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Executive Summary

ISOTOPE SOURCES IN U.S. WOULD BE ASSURED UNDER DoE LEGISLATION that will be proposed for the fiscal & 1995 budget to make "appropriate capital expenditures," including those necessary to revamp the Omega West reactor at Los Alamos, N.M. for isotope production, Department of Energy Deputy Secretary William White said at a Dec. 6 hearing of Rep. Synar's (D-Okla.) House Government Operations/Environment Subcommittee. Omega West has been shut down since December 1992 and needs extensive repairs before it can function again. White said he hoped his statement, "which is the clearest one you have heard from the Administration so far, will be the first step" in putting fears of U.S. dependence on a foreign source of isotopes to rest. Over 90% of nuclear medicine procedures use Technetium-99m (Tc-99m) which is obtained from Molybdenum-99 (Mo-99), a reactor- produced raw material, said Mallinckrodt Medical Director of Regulatory and Professional Affairs Roy Brown. Testifying on behalf of the Council on Radionuclides and Radiopharmaceuticals (CORAR), Brown noted that the other 10% of nuclear medicine procedures use radionuclides produced in cyclotrons. He pointed out that "all of the major manufacturers have their own cyclotrons." The only current North American producer of Mo-99 is Atomic Energy of Canada Ltd. (AECL), a reactor owned and operated by the Canadian government. Privately-owned Kanata, Ontario-based Nordion International processes and purifies the Mo-99 it receives from AECL before shipping the purified Mo-99 to U.S. manufacturers. Until August 1991, stable isotopes, the raw material used in cyclotrons, were produced in DoE's calutrons at the Oak Ridge National Lab in Tennessee. However, the stable isotopes from Oak Ridge cost as much as 25% more than material available on the world market. Subsequently, DoE was forced to shut down Oak Ridge production. Prepared testimony from the American College of Nuclear Physicians and the Society of Nuclear Medicine states that "Russia is the only country producing stable, enriched isotopes." Although these isotopes can be stored indefinitely, "the supply is finite and there is currently no immediate plan for their replenishment in the U.S." Brown noted that although Mallinckrodt currently is constructing a Mo-99 production facility in The Netherlands that is scheduled to open in 1995, the "facility will only produce enough Mo-99 to supply Mallinckrodt's needs." Speaking on behalf of CORAR, Brown said the Council "believes that in order for the industry to have a secure supply of Mo-99 and other necessary radionuclides with adequate backup supply, the DoE should develop the technology and capability to produce these radionuclides." In addition, "CORAR feels it is necessary for DoE to stay in the stable isotope market through revitalizing the calutrons at Oak Ridge, or employing new technology to produce these materials," Brown said. The hearing was a follow-up to a subcommittee meeting in August 1992 that examined problems with DoE's Isotope Production and Distribution Program (IPDP) ("The Pink Sheet" Aug. 24, 1992, T&G-7). At the time, Synar said, DoE told the subcommittee "that this program simply "wasn't a high priority." In addition, IPDP faced major funding and management problems. A number of facilities had been shut down or were not financially solvent because they could not produce isotopes at market prices and were required fully to recover costs under Public Law 101-101. Legislation is among several remedies White offered at the hearing to address DoE's IPDP problems. He also said DoE will seek to eliminate revolving funds requirements, which essentially requires the program to finance itself, "emphasize and reemphasize to the people working in the program...the priority given to this program within the nuclear reactor research" programs at DoE; make management changes; implement recommendations of a DoE- commissioned Arthur Anderson management study of the EPDP program; and collect outside experts in various fields to advise DoE on the program. Addressing the question of whether the DoE's isotope program as a whole is a priority, White said, "I believe the answer is definitely yes." Although Synar called White's comments and proposed actions "encouraging," he added that "we've heard this before" and called for a departure from "business as usual, or even business as a little bit different than usual."

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