5
Alternative Regulatory Systems

One of the committee's tasks was to make recommendations on a uniform national approach to the regulation of ionizing radiation in all medical applications; the underlying aim was to promote the benefits of radiation and to improve patient care and outcome. During its deliberations on which form a uniform national approach should take, the committee considered a wide spectrum of alternative regulatory structures. By exploring a full range of options and elucidating the pros and cons of each, the committee sought to identify both strengths and problems within the current system and to focus on the alternative most likely to deliver the greatest net benefit to society.

In this chapter, the committee analyzes and synthesizes all of the information presented in Chapters 2, 3, and 4, and explores a range of options for the regulation of ionizing radiation in medicine. 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. The preferred alternative outlined and discussed in this chapter forms the basis for the recommendations presented in Chapter 6.

On balance, after assessing the existing regulatory system, the committee's impressions of its major problems are:

  • the Nuclear Regulatory Commission (NRC) regulates only 10 percent of all ionizing radiation in medicine and that uniform regulation of all ionizing radiation in medicine is desirable in the medical context;



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Radiation in Medicine: A Need for Regulatory Reform 5 Alternative Regulatory Systems One of the committee's tasks was to make recommendations on a uniform national approach to the regulation of ionizing radiation in all medical applications; the underlying aim was to promote the benefits of radiation and to improve patient care and outcome. During its deliberations on which form a uniform national approach should take, the committee considered a wide spectrum of alternative regulatory structures. By exploring a full range of options and elucidating the pros and cons of each, the committee sought to identify both strengths and problems within the current system and to focus on the alternative most likely to deliver the greatest net benefit to society. In this chapter, the committee analyzes and synthesizes all of the information presented in Chapters 2, 3, and 4, and explores a range of options for the regulation of ionizing radiation in medicine. 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. The preferred alternative outlined and discussed in this chapter forms the basis for the recommendations presented in Chapter 6. On balance, after assessing the existing regulatory system, the committee's impressions of its major problems are: the Nuclear Regulatory Commission (NRC) regulates only 10 percent of all ionizing radiation in medicine and that uniform regulation of all ionizing radiation in medicine is desirable in the medical context;

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Radiation in Medicine: A Need for Regulatory Reform the NRC's regulatory enforcement strategy is burdensome; the benefits from this process are not commensurate with the burdens imposed; the NRC intrudes into the practice of medicine; promulgation of the Quality Management Program and Notification, Reports and Records of Misadministrations, 10 CFR 35.32 and 35.33 respectively, involves the practice of medicine; and, the expenditure of resources (funded exclusively by user fees) to reduce adverse events involving byproduct material, extends beyond the point at which the additional dollar spent on regulation achieves an equivalent dollar of benefit to patients or the public. In considering each of the proposed alternatives, the reader should remember that, in all but the laissez-faire model (Alternative B), the basic structure of federal regulation and responsibility would remain in place. 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), continue to license the production and use of byproduct material; the Department of Transportation (DOT) would continue to regulate the transport of radioactive materials; the Environmental Protection Agency (EPA) would continue to develop guidelines that set occupational and public exposure limits to be implemented by the respective federal agencies; the Food and Drug Administration (FDA) would continue to regulate the manufacture and labeling of radiopharmaceuticals and medical devices. the FDA would also continue to regulate the mammography program under the Mammography Quality Standards Act (MQSA); the Department of Defense (DOD), the Department of Veterans Affairs (VA), and the Public Health Service (PHS) would continue to be responsible, under the regulations of the appropriate agencies, for the safe use of radioactive materials and radiation-producing machines in their hospitals and laboratories; and the Health Care Financing Administration (HCFA) would continue to develop reimbursement guidelines for Medicare and Medicaid (as will other federal agencies for other health care purchased from the private sector).

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Radiation in Medicine: A Need for Regulatory Reform Additionally, under the alternatives where each state has a role in regulating the use of ionizing radiation in medicine, the committee assumes that the Conference of Radiation Control Program Directors (CRCPD) will continue to develop suggested state regulations and to help coordinate state programs. 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. 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. The committee first discusses the status quo (A1) and a variation upon that situation (A2). It then proceeds to discuss a spectrum of alternatives, varying from a market-based system (B) to a comprehensive and centralized federal system (G). Alternatives C, D, E, and F present a more conventional continuum for addressing regulation. These latter alternatives examine the differences between exclusive state regulation (C), state regulation accompanied by a federal advisory presence (D), state regulation accompanied by limited federal authority (E), and centralization of federal regulation at the federal level (F). In particular, the NRC retains responsibility for licensing the production of byproduct material for use in radiation-producing devices and radiopharmaceuticals. Each alternative is described, followed by a discussion of its pros and cons. The last section of this chapter assesses the alternatives and identifies the one preferred by the majority of the committee. Alternative A1: Status Quo Before determining whether an alternative to the existing system should be devised to regulate ionizing radiation in all medical applications, the committee assessed the NRC's current program and considered two possible options for NRC action. The first possibility is for the NRC to continue operating exactly as it has in the past and does today. In Chapter 4, estimates of the actual rates of misadministrations were presented. In the early stages of regulating ionizing radiation in medicine, NRC regulations may have contributed to the low incidence of misadministrations because they imposed considerable constraints on the users. Such constraints included strict licensing of physicians and institutions and limits on permissible uses of radioactive materials and on the amount of such materials that an institution could possess. If one infers that the current low rate of misadministrations is a direct result of the history of these regulations and the current

