The Nuclear Regulatory Commission has knocked a year off its schedule for the review of SHINE Medical Technologies’ license application to operate its medical isotope production plant in Janesville, Wisc.
The agency had expected it would need 36 months to complete the technical review after the application was formally accepted in October 2019. The anticipated end date is now October 2021, according to a letter Thursday from Steven Lynch, a project manager in the NRC’s Non-Power Production and Utilization Facility Licensing Branch, to SHINE founder and CEO Greg Piefer.
The expedited schedule resulted from public meetings on the application in December 2019 and March of this year, regulatory audits, and additional data from SHINE, Lynch wrote.
Taking into consideration the information exchanged during these public meetings and the regulatory audits, as well as the receipt of supplemental information provided by SHINE, Lynch wrote.
“In the coming months, the NRC staff expects to conduct additional regulatory audits and public meetings with SHINE to further the NRC staff’s understanding of the information provided in SHINE’s operating license application, as supplemented, and promote the efficiency of the NRC staff’s review,” his letter says.
Staff are also likely to request additional data not provided in the initial application and to further confirm that SHINE’s operations would not breach NRC rules or create hazards to human health and safety, Lynch added. In total, the agency expects to expend 22,000 work hours on reviewing the application.
SHNE’s facility will house its accelerator-based neutron-source system for production of the isotope molybdenum-99, which decays into the isotope technetium-99m. That isotope is used widely in the United States and around the world for medical imaging.
Construction began in May 2019, with commercial output anticipated in 2022.
