The Nuclear Regulatory Commission said submissions must be filed by 10 March 2020 by anyone who wishes to participate in the hearing process for the application.
Shine has proposed to construct and operate a facility in Janesville, Wisconsin for the production of the radioisotope molybdenum-99 (Mo-99) through the irradiation and processing of a uranyl sulfate solution. The company said this patented process replaces a nuclear reactor with a low-energy, accelerator-based neutron source.
This source functions by colliding deuterium ions with tritium gas to cause fusion. The fusion reaction results in high energy neutrons and helium-4. In other words, the accelerator takes a radioactive by-product created by nuclear power plants (tritium) and turns it into the same clean, harmless gas used to make balloons float.
According to the NRC, the proposed facility would comprise of an irradiation facility and a radioisotope production facility. The irradiation facility would consist of eight subcritical operating assemblies, or irradiation units.
The NRC said the Shine operating licence application is a first-of-a-kind submission involving a novel use of technology for which there is “limited precedent to establish consistent standards for acceptance”.
It said that in light of recurring global supply chain disruptions for Mo-99, the establishment of a domestically-produced commercial supply of the radioisotope is in the interest of public health. It said the production of Mo-99 without the use of highly-enriched uranium supports US national security interests and nuclear non-proliferation policy objectives.
Shine said the facility will be capable of supplying two-thirds of the US patient demand for Mo-99, which decays into the diagnostic imaging agent technetium-99m (Tc-99m), which is used in more than 40 million medical imaging procedures each year, primarily to diagnose heart disease and cancer.
The supply of Mo-99 and Tc-99m to health care providers has often been unreliable over the past decade due to unexpected shutdowns and extended maintenance periods at some of the nuclear research reactor facilities that produce Mo-99, many of which are relatively old.
These shutdowns have created extended global shortages. In particular in 2009 and 2010, a series of unexpected outages of some reactors required for Mo-99 production led to a global supply crisis and a severe shortage of Tc-99m.
In February 2019 the US Department of Energy said its goal is to establish reliable supply of Mo-99 made in the US without the use of HEU.
According to DOE data, all Mo-99 in the US is supplied by foreign vendors, most of which still use HEU in their production processes.