. To aid in that process, the NRC is holding a public meeting to solicit input from representatives of professional specialty boards and other interested parties that may be useful in drafting a proposed rule.

DATE/TIME/LOCATION:

The meeting will be held from 8:30 a.m. to 12 p.m. on Tuesday, May 20, 2003, at NRC headquarters, One White Flint North, Room 1F16, 11545 Rockville Pike, Rockville, Maryland.

FOR FURTHER INFORMATION CONTACT:

Roger W. Broseus, Office of Nuclear Material Safety and Safeguards, Division of Industrial and Medical Nuclear Safety, Rulemaking and Guidance Branch, Mail Stop T9-C24, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: [phone]; E-mail: [e-mail]. All persons planning to attend the meeting should contact Ms. Jayne McCausland in advance at [phone] or by E-mail at [e-mail] to facilitate entrance into the building on the day of the meeting. If calling from outside of the Washington, DC metropolitan area, Ms. McCausland can be reached at 1-800-368-5642, extension 6219. Individuals who need accommodations under the Americans with Disabilities Act should also provide advanced notification to Ms. McCausland. Attendees should arrive early to allow time to clear security check points.

SUPPLEMENTARY INFORMATION:

The NRC is conducting a rulemaking to revise 10 CFR part 35, “Medical Use of Byproduct Material,” to address training and experience issues associated with recognition of specialty boards by the NRC. The issues were identified by the NRC's Advisory Committee on the Medical Use of Isotopes (ACMUI) during a briefing of the Commissioners on February 19, 2002, during which they expressed concern there could be potential shortages of authorized individuals without changes to the rule. At the time, the NRC was preparing to publish a final comprehensive revision to 10 CFR part 35. Under provisions of 10 CFR part 35, the use of byproduct material in medicine must be done by or under the supervision of authorized users who meet specific training and experience (T&E) criteria. Likewise, T&E requirements are also specified for an individual serving as Radiation Safety Officer (RSO), Authorized Nuclear Pharmacist (ANP), or Authorized Medical Physicist (AMP). One method of satisfying the T&E requirements specified in the draft-final revision of 10 CFR part 35 was for individuals to be certified by a specialty board “recognized” by the NRC. To be “recognized,” a board's certification process must satisfy the specific requirements for T&E in 10 CFR part 35. However, the ACMUI noted that most boards did not meet the requirements for recognition by the NRC. The ACMUI recommended that the NRC remedy the situation to avoid a shortage of authorized individuals and RSOs. As a result, the Commission decided to retain the original subpart J in 10 CFR 35 to provide a short-term solution. Subpart J was set to be effective for 2 years from the effective date of the final revision to 10 CFR part 35, i.e., until October 2004, thereby continuing the recognition of specialty boards in Subpart J. The Commission instructed the NRC staff to work towards a resolution of the problem during this period of time. Working in consultation with the ACMUI, the staff presented three options for addressing the issues related to recognition of specialty boards in a commission paper dated October 30, 2002. The issues mentioned above, including options for rulemaking, are discussed in more depth in a Commission paper entitled “Options for Addressing Part 35 Training and Experience Issues Associated With Recognition of Specialty Boards by NRC” (SECY-02-0194).

The Commission, in a Staff Requirements Memo (SRM) dated February 12, 2003 (SRM SECY-0-2-0194), directed the NRC staff to proceed with rulemaking related to recognition of specialty boards and the T&E requirements. In the SRM, the NRC staff was directed to move directly to preparing a proposed rule, followed by a final rule, with the expectation that a final rule would be published while subpart J of 10 CFR part 35 remains in effect, i.e., October 24, 2004. This SRM and the associated Commission Paper (SECY-02-0194) referenced above, are available on the NRC's Web site at http://www.nrc.gov/​reading-rm/​doc-collections/​commission.

In addition, the Commission SRM directed the staff to address the following: revise 10 CFR part 35 based on recommendations of the ACMUI (discussed as part of option 3 in SECY-02-0194); list boards recognized by the NRC on it's Web site rather than in the rule; retain in the rule a requirement for a preceptor statement, with the clarifications that a statement of general clinical competency is not required, but, that the attestation should include a statement that the candidate has the knowledge to fulfill the duties of the position for which certification is sought; and, preserve this form of attestation for both pathways of demonstrating adequacy of T&E. The Commission also indicated that, because of the important role of board certification, there should be a clear regulatory determination that all boards, both new and existing, are to meet relevant criteria. Staff was directed to discuss implementing procedures for additions to, or deletion from, the listing of recognized specialty boards.

The purpose of the meeting, to be conducted on May 20, 2003, is to solicit input from stakeholders in the specialty board community, and other interested parties, on the issues discussed above as input to the staff development of a proposed rule. The meeting will be open to observation by the public. The proposed rule will be published for public comment in the Federal Register at a later date and posted on the NRC's RuleForum, located on the web at http://ruleforum.llnl.gov/​.

Dated at Rockville, Maryland, this 16th day of April, 2003.

For the Nuclear Regulatory Commission.

Gary S. Janosko,

Acting Chief, Rulemaking and Guidance Branch, Division of Industrial and Medical Nuclear Safety, Office of Nuclear Material Safety and Safeguards.