Summary

In November 1992, a misadministration1 of radiation to a patient win Indiana, Pennsylvania, preceded a week-long series in the December 1992 Cleveland Plain Dealer entitled ''Lethal Doses: Radiation That Kills." In response, Senator John H. Glenn (then chairman of the Governmental Affairs Committee) announced a congressional investigation into radiation medicine. This sequence of events prompted the U.S. Nuclear Regulatory Commission (NRC) to carry out an internal review of its Medical Use Program (described below) and to request an external review by the National Academy of Sciences' Institute of Medicine (IOM).

The NRC, pursuant to the Atomic Energy Act of 1954 (AEA), as amended, 2 is responsible for the regulation of nuclear reactors and reactor-generated byproduct material. Byproduct material consists of radionuclides produced during the process of nuclear reactor operation and accounts for approximately 10 percent of ionizing radiation used for medical purposes. Although much of this material is considered waste and must be properly disposed of, quantities of certain byproduct radionuclides are marketed for use by various industries, including the

1  

A misadministration is defined by the Nuclear Regulatory Commission, generally, as the administration of some radioactive substance in an amount that exceeds by a certain percentage the prescribed dosage. The percentage calculation depends upon the substance in question. A misadministration may also be the administration of a correct dosage, but of the wrong substance, or to the wrong patient. (For the full definition of misadministration, see 10 CFR 35.2 in Appendix D of the full report.)

2  

The acronym "AEA" as it appears throughout the report refers to the 1954 act, as amended, unless otherwise noted.



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Radiation in Medicine: A Need for Regulatory Reform Summary In November 1992, a misadministration1 of radiation to a patient win Indiana, Pennsylvania, preceded a week-long series in the December 1992 Cleveland Plain Dealer entitled ''Lethal Doses: Radiation That Kills." In response, Senator John H. Glenn (then chairman of the Governmental Affairs Committee) announced a congressional investigation into radiation medicine. This sequence of events prompted the U.S. Nuclear Regulatory Commission (NRC) to carry out an internal review of its Medical Use Program (described below) and to request an external review by the National Academy of Sciences' Institute of Medicine (IOM). The NRC, pursuant to the Atomic Energy Act of 1954 (AEA), as amended, 2 is responsible for the regulation of nuclear reactors and reactor-generated byproduct material. Byproduct material consists of radionuclides produced during the process of nuclear reactor operation and accounts for approximately 10 percent of ionizing radiation used for medical purposes. Although much of this material is considered waste and must be properly disposed of, quantities of certain byproduct radionuclides are marketed for use by various industries, including the 1   A misadministration is defined by the Nuclear Regulatory Commission, generally, as the administration of some radioactive substance in an amount that exceeds by a certain percentage the prescribed dosage. The percentage calculation depends upon the substance in question. A misadministration may also be the administration of a correct dosage, but of the wrong substance, or to the wrong patient. (For the full definition of misadministration, see 10 CFR 35.2 in Appendix D of the full report.) 2   The acronym "AEA" as it appears throughout the report refers to the 1954 act, as amended, unless otherwise noted.

