Time-Limited Waiver Issued for ARM in Radiopharmaceuticals

September 1, 2005

Time-Limited Waiver Issued for ARM in Radiopharmaceuticals

An announcement regarding the Energy Policy Act was made in the August 31 Federal Register...

"SUMMARY: The Nuclear Regulatory Commission (NRC) is issuing a time-limited waiver of the requirements enacted by section 651(e) of the Energy Policy Act of 2005, titled "Treatment of Accelerator-Produced and Other Radioactive Material as Byproduct Material", as they pertain to byproduct material as defined in paragraphs (3) and (4) of section 11 e. of the Atomic Energy Act of 1954, as added by section 651(e). The waiver will allow persons owning, using, and otherwise engaging in activities involving the material to continue with their activities and States to continue to regulate this material during the applicable waiver period."

"DATES: This waiver is effective August 31, 2005. This 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. For all other matters, it is effective through August 7, 2009, unless terminated sooner if the Commission determines that an earlier termination is warranted or required."

The announcement also contains the following paragraph concerning the NRC's efforts to ensure the safe availability of radiopharmaceuticals for patients in need of nuclear medicine procedures...

"The authorization to grant waivers is subject to the Commission's determination that the waiver is in accordance with the protection of the public health and safety and the promotion of the common defense and security. The Commission has determined that there is no basis on which to conclude that these materials will not continue to be used in a manner that ensures that the public health and safety will be protected while this waiver is in effect. The Energy Policy Act of 2005 also specifically requires the Commission to consider, in promulgating regulations, the impact on the availability of radiopharmaceuticals to physicians and to patients the medical treatment of which relies on radiopharmaceuticals. The Commission believes that it is in the best interests of the country to allow continued use of the newly defined byproduct material in radiopharmaceuticals for medical purposes, and to allow the States to continue to regulate the newly defined byproduct material until the Commission can codify new regulations for these materials."

Read the full Federal Register announcement