G
History of Radiation Regulation in Medicine

This appendix briefly covers the history of the regulation of ionizing radiation in medicine. It begins with a discussion of early guidelines by the scientists involved in the evolving profession. It moves next to descriptions of various forms of governmental regulation, looking at both federal regulation by several agencies and at state regulation. This history is meant to give context to the discussions on regulation contained within the main text of the report.

PROFESSIONAL SELF-REGULATION

Today, regulations to ensure personal safety and public health are considered primarily a governmental responsibility. For several decades after the discovery of ionizing radiation, however, individuals sought protection from the adverse effects of radiation primarily through professional guidelines. Citing the deaths of radiologists, the German Roentgen Society first provided guidelines in 1913 to reduce the dangers of radiation exposure to medical workers (Taylor, 1981). In 1915 and 1921, recommendations in Great Britain to protect x-ray operators included maximum work schedules, required amounts of leisure time, and special accommodations for the workers (British X-Ray and Radium Protection Committee, 1921). In the United States, the American Roentgen Ray Society and the American Radium Society were encouraged by George Pfahler to create specific guidelines for radiation protection. Dr. Pfahler suggested that:

  1. The principles of radiology be thoroughly mastered, so that they can be adapted to the individual establishment, for the protection of both operator and patient;



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Radiation in Medicine: A Need for Regulatory Reform G History of Radiation Regulation in Medicine This appendix briefly covers the history of the regulation of ionizing radiation in medicine. It begins with a discussion of early guidelines by the scientists involved in the evolving profession. It moves next to descriptions of various forms of governmental regulation, looking at both federal regulation by several agencies and at state regulation. This history is meant to give context to the discussions on regulation contained within the main text of the report. PROFESSIONAL SELF-REGULATION Today, regulations to ensure personal safety and public health are considered primarily a governmental responsibility. For several decades after the discovery of ionizing radiation, however, individuals sought protection from the adverse effects of radiation primarily through professional guidelines. Citing the deaths of radiologists, the German Roentgen Society first provided guidelines in 1913 to reduce the dangers of radiation exposure to medical workers (Taylor, 1981). In 1915 and 1921, recommendations in Great Britain to protect x-ray operators included maximum work schedules, required amounts of leisure time, and special accommodations for the workers (British X-Ray and Radium Protection Committee, 1921). In the United States, the American Roentgen Ray Society and the American Radium Society were encouraged by George Pfahler to create specific guidelines for radiation protection. Dr. Pfahler suggested that: The principles of radiology be thoroughly mastered, so that they can be adapted to the individual establishment, for the protection of both operator and patient;

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Radiation in Medicine: A Need for Regulatory Reform A committee of the society be appointed to cooperate with other bodies of national organizations, to study and formulate definite directions and rules of protection; The committee cooperate insofar as possible with the Bureau of Standards in Washington in order to secure definite and permanent products, and possibly definite calibration of units; Radium be insured against loss, so that men will not be suddenly hampered financially and prevented from carrying on the good work which has been started; Every radiologist be provided with legal protection, with protection from insurance companies and the protection and cooperation of his county medical society; [and] Every radiologist in the country associate himself with the American Radium Society, both for his good and the good of the Society. (Taylor, 1979, 2-009-2-010) The third of Pfahler's recommendations delineates a governmental role in the regulation and control of radiation sources. In 1927, the National Bureau of Standards began a voluntary program to inspect and calibrate radiation equipment and to send government representatives into laboratories to evaluate the safety of radiation sources, including x-ray machines. This program followed the model of a national inspection program initiated in 1921 by the National Physical Laboratory in Great Britain. The International Commission on Radiological Protection (ICRP) held its formative meeting in 1928 and requested that each represented country develop a coordinated program of radiation control. The U.S. representative, Lauriston Taylor from the U.S. Bureau of Standards, formed the U.S. Advisory Committee on X-Ray and Radium Protection, later named the National Committee (now Council) on Radiation Protection and Measurements (NCRP). The NCRP received a congressional charter in 1964, and to this day it maintains a nongovernmental commitment to the development of guidelines to protect individuals and the public from excessive exposure to radiation. By 1931, early philosophical constructs of radiation protection had been developed by the ICRP and NCRP, and the concept of ''tolerance dose" was adopted as an upper limit for exposure of workers (Hendee, 1995). About the same time, the International Commission on Radiation Units and Measurements (ICRU) defined the unit "roentgen (R)" as the amount of radiation that would produce a certain amount of ionization in a given volume of air at standard temperature and pressure. In 1934 the ICRP established a tolerance dose of 0.2 R per day for exposure of workers to radiation, and in 1936 the NCRP reduced this limit to 0.1 R per day. This limit was maintained through World War II and was applied to workers in the Manhattan Project (Hendee, 1993).

