Jeremy L. Dillon
RW Monitor
7/11/2014
The Nuclear Regulatory Commission staff is seeking Commission approval to enable a speedier and more efficient review of Shine Medical Industries’ low-energy neutron source design for the production of molybdenum-99. 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. Shine 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, NRC Staff is seeking Commission approval to apply the facility as a “utilization facility” under 10 CFR 50 as a way to speed the process up. “The NRC staff has determined that the regulations for utilization facilities in 10 CFR Part 50 provide the most appropriate, efficient, and effective licensing process for the SHINE irradiation units,” the NRC Staff said in a SECY letter to the Commission, released last week. “However, while it is within the NRC’s authority to designate each of SHINE’s proposed irradiation units as a utilization facility under the Atomic Energy Act of 1954, as amended (AEA), the irradiation units do not meet the current definition of utilization facility in 10 CFR 50.2.”
For this to move forward, the Staff needs Commission approval to publish a direct final rule and companion proposed rule. The Staff argued that Shine’s irradiation units operate similar to how a nuclear reactor works. “The premise of the SHINE technology is that the irradiation units will not be operated such that the effective neutron multiplication factor is greater than or equal to 1.0, a range for which nuclear reactors are designed, analyzed, and licensed to operate safely,” the Staff said. “Instead, the irradiation units will only operate in a minimally subcritical range of [that factor]. To operate safely within this margin of subcriticality, the irradiation units are designed with several features of a nuclear reactor except that, by design, the target solution vessels have insufficient reactivity to sustain a chain reaction.”
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 to reaching production capabilities, but regulatory hurdles lie ahead. The National Nuclear Security Administratoin 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. Shine was one of these companies. Shine submitted a construction permit application to the NRC in 2013 and expects to be operational by early 2017.
