Joint Certification of Sufficient Mo-99 Supply Without HEU for US Patient Needs

Strategic Insights -

The National Nuclear Security Administration (NNSA), Department of Energy (DOE) and the Department of Health and Human Services (HHS) have jointly certified that there is a sufficient global supply of non-highly enriched uranium (non-HEU) based Molybdenum-99 (Mo-99) available to meet the needs of patients in the United States. This certification comes into effect as of January 2, 2022. The joint certification is based on expert third-party market analysis and the assessment of subject matter experts in both agencies, indicating that the export of U.S.-origin HEU for medical isotope production is no longer necessary to meet U.S. patient needs.

Key Takeaways:

  • The American Medical Isotopes Production Act of 2012 (AMIPA) has been amended to prohibit the Nuclear Regulatory Commission (NRC) from issuing a license for the export of HEU from the United States for the purposes of medical isotope production, effective seven years after its enactment on January 2, 2013.
  • The Secretary of Energy, in collaboration with the Secretary of Health and Human Services, has jointly certified that there is a sufficient supply of non-HEU based Mo-99 available to meet U.S. patient needs, effective as of January 2, 2022.
  • Three of the four major global producers now produce Mo-99 using low enriched uranium (LEU), with the remaining major producer on track to convert to LEU-based processes in 2022.
  • The Department of Health and Human Services has played a critical role in achieving this milestone through the approval of LEU Mo-99 technologies and the 2018 approval of a New Drug Application for the first domestic production of Mo-99 in nearly 30 years.
  • The global market is now capable of producing sufficient Mo-99 using LEU to meet U.S. demand, subject to ongoing engagement between producers, radiopharmaceutical companies, and other private sector stakeholders to maintain supply security and accessibility.
  • The export of HEU would not mitigate potential shortages of other medical isotopes, including iodine-131 and xenon-133.

Statistics:

  • Seven years after the enactment of AMIPA, effective as of January 2, 2020.
  • January 2, 2022: Effective date for joint certification of sufficient Mo-99 supply.
  • 2020: DOE conducted periodic reviews of the domestic U.S. and global Mo-99 market.
  • January 21, 2020: DOE published a Federal Register notice certifying an insufficient global supply of Mo-99 produced without HEU and the export of U.S.-origin HEU for medical isotope production.
  • 2018: Approval of a New Drug Application for the first domestic production of Mo-99 in nearly 30 years.
  • 2022: Remaining major producer expected to convert to LEU-based processes.

Sources:

  • "DEPARTMENT OF ENERGY National Nuclear Security Administration Exports of U.S.-Origin Highly Enriched Uranium (HEU) for Medical Isotope Production: Certification of Sufficient Supplies of Non-HEU-based Molybdenum-99 (Mo-99) To Meet Needs of Patients in the United States" (Federal Register, December 23, 2021).
  • American Medical Isotopes Production Act of 2012 (AMIPA) (subtitle F, Title XXXI of the National Defense Authorization Act for Fiscal Year 2013 (Pub. L. 112-139)).
  • Federal Register, Volume 85, No. 14, January 21, 2020: "Exports of U.S.-Origin Highly Enriched Uranium (HEU) for Medical Isotope Production: Certification of Insufficient Supplies of Non-HEU-based Molybdenum-99 (Mo-99) To Meet Needs of Patients in the United States".