SNM panel finds no easy path to expand molybdenum-99 supplies

July 11, 2008

A draft report from an SNM expert panel has found no quick fix for the medical imaging community’s molybdenum-99m supply problems. Its results suggest that North American healthcare providers will continue to depend on Canada’s National Research Universal reactor in Chalk River, ON, for most of the precursor isotope of technetium-99m for several years as plans for alternative sources move toward implementation.

A draft report from an SNM expert panel has found no quick fix for the medical imaging community's molybdenum-99m supply problems. Its results suggest that North American healthcare providers will continue to depend on Canada's National Research Universal reactor in Chalk River, ON, for most of the precursor isotope of technetium-99m for several years as plans for alternative sources move toward implementation. The task force noted that the last domestic supplier of Mo-99 isotope closed down in 1989, forcing U.S. nuclear medicine service to rely on sources in Canada, Belgium, and South Africa for the nuclear reactor-generated tracer. The May 2008 cancellation of Atomic Energy of Canada Ltd.'s Multipurpose Applied Physics Lattice Experiment (MAPLE) project - a research reactor complex designed as the next-generation source of Mo-99 - has amplified the need for an alternative domestic source, according to working group.The SNM task force plans to initiate discussions with organizations that produce or could produce FDA-approved medical radioisotopes. It will also examine the feasibility of various Mo-99 production options including industry consortia, private/public partnerships, and government funding. It anticipates that the results of the national election in November will also ultimately have a bearing on how the federal government responds to the isotope supply issue. Its members are SNM president Robert Atcher, Ph.D.; Roy Brown of the Council on Radionuclides and Radiopharmaceuticals in Moraga, CA; Jeffrey Norenberg, Ph.D., chair of the radiopharmaceutical sciences program at the University of New Mexico in Albuquerque; Wolfgang Runde, Ph.D., isotope program manager at the Los Alamos National Laboratory in New Mexico; and Wynn Volker, Ph.D., director of the Radiopharmaceutical Sciences Institute at the University of Missouri in Columbia.The task force's preliminary findings were based on discussions with AECL officials and sources that have actual plans in place or the technical know-how to develop new Mo-99 production capabilities. The following groups represent from 80% to 90% of the organizations having a realistic chance of helping to solve the Mo-99 problem, according to the task force.

University of Missouri Research Reactor Center

MURR could meet about half of the current market need for Mo-99, with little change to its working research reactor. A processing center that would be adjacent to the reactor building is being designed. The reactor uses low-enriched uranium fuel and plans to use LEU as molybdenum target. Several funding options, including a public-private partnership, are under consideration. Political opposition could arise because of the reactor's location near the town and university campus. Mo-99 isotope production could begin by 2012.

Australian Nuclear Science and Technology Organization (ANSTO)
ANSTO Radiopharmaceutical and Industrials (ARI)

The reactor will be able to produce enough Mo-99 to cover the medical needs of Australia with one manufacturing run per week by October 2008. Additional runs could be added to address a portion of the North American need. The reactor is fueled by LEU and designed to use LEU as its target. ARI would be required to file for a new drug application with the FDA, a process that could take up to six months, and ANSTO would need to submit a drug master file with the FDA. The export of isotopes to the U.S. and the nuclear waste associated with isotope production could be politically dicey considering the antinuclear sentiment of the Australian government and general population.

Babcock & Wilcox Technical Services Group

The Lynchburg, VA, firm estimates it could meet the need for 50% of the U.S. market for Mo-99 produced in new installations of its 3200-Kw aqueous homogeneous reactors. The reactors are small and modular and involve few moving parts. A batch of Mo-99 reaches its optimal concentration in about 120 hours. Conventional purification is required. The first facility will be built in either St. Louis or Boston near processing facilities owned by Lantheus Medical Imaging or Covidien, the two major distributors of molybdenum generators. The first reactor, including research and development costs, can be built for less than $100 million of private funding. B&W has made a commitment to proceed in partnership with an undisclosed pharmaceutical company.The reactor will require Nuclear Regulatory Commission approval for construction. The use of LEU will result in small amounts of plutonium, requiring special handling and storage.

Annular Core Research (ACRR) at Sandia National Laboratories

The ACRR would handle the entire demand for Mo-99 for medical applications in the U.S. However, the reactor's current designation for Department of Defense use would have to be modified by the Department of Energy to free up time for isotope production. The estimated conversion costs range from $10 million to $50 million. The reactor would have to be modified to operate in a steady-state mode and be converted to LEU fuel. The costs could be shared with potential industrial partners, the DOE, or the National Nuclear Security Administration (NNSA).

NNSA

Isotope production would be a new role for NNSA. It is mainly responsible for minimizing the civilian use of high-enriched uranium. An existing DOE reactor could not be used, and the process of selecting the site for a new reactor would be costly, potentially politically controversial, and time-consuming. The economic feasibility of producing Mo-99 with LEU will be discussed in a National Academies of Science report later this year. After those costs are known, NNSA could examine proposals to assemble an industry consortium to research LEU use for Mo-99 production, a role that is consistent with its mission to minimize the civilian use of HEU.

Atomic Energy of Canada Limited (AECL) / MDS

Although AECL canceled the MAPLE project in May, it still plans to extend the license of the NRU reactor. This provides about 40% of world's supply of Mo-99 and could handle up to 80% of the worldwide need. The 130-MW NRU facility was commissioned in 1957. It has been modified to use LEU fuel but still uses HEU targets. For more information from the Diagnostic Imaging archives:

Isotope supply crash drive push for new moly sources

Canadian agency pulls plug on molybdenum reactors

Fear of nuclear terrorism lurks behind molybdenum supply debate