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Radiation in Medicine: A Need for Regulatory Reform
The underlying premise of this report is that a balance must be achieved between the benefits and costs of regulation. In an ideal world of limitless resources, risks could be reduced to their minimum possible level. In reality, however, resources are not infinite. Policymakers must determine where scarce resources ought to be applied. Within the medical context, innumerable areas require attention. Resources committed to reducing the risk of adverse events in one area of medicine might be better committed elsewhere.
The concentration of resources spent to reduce adverse events involving byproduct material, although seemingly effective, appears to have gone beyond the point at which the additional dollar spent on regulation achieves an equivalent dollar of benefit. The implication is that decreasing somewhat the resources directed at regulation may not pose commensurate risks or, similarly, may yield benefits in the form of resources that can be put to better or more efficient use. In the judgment of the committee, reduction of NRC regulatory authority will not increase the incidence of adverse events significantly, if at all.
The intensity with which the byproduct area of radiation medicine is being regulated at the federal level—while the rest of ionizing radiation used in medicine and, indeed, most of the rest of medical practice remains free from this level of federal oversight—has little if any justification. Moreover, no clear reason exists for singling out this particular facet of ionizing radiation in medicine for such tightly controlled regulation. One might, theoretically, regulate all of medicine at the federal level to ensure greater uniformity, but the committee recognized that such an improbable restructuring of the total medical system would entail great cost, not achieve complete uniformity (due to how widely disseminated regulatory responsibility for radiation presently is), and yield questionable results for the resources expended.
Second, at the crux of this report lies a fundamental philosophical and political perspective concerning state and federal regulation. All of ionizing radiation, with the exception of byproduct material, is currently regulated at the state level. No evidence of major problems with state regulation has ever been documented. The committee, of course, cannot know whether states will continue their regulatory programs. The committee judged, however, given the strength and leadership of the Conference of Radiation Control Program Directors (CRCPD) and the Suggested State Regulations for the Control of Radiation (SSRCR) it promulgates, that state radiation programs would remain intact and expand to the area of byproduct use if federal regulation in this area is relaxed. Thus, all sources of ionizing radiation would be treated more uniformly than before, in that they would all be subject to state regulation. Admittedly, the extent of state regulatory programs varies, but for the majority, the SSRCR are the common denominator nationwide.