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Radiation in Medicine: A Need for Regulatory Reform
Adopting this alternative does not address two of the committee's concerns: (1) that ionizing radiation in medicine is not regulated consistently—sources used regularly in the practice of medicine are treated unevenly; and (2) that safety can be maintained at lower cost. The existing, illogical system would remain intact, allowing what might still be fairly intense regulation of reactor byproduct material at the federal level and no comparable federal regulation of the uses of other sources of radioactivity (which add up to a significantly greater percentage of all the uses in radiation medicine). Since World War II and the advent of the use of radiation for peaceful purposes, a regulatory differentiation has existed between byproduct materials, on the one hand, and naturally occurring and accelerator-produced radioactive materials (NARM) and machine-produced radiation, on the other. Numerous congressional committees have examined this issue, but no changes have been effected to eliminate the disproportion. Indeed, the issue arises as to whether NRC regulation is at all necessary, given the fact that the regulation of NARM and machine-produced radiation has, since the early 1900s, been left to the states and to the FDA via the premarket approval process of drugs and devices.
In addition, this slight modification to the status quo with regard to NRC regulation fails to solve the problem of the rising costs of the existing NRC licensing program. As more states become Agreement States, license fees for users in the remaining states keep increasing to meet the NRC's administrative expenses. Nor does it completely alter the increasingly prescriptive NRC regulations and aggressive enforcement that seem inappropriate in the medical context.
Alternative B:Laissez Faire
Available data, as reviewed in Chapter 4, indicate that the quality of practice that utilizes ionizing radiation is relatively good, perhaps excellent, though data on the point are not as strong as desired. Further, this seems to be the case for both the areas regulated by the NRC and the areas of ionizing radiation use outside the NRC's control. In light of this information, the committee considered the proposition that all forms of medical radiation regulation—federal and state—should be eliminated and that responsibilities for radiation safety should be left to medical practice, medical societies, and the marketplace.
A market system pervades the developed world. Individuals retain a wide area in which personal decisionmaking is subject to little or no government intervention. Most choices are left entirely to the consumer, with only a warning of caveat emptor. Even extremely risky personal activities such as skydiving, spelunking, and mountain climbing are generally free of government regulations. Personal choice is valued over the risk of occasional deaths and injuries.
Medical care, in contrast, is usually regulated to some degree. The level of regulation varies by country, by type of health care system, by type of health care