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Radiation in Medicine: A Need for Regulatory Reform regulatory regime, a change in structure may not be justified on the basis of safety. Pro For reasons discussed below, the committee found it difficult to see any positive aspects to this alternative. Given the inherently conservative nature of federal agencies, this might be the easiest alternative to realize, inasmuch as no action is required. Con The NRC currently regulates only 10 percent of all ionizing radiation in medicine and the committee feels that uniform regulation of all such use is desirable. 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. In particular, the committee found that the NRC's present set of regulations and its approach to enforcement has evolved to the point where it is overly prescriptive rather than performance-based. Actions taken by the NRC against user institutions tend to be disproportionate to the violations, not so much in the magnitude of fines as in its public announcements of citations, and its unrealistic paperwork demands. Alternative A2: Status Quo Modified A second possibility requires some minimal change to the current system to deal with these problems. One criticism of the NRC's regulation of the medical use of ionizing radiation is directed specifically at 10 CFR 35.32 (quality management program) and 35.33 (notifications, reports, and records of misadministrations), both of which became effective in 1992. This alternative would either eliminate these two sections of the NRC's regulations or make the sections voluntary by having the NRC announce that it will ease the manner of definition and thus enforcement. The committee believes that less stringent programs enforced by existing professional organizations and societies, such as the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) and the American College of Radiology (ACR), and liability law would be sufficient to maintain the low rate of problems reported in Chapter 4. This new approach is something that the NRC, within its current legislative authority, could implement without delay or public comment. This single change would greatly facilitate bringing NRC regulations into line with the way that health care in general and ionizing radiation in particular (except for byproduct

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Radiation in Medicine: A Need for Regulatory Reform materials) is regulated. The committee judged that this step toward uniformity would be of real value. The concepts that are currently reflected in 10 CFR 35.32 and 35.33 could be incorporated into NRC educational programs and enforced by the states or professional societies. 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. The NRC might contract with the CRCPD to write these guidelines, or it might adopt the quality management programs set forth by the JCAHO or the ACR. The reporting requirements in 10 CFR 35.32 and 35.33 could be handled through the FDA, which requires notification of adverse events and medical device failure incidents under the authority of the Food, Drug, and Cosmetic Act. The NRC could strengthen its collaboration with the FDA so that incident reports associated with products would be made available to the NRC. This could provide a continuous assessment of the adverse event rate for byproduct materials used in medicine. Pro Adopting Alternative A2 would not require legislative change. It would only require the NRC to exercise discretion by indicating to the regulated community that the agency does not intend to enforce existing regulations in the current manner defined, monitored, and policed. The NRC could possibly promulgate a new regulation that does away with 10 CFR Part 35 entirely, but that step would entail the cost and resources of a formal public comment period. Thus, this alternative is the easiest and fastest way to effect a change in the existing system and to address the concern expressed by the medical community without calling for a sweeping reorganization. However, this alternative does not address the committee's concerns, as discussed below. This alternative also provides the NRC with an opportunity to make useful changes in its work culture. The NRC would no longer treat minor deviations as serious violations. Emphasis on working with the regulated institutions by answering questions, providing help in meeting regulations, and viewing violations in terms of risk could alter and improve their performance. Thus, this alternative enables the NRC to retain highly trained personnel who can be reassigned to more productive tasks. It would also produce a work environment more responsive to the concerns of the medical community, without sacrificing the radiation safety accomplishments that NRC has achieved over the years.