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Radiation in Medicine: A Need for Regulatory Reform The ICRP and, in the United States, the NCRP have remained to this day as the principal voluntary advisory agencies concerning radiation protection and limits for radiation exposure. In 1954 the NCRP adopted the concept of "maximum permissible dose" in place of "tolerance dose," accepted the use of absorbed dose rather than exposure as a preferred way to express protection limits, and acknowledged the linear, no-threshold model of radiation injury as the guiding philosophy for establishing upper limits for radiation exposure (NCRP, 1954). Over the next 25 years, several other changes were introduced, including use of ''effective dose equivalent" in place of absorbed dose as a way to accommodate variations in the effectiveness of different types of radiation to inflict biological damage. In 1977 the ICRP proposed the concept of "effective dose" as an approach that considers the overall impact of irradiating different regions of the body. In the same report (ICRP, 1977), the ICRP recommended that protection standards should be based on acceptable health risks rather than on arbitrary dose limits. GOVERNMENT REGULATION NUCLEAR REGULATORY COMMISSION Atomic Energy Act The Hiroshima and Nagasaki explosions brought the nuclear age abruptly into worldwide consciousness. The end of World War II gave rise to a bitter dispute in the United States between military leaders and civilian officials concerning the best way to control nuclear energy and inhibit development of nuclear weapons by other countries. This dispute culminated in congressional passage of the Atomic Energy Act (AEA) of 1946. This act affirmed civilian control over nuclear energy while leaving weapons development with the military. The AEA created the Atomic Energy Commission (AEC) to oversee development of nuclear technologies. The AEC's principal function was to foster the continued development of nuclear weapons in the United States, including assurance of a sufficient supply of weapons-grade fissionable material. A secondary purpose of the AEC was to encourage peaceful uses of nuclear energy (Mazuzan and Walker, 1984). By 1954, the Isotopes Division of Oak Ridge National Laboratory had delivered 47,000 shipments of reactor-produced radioactive nuclides around the country, many of which were intended for medical uses. The AEA also created a congressional Joint Committee on Atomic Energy (JCAE) to provide legislative oversight of the activities of the AEC. In 1952 the JCAE issued a document entitled Atomic Power and Free Enterprise that encouraged private enterprise to develop nuclear power for commercial purposes. Two years later President Eisenhower urged Congress to change the AEA to facilitate private development of nuclear technologies for peaceful purposes. In

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Radiation in Medicine: A Need for Regulatory Reform response, Congress passed the AEA of 1954 that endorsed Eisenhower's Project Plowshare to turn "atomic swords into plowshares." The 1954 AEA qualified the endorsement of peaceful applications of nuclear energy by limiting them "to the maximum extent consistent with the common defense and security and with the health and safety of the public." The act gave the AEC a difficult mandate: it was to encourage a private nuclear enterprise while at the same time regulating its activities to ensure compliance with national security and with personal and public health. The application of radioactive material in medicine was included within the purview of the AEC's regulatory powers. Concerning biomedical research, the AEC was directed in the 1954 AEA to "exercise its powers in such manner as to insure the continued … research … in … utilization of … radioactive material for medical, biological [and] health … purposes" (AEA, 1954, section 31.a.(3)). This encouragement was balanced by provisions to: "(1) protect health, (2) minimize danger to life or property, and (3) require the reporting and permit the inspection of work performed thereunder, as the Commission may determine" (AEA, 1954, section 31.d). The AEC was authorized to issue licenses to persons applying therefore for utilization facilities for use in medical therapy. In issuing such licenses the Commission is directed to permit the widest amount of effective medical therapy possible with the amount of special nuclear material available for such purposes, and to impose the minimum amount of regulation consistent with its obligations under this Act to promote the common defense and security and to protect the health and safety of the public. (AEA, 1954, section 104.a) The dual mandate of the AEC to foster development of nuclear technologies and to protect national security and public health was viewed by many as a set of contradictory objectives. After years of public debate on this issue, Congress passed the Energy Reorganization Act (ERA) in 1974 to separate the two conflicting objectives. A new Energy Research and Development Administration (ERDA, subsequently changed to the cabinet-level Department of Energy (DOE)) assumed "activities relating to research and development on the various sources of energy (and) other functions, including but not limited to the Atomic Energy Commission's military and production activities and its general basic research activities." The act also created the Nuclear Regulatory Commission (NRC) to continue the licensing and related regulatory functions of the Atomic Energy Commission. The NRC was to be directed by five commissioners appointed by the President with approval of the Senate.