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Radiation in Medicine: A Need for Regulatory Reform health care industry. (Throughout, the report such reactor-generated material will typically be referred to as "byproduct material" or "byproducts.") The radiation source involved in the Indiana, Pennsylvania, case was such a byproduct. As part of its broad monitoring responsibility, the NRC instituted its Medical Use Program to regulate the use of byproduct material in medicine. The review of this program is the subject of the NRC's charge to the IOM. Reactor-generated byproduct material is a source of ionizing radiation, and as such, it poses risks to health and safety that sources of nonionizing radiation do not. Reactor-generated byproduct material is not the only source of ionizing radiation; other sources are radioactive materials that occur naturally or are accelerator-produced, and radiation produced by x-ray machines and particle accelerators.3 In examining the existing NRC Medical Use Program, the IOM Committee for Review and Evaluation of the Medical Use Program of the Nuclear Regulatory Commission compared the regulation of byproducts with the regulation of other sources of medically used ionizing radiation and with the regulation of medicine in general. The scope of this comparison was occasioned by an awareness of problems among the NRC, Congress, the states, and the regulated community that suggested the entire regulatory system needed to be examined. In particular, a major question for the IOM committee was whether the quantitative risks associated with reactor-generated byproduct material used in radiation medicine justify the extent to which byproducts are regulated compared to other sources of radiation in medicine and to medicine in general. To provide the reader with background information, the successes and problems of radiation medicine and the clinical applications of ionizing radiation are discussed in the full report. The discussion of the current regulatory system pertaining to radiation medicine and the evolution of that system, together with an examination of several aspects of the risks that are associated with ionizing radiation in medicine, are the centerpiece of the report. The committee also considers in some detail general observations about the goals of regulation; the roles of the NRC, other federal entities, and the states; and the fee and non-fee costs of regulation (to the regulated community). The report describes a spectrum of seven alternative regulatory systems that were devised and debated by the committee, and presents the committee's findings, conclusions, and recommendations. The main focus of the report is on the existing regulatory framework for ionizing radiation in medicine and the committee's evaluation as to what would be an appropriate regulatory model for this particular aspect of medicine. 3   Naturally occurring and accelerator-produced radioactive materials are collectively referred to as "NARM" to distinguish them from reactor-generated byproducts. The term "radionuclide" refers to both accelerator-produced materials and reactor-generated byproducts.

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Radiation in Medicine: A Need for Regulatory Reform BENEFITS OF IONIZING RADIATION Diagnostic and therapeutic clinical applications of ionizing radiation range from simple procedures like taking a chest x-ray to the complex regimens used to treat a brain tumor. Each of these applications benefits patients. The diagnostic uses of ionizing radiation are classified under two basic headings: radiology and nuclear medicine. In radiology, the radiation administered is external to the patient; in nuclear medicine, it is internal. Ionizing radiation applied for therapeutic purposes is also typically classified into categories based on whether the source of the radiation is external or internal to the patient. These areas are called radiation oncology and teletherapy (external sources), brachytherapy (internal), and therapeutic nuclear medicine (internal). 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, health care 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 less accessible to patients. Regulatory steps that lower the probability of risk only slightly, if at all, but seriously affect access to services through significant increases in cost or in the 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 added benefit for a patient's outcome and well-being or that of health care personnel. THE REGULATORY FRAMEWORK Regulatory authority over ionizing radiation in medicine is widely dispersed among several government agencies at the federal, state, and local levels. Among the federal agencies with oversight, the NRC has regulatory authority over the use of byproduct materials in medicine. The Food and Drug Administration (FDA) in the Department of Health and Human Services (DHHS) oversees the approval of radiation-producing devices and radiopharmaceuticals. In addition to the NRC, the Environmental Protection Agency (EPA), the Occupational Safety and Health Administration, and the Department of Energy oversee exposure standards for the public and for workers. The transportation of radionuclides is regulated by another federal agency, the Department of Transportation (DOT). In some cases, regulatory standards, though crafted at the federal level, are administered by the states, as with the NRC's Agreement State Program (described below).

