6
Findings, Conclusions, and Recommendations

In response to the three major goals defined by the Nuclear Regulatory Commission (NRC), the committee has addressed:

  • the broad policy issues that underlie the regulation of medical uses of radionuclides;

  • the overall risks associated with the use of ionizing radiation in medicine, assessing the error rates and consequences of the use of byproduct materials in comparison to other forms of ionizing radiation and other medical modalities; and

  • the current statutory and regulatory framework for the control of medical uses of byproduct materials and a uniform national approach to the regulation of ionizing radiation in all medical applications.

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) that states have the ability to regulate radiation effectively within their borders. Next, the chapter lays out the committee's findings. These are followed by a discussion of the committee's conclusions and of its eight recommendations, which include suggestions for action that might be taken immediately and plans for long-range adjustment of the regulatory system. The recommendations are based upon the committee's endorsement of Alternative D (federal guidance) in Chapter 5.



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Radiation in Medicine: A Need for Regulatory Reform 6 Findings, Conclusions, and Recommendations In response to the three major goals defined by the Nuclear Regulatory Commission (NRC), the committee has addressed: the broad policy issues that underlie the regulation of medical uses of radionuclides; the overall risks associated with the use of ionizing radiation in medicine, assessing the error rates and consequences of the use of byproduct materials in comparison to other forms of ionizing radiation and other medical modalities; and the current statutory and regulatory framework for the control of medical uses of byproduct materials and a uniform national approach to the regulation of ionizing radiation in all medical applications. 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) that states have the ability to regulate radiation effectively within their borders. Next, the chapter lays out the committee's findings. These are followed by a discussion of the committee's conclusions and of its eight recommendations, which include suggestions for action that might be taken immediately and plans for long-range adjustment of the regulatory system. The recommendations are based upon the committee's endorsement of Alternative D (federal guidance) in Chapter 5.

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Radiation in Medicine: A Need for Regulatory Reform REPORT PREMISES The underlying premise of this report is that a balance must be achieved between the benefits and costs of regulation. In an ideal world of limitless resources, risks could be reduced to their minimum possible level. In reality, however, resources are not infinite. Policymakers must determine where scarce resources ought to be applied. Within the medical context, innumerable areas require attention. Resources committed to reducing the risk of adverse events in one area of medicine might be better committed elsewhere. 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. In the judgment of the committee, reduction of NRC regulatory authority will not increase the incidence of adverse events significantly, if at all. The intensity with which the byproduct area of radiation medicine is being regulated at the federal level—while the rest of ionizing radiation used in medicine and, indeed, most of the rest of medical practice remains free from this level of federal oversight—has little if any justification. Moreover, no clear reason exists for singling out this particular facet of ionizing radiation in medicine for such tightly controlled regulation. One might, theoretically, regulate all of medicine at the federal level to ensure greater uniformity, but the committee recognized that such an improbable restructuring of the total medical system would entail great cost, not achieve complete uniformity (due to how widely disseminated regulatory responsibility for radiation presently is), and yield questionable results for the resources expended. Second, at the crux of this report lies a fundamental philosophical and political perspective concerning state and federal regulation. All of ionizing radiation, with the exception of byproduct material, is currently regulated at the state level. No evidence of major problems with state regulation has ever been documented. The committee, of course, cannot know whether states will continue their regulatory programs. The committee 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) it promulgates, that state radiation programs would remain intact and expand to the area of byproduct use if federal regulation in this area is relaxed. Thus, all sources of ionizing radiation would be treated more uniformly than before, in that they would all be subject to state regulation. Admittedly, the extent of state regulatory programs varies, but for the majority, the SSRCR are the common denominator nationwide.

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Radiation in Medicine: A Need for Regulatory Reform FINDINGS During its deliberations, the committee reviewed information from a variety of sources, including commissioned papers, literature reviews, site visits, official presentations by NRC personnel, a public hearing, and interviews with radiation safety officers. The lack of data for comparing byproduct material, naturally occurring and accelerator-produced radioactive materials (NARM), and machine-produced radiation limited the scientific basis of the committee's findings. This section enumerates the findings the committee generally agreed upon given the existing data, as presented in Chapters 2, 3, and 4. The issues are summarized in terms of risks and benefits, regulations, the regulated community, and private and voluntary involvement in radiation safety. Risks and Benefits The use of ionizing radiation in medicine offers tremendous benefits to patients but also carries a nontrivial potential for harm. 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. 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 The fragmented regulation of the use of ionizing radiation in medicine—namely, its division into (a) the NRC's exclusive regulation of reactor-generated byproduct material, and (b) state regulation of NARM and machine-produced radiation—is a historical artifact. This has resulted in appreciable variation in the intensity and nature of regulatory control of various forms of radiation that have roughly equivalent risks. Regulation of reactor-generated byproducts exceeds in intensity and burden that of all other aspects of ionizing radiation in medicine. The regulation of reactor-generated byproduct material is also more vigorous than that of any other aspect of high-risk health care. It greatly exceeds the regulation of chemotherapy, surgery, anesthesia, and the use of general pharmaceuticals except for controlled substances, all of which are unregulated at the federal level.

