Radiation in Medicine A Need for Regulatory Reform (1996) / Chapter Skim
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6 Findings, Conclusions, and Recommendations
6 Findings, Conclusions, and Recommendations
Pages 169-180
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From page 169... ...
This final chapter first sets out two premises of the report: (1) that regulation of ionizing radiation in medicine warrants as rigorous an analysis of the costs and benefits of such regulation as the data will permit, and (2)
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From page 170... ...
The concentration of resources spent to reduce adverse events involving byproduct material, although seemingly effective, appears to have gone beyond the point at which the additional dollar spent on regulation achieves an equivalent dollar of benefit. The implication is that decreasing somewhat the resources directed at regulation may not pose commensurate risks or, similarly, may yield benefits in the form of resources that can be put to better or more efficient use.
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From page 171... ...
However, because data on adverse events in the use of ionizing radiation are limited, it is difficult to compare risks involving byproduct material with risks involving machine-produced radiation, or to compare overall risks of the use of ionizing radiation in medicine with those of other medical modalities. Regulations 1.
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From page 172... ...
2. Despite official cautions against overzealous inspection in the NRC inspection manual, the regulated community maintains that these cautions are virtually ignored by the inspectors.
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From page 173... ...
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, and it is understandable that the Atomic Energy Commission, and later the NRC, were at the outset delegated general authority for regulation in these fields, as described in Chapters 2 and 3.
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From page 174... ...
to achieve this result. Alternative D removes the NRC from regulating byproducts used in medicine, shifts responsibility for federal guidance to the DHHS, and delegates regulatory authority over the use of byproducts in medicine to the states, with the proviso that only licensed users will have access to byproduct material.
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From page 175... ...
Third, it promotes uniform treatment, in that radionuclides and machine-produced radiation are regulated by a single level of government at equal intensity, regardless of their source. It should be emphasized, however, that the NRC would retain regulatory authority over manufacturers of byproduct materials used in medicine, such as nuclear power plants and radiopharmaceutical companies.
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From page 176... ...
At a minimum, the NRC could immediately notify its licensees of its intent to relax its detailed enforcement and monitoring of sections 35.32 and 35.33, until a more permanent change is effected. 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)
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From page 177... ...
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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From page 178... ...
If Congress acts in accordance with the committee's recommendation to transfer authority for regulation of reactor-generated radionuclides to the states, the states should either amend their existing radiation legislation to encompass reactor-generated byproduct material or promulgate new legislation that addresses byproduct material. States that did not include byproduct material in their existing regulatory programs, which means they would not license users within their borders, would effectively preclude those users from obtaining byproduct material from manufacturers, which (by other NRC regulations)
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From page 179... ...
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 ~ owledge regarding benefits and risks related to medical and biomedical research uses of ionizing radiation In · ~ met Icme.
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From page 180... ...
This report offers to the nation an approach to the regulation of all ionizing radiation in medicine that will adequately protect the public's health and safety and assure broadest access of the public to the benefits of the full range of medical uses of ionizing radiation.
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