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Radiation in Medicine: A Need for Regulatory Reform
and that information sharing and monitoring of the general public health and safety would be enhanced. Thus, the committee narrowed its focus to Alternatives D, federal guidance, and E, limited federal authority. It examined the notions of federal guidance and federal authority very closely and spent a great deal of time debating the virtues and drawbacks of these remaining strategies.
Alternative E provides for the exercise of reserve federal authority if a state chooses not to expand its radiation control program to include byproducts. This is the primary difference between Alternatives D and E. The committee's concern about this alternative focused on the delegation of federal regulatory authority for what is likely to be a minority of states. Federal regulation of medical uses of ionizing radiation in states without a program for byproducts also raises the question of what the minimum level of regulation ought to be and how minimum standards might be established. In effect, Alternative E would replicate the existing NRC Agreement State Program. Thus, the committee arrived at its preferred choice: Alternative D.
The Preferred Choice: Alternative D, Federal Guidance
Alternative D modifies state regulation (Alternative C) by adding a federal agency with two key roles. First, the agency would be responsible for working in conjunction with the CRCPD and other professional organizations to provide voluntary guidelines and model regulations for states. Second, it would assume a leadership role for the regulated community.
Although, under Alternative D, states cannot be compelled to accept the voluntary guidelines or the SSRCR, a variety of forces can greatly influence them to do so. For example, the committee envisions a collaborative effort of the proposed federal agency, the states, the CRCPD, and other professional organizations not unlike the process utilized in developing the mammography regulations that involved the FDA, the American College of Radiology, and other professional organizations. This would facilitate an interactive process and allow an exchange of ideas, so that controversies might be resolved before implementation. Respect for and investment in the process would foster a keen vested interest in successful implementation on the part of all participants.
Other reasons exist for states to adopt voluntary guidelines and the SSRCR. Professional peer pressure, from the people within each state who are involved in developing the SSRCR, would exert substantial influence to make the process work. Consumer groups and the media, seeking to ensure that the citizenry is protected, would also exert pressure. State medical societies would also want regulatory oversight to prevent unskilled users of radiation from embarrassing the medical profession by their questionable practices.
Finally, corporate pressure from manufacturers in a state that does not have a program cannot be underestimated. Alternative D would mean that, for facilities in any state to use byproduct materials, that state would have to establish a