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Regulation and Radiation Medicine

In describing the clinical applications of ionizing radiation, Chapter 2 discusses some of the forms government regulation takes with respect to particular sources of radiation and procedures for applying it. This chapter gives perspective to that discussion by presenting an overview of the entire regulatory system that applies to ionizing radiation in medicine.

The chapter begins by making important general observations about the goals of regulating medical products. It next describes the development of regulation with respect to different types of ionizing radiation products and details the current roles of the Nuclear Regulatory Commission (NRC), the Food and Drug Administration (FDA), the other federal agencies, and the states. The discussion then moves on to examine the fee and non-fee costs of regulation to the regulated community. This section is followed by a summary of qualitative assessments about regulation that the committee found to be prevalent.

REGULATORY GOALS

All regulation of medical products shares two important goals. The first objective of regulation is to protect the public health and safety by preventing the marketing of unsafe or ineffective products. The second goal of regulation is to promote the availability of safe and effective products that will enhance the public health and safety. Regulation of medical products that emit ionizing radiation is no different than regulation of any other form of therapeutic or diagnostic products in these two respects.



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Radiation in Medicine: A Need for Regulatory Reform 3 Regulation and Radiation Medicine In describing the clinical applications of ionizing radiation, Chapter 2 discusses some of the forms government regulation takes with respect to particular sources of radiation and procedures for applying it. This chapter gives perspective to that discussion by presenting an overview of the entire regulatory system that applies to ionizing radiation in medicine. The chapter begins by making important general observations about the goals of regulating medical products. It next describes the development of regulation with respect to different types of ionizing radiation products and details the current roles of the Nuclear Regulatory Commission (NRC), the Food and Drug Administration (FDA), the other federal agencies, and the states. The discussion then moves on to examine the fee and non-fee costs of regulation to the regulated community. This section is followed by a summary of qualitative assessments about regulation that the committee found to be prevalent. REGULATORY GOALS All regulation of medical products shares two important goals. The first objective of regulation is to protect the public health and safety by preventing the marketing of unsafe or ineffective products. The second goal of regulation is to promote the availability of safe and effective products that will enhance the public health and safety. Regulation of medical products that emit ionizing radiation is no different than regulation of any other form of therapeutic or diagnostic products in these two respects.

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Radiation in Medicine: A Need for Regulatory Reform For both radiation products and any other form of drug or device, a patient is deliberately exposed to a potentially toxic ingredient because, in the concerted judgment of the patient and the physician, after weighing the risks and benefits of the therapy or diagnosis and of available alternatives, it is considered the most effective and beneficial procedure for the patient. Risks that would never be tolerated for individuals who are not suffering from disease become acceptable for the ill patient because the potential benefits outweigh the potential risks. For all medical products, needless or excessive exposure is never justified. Having accepted a certain level of risk, patients seek assurance that the drug or device is sufficiently reliable and that the health personnel administering the therapy are sufficiently competent. Safety is not the only regulatory goal for radiation products or any other form of drug or device. Although the legislation enacted by Congress to regulate radiation products as well as other drugs and devices often focuses primarily upon safety, inherent in all of this legislation is the equally important goal of promoting new medical technology that will address the nation's important health needs. Many of our most serious diseases can effectively be treated in the future only through the development of new medicine, including radiation products, that will make major advances in diagnosis and therapy. These twin goals for regulation of medical products—promoting safety and promoting technological advance—require a delicate balance. Overprotection against unsafe products will reduce technological advances, raise health care costs, and harm the public health. Overpromotion of technological advances could reduce safety protections and also harm the public health. Inevitably, regulators must balance safety, effectiveness, the need for important new medical products, the cost of complying with regulatory requirements, and access by patients to new therapies on a reasonable timetable. THE CURRENT REGULATORY FRAMEWORK How Society Regulates Health Care Delivery Government regulation of pharmaceutical products, and of the health professionals who administer them, has a long and complex history. At the time our country was founded, there was very little regulation of either products or practitioners. Injured consumers could bring suit in the courts for damages caused by unsafe or ineffective medical products only under limited conditions; and neither licensure nor minimum training was necessary to practice medicine. State regulation of domestic drugs and federal regulation of imported drugs began in the mid-1800s, but premarket testing and approval was not a part of these early programs. The basic philosophy was that consumers should be prudent purchasers, scrutinizing the quality of the goods and services offered in an open market economy.

