August 3, 2005
The Energy & Natural Resources Conference Committee released their report dealing with the Energy Policy Act. Among the items of interest within the report include Sec. 630 (page 588) dealing with medical isotope production, and language within Sec. 170H (page 655) dealing with the treatment of accelerator-produced radioactive material as byproduct material. The Conference Report on the Energy Policy Act was voted on in the House on July 28 and in the Senate on July 29; the bill passed both the House and Senate and awaits the President's signature.
Medical Isotope Production
Sec. 630 “Medical Isotope Production” amends Sec. 134 of the Atomic Energy Act of 1954 to impose requirements on the export of HEU for medical purposes that will ensure the safe, timely and secure use of such material. This will help address flaws within Sec. 134 that cause licensing delays due to its failure to separate the use of HEU to produce medical radioisotopes from other uses.
The safe passage of this provision has been a key advocacy initiative of the Council on Radionuclides and Radiopharmaceuticals (CORAR), an association comprised of companies in the United States and Canada who manufacture and distribute radiopharmaceuticals, sealed sources, and radionuclides primarily used in medicine and life science research. Molecular/nuclear medicine societies, including the Society of Nuclear Medicine (SNM) and the American College of Nuclear Physicians (ACNP), have also assisted CORAR in their efforts.
Accelerator-Produced Radioactive Material
Sec. 170H “Radiation Source Protection”—which surprised the nuclear medicine community when negotiated into the Conference Report by Representative Edward J. Markey (D-MA 7th)—essentially contains language (starting at the bottom of page 655) granting the Nuclear Regulatory Commission (NRC) jurisdiction over accelerator-produced radioactive material. SNM is very concerned that this language could have an unintended, but highly detrimental impact on U.S. patients who need unfettered access to life saving diagnostic and therapeutic nuclear medicine procedures.
In 1959, Congress amended the Atomic Energy Act, authorizing states to assume regulatory control for certain types of man-made radioactive materials, provided the state had an adequate program to protect the public health and safety. Currently there are 33 states that have assumed this authority. Such states are called "Agreement States," as they have a written agreement with the Nuclear Regulatory Commission (NRC). Since the early 1960s states have had successful comprehensive radiation control programs that included, but were not limited to, regulating the use of diagnostic and therapeutic x-ray, environmental monitoring, and regulating the use of certain radioactive materials, including Accelerator-Produced Radioactive Material (ARM). SNM is concerned that transferring regulation of accelerator-produced radioactive material to the NRC—which does not have experience in this area—from the States would impede patient access to nuclear medicine.
SNM, together with partner associations, will now focus on working cooperatively with the NRC to ensure upcoming regulations are written in a manner that ensures consumers’ access to the radiopharmaceuticals essential for nuclear medicine procedures.