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Radiation in Medicine: A Need for Regulatory Reform The Current Situation The NRC currently regulates only 10 percent of all ionizing radiation used in medicine. The committee concluded, however, after assessing the existing regulatory system, that the health and safety of the public would be better served by uniform regulation of all such use. Therefore, the committee believes that the NRC's current system for regulating the use of byproduct material in medicine and for enforcing those regulations should be revised. The committee further scrutinized the existing regulatory system and identified several problems that it concluded needed to be addressed. In particular, the committee found that the NRC's present set of regulations and its approach to enforcement are burdensome, costly, and unduly prescriptive. In addition, 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. The committee also determined that the benefits resulting from the NRC's efforts to reduce adverse events involving byproduct material, may not be commensurate with the constraints imposed. That is, the NRC's regulatory policy, although seemingly effective, may have gone beyond the point at which an additional dollar spent on regulation achieves an equivalent dollar of benefit to patients or the public. The implication is that decreasing somewhat the resources directed at regulation may not pose additional risks and, similarly, may yield benefits in the form of freeing resources that can be put to better or more efficient use. The committee also found that 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 that there is little, if any, justification for the intensity of federal regulation of the use of byproducts in medicine given that 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. Finally, at the crux of this report lies a fundamental philosophical and political perspective concerning state and federal regulation. All ionizing radiation, with the exception of byproduct material, is currently regulated at the state level. Several federal agencies do still have regulatory authority over various aspects of the production, use, and disposal of ionizing radiation (see below). The committee, of course, cannot know whether states will continue their regulatory programs. It 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 ) that the CRCPD promulgates, that state radiation programs would remain intact and expand to cover the area of byproduct use if federal regulation in this area were to be relaxed. In this way, all sources of ionizing radiation would be treated more uniformly than before, in

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Radiation in Medicine: A Need for Regulatory Reform that they would all be subject to state regulation. Admittedly, the extent of state regulatory programs varies, but for the majority, the common denominator nationwide is the SSRCR. If the NRC's Medical Use Program were to be eliminated, the basic structure of federal regulation and responsibility would remain in place under the regulatory alternatives considered by the committee. Federal agencies would retain responsibility for the generation, transport, nonmedical use, and disposal of radionuclides and for the approval of radiopharmaceuticals and 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 in the medical context; the NRC and its Agreement States would, as relates to the nonmedical use of byproduct material (i.e., industrial, educational, and nonmedical research), continue to license the production and use of byproduct material; the DOT would continue to regulate the transport of radioactive materials; the EPA would continue to develop guidelines that set occupational and public exposure limits to be implemented by the respective federal agencies; the FDA would continue to regulate the manufacture and labeling of radiopharmaceuticals and medical devices; the FDA would continue to regulate the mammography program under the Mammography Quality Standards Act; 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 for Medicare and Medicaid (and other federal agencies for other health care purchased from the private sector) would continue to develop reimbursement guidelines. Additionally, where each state has a role in regulating the use of ionizing radiation in medicine, the committee assumes that the CRCPD would continue to develop suggested state regulations, to help coordinate state programs, and to act in the area of the nonmedical use of radioactive materials. The NRC Medical Use Program The NRC is responsible for regulating the "medical use" of byproduct materials. This responsibility, which the NRC carries out through its Medical Use

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Radiation in Medicine: A Need for Regulatory Reform Program, derives from the NRC's general responsibilities for protecting public health and safety in connection with nuclear reactors. All other sources and medical uses of ionizing radiation are regulated by other entities, such as the states or the FDA.4 Through the Medical Use Program, the NRC licenses facilities, authorizes physician users, develops radiation safety regulations, sets criteria for determining misadministration of byproduct materials in medical use, orders prompt reporting of misadministrations, conducts compliance inspections, applies a system of sanctions for infractions of its regulations, and assesses and collects fees and fines. The program is administered through two different systems. In 29 states ("Agreement States"), the NRC formally delegates authority to regulate byproduct material to the state government. In the remaining 21 states ("Non-Agreement States"), the NRC directly licenses, monitors, inspects, and enforces its regulations for approximately 2,000 licensed users and institutions. Over the years, the NRC has intensified its regulation of radiation medicine. In 1967, its predecessor, the Atomic Energy Commission (AEC), codified its medical regulations into a new Part 35 of Title 10 of the Code of Federal Regulations (CFR); this covered both the medical use of radioactive drugs and the use of radiation devices. although medical licensees are required to comply with many other sections of Title 10, Part 35 (Medical Use of Byproduct Material) is the most important. Part 35 contains provisions designed to protect workers from radiation devices, beams, and sources. For example, to protect patients scheduled for radiation procedures, Part 35 requires quality management (QM) procedures (35.32), a measurement of each dose prior to administration (35.53), a survey of the patient after removal of temporary implants (35.406), and safety checks of teletherapy machines and rooms (35.615). Finally, other sections pertain to protection of the public and of patients not scheduled for radiation procedures; these provisions include surveys before returning radiation areas to unrestricted use (35.315, 35.415), criteria for releasing patients who have received doses of radioactivity (35.75), and QM redundancy procedures for verifying patient identity (35.32). The NRC oversees medical use licensees through its inspection, investigation, and enforcement programs. Inspections involve (a) unannounced visits by NRC personnel to each licensed facility on a periodic basis (ranging from once a year to once every four years, depending on the scope of the license), and (b) special inspections to follow up a particular incident. Inspections are intended to ensure that licensed programs are conducted in accordance with NRC requirements, with specific provisions of the license, and with the health and safety requirements 4   Boron neutron capture therapy, which does not involve byproduct material but rather uses radiation directly from a nuclear reactor to treat patients, is also regulated by the NRC.

