• the NRC's regulatory enforcement strategy is burdensome; the benefits from this process are not commensurate with the burdens imposed;

  • the NRC intrudes into the practice of medicine; promulgation of the Quality Management Program and Notification, Reports and Records of Misadministrations, 10 CFR 35.32 and 35.33 respectively, involves the practice of medicine; and,

  • the expenditure of resources (funded exclusively by user fees) to reduce adverse events involving byproduct material, extends beyond the point at which the additional dollar spent on regulation achieves an equivalent dollar of benefit to patients or the public.

In considering each of the proposed alternatives, the reader should remember that, in all but the laissez-faire model (Alternative B), the basic structure of federal regulation and responsibility would remain in place. Federal agencies would retain their existing responsibilities for the generation, transport, nonmedical use, and disposal of radionuclides, for the approval of radiopharmaceuticals, and for certification or approval of equipment that generates ionizing radiation. In particular, this means that:

  • the NRC and its Agreement States would continue to license the production of byproduct material for radiation-producing devices and radiopharmaceuticals;

  • the NRC and its Agreement States would, as relates to nonmedical uses (i.e., industrial, educational, and nonmedical research), continue to license the production and use of byproduct material;

  • the Department of Transportation (DOT) would continue to regulate the transport of radioactive materials;

  • the Environmental Protection Agency (EPA) would continue to develop guidelines that set occupational and public exposure limits to be implemented by the respective federal agencies;

  • the Food and Drug Administration (FDA) would continue to regulate the manufacture and labeling of radiopharmaceuticals and medical devices.

  • the FDA would also continue to regulate the mammography program under the Mammography Quality Standards Act (MQSA);

  • the Department of Defense (DOD), the Department of Veterans Affairs (VA), and the Public Health Service (PHS) would continue to be responsible, under the regulations of the appropriate agencies, for the safe use of radioactive materials and radiation-producing machines in their hospitals and laboratories; and

  • the Health Care Financing Administration (HCFA) would continue to develop reimbursement guidelines for Medicare and Medicaid (as will other federal agencies for other health care purchased from the private sector).



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