Comprehensive technical and safety review of large-scale medical isotope production facility complete
JANESVILLE, Wisconsin, Feb. 27, 2023 – SHINE Technologies, LLC, a next-generation fusion technology company, today announced that the U.S. Nuclear Regulatory Commission (NRC) has issued its Final Safety Evaluation Report related to the Operating License Application for SHINE’s large-scale medical isotope production facility, The Chrysalis, in Janesville.
The report provides a comprehensive review of all important safety aspects of the design and operation of The Chrysalis. It concludes that the technical requirements for issuing an operating license have been met.
SHINE’s Operating License Application was filed with the NRC in July 2019. When The Chrysalis is fully operational, the company plans to produce medical isotopes, including molybdenum-99, which powers more than 40 million medical procedures annually to diagnose heart disease, cancer, and other diseases.
“This is an achievement that’s been a decade in the making. In 2013, when we applied for the construction permit to build our isotope facility, we knew we had hard work ahead of us. By reaching this milestone not seen with the NRC in more than 35 years, we’ve managed to accomplish what no startup has done before, and are that much closer to reaching our goal of using fusion to make life-saving medicine,” said Greg Piefer, founder and CEO of SHINE. “We will continue to do the hard things that are important to the world and will unlock value for our shareholders. The achievement of this milestone makes me more confident than ever that our team will be able to do the hard things in nuclear, including growth into waste recycling and ultimately fusion energy.”
SHINE submitted its construction permit application to the NRC in 2013 and was granted that permit in 2016.
In the process of supporting the technical review for the Final Safety Evaluation Report related to the Operating License Application, SHINE responded to more than 300 formal requests for additional information and participated in regulatory audits on more than two dozen topics. After meeting with SHINE over a total of 11 days in 2022, the NRC’s Advisory Committee on Reactor Safeguards, in a letter to the Commission, recommended issuance of the operating license.
“The SHINE team has put in an extraordinary amount of effort over the last 42 months to support the NRC’s technical review,” said Jim Costedio, SHINE Vice President of Regulatory Affairs and Quality. “This is an extraordinary accomplishment in what has been a very successful 10-year regulatory process.”
Recently the NRC also issued the Final Environmental Impact Statement Supplement related to the Operating License Application. The supplement covers matters that differ from, or that reflect significant new information relative to, that considered in the Final Environmental Impact Statement that was prepared in connection with SHINE being issued its construction permit. The Final Environmental Impact Statement Supplement recommends the operating license be issued as proposed.
Production equipment will continue to be installed in The Chrysalis as SHINE keeps the NRC apprised of construction progress. Upon completion of operational readiness inspections, the NRC will decide on the issuance of an operating license.
SHINE’s work in producing medical isotopes is supported by the Department of Energy’s National Nuclear Security Administration’s molybdenum-99 program, which seeks to develop reliable and sustainable domestic production of Mo-99 without the use of highly enriched uranium.
SHINE deploys its safe, cost-effective and environmentally friendly fusion technology in a stepwise approach. Its systems are used to inspect industrial components in aerospace, defense, energy and other sectors. SHINE’s proprietary medical isotope production processes are expected to create molybdenum-99 once its medical isotope production facility, The Chrysalis, is operational, and currently create non-carrier-added lutetium-177. These important medicines are used in tens of thousands of daily procedures to diagnose and treat heart disease, late-stage cancer, and other serious illnesses. In the future, SHINE plans to scale its fusion technology to help solve one of energy’s toughest hurdles by recycling nuclear waste. Through a purpose-driven and phased approach, SHINE aims to generate fusion power to deliver clean, abundant energy that could transform life on Earth. Learn more at shinefusion.com and follow us @shinefusion