[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]
 BILLING CODE 6450-01-P