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Radiation in Medicine: A Need for Regulatory Reform of workers and the general public. NRC inspectors utilize direct observations of work activities, interviews with workers, and detailed reviews of licensee records to determine compliance with regulatory requirements. Enforcement actions may be taken against licensees when violations of NRC regulations are discovered. Such violations range from failure to follow procedures detailed in a QM program to threats to public health and safety. Sanctions include more frequent inspections, release of negative publicity to the media, civil fines and penalties, and license revocation. The discussion throughout the report focuses on "quality management" as the concept has been defined by the NRC and put into operational form through its QM rule. The committee recognized, however, that issues relating to the measurement and improvement of quality of health care go far beyond this narrow interpretation. Given the complexities of its charge, the committee opted not to examine issues relating to quality assurance in any detail, but it recognized that the NRC's approach was not consistent with contemporary efforts by health care institutions and plans to implement continuous quality improvement programs within their own facilities and by their own practitioners and members. The Quality Management Rule The NRC's QM rule calls upon NRC licensees to establish a QM program in compliance with 10 CFR 35.32 and 35.33 in three circumstances: (1) if they administer radiation from sealed sources containing byproduct material for therapy (brachytherapy); (2) if they administer cobalt teletherapy; or (3) if they administer therapeutic unsealed radionuclides (therapeutic nuclear medicine). The rule also applies to any diagnostic administration of greater than 30 microcuries of sodium iodide containing I-125 or I-131. Moreover, it requires NRC licensees to submit written certification that they have implemented a QM program, Whereas NRC licensees have been living with this rule since January 1992, Agreement States were not required to follow suit until January 1995. The QM rule is a performance-based approach to quality management. This approach has five specific objectives: Prior to an administration, a written directive must be prepared. Prior to each administration, the patient's identity must be verified using more than one method as the individual named on the written directive. Final plans of treatment and related calculations for brachytherapy, teletherapy, and gamma stereotactic radiosurgery must be in accordance with the respective written directives. Each administration must be in accordance with the written directive. Any unintended deviation from the written directive must be identified and evaluated, and appropriate action must be taken.

