NRC ACMUI Briefs Commission on Written Attestation Requirements and Increased Controls
The U.S. Nuclear Regulatory Commission (NRC) Advisory Committee on the Medical Uses of Isotopes (ACMUI) met on April 28 and 29 in Rockville, Maryland. After the meeting, ACMUI members Leon Malmud, MD (Chair), Douglas Eggli, MD, and Richard Vetter, PhD, briefed the Commissioners on medical licensees’ concerns regarding the written attestation requirements in 10 CFR Part 35 and the financial impact on medical facilities of the fingerprinting orders for increased controls. ACR government relations staff and other representatives of the stakeholder community were in attendance.
During the committee meeting, ACMUI discussed the ongoing Y-90 microsphere guidance revision efforts, the National Academy of Sciences (NAS) study on replacement of CsCl sources, causes of medical events, and other topics. Sally Schwarz, RPh, MS, nearing the end of her term as the nuclear pharmacist representative on ACMUI, discussed F-18, O-15, and C-11 production and internal delivery systems at Washington University in St. Louis. Additionally, NRC staff requested the committee’s guidance on potential revisions to the abnormal occurrence (AO) criteria to capture only medical events resulting in long-lasting harm.
The public Commission briefing was subsequent to the ACMUI meeting. Dr. Eggli, on behalf of the committee, asked the Commissioners to modify the written attestation requirements for individuals seeking Authorized User (AU) or Radiation Safety Officer (RSO) status, because attesting to a person’s competency could have legal implications for the preceptor. Instead, ACMUI recommended that “competency” be changed to “mastery of a body of knowledge.” The other major concern was that the attestation statement is mandatory for all prospective AUs and RSOs—even those already board certified. Many stakeholders think that the preceptor’s attestation should only be required for those applicants without board certification. The Commissioners were receptive to ACMUI’s concerns and asked NRC staff to develop alternatives.
Following Dr. Eggli’s presentation, Dr. Vetter discussed the fingerprinting orders for personnel with unescorted access to radioactive material in quantities of concern (RAMQC). ACMUI was concerned that the order was an unfunded mandate, and that the cost would be burdensome for hospitals with no added security benefit. The Commissioners were less receptive to these concerns, and stated that Congress limited NRC’s flexibility on fingerprinting issues.
Visit the NRC ACMUI website for additional information: http://www.nrc.gov/about-nrc/regulatory/advisory/acmui.html