Radiation in Medicine A Need for Regulatory Reform (1996) / Chapter Skim
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3 Regulation and Radiation Medicine
3 Regulation and Radiation Medicine
Pages 77-110
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From page 77... ...
The chapter begins by making important general observations about the goals of regulating medical products. It next describes the development of regulation with respect to different types of ionizing radiation products and details the current roles of the Nuclear Regulatory Commission (NRC3, the Food and Drug Administration (FDA)
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From page 78... ...
Many of our most serious diseases can effectively be treated in the future only through the development of new medicine, including radiation products, that will make major advances in diagnosis and therapy. These twin goals for regulation of medical products-promoting safety and promoting technological advance-require a delicate balance.
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From page 79... ...
For all forms of medical products, regulation is justified by the dangers that could be presented by unsafe materials, ineffective products, and incompetent professionals. Many drugs and devices are inherently injurious when applied under any but the strictest regimens.
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(now the NRC) to regulate three particular types of ionizing radiation products: byproduct materials, source materials, and special nuclear materials.
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In 29 states ("Agreement States") , the NRC formally delegates authority to regulate byproduct material to the state government.
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From page 82... ...
in 1972 to issue a report entitled Problems of the Atomic Energy Commissior' Associated with the Regulation of Users of Radioactive Materials for Industrial, Commercial, Medical, and Related Purposes (GAO, 1972~. Noting the lack of information on overexposures, and tallying approximately 20 incorrect doses brought to the AEC's attention over the prior 10 years, the GAO criticized the AEC's "lax oversight" of byproduct material licensees.
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From page 83... ...
(For the full definition of misadministration, see 10 CFR 35.2 in Appendix D.) Over the following four years, NRC licensees reported 27 therapy misadministrations, or about 7 per year.
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From page 84... ...
Whereas NRC licensees have been living with this rule since January 1992, Agreement States were not required to follow suit until January 1995.
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From page 85... ...
NRC authority regarding radiological health and safety aspects of nuclear materials is transferred to the states through a formal agreement between the governor of the state and the NRC (Public low 83-703, 1954~. Currently, there are 29 Agreement States, and several other states are exploring agreement status.2 Use of the Agreement State arrangement requires that the NRC must 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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From page 86... ...
These actions include: . periodically assessing Agreement State radiation control programs against established review criteria; · providing assistance to help address weaknesses or areas within an Agreement State radiation control program requiring improvement; · placing a state on a probationary status for serious program deficiencies that require heightened oversight; · temporarily suspending an agreement and reasserting NRC regulatory authority in an emergency if an Agreement State program experiences any immediate program difficulties that prevent the state from continuing to ensure adequate protection of the public health and safety; and · suspending or terminating an agreement and reasserting NRC regulatory authority if the Agreement State experiences difficulties that jeopardize the state's ability to continue to ensure adequate protection of the public health and safety.
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From page 87... ...
Congress enacted the Radiation Control for Health and Safety Act of 1968 to provide additional regulatory authority for all "electronic products" that emit ionizing or nonionizing radiation, including medical products. The responsibility for administering the 1968 act was transferred to the FDA in 1971 and combined with the FDA medical device program in 1982.
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From page 88... ...
Both the FDA and the NRC separately approve the method of manufacture, require continuing compliance with good manufacturing practice requirements, and inspect the establishments to assure compliance, for the same radiation products. Both the FDA and the NRC, as already noted, also separately impose reporting requirements regarding adverse reactions for the same radiation products.
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From page 89... ...
The EPA has also published guidance on topics such as occupational radiation exposure, and it has issued proposed guidance on radiation exposure for members of the general population. Although EPA has not proposed guidance for nuclear medicine quality assurance, it has the legal authority to do so.
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From page 90... ...
Although it has no independent regulatory authority, it is actively involved in information sharing and technical assistance activities. The CRCPD membership represents both NRC Agreement States and states directly regulated by the NRC; thus, it participates in implementing and providing feedback on NRC regulations.