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Radiation in Medicine: A Need for Regulatory Reform Other Federal Agencies Federal Radiation Council In 1959, at President Eisenhower's request, the Bureau of the Budget analyzed the radiation protection roles of various federal agencies. Perceiving a conflict of interest within the AEC between its promotion of weapons and energy development and its obligations to protect public health and safety, the Bureau recommended several changes to restore public confidence in federal control of radioactive materials. Among the recommendations was the creation of the Federal Radiation Council (FRC), which comprised the secretaries of the Departments of Commerce, Defense, and Health, Education and Welfare (DHEW), as well as the AEC chairperson. The FRC was directed to rely on the expertise of the NCRP in proposing recommendations to the President on protection standards. These recommendations were to be limited to general standards and guidance; federal agencies retained their responsibilities for setting legally binding standards within their jurisdictions, and the NCRP retained its unofficial status as an independent voluntary agency. In proposing protection guidelines for workers and the general public, the FRC abandoned the concept of "maximum permissible dose" and substituted the term "radiation protection guide (RPG)." The FRC defined the RPG as "the radiation dose which should not be exceeded without careful consideration of the reasons for doing so; every effort should be made to encourage the maintenance of radiation doses as far below this guide as practicable." The FRC stated that "[t]hese guides are not intended to apply to radiation exposure resulting from natural background or the purposeful exposure of patients by practitioners of the healing arts." In 1970, President Nixon issued Executive Order No. 3. This order disbanded the FRC, placing its functions within the newly created Environmental Protection Agency (EPA). The plan also transferred to the EPA certain functions of the DHEW Bureau of Radiological Health and of the AEC. Other Executive Agencies The Radiation Policy Council (RPC) was established in 1980 by President Carter. One year later, President Reagan disbanded it, creating in its place the Committee on Interagency Radiation Research and Policy Coordination (CIRRPC), which was to coordinate policy and resolve conflicts between agencies. No disputes between agencies were brought before the CIRRPC before its demise in 1995. Neither the RPC nor the CIRRPC had regulatory or enforcement authority, and their power as executive agencies was severely limited.

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Radiation in Medicine: A Need for Regulatory Reform PHS Radiological Health Program The U.S. Public Health Service (PHS) has been involved in radiation protection matters since the 1920s. In its early years before World War II, its responsibilities included investigations of radium poisonings of watch dial painters, radium and x-ray hazards in hospitals, and radiation safety programs for photofluorographic technicians. In 1948 the Radiological Health Branch was established to help states limit hazards from the use of radioisotopes and other industrial radiation sources and to assist the AEC in studying effects of nuclear waste in rivers and streams. It also surveyed the use of x-rays in PHS hospitals, provided training in radiation protection for state personnel, and worked with the Department of Defense to monitor fallout from nuclear weapons testing in Nevada and the Pacific. In 1958 the Surgeon General established the National Advisory Committee on Radiation, which recommended unification of all PHS activities related to radiation control. In response, the PHS established the Division of Radiological Health to conduct research on the effects of radiation, provide technical assistance and training to state radiological health programs, and coordinate with other federal radiation programs. A year later, the Division intensified its radiological health efforts; in particular, it assumed primary responsibility for the collection, analysis, and interpretation of data on environmental radiation levels, assessment of all forms of radiation exposure in the United States, and development of recommendations for acceptable levels of radiation exposure from air, water, milk, medical procedures, and the general environment. In 1967 the Division was renamed the National Center for Radiological Health. In 1968 the Center was renamed again as the Bureau of Radiological Health (BRH), a component of the PHS's Environmental Control Administration, and was granted regulatory authority to implement the Radiation Control for Health and Safety Act (Public Law 90-602). This act called for a control program over electronic product radiation to include "the development and administration of performance standards to control the emissions of electronic product radiation from electronic products, and the undertaking by public and private organizations of research and investigation into the effects and control of such emissions." As a reflection of its assistance program to states, the BRH supported establishment of the Conference of Radiation Control Program Directors (CRCPD), which continues today as an important organization of state personnel involved in radiation control (see below). In 1971, pursuant to Executive Order No. 3, the Office of Management and Budget transferred 318 persons and $7 million from the BRH to the newly created EPA. The remaining 389 individuals in the BRH were reassigned to the Food and Drug Administration (FDA) within the PHS. A decade later, the BRH and the Bureau of Medical Devices (BMD) were combined into the Center for Devices and Radiological Health (CDRH) within the FDA.

