Notice2021-28017
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 27, 2021
Issuing agencies
Energy DepartmentNational Nuclear Security Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 245 (Monday, December 27, 2021)</title>
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[Federal Register Volume 86, Number 245 (Monday, December 27, 2021)]
[Notices]
[Pages 73270-73271]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<a href="/cdn-cgi/l/email-protection#b3fcd5d5dad0d6dcd5f0dcddc5d6c1c0dadcddf3ddddc0d29dd7dcd69dd4dcc5"><span class="__cf_email__" data-cfemail="80cfe6e6e9e3e5efe6c3efeef6e5f2f3e9efeec0eeeef3e1aee4efe5aee7eff6">[email protected]</span></a> 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
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