The House Committee on Energy and Commerce, Subcommittee on Energy and the Environment held a hearing this month on the current concern regarding medical Isotopes (See DM 10148). The legislative hearing focused on H.R. 3276, the American Medical Isotopes Production Act of 2009.

The legislation promotes production of molybdenum-99 in the United States for medical uses. Molybdenum 99 is a "parent" generator radioisotope to the radioisotope technetium-99.

The bill has $163 million earmarked for the Secretary of Energy to support domestic production of molybdenum-99 without the use of highly enriched uranium (HEU). HEU is a concern due to its use in nuclear weapons and explosives, and excess material being used by terrorists or rogue states. The legislation also amends the Atomic Energy Act, prohibiting issuance of any export licenses for highly enriched uranium for medical isotope production for seven to ten years.

Three witnesses testified at the hearing, all supporting the legislation. Dr. Parrish Staples of the National Nuclear Security Administration (NNSA), Department of Energy, began the hearing by describing recent efforts in addressing the current and anticipated shortages of molybdenum-99 and the NNSA's efforts to accelerate the establishment of a domestic commercial supply of molybdenum-99 that does not require HEU. Dr. Staples pointed out no facilities now exist within the United States dedicated to the production of molybdenum-99 for medical uses; the U.S. imports 100 percent of domestic supply from foreign production facilities that use HEU in the production processes. In the past few years, unexpected shutdowns of the primary producers have severely impacted the global molybdenum-99 supply chain, as DOTmed News has reported.

Dr. Staples cited a 2009 National Academies report that confirmed production of molybdenum-99 production without use of HEU is technically and economically feasible. NNSA is developing projects to advance domestic commercial sources of molybdenum-99, including cooperative agreements with potential commercial producers. The commercial producers' quantities of molybdenum-99 are hoped to be adequate for medical demand by 2013. The producers are using differing non-HEU technologies. Dr. Staples stated the NNSA intends to spend about $30 million annually to establish a non-HEU domestic molybdenum-99 production process, funded from the Global Threat Reduction Initiative budget.

The next witness was Steven M. Larson, M.D., Chief, Nuclear Medicine Service, Department of Radiology, Memorial Sloan-Kettering Cancer Center, Vice-Chairman, Committee on Medical Isotope Production Without Highly Enriched Uranium, National Academy of Sciences. The clinic Dr. Larson directs at Sloan-Kettering sees over 110 patients per day. Two-thirds of those patients' diagnostic procedures utilize technetium-99. Dr. Larson recounted from a personal perspective how shutdowns of foreign reactors have interrupted supplies of the isotope to his clinic and others, and how more shortages are expected. Dr. Larson then described the National Academy's report in detail. He explained that the report found the anticipated average cost increase of conversion to non-HEU isotope production would be less than ten percent for most current large-scale producers.

The report also identifies additional steps that the Department of Energy (DOE) and others may take to improve the likelihood of medical isotope production, including the DOE making technical expertise available to producers for conversion-related research; diplomatic pressure on countries still using HEU to convert; the FDA working with industry experts for an understanding of probable FDA requirements in regulatory approvals for low-enriched uranium molybdenum-99; congressional policy directions on conversion and phase-out of HEU exports; and incentives for development of domestic sources. H.R. 3275 contains many of these steps.

Finally, the subcommittee heard from Michael Duffy, Vice President and General Counsel, Lantheus Medical Imaging. Mr. Duffy testified that due to unscheduled outages and shutdowns in foreign reactors, molybdenum-99 supply is now a chronic crisis; the U.S. and international demand is beyond the capability of the global reactor community to supply. An additional concern is that molybdenum-99 continually decays from the time of its manufacture with a half-life of approximately 66 hours; that makes a shorter transport time necessary for less decay and more efficient use.

Mr. Duffy explained Lantheus is considering different U.S.-based opportunities for molybdenum-99 in the short- and long-term, as U.S-based supply solutions are more attractive. However, Mr. Duffy pointed out, the opportunities require cooperation between regulators and project sponsors on various aspects. In addition, public partnership is necessary to level the field with government support of reactors outside of the U.S. Mr. Duffy suggested that government financial support in grants or loans may be the key to the viability of domestic producers.

The hearing testimony may be accessed at: http://energycommerce.house.gov/index.php?option=com_content&view=article&id=1735:the-american-medical-isotopes-production-act-of-2009&catid=130:subcommittee-on-energy-and-the-environment&Itemid=71