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Radiation in Medicine: A Need for Regulatory Reform Beginning with the Biologics Act of 1902 and the Pure Food and Drugs Act of 1906, Congress has enacted increasingly stringent controls over all medical care products throughout this century. As the potential risk of increasingly sophisticated drugs and devices has been recognized, new forms of government control have been imposed. For all forms of medical products, regulation is justified by the dangers that could be presented by unsafe materials, ineffective products, and incompetent professionals. Many drugs and devices are inherently injurious when applied under any but the strictest regimens. Inappropriate use of drugs or devices can injure or kill a patient. Radiation used in medicine presents the additional concern that it can harm not only the patient, but also the health professional who administers it. Another justification for government regulation is the fear that patients might have inadequate information, be unable to interpret available information, or make bad decisions even when information is available and understood. This concern persists despite growing patient insistence on personal involvement in making decisions about their own care, particularly when confronted with life-threatening disease. Medical decisions are often viewed as different from other consumer decisions because time is frequently of the essence and emotions arising from emergencies may interfere with rational choice. Regulation is thus intended to facilitate informed and rational decision making and to protect against unwise choices. Although these factors justify some level of regulation, not all societies and not all individuals agree on the appropriate amount of public protection. The same pharmaceutical product may be available by prescription in some countries and without a prescription in other countries. The degree of government review of drugs and devices prior to marketing varies even among the most sophisticated countries. Countries also have differing standards for licensing health professionals. In all of these areas, the United States has been relatively risk averse and has chosen to impose a high level of regulation. There is overlapping and often contradictory regulation of health care by many agencies at both the federal and state levels. This complex regulatory framework is discussed next. The Regulatory Framework Regulatory authority over ionizing radiation in medicine is widely dispersed among several government agencies at the federal, state, and local levels. At the federal level, the NRC and the FDA exercise primary regulatory authority over the use of ionizing radiation in medicine. In addition to the NRC and the FDA, the Environmental Protection Agency (EPA), the Occupational Safety and Health Administration (OSHA), and the Department of Energy (DOE) oversee exposure standards for the public and for workers. The transportation of radionuclides is regulated by the Department of Transportation (DOT). In some

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Radiation in Medicine: A Need for Regulatory Reform cases, regulatory standards are established at the federal level but are administered by the states. Where federal oversight is absent, some states regulate independently in their roles as protectors of the public health and safety, but state laws and regulations often differ. Nuclear Regulatory Commission The Atomic Energy Act (AEA) of 1954 authorized the Atomic Energy Commission (AEC) (now the NRC) to regulate three particular types of ionizing radiation products: byproduct materials, source materials, and special nuclear materials. Byproduct materials used in medicine are subject to regulation under Title 10 of the Code of Federal Regulations (CFR) Part 35. Other forms of ionizing radiation used in medical products, however, such as radium, accelerator-produced materials, and machine-produced radiation were not included under the 1954 act and thus are not subject to NRC regulation. (They are, however, subject to FDA regulation, as discussed below.) The NRC regulates byproduct materials by directly licensing the manufacturers of byproducts used in radiation medicine and by approving the marketing of individual products containing those materials based upon an evaluation of their safety and effectiveness. The NRC imposes strict control over medical use. Under the Medical Use Program (described below in greater detail), the NRC exercises licensing authority over the physicians who use byproducts and sets criteria for determining proper use. The NRC also has reporting requirements (that overlap with the FDA reporting requirements) in order to oversee its medical use standards. For other sources of ionizing radiation that are not subject to NRC jurisdiction, there is no parallel to the NRC's Medical Use Program. Thus, the use of some products in radiation medicine is very strictly controlled at the federal level while the medical use of others is regulated to varying degrees at the state level. At the federal level, these other radioactive products are subject to the general FDA policy that excludes medical practice from regulatory requirements for all drugs and devices. The NRC's 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 Program, derives from the NRC's general responsibilities for protecting public health and safety in connection with nuclear reactors. All other medical uses and sources of ionizing radiation are regulated by other entities, such as the states or the FDA.1 1   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 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. Since World War II, the regulation of radiation medicine has intensified. In 1967, the NRC's predecessor, the AEC, codified its medical regulations into a new Part 35 of Title 10 of the CFR, called "Medical Use of Byproduct Material," which covered the medical use of both radioactive drugs and radiation devices. Although medical licensees are required to comply with many other sections of Title 10, Part 35 is the most important. Part 35 contains provisions designed to protect patients and workers from devices, beams, and radiation sources. For example, to protect patients scheduled for radiation procedures, Part 35 requires implementation of quality management (QM) procedures (section 35.32) (see discussion below), 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). Other sections pertain to protection of the public and 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 (1) 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 (2) special inspections to follow up a particular incident. Inspections are intended to assure that licensed programs are conducted in accordance with NRC requirements, with specific provisions of the license, and with the health and safety requirements 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.

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Radiation in Medicine: A Need for Regulatory Reform Misadministration rule. In 1968, six years before the Energy Reorganization Act split the AEC into two separate agencies, a patient died when exposed to 1,000 times the intended therapeutic dose of radioactive gold (Au-198). This error led the U.S. General Accounting Office (GAO) in 1972 to issue a report entitled Problems of the Atomic Energy Commission Associated with the Regulation of Users of Radioactive Materials for Industrial, Commercial, Medical, and Related Purposes (GAO, 1972). Noting the lack of information on overexposures, and tallying approximately 20 incorrect doses brought to the AEC's attention over the prior 10 years, the GAO criticized the AEC's "lax oversight" of byproduct material licensees. In response, the AEC proposed several revisions in its procedures. However, the AEC failed to act on the proposed revisions, which gradually faded into obscurity. For several months in 1975 and 1976, a cobalt (Co-60) teletherapy unit was miscalibrated at the Riverside Methodist Hospital in Columbus, Ohio. During this period, almost 400 patients undergoing radiation therapy were overexposed by as much as 40 percent above the prescribed dose. By the time the error was reported, two patients had died as a direct result of the miscalibration. Over the next several months, eight additional deaths occurred that were probably attributable to the mistake. The NRC modified Riverside's byproduct materials license to require full annual calibrations, monthly spot checks, and detailed record keeping. In 1979 the NRC extended these requirements to all Co-60 teletherapy licensees; it also implemented the GAO's 1972 recommendation that misadministrations of radiation be reported to the NRC and brought to the attention of the patient or family. This requirement was contested by physicians and professional organizations who considered it an intrusion into medical judgment and practice. Several states, however, endorsed the NRC's position of attempting to ensure greater protection of patient welfare, and the GAO supported the NRC by declaring that reporting of misadministrations would not constitute an intrusion into medical practice. After public hearings on the issue, the NRC issued a "Medical Policy Statement," which proposed three actions The NRC will continue to regulate the medical uses of radioisotopes as necessary to provide for the radiation safety of workers and the general public. The NRC will regulate the radiation safety of patients where justified by the risk to patients and where voluntary standards, or compliance with these standards, are inadequate. The NRC will minimize intrusion into medical judgments affecting patients and into other areas traditionally considered to be a part of the practice of medicine. (NRC, 1979)