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Radiation in Medicine: A Need for Regulatory Reform Con Adopting this alternative does not address two of the committee's concerns: (1) that ionizing radiation in medicine is not regulated consistently—sources used regularly in the practice of medicine are treated unevenly; and (2) 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). Since World War II and the advent of the use of radiation for peaceful purposes, a regulatory differentiation has existed between byproduct materials, on the one hand, and naturally occurring and accelerator-produced radioactive materials (NARM) and machine-produced radiation, on the other. Numerous congressional committees have examined this issue, but no changes have been effected to eliminate the disproportion. Indeed, the issue arises as to whether NRC regulation is at all necessary, given the fact that the regulation of NARM and machine-produced radiation has, since the early 1900s, been left to the states and to the FDA via the premarket approval process of drugs and devices. In addition, this slight modification to the status quo with regard to NRC regulation fails to solve the problem of the rising costs of the existing NRC licensing program. As more states become Agreement States, license fees for users in the remaining states keep increasing to meet the NRC's administrative expenses. Nor does it completely alter the increasingly prescriptive NRC regulations and aggressive enforcement that seem inappropriate in the medical context. Alternative B: Laissez Faire Available data, as reviewed in Chapter 4, indicate that the quality of practice that utilizes ionizing radiation is relatively good, perhaps excellent, though data on the point are not as strong as desired. Further, this seems to be the case for both the areas regulated by the NRC and the areas of ionizing radiation use outside the NRC's control. In light of this information, the committee considered the proposition that all forms of medical radiation regulation—federal and state—should be eliminated and that responsibilities for radiation safety should be left to medical practice, medical societies, and the marketplace. A market system pervades the developed world. Individuals retain a wide area in which personal decisionmaking is subject to little or no government intervention. Most choices are left entirely to the consumer, with only a warning of caveat emptor. Even extremely risky personal activities such as skydiving, spelunking, and mountain climbing are generally free of government regulations. Personal choice is valued over the risk of occasional deaths and injuries. Medical care, in contrast, is usually regulated to some degree. The level of regulation varies by country, by type of health care system, by type of health care

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Radiation in Medicine: A Need for Regulatory Reform intervention, and any other number of variables. Many activities risky to patients (e.g., anesthesia, surgery, and the prescribing of pharmaceuticals) are subject to minimum or moderate levels of regulation. Others, such as the use of byproduct material in medicine, are subject to far more stringent regulations. 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. It would encourage the replacement of existing governmental regulation with guidelines developed and implemented by organized medical groups and professional societies. Product approval and the regulation of the sale of source material to users would no longer be a federal responsibility. Neither the NRC nor the FDA would have any role in regulating the medical use of ionizing radiation. The federal role would encompass only what is necessary to facilitate interstate commerce, namely, transport of hazardous materials. Thus, even under this alternative the DOT would continue to regulate transport of hazardous materials, HCFA would still determine what it would reimburse under Medicare and Medicaid, and agencies that operate medical facilities would still promulgate their internal rules. Under this alternative, states would have a minimal role, which would not extend beyond licensing professionals and facilities. Unsafe uses of ionizing radiation would be subject to such penalties as loss of license and malpractice suits. Additionally, physicians might lose hospital privileges, and hospitals could be subject to loss of accreditation. Alternative B is predicated on the view that current regulation is excessive for the risks involved in the medical use of radiation. It assumes that patients, medical workers, and members of the general public are not at significant risk and that the necessary degree of protection can be reached through the voluntary and educational activities of professional societies and associations. It would also require abolition of several federal regulations. Pro This is the least costly alternative of all those considered by the committee. Because it requires neither federal nor state regulatory funding, taxpayers save money. In effect, it lifts a large administrative burden. The medical profession would assume sole responsibility for medical safety and would be freed from what some perceive as overregulation. Physicians would have the opportunity to be more innovative in patient care. In theory, competition could lower prices, creating greater access for the patient community.

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Radiation in Medicine: A Need for Regulatory Reform Con Not everybody is conscientious about radiation protection. Neither does anybody really know the possible long-term consequences of ionizing radiation exposure. The unregulated use of ionizing radiation in medicine may lead to more radiation injuries than occur at present. Without an outside stimulus, such as regulation and enforcement, the health care sector might not invest the time and money necessary to effect voluntary quality management programs. The threat of malpractice litigation might not work to prevent injuries. Another problem is the inability of patients and consumers to judge the effectiveness of a facility's radiation control program, especially at a time when patients are preparing for diagnosis or treatment. Patients may not understand the potential dangers and benefits of ionizing radiation, and they may lack sufficient information to make informed decisions, although the same is true of the risks of almost all medical procedures. In addition, the public in general is concerned about radiation exposure. Even though public perception of the risk of the use of radiation in medicine is challenged by experts, the public is probably still sufficiently concerned about the release of radiation into the environment that it might oppose completely unregulated use. Many committee members had little expectation that the marketplace, the malpractice system, and the professional societies could, by themselves, weed out incompetent practitioners and ineffective procedures. Without the role of government in maintaining standards, the committee believed that this approach to regulation would be unacceptable to the majority of Americans. This extreme deregulation alternative assumes that existing federal and state laws would be amended and regulations revoked. Yet, given that most states already regulate ionizing radiation in medicine to some degree, it seems unlikely that all these states could be convinced to follow the approach outlined in this alternative. Although a trend is developing in the United States toward greater reliance on the marketplace for health care delivery, there is no serious movement toward a true laissez-faire structure. On the federal level as well, it would be difficult to overcome a half-century's tradition of regulation. Finally, limiting this approach to medical uses of ionizing radiation might be unwieldy, as the existing federal regulatory structure for radiation control in industry, research, and consumer products would continue unchanged. 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. Under this alternative, byproduct materials would be regulated in the same way that x-ray

