The Nuclear Regulatory Commission has issued the final supplemental environmental impact statement (EIS) for SHINE Technology’s application for a license to operate a medical isotope production facility in Janesville, Wis.

In a former farm field just outside the historic town of Janesville in south-central Wisconsin, a large concrete-and-steel building is taking shape. Dubbed the Chrysalis, the building will eventually house eight accelerator-based neutron generators, which start-up company SHINE Technologies will use to produce molybdenum-99. As the precursor to the medical radioisotope technetium-99m, Mo-99 is used in tens of millions of diagnostic procedures every year, primarily as a radioactive tracer.

At the heart of the Chrysalis will be the high-flux neutron generators, being supplied by SHINE’s sister company, Phoenix. The compact accelerators use a deuterium-tritium fusion process to produce neutrons, which in turn induce a subcritical fission reaction in an aqueous low-enriched uranium target (19.75 percent uranium-235) to produce Mo-99.

Nuclear medicine company NorthStar Medical Radioisotopes announced that it has successfully produced molybdenum-99 at its recently completed accelerator production facility at its Beloit, Wis., campus. According to NorthStar, the event marks a major milestone in advancing the company’s proprietary electron accelerator technology for the non-uranium–based production of the critical medical radioisotope.

NorthStar Medical Radioisotopes has completed construction and all equipment installation at its new facility in Beloit, Wis., to produce the medical radioisotope molybdenum-99 without the use of high-enriched uranium, the Department of Energy’s National Nuclear Security Administration announced last week.

BWXT Medical has submitted a new drug application to the U.S. Food and Drug Administration to request approval of its technetium-99m generator for medical imaging. A daughter isotope of molybdenum-99, Tc-99m is used in more than 40 million diagnostic procedures annually. BWXT Medical is a subsidiary of Lynchburg, Va.-based BWX Technologies.

The Nuclear Regulatory Commission is holding a virtual event and teleconference on SHINE Medical Technologies’ plans to license and operate a medical isotope production facility in Janesville, Wis. The online public meeting will be held on July 27 from 7:00 p.m. to 9 p.m. (EDT).

The NRC is also seeking the public’s views regarding the agency’s draft supplemental environmental impact statement for SHINE’s application for a license to operate the facility, particularly regarding the conclusion that the environmental impacts are not great enough to prevent the NRC from considering issuance of the license.

The Department of Energy has determined that the sale, lease, or transfer of up to 750 kilograms of high-assay low-enriched uranium (HALEU) per calendar year to support the production of molybdenum-99 will not have an adverse material impact on the domestic uranium mining, conversion, or enrichment industry.

SHINE Europe, a nascent subsidiary of Wisconsin-based SHINE Technologies, announced Wednesday that it has secured funding to begin designing an advanced medical isotopes facility in Veendam, the Netherlands. The new facility will use the same fusion-based neutron generator system SHINE is employing at its Janesville, Wis., facility to produce medical isotopes, including molybdenum-99, which is used in diagnostic imaging.

The Department of Energy’s National Nuclear Security Administration and Office of Environmental Management (EM) have signed the first contracts under the DOE’s Uranium Lease and Take-back Program with SHINE Technologies. The DOE called it a milestone in its effort to increase domestic production of molybdenum-99 (Mo-99), a medical isotope used in more than 40,000 medical procedures in the United States each day, without the use of high-enriched uranium.

SHINE Technologies, of Janesville, Wis., is one of the NNSA’s cooperative agreement partners. In October 2021, the NNSA awarded SHINE $35 million to support its efforts to produce Mo-99 commercially by the end of 2023.

Click here for more information on the NNSA efforts to establish a reliable supply of Mo‑99 without the use of HEU.

The Department of Energy’s National Nuclear Security Administration has issued a cooperative agreement worth $13 million to Niowave, of Lansing, Mich., to support the commercial production of molybdenum-99, a critical isotope used in more than 40,000 medical procedures in the United States each day, including the diagnosis of heart disease and cancer.

The Canadian Nuclear Safety Commission (CNSC) has amended Ontario Power Generation’s (OPG) operating license for its Darlington nuclear power station near Clarington, Ontario, allowing the company to produce the medical radioisotope molybdenum-99 using Darlington’s Unit 2 CANDU reactor. OPG subsidiary Laurentis Energy Partners, in conjunction with BWXT Medical, is leading the program to produce Mo-99 at Darlington.

The Department of Energy’s National Nuclear Security Administration has issued a cooperative agreement worth $35 million to SHINE Technologies, based in Janesville, Wis., to support the commercial production of molybdenum-99, a critical isotope used in more than 40,000 medical procedures in the United States each day, including the diagnosis of heart disease and cancer.

NorthStar Medical Technologies of Beloit, Wis., will receive $37 million under two cooperative agreements with the National Nuclear Security Administration for the production of molybdenum-99 without the use of high-enriched uranium. Considered a critical medical radioisotope, Mo-99 is used in more than 40,000 medical procedures in the United States each day, including the diagnosis of heart disease and cancer.

SHINE Medical Technologies plans to locate its European medical isotope production facility in the Netherlands after a yearlong search and a review of more than 50 proposals from sites across Europe. The company announced on May 20 that construction at the site should begin in 2023 with commercial production starting in late 2025.

The Nuclear Regulatory Commission has approved a request by SHINE Medical Technologies for an exemption from regulations on how commercial grade equipment is defined, allowing the company to more easily procure components for the medical isotope production facility it is building in Janesville, Wis.

Completing a 5,700-mile journey from Belgium, two 24-ton particle accelerators were delivered to NorthStar Medical Radioisotopes’ facility in Beloit, Wis., on April 22, the Wisconsin State Journal reported. Photos and a video of the accelerators being received at the facility are included in the report.

Darlington nuclear generating station. Photo: OPG

Ontario Power Generation, its subsidiary Laurentis Energy Partners, and BWXT ITG Canada and its affiliates announced on September 24 that the companies are making “significant progress” toward the production of molybdenum-99 at OPG’s Darlington nuclear power plant. Darlington will become the first commercial operating nuclear reactor to produce the medical radioisotope.

A precursor to technetium-99m, Mo-99 is used in more than 40 million procedures a year to detect cancers and diagnose various medical conditions.

Shine Medical Technologies, which is building a medical isotope production facility in Janesville, Wis., said on May 11 that it expects to have an operating license issued by the Nuclear Regulatory Commission by October 2021. Shine’s application seeking approval to operate the facility, which will produce isotopes including molybdenum-99, was accepted and docketed by the NRC last October. Mo-99, the precursor to technetium-99m, is used in more than 40 million medical patient procedures every year.

Belgium’s National Institute of Radioelements (IRE) announced on April 30 that it has produced its first batch of commercial molybdenum-99 from low-enriched uranium (LEU) targets. The first batch of Mo-99, whose decay product, technetium-99m, is used in nuclear medicine for diagnostic imaging, was produced for the U.S. health market. IRE said that the conversion to LEU represents a key milestone for the institute in the global commitment to end the civilian use of highly enriched uranium (HEU) for the production of Mo-99.

The U.S. healthcare industry is warning that the COVID-19 pandemic may threaten supplies of the medical radioisotope molybdenum-99, whose decay product, technetium-99m, is considered the workhorse isotope in nuclear medicine for diagnostic imaging. The online magazine Radiology Business recently reported that the American Society of Nuclear Cardiology (ASNC) alerted its members on April 1 that it is monitoring supply shortages of Mo-99 “more closely than ever” during the pandemic.