By John Stang
Northwest Medical Isotopes (NWMI) made it through a Nuclear Regulatory Commission public hearing Tuesday without major warning signs for its plan to build and operate a medical isotope production plant in Missouri.
It could take the commission anywhere from one to four months to rule on the construction permit for the facility, according to recent schedule estimates.
The Corvallis, Ore., company wants to build a facility in Columbia, Mo., for manufacturing molybdenum-99, which decays into technetium-99m, an isotope used in medical imaging for heart disease, lung disease, cancer, and other health threats. Molybdenum-99 is not produced in the United States, despite the nation accounting for roughly 50 percent of global consumption.
“Congress has identified that this is an area that U.S. should work to rectify,” said NRC Chair Kristine Svinicki.
Northwest Medical Isotopes (NWMI) executives briefed the three commissioners on how the firm addressed design, safety, and environmental matters in planning its facility. The NRC’s Advisory Committee on Reactor Safeguards has recommended approval of the construction permit, and the project cleared an agency staff safety review in December. Staff told the commissioners Tuesday that certain design work will need to be reviewed as work proceeds, and that they wanted NWMI to more extensively explore the site’s soil characteristics and sinkhole potential.
Commissioners asked follow-up questions after the briefings and appeared satisfied with the answers. There seems to be no environmental or safety “showstopper” in the project, Commissioner Stephen Burns said.
Northwest Medical CEO Nicholas Fowler emphasized the company’s intention to provide the United States with a secure, reliable source of moly-99. He noted the “significant shortages” of 2008 to 2010, and cautioned that such a situation could occur again: “As we gather in this hearing, both South Africa and Australia reactor capabilities are currently offline and straining the existing supply chain for moly-99.”
“While the United States continues to receive moly-99 from overseas suppliers, significant amounts are lost in transit due to radioactive decay,” said Michele Evans, deputy director for reactor safety programs at the NRC.
The NRC has already issued a construction permit to one other molybdenum-99 venture: SHINE Medical Technologies, which wants to open a $100 million isotope production plant in Janesville, Wis. The U.S. National Nuclear Security Administration is providing up to $25 million for the project, and construction of the first building began in August 2017.
Northwest Medical does not plan to ask for federal money for its project, which has an undisclosed price tag. Management wants to start construction later this year on 7.4 acres of the 550-acre Discovery Ridge Research Park, finishing in the second half of 2019. It hopes to start commercial operations in early 2020, cranking up to 2,500 6-day curies a week. The plant’s design is currently 40 to 45 percent complete, with expectation that design work will be at least 80 to 85 percent done when construction begins, said Chief Operating Officer Carolyn Haass.
NWMI would use two existing nearby University of Missouri reactors in producing the molybdenum-99, with the company mentioning the potential building of a third reactor if needed.
The company would build a radioisotope production facility to extract the molybdenum from the low-enriched uranium targets complete with a target fabrication area, hot cells to process the molybdenum–99 from the irradiated targets and to manage wastes from the processes. The ground floor would be 52,000 square feet for the main work, with a second floor of 17,000 square feet for utilities, ventilation, and off-gas equipment. A 2,000-square-foot basement would hold one hot cell and a decay vault. A 10,000-square-foot administration building would stand outside of the radioisotope production facility.
Missouri’s central location in the United States would give NWMI an edge over foreign producers in dealing with the short half-lives of the isotopes, company executives told the NRC. The isotopes would be sold to a pharmacy-type business that would then sell the material to hospitals and healthcare providers, according to NWMI’s briefing slides.
“We intend to build production capacity for a minimum of half of the U.S. supply requirements with the ability of surge capacity to go to nearly 100 percent of the U.S. supply as necessary,” Fowler said.
The NRC staff recommended some extra technical conditions be attached to a potential NWMI construction permit, including advanced work on designing the stacks for emissions. Also, staff wanted to ensure that NWMI followed through on its criticality safety and quality assurance plans.
“Obviously, whether we come to an ultimate decision on operation, there are still some steps ahead of us and ahead of the applicant.,” Burns said. NWMI will also have to obtain an operations permit in the future from the NRC.
Fowler cautioned that a good technical plan can still run afoul of the pitfalls of the business world.
“From a purely business standpoint… not from a technical guidance standpoint … the schedule risk and unknown risks are the most challenging and most expensive to manage, and given the small number of companies that have gone through this process, there is significant risk inserted into our businesses because of the lack of precedent actions,” he said.
