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Radiation in Medicine: A Need for Regulatory Reform
B2. The committee recommends that the NRC initiate formal steps under the Administrative Procedure Act to revoke Part 35 in its entirety, if Congress fails to act within two years in response to the two recommendations to Congress stated above.
In addition to overly stringent enforcement, the regulations themselves are excessive and duplicative: 10 CFR Part 35 covers areas that either are already regulated at the institutional level or are best left to the states, to professional societies, and to patients in consultation with their doctors. States regulate the medical uses of other forms of ionizing radiation and, as discussed below, could easily fold byproduct material into their regulatory programs. The CRCPD could add byproduct material to its suggested state regulations. These additions could incorporate relevant concepts currently in Part 35 (see discussion below under Recommendation C1 to the CRCPD and states). The FDA collects data on adverse effects of radiopharmaceuticals and incidents of failure of radiation-emitting medical devices, and it could assume the monitoring responsibilities of the NRC.
Quality improvement programs are put in place by institutions and health plans, with the support of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and other private accreditation organizations. Doctors have ethical obligations, codified in professional standards, for informing patients of medical errors. The committee believes that the relatively low misadministration rate could be maintained by less stringent programs that are administered at the state level by professional societies, and by existing liability law.
The committee strongly endorses the formal route of notice and comment, subject to the Administrative Procedure Act, to accomplish the rescission of all of Part 35. The committee recognizes that this process will take some time.
B3. The committee recommends that the NRC separate the costs of formulating regulations from the costs of administering those regulations.
Fees cover both development and administration of regulations. Licensing fees charged to health care facilities to meet the cost of the existing NRC program are becoming increasingly expensive as more states become Agreement States. The reason is that the NRC program and overhead costs do not drop, but the costs are spread over institutions in fewer and fewer states.
Congress ordered the NRC to recover 100 percent of its costs from user fees, and thus all NRC costs have been divided among the institutions it licenses. Congress also permitted the NRC to discontinue its authority over states interested in entering into formal agreements with the NRC, becoming Agreement States subject to NRC oversight. These Agreement States do not bear any of the NRC's costs. As more states have decided to become Agreement States, the NRC's costs have declined somewhat, but not nearly in proportion to the number