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Radiation in Medicine: A Need for Regulatory Reform The NRC Agreement State Program The NRC Agreement State Program provides an opportunity for the NRC to "discontinue" its regulatory authority over byproducts; it allows states to assume responsibility to license and regulate byproduct material, source material, and small quantities of special nuclear material. The NRC's authority regarding radiological health and safety aspects of nuclear materials is transferred to the states through a formal agreement between the governor of the state and the NRC. 5 Currently, there are 29 Agreement States, and 4 other states are exploring agreement status. An Agreement State arrangement requires that the NRC conclude that a state's radiation control program "is compatible with the Commission's, meets the applicable parts of Section 274 [of the AEA] and … is adequate to protect the public health and safety." Once the state has passed enabling legislation to establish its authority to enter into the agreement, and after its radiation control program is found to be both adequate and compatible with NRC requirements, state assumption of authority becomes effective on the date the agreement is signed. Section 274j of the AEA stipulates, however, that the NRC may terminate or suspend all or part of an agreement with a state if it deems that such action is necessary to protect public health and safety. Although Agreement States administer their own programs and regulate licensees, the NRC maintains significant authority over the states. Biennially, the NRC's Management Review Board reviews each state's performance to determine whether its program is "adequate" and to ensure that its regulatory requirements do not significantly deviate from the NRC's. Despite these reviews, NRC oversight of the Agreement State Program has been criticized for lacking data adequate for comparing the regulatory performance of the NRC (for the 21 states it regulates) with that of Agreement States. In April 1993, the General Accounting Office (GAO) reported that the NRC lacks common performance indicators for inspection backlogs, radiation overexposures, and numbers of violations. Because the programs of NRC-regulated states and Agreement States use different indicators to measure effectiveness, the GAO report asserts that the NRC cannot determine whether people in each state are receiving the same minimum level of protection. Partly in response to such criticism, the NRC amended and clarified its policies for overseeing the Agreement State Program. As of 1995, Agreement States are required to report data on misadministrations in the same form and using the same definitions as those used by the NRC for the Non-Agreement States. In May 1995, a new "Final Statement of Principles and Policy for the 5   Public Law 83-703 (68 Stat. 919) (1954) as amended by Public Law 86-373 (73 Stat. 688) (1959), sec. 1, added sec. 274, Cooperation with States, which includes the criteria for these agreements.

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Radiation in Medicine: A Need for Regulatory Reform Agreement State Program" established a stronger performance evaluation process; it was intended to enable the NRC to take more effective, graduated actions to ensure that the radiation control safety programs of the Agreement States remain adequate and compatible. ALTERNATIVE REGULATORY SYSTEMS Having examined the available information and data pertaining to the existing regulatory system and its inherent strengths and weaknesses, the committee proceeded to explore potential regulatory options. Specifically, it examined a wide spectrum of alternative structures through which all ionizing radiation in medicine might be regulated. By elucidating the pros and cons of each alternative, the committee sought to identify problems within the current system and to determine which alternative would be most likely to deliver the greatest net benefit to society. Chapter 5 of the report provides an overall assessment of each alternative and explains the rationale behind the alternative that the committee ultimately preferred. In considering the proposed alternatives briefly described below, the reader should remember one key point: in all but one model (the "laissez-faire" approach), the basic structure of federal regulation and responsibility would remain in place, except for those alternatives that propose to eliminate the NRC's Medical Use Program. In particular, federal agencies would retain responsibility for the generation, transport, nonmedical use, and disposal of radionuclides and for the approval of radiopharmaceuticals and certification or approval of equipment that generates ionizing radiation. Seven Alternative Structures The alternatives considered pertain to two relevant parts of the 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 alternatives reflect the thinking of the committee and incorporate certain assumptions that cannot be substantiated in any quantitative way. Nevertheless, the committee believes that these alternatives illustrate the theoretical spectrum, ranging from essentially no regulation—Alternative B, a market-based approach—to the other extreme, creation of an all-encompassing regulatory apparatus pertaining to all of health care—Alternative G. Two versions of Alternative A, essentially the status quo, retain the existing regulatory system. alternatives C, D, E, and F present a more conventional continuum for addressing regulation. These four alternatives examine the differences between exclusive state regulation (C), state regulation accompanied by a federal advisory