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Radiation in Medicine: A Need for Regulatory Reform machines, linear accelerators, pharmaceuticals, and other medical devices and materials are currently regulated. As mentioned at this chapter's outset, federal agencies would still have certain regulatory responsibilities. 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. Regulatory responsibility for the use of byproduct materials in medicine, however, would pass from federal to state agencies. Each state could choose from a variety of approaches. For example, one state might choose to regulate stringently through a state agency; another might control medical practice through its licensure of providers; a third might delegate disciplinary authority to professional medical associations; and a fourth might entrust safety to the threat of malpractice suits. The emphasis on state regulations does not preclude uniformity among the states, given the CRCPD's longtime efforts in devising the Suggested State Regulations for Control of Radiation (SSRCR) and their widespread adoption by the vast majority of the states. Although, theoretically, Alternative C allows for one state to embrace a laissez-faire approach while another increases the intensity of existing state radiation regulations, the expectation is that the states with existing programs based on the SSRCR would continue their programs and reinforce the movement toward greater uniformity. The majority of states have adopted the SSRCR, either in toto or in part. States have been using the SSRCR since 1962. These regulations are written so that, when they are adopted by the states, they do not conflict with existing federal radiation regulations. The CRCPD, in conjunction with several federal agencies, now revises them on an ongoing basis. The primary federal agencies working on the revisions with the states are the NRC and the FDA, but depending on the regulatory subparts being revised, the EPA, the DOT, and the Department of Energy may also be involved. The CRCPD also gets input from standard-setting groups, professional organizations, industry associations, and international organizations. The success of this alternative would be aided by the continued funding of the CRCPD, which is presently supported by the NRC, FDA, and EPA, and by continued cooperation in the updating of the SSRCR. In short, under this alternative, the CRCPD would encourage all 50 states and the U.S. territories presently subject to NRC regulation to adopt the SSRCR. Nevertheless, the states would be the sole regulatory structure in place, and each would clearly have the option of not regulating at all. Pro Alternative C eliminates the detailed and burdensome regulatory procedures of the NRC on medical practice, and it places regulatory authority and responsibility

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Radiation in Medicine: A Need for Regulatory Reform squarely within the states. Because almost all states exercise some form of regulation over the use of ionizing radiation in medicine in addition to conducting regulatory programs for all sources of ionizing and nonionizing radiation used in industry and research, this alternative could build on programs already in place and move in the direction of greater uniformity. This should result in less expense at the federal level, without necessarily shifting equivalent costs to the states. The committee believes that states should strive towards uniformity among themselves, based on the CRCPD's longtime efforts in devising the SSRCR and their widespread adoption by most states. Theoretically, therefore, this alternative allows for a state either to embrace a laissez-faire approach or to increase the intensity of its existing state radiation regulations. The main assumption for Alternative C, however, is that all of the states with existing programs would continue and expand their programs based on the SSRCR and thus reinforce the movement toward greater uniformity. Con The committee, in all its fact-finding, found no real assurance that states want to assume this responsibility. Although the majority of the CRCPD representatives1 seem to favor assumption of state regulation for all ionizing radiation, no official statement has been made. In addition, the committee recognizes that not all states currently have strong regulatory programs in place for NARM and machine-produced radiation. Twenty-one states, those that are not currently Agreement States, would have to absorb the additional expense of regulating byproduct material. These states may lack the resources, including qualified personnel, that would enable them to set up their own safety programs. However, these states face higher costs in any case, because under the existing program, the declining base of licensees (as more states become Agreement States) 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 material. Moreover, some state legislatures might be receptive to strong antiregulatory interest groups and ignore weak consumer 1   Several CRCPD representatives drafted a paper, ''A New Concept for Developing Regulations Relating to the Use of Sources of Radiation," that was presented at the CRCPD's annual meeting in 1995. That paper proposes that a new entity be formed within the CRCPD that would have, as its sole function, the development and promulgation of regulations relating to the use of sources of radiation, thereby delegating to the states regulatory authority over virtually all radioactive materials. The CRCPD appointed a committee to review the feasibility of the report.

