September 19, 2020
SNMMI along with the American Society of Nuclear Cardiology (ASNC), the American Society for Radiation Oncology (ASTRO) and the American College of Radiology (ACR) received a response U.S. Nuclear Regulatory Commission (NRC) regarding their request for regulatory relief for training for imaging and localization studies during the COVID-19 Public Health Emergency (PHE). In its letter, the NRC staff states they are "prepared to consider, on an expedited basis, requests for an exemption from the requirement to obtain the hands-on work experience described in 35.290(c)(1)(ii)(G)."
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 June 11th joint letter requested the 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.”
The NRC received a similar request from the Certification Board of Nuclear Cardiology (CBNC), dated June 24, 2020, and has granted that request via a temporary exemption. The exemption allows for individuals seeking board certification to fulfill this work experience requirement virtually, rather than hands-on, from January 31, 2020, the date the U.S. Department of Health and Human Services declared a PHE for the U.S., through December 31, 2020. Notwithstanding the regulatory relief provided by this exemption, a licensee that uses generator systems should, as soon as is safely possible, provide hands-on work experience involving the tasks described in 10 CFR 35.290(c)(1)(ii)(G) to its authorized users that obtained this work experience virtually.