Production of Mo-99 Without Highly Enriched Uranium

U.S. Secretary of Energy Jennifer M. Granholm and U.S. Secretary of Health and Human Services (HHS) Xavier Becerra have jointly certified that there is now a sufficient worldwide supply of the medical isotope molybdenum-99 (Mo-99), made without highly enriched uranium (HEU), to meet the needs of patients in the United States.

HEU is a proliferation-sensitive material that, if diverted or stolen, could be used as a component of a nuclear weapon.

"Doctors and patients around the globe can be confident that the critical medical isotope Mo-99 is there when they need it, and we can provide that assurance without further exports of highly enriched uranium," said DOE Secretary Jennifer M. Granholm. “Today's certification is another example of DOE's world-leading expertise creating win-win results that make the world safer while promoting jobs, improving health care and enhancing the quality of life at home."

Molybdenum-99 is an isotope that is used in more than 40,000 medical diagnostic procedures every day in the United States. For example, patients undergoing a common procedure: a cardiac "stress test" are likely to benefit from this medical isotope. For decades, the U.S. did not have the capacity to produce molybdenum-99 domestically, and to ensure a steady supply, the U.S. exported HEU to foreign medical isotope producers who used the material to produce Mo-99 for the U.S. and global markets.

“Since more than 80 percent of diagnostic imaging in the United States relies on nuclear medicine isotopes like molybdenum-99, the FDA plays a critical role in ensuring adequate supplies for critical routine medical procedures," said Janet Woodcock, M.D., acting FDA commissioner. "We are pleased to work with the Department of Energy and other federal partners to contribute to this important accomplishment."

HEU is sensitive in terms of nuclear proliferation, and the Department of Energy's National Nuclear Security Administration (NNSA) works to minimize the civilian use of highly enriched uranium globally.

Achieving an adequate supply of Mo-99 produced without HEU is the result of significant accomplishments by DOE, HHS, and the commercial molybdenum-99 industry. DOE/NNSA has provided financial and technical assistance to help global Mo-99 producers convert from HEU to LEU. DOE/NNSA has also supported the development of domestic molybdenum-99 production without HEU through cost-sharing cooperative agreements with commercial entities in excess of $200 million, technical support from U.S. national laboratories, and the establishment of a uranium lease and take-back program for industry.

HHS's role in achieving this milestone includes approval of molybdenum-99 production using low-enriched uranium from a global supplier and approval of a new drug application for a molybdenum-99 production system from NorthStar Medical Radioisotopes, one of NNSA's commercial partners, in 2018. DOE/NNSA and HHS will continue to work together to further enhance the availability of Mo-99 for non-HEU in the United States.

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