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Radiation in Medicine: A Need for Regulatory Reform groups, leaving patients in those states relatively unprotected from poor or unsafe medical practice in this area. The lack of leadership at the federal level, under this scenario, would make it more difficult to encourage states to adopt CRCPD guidelines, to provide training of state personnel, and to facilitate state interface with various organized medical professional groups. Because the CRCPD is funded mainly by federal agencies, Alternative C, which eliminates the regulatory authority of those agencies, might also seriously undermine the CRCPD's continued operation. In addition, states might abandon the radiation safety programs already in place without the incentive from a federal agency to continue operating them. Considering the current fiscal crises in many jurisdictions, states might well shift money from such safety programs to meet other social needs. Finally, a patchwork system of regulations might compromise the ability of businesses to participate in interstate commerce. 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. Alternative D: Federal Guidance Alternative D modifies Alternative C by identifying a federal agency, other than the NRC, to exercise a leadership role in the radiation safety community. Such a federal agency would assist in developing recommended state laws and regulations for all ionizing radiation in medicine, building on the activities of the CRCPD and the SSRCR . It would also provide leadership, act as an information clearinghouse, and distribute resources for training and research. Similar to the MQSA effort that brought together the FDA and professional organizations, the Department of Health and Human Services (DHHS), for example, could work in conjunction with the CRCPD and other professional organizations to enhance the existing SSRCR and promote their adoption, thereby encouraging greater regulatory uniformity among the states. Because the majority of states already follow the SSRCR, an important DHHS function would be to ensure the continued viability of the CRCPD and to update material in a timely fashion. Although, under this alternative, states cannot be compelled to accept the voluntary guidelines or SSRCR, a variety of forces can greatly influence them to do so. A collaborative effort of the proposed federal agency, the states, the CRCPD, and other professional organizations (not unlike the process utilized in developing the mammography regulations that involved the FDA, the ACR, and other professional organizations) would facilitate an interactive process, allowing an exchange of ideas, so that controversies might be resolved before implementation. Respect for and investment in the process, in contrast to a unilateral

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Radiation in Medicine: A Need for Regulatory Reform a state has no protections devised to ensure the health and safety of its citizens pertaining to byproduct materials. Placing the DHHS in the leadership role, based on its history of involvement in radiation issues and its public health orientation, may yield more reasonable regulations, if they are needed. Otherwise the agency would provide funding to ensure that state development of model laws and regulations continues. Con Incorporating a legislative provision that authorizes the federal agency to regulate states that have no program raises the following issues. First, what minimum level of regulation would be required by the states to prevent federal regulation? The federal agency would need to establish baseline minimum standards that each state must satisfy. 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. Third, how elaborate might the federal structure need to be to accommodate a small number of states? This federal agency would require more funds than the one described in Alternative D to address the potential need for exercising regulatory authority. The experience that is being gained in the MQSA program could be used to estimate the resources needed for this program. Congress might be reluctant to appropriate the funds for even the minimal expenses of this agency, but a system of user fees could be devised to support part of the agency's activities. One problem with this option is that legislation will need to be passed to establish that federal law preempts state law if a state does nothing. Most notably, the drawback with this alternative is the delegation of federal regulatory authority for what is likely to be a minority of states. At the present time virtually all states have some form of regulation for radiation control. Alternative F: Centralization of Regulation Within One Federal Agency The committee believed that certain advantages could be realized if all ionizing radiation in medicine were treated in a similar manner. For this reason, the committee considered another option that would grant a federal agency regulatory responsibility not only for byproduct materials, but also for NARM and machine-produced radiation used in medicine. This responsibility could range from setting minimum standards and encouraging the states to implement these

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Radiation in Medicine: A Need for Regulatory Reform standards to establishing stringent federal regulations and enforcing them rigorously. The major change wrought by Alternative F would be to usher in the federalization of all regulation of ionizing radiation medicine. The federal government would be given the authority to regulate all of ionizing radiation in medicine. It would also be responsible for writing standards, for ensuring technician training, for licensing users, and for inspection of x-ray machines and other devices. This alternative, unifying all regulation at the federal level, would result in a major expansion of federal responsibility. This federal regulatory apparatus could be housed in any of the federal agencies that have regulatory responsibility for some aspect of ionizing radiation. The two likely candidates would be the DHHS and the NRC. If Alternative F were adopted, the committee would recommend centralization within the DHHS because it is best suited to administer public health programs and because it already has various levels of authority over ionizing radiation in medicine. 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. Furthermore, were a new federally centralized apparatus to be housed within the NRC, the NRC's legislative authority would have to be expanded a great deal because it now has jurisdiction only over byproduct materials, which, as discussed in Chapter 4, account for only about 10 percent of ionizing radiation in medicine. The committee did not further examine placement of this agency with the NRC, therefore, for both these practical reasons and the fact that it would leave in place, if not exacerbate, the problems already laid out in Chapters 3 and 4. The committee gave considerable attention to the fiscal arrangements of Alternative F, assuming the federal agency were to be in the DHHS. Presumably (although not inevitably), this new DHHS agency would be subject to user fee requirements like those Congress imposed on the NRC. If a DHHS-based system allowed states to become Agreement States, then those that chose to do so would stop contributing fees to support the agency's activities. Thus, even though the agency would continue to develop standards for all states, the remaining Non-Agreement States would be forced to bear an ever larger fraction of the financial support required for these tasks. This financial pressure would likely drive all states to become Agreement States (as is now the trend with the NRC-based system for byproducts alone), leaving the agency with no revenue to pay for its standard-setting functions. One way to avoid this within Alternative F would be to separate the budget for standard-setting functions from that for enforcement functions. The costs of the former would be spread across all regulated institutions, whether in Agreement

