January 30, 2019
The Society of Nuclear Medicine and Molecular Imaging (SNMMI) and the American College of Nuclear Medicine (ACNM) submitted joint comments to the Nuclear Regulatory Commission (NRC) on the training and experience requirements for authorized users for medical uses under Subpart E, “Unsealed Byproduct Material—Written Directive Required,” of Title 10 of the Code of Federal Regulations (10 CFR) Part 35, “Medical Use of Byproduct Material.”
As previously reported, the NRC published a Federal Register notice in October 2018, requesting feedback from the public. The Federal Register notice can be accessed here. The NRC also held several public meetings to gain input on several topic areas outlined below.
A. Tailored Training & Experience Requirements
B. NRC’s Recognition of Medical Specialty Boards: The NRC is requesting comments on its recognition of medical specialty boards. The NRC’s procedures for recognizing medical specialty boards are located on the Medical Uses Licensee Toolkit website.
C. Patient Access: The NRC is requesting comments on whether there is a shortage in the number of AUs for 10 CFR 35.300.
D. Other Suggested Changes to the T&E Regulations: In 2002, the NRC revised its regulatory framework for medical use. The goal was to focus the NRC’s regulations on those medical procedures that pose the highest risk to workers, the public, patients, and human research subjects and to structure the regulations to be more risk-informed and more performance-based. The 2002 rule reduced the unnecessary regulatory burden by either reducing or eliminating the prescriptive nature of some regulations. Instead, the rule provided for a performance-based approach that relied on the training and experience of the AUs, authorized nuclear pharmacists, and radiation safety officers. The NRC is requesting comments on whether there are any other changes to the T&E regulations in 10 CFR part 35 that should be considered.
SNMMI-ACNM's comments highlight the importance of patient and public safety, while ensuring access to quality care.
SNMMI has previously submitted comments to the NRC on this issue. You can read SNMMI's comments from 2018 here. Many other stakeholders submitted comments to NRC as well, including the American Board of Nuclear Medicine. ABNM's comments can be viewed here.
You can find general information on the NRC's training and experience evaluation here.