The U.S. Nuclear Regulatory Commission has formally accepted SHINE Medical Technologies’ application to obtain a 30-year operating license for a proposal medical isotope production facility in Wisconsin.
The agency said in a Federal Register notice, issued Saturday and dated Tuesday, that it had docketed the application following its acceptance review. That license application will now undergo a full technical review covering environmental, safety, and security aspects of the project.
“Notwithstanding the acceptance and docketing of the application, the NRC staff has determined that additional information is necessary to complete a detailed technical review,” Steven Lynch, Project Manager for the NRC’s Research and Test Reactors Licensing Branch, wrote in the Oct. 8 letter to SHINE founder and CEO Gregory Piefer. “As such, the NRC staff plans to promptly engage SHINE in public meetings and conduct regulatory audits to efficiently resolve certain information gaps as part of a detailed technical review of the application.”
The regulator expects, within “approximately 30 days” of the letter, to submit a comprehensive outline of the information it will want as part of its audit, Lynch wrote.
Lynch’s letter described SHINE’s application as “a first-of-a-kind submission involving a novel use of technology for which there is limited precedent to establish consistent standards for acceptance.” He estimated the NRC review could take three years.
SHINE, based in the city of Janesville, plans to use accelerator-based neutron source technology to produce the medical isotope molybdenum-99 (Mo-99). Molybdenum-99 decays into technetium-99m, which is used in 40 million medical procedures each year around the world, including diagnosing various cancers. SHINE believes it can eventually produce one-third of the world’s need for Mo-99.
