Jeremy L. Dillon
RW Monitor
8/29/2014
The Nuclear Regulatory Commission unanimously voted this week 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 NRC’s 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 the project forward, especially in light of the predicted moly-99 shortage in the coming years. “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 record.
With Canada set to stop government spending in 2016 on the National Research Universal (NRU) reactor, one of the world’s largest suppliers of moly-99 and technetium-99m, the medical isotope industry is expecting a shortage in the market in the coming years. This shortage had led to a slew of startups –eight-to-nine companies have already sent the NRC letters of intent to submit construction authorization licenses for a potential Moly-99 production facility—looking to fill the lucrative void. Most, if not all, of these companies have a timeline for the end of 2016/beginning of 2017 for reaching production capabilities, but regulatory hurdles lie ahead. The National Nuclear Security Administration has been helping to jump start domestic production of medical isotopes through a cost-sharing cooperative agreement with four companies to develop technology to produce Moly-99.
NRC Chair Gives Moly-99 Regulation Update
Meanwhile, NRC Chair Allison Macfarlane gave a regulatory update at the American Nuclear Society 8th International Conference on Isotopes in Chicago this week on NRC activities related to Moly-99 production. Macfarlane stressed that any company looking to gain regulatory approval should maintain an on-going dialogue with the NRC to ensure a timely review. “As with nuclear power plants or any of the other facilities we regulate, a complete, high-quality license application is essential for a timely review,” Macfarlane said. “Our staff has been conducting extensive outreach to help ensure that potential licensees understand our regulatory requirements. It’s also important to emphasize that the NRC allocates resources and staff for future work in large measure based on information we receive from the industry regarding planned application submittals. We therefore urge licensees to give us design-mature information as soon as possible and realistic timeframes so we can plan accordingly.”
The Chair reiterated the NRC’s commitment in helping move this federal initiative forward, but she stressed that safety and security will be regulated to the NRC’s usual standards. “The Commission is mindful of the fact that the availability of medical isotopes, regardless of where or how they are produced, enables people to receive medical treatments,” Macfarlane said. “At the same time, the NRC’s responsibility is to ensure that all NRC and Agreement State-licensed facilities operate safely and securely and we intend to apply the same rigorous oversight with respect to isotope production.”