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Radiation in Medicine: A Need for Regulatory Reform or Non-Agreement States. Only Non-Agreement States' institutions would be charged the cost of federal enforcement functions. Pro Alternative F unifies all regulation of radiation medicine at the federal level, a factor that supports the committee's aim of promoting uniformity across all modalities in radiation medicine. It also provides a mechanism for dealing with those states that do not wish to take on the responsibility for regulation should the NRC cease to regulate under 10 CFR Part 35, as proposed in Alternative A2 (above) and the committee formally recommends in Chapter 6. This DHHS agency could, under this system, issue mandatory minimum standards for all radiation use in the healing arts, including x-rays, linear accelerators, and cyclotrons. It could also carry out technician training and licensure and inspection of radiation-producing machines. It would be able to provide a consistent regulatory approach for all sources of ionizing radiation in medicine based on consistent radiation protection criteria, derived from the National Commission on Radiation Protection and Measurements guidelines or the EPA's federal guidelines. It would assure that every person in the country who needs ionizing radiation for diagnosis or treatment would have it administered by a program held to national standards. All licensees would be subject to the federal regulations, whether implemented through some arrangement with the states or by the federal government. The appeal of Alternatives D and E, which enable a federal entity to assume a role in such functions as leadership, education, research, and data collection, applies to this alternative as well. Alternative F would undoubtedly include the above-mentioned functions and perhaps others. 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. It would also require legislation to transfer the regulatory responsibility from the NRC to the DHHS, as well as new enabling legislation, rulemaking, and regulations in the DHHS. Although Alternative F comes closest to centralizing responsibility in one agency of any of the alternatives described to this point, true uniformity is impossible to achieve. This fact undercuts the attractiveness of this alternative. The complicated reality of radiation regulation, which involves the participation of several agencies, including the DOT, EPA, and the Occupational Safety and

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Radiation in Medicine: A Need for Regulatory Reform Health Administration, makes successful centralization of all regulatory functions within the DHHS simply not feasible. Alternative F would not change the present scheme of regulating the nonmedical uses of byproduct material. Inconsistencies could develop between the regulation of medical and nonmedical applications unless the DHHS and the NRC worked closely together. Some aspects of basic radiation protection (personnel dosimetry, limits of occupational and general population exposure) in 10 CFR Part 20 apply in both medical and nonmedical settings. If the NRC remained responsible for the regulation of Part 20, then elements of Part 20 would have to be enforced by both the DHHS (medical) and the NRC (nonmedical). Consequently, even Alternative F does not unify all regulations pertaining to ionizing radiation. That issue, however, is a multifaceted and complicated regulatory problem that is beyond the committee's purview and expertise. Alternative G: Health Finance Agency As was clear from all the materials reviewed and activities pursued by this committee, regions of the country differ vastly in their uses of medical procedures, reimbursement levels, and methods for delivery of health care. When viewed together, the various approaches to health care organizations are seen as scattered, inconsistent, and decentralized. Some on the committee were uncomfortable with this degree of decentralization, an issue the committee considered by weighing the points set out in Alternative G. 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. Rather, it would eschew changes like those in the alternatives described above in favor of creating an entire health care financing and regulatory apparatus that is coordinated, accountable, and subject to budget controls. Specifically, Alternative G would create a Health Finance Agency (HFA), which would, as in Alternative F, acquire regulatory power currently held by the NRC (its medical component) and by parts of the DHHS. In addition, the HFA would have authority over reimbursement for all DHHS programs, such as Medicare and Medicaid. This agency would also have power to regulate health care, broadly eliminating practices that were shown not to be effective or beneficial. The HFA could conduct clinical trials and other studies to determine what procedures were cost-effective. Establishment of an HFA would encourage greater uniformity in the practice of medicine and would help to exclude practitioners who were incompetent or dangerous. The HFA could also choose to limit choices of medical practitioners. This is an extreme approach for addressing a very specific issue that focuses on one aspect of medicine. The committee recognizes that it is an unusual proposal

