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Radiation in Medicine: A Need for Regulatory Reform
materials) is regulated. The committee judged that this step toward uniformity would be of real value.
The concepts that are currently reflected in 10 CFR 35.32 and 35.33 could be incorporated into NRC educational programs and enforced by the states or professional societies. This step would greatly assist in reinstating the NRC as a professional leader rather than enforcer. Because there is value in having a thoughtful set of guidelines concerning the use of byproduct materials, the NRC might continue to formulate voluntary guidelines concerning quality management. The NRC might contract with the CRCPD to write these guidelines, or it might adopt the quality management programs set forth by the JCAHO or the ACR.
The reporting requirements in 10 CFR 35.32 and 35.33 could be handled through the FDA, which requires notification of adverse events and medical device failure incidents under the authority of the Food, Drug, and Cosmetic Act. The NRC could strengthen its collaboration with the FDA so that incident reports associated with products would be made available to the NRC. This could provide a continuous assessment of the adverse event rate for byproduct materials used in medicine.
Adopting Alternative A2 would not require legislative change. It would only require the NRC to exercise discretion by indicating to the regulated community that the agency does not intend to enforce existing regulations in the current manner defined, monitored, and policed. The NRC could possibly promulgate a new regulation that does away with 10 CFR Part 35 entirely, but that step would entail the cost and resources of a formal public comment period. Thus, this alternative is the easiest and fastest way to effect a change in the existing system and to address the concern expressed by the medical community without calling for a sweeping reorganization. However, this alternative does not address the committee's concerns, as discussed below.
This alternative also provides the NRC with an opportunity to make useful changes in its work culture. The NRC would no longer treat minor deviations as serious violations. Emphasis on working with the regulated institutions by answering questions, providing help in meeting regulations, and viewing violations in terms of risk could alter and improve their performance. Thus, this alternative enables the NRC to retain highly trained personnel who can be reassigned to more productive tasks. It would also produce a work environment more responsive to the concerns of the medical community, without sacrificing the radiation safety accomplishments that NRC has achieved over the years.