regulatory regime, a change in structure may not be justified on the basis of safety.


For reasons discussed below, the committee found it difficult to see any positive aspects to this alternative. Given the inherently conservative nature of federal agencies, this might be the easiest alternative to realize, inasmuch as no action is required.


The NRC currently regulates only 10 percent of all ionizing radiation in medicine and the committee feels that uniform regulation of all such use is desirable. All in all, the committee believes that the NRC's current system for regulating the use of byproduct material in medicine and for enforcing those regulations should not remain as it is. The committee uncovered several problems with the status quo that need to be addressed and are discussed throughout the report. In particular, the committee found that the NRC's present set of regulations and its approach to enforcement has evolved to the point where it is overly prescriptive rather than performance-based. Actions taken by the NRC against user institutions tend to be disproportionate to the violations, not so much in the magnitude of fines as in its public announcements of citations, and its unrealistic paperwork demands.

Alternative A2: Status Quo Modified

A second possibility requires some minimal change to the current system to deal with these problems. One criticism of the NRC's regulation of the medical use of ionizing radiation is directed specifically at 10 CFR 35.32 (quality management program) and 35.33 (notifications, reports, and records of misadministrations), both of which became effective in 1992. This alternative would either eliminate these two sections of the NRC's regulations or make the sections voluntary by having the NRC announce that it will ease the manner of definition and thus enforcement. The committee believes that less stringent programs enforced by existing professional organizations and societies, such as the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) and the American College of Radiology (ACR), and liability law would be sufficient to maintain the low rate of problems reported in Chapter 4.

This new approach is something that the NRC, within its current legislative authority, could implement without delay or public comment. This single change would greatly facilitate bringing NRC regulations into line with the way that health care in general and ionizing radiation in particular (except for byproduct

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