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Radiation in Medicine: A Need for Regulatory Reform 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. Chapter 5 of the report describes each alternative and discusses its strengths and limitations. The chapter also provides an overall assessment of the alternatives and identifies the one preferred by the majority of the committee. Assessment of the Alternatives The discussion of the committee's seven alternative regulatory systems examines the extremes and then moves toward the preferred alternative. The committee rejected retaining the status quo described in the two versions of Alternative A, essentially because they do not address the committee's judgment that all ionizing radiation in medicine ought to be administered and regulated more uniformly, rather than having byproduct use under federal (NRC) regulation and the other 90 percent of medical use of ionizing radiation regulated under other mechanisms. Alternative A also does not address the committee's desire to shift federal involvement from the NRC to the DHHS. 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. Many committee members had little expectation 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 rejected the Health Finance Agency (HFA) posed in Alternative G. This alternative, rather than letting providers and patients make choices essentially without government interference, could limit choices. As posed by the committee, 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 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

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Radiation in Medicine: A Need for Regulatory Reform of ionizing radiation in medicine, was unwilling to recommend this all-encompassing 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 used 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, the 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 pursuing these goals 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 and unwieldy. Furthermore, the benefit from such an expanded program would be questionable and would alter the practice of radiation medicine. Although not a reason in and of itself to preclude such an expansion, such a change may require time-consuming enabling legislation. From a cost-benefit perspective, the committee saw little reason to pursue this alternative. 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 and consistent regulation of these health care interventions. Although this system of state regulation is not perfect, it seems to function to the satisfaction of the public, its representatives, and health care practitioners. Furthermore, the committee sees little difference between radionuclides generated naturally or by accelerator or reactor, and it could find no real evidence to suggest that state regulation of the first two sources is not working well. Thus, it concluded that primary state regulation would be appropriate. One concern with Alternative C, however, was that states could decide not to regulate in this area of ionizing radiation at all, effectively instituting Alternative B within their borders. In the end, the committee was not comfortable with this possibility. It wanted to be sure that state regulation of ionizing radiation would evolve in accordance with scientific and technological advances; that Non-Agreement States would be assisted with any transition from NRC regulation;

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Radiation in Medicine: A Need for Regulatory Reform and that information sharing and monitoring of the general public health and safety would be enhanced. Thus, the committee narrowed its focus to Alternatives D, federal guidance, and E, limited federal authority. It examined the notions of federal guidance and federal authority very closely and spent a great deal of time debating the virtues and drawbacks of these remaining strategies. Alternative E provides for the exercise of reserve federal authority if a state chooses not to expand its radiation control program to include byproducts. This is the primary difference between Alternatives D and E. The committee's concern about this alternative focused on the delegation of federal regulatory authority for what is likely to be a minority of states. Federal regulation of medical uses of ionizing radiation in states without a program for byproducts also raises the question of what the minimum level of regulation ought to be and how minimum standards might be established. In effect, Alternative E would replicate the existing NRC Agreement State Program. Thus, the committee arrived at its preferred choice: Alternative D. The Preferred Choice: Alternative D, Federal Guidance Alternative D modifies state regulation (Alternative C) by adding a federal agency with two key roles. First, the agency would be responsible for working in conjunction with the CRCPD and other professional organizations to provide voluntary guidelines and model regulations for states. Second, it would assume a leadership role for the regulated community. Although, under Alternative D, states cannot be compelled to accept the voluntary guidelines or the 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 and allow 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

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Radiation in Medicine: A Need for Regulatory Reform regulatory program that includes reactor-generated byproduct material. The NRC and its Agreement States would continue to regulate the manufacture of byproduct material for use in radiation devices and radiopharmaceuticals; thus, manufacturers would not be able to distribute radioactive byproduct material to users unless they were licensed by their states. Consequently, this requirement provides an inducement to states to expand or revise their existing radiation control programs to include byproducts. The committee was also concerned that a purely voluntary agency such as the CRCPD, sustained by states, professional associations, or both, 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 the study. The committee's conclusion was that Alternative D would be sufficient to protect quality of care and public health, and rested its conclusion on two considerations. The first consideration 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 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. Additionally, the NRC would retain responsibility for licensing manufacturers that produce byproduct material for use in radiation devices and radiopharmaceuticals. These manufacturers must adhere to NRC regulations for their licensure and thus could not sell byproducts to unlicensed users. Consequently, as noted above, this requirement provides an inducement to states to expand their existing radiation control programs to include byproducts. The second consideration is that millions of people have been treated with machine-produced radiation and accelerator-produced radionuclides with no indication of injury to them or to the public at large beyond that common to medical procedures in general. Current state regulations seem to work for non-byproduct ionizing radiation in medicine, and the committee expects that byproduct materials can be accommodated in the state systems. The burden is on

