Federal · Title 42 — Public Health and Welfare

42 U.S.C. § 18649: Isotope research, development, and production

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the domestic commercial production of which is unavailable or inadequate to satisfy the demand of research, medical, industrial, or related industries in the United States; and Department production; or foreign suppliers. In this section, the term “critical radioactive and stable isotope” does not include the medical isotope molybdenum-99, the production and supply of which is addressed in the American Medical Isotopes Production Act of 2012 ( Public Law 112–239 ; 126 Stat. 2211 ) (including the amendments made by that Act). for the production of critical radioactive and stable isotopes, including the development of techniques to produce isotopes, that the Secretary determines are needed and of sufficient quality and quantity for research, medical, industrial, or related purposes; for the production of critical radioactive and stable isotopes that are in short supply or projected to be in short supply in the future, including byproducts, surplus materials, and related isotope services; to maintain and enhance the infrastructure required to produce and supply critical radioactive and stable isotope products and related services; to conduct research and development on new and improved isotope production and processing techniques that can make critical radioactive and stable isotopes available for research and application as soon as possible while assisting in workforce development; to reduce domestic dependency on the foreign supply of critical radioactive and stable isotopes to ensure national preparedness; and evidence-based reports, such as the 2015 report of the Nuclear Science Advisory Committee entitled “Meeting Isotope Needs and Capturing Opportunities for the Future”; and assessments of isotope supply chains, including the assessment described in paragraph (3), any reports submitted pursuant to subsection (d), and other current and future assessments; ensure that isotope production activities carried out under this subsection are consistent with the statement of policy entitled “Policies and Procedures for Transfer of Commercial Radioisotope Production and Distribution to Private Industry” (30 Fed. Reg. 3247 ( March 9, 1965 )); assess the domestic requirements of current and emerging critical radioactive and stable isotopes and associated applications, including by consulting end-users, to identify areas that may require Federal investment for expedited development of domestic production capacity for those isotopes, including through public-private partnerships, as appropriate; ensure that actions taken by the Department do not interfere with, delay, compete with, or otherwise adversely affect efforts by the private sector to make available or otherwise facilitate the supply of critical radioactive and stable isotopes, including efforts under existing agreements between the Department or contractors of the Department and the private sector; and in coordination with the Assistant Secretary for Nuclear Energy, assess options for demonstrating the production of critical radioactive and stable isotopes in research, test, or commercial nuclear reactors and accelerators, including reactors and accelerators operated at universities. to carry out the activities previously executed as part of the Isotope Subcommittee of the Nuclear Science Advisory Committee; and to provide expert advice and assistance to the Director in carrying out that program. update the 2015 Nuclear Science Advisory Committee Isotopes Subcommittee Report entitled “Meeting Isotope Needs and Capturing Opportunities for the Future”; and periodically update that report thereafter as needed. current demand in the United States for critical radioactive and stable isotopes; the impact of continued reliance on foreign supply of critical radioactive and stable isotopes; are not commercially available; or to satisfy domestic demand; and to minimize production constraints and supply disruptions to the United States healthcare and industrial isotope industries; current facilities, including upgrades to those facilities, and new facilities needed to meet domestic critical isotope needs; and workforce development needs. The committee shall work in alignment with, and shall not duplicate the efforts of, preexisting advisory committees that are advising the program established under subsection (b). The committee shall be subject to the Federal Advisory Committee Act (5 U.S.C. App.). 1 1 See References in Text note below. Not later than the end of the first fiscal year beginning after August 9, 2022 , and biennially thereafter, the Secretary of Energy Advisory Board shall submit to the Committees on Energy and Natural Resources and Environment and Public Works of the Senate and the Committees on Science, Space, and Technology and Energy and Commerce of the House of Representatives a report describing the progress made under the program established under subsection (b) during the preceding 2 fiscal years. an updated assessment of any critical radioactive and stable isotope shortages in the United States; any disruptions in the international supply of critical radioactive and stable isotopes during the preceding 2 fiscal years; and the impact of those disruptions on related activities; and a projection of anticipated disruptions in the international supply, or supply constraints, of critical radioactive and stable isotopes during the next 2 fiscal years; and the anticipated impact of those disruptions or constraints, as applicable, on related domestic activities. $175,708,000 for fiscal year 2023; $196,056,480 for fiscal year 2024; $215,759,869 for fiscal year 2025; $200,633,461 for fiscal year 2026; and $146,293,469 for fiscal year 2027. The Secretary of Energy (referred to in this subsection as “the Secretary”) shall construct a radioisotope processing facility to provide for the growing radiochemical processing capability needs associated with the production of critical radioactive isotopes authorized under section 311 of the Department of Energy Research and Innovation Act [ 42 U.S.C. 18649 ]. $30,500,000 for fiscal year 2023; $75,000,000 for fiscal year 2024; $105,000,000 for fiscal year 2025; $83,000,000 for fiscal year 2026; and $43,000,000 for fiscal year 2027. to expand the ability of the United States to perform multiple stable isotope production campaigns at large-scale production, as authorized under section 311 of the Department of Energy Research and Innovation Act; to mitigate the dependence of the United States on foreign-produced stable isotopes; to promote economic resilience; and to conduct research and development on stable isotope production and associated methods and technology. $74,400,000 for fiscal year 2023; $46,000,000 for fiscal year 2024; $31,200,000 for fiscal year 2025; $33,300,000 for fiscal year 2026; and $13,900,000 for fiscal year 2027.”

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