May 18, 2021
On May 11, 2021, ASTRO sent a letter to the Nuclear Regulatory Commission urging caution on the NRC staff’s recommendation to initiate rulemaking to establish requirements for rubidium-82 (Rb-82) generators and emerging medical technologies (EMTs). According to NRC staff, if endorsed by the Commission, the rulemaking plan would revise outdated, prescriptive quality assurance regulations with risk-informed, performance-based quality assurance programs, improving the overall flexibility of the NRC’s medical regulations and better accommodating of future EMTs. The NRC staff recommended that the rulemaking address Rb-82 generators along with all current, well-established emerging medical technologies, plus create added flexibility throughout 10 CFR Part 35 to accommodate future emerging medical technologies, such as “radiotheranostics” and novel designs within manual brachytherapy, such as Radiogel and AlphaDaRt seeds. However, ASTRO believes that care must be taken to ensure that the fundamental requirements found in current licensing guidance documents are maintained. This will avoid licensee confusion and aid in the implementation of the revised regulations. Further, we urge the Commission to issue strict guidelines for implementation of a rulemaking plan, ensuring that the rulemaking is focused on true emerging medical technologies and important patient safety provisions, and not changes to existing provisions.