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From page 91... ...
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.
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From page 94... ...
The remaining P-lE;s are considered overhead and general and administrative personnel (NRC, 1994~. The work of the directsupport I;lL;s represents $376.6 million of the NRC's total operating budget; s On June 21, 1995, the NRC issued a press release that read, in part, as follows: The Nuclear Regulatory Commission is making changes to the licensing, inspection and annual fees it charges applicants and licensees....
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From page 96... ...
For an eight-hour day, the corresponding rate would be $1,064. Fee Schedules for Selected NRC License Categories As stated above, the NRC has established 57 categories of materials licenses.
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From page 97... ...
v' 'e 3 o o z Cal Q)
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From page 98... ...
One licensee said that 60,000 packages had been surveyed in the past 20 years, with not 6 RSOs are professional support personnel who design, write licenses for, and operate radiation safety programs, and they deal with the NRC directly. Medical personnel such as physicians, nuclear medicine technologists, radiation therapy technologists, and nuclear pharmacists generally have different interactions with the NRC and different kinds of duties.
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From page 100... ...
The QM rule, instituted for NRC licensees in 1992 and required for Agreement States in 1995, was cited as another example of overregulation. Many RSOs and professional groups believe that benefits derived from the QM program are outweighed by the costs of maintaining a prescriptive regulatory program.
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From page 101... ...
Radioactive Waste Management There was general consensus among interviewees and witnesses that the difficulty and expense of waste disposal have driven up costs and eliminated some benefits of the use of NRC-licensed materials. All RSOs stated that radioactive waste management policies had had severe impacts on themselves, on the users of licensed radioactive materials, and on the kinds of patient care and research being performed in their institution.
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From page 102... ...
Cost Savings Estimates for Some NRC Licensffl RSOs from four NRC licensees were asked how many personnel could be eliminated if NRC regulations were revised to eliminate tasks such as package receipt, log-in, and surveys, unneeded and unproductive recordkeeping, inconsistent waste disposal provisions, time-consuming licensing and inspection programs, and high fees. Three RSOs estimated savings of 1 FTE, and one estimated savings of 2.5 ~ Lois.
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From page 104... ...
QUALITATIVE ASSESSMENTS OF NRC REGULATIONS As described in Chapter 1, the committee's fact-finding efforts included eliciting information from individuals and organizations via a public hearing, a technical panel comprising health professionals, and site visits to various medical institutions and state organizations in the states of Georgia, Minnesota, Massachusetts, and California. Many of the experts from whom the committee heard believed that over the past two decades, NRC regulation had helped bring a high level of quality and accountability and had provided some useful services to radiation medicine.
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From page 105... ...
In one example, a radiation safety officer, for fear of establishing two separate standards of medical care, one for NRC-regulated activities and another for state-regulated activities, applies NRC standards throughout his institution, resulting in massive costs for additional linear accelerator shielding and the extension of the NRC-mandated QM program. In another example, a university hospital plans all radiation therapy, the majority of which employs a linear accelerator, according to 10 CFR Part 35 requirements, just in case the accelerator fails and the patient must be switched to the cobalt unit.
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From page 107... ...
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From page 108... ...
Finally, the committee recognized that the patient notification requirement in 10 CFR 35.33 was particularly controversial, even within the NRC itself, and will have negligible marginal positive effects and generally negative effects, when seen in the context of usual medical practice and monitoring Fees and Fines NRC fees and fines were identified as excessive for the amount of risk posed by the use of radionuclides in medicine. Fees and fines were cited as one of the main reasons that Non-Agreement States are becoming Agreement States.
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From page 109... ...
NRC. Final Statement of Principles and Policy for the Agreement State Program and Procedures for Suspension and Termination of an Agreement State Program.
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From page 110... ...
Paper commissioned by the Institute of Medicine Committee for Review and Evaluation of the Medical Use Program of the Nuclear Regulatory Commission.
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