Nuclear medicine affected by Energy Policy Act of 2005.

New Authority Over Radioisotopes One set of regulations delegates new authority over radioisotopes to the Nuclear Regulatory Commission (NRC) and is a direct result of testimony submitted by NRC officials to the U.S. House of Representatives Subcommittee on National Security, Emerging Threats, and International Relations and to the U.S. Senate in 2004. In addition to enhanced security measures (including provisions for licensee security guards to use more powerful weapons), the bill empowers the NRC for the first time to exercise regulatory authority over additional radioactive materials, including certain sources of 226Ra and accelerator-produced radioisotopes. “This wide-ranging legislation enhances our ability to ensure the protection of public health, safety, and the common defense,” said NRC Chairman Nils J. Diaz. “These provisions will make an industry that is already well protected even safer from the threats of terrorism and radiological sabotage.” The wording of the new authority leaves it to the NRC to determine which radioactive sources pose dangers. Covered in the wording are “any discrete source of 226Ra that is produced, extracted, or converted after extraction or use in a commercial, medical, or research activity; any material that has been made radioactive by use of a particle accelerator and is produced, extracted, or converted after extraction for use in a commercial, medical, or research activity; and any discrete source of naturally occurring radioactive material, other than source material, that the NRC determines would pose a threat similar to that posed by a discrete source of 226Ra to the public health and safety or the common defense and security and is extracted or converted after extraction for use in a commercial, medical, or research activity.” The NRC was charged at the time of the signing of the bill with publishing and implementing a transition plan designed to transfer authority over these materials from agreement states. On August 31, the current status of licensees with accelerator-produced radioisotopes was clarified by an NRC announcement in the Federal Register issuing a time-limited waiver. The waiver will “allow persons owning, using, and otherwise engaging in activities involving the material to continue with their activities and [Agreement] States to continue to regulate this material during the applicable waiver period.” The waiver is effective through August 7, 2006, “for the import and export of materials covered by the waiver, unless terminated sooner if the Commission determines that an earlier termination is warranted.” The announcement also contained the following paragraph about NRC efforts to ensure the safe availability of radiopharmaceuticals for patients in need of nuclear medicine procedures: