Modernizing NRC Regulations for Byproduct Material Use

SOFIE Biosciences, a national PET radiopharmacy network, supports the NRC's proposed modernization of byproduct material regulations. They argue that the new rules will improve operational resilience, promote consistency across jurisdictions, and better align regulatory requirements with modern radiopharmaceutical technologies to improve patient access.

The National Association of Nuclear Pharmacies (NANP) supports the NRC's proposed rule to modernize regulations for byproduct material use, praising its risk-informed approach to reducing regulatory burdens. While supportive, they specifically recommend increasing the Appendix B value for germanium-68 from 10 µCi to 100 µCi to better reflect operational risks and facilitate patient access.

Zeno Power Systems, Inc., a company developing radioisotope power systems (RPS), supports the NRC's efforts to modernize byproduct material regulations to reduce administrative burdens. They specifically advocate for the inclusion of language that establishes a framework for fleet-wide licensing of RPSs once the technology is demonstrated and market demand is established.

The Society of Nuclear Medicine and Molecular Imaging (SNMMI) supports the NRC's proposed rulemaking to modernize byproduct material regulations, noting it will reduce regulatory burdens and increase patient access to radiopharmaceuticals. The organization specifically advocates for risk-informed radionuclide activity values, the creation of standard general licenses (SGLs), and expanded distribution pathways for microsources.

The Nuclear Information and Resource Service (NIRS), Citizens Awareness Network (CAN), and Don’t Waste Michigan (DWM) oppose the proposed rule change, arguing that it relaxes safety standards and increases public risk without sufficient scientific analysis or justification. They specifically oppose increasing allowable radiation exposure levels for decommissioning and the creation of a new "Standard General License" class, which they claim would reduce transparency and public safety.

Subatomic Industries Corp., a new uranium exploration and development company, strongly supports the proposed rule's deregulatory direction to reduce barriers for new market entrants. They specifically advocate for a robust Standard General License (SGL) framework, modernized decommissioning financial assurance, and streamlined well logging requirements to facilitate domestic uranium production.

The Health Physics Society, a nonprofit scientific and professional organization specializing in radiation safety, submitted comments regarding the proposed modernization of byproduct material regulations. They request that the NRC provide a safety evaluation for including Mo-99/Tc-99m generators in the Standard General License and argue for the inclusion of PET radionuclides to ensure regulatory consistency within the same diagnostic use class.

The American Society of Nuclear Cardiology (ASNC) supports the NRC's proposed rulemaking to modernize regulations for byproduct material use, specifically praising the updates to decommissioning requirements and general licensing. They advocate for further expansion of these modernizations to include PET radionuclides for diagnostic imaging to align with current medical practices.

The American Society for Radiation Oncology (ASTRO) supports the proposed updates to modernize NRC regulations for byproduct material use. They specifically advocate for the exemption of certain radionuclides from decommissioning cost estimates, the creation of Standard General Licenses for specific medical uses, the removal of the redundant "physician" definition, and expanded distribution pathways for microspheres to reduce regulatory burdens and improve patient access.