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Radiation in Medicine: A Need for Regulatory Reform In 1980 the NRC issued its rule on "Misadministration Reporting Requirements," which broadened reporting requirements to encompass both diagnostic and therapeutic procedures. The misadministration rule was incorporated into 10 CFR 35.41 and 35.45 and required licensees to (1) keep records of all misadministrations; (2) promptly (within 24 hours) report all therapy misadministrations to the NRC, referring physicians, and the patient or responsible relative or guardian; and (3) report diagnostic misadministrations quarterly to the NRC. The NRC estimated that the cost of the misadministration rule would be about $1.2 million, which it deemed reasonable if it saved even a single life. A misadministration is defined by the NRC, 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.) Over the following four years, NRC licensees reported 27 therapy misadministrations, or about 7 per year. Sixteen of these incidents involved teletherapy equipment; five, brachytherapy treatment; and six, radiopharmaceutical therapy. In analyzing these incidents, the NRC identified three basic causes: inadequate training, inattention to detail, and lack of procedural redundancy. The NRC, through its office for Analysis and Evaluation of Operational Data (AEOD) noted that although professional medical groups involved with radiotherapy and related government agencies encourage quality assurance programs in radiotherapy facilities, no government agency or non-governmental accrediting body requires that radiotherapy facilities have quality assurance programs that conform to the programs recommended by professional medical groups. Thus, many facilities may not have quality assurance programs that are consistent with recommendations of medical professional groups involved with radiation therapy. (AEOD, 1985) The NRC instructed its Office of Nuclear Material Safety and Safeguards to: dispense the information contained in its report to affected licensees; contact appropriate professional organizations to encourage and support the initiation of a voluntary industry-directed quality assurance program for radiotherapy facilities; determine the effectiveness of the voluntary program within two years; consider the possibility of imposing a quality management rule if substantial progress toward completion of the voluntary program, including a final completion date, had not been demonstrated at the end of two years (AEOD, 1985).

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Radiation in Medicine: A Need for Regulatory Reform In January 1986, Washington Hospital Center in Washington, D.C., reported that a patient was administered 150 rads of radiation with no request or desire for treatment from the referring physician. This event caused the NRC commissioners to direct staff to develop rulemaking that would initiate quality assurance (QA) programs to reduce the chance for therapy misadministrations. A year later the NRC published a proposed rule of "Basic Quality Assurance in Radiation Therapy" and an advance notice of proposed rulemaking, which called for a comprehensive QA program for any medical use of radioactive byproduct material. The NRC claimed that voluntary QA programs may not adequately assure public health and safety, but it limited the scope of the proposed prescriptive rule to radiation therapy and diagnostic procedures involving radioactive iodine. These actions precipitated a major response from the medical community, including the recommendation that the proposed rulemaking should be performance-based rather than prescriptive. After several public hearings and discussions with medical organizations, the NRC published a proposal in 1990 for a new performance-based QM program and for revised recordkeeping and reporting requirements related to misadministrations. the NRC also announced that it would conduct a pilot program to evaluate the effectiveness of the proposed rule. The NRC made a concerted effort to respond to critics of the 1990 proposed rule. In response to those who claimed that the rule would have little impact on reducing the already small number of misadministrations, the NRC emphasized that the number of reported therapeutic misadministrations in 1990 had increased to 24 from the average number of 10 for previous years. The proposed QM rule, it argued, was a legitimate regulatory response to a continuing problem in the use of radioactive byproduct material. Responding to critics who asserted that the NRC was duplicating standards of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the agency claimed that adherence to JCAHO standards is voluntary and that there is no guarantee that all licensees would implement a QM program. Quality management rule. In January 1992, the NRC implemented the final version of its QM rule (NRC, 1992). The NRC's QM rule calls upon NRC licensees to establish a QM program in compliance with 10 CFR 35.32 and 35.33 if they administer radiation from sealed sources containing byproduct material for therapy (brachytherapy), if they administer cobalt teletherapy, or if they administer therapeutic unsealed radionuclides (therapeutic nuclear medicine) (see Chapter 2). The rule also applies to any diagnostic administration of greater than 30 microcuries of sodium iodide I-125 or I-131 (see Chapter 2 and Appendix D). 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.

