NRC ACMUI Public Teleconference
The US Nuclear Regulatory Commission (NRC) Advisory Committee on the Medical Uses of Isotopes (ACMUI) hosted a public teleconference on July 21, 2008 to discuss the status of several issues, including the rulemaking to clarify “medical event” criteria in permanent brachytherapy, the medical physicist petition for rulemaking, and draft guidance for training and education to achieve authorized use (AU) status for use of Y-90 microspheres.
The first issue discussed was the NRC’s rulemaking to address medical event criteria in permanent brachytherapy procedures. ACMUI members—specifically, those involved with radiation oncology—expressed their concerns about differences in defining seed placement in and outside of the treatment site between the committee’s original recommendations and the preliminary draft rule released in February 2008. They indicated that an ACMUI preview of the preliminary draft rule prior to its public release would have been best to resolve differences between the committee’s recommendations and the rulemaking before public release.
The next publicly visible step in the rulemaking process will be the publication of the proposed rule in the Federal Register, expected to occur in the near future. This will afford stakeholders the opportunity to comment.
The second issue discussed by the committee was the recently published resolution of the petition for rulemaking to revise 10 CFR Part 35 to grandfather prospective Authorized Medical Physicists and Radiation Safety Officers with board certifications that were acceptable prior to October 25, 2005. At this writing, only individuals specifically listed on a NRC or Agreement State license on or before October 25, 2005 are grandfathered and all others are not, regardless of board certification status. The NRC indicated in their resolution that they would address the issue through the rulemaking process if a technical basis could be developed.
NRC staff reported to ACMUI members that they would soon be contacting the relevant certification boards to help compile data in preparation for the technical basis. The committee recommended that NRC contact the various professional associations in addition to the certification boards. NRC has not yet solidified a timetable for the coordination and development of the technical basis.
The final issue addressed by the committee was the effort to revise training and education requirements for the authorized use of Y-90 microspheres. ACMUI voted to accept the manufacturers’ recommendations to allow a one-day course followed by three cases supervised by the manufacturer or three cases supervised by an AU proctor as acceptable alternative criteria for achieving eligibility for AU status for use of these products. The committee’s recommendation will now be considered by NRC staff.
The next ACMUI meeting is scheduled to occur in October 2008.