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Radiation in Medicine: A Need for Regulatory Reform The CDRH assumed the BMD's responsibility for administering the Medical Device Amendments of the Food, Drug and Cosmetic Act of 1938, as well as continuing BRH obligations for control of radiation from electronic products and medical devices. In 1992 the CDRH was identified as the implementing agency for the Mammography Quality Standards Act (MQSA), to include the publication of national standards for mammography and the establishment of quality control criteria and a certification program for the more than 10,000 medical facilities providing mammography services in the United States. To accommodate the increasing demand for services in the medical device area, voluntary educational programs of the CDRH directed to medical uses of radiation have been curtailed in recent years. Nevertheless, the CDRH has maintained a continued interest in public health aspects of medical uses of radiation. Environmental Protection Agency The Environmental Protection Agency was created by Executive Order No. 3 in 1970 to accept certain functions and responsibilities from other federal agencies and departments. These responsibilities included establishment and enforcement of environmental protection standards consistent with national environmental goals. They also involved, as already noted, enforcement of specific radiation criteria and standards that had originally been placed in the AEC and BRH. The FRC was abolished by the executive order. Since its inception, the EPA has maintained environmental radiation programs such as off-site monitoring around nuclear power plants and radioactive waste disposal sites, and it has been concerned with natural sources of radioactivity such as radon. It did not, however, exercise the authority transferred from the FRC until 1978, when it published a document on medical x-ray guidance for federal agencies. This document contained 12 recommendations that federal agencies were expected to implement. They covered several aspects of medical and dental radiology, including the need for quality assurance programs and procedures to ensure minimal exposures of patients to radiation. Other recommendations were directed at qualifications of prescribers and specifications on radiographic techniques, fetal exposures, proper collimation, and gonadal shielding. Under its derivative FRC authority, the EPA has published guidance for federal agencies on topics such as occupational radiation exposures and limits on radiation exposure for members of the general population. Although the EPA has not offered recommendations on QA programs for nuclear medicine, it could do so under its FRC-derived authority. STATE REGULATION The responsibility for public health and safety has traditionally been assumed principally by the states. With the exception of the use of radioactive byproduct

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Radiation in Medicine: A Need for Regulatory Reform material, this holds true for all applications of ionizing radiation in medicine. As early as 1949, California consulted the NCRP in an effort to regulate protection of workers exposed to ionizing radiation. In its response, the NCRP seemed more concerned that state regulations not disturb the national uniformity of radiation protection and less concerned that states move toward self-regulation (Taylor, 1981). When the AEA assigned to the AEC the responsibility for encouraging civilian applications of nuclear energy, together with the exclusive jurisdiction for ensuring health and safety associated with these applications, state governments raised objections. After extended debate, Congress in 1959 revised the 1954 act to establish the Agreement State Program in which AEC responsibilities for health and safety may be delegated to a state. In 1962, Kentucky became the first Agreement State. Several amendments to the Agreement State Program have been added over the years. In 1978, Congress instructed the NRC to review state programs periodically for compliance, and in 1980 it gave the NRC power to suspend state programs that do not meet minimum standards. In 1995, the NRC applied its quality management rule to all Agreement States. The CRCPD, established in 1968, is a voluntary network of state and local government officials responsible for radiation regulation and enforcement. The CRCPD periodically updates its Suggested State Regulations for Control of Radiation, a publication first issued in 1962 by the Council of State Governments. Most state and local radiation protection programs are based on these suggested guidelines. Despite the fact that the CRCPD is composed of radiation regulators, it has no regulatory authority of its own. As mentioned above, Congress acted in 1959 to provide a statutory framework for the federal government to relinquish to the states some of its regulatory authority concerning radioactive nuclear and byproduct materials. NRC authority is transferred to a state through a formal agreement between the governor and the NRC. The NRC must conclude that the state's radiation control program "is in accordance with the requirements of [applicable parts of the AEA] and in all other respects compatible with the Commission's program for regulation of such materials, and that the State program is adequate to protect the public health and safety. …" States, for their part, must pass enabling legislation compatible with NRC requirements to establish their authority to enter into these agreements. Once they have done so, and the NRC finds them capable of enforcing the requirements, then state assumption of authority may become effective on the date the agreement is signed. Although Agreement States regulate their own licensing and enforcement decisions, the NRC maintains significant authority over the states. Biennially, the NRC's Management Review Board reviews each state's performance to ensure that the state's program is adequate and that the state's requirements do not deviate significantly from those of the NRC. The Management Review Board is

