Notice2021-21634
Supply of Molybdenum-99 (Mo-99) Produced Without the Use of Highly Enriched Uranium (HEU)
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
October 5, 2021
Issuing agencies
Energy DepartmentNational Nuclear Security Administration
Abstract
DOE, in accordance with Section 3174 of the American Medical Isotopes Production Act of 2012 (AMIPA), is preparing for a Secretarial certification regarding the sufficiency of supply of non-HEU based Mo- 99. DOE is seeking public input as part of its certification development process and analysis to determine the sufficiency of Mo-99 supply to meet U.S. patient needs.
Full Text
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<title>Federal Register, Volume 86 Issue 190 (Tuesday, October 5, 2021)</title>
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[Federal Register Volume 86, Number 190 (Tuesday, October 5, 2021)]
[Notices]
[Pages 54961-54962]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-21634]
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DEPARTMENT OF ENERGY
National Nuclear Security Administration
Supply of Molybdenum-99 (Mo-99) Produced Without the Use of
Highly Enriched Uranium (HEU)
AGENCY: National Nuclear Security Administration (NNSA), Department of
Energy (DOE).
ACTION: Request for information (RFI).
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SUMMARY: DOE, in accordance with Section 3174 of the American Medical
Isotopes Production Act of 2012 (AMIPA), is preparing for a Secretarial
certification regarding the sufficiency of supply of non-HEU based Mo-
99. DOE is seeking public input as part of its certification
development process and analysis to determine the sufficiency of Mo-99
supply to meet U.S. patient needs.
DATES: DOE will accept comments, data, and information in response to
this RFI on or before November 4, 2021.
ADDRESSES: Interested persons may submit comments via email to the
Office of Conversion at <a href="/cdn-cgi/l/email-protection#064960606f65636960456968706374756f696846686875672862696328616970"><span class="__cf_email__" data-cfemail="a2edc4c4cbc1c7cdc4e1cdccd4c7d0d1cbcdcce2ccccd1c38cc6cdc78cc5cdd4">[email protected]</span></a>.
Although DOE has routinely accepted public comment submissions
through a variety of mechanisms, including postal mail and hand
delivery/courier, the Department has found it necessary to make
temporary modifications to the comment submission process in light of
the ongoing coronavirus (COVID-19) pandemic. DOE is currently accepting
only electronic submissions at this time.
If a commenter finds that this change poses an undue hardship,
please contact the Office of Conversion at
<a href="/cdn-cgi/l/email-protection#460920202f25232920052928302334352f292806282835276822292368212930"><span class="__cf_email__" data-cfemail="7e311818171d1b11183d1110081b0c0d1711103e10100d1f501a111b50191108">[email protected]</span></a> to discuss the need for alternative
arrangements. Once the COVID-19 pandemic health emergency is resolved,
DOE anticipates resuming all of its regular options for public comment
submission, including postal mail and hand delivery/courier. No
facsimiles (faxes) will be accepted.
Instructions: All submissions received must include the agency name
and title for this RFI in Microsoft Word or PDF file format and avoid
the use of special characters or any form of encryption.
FOR FURTHER INFORMATION CONTACT: Requests for additional information
may be sent to Max Postman in the Office of Conversion at 240-246-5564,
<a href="/cdn-cgi/l/email-protection#eda08c95c3bd829e99808c83ad83839e8cc3898288c38a829b"><span class="__cf_email__" data-cfemail="5518342d7b053a262138343b153b3b26347b313a307b323a23">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Authority and Background
The U.S. medical community depends on a reliable supply of the
radioisotope Mo-99 for nuclear medical diagnostic procedures.
Approximately 80 percent of these procedures depend on the use of
technetium-99m (Tc-99m), a decay product of Mo-99. Tc-99m is used in
over 40,000 medical procedures every day in the United States. Its
primary uses include diagnosing heart disease and cancer, as well as
studying organ structure and function. Historically, the United States
has not had the capability to produce Mo-99 domestically and, until
2018, imported 100 percent of its supply from international producers,
some of which supply was produced using targets fabricated with
proliferation-sensitive HEU.
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.
Section 3174 of 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 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.
DOE published a Federal Register notice (84 FR 65378) on November
27, 2019 requesting public comment on the status of Mo-99 supplies for
U.S. patients in preparation for a Secretarial certification regarding
the sufficiency of supply of non-HEU based Mo-99. The Secretary of
Energy certified on January 2, 2020, 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
published in the Federal Register on January 21, 2020 (85 FR 3362).
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 markets and would work toward a certification to Congress
regarding the
[[Page 54962]]
sufficiency of supply as soon as the statutory conditions are
satisfied.
DOE must issue a new certification on or before January 2, 2022. In
accordance with AMIPA and to ensure public review and comments, the
development of the certification is being announced in the Federal
Register.
II. Issues on Which DOE Seeks Comment and Information
DOE is seeking information from interested parties on the status of
Mo-99 supplies for U.S. patients. DOE requests that commenters fully
explain any assumptions that underlie their reasoning. DOE also
requests that commenters provide underlying data or other information
sufficient to allow DOE to review and verify any of the assumptions,
calculations, or views expressed by the commenters. DOE specifically
invites responses to the following questions:
(1) Do current supplies of Mo-99 meet U.S. patient demand?
(2) Do current supplies of non-HEU based Mo-99 meet U.S. patient
demand?
(3) Since the publication of DOE's November 27, 2019 Federal
Register notice requesting public comment on the status of Mo-99
supplies for U.S. patients (84 FR 65378) have there been shortages of
Mo-99 in the United States? If so, how severe, how often, and how did
shortages impact patient care? What caused such shortages?
(4) How would extending the period that the NRC may issue HEU
export licenses for medical isotope production impact the supply of Mo-
99 in the United States?
(5) How would enacting a ban on the export of HEU for medical
isotope production impact the supply of Mo-99 in the United States?
In addition, DOE welcomes information on other topics that
interested parties consider significant in preparing for the
Secretarial certification.
Confidential Business Information: According to 10 CFR 1004.11, any
person submitting information he or she believes to be confidential and
exempt from public disclosure should submit via email two well-marked
copies: One copy of the document marked ``confidential'' including all
the information believed to be confidential, and one copy of the
document marked ``non-confidential'' with the information believed to
be confidential deleted. DOE will make its own determination about the
confidential status of the information and treat it according to its
determination.
Signing Authority
This document of the Department of Energy was signed on September
29, 2021, by Kasia Mendelsohn, Acting 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 September 30, 2021.
Treena V. Garrett,
Federal Register Liaison Officer, U.S. Department of Energy.
[FR Doc. 2021-21634 Filed 10-4-21; 8:45 am]
BILLING CODE 6450-01-P
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