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OCR for page 246
Radiation in Medicine: A Need for Regulatory Reform F Regulatory Chronology 1929 Advisory Committee on X-ray and Radium Protection is established (later becomes National Council on Radiation Protection (NRCP)). 1946 Atomic Energy Act (AEA) (Public Law 79-585, 60 Stat. 755) establishes Atomic Energy Commission (AEC) and Joint Committee on Atomic Energy. Manhattan Project reactor-produced isotopes are first distributed for medical applications. 1953 NCRP publishes recommendations on maximum permissible amounts of radioisotopes in the human body and maximum permissible concentrations in air and water. 1954 AEA of 1954 opens nuclear technologies to commercial enterprise. 1956 National Academy of Sciences issues The Biological Effects of Atomic Radiation. 1959 Congress establishes Agreement State Program. President Eisenhower issues executive order establishing the Federal Radiation Council (FRC).
OCR for page 247
Radiation in Medicine: A Need for Regulatory Reform 1960 FRC issues radiation protection guidelines. 1962 Kentucky becomes first Agreement State. 1967 AEC codifies medical regulation into new 10 CFR Part 35. U.S. Public Health Service establishes the National Center for Radiological Health (predecessor to Food and Drug Administration's Bureau of Radiological Health (BRH), which is today part of Center for Devices and Radiological Health (CDRH)). 1968 Radiation Control for Health Safety (RCHS) Act directs Secretary of Health, Education and Welfare to establish and conduct radiation control program. 1972 General Accounting Office (GAO) report advises AEC to strengthen control over medical use of radioactive materials. 1974 Energy Reorganization Act establishes the Nuclear Regulatory Commission (NRC) and the Energy Research and Development Administration (ERDA) to replace the AEC. 1976 Riverside Hospital incident results in overexposure of 393 people. Medical Device Amendments are enacted. 1978 Section 274j of the AEA requires NRC to review Agreement States periodically to ensure compliance with Section 274. 1979 GAO issues report stating that the NRC's reporting requirement does not constitute unprecedented intrusion into medical practice. NRC issues final rule governing proper calibration checks. NRC issues Medical Use Policy, incorporating policy statement with three basic provisions: (1) NRC continues regulating medical uses to protect workers and public; (2) NRC regulates safety of patients where justified by risk and where compliance with voluntary standards is inadequate; (3) NRC minimizes intrusion into medical judgment and other areas of practice of medicine. 1980 Congress grants NRC authority to suspend either all or part of an Agreement State's program.
OCR for page 248
Radiation in Medicine: A Need for Regulatory Reform Commission approves final rule regarding misadministrations. President Carter issues Executive Order 12914, establishing Radiation Policy Council. President Reagan disbands Council the following year. 1981 Consumer-Patient Radiation Health Safety Act is enacted. 1982 BRH and Bureau of Medical Devices (BMD) merge to form new CDRH within the FDA. 1984 Committee on Interagency Radiation Research and Policy Coordination (CIRRPC) is created to coordinate radiation policy among agencies and resolve policy conflicts. 1985 NRC's Office for Analysis and Evaluation of Operational Data issues report finding that quality assurance programs in radiotherapy facilities are inadequate. 1986 Commission instructs staff to formulate rules to strengthen oversight of performance by licensees. 1987 Major revision to Part 35 codifies radiation safety practices that had become standard in licensed medical use. EPA implements Federal Radiation Protection Guidance for Occupational Exposure. 1989 NRC proposes performance-based quality assurance rule. 1991 NRC "quality management rule" is finalized, effective January 27, 1992 (effective in Agreement States in January 1995).
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