[Federal Register Volume 86, Number 245 (Monday, December 27, 2021)]
[Notices]
[Pages 73270-73271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-28017]


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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

AGENCY: National Nuclear Security Administration (NNSA), Department of 
Energy (DOE).

ACTION: Notice.

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SUMMARY: DOE and Department of Health and Human Services (HHS), in 
accordance with the American Medical Isotopes Production Act of 2012 
(AMIPA), have issued a joint Secretarial certification that there is a 
sufficient global supply of Mo-99 produced without the use of HEU 
available to meet the needs of patients in the United States and that 
it is not necessary to export United States-origin HEU for the purposes 
of medical isotope production in order to meet United States patient 
needs. This certification is effective as of January 2, 2022.

FOR FURTHER INFORMATION CONTACT: Requests for additional information 
may be sent to Max Postman in the Office of Conversion 
[email protected] or 202-586-9114.

SUPPLEMENTARY INFORMATION:

Authority and Background:

    The 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)), enacted on January 2, 2013, 
amended section 134 of the Atomic Energy Act of 1954 (42 U.S.C. 2160d) 
by striking subsection c. and inserting language that prohibits 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 enactment of AMIPA, 
subject to a certification regarding the sufficiency of Mo-99 supply in 
the United States.
    AMIPA requires the Secretary of Energy to either jointly certify, 
with the Secretary of Health and Human Services, that there is a 
sufficient supply of Mo-99 produced without the use of HEU available to 
meet U.S. patient needs, and that it is not necessary to export U.S.-
origin HEU for the purposes of medical isotope production in order to 
meet U.S. patient needs, or to unilaterally certify that there is 
insufficient supply of Mo-99 produced without the use of HEU available 
to satisfy the domestic market and that the export of U.S.-origin HEU 
for the purposes of medical isotope production is the most effective 
temporary means to increase the supply of Mo-99 to the domestic U.S. 
market, thereby delaying the enactment of the export license ban for up 
to six years.
    DOE published a Federal Register notice (85 FR 3362) on January 21, 
2020 certifying that, at the time, there was an insufficient global 
supply of Mo-99 produced without the use of HEU and that the export of 
U.S.-origin HEU for the purposes of medical isotope production was the 
most effective temporary means to increase the supply of Mo-99 to the 
domestic U.S. market. This certification was effective for no more than 
two years from the effective date of January 2, 2020. The Federal 
Register notice stated that DOE would conduct periodic reviews of the 
domestic U.S. and global Mo-99 market and would work toward a 
certification to Congress, regarding the sufficiency of supply as soon 
as the statutory conditions are satisfied.
    Based on an expert third party market analysis, as well as the 
assessment of subject matter experts in both agencies, the Secretary of 
Energy and the Secretary of Health and Human Services have jointly 
certified that there is a sufficient global supply of Mo-99 produced 
without the use of HEU available to meet the needs of patients in the 
United States. Furthermore, while there is the potential for future 
shortages of other medical isotopes, including iodine-131 and xenon-
133, the export of HEU would not mitigate these risks. Therefore, the 
Secretaries also have jointly certified that it is not necessary to 
export United States-origin HEU for the purposes of medical isotope 
production in order to meet United States patient needs.

[[Page 73271]]

    This joint certification reflects DOE's progress in working with 
international partners to convert medical isotope production facilities 
to the use of low enriched uranium (LEU) and in supporting the 
establishment of domestic supplies of Mo-99 produced without use of 
HEU. Three of the four major global producers now produce Mo-99 using 
LEU. The other major producer still relies partially on HEU but is on 
track to convert to LEU-based processes in 2022. The Department of 
Health and Human Services has also played a critical role in achieving 
this milestone, including approval of LEU Mo-99 technologies and 
through 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 enough Mo-99 using 
LEU to meet U.S. demand, but ongoing engagement between producers, 
radiopharmaceutical companies, and other private sector stakeholders 
will be needed to ensure that U.S. patient needs continue to be met. 
Mo-99 producers must continue to coordinate regarding the security of 
global supply and must maintain the ability to ramp up production where 
needed to compensate for shortfalls from other producers and maintain 
accessibility of Mo-99 through the supply chain. DOE will reinforce 
this message through its ongoing engagements with the Mo-99 community.

Signing Authority

    This document of the Department of Energy was signed on December 8, 
2021, by Corey Hinderstein, Deputy Administrator for Defense Nuclear 
Nonproliferation, pursuant to delegated authority from the Secretary of 
Energy. That document with the original signature and date is 
maintained by DOE. For administrative purposes only, and in compliance 
with requirements of the Office of the Federal Register, the 
undersigned DOE Federal Register Liaison Officer has been authorized to 
sign and submit the document in electronic format for publication, as 
an official document of the Department of Energy. This administrative 
process in no way alters the legal effect of this document upon 
publication in the Federal Register.

    Signed in Washington, DC, on December 21, 2021.
Treena V. Garrett,
Federal Register Liaison Officer, U.S. Department of Energy.
[FR Doc. 2021-28017 Filed 12-23-21; 8:45 am]
BILLING CODE 6450-01-P