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Radiation in Medicine: A Need for Regulatory Reform The QM rule is a performance-based approach to quality management. This approach includes five specific objectives: Prior to an administration, a written directive must be prepared. Prior to each administration, the patient's identity must be verified by 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. The NRC Agreement State Program. The NRC Agreement State Program provides an opportunity for states to assume responsibility from the NRC to license and regulate byproduct material, source material, and small quantities of special nuclear material. NRC authority regarding radiological health and safety aspects of nuclear materials is transferred to the states through a formal agreement between the governor of the state and the NRC (Public Law 83-703, 1954). Currently, there are 29 Agreement States, and several other states are exploring agreement status.2 Use of the Agreement State arrangement requires that the NRC must conclude that a state's radiation control program "is compatible with the Commission's, meets the applicable parts of Section 274 [of the AEA] 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 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 2   See Appendix E for a map and list of Agreement and Non-Agreement States. According to the NRC, four states have expressed an interest in becoming Agreement States: Oklahoma, Ohio, Pennsylvania, and Massachusetts (see Appendix E).

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Radiation in Medicine: A Need for Regulatory Reform of NRC states with that of Agreement States. In April 1993, the GAO reported that the NRC lacks common performance indicators for inspection backlogs, radiation overexposures, and numbers of violations (GAO, 1993). Because the programs of NRC states and Agreement States use different indicators to measure effectiveness, the report asserts, the NRC cannot determine whether the public in each state is 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 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 (NRC, 1995). These actions include: periodically assessing Agreement State radiation control programs against established review criteria; providing assistance to help address weaknesses or areas within an Agreement State radiation control program requiring improvement; placing a state on a probationary status for serious program deficiencies that require heightened oversight; temporarily suspending an agreement and reasserting NRC regulatory authority in an emergency if an Agreement Sstate program experiences any immediate program difficulties that prevent the state from continuing to ensure adequate protection of the public health and safety; and suspending or terminating an agreement and reasserting NRC regulatory authority if the Agreement State experiences difficulties that jeopardize the state's ability to continue to ensure adequate protection of the public health and safety. Food and Drug Administration Biological drugs first became subject to federal premarket approval for safety and effectiveness under the Biologics Act of 1902, and the 1902 act remains basically unchanged to this day. The 1902 act was administered by the Public Health Service until it was transferred to the FDA in 1972. The Pure Food and Drugs Act of 1906 imposed federal policing of all drugs (including biological drugs) to prevent adulteration or misbranding, but did not include premarket approval requirements. The 1906 act was replaced by the Federal Food, Drug, and Cosmetic Act of 1938, which required premarket notification (but not premarket approval) for the safety (but not the effectiveness) of new drugs (but not old drugs). The 1938 act was supplemented by the Drug

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Radiation in Medicine: A Need for Regulatory Reform Amendments of 1962, following the thalidomide tragedy, to require premarket approval by the FDA of all new drugs for safety and effectiveness. The FDA is responsible for administering these statutes. Medical devices were first made subject to general policing authority by the FDA to prevent adulteration or misbranding under the 1938 act. The 1938 act was supplemented by the Medical Device Amendments of 1976, which imposed premarket notification regarding the safety and effectiveness for most medical devices and premarket approval for safety and effectiveness for important new devices. All radiation products were included within these statutory requirements for drugs and devices administered by the FDA. Thus, all of these laws, by their terms, required complete compliance by radiation products to the same extent and in the same way as any other drug or device. Congress enacted the Radiation Control for Health and Safety Act of 1968 to provide additional regulatory authority for all "electronic products" that emit ionizing or nonionizing radiation, including medical products. The responsibility for administering the 1968 act was transferred to the FDA in 1971 and combined with the FDA medical device program in 1982. The 1968 act also authorized the FDA to work with other federal and state agencies and private organizations to minimize exposure to electronic radiation. Pursuant to this authority, the FDA has issued guidelines and recommendations regarding public exposure to ionizing and nonionizing radiation. Under the 1938 act, as amended for new drugs in 1962 and for medical devices in 1976, the FDA exercises direct authority to determine the safety and effectiveness, and to approve the marketing, of all radiation products used in medicine.3 No radiation product may be investigated in humans without an investigational new drug (IND) application submitted to the FDA or may be marketed without FDA approval of a new drug application (NDA), a product license application (PLA) if it is a biological product, or one of two types of medical device approvals if it is a device. The FDA must review and approve the labeling of all of these products prior to marketing and must approve the manufacturing procedures for all of these products except medical devices that are substantially equivalent to previously marketed devices. 3   Following enactment of the Drug Amendments of 1962, the NRC suggested that the FDA take over responsibility for approving the marketing of all new radioactive drugs, including those subject to NRC jurisdiction. The FDA declined to do this and, as an exercise of administrative discretion, exempted from its new drug approval requirements radioactive drugs approved for marketing by the NRC. In 1974, however, the FDA reversed itself, repealed the exemption, and thus took over from the NRC responsibility for determining the safety and effectiveness and approving the marketing of all radioactive drugs, including those containing materials that remained subject to an NRC manufacturing license and the NRC Medical Use Program.