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Radiation in Medicine: A Need for Regulatory Reform the states to adequately protect the public health and safety of their citizens 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. 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 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 contribute to an efficient, safe means of regulating ionizing radiation in medicine without imposing more requirements on one aspect of ionizing radiation than on another. FINDINGS AND CONCLUSIONS 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 material (NARM), and machine-produced radiation limited the scientific basis of the committee's findings. The committee's findings are outlined in Chapter 6 of the report by category: risks and benefits; regulation; the regulated community; and private, voluntary involvement in radiation safety. In brief, the committee's major findings and conclusions include the following: 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. The most important difference between radiation sources is that machines produce radiation only when they are activated, whereas radionuclides produce

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Radiation in Medicine: A Need for Regulatory Reform radiation until they decay fully. In terms of their uses 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; it is understandable that the Atomic Energy Commission, and later the NRC, were at the outset delegated general authority for regulation in these fields. 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 treatment of different sources of ionizing radiation in medicine can be construed as illogical if not counterproductive. Taking the view that regulation of ionizing radiation in medicine should be considered in its entirety, the committee concluded that special treatment of reactor-generated byproduct material is inappropriate. It also concluded 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. The committee has identified and proposes to eliminate regulations that achieve little reduction in risk but result in excessive costs. 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 ionizing radiation in medicine. To bring this about, the committee developed eight interlocking recommendations, as discussed next. RECOMMENDATIONS The committee's specific recommendations were developed for three different audiences: (a) proposals for Congress, (b) steps for immediate action by the NRC, and (c) actions for professional entities. 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

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Radiation in Medicine: A Need for Regulatory Reform 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 uses of byproduct material has three benefits. First, it eliminates prescriptive and 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.

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Radiation in Medicine: A Need for Regulatory Reform 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. 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.

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Radiation in Medicine: A Need for Regulatory Reform 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. 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 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.

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Radiation in Medicine: A Need for Regulatory Reform 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 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.

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Radiation in Medicine: A Need for Regulatory Reform 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. 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 Joint Commission on Accreditation of Healthcare Organizations, 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.

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Radiation in Medicine: A Need for Regulatory Reform CONCLUDING OBSERVATIONS 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 regulation 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 opposed to state regulation, took place. Ultimately, from a wide spectrum of alternative approaches to the regulation of radiation medicine (including the existing one), the committee selected Alternative D, which removes regulatory authority from the NRC, shifts federal guidance to the DHHS, and delegates regulatory responsibility for byproduct material to the states, with the proviso that only licensed users 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. SUMMARY OF RECOMMENDATIONS TO THE CONGRESS, THE NUCLEAR REGULATORY COMMISSION, THE CONFERENCE OF RADIATION CONTROL PROGRAM DIRECTORS, AND THE STATES The committee recommends that: A1. 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. A2. 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;

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Radiation in Medicine: A Need for Regulatory Reform 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. B1. The NRC immediately relax enforcement of 10 CFR 35.32 and 35.33 through its present mechanisms. B2. 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. B3. The NRC separate the costs of formulating regulations from the costs of administering those regulations. C1. 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. C2. All state legislatures enact enabling legislation to incorporate the regulation of reactor-generated byproducts into existing state regulatory programs. C3. 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.