Exports of U.S-Origin Highly Enriched Uranium for Medical Isotope Production: Sufficient or Insufficient Supplies of Non-HEU-based Molybdenum-99 for United States Domestic Demand; Request for Public Comment, 65378-65379 [2019-25784]

Agencies

• DEPARTMENT OF ENERGY

[Federal Register Volume 84, Number 229 (Wednesday, November 27, 2019)]
[Notices]
[Pages 65378-65379]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25784]


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DEPARTMENT OF ENERGY


Exports of U.S-Origin Highly Enriched Uranium for Medical Isotope 
Production: Sufficient or Insufficient Supplies of Non-HEU-based 
Molybdenum-99 for United States Domestic Demand; Request for Public 
Comment

AGENCY: National Nuclear Security Administration, Department of Energy.

ACTION: Notice; request for public comment.

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SUMMARY: The U.S. Department of Energy (DOE), in accordance with the 
American Medical Isotope Production Act of 2012 (AMIPA), is preparing 
for a Secretarial certification regarding the sufficiency of supply of 
non-HEU based molybdenum-99 (Mo-99). DOE will collect input from the 
public as part of its certification development process and consider 
this information as part of its analysis to determine the state of Mo-
99 supply to meet U.S. patient needs.

DATES: DOE will accept comments, data, and information in response to 
this notice on or before December 27, 2019.

ADDRESSES: Interested persons may submit comments by any of the 
following methods.
    1. Email: [email protected];
    2. Postal Mail: Joan Dix, Deputy Director, Office of Conversion, 
Department of Energy, National Nuclear Security Administration, 1000 
Independence Avenue SW, Washington, DC 20585.
    Instructions: All submissions received must include the agency name 
for this request for public comment. No facsimiles (faxes) will be 
accepted. Due to potential delays in DOE's receipt and processing of 
mail sent through the U.S. Postal Service, DOE encourages responders to 
submit comments electronically to ensure timely receipt.

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:

Table of Contents

I. Authority and Background
II. Issues on Which DOE Seeks Comment and Information
III. Submission of Comments
IV. Confidential Business Information

I. 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 highly enriched uranium (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 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 regarding the 
sufficiency of Mo-99 supply, 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.
    In accordance with AMIPA and to ensure public review and comments 
the development of the certification is being announced in the Federal 
Register.
    The U.S. medical community depends on a reliable supply of the 
radioisotope Mo-99 for nuclear medical diagnostic and therapeutic 
procedures. Approximately 80 percent of all of these procedures depend 
on the use of technetium-99m (Tc-99m), a decay product of Mo-99. Tc-99m 
is used in approximately 40,000 diagnostic and therapeutic nuclear 
medicine procedures every day in the United States. Its primary uses 
include diagnosing heart disease, treating cancer, and 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 was 
produced using targets fabricated with proliferation sensitive HEU.

II. Issues on Which DOE Seeks Comment and Information

    This request for public comment seeks information from interested 
parties on the status of Mo-99 supplies for U.S. patients. For all 
comments, DOE requests that interested parties 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 public 
comment on 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) Have there been shortages of Mo-99 in the United States? If so, 
how severe, how often, and how did shortages impact patient care?
    (4) What has caused shortages of Mo-99 in the United States?
    (5) How would extending the period that the NRC may issue HEU 
export licenses for medical isotope production impact the supply of Mo-
99 to the United States?
    (6) How would enacting a ban on the export of HEU for medical 
isotope production impact the supply of Mo-99 to the United States?
    Although comments are particularly welcome on the issues discussed 
above, DOE also requests comments on other topics that commenters 
consider significant in preparing for the Secretarial certification.

[[Page 65379]]

III. Submission of Comments

    DOE will accept comments, data, and information in response to this 
notice on or before December 27, 2019. Any information that may be 
confidential and exempt by law from public disclosure should be 
submitted as described in section IV of this document, Confidential 
Business Information.

IV. Confidential Business Information

    Pursuant to 10 CFR 1004.11, any person submitting information he or 
she believes to be confidential and exempt by law from public 
disclosure should submit via email or postal mail 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.

    Dated: November 20, 2019.
For the Department of Energy.
Brent K. Park,
Deputy Administrator, Defense Nuclear Nonproliferation.
[FR Doc. 2019-25784 Filed 11-26-19; 8:45 am]
 BILLING CODE 6450-01-P