SNMMI Requests Regulatory Relief for Training for Imaging and Localization Studies

June 11, 2020

Today, SNMMI along with the American Society of Nuclear Cardiology (ASNC), the American Society for Radiation Oncology (ASTRO) and the American College of Radiology (ACR) requested regulatory relief for training for imaging and localization studies during the COVID-19 Public Health Emergency (PHE). The current regulation reads, “Work experience must involve: Eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs.” 10 CFR Part 35.290 (c)(1)(ii)(G)

The joint letter requested Nuclear Regulatory Commission (NRC) to allow this requirement to be met using virtual technology (video/webinar), and adds this as an already vetted area for regulatory relief when requested by licensees. This request is similar to our NRC Advisory Committee on the Medical Uses of Isotopes (ACMUI) subcommittee recommendation for a one-time modification due to COVID-19. The request stated, “In situations when hands-on training (hot lab) is not feasible, then video/webinar observational training may be considered.  Similarly, when work experience cannot be met in person, then virtual training may be considered.”