health care industry. (Throughout, the report such reactor-generated material will typically be referred to as "byproduct material" or "byproducts.") The radiation source involved in the Indiana, Pennsylvania, case was such a byproduct. As part of its broad monitoring responsibility, the NRC instituted its Medical Use Program to regulate the use of byproduct material in medicine. The review of this program is the subject of the NRC's charge to the IOM.

Reactor-generated byproduct material is a source of ionizing radiation, and as such, it poses risks to health and safety that sources of nonionizing radiation do not. Reactor-generated byproduct material is not the only source of ionizing radiation; other sources are radioactive materials that occur naturally or are accelerator-produced, and radiation produced by x-ray machines and particle accelerators.3

In examining the existing NRC Medical Use Program, the IOM Committee for Review and Evaluation of the Medical Use Program of the Nuclear Regulatory Commission compared the regulation of byproducts with the regulation of other sources of medically used ionizing radiation and with the regulation of medicine in general. The scope of this comparison was occasioned by an awareness of problems among the NRC, Congress, the states, and the regulated community that suggested the entire regulatory system needed to be examined. In particular, a major question for the IOM committee was whether the quantitative risks associated with reactor-generated byproduct material used in radiation medicine justify the extent to which byproducts are regulated compared to other sources of radiation in medicine and to medicine in general.

To provide the reader with background information, the successes and problems of radiation medicine and the clinical applications of ionizing radiation are discussed in the full report. The discussion of the current regulatory system pertaining to radiation medicine and the evolution of that system, together with an examination of several aspects of the risks that are associated with ionizing radiation in medicine, are the centerpiece of the report. The committee also considers in some detail general observations about the goals of regulation; the roles of the NRC, other federal entities, and the states; and the fee and non-fee costs of regulation (to the regulated community). The report describes a spectrum of seven alternative regulatory systems that were devised and debated by the committee, and presents the committee's findings, conclusions, and recommendations. The main focus of the report is on the existing regulatory framework for ionizing radiation in medicine and the committee's evaluation as to what would be an appropriate regulatory model for this particular aspect of medicine.

3  

Naturally occurring and accelerator-produced radioactive materials are collectively referred to as "NARM" to distinguish them from reactor-generated byproducts. The term "radionuclide" refers to both accelerator-produced materials and reactor-generated byproducts.



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