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No. 98-74
May 15, 1998
IN QUANTITIES THAT EXCEED LICENSE LIMITS
The Nuclear Regulatory Commission has temporarily authorized some licensees to possess certain radioisotopes in quantities that exceed their license limits in order to offset an anticipated shortage of the radioisotope that may be caused by a labor strike in Canada where most of it is manufactured.
Because there is no domestic supply of molybdenum-99, a labor dispute at the Chalk River Laboratories of Atomic Energy Canada Limited, potentially could disrupt the supply of radiopharmaceutical used in the U.S. for medical diagnosis. Molybdenum-99, which is supplied from Canada, is used to generate technetium-99m, an extremely short-lived radioisotope used in many diagnostic procedures. Technetium-99m cannot be stockpiled because it is useful for only about six hours.
To help minimize the effects of a possible shortage, the Commission has authorized licensees to possess molybdenum-99 and molybdenum-99/technetium-99m generators in quantities it might otherwise not allow. Thousands of facilities affected include medical users like clinics and hospitals, commercial nuclear pharmacies that prepare doses of radioisotopes for medical use, and radiopharmaceutical manufacturers that use molybdenum-99 to produce molybdenum-99/technetium-99m generators for medical users.
Dr. Carl Paperiello, Director of the NRC's Office of Nuclear Material Safety and Safeguards said the NRC will permit its licensees to temporarily exceed possession limits for molybdenum-99 and the generators until further notice. However, he said, this exercise of temporary enforcement discretion does not relieve licensees from current molybdenum-99 testing requirements, other applicable NRC requirements, or with maintaining compliance with other applicable federal and state requirements governing radioactive drugs.
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