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Radiation in Medicine: A Need for Regulatory Reform Regulatory guides, such as the NRC's ''as low as reasonably achievable" regulatory guide, that do not require formal public discussion become in effect enforceable regulations because institutions often must demonstrate compliance with the guides to get their licenses renewed. As more states become Agreement States, the institutions in the shrinking number of Non-Agreement States experience significant increases in fees to continue to support the NRC's Medical Use Program, which relies exclusively on user fees for funding. In addition to the regulations written by the NRC, other federal regulations exist to protect the public from potential harm caused by radiation. These include regulations from the Food and Drug Administration (FDA) within the Department of Health and Human Services (DHHS), the Department of Transportation (DOT), and the Environmental Protection Agency (EPA). The Regulated Community The regulated community has expressed interest in an external regulatory presence. Some parts of the community specify a desire for a federal regulatory presence, while the majority appears to prefer a shift to state regulation. Despite official cautions against overzealous inspection in the NRC inspection manual, the regulated community maintains that these cautions are virtually ignored by the inspectors. The regulated community has expressed reservations about seeking advice from the NRC, fearing that it may become the target of punitive reprisals rather than assistance. Private and Voluntary Involvement in Radiation Safety Professional societies have taken an active role in developing guidelines and quality assurance programs and in fostering and setting standards for education and training in the area of safe and appropriate use of ionizing radiation in medicine. Guidelines created by the CRCPD have been adopted to various degrees by states. Other professional groups and federal entities have also created standards and guidelines that can be adopted voluntarily by the states. CONCLUSIONS Modern medicine would be impossible without ionizing radiation. X-ray imaging, computed tomography scans, diagnostic and therapeutic nuclear medicine, brachytherapy, the gamma knife, and linear accelerators are a few of the technologies that have revolutionized medical diagnosis and treatment. As discussed in Chapter 2, radiation's benefits for human health can be measured in thousands of lives saved and even greater numbers of persons whose quality of

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Radiation in Medicine: A Need for Regulatory Reform life has been improved each year by these technologies. Even though the use of ionizing radiation in medicine offers enormous benefits, however, it also poses potential risks to patients, medical personnel, and the general public. The diagnostic and therapeutic tools that cure also can cause acute injuries and chronic illness, such as cancer. The committee recognizes both the tremendous benefits derived from the use of ionizing radiation in medicine and its potential for harm. The committee's goal is to promote the benefits while advocating a regulatory structure that adequately protects the health and safety of patients, workers, and the public. An important component to this balance is patient access to radiation medicine. Fewer people will benefit if regulation makes radiation medicine needlessly expensive or moves its tools a great distance from patients. Regulatory steps that lower the probability of risk only slightly, if at all, but seriously affect access through significant increases in cost and distance from patient populations should be foregone. The committee has identified and proposes to eliminate regulations that result in added costs but achieve little, if any, reduction in risk or additional benefit to a patient's outcome and well-being or that of health care personnel. The committee has determined that the NRC's current regulatory procedures are unjustifiably intense and burdensome, that they may have compromised the availability of the benefits of radiation, and that they do not decrease the risks of medical use of ionizing radiation in any meaningful way. That is, current NRC regulatory policy, as embodied in the Medical Use Program, provides no obvious positive value to consumers or providers of health care. The committee also concludes that it is appropriate to promote equal treatment of all ionizing radiation in medicine, insofar as the risks of reactor-generated byproduct material and those of other forms of radiation are equal, as set forth in Chapter 4. The most important difference between radiation sources is that machines produce radiation only when activated, whereas radionuclides produce radiation until they decay fully. In terms of their use in health care, this difference, which requires special considerations in the storage, shipping, and handling of radionuclides, is minor when compared to the similarities of the medical applications of the various types of radiation. The regulatory system specifically covering the medical use of reactor-generated 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. Today, however, many accelerator-produced radionuclides play a central role in the practice of nuclear medicine, and in radiation oncology, accelerator-produced radiation continues to displace the use of byproduct radiocobalt. Consequently, the unequal

