[Federal Register Volume 85, Number 13 (Tuesday, January 21, 2020)]
[Notices]
[Pages 3362-3363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00902]
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DEPARTMENT OF ENERGY
Exports of U.S-Origin Highly Enriched Uranium for Medical Isotope
Production: Certification of Insufficient Supplies of Non-Highly
Enriched Uranium (HEU)-Based Molybdenum-99 for United States Domestic
Demand
AGENCY: National Nuclear Security Administration, Department of Energy.
ACTION: Notice.
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SUMMARY: The Secretary of Energy, in accordance with the American
Medical Isotopes Production Act of 2012 (AMIPA), issued a certification
that there is an insufficient global supply of
[[Page 3363]]
molybdenum-99 (Mo-99) produced without the use of HEU available to
satisfy the domestic U.S. 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. This certification is effective for no more than two years from
the effective date of January 2, 2020.
FOR FURTHER INFORMATION CONTACT: Requests for additional information
may be sent to: Joan Dix, Deputy Director, Office of Conversion,
[email protected], 202-586-2695.
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. 112-239)), 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 inserted 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.
The law provides that the ban on HEU exports would become effective
seven years after enactment of AMIPA only if the Secretary of Energy
jointly certifies, 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. The law further provides that the Secretary of Energy can
extend the deadline for the joint certification if the Secretary
certifies that there is insufficient global 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 effective
date of the export license ban for up to six years.
In preparation for a Secretarial certification regarding the
sufficiency of supply of non-HEU based Mo-99, the Department of Energy
(DOE) published a notice and request for public comment in the Federal
Register (84 FR 65378) on November 27, 2019 to collect input from the
public on the state of the Mo-99 supply. DOE accepted comments, data,
and information through December 27, 2019.
Based on these submissions, along with other publicly available
healthcare data, and in coordination with the Department of Health and
Human Services' Food and Drug Administration, the Secretary of Energy
has certified that there is insufficient global supply of non-HEU-based
Mo-99 to meet U.S. market needs and that the export of U.S.-origin HEU
is the most effective temporary means to increase the supply of Mo-99
to the U.S. market. While the statute provides that the resulting delay
in the effective date of the HEU export licensing ban can be for up to
six years, the Secretary's certification is effective for a period of
no more than two years, following the certification's effective date of
January 2, 2020. DOE will conduct periodic reviews of the domestic U.S.
and global Mo-99 market and will work toward a certification to
Congress, regarding the sufficiency of supply as soon as the statutory
conditions are satisfied.
Certification
I hereby certify, pursuant to 42 U.S.C. 2160d(d), that there is an
insufficient global supply of molybdenum-99 produced without the use of
highly enriched uranium available to satisfy the domestic U.S. market
and that the export of U.S.-origin highly enriched uranium for the
purposes of medical isotope production is the most effective temporary
means to increase the supply of molybdenum-99 to the domestic U.S.
market. This certification shall be effective on January 2, 2020, for a
period of no more than two years from the effective date.
Dan Brouillette
JAN-2 2020
Dated: January 10, 2020.
For the Department of Energy.
Brent K. Park,
Deputy Administrator, Defense Nuclear Nonproliferation.
[FR Doc. 2020-00902 Filed 1-17-20; 8:45 am]
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