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Radiation in Medicine: A Need for Regulatory Reform on a rather discrete issue and that it has not been developed to its full logical extension. Pro A major advantage of the HFA, which would control perhaps 14 percent of gross domestic product, would be its authority to determine which practitioners and procedures were not effective or beneficial and exclude them. It could improve minimal standards and work to ensure that everybody had access to treatment. If the system worked well, it could be efficient, equitable, transparent, and easy to administer; it would define the goals of safety and high-quality care and work to achieve them. Con The first-mentioned advantage of the HFA leads to its principal disadvantage: it would have almost complete power over the delivery of health care. If the system did not work well, it could be very inefficient and inequitable. 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. A centralized system would inevitably mean a large increase in bureaucracy and reduce provider incentives and responsibility. Diversity, provider responsibility, and the ability of consumers to select their care givers are fundamental strengths of the current medical care system. These characteristics of the health care sector remain highly valued, and they might be inconsistent with the centralized and bureaucratic elements that must be assumed for Alternative G. ASSESSMENT OF THE ALTERNATIVES Alternatives Eliminated from Consideration The committee chose the seven alternatives described above as representative of a wide theoretical range. Each addresses problems with the current system, applying a particular solution. The committee devoted careful attention to clarifying the major underlying problems, crafting possible solutions, analyzing the alternatives. As mentioned earlier, in all of the alternatives, with the exception of Alternative B, several federal agencies retain regulatory control over various aspects of radiation used in medicine. The discussion of the alternatives will examine the extremes and move toward the preferred alternative.

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Radiation in Medicine: A Need for Regulatory Reform The committee rejected retaining the status quo described in Alternative A, even in its modified form (A2), essentially because it does not address the committee's concern that all ionizing radiation in medicine be administered and regulated more consistently. 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. Although laissez-faire markets work well for many goods and services, the market for health care is distinctive for several reasons. These include the fact that health insurance insulates people from the true price of medical services. Additionally, at the point at which patients must make sensitive choices about illness and health care, they may be distraught, lack sufficient or appropriate information, and find it difficult to think systematically about their options. These problems may arise from a number of factors; for instance, their physicians may not themselves understand the probabilities of risks and benefits of all therapeutic options or may not communicate that information in ways that patients find helpful. The challenges of communicating such information are particularly serious for medical uses of radiation, because the problems of excessive radiation exposure can be subtle and not likely to occur for many years. For these reasons, patients may find it hard to appreciate the full set of benefits and risks of alternative procedures involving the use of ionizing radiation (or to weigh those benefits and risks against those of alternative procedures not involving radiation) or to understand the risks of procedures that are done poorly. To the extent that this is so, they will not be able to enter into appropriate, fully informed decisionmaking with their physicians. As mentioned earlier, many committee members were not convinced that the marketplace, the malpractice system, and the watchful eyes of professional societies, by themselves, could weed out incompetent practitioners and ineffective procedures. Because Alternative B precludes a governmental role in maintaining standards, the committee was concerned that the quality of the delivery of ionizing radiation in medicine would sink to a lowest common denominator, a level considered too risky even by those who believe that the existing regulatory system is incommensurate with the actual risks associated with ionizing radiation. Finally, the committee recognized that this laissez-faire approach would be unacceptable to most Americans. Moving to the other extreme of the scale, the committee then rejected the HFA in Alternative G. This alternative, rather than letting providers and patients make choices essentially without government interference, could limit choices available to them. The HFA would set guidelines for appropriate health care interventions and then enforce compliance with those guidelines through nonpayment, exclusion from federal programs, or similar regulatory steps. The crucial problem for the committee is that such guidelines and regulatory actions

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Radiation in Medicine: A Need for Regulatory Reform would, as this alternative was envisioned, necessarily extend beyond the use of ionizing radiation to cover all aspects of health care. The committee, asked to address a very specific problem regarding regulation of ionizing radiation in medicine, was unwilling to recommend this all-encompassing and overwhelming solution. Promoting such a system might or might not result in much needed controls of escalating health care costs or expand access to care, but neither Congress nor the country as a whole, in the view of the committee, is prepared for such a massive reorganization of the health care system. Alternative F, which centralizes regulation of ionizing radiation in one federal agency, has several appealing characteristics. It would achieve regulatory clarity and simplicity by transferring the authority to regulate ionizing radiation 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, to 90 percent of radiation medicine now regulated at the state level. Although some committee members thought that safety should be increased and usage reduced for some radiation sources, such as x-ray machines, they did not see this as the job of the federal government. A federal agency might fund research, foster professional consensus, or advocate improved health care, but in the committee's view a federal regulatory agency responsible for all uses of ionizing radiation in medicine would be expensive, unwieldy, and too powerful. Although not a reason in and of itself to preclude such an expansion, such a change would require time-consuming enabling legislation. From a cost-benefit perspective, the committee as a whole saw little reason to pursue this alternative. Thus, the committee narrowed down the alternatives to C (state control), D (federal guidance), and E (reserve federal authority). The committee found many appealing qualities in Alternative C, in which all regulatory authority is given to the states. 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. Although this system is not always perfect, it seems to function to the satisfaction of the public, its representatives, and health care practitioners. Because the committee sees little difference between radionuclides generated naturally or by accelerator or reactor, and because state regulation of the first two sources appears to be working well, the committee concluded that primary state regulation would be appropriate. In the end, the committee was not comfortable with this possibility. The committee was concerned that state regulation of ionizing radiation evolve in accordance with scientific and technological advances; that Non-Agreement States be assisted with any transition from NRC regulation; and that information

