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Radiation in Medicine: A Need for Regulatory Reform
Another nongovernmental organization that is influential in the regulation of ionizing radiation in medicine is the United States Pharmacopoeia (USP). Standards for all marketed radiopharmaceuticals are set out in USP's National Formulary. Monographs in the Formulary also set out acceptable uses for the substances, both labeled and otherwise. The USP standards are used by state pharmacy boards, by other professional medical societies, and by the FDA itself.
THE COSTS OF NRC REGULATION
This section examines the fee and non-fee costs of NRC regulation of ionizing radiation in medicine. The NRC supports its regulation of medical programs through the fees it charges licensees for licensing and inspections (NRC, 1994), and it imposes a variety of additional costs through its reporting and other requirements. It is important to note here that in Agreement States, all licensing of radioactive materials used in medicine is done by the state. In Non-Agreement States, NARM is licensed by the state while byproduct material is licensed by the NRC. Whether they are Agreement States or not, most states do not operate their licensing agencies like the NRC; their fees are generally lower than the NRC's fees. Licensees in Agreement States do not, in general, pay as much in fees as they would in states regulated by the NRC.4
In examining the costs of NRC regulation, this section addresses both cost recovery by the NRC through its fee collection process and the additional costs beyond license fees and fines ("non-fee costs") borne by NRC licensees. The discussion of non-fee costs reports the consensus view expressed to the committee about recordkeeping requirements, security requirements, and waste management policies. There is, in addition, some consideration of estimated cost savings to NRC licensees if certain NRC requirements were eliminated or revised.
This discussion of costs does not attempt to evaluate the financially unquantifiable costs associated with NRC medical use regulation, such as potential restrictions in access to medical care, impacts on choice of therapy, or other consequences of detailed NRC regulations. Nor does it attempt to quantify or detail the potential benefits of NRC regulation. The relative value of such regulation is discussed in the section on risk assessment in Chapter 4.
Institute of Medicine staff attempted to obtain consistent, organized data on state fees. Apparently the CRCPD had made efforts in the past to collect this information. From 1978 to 1987 about 50 states contributed information on fees. During 1984–1992 approximately 30 states contributed partial information. One of the problems associated with collection of these data and any attempt to categorize the data for comparative purposes is that some states have as many as 60 categories of fees. Based on the difficulties encountered in collecting these data and the dwindling participation on the part of the states, an executive decision was made by senior staff at the CRCPD not to pursue collection of these data.