The US Department of Energy (DOE) is requesting comments on whether there is a sufficient supply of molybdenum-99 (Mo‑99) to meet medical needs without the export of highly enriched uranium (HEU) from the United States. Comments are due by December 27, 2019. The comments will support a certification that the secretary of Energy must submit in early 2020 pursuant to the American Medical Isotopes Production Act of 2012, Pub. L. 112-239, 126 Stat. 2211 (the Act). The content of this certification will determine whether the US Nuclear Regulatory Commission (NRC) will have authority to issue HEU export licenses for Mo-99 production in foreign research and test reactors.
According to the notice in the November 27 Federal Register, “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.” Congress passed the Act as part of a decades-long effort to ensure domestic availability of Mo‑99, which is used in medical diagnostic and therapeutic procedures. According to the notice, approximately 80% of all of these procedures depend on the use of technetium-99, a decay product of Mo-99. Importantly, Section 3174 of the Act amended the Atomic Energy Act to prohibit the NRC from issuing licenses to export HEU from the United States for purposes of medical isotope production, effective seven years from the date of enactment of the Act. The Act became law on January 2, 2013, and thus the ban on NRC export licenses is scheduled to go into effect in early 2020, unless it is extended through a certification from the Energy secretary.
Recognizing that the United States must maintain a dependable supply of Mo-99, Congress provisionally authorized a six-year extension of the period—from 2020 to 2026—before the NRC would be prohibited from issuing export licenses. Congress authorized the extension on the condition that the Energy secretary certify to Congress that (1) there is insufficient global supply of Mo‑99 produced without the use of HEU to satisfy the domestic market, and (2) the export of US‑origin HEU for medical isotope production is the most effective temporary means to increase the supply of Mo‑99.
If the Energy secretary believes that an extension of the deadline is not necessary, then the secretary of Energy and the secretary of Health and Human Services must jointly certify that there is a sufficient global supply of Mo-99 produced without the use of HEU, and that it is not necessary to export US-origin HEU to meet domestic medical needs.
DOE is asking for comments on the status of Mo-99 supplies for US patients with the following questions:
- Do current supplies of Mo‑99 meet US patient demand?
- Do current supplies of non-HEU-based Mo‑99 meet US patient demand?
- Have there been shortages of Mo‑99 in the United States? If so, how severe and how often, and how did shortages impact patient care?
- What has caused shortages of Mo‑99 in the United States?
- 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?
- How would enacting a ban on the export of HEU for medical isotope production impact the supply of Mo‑99 to the United States?
The notice also requests “comments on other topics that commentators consider significant in preparing for the Secretarial certification.” DOE asks that “interested parties fully explain any assumptions that underlie their reasoning,” and that commenters provide underlying data or other information to allow DOE to confirm the assumptions, calculations, or views expressed in the comments.