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Radiation in Medicine: A Need for Regulatory Reform sharing and monitoring of the general public health and safety be enhanced. In the end, the committee elected not to endorse Alternative C. Alternative E is similar to Alternative D, But in addition provides for the exercise of limited federal authority, through the licensing of user sites and users, if a state chooses not to expand its radiation control program to include byproducts. This is the primary difference between these two alternatives. The committee's concern about Alternative E focused on the delegation of federal regulatory authority for what is likely to be a minority of states. Federal regulation of states without a program for byproducts also calls into question what minimum level of regulation would be required and the need to establish minimum standards. In effect, this alternative could replicate the existing NRC Agreement State program with potentially all the peculiar funding characteristics and practical drawbacks that are now apparent in the NRC approach. Thus, the committee arrived at its preferred choice: Alternative D. Alternative D: The Preferred Alternative Alternative D modifies state regulation (Alternative C) by adding a federal agency with two key roles: (1) it would be responsible for working in conjunction with the CRCPD and other professional organizations to provide voluntary guidelines and model regulations for states, and (2) it would assume a leadership role for the regulated community. Although, under Alternative D, states cannot be compelled to accept the voluntary guidelines or SSRCR, a variety of forces can greatly influence them to do so. For example, the committee envisions a collaborative effort of the proposed federal agency, the states, the CRCPD, and other professional organizations not unlike the process utilized in developing the mammography regulations that involved the FDA, the American College of Radiology, and other professional organizations. This would facilitate an interactive process, allowing an exchange of ideas, so that controversies might be resolved before implementation. Respect for and investment in the process would foster a keen vested interest in successful implementation on the part of all participants. Other reasons exist for states to adopt voluntary guidelines and the SSRCR. Professional peer pressure, from the people within each state who are involved in developing the SSRCR, would exert substantial influence to make the process work. Consumer groups and the media, seeking to ensure that the citizenry is protected, would also exert pressure. State medical societies would also want regulatory oversight to prevent unskilled users of radiation from embarrassing the medical profession by their questionable practices. 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. The NRC

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Radiation in Medicine: A Need for Regulatory Reform 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. Consequently, this requirement provides an inducement to states to expand or revise their existing radiation control programs to include byproducts. The committee was concerned that a purely voluntary agency, sustained by states or professional associations or both, such as the CRCPD, might receive insufficient funding during periods when states had fiscal crises. A modest federal presence could head off potential difficulties at what the committee believed would be a relatively low cost. The committee determined that this agency should be one other than the NRC, because the NRC's mission is to regulate only those materials used in medicine that are products of nuclear reactors. The NRC, therefore, has responsibility for only 10 percent of ionizing radiation in medicine. The more logical choice for a responsible agency would be the DHHS, which has an extensive history in regulating radiation. Eliminating federal regulation of byproducts made some committee members apprehensive about the possibility of decrements in quality of care. This point was discussed at great length during this study. The committee's conclusion that Alternative D was sufficient to protect quality of care and public health rested on several considerations. The first was that current federal regulation of pharmaceuticals, medical devices, equipment, transport, disposal, and worker and public exposure would continue under Alternative D. In addition, the federal government would have to regulate the use of ionizing radiation in medicine in the PHS, VA, and DOD medical facilities. Moreover, nothing in this alternative would weaken current licensure or certification requirements for physicians and other health workers. Radionuclides per se would continue to be regulated stringently to ensure that they do not injure the public. Second, the NRC would retain responsibility for licensing both manufacturers of byproduct material (nuclear power plants) and producers of radioactive products (i.e., radiopharmaceutical companies). These producers, adhering to federal regulations for their licensure, could not legally sell byproducts to unlicensed users. 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. Current state regulations seem to work for non-byproduct ionizing radiation in medicine, which accounts for 90 percent of ionizing radiation used in medicine, and the committee expects that byproduct materials can be accommodated in the

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Radiation in Medicine: A Need for Regulatory Reform state systems. The burden is on the states to protect the public health and safety of their citizens adequately by devising effective regulatory programs that encompass byproducts. Because the states already provide effective regulation for non-byproduct radiation in medicine, the committee sees no good argument for subjecting all of radiation medicine to federal regulation for the first time. Nonetheless, the presence of a federal agency, the purpose of which is leadership and guidance rather than regulation, could add a great deal to the effectiveness of a state-based regulatory system. 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. CHAPTER SUMMARY The committee defined a wide range of alternatives for the regulation of ionizing radiation in medicine. It then sought to elucidate both strengths and problems within each option and to identify the alternative most likely to deliver the greatest net benefit to society. Having considered everything from the status quo to a system of laissez faire to a complete centralization of all medical regulation, the committee chose Alternative D, as described above. The next chapter presents the committee's findings and conclusions, and makes recommendations for the implementation of Alternative D.

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