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Radiation in Medicine: A Need for Regulatory Reform treatment of different sources of ionizing radiation in medicine can be construed as illogical if not counterproductive. The committee set out to determine what the appropriate level of regulation should be for all ionizing radiation in medicine. Taking the view that such regulation should be considered in its entirety, the committee concluded that special treatment of reactor-generated byproduct material is inappropriate and that the regulation that would be appropriate should not be conducted by the NRC, given that the risks are spread more or less evenly across all sources of ionizing radiation. All these factors, taken together, argue for the need to remove regulatory authority over the use of byproduct material in medicine from the NRC and to replace it with a broader and more appropriate system for the regulation of all ionizing radiation in medicine. The committee identified its preference for Alternative D (federal guidance) (as discussed in Chapter 5) 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. To effect this outcome, the committee outlines eight specific recommendations. The next section presents these recommendations in the form of (a) proposals for Congress, (b) steps for immediate action by the NRC, and (c) actions for professional entities. RECOMMENDATIONS A: Recommendations to Congress A1. The committee recommends that Congress eliminate all aspects of the NRC's Medical Use Program, 10 CFR Part 35, and those regulatory activities conducted under 10 CFR Part 20 that are applicable to medical uses. The committee proposes that Congress revoke the NRC's authority to regulate the medical and biomedical research uses of reactor-generated byproduct material. By nullifying the NRC's authority, Congress can effectively relinquish to each state, at its option, responsibility for regulation of reactor-generated byproduct material. Elimination of the NRC's Medical Use Program should only take place once the second recommendation to Congress (A2, below) has been fulfilled. Additionally, any legislation that accomplishes the revocation of Part 35 should provide for a transition period, during which the federal government transfers authority to the states. Rescission of authority at the federal level for regulation of the medical use of byproduct material has three benefits. First, it eliminates prescriptive and

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Radiation in Medicine: A Need for Regulatory Reform costly regulations that yield marginal risk reduction. Second, it shifts responsibility, by giving state governments authority over the health and safety of their citizens. 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. Also, as mentioned in Chapter 5, other federal agencies, such as the FDA, the DOT, and the EPA, would retain their regulatory authority over radiation. A2. The committee recommends that Congress direct the Secretary of Health and Human Services to support, coordinate, and encourage the following activities involving regulation of all ionizing radiation in medicine: supporting the operation of the Conference of Radiation Control Program Directors; providing a venue for the review and evaluation of Suggested State Regulations for Control of Radiation; assisting states in implementation of their regulations; aiding in assessment of the effectiveness of state programs through the collection and analysis of data; helping develop survey methods by which the rate of adverse events for a wide range of procedures and devices might be measured; monitoring the effects of deregulation; enhancing training and standards for health care personnel; and investigating future significant radiation medicine incidents. The Secretary of the DHHS can accomplish the above functions either by creating a new office within the DHHS or by assigning these functions to an existing office, such as the FDA's Center for Devices and Radiological Health. The committee deliberately chooses not to suggest an exact location, as it believes that the Secretary is in a better position to make such a decision. The committee recommends that the functions of this agency include the responsibility of funding the CRCPD and of encouraging and assisting the CRCPD in the continuous revisions of model legislation for adoption by the states. This "bully pulpit" role lends credibility to the CRCPD's efforts by giving it a federal imprimatur. Also, this nonregulatory federal entity, by convening the appropriate professional organizations to review and analyze new information that comes to light, provides a vehicle for integrating and coordinating efforts that will have national consequences.