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Radiation in Medicine: A Need for Regulatory Reform one incident of leakage or damage. Several RSOs pointed out that manufacturers have had, since the late 1970s, excellent packaging practices that obviate the need for such strict receipt, log-in, and survey practices. The QM rule, instituted for NRC licensees in 1992 and required for Agreement States in 1995, was cited as another example of overregulation. Many RSOs and professional groups believe that benefits derived from the QM program are outweighed by the costs of maintaining a prescriptive regulatory program. None of the RSOs contacted believed that the QM programs and enough value to justify the level of recordkeeping that is required.7 Security Requirements The committee found universal agreement among interviewees and witnesses that in the recent past the NRC has excessively tightened its enforcement of provisions meant to ensure the safekeeping of byproduct material (10 CFR 20.1801 and 20.1802). Typically, a licensee secures radioactive materials under lock and key when they are not attended, but in the past this had been interpreted as covering evenings and weekends, not the course of a workday. In several instances in NRC Region I, RSOs reported that their programs have been cited, fined, and threatened with enforcement conferences at regional headquarters for innocuous, if widespread, violations of security in research laboratories and nuclear medicine departments. The violations in question involved leaving small quantities of unsealed radionuclides unattended in laboratories, although they were always clearly marked as dangerous radioactive material. The significance of this can be considered in terms of the annual limit on intake (ALIs), which is the quantity of each radionuclide in a particular chemical and physical form that, if ingested (or inhaled), produces an effective dose equivalent of 5 rems. The NRC's annual dose equivalent limit for the general public is 0.1 rem. The quantities in question for these licensees were on the order of 1 to 10 ALIs. By way of comparison, a common household smoke detector, which sits in many homes, typically contains 0.9 microcuries (µCi) of americium-241 (Am-241). The inhalation ALI of Am-241 is 0.01 µCi (10 CFR Part 20, 7   On December 24, 1991, the NRC submitted an information collection request to the Office of Management and Budget (OMB), as required under the Paperwork Reduction Act. The request sought authorization to require recordkeeping under the QM rule. The OMB denied the request, citing the low incidence of adverse events. Although the OMB was unable to determine with any accuracy the burden that would be imposed by the requirements (with estimates ranging from 20,000 to 200,000 extra hours per year), it felt that any burden was unreasonable, given its finding that "reporting and recordkeeping requirements will have little if any practical utility furthering the goal of reducing injuries from misadministrations" (MacRae, 1992). A majority of the NRC's commissioners voted to override the OMB denial, using a provision within the Paperwork Reduction Act that allows independent regulatory agencies to do so.

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Radiation in Medicine: A Need for Regulatory Reform Appendix B, Table 1, Column 2). Such smoke detectors, therefore, contain 90 ALIs and, if leakage occurs, may produce an effective dose equivalent of 450 rems. This serious dose would be 4,500 times the NRC's limit. The committee did not find any challenge to the need for tight security for large, life-threatening sources. The point of the interviewees' and witnesses' observations was that a graded approach is needed to keep the regulatory requirements and response in line with the hazards. Radiation hazards, interviewees and witnesses also pointed out, must be viewed in the context of laboratories that safely use other, far more hazardous chemical, biological, and physical agents without the need for such tight security regulations. According to the RSOs and many practitioners interviewed during site visits, the recently tightened security enforcement has caused researchers and subspecialists to conclude that the NRC and its inspectors are overly zealous, and that their actions impede both patient care and research. The RSOs stated that, as a result, respect for NRC employees and regulations suffers among scientists and clinicians who understand the relative hazards. Several RSOs stated that regulations and procedural requirements that are "clearly out of line with common sense" erode the collaborative relationship between radiation protection staff and users of licensed materials; for this reason, these experts believe that such stringent requirements and aggressive enforcement strategies may ultimately reduce rather than heighten safety. Radioactive Waste Management There was general consensus among interviewees and witnesses that the difficulty and expense of waste disposal have driven up costs and eliminated some benefits of the use of NRC-licensed materials. All RSOs stated that radioactive waste management policies had had severe impacts on themselves, on the users of licensed radioactive materials, and on the kinds of patient care and research being performed in their institution. Some said that procedures generating waste that could not be held for decay were being abandoned because nothing could be done with the waste except store it. One licensee stated that a building for waste storage had just been completed at his facility at a cost of $1 million; another licensee indicated that the budget for waste disposal at his institution was $750,000 for FY 1995. These increased costs were attributed in part to NRC requirements that are not risk based. RSOs pointed out that the NRC will not deregulate licensed material even after it decays to concentrations that are below concern. Byproducts with half-lives of less than 65 days are the exception to this statute, because they shift eventually to a "below regulatory concern" category. Such below regulatory concern (BRC) concentrations are listed in 10 CFR Part 30 for many nuclides. All RSOs agreed that medical uses of NRC-licensed materials would benefit from a BRC policy and that, if such a policy were put in place, safety would not