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Radiation in Medicine: A Need for Regulatory Reform made up solely of NRC staff, although Agreement States have requested representation on several occasions. As described in the NRC's "Final Statement of Principles and Policy for the Agreement State Program," the actions of the Management Review Board will include (1) periodic assessments of Agreement State radiation control programs against established review criteria; (2) provision of assistance to help address weaknesses or areas within an Agreement State radiation control program requiring improvement; (3) placing a State on probationary status for serious program deficiencies that require heightened oversight; (4) temporary suspensions of an agreement and reassertion of NRC regulatory authority in an emergency if an Agreement State program experiences any immediate program difficulties preventing the State from continuing to ensure adequate protection of the public health and safety. The basis for NRC's actions will be based on a well defined and predictable process, and a performance evaluation which will be consistently and fairly applied. In 1993, the General Accounting Office (GAO) published a report entitled Better Criteria and Data Would Help Ensure Safety of Nuclear Materials that reviewed the comparability of NRC's programs for Agreement States to those of the NRC-regulated states. The report concluded that NRC lacks adequate criteria and data to evaluate the comparative effectiveness of the two programs. It further stated that the NRC does not have common performance indicators on inspection backlogs, radiation overexposures, or frequency of violations; thus, the GAO concluded, the NRC cannot determine if its goals are being met or even if the public is receiving at least a minimum level of protection in different states. The GAO found that the NRC's criteria for program evaluation are vague; evaluation, therefore, depends on the professional judgment of NRC staff. The GAO concluded that without specific criteria and procedures it is questionable whether the NRC can legitimately initiate the process to revoke its agreement with a state. Hence, it is uncertain whether the Commission adequately protects the public in Agreement States now or could do so in the future. REFERENCES British X-Ray and Radium Protection Committee. X Ray and Radium Protection. Journal of the Roentgen Society 17:100, 1921. Hendee, W. History, Current Status, and Trends of Radiation Protection Standards. Medical Physics 20:1303–1314, 1993. Hendee, W. Concepts, Units, History and Present Status of Radiation Protection. In: W. Hendee and E.M. Edwards, eds. Health Effects of Low Level Exposure to Ionizing Radiation. Philadelphia, PA: Institute of Physics, in press. ICRP (International Commission on Radiological Protection). Recommendations of the ICRP. Oxford, England: Pergamon Press, ICRP Publication No. 26, 1977.

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Radiation in Medicine: A Need for Regulatory Reform ICRU (International Commission on Radiation Units and Measurements). Recommendations by the International Committee. Radiology 22:289, 1934. Mazuzan, G.T., and Walker, J.S. Controlling the Atom: The Beginnings of Nuclear Regulation 1946–1962. Berkeley, CA: University of California Press, 1984. NCRP (National Council on Radiation Protection and Measurements). X-Ray Protection. Washington, DC: U.S. Government Printing Office, NCRP Report No. 3, National Bureau of Standards Handbook 20, 1936. NCRP. Permissible Dose from External Sources of Ionizing Radiation Including Maximum Permissible Exposure to Man. Washington, DC: U.S. Government Printing Office, NCRP Report No. 17, National Bureau of Standards Handbook 59, 1954. Taylor, L.S. Organization for Radiation Protection: The Operations of the ICRP and NCRP 1928–1974. Assistant Secretary for Environment, Office of Health and Environmental Research and Office of Technical Information, U.S. Department of Energy, 1979. Taylor, L.S. The Development of Radiation Protection Standards (1925–40). Health Physics 41:227–232, 1981.