NRC Approves Faster Regulatory Path for SHINE Moly-99 Technology

The Nuclear Regulatory Commission unanimously voted yesterday to approve the Staff’s proposal to enable a speedier and more efficient review of SHINE Medical Industries’ low-energy neutron source design for the production of molybdenum-99 under the 10.CFR.50 regulations. SHINE is one of several companies trying to get through the regulatory hurdles to begin the production of the medical isotope used in millions of medical procedures annually. The company submitted a construction authorization application to the NRC back in December to gain approval for its production design, but because the irradiation elements of the design do not match current regulations, the NRC Staff sought Commission approval to apply the facility as a “utilization facility” under 10 CFR 50  as a way to speed the process up.

 

In the individual commissioner vote docket, each commissioner cited the importance of moving this forward, especially in light of the predicted moly-99 shortage. “After a review and considerations of the staff’s regulatory analysis and discussion of options, I conclude that this rule of particular applicability presents the superior option for addressing the unique technology presented by SHINE within a regulatory process that will be efficient and effective, while avoiding over inclusion or other unintended effects to existing or future licensees, which could possibly occur under a rule of general applicability,” Commissioner Kristine Svinicki said in her vote reasoning.