Landmark Certification Demonstrates Success in Producing Molybdenum-99 Without Use of Proliferation-Sensitive Highly Enriched Uranium
WASHINGTON, D.C.— U.S. Secretary of Energy Jennifer M. Granholm and U.S. Secretary of Health and Human Services (HHS) Xavier Becerra jointly certified that there is now enough worldwide supply of the medical isotope molybdenum-99 (Mo-99) made without using highly enriched uranium (HEU) to meet the needs of patients in the United States. This certification paves the way for a nuclear nonproliferation milestone and supports U.S. companies by triggering a congressionally mandated ban on exports of HEU for foreign medical isotope production. HEU is a proliferation-sensitive material that, if diverted or stolen, could be used as a component of a nuclear weapon.
“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,” said Secretary of Energy Jennifer M. Granholm. “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.”
Mo-99 is an isotope used in more than 40,000 medical diagnostic procedures in the United States each day. For example, patients undergoing a common procedure—the cardiac “stress test”—likely have benefited from this medical isotope. For decades, the United States had no capability to produce Mo-99 domestically. In order to ensure a stable supply, the United States exported HEU to foreign medical isotope producers, which used the material to produce Mo-99 for the U.S. and global markets.
“With more than 80% 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,” said Acting FDA Commissioner Janet Woodcock, M.D. “We’re pleased to partner with DOE and other federal partners to contribute to this important achievement.”
HEU is sensitive in terms of nuclear proliferation, and DOE’s National Nuclear Security Administration (NNSA) works to minimize the civilian use of HEU globally.
Achieving a sufficient supply of Mo-99 produced without the use of HEU is a result of significant accomplishments by DOE, HHS, and the commercial Mo-99 industry. DOE/NNSA has provided financial and technical assistance to help global Mo-99 producers convert from HEU to low enriched uranium LEU. DOE/NNSA has also supported the development of a domestic production capability for Mo-99 without use of HEU by awarding over $200 million in cost-shared cooperative agreements with commercial entities, providing technical support from the U.S. national laboratories, and by 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 New Drug Application the Mo-99 production system of NorthStar Medical Radioisotopes, one of 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.