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Radiation in Medicine: A Need for Regulatory Reform decrease. Such a policy, it was believed, would dramatically decrease waste disposal costs, and this in turn would reduce the overhead of radiation safety programs. The BRC policy has been surrounded by political controversy between congressional representatives and the NRC for a number of years. Consequently, the NRC is not working on implementation now. Cost Savings Estimates for Some NRC Licensees RSOs from four NRC licensees were asked how many personnel could be eliminated if NRC regulations were revised to eliminate tasks such as package receipt, log-in, and surveys, unneeded and unproductive recordkeeping, inconsistent waste disposal provisions, time-consuming licensing and inspection programs, and high fees. Three RSOs estimated savings of 1 FTE, and one estimated savings of 2.5 FTEs. In addition, the RSO for one licensee estimated that 0.5 FTE would be eliminated in the nuclear medicine department. The RSO estimates are shown in Table 3.5. These estimates are clearly speculative. Developing more exact estimates would entail enormous difficulties and effort, and the results would still be approximate. Estimated savings in salaries ranged from about $42,000 to $150,000 annually (not including nuclear medicine), generally comparable to total license fees. Estimated FTE savings ranged from 3 to 15 percent of each overall budget. As suggested earlier, a full assessment of the relative value of NRC regulations cannot examine only costs and administrative burdens. It must also analyze the relative risks posed by ionizing radiation and the benefits of NRC regulations in reducing those risks. That subject is examined in more detail in Chapter 4. Summary of Fee and Non-Fee Costs of NRC Regulation In 1993, the average teletherapy licensee paid NRC fees of nearly $15,000; the average broad scope medical licensee paid about $21,500; the average small medical licensee, about $5,000; the average manufacturer or processor, $14,293; and the average distributor or redistributor, about $5,500. Large licensees pay well in excess of twice these fees. Three broad scope licensees estimated savings of more than twice the amount of fees they paid if NRC regulations were, in their view, brought into line with the risks being regulated. These licensees all concluded that, if NRC regulations were revised, they could reduce their safety and compliance programs considerably while still maintaining the same degree of protection for workers, patients, the public, and the environment.

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Radiation in Medicine: A Need for Regulatory Reform TABLE 3.5 Savings Estimated from Projected Reduction at Four NRC Licensees Inst. Region Dept. Annual Budget Number of Separate Licenses at Institution Total Costs Salary as a Percent-age of Budget FTEs Staff Time on NRC Reg. (%) FTEs that Could Be Eliminated Savings Savings as a Percent-age of Costs A 1 RSO $650,000 3 $700,000 60 9 43 1.0 $43,333 7 B 1 RSO $1,000,000 3 $1,000,000   16 25 2.5 $150,000 15 C 2 RSO $500,000 1 $500,000 70 7 36 1.0 $50,000 10 C 2 Nuc. Med. N/A 1 N/A N/A N/A N/A 0.5 $30,000 ? D 3 RSO $1,316,828 7 $1,316,828 51 16 20 1.0 $42,000 3 NOTE: Dept. = department; Inst. = institution; med. = medicine; N/A = not available; Nuc. Med. = nuclear medicine SOURCE: Strom, 1995.

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Radiation in Medicine: A Need for Regulatory Reform With respect to non-fee costs, several criticisms of current NRC regulations emerged from interviews with RSOs and others. To save money without compromising safety, it was believed, the NRC should relax: package receiving and opening requirements; security requirements for small amounts of activity; recordkeeping requirements; enforcement actions for minor infractions; and waste disposal requirements that are not risk based. QUALITATIVE ASSESSMENTS OF NRC REGULATIONS As described in Chapter 1, the committee's fact-finding efforts included eliciting information from individuals and organizations via a public hearing, a technical panel comprising health professionals, and site visits to various medical institutions and state organizations in the states of Georgia, Minnesota, Massachusetts, and California. Many of the experts from whom the committee heard believed that over the past two decades, NRC regulation had helped bring a high level of quality and accountability and had provided some useful services to radiation medicine. Several criticisms emerged, however, of current NRC regulation of medical programs. The committee notes that these criticisms are difficult to substantiate quantitatively because of the lack of adequate data, particularly with regard to risk assessment. A detailed examination of risk assessment is reserved for Chapter 4. Within the scope of the present chapter, however, the committee underscores the fact that the reported incidence of misadministrations of byproducts is low, which may or may not be attributable to the NRC regulatory structure now in place. As to state-regulated radiation, the committee is not aware of data on the rates of misadministrations traceable to NARM or machine-produced radiation, or reports of unusual sources or serious incidents.8 Criticism of the Regulatory System The criticism that emerged from the committee's interviews among the regulated community and other information-gathering efforts led the committee to reflect on specific aspects of the regulatory system. Among these aspects are the fragmentation and intensity of regulation according to radiation source; the administrative burdens; the NRC fees and fines; and the increasing burden and unwarranted detail of NRC inspections. 8   In one area of state-regulated radiation, namely, fluoroscopy, a pattern of misadministration has been identified; this was addressed through an FDA alert (FDA, 1994).

