Nuclear Energy Research Advisory Committee (NERAC) Subcommittee for Isotope Research & Production Planning Final Report April 2000 2 Table of Contents Page Transmittal Letter---------------------------------------------------------------------------------------------------------------------------- 4 Charge to the Subcommittee -------------------------------------------------------------------------------------------------------------- 6 Executive Summary------------------------------------------------------------------------------------------------------------------------- 9 Introduction ---------------------------------------------------------------------------------------------------------------------------------- 11 Use of Isotopes in Research, Medicine, and Industry --------------------------------------------------------------------------- 11 How Isotopes are Supplied ------------------------------------------------------------------------------------------------------------ 13 Reactor and Accelerator Production and Hot Cell Processing of Radioisotopes --------------------------------------- 13 Markets and Users of Radioisotopes --------------------------------------------------------------------------------------------- 14 Federal Support for Isotope Production and Processing --------------------------------------------------------------------- 15 Stable Isotopes ------------------------------------------------------------------------------------------------------------------------- 17 Problems with Radioisotope Supply ------------------------------------------------------------------------------------------------ 17 Iodine-124, a Long-Lived Isotope for Positron Emission Tomography--------------------------------------------------- 17 Bismuth-212 and -213, Alpha-Emitting Isotopes for Cancer Therapy ---------------------------------------------------- 19 Copper-67, an Isotope for Radiolabeling Monoclonal Antibodies --------------------------------------------------------- 21 Recommendations -------------------------------------------------------------------------------------------------------------------------- 22 Discussion of Short-term Recommendations-------------------------------------------------------------------------------------- 22 Discussion of Long-term Recommendations -------------------------------------------------------------------------------------- 25 Site Evaluations ----------------------------------------------------------------------------------------------------------------------------- 27 Evaluation Procedure and Criteria -------------------------------------------------------------------------------------------------- 27 Site Assessment Results ---------------------------------------------------------------------------------------------------------------- 29 Observations ------------------------------------------------------------------------------------------------------------------------------ 30 Comments and Recommendations on the Fast Flux Test Facility for Isotope Production -------------------------------- 31 NERAC Subcommittee for Isotope Research and Production Planning------------------------------------------------------- 32 Site Visit Reports Appendix A: Missouri University Research Reactor -------------------------------------------------------------------------- A-1 Appendix B: International Isotopes, Inc. ----------------------------------------------------------------------------------------- B-1 Appendix C: Brookhaven National Laboratory -------------------------------------------------------------------------------- C-1 Appendix D: Oak Ridge National Laboratory ---------------------------------------------------------------------------------- D-1 Appendix E: Los Alamos National Laboratory --------------------------------------------------------------------------------- E-1 Appendix F: Sandia National Laboratory ----------------------------------------------------------------------------------------- F-1 Appendix G: Pacific Northwest National Laboratory ------------------------------------------------------------------------ G-1 3 4 NERAC Subcommittee for Isotope Research and Production Planning Charge to the Subcommittee 5 6 NERAC Subcommittee for Isotope Research and Production Planning Charge to the Subcommittee 7 8 NERAC Subcommittee for Isotope Research and Production Planning EXECUTIVE SUMMARY All of this is enabled by an abundant supply of isotopes that can meet the changing needs of a vigorous and Isotopes, including both radioactive and stable isotopes, growing research community. If the widespread uses of make important contributions to research, medicine, and radioactive materials are not maintained through industry in the United States and throughout the world. research, it will not be possible for this country to sustain, For nearly fifty years, the Department of Energy (DOE) much less expand, our high standard of living and has actively promoted the use of isotopes by funding (a) advanced industrial economy. production of isotopes at a number of national laboratories with unique nuclear reactors or particle Recent levels of federal appropriations, averaging about accelerators, (b) nuclear medicine research at the $20 million per year, have not permitted the DOE’s laboratories and in academia, (c) research into industrial isotope supply to adequately keep pace with the applications of isotopes, and (d) research into isotope changing needs of the research community. It is now production and processing methods. The radio- widely conceded that limited availability of specific pharmaceutical and radiopharmacy industries have their radionuclides is a constraint on the progress of research. origin in these DOE-funded programs. Currently, more The problem is especially apparent in a number of than 12 million nuclear medicine procedures are medical research programs that have been terminated, performed each year in the United States, and it is deferred, or seriously delayed by a lack of isotope estimated that one in every three hospitalized patients availability. has a nuclear medicine procedure performed in the The Nuclear Energy Research Advisory Committee management of his or her illness. (NERAC) convened a Subcommittee for Isotope Research and Production Planning in January 1999 to study the issue of isotope availability. The Subcommittee visited seven isotope production sites: five within the national Short-Term Recommendations (the next five years) laboratory system and two outside producers. A number 1. Refocus the Office of Isotope Programs on the of recommendations, both short- and long-term, were supply of radioisotopes and stable enriched made regarding the supply of isotopes: isotopes for research within its mission to serve the national need for a reliable supply of isotope Long-Term Recommendations (the next ten years) products and services for research, medicine, and industry. 1. Promote the greatest synergism among the national labs, academia, and industry to fulfill 2. Limit commercial isotope production to products the Isotope Program's mission. where the DOE has a unique production 2. Acquire a dedicated, single-mision, isotope capability and where other market supplies are production and processing facility that would be not sufficient to meet U.S. demand. fully operational by 2010. The facility should 3. Establish an Isotope Review Panel to review and include a cyclotron and a reactor both dedicated recommend proposals to produce isotopes to to isotope production based on off-the-shelf the Director of Isotope Programs. The Panel designs. should identify isotopes of interest and preferred 3. Maintain a stable/enriched isotope inventory for sites for production, including alternative supply research purposes. options, and provide other advice as requested. 4. Ensure an adequately sized and properly trained 4. Consolidate existing radioisotope processing work force to meet national isotope needs. capabilities. 5. Implement a contingency plan to guarantee an uninterrupted radioisotope and stable isotope 5. Contract with the academic and private sectors supply for the country's research needs. to accomplish the primary focus and mission. 6. Expand innovative research in diagnostic and therapeutic nuclear medicine by increasing funding for the Advanced Nuclear Medicine Initiative. 7. Increase the funding for academic training to support the primary focus and mission. 8. Begin conceptual design of a dedicated cyclotron to support the mission to serve the national need for a reliable supply of isotope products and services for research, medicine, and industry. Executive Summary 9 10 NERAC Subcommittee for Isotope Research and Production Planning FINAL REPORT Introduction Beginning with the Atomic Energy Act of 1954, the Department of Energy (DOE) and its predecessor organizations, the Energy Research and Development Agency (ERDA) and the Atomic Energy Commission (AEC), have actively promoted the use of isotopes by funding (a) production of isotopes at a number of national laboratories with unique nuclear reactors or particle accelerators, (b) nuclear medicine research at the laboratories and in academia, (c) research into beneficial industrial applications of isotopes, and (d) research into isotope production and processing methods. The radiopharmaceutical and radiopharmacy industries have their origin in these DOE-funded programs. Currently, more than 12 million nuclear medicine procedures are performed each year in the United States, and it is estimated