February 7, 2022
Along with voting on training and experience requirements for authorized users, the Nuclear Regulatory Commission (NRC) approved of initiating rulemaking to modernize 10 Code of Federal Regulations (CFR) Part 35.
NRC anticipates there will be an increase in the number of emerging medical technologies licensed by the NRC, as the use of medical applications of radioisotopes continues to increase and new advancements in medical technologies are expected. To address these challenges, the NRC staff recommends updating Part 35 to establish generally applicable, performance-based requirements for emerging medical technologies that would focus on the essential, safety-related elements necessary to ensure radiation safety for workers, patients, and the general public (Option 3). The revised regulation would also include performance-based requirements for rubidium-82 generators, GSR units, and Y-90 microspheres.
Currently, Part 35 does not specifically address rubidium-82 generators, which produce an imaging radiopharmaceutical. In lieu of appropriate regulatory requirements, NRC has relied on enforcement discretion in this area. But, as the staff explained in their rulemaking plan, “longstanding reliance on temporary enforcement guidance to exercise enforcement discretion is inconsistent with NRC Enforcement Policy and is not a substitute for resolving the underlying technical issues associated with calibration and dosage measurement for Rb-82 generators.”
SNMMI is looking forward to attending the various stakeholder calls that will be scheduled and participating in the comment process.