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Radiation in Medicine: A Need for Regulatory Reform Fragmentation and Disproportionality Fragmentation of regulation and the difference in detail and intensity between state and federal regulations were cited by the regulated community. Along with the ''fracture" that gives the NRC responsibility for byproduct material while leaving regulation of NARM and machine-produced radiation to the states, the disproportion between the two levels of regulation leads to needless upgrading of requirements for state-regulated activities. In one example, a radiation safety officer, for fear of establishing two separate standards of medical care, one for NRC-regulated activities and another for state-regulated activities, applies NRC standards throughout his institution, resulting in massive costs for additional linear accelerator shielding and the extension of the NRC-mandated QM program. In another example, a university hospital plans all radiation therapy, the majority of which employs a linear accelerator, according to 10 CFR Part 35 requirements, just in case the accelerator fails and the patient must be switched to the cobalt unit. An additional problem, related to fragmentation, concerned the lack of communication among the federal agencies (FDA, EPA, OSHA, DOT) responsible for overlapping aspects of radiation protection. This lack of communication occurs despite formal memoranda of understanding between some of the agencies. This situation is exemplified in the GAO report Nuclear Health and Safety: Consensus on Acceptable Radiation Risk to the Public Is Lacking (GAO, 1994). The report examined whether existing radiation protection standards provide a coherent, complete federal framework for public protection. The GAO found large disparities in the standards established by different agencies and no consensus emerging on what those standards ought to be. Most importantly, the GAO found that at least 26 different draft or final federal radiation standards or guidelines contain specific radiation limits, some of which differ numerically from others. Table 3.6 illustrates these disparities. Administrative Requirements The NRC's administrative requirements are an area of concern. 10 CFR 35.20, for example, presents the concept of "as low as reasonably achievable" (ALARA) as a regulatory process. ALARA guidelines issued by the NRC are treated not as an operational philosophy but as enforceable standards. Section 35.21 sets out strict procedures for routine monitoring of everything associated with radioactivity, from receiving and opening packages to keeping records in a

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Radiation in Medicine: A Need for Regulatory Reform TABLE 3.6 Federal Radiation Exposure Limits Standard or Guideline/Agency Type/Effective Date Limit Estimated Lifetime Risk of Premature Cancer Deatha General Standards/Guidelines 1. General public/NRC Regulation (10 CFR 20), 1993 0.1 rem/yr   2. General public/EPA Guidance, 1960 0.5 rem/yr   3. General public/EPA (draft) Proposed guidance 0.1 rem/yr   4. General public/DOE (draft) Proposed regulation (10 CFR 834) 0.1 rem/yr   Source-Specific Standards/Guidelines 5. Uranium mill tailings/NRC Regulation (10 CFR 40), 1985         Radium-226:5 pCi/g 1 in 50b     Radon: 20 pCi/m2s 1 in 14,000c 6. Drinking water (interim)/EPA Regulation (40 CFR 141), 1977 Beta/photon:d 0.004 rem/yr   6a. Drinking water (draft)/EPA Proposed regulation (40 CFR 141)         Radium: 20 pCi/l       Radon: 300 pCi/l       Beta/photon:d 0.004 rem/yr   7. Uranium fuel cycle/EPA Regulation (40 CFR 190), 1979-1983 0.025 rem/yr   8. Spent fuel, high-level, transuranic waste disposal/EPA Regulation (40 CFR 191), 1994         All pathways: 0.015 rem/yr       Groundwater: 0.004 rem/yrd  

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Radiation in Medicine: A Need for Regulatory Reform     Containment: 1,000 deaths in 10,000 yrs   9. Uranium mill tailings/EPA Regulation (40 CFR 192), 1983         Radium 226:5 pCi/g 1 in 50b     Radon: 20 pCi/m2s 1 in 14,000c Occupational Standards/Guidelines       10. Occupational/NRC Regulation (10 CFR 20) 5 rem/yr   11.Occupational/EPA Guidance, 1987 5 rem/yr   12. Radon in uranium mines/EPA Guidance, 1971 4 WLM/yre   13. Occupational/DOE Regulation (10 CFR 835), 1993 5 rem/yr   14. Under-ground mines/MSHAf Regulation (30 CFR 57), 1977 Radon: 4 WLM/yr   15. Occupational/OSHA Regulation (29 CFR 1910.96), 1971 5 rem/yr   a For purposes of comparison, the estimated risks in the table are derived from commonly used assumptions (e.g., a cancer death risk of 5 × 10-4 per rem to an individual continuously exposed over a 70-year lifetime; for workers, 50-year exposure). The estimated risks may differ from those derived by agencies, which used various assumptions in setting standards and guidelines. Some estimated risks are to individuals, and others are to larger defined populations. Risks are rounded. b Based on exposure to an individual residing on-site after cleanup. The estimated risk to an individual off-site could be considerably less. c Based on average population exposure. According to EPA and DOE, the estimated risk to a maximally exposed individual could be considerably greater. d Beta particle and photon radioactivity from man-made radionuclides in community water systems. e WLM = working level month, equivalent to about 100 pCi per liter of radon in equilibrium with its progeny for 170 hours of worker exposure. f MSHA = Mine Safety and Health Administration NOTE: g = gram; l = liter; m2 = square meter; pCi = picocurie; s = second. SOURCE: Adapted from GAO, 1994.

