Radiation in Medicine A Need for Regulatory Reform (1996) / Chapter Skim
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, as amended,2 is responsible for the regulation of nuclear reactors and reactor-generated byproduct matenal. Byproduct material consists of radionuclides produced during the process of nuclear reactor operation and accounts for approximately 10 percent of ionizing radiation used for medical purposes.
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Reactor-generated byproduct material is not the only source of ionizing radiation; other sources are radioactive materials that occur naturally or are accelerator produced, and radiation produced by x-ray machines and particle accelerators.3 In examining the existing NRC Medical Use Program, the IOM Committee for Review and Evaluation of the Medical Use Program of the Nuclear Regulatory Commission compared the regulation of byproducts with the regulation of other sources of medically used ionizing radiation and with the regulation of medicine in general. The scope of this comparison was occasioned by an awareness of problems among the NRC, Congress, the states, and the regulated community that suggested the entire regulatory system needed to be examined.
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Among the federal agencies with oversight, the NRC has regulatory authority over the use of byproduct materials in medicine. The Food and Drug Administration (FDA)
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It judged, however, given the strength and leadership of the Conference of Radiation Control Program Directors (CRCPD) and the Suggested State Regulations for the Control of Radiation (SSRCR)
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Additionally, where each state has a role in regulating the use of ionizing radiation in medicine, the committee assumes that the CRCPD would continue to develop suggested state regulations, to help coordinate state programs, and to act in the area of the nonmedical use of radioactive materials. The NRC Medical Use Program The NRC is responsible for regulating the "medical use" of byproduct materials.
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, the NRC formally delegates authority to regulate byproduct material to the state government. In the remaining 21 states ("NonAgreement States")
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The Quality Management Rule The NRC's QM rule calls upon NRC licensees to establish a QM program in compliance with 10 CFR 35.32 and 35.33 in three circumstances: (1) if they administer radiation from sealed sources containing byproduct material for therapy (brachytherapy)
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An Agreement State arrangement requires that the NRC conclude that a state's radiation control program "is compatible with the Commission's, meets the applicable parts of Section 274 [of the AEA]
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Seven Alternative Structures The alternatives considered pertain to two relevant parts of the CFR: 10 CFR Part 35: Medical Use of Byproduct Material, and Part 20: Standards for Protection Against Radiation. The focus is on those CFR provisions as they affect institutions and individuals involved in the medical and biomedical research use of radiation in medicine.
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. In particular, the NRC retains responsibility for licensing the production of byproduct material for use in radiation-producing devices and radiopharmaceuticals.
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It would achieve regulatory clarity and simplicity by transferring the authority to regulate ionizing radiation used in medicine to an agency responsible for federal oversight of health care. However, as the committee explored this alternative, it could find little reason for creating an expanded federal role in the regulation of accelerator-produced radionuclides and machine-produced radiation that is, the 90 percent of radiation medicine now regulated at the state level.
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Federal regulation of medical uses of ionizing radiation in states without a program for byproducts also raises the question of what the minimum level of regulation ought to be and how minimum standards might be established. In effect, Alternative E would replicate the existing NRC Agreement State Program.
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The second consideration is that millions of people have been treated with machine-produced radiation and accelerator-produced radionuclides with no indication of injury to them or to the public at large beyond that common to medical procedures in general. Current state regulations seem to work for nonbyproduct ionizing radiation in medicine, and the committee expects that byproduct materials can be accommodated in the state systems.
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· Compared to the regulatory systems in place for the other 90 percent of medical use of ionizing radiation, the more detailed reporting and enforcement systems required for byproduct materials do not seem to result in even a marginal decrease in risk to providers, patients, or members of the public. Equal treatment of all ionizing radiation in medicine would be a sensible national policy insofar as the risks of reactor-generated byproduct material and other forms of radiation are equal.
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· The regulatory system specifically covering the medical use of reactorgenerated byproduct material has outlived its original logic. Nuclear medicine and radiation oncology expanded greatly with the availability of reactor byproduct material for peaceful uses; it is understandable that the Atomic Energy Commission, and later the NRC, were at the outset delegated general authority for regulation in these fields.
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supporting the operation of the Conference of Radiation Control Program Directors; b. providing a venue for the review and evaluation of Suggested State Regulations for Control of Radiation; c.
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This single change is a move toward bringing NRC regulations into line with the way that medical care in general and ionizing radiation in particular (except for byproduct materials) are regulated.
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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)
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C: Recommendations to the Conference of Radiation Control Program Directors and to the States C1. The committee recommends that the Conference of Radiation Control Program Directors incorporate into its Suggested State Regulations for Control of Radiation any relevant concepts from 10 CFR Part 35 that are not already integrated in those suggested regulations.
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C3. The committee recommends that the Conference of Radiation Control Program Directors and the states continually reevaluate their regulations and procedures pertaining to radiation medicine to ensure congruence with evolving scientific understanding of radiation bioeffects and to be in accord with advances in knowledge regarding benefits and risks related to medical and biomedical research uses of ionizing radiation in medicine.
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, the committee selected Alternative D, which removes regulatory authority from the NRC, shifts federal guidance to the DHHS, and delegates regulatory responsibility for byproduct material to the states, with the proviso that only licensed users would have access to byproduct material. With the articulation of this alternative and the recommendations set forth above, the committee believes that it has fulfilled its assigned task.
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