Radiation in Medicine A Need for Regulatory Reform (1996) / Chapter Skim
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5 Alternative Regulatory Systems
5 Alternative Regulatory Systems
Pages 141-168
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From page 141... ...
This chapter describes the seven main regulatory structures that the committee considered. It discusses the advantages and disadvantages of each and provides an overall assessment of each, ultimately explaining the rationale behind the preferred alternative.
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From page 142... ...
Federal agencies would retain their existing responsibilities for the generation, transport, nonmedical use, and disposal of radionuclides, for the approval of radiopharmaceuticals, and for certification or approval of equipment that generates ionizing radiation. In particular, this means that: · the NRC and its Agreement States would continue to license the production of byproduct material for radiation-producing devices and radiopharmaceuticals; · the NRC and its Agreement States would, as relates to nonmedical uses (i.e., industrial, educational, and nonmedical research)
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From page 143... ...
The CRCPD will continue in its role for the nonmedical use of radioactive materials. SEVEN ALTERNATIVE STRUCTURES The alternatives discussed below pertain to two parts of the Code of Federal Regulation (CFR - 10 CFR Part 35: Medical Use of Byproduct Material, and Part 20: Standards for Protection Against Radiation.
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From page 144... ...
All in all, the committee believes that the NRC's current system for regulating the use of byproduct material in medicine and for enforcing those regulations should not remain as it is. The committee uncovered several problems with the status quo that need to be addressed and are discussed throughout the report.
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From page 145... ...
This step would greatly assist in reinstating the NRC as a professional leader rather than enforcer. Because there is value in having a thoughtful set of guidelines concerning the use of byproduct materials, the NRC might continue to formulate voluntary guidelines concerning quality management.
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From page 146... ...
that safety can be maintained at lower cost. The existing, illogical system would remain intact, allowing what might still be fairly intense regulation of reactor byproduct material at the federal level and no comparable federal regulation of the uses of other sources of radioactivity (which add up to a significantly greater percentage of all the uses in radiation medicine)
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From page 147... ...
Depending on the country, governments may regulate some medical modalities disproportionately in comparison to others, sometimes without considering the relative risks involved. In keeping with the value placed on personal choice in a free market environment, Alternative B would do away with existing federal and state regulatory controls over the use of all ionizing radiation in medicine, including byproduct material, NARM, and machine-produced radiation.
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From page 148... ...
Alternative C: State Control Alternative C would eliminate NRC control of the medical uses of byproduct material. Instead, it would give regulatory authority over such uses to the states, and it would rely on the states to expand their existing radiation control programs that apply to NARM to include byproduct material as well.
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From page 149... ...
For instance, the FDA would continue to regulate the safety and efficacy of radiopharmaceuticals and radiation-emitting medical devices, and the DOT would continue to regulate the transportation of byproduct materials. The NRC would still license the manufacture of byproduct materials.
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From page 150... ...
would most likely result in higher fees for the remaining Non-Agreement States. Furthermore, state legislatures might not appreciate the reasons for NRC regulation of industrial uses of byproduct materials, while expecting the states to assure safety for medical uses of such matenal.
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From page 151... ...
Public safety in the medical use of ionizing radiation would yet exist in the fact that the NRC would still retain the responsibility of licensing manufacturers (i.e., nuclear power plants and radiopharmaceutical companies) and, consequently, could ensure that byproduct material was withheld from any state that failed to license users and regulate the use and safety of byproduct material.
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From page 152... ...
Alternative D would mean that, in order for facilities in any state to use byproduct materials, that state would have to establish a regulatory program that includes reactor-generated byproduct material. The NRC and its Agreement States would continue to regulate the manufacture of byproduct material for use in radiation devices and radiopharmaceuticals; thus, manufacturers would not be able to distribute radioactive byproduct material to users unless they were licensed by their states.
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From page 153... ...
Byproduct misadministrations are reported to the NRC and adverse events for investigational drugs and blood products must be reported to the FDA, but data on adverse events involving other sources of ionizing radiation in medicine are reported on a voluntary basis, and are therefore either not available for comparison or underreported. This federal agency could gather such data (or act as a clearinghouse)
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From page 154... ...
