NRC Staff Seeks Approval to Help Shine Application

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, the Staff is seeking Commission approval to apply the facility as a “utilization facility” under 10 CFR 50 to this review 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.”