Executive Summary

This Academies study was mandated by the American Medical Isotopes Production Act of 2012. Key results¹ for each of the five study charges are summarized below; additional details are provided in the report summary and individual chapters.

Study charge 1: Provide a list of facilities that produce molybdenum-99 (Mo-99) for medical use including an indication of whether these facilities utilize highly enriched uranium (HEU). (Chapter 3) About 95 percent of the global supply of Mo-99 for medical use is produced in seven research reactors and supplied from five target processing facilities located in Australia, Canada, Europe, and South Africa. About 5 percent of the global supply is produced in other locations for regional use. About 75 percent of the global supply of Mo-99 for medical use is produced using HEU targets; the remaining 25 percent is produced with low enriched uranium targets. One of the reactors used to produce Mo-99 is fueled with HEU.

Study charge 2: Review international production of Mo-99 over the previous 5 years.² (Chapter 3) New Mo-99 suppliers have entered the global supply market since 2009 and further expansions are planned. An organization in Australia (Australian Nuclear Science and Technology Organisation) has become a global supplier and is currently expanding its available supply capacity; existing global suppliers in Europe (Mallinckrodt) and South Africa (NTP Radioisotopes) are also expanding their supply capacities; the

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¹ Study results are based on information obtained through June 2016.

² These examinations are referenced to 2009, the year of publication of the previous Academies report on medical isotope production (NRC, 2009).

Russian Federation plans to become a global supplier at some point in the future; and entities in other countries have plans to produce Mo-99 for regional consumption. A reactor in France (OSIRIS) that produced Mo-99 shut down permanently in December 2015. The reactor in Canada (NRU) will stop the routine production of Mo-99 after October 2016 and permanently shut down at the end of March 2018.

Study charge 3: Assess progress made in the previous 5 years toward establishing domestic production of Mo-99 and associated medical isotopes iodine-131 (I-131) and xenon-133 (Xe-133). (Chapter 4) The American Medical Isotopes Production Act of 2012 and financial support from the Department of Energy’s National Nuclear Security Administration (DOE-NNSA) have stimulated private-sector efforts to establish domestic production of Mo-99 and associated medical isotopes. Four NNSA-supported projects and several other private-sector efforts are under way to establish domestic capabilities to produce Mo-99; each project is intended to supply half or more of U.S. needs. Potential domestic Mo-99 suppliers face technical, financial, regulatory, and market penetration challenges; it is unlikely that substantial domestic supplies of Mo-99 will be available before 2018. Neither I-131 nor Xe-133 is currently produced in the United States, but one U.S. organization (University of Missouri Research Reactor Center) is developing the capability to supply I-131; some potential domestic Mo-99 suppliers also have plans to supply I-131 and/or Xe-133 in the future.

Study charge 4: Assess the adequacy of Mo-99 supplies to meet future domestic medical needs, particularly in 2016 and beyond. (Chapters 6-7) The United States currently consumes about half of the global supply of Mo-99/technetium-99m (Tc-99m)³ for medical use; global supplies of Mo-99 are adequate at present to meet domestic needs. Domestic demand for Mo-99/Tc-99m has been declining for at least a decade and has declined by about 25 percent between 2009-2010 and 2014-2015; domestic medical use of Mo-99/Tc-99m is unlikely to increase significantly over the next 5 years. The committee judges that there is a substantial (>50 percent) likelihood of severe Mo-99/Tc-99m supply shortages after October 2016, when Canada stops supplying Mo-99, lasting at least until current global Mo-99 suppliers complete their planned capacity expansions (planned for 2017) and substantial new domestic Mo-99 supplies enter the market (not likely until 2018 and beyond). The study recommends that the U.S. government continue to work with the Canadian government to ensure that there is an executable and well-communicated plan in place to restart production of Mo-99 in Canada should such shortages occur.

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³ Tc-99m, the decay product of Mo-99, is used for medical diagnostic imaging. Mo-99 is not used directly for this purpose. The letter “m” denotes that the isotope is metastable. See Chapter 2.

Study charge 5: Assess progress made by the DOE and others to eliminate worldwide use of HEU in reactor targets and medical isotope production facilities and identify key remaining obstacles for eliminating HEU use. (Chapter 5) The American Medical Isotopes Production Act of 2012 is accelerating the elimination of worldwide use of HEU for medical isotope production. Current global Mo-99 suppliers have committed to eliminating HEU use in reactor targets and medical isotope production facilities and are making uneven progress toward this goal. Progress is being facilitated by financial support from NNSA and technical support from U.S. national laboratories, but progress is also being impeded by the continued availability of Mo-99 produced with HEU targets. The study recommends that the U.S. government and others take additional actions to promote the wider utilization of Mo-99/Tc-99m produced without the use of HEU targets. Even after HEU is eliminated from Mo-99 production, large quantities of HEU-bearing wastes from past production will continue to exist at multiple locations throughout the world. The study recommends that the U.S. government continue to work with global Mo-99 suppliers and their regulators to reduce the proliferation hazard from wastes containing HEU.

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