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Radiation in Medicine: A Need for Regulatory Reform form acceptable to NRC inspectors.9 Much time, effort, and money is spent satisfying such administrative demands. Perhaps the greatest attention went to the quality management and notification requirements set out in sections 35.32 and 35.33. The consensus among the technical panel representatives, interviewees at medical institutions, and those who spoke at the public hearing was that elimination of the QM rule would not lessen the radiation protection of the public, the occupational worker, or the patient. The committee shared this opinion, based on members' experience, expertise, and the results of their findings. Finally, the committee recognized that the patient notification requirement in 10 CFR 35.33 was particularly controversial, even within the NRC itself, and will have negligible marginal positive effects and generally negative effects, when seen in the context of usual medical practice and monitoring Fees and Fines NRC fees and fines were identified as excessive for the amount of risk posed by the use of radionuclides in medicine. Fees and fines were cited as one of the main reasons that Non-Agreement States are becoming Agreement States. Several individuals interviewed during site visits voiced concern that excessive costs force laboratories to stop using radionuclides, which in turn delays or prohibits the development and implementation of new uses of radionuclides in medicine. Boron neutron capture therapy was given as one example of a new technology whose development and diffusion is impeded by the costs of NRC regulation. In addition, many individuals in the regulated community objected to the NRC's budget being funded solely through licensing and enforcement fees. In no case did any of the RSOs interviewed believe that they receive value or services from the NRC that are commensurate with the fees they pay. CHAPTER SUMMARY This chapter has set out the costs, economic and otherwise, of the current system of regulating ionizing radiation in medicine. Regulation always has its costs, but they must be weighed against any benefits derived, such as the protection 9   Chapters 1245 and 1246 pertaining to inspector qualifications and materials license reviewer qualifications include the following language: "They must also be keenly aware of the potential for negative impact on safety if the inspection process is allowed to become overly intrusive in areas of licensee operation where problems are not occurring" (NRC Inspection Manual, 9/91, p.1). "The reviewer must also become aware of the possibility of his/her inadvertently handicapping the licensee's activities by imposing unreasonable or unnecessary license conditions" (NRC Inspection Manual, 2/94, p.1). The regulated community asserts that these policies are not heeded. The committee gathered much detail on such instances.

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Radiation in Medicine: A Need for Regulatory Reform of public health and safety. The next chapter explores the risks of using ionizing radiation in medicine, to determine whether a problem exists that necessitates regulatory intervention. REFERENCES AEOD (Office for Analysis and Evaluation of Operational Data). Case Study Report on the Therapy Misadministrations Reported to NRC Pursuant to 10 CFR 35.42. O&M-2 (AEOD). Rockville, MD: U.S. Nuclear Regulatory Commission, December 1985. DHHS (Department of Health and Human Services). Requirements for Accrediting Bodies of Mammography Facilities. 21 CFR Part 900. In: Federal Register, Vol. 58. Washington, DC: National Archives and Records Administration, pp. 67558–67565, 1993. Dowd, S.B., and Archer, J. Radiation Safety Regulations—The Evolution and Development of Standards. Radiology Management 16(1):39–45, 1994. FDA (Food and Drug Administration). Avoidance of Serious X-Ray-Induced Skin Injuries to Patients During Fluoroscopically-Guided Procedures: An FDA Public Health Advisory. Rockville, MD: Food and Drug Administration, September 9, 1994. GAO (General Accounting Office). Problems of the Atomic Energy Commission Associated with the Regulation of Users of Radioactive Materials for Industrial, Commercial, Medical and Related Purposes. B-164105. Washington, DC: General Accounting Office, August 18, 1972. GAO. Nuclear Regulation: Better Criteria and Data Would Help Ensure Safety of Nuclear Materials. RCED-93-90. Washington, DC: General Accounting Office, April 1993. GAO. Nuclear Health and Safety: Consensus on Acceptable Radiation Risk to the Public Is Lacking . RCED-94-190. Washington, DC: General Accounting Office, September 1994. Hutt, P.B., and Merrill, R.A. Food and Drug Law: Cases and Materials, 2nd Edition. Westbury, NY: The Foundation Press, 1991. MacRae, J.B. Letter to James Taylor, Executive Director of Operations, Nuclear Regulatory Commission, Washington, DC, June 26, 1992. NRC (U.S. Nuclear Regulatory Commission). Medical Policy Statement. In: Federal Register, Vol. 44. Washington, DC: National Archives and Records Administration, p. 8242, 1979. NRC. Final Rule. In: Federal Register, Vol. 56. Washington, DC: National Archives and Records Administration, p. 34104, 1992. NRC. Revision of Fee Schedules: 100% Fee Recovery, FY 1994. In: Federal Register, Vol. 59. Washington, DC: National Archives and Records Administration, p. 36895, 1994. NRC. Final Statement of Principles and Policy for the Agreement State Program and Procedures for Suspension and Termination of an Agreement State Program. NRC SECY-95-115. Rockville, MD: U.S. Nuclear Regulatory Commission, 1995. 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.

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Radiation in Medicine: A Need for Regulatory Reform Public Law 102-539 (106 Stat. 3547). Mammography Quality Standards Act of 1992. H.R. 6182. Washington, DC: House of Representatives, October 27, 1992. Strom, D.J. Regulatory Costs of the Medical Use Program. Paper commissioned by the Institute of Medicine Committee for Review and Evaluation of the Medical Use Program of the Nuclear Regulatory Commission. June 21, 1995.