Secretary of energy Jennifer Granholm and secretary of health and human services (HHS) Xavier Becerra on December 20 jointly certified that the worldwide supply of the medical radioisotope molybdenum-99 produced without the use of high-enriched uranium is now sufficient to meet the needs of patients in the United States.
According to the DOE, the certification paves the way for a nuclear nonproliferation milestone and supports U.S. companies by triggering a congressionally mandated ban on exports of proliferation-sensitive HEU for foreign medical isotope production.
Moly-99 supply chain: For decades, the United States had no capability to domestically produce Mo-99, which decays into technetium-99m, the isotope used in more than 40,000 medical diagnostic procedures in the U.S. each day. In order to ensure a stable supply, the U.S. exported HEU to foreign medical isotope producers that used the material to produce Mo-99 for the U.S. and global markets.
Previously, most of the U.S. supply of Mo-99 was produced by Canada’s National Research Universal reactor, which produced about 40 percent of the world's supply of Mo-99 until it ceased operations in 2016. Since then, the majority of Mo-99 has been produced by research reactors in Australia, Belgium, the Netherlands, and South Africa, many of which have been in use since the 1960s. In 2012, Congress passed the American Medical Isotopes Production Act, which directed the National Nuclear Security Administration to establish a technology-neutral program to support the establishment of domestic supplies of Mo-99 without the use of HEU.
Quotes: “Doctors and patients across the globe can be confident that the critical medical isotope Mo-99 will be there when they need it, and we can provide that assurance without making any further exports of highly enriched uranium,” Granholm said. “Today’s certification is another example of DOE’s world-leading expertise creating win-win outcomes that make the world safer while advancing jobs, improving health care, and increasing the quality of life here at home.”
Janet Woodcock, acting commissioner of the Food and Drug Administration, said, “With more than 80 percent of diagnostic imaging in the U.S. relying on nuclear medicine isotopes like Mo-99, the FDA has a key role to play to ensure a sufficient supply is available for critical daily medical procedures.”
Meeting the demand: To build a sufficient supply of non-HEU-based Mo-99, the DOE, through the NNSA, has provided financial and technical assistance to help global Mo-99 producers convert from HEU to low-enriched uranium. The NNSA has also supported the development of a domestic production capability for Mo-99 without the use of HEU by awarding over $200 million in cost-shared cooperative agreements with commercial entities, providing technical support from U.S. national laboratories, and establishing a uranium lease and take-back program for industry.
HHS’s role in achieving this milestone includes approvals for the use of Mo-99 produced by the global suppliers using LEU and the 2018 approval of the application for the Mo-99 production system of NorthStar Medical Radioisotopes, one of the NNSA’s commercial partners. “DOE/NNSA and HHS will continue to work together to further bolster the U.S. supply of non-HEU-based Mo-99,” the DOE said.