This would, in turn, effectively encourage consistency across the nation by providing training to state officials, helping set priorities for action concerning various radiation sources, and assisting in the development of survey instruments and test methodologies. This alternative would ensure that, in order for facilities within its borders to use byproduct materials, a state would have to establish a regulatory program that includes reactor-generated byproduct material.
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From page 155... ...
Likewise, the states could also institute a system of user fees that would provide them with essential funding for expanding their radiation safety control programs to include reactorgenerated byproduct material. Part of these fees would need to go to the CRCPD, which currently depends on funding from those federal agencies, including the NRC, that regulate the use of ionizing radiation.
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From page 156... ...
The committee sees no reason, however, to assume that the states would discontinue their existing programs for regulating non-byproduct radiation. Rather, it is presumed, based on their existing radiation control programs, that states would expand these programs to include byproduct material as well.
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From page 157... ...
. Any state that currently does not have a radiation safety program that is comprehensive for all sources used in medicine would have the following options: · adopt the SSRCR and set up an enforcement mechanism within a state agency; · adopt the SSRCR through its own legislative process but join a consortium of states for the purposes of implementation and oversight, formally authorizing another state to assume responsibility for an effective radiation safety program; or · refuse to adopt a program or include reactor-generated byproduct material within its existing radiation safety program.
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From page 158... ...
Second, what evaluation mechanism would be set in place to assess the programs enacted by the states? In effect, this proposal could replicate, within the DHHS, the existing NRC Agreement State program, which permits states to enter formal agreements with the NRC to regulate reactor-generated byproduct material and necessitates that each Agreement State adopt programs virtually identical to the NRC's program for Non-Agreement States.
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From page 159... ...
The likely entity within the DHHS is the FDA, specifically the Center for Devices and Radiological Health; however, a new division within the FDA might also be created. The committee believes that for appropriate regulation of ionizing radiation in medicine, knowledge and experience with the medical issues should be emphasized over knowledge and experience with byproduct materials.
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From page 160... ...
Con The cost of this program at the federal level would almost certainly be greater than either the existing NRC regulatory activities or any of the previously described alternatives, because Alternative F ushers in the federalization of all regulation of radiation medicine. That is, it not only unifies but also greatly expands regulation at the federal level.
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From page 161... ...
Alternative G would place regulatory authority into a single, centralized agency to counter inconsistency and inefficiency. The key point to this alternative is that it would not be limited to regulating ionizing radiation in medicine.
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From page 162... ...
Although the HFA would have the potential for increasing efficiency, equity, and the quality of care, the committee believes the health care system is inherently too complicated and diverse to be centrally administered in this way. There are legitimate differences in the incidence of disease, conditions, and what can be expected from the patient in different demographic and geographical areas.
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From page 163... ...
The existing inequity between byproduct material and NARM and machine-produced radiation remains unchanged: intensive regulation of byproduct material at the federal level and no federal regulation of the uses of other sources of radioactivity. The committee also rejected the laissez-faire approach in Alternative B
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From page 164... ...
Although several federal agencies regulate radiopharmaceuticals, radiation-emitting medical devices, transport of radionuclides, and radiation exposure of workers and the public, most states regulate the use of all ionizing radiation in medicine except for byproduct materials. State government is, therefore, a logical locus for more comprehensive regulation of these modalities.
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From page 165... ...
Finally, corporate pressure from manufacturers in a state that does not have a program cannot be underestimated. Alternative D would mean that, for facilities in any state to use byproduct materials, that state would have to establish a regulatory program that includes reactor-generated byproduct material.
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From page 166... ...
Consequently, states are induced to expand their existing radiation control programs to include byproducts, or users within their borders would be unable to obtain byproduct materials. Third, millions of patients have been treated with machine-produced radiation and accelerator-produced radionuclides with no indication of patient or public injury beyond that common to medical care procedures in general.
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From page 167... ...
As discussed above, the federal agency as envisioned in Alternative D would fulfill several functions: assisting states in establishing regulatory programs, training inspectors, addressing problematic incidents of national concern, educating the public as to the benefits and risks of radiation medicine, collecting risk data so that more informed policy decisions might be made by the states, conducting research so that the science of radiation medicine continues to advance, and monitoring the effects of deregulation. By acting in these traditional capacities, the federal agency would add to the safe administration of ionizing radiation in medicine without imposing more requirements on one aspect of ionizing radiation than on another.
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