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 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.

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 Association of Physicists in Medicine (AAPM) supports the NRC's proposed rule to modernize byproduct material regulations and reduce administrative burdens. They specifically endorse the Standard General License (SGL) pathway, decommissioning financial assurance updates, and microsource distribution changes, while requesting further technical clarifications on eligibility, leak-testing, and multi-state reciprocity.

The Organization of Agreement States (OAS) opposes the proposed Standard General License (SGL) framework, arguing it creates regulatory confusion, increases inspection workloads for state programs, and poses significant security risks by reducing oversight on radioactive materials. They specifically express concern that the move from pre-licensing reviews to inspections will increase costs and burdens for both regulators and licensees.

The Council on Radionuclides and Radiopharmaceuticals, Inc. (CORAR), an industry association representing manufacturers of radiopharmaceutical drugs and medical radionuclides, supports the NRC's proposed rulemaking to modernize regulations for byproduct material use. They argue that the updates will improve efficiency, reduce unnecessary regulatory burdens, and enhance regulatory consistency across various medical applications while maintaining safety standards.

An independent researcher and environmental policy consultant with a background from the Harvard Kennedy School expresses concern that the proposed rule's cumulative regulatory relaxations will result in insufficient oversight. They specifically argue that these changes could negatively impact the safety profile of emerging technologies like commercial fusion energy by locking in weakened protections.

The commenter, who appears to be a private individual, strongly opposes the proposed amendments to NRC regulations. They argue that the changes would weaken protections against radioactive byproducts, leading to increased risks of cancer and other radiation-related illnesses.