Supply of Molybdenum-99 (Mo-99) Produced Without the Use of Highly Enriched Uranium (HEU), 54961-54962 [2021-21634]

Agencies

• DEPARTMENT OF ENERGY
• National Nuclear Security Administration

[Federal Register Volume 86, Number 190 (Tuesday, October 5, 2021)]
[Notices]
[Pages 54961-54962]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 [email protected].
    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 
[email protected] 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, 
[email protected].

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