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Radiation in Medicine: A Need for Regulatory Reform B: Recommendations to the Nuclear Regulatory Commission B1. The committee recommends that the NRC immediately relax enforcement of 10 CFR 35.32 and 35.33 through its present mechanisms. Appreciative of the weight of the NRC's regulatory responsibilities, the committee nevertheless explored problems with the NRC's Medical Use Program that should be addressed. In hearings, committee members heard consistent criticisms of NRC regulations and enforcement as burdensome, costly, and overly prescriptive. The NRC's regulatory program for the industrial sector is based on the premise that radiation and people should be kept apart. In the medical context, radiation and people are intentionally brought together in an effort to improve health and save lives. Thus, the committee found that the regulated community's desire for a collegial, more cooperative approach on the part of the NRC could improve the quality of medical care and lower the rates of misadministrations. The level at which the NRC currently enforces 10 CFR 35, sections 35.32 and 35.33—through detailed and voluminous documentation, reporting, and penalties—is inconsistent with the NRC's Medical Policy Statement, which favors minimum regulatory intrusion into the practice of medicine. Indeed, NRC's written regulations nowhere require such strict enforcement. The NRC has the authority to cease its present methods of enforcing sections 35.32 and 35.33, of its own volition. 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) are regulated. Reporting requirements currently in section 35.33 would not be entirely abandoned. On August 26, 1993, the NRC and the FDA created a memorandum of understanding to coordinate existing NRC and FDA regulatory programs for medical devices, drugs, and biological products that use byproduct, source, or special nuclear material. The committee urges the NRC to continue to cooperate with the FDA as provided in their memorandum of understanding to obtain data on devices, drugs, and biological products that relate to device malfunction, serious injury, and death. This coordinated effort between the two agencies will capture important data on technology and human (user) error related to device use but will exclude information relative to medical or technical judgment. This also reinforces the notion that the NRC, like the FDA, should not intervene in the practice of medicine.

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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

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Radiation in Medicine: A Need for Regulatory Reform of institutions it licenses. The result is rapidly rising fees levied on the institutions it does license, and this in turn increases the pressure for the remaining states to become Agreement States. This existing system is unfair. Only NRC-licensed institutions should bear the NRC's costs of licensing and inspection, whereas the costs of developing standards should be borne by all institutions, whether or not they are located in NRC-regulated states. 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. The CRCPD, comprising the radiation control programs in the 50 states (except Wyoming), the District of Columbia, and Puerto Rico, has developed and improved model state legislation for the regulation of all of ionizing radiation in medicine. The model legislation was first crafted by the Council of State Governments in 1962 and is revised periodically, most recently in 1991. On an ongoing basis the CRCPD has reviewed and revised its suggested state regulations in accordance with evolving scientific and technical information. Although the committee has determined that provisions in 10 CFR Part 35 need not be regulated at the federal level, it does encourage the CRCPD to undertake a systematic review and analysis of the concepts in Part 35 for possible adoption where relevant and appropriate. C2. The committee recommends that all state legislatures enact enabling legislation to incorporate the regulation of reactor-generated byproducts into existing state regulatory programs. Currently, almost all states have legislation governing the regulation of radiation, as noted in Chapter 3. These statutes include, to varying degrees, naturally occurring and accelerator-produced radionuclides and machine-produced radiation. 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) require proof of licensure before selling the material.

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Radiation in Medicine: A Need for Regulatory Reform Although the committee cannot guarantee that states will effectively regulate byproduct material, it believes that they will. This conclusion is based on the fact that states have effectively regulated naturally occurring and accelerator-produced radioactive material in the past and continue to do so. The CRCPD's SSRCR have been adopted, to varying degrees, by the majority of states. Additionally, the current NRC Agreement States already regulate byproduct material within their borders. There is no reason to think that any of these programs will be disbanded. Additionally, the JCAHO, the threat of malpractice suits, and the fear of adverse publicity in a competitive health care market all weigh against laxity that might lead to or not prevent adverse events. 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. As the CRCPD and the states fulfill their advisory, regulatory, and enforcement obligations, their revised recommendations, regulations, and procedures will reflect developments in scientific, technological, and regulatory knowledge. The committee wishes to stress the importance of promulgating and maintaining recommendations, regulations, and procedures in accord with state-of-the-art information. This is perhaps the most important function of the federal advisory agency envisioned in Alternative D described above—providing leadership and a level of assurance that the states are equipped with the most up-to-date information on the scientific and technical fronts. CONCLUDING STATEMENT The most important goals of regulation of radiation medicine are to assure the safety of patients, workers, and the public and to ensure that the benefits of regulating ionizing radiation will outweigh the risks. Whether the existing NRC regulatory system is the best approach for achieving this outcome was the focus of the committee's inquiry. Extensive discussion, throughout the study process, about the virtues and drawbacks of federal regulation, as contrasted with state regulation, took place. Ultimately, from a wide spectrum of possibilities, the committee identified Alternative D (described in Chapter 5), as its preferred strategy for addressing the issues originally set out in its charge. This approach removes regulatory authority from the NRC, shifts federal guidance to the DHHS, and delegates regulatory responsibility for byproduct material to the

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Radiation in Medicine: A Need for Regulatory Reform states, with the proviso that only user sites and users that are licensed by the responsible state authority 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. 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.