By John Stang
The U.S. Nuclear Regulatory Commission has formally accepted SHINE Medical Technologies’ application to obtain a 30-year operating license for its planned 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. The license application will now undergo a full review covering the technical plans for the environmental, public health, safety, and physical 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 roughly one month of the letter, to submit a comprehensive outline of the information it will want as part of its audit, Lynch wrote.
Lynch’s letter describes 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, headquartered in the city of Janesville, received its NRC construction permit for the plant there in February 2016. Excavation began in September, and workers are scheduled to begin laying concrete this month, according to an Oct. 15 company press release.
The company 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 believe it can eventually produce one-third of the world’s need for Mo-99.
The Janesville facility is also expected to produce lutetium-177, a therapeutic isotope used to treat neuroendocrine cancer that is being researched for the potential treatment of metastatic prostate cancer. It will also produce iodine 131, iodine-125 and xeon-133, which are used for various diagnostic and therapeutic purposes.
SHINE hopes to finish construction and begin production in 2021, reaching a commercial level of output in 2022. However, that timetable is possible only if there are no delays in the NRC review process.
The proposed 43,000-square-foot Janesville facility is to have eight units in which low-enriched uranium would be irradiated to produce Mo-99. Each unit will hold a neutron generator that SHINE has been co-developing with Phoenix LLC, a Monona ,Wisc., company that designs and builds neutron generators for various purposes. A neutron generator contains a particle accelerator that bombards a target with ions — a process starting to be used for production of Mo-99 without having to send highly enriched or low-enriched uranium to a reactor, which is the current standard approach for generating the isotope.
On Oct. 2, Phoenix and SHINE announced that their generator achieved a new world record in nuclear fusion reactions in a steady-state system — 46 trillion neutrons per second — in July. That beat the previous world record by close to 25 percent. Another test showed the neutron generator operating 132 hours with 99 percent uptime during that period. Those achievements increase the neutron generator’s potential for reliable production of mo-99, the two companies said in a news release.
Last week, SHINE also announced that it has secured $50 million in financing from the investment firm Oaktree Capital Management to support ongoing construction of the site.
“We are excited to welcome Oaktree to SHINE’s growing list of top-tier institutional investors,” Piefer said in a press release. “Oaktree has broad expertise in complex infrastructure projects like our medical isotope facility. It joins Deerfield Management, a leading health care investment firm, as one of our key partners.”
In late 2018, SHINE also received $150 million — to be paid in installments — from Deerfield, a New York City-based healthcare investment firm, to help fund construction. That means the company has received at least $200 million in private investments. In two separate agreements, the U.S. National Nuclear Security Administration has also committed $40 million to SHINE as part of the agency’s mission to promote domestic production of Mo-99 without use of weapon-grade uranium.
SHINE has not revealed how much the facility will cost to build.
