form acceptable to NRC inspectors.9 Much time, effort, and money is spent satisfying such administrative demands.

Perhaps the greatest attention went to the quality management and notification requirements set out in sections 35.32 and 35.33. The consensus among the technical panel representatives, interviewees at medical institutions, and those who spoke at the public hearing was that elimination of the QM rule would not lessen the radiation protection of the public, the occupational worker, or the patient. The committee shared this opinion, based on members' experience, expertise, and the results of their findings.

Finally, the committee recognized that the patient notification requirement in 10 CFR 35.33 was particularly controversial, even within the NRC itself, and will have negligible marginal positive effects and generally negative effects, when seen in the context of usual medical practice and monitoring

Fees and Fines

NRC fees and fines were identified as excessive for the amount of risk posed by the use of radionuclides in medicine. Fees and fines were cited as one of the main reasons that Non-Agreement States are becoming Agreement States. Several individuals interviewed during site visits voiced concern that excessive costs force laboratories to stop using radionuclides, which in turn delays or prohibits the development and implementation of new uses of radionuclides in medicine. Boron neutron capture therapy was given as one example of a new technology whose development and diffusion is impeded by the costs of NRC regulation. In addition, many individuals in the regulated community objected to the NRC's budget being funded solely through licensing and enforcement fees. In no case did any of the RSOs interviewed believe that they receive value or services from the NRC that are commensurate with the fees they pay.

CHAPTER SUMMARY

This chapter has set out the costs, economic and otherwise, of the current system of regulating ionizing radiation in medicine. Regulation always has its costs, but they must be weighed against any benefits derived, such as the protection

9  

Chapters 1245 and 1246 pertaining to inspector qualifications and materials license reviewer qualifications include the following language: "They must also be keenly aware of the potential for negative impact on safety if the inspection process is allowed to become overly intrusive in areas of licensee operation where problems are not occurring" (NRC Inspection Manual, 9/91, p.1). "The reviewer must also become aware of the possibility of his/her inadvertently handicapping the licensee's activities by imposing unreasonable or unnecessary license conditions" (NRC Inspection Manual, 2/94, p.1). The regulated community asserts that these policies are not heeded. The committee gathered much detail on such instances.



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