RADIATION IN MEDICINE -- Copyright -- Preface -- Acknowledgments -- Contents -- Summary -- BENEFITS OF IONIZING RADIATION -- THE REGULATORY FRAMEWORK -- The Current Situation -- The NRC Medical Use Program -- The Quality Management Rule -- The NRC Agreement State Program -- ALTERNATIVE REGULATORY SYSTEMS -- Seven Alternative Structures -- Assessment of the Alternatives -- The Preferred Choice: Alternative D, Federal Guidance -- FINDINGS AND CONCLUSIONS -- RECOMMENDATIONS -- A: Recommendations to Congress -- B: Recommendations to the Nuclear Regulatory Commission -- C: Recommendations to the Conference of Radiation Control Program Directors and to the States -- CONCLUDING OBSERVATIONS -- 1 Introduction -- ERRORS AND SUCCESSES, BENEFITS AND PROBLEMS OF RADIATION MEDICINE -- THE CURRENT REGULATORY SYSTEM -- The NRC Medical Use Program -- Regulation of Other Sources -- Evolution of Federal and State Regulatory Programs -- THE INSTITUTE OF MEDICINE STUDY -- The NRC Request to the IOM and the Committee Charge -- Elements of the Study -- Meetings -- Public Hearing -- Technical Panel -- Commissioned Papers -- Site Visits -- Professional Meetings -- Organization of the Report -- Scope and Limitations of the Report -- CHAPTER SUMMARY -- REFERENCES -- 2 Clinical Applications of Ionizing Radiation -- MEASURES OF PATIENT EXPOSURE TO IONIZING RADIATION -- DIAGNOSTIC APPLICATIONS OF IONIZING RADIATION -- External Sources: Radiology -- Types of Procedures -- Utilization Rates -- Radiation Doses -- Radiation Regulation and Control -- Internal Sources: Diagnostic Nuclear Medicine -- Types of Procedures -- Utilization Rates -- Radiation Doses -- Radiation Regulation and Control -- THERAPEUTIC APPLICATIONS OF IONIZING RADIATION -- External Sources: Radiation Oncology and Teletherapy -- General Approaches -- Clinical Uses in Illustrative Medical Conditions.

Utilization Rates -- Collective Dose -- Radiation Regulation and Control -- Internal Sources: Brachytherapy -- Overview -- Types of Procedures -- Radiation Regulation and Control -- Internal Unsealed Sources: Therapeutic Nuclear Medicine -- Overview -- Types of Procedures and Number of Treatments -- Radiation Regulation and Control -- CHAPTER SUMMARY -- REFERENCES -- 3 Regulation and Radiation Medicine -- REGULATORY GOALS -- THE CURRENT REGULATORY FRAMEWORK -- How Society Regulates Health Care Delivery -- The Regulatory Framework -- Nuclear Regulatory Commission -- Food and Drug Administration -- Environmental Protection Agency -- States -- THE COSTS OF NRC REGULATION -- Cost Recovery by the NRC Through Fee Collection -- Cost of a Full-Time Equivalent at NRC -- Fee Schedules for Selected NRC License Categories -- Fees Collected from Selected NRC License Categories in 1993 -- Fines Collected from Selected NRC License Categories in 1993 -- Non-Fee Costs of NRC Regulation -- Recordkeeping Requirements -- Security Requirements -- Radioactive Waste Management -- Cost Savings Estimates for Some NRC Licensees -- Summary of Fee and Non-Fee Costs of NRC Regulation -- QUALITATIVE ASSESSMENTS OF NRC REGULATIONS -- Criticism of the Regulatory System -- Fragmentation and Disproportionality -- Administrative Requirements -- Fees and Fines -- CHAPTER SUMMARY -- REFERENCES -- 4 Risks of Ionizing Radiation in Medicine -- RISK ASSESSMENT -- Kinds of Radiation Injury -- Human Study Limitations -- Models of Radiation Injury -- The Tolerance Dose, Threshold Model -- Introduction of the Linear, No-Threshold Model -- Summary Observations -- RISKS OF IONIZING RADIATION IN MEDICAL TREATMENT -- Risk of Unintended Exposures in Radiation Medicine -- Human Error and Unintended Events -- Rates of Misadministration.

Misadministrations in Byproduct-Related Ionizing Radiation in Medicine -- Gaps in Data Collection -- Comment -- Conclusion -- Misadministrations and Adverse Events in Other Medical Modalities -- Medications -- Anesthesia -- Blood Transfusions -- Comparison of Risks in the Use of Ionizing Radiation in Medicine with Those in Other Medical Modalities -- Inappropriate and Unnecessary Care -- Efforts That Reduce Adverse Events and Inappropriate Care -- Section Summary -- PUBLIC PERCEPTION OF RADIATION RISK -- Nature of Risk Perception -- Perception of Radiation Risk -- Impact of Perceptions -- Risk Communication and Trust -- Implications for Radiation Medicine -- CHAPTER SUMMARY -- REFERENCES -- 5 Alternative Regulatory Systems -- SEVEN ALTERNATIVE STRUCTURES -- Alternative A1: Status Quo -- Pro -- Con -- Alternative A2: Status Quo Modified -- Pro -- Con -- Alternative B: Laissez Faire -- Pro -- Con -- Alternative C: State Control -- Pro -- Con -- Alternative D: Federal Guidance -- Functions of the Federal Agency -- Pro -- Con -- Alternative E: Reserve Federal Authority -- Pro -- Con -- Alternative F:Centralization of Regulation Within One Federal Agency -- Pro -- Con -- Alternative G: Health Finance Agency -- Pro -- Con -- ASSESSMENT OF THE ALTERNATIVES -- Alternatives Eliminated from Consideration -- Alternative D: The Preferred Alternative -- CHAPTER SUMMARY -- 6 Findings, Conclusions, and Recommendations -- REPORT PREMISES -- FINDINGS -- Risks and Benefits -- Regulations -- The Regulated Community -- Private and Voluntary Involvement in Radiation Safety -- CONCLUSIONS -- RECOMMENDATIONS -- A: Recommendations to Congress -- B: Recommendations to the Nuclear Regulatory Commission -- C: Recommendations to the Conference of Radiation Control Program Directors and to the States -- CONCLUDING STATEMENT -- A Committee Biographies -- COMMITTEE STAFF.

B Abbreviations and Acronyms -- ASSOCIATIONS AND SOCIETIES -- FEDERAL GOVERNMENT PROGRAMS AND AGENCIES -- INTERNATIONAL ORGANIZATIONS -- LEGISLATION AND EXECUTIVE ORDERS -- MISCELLANEOUS -- C Glossary -- D Selected Sections of the United States Code of Federal Regulations -- PART 20-STANDARDS FOR PROTECTION AGAINST RADIATION -- Subpart A-General Provisions -- Subpart B-Radiation Protection Programs -- Subpart C-Occupational Dose Limits -- Subpart D-Radiation Dose Limits for Individual Members of the Public -- Subpart E-(Reserved) -- Subpart F-Surveys and Moniforing -- Subpart G-Control of Exposure From External Sources in Restricted Areas -- Subpart H-Respiratory Protection and Controls to Restrict Internal Exposure in Restricted Areas -- Subpart I-Storage and Control of Licensed Material -- Subpart J-Precautionary Procedures -- Subpart K-Waste Disposal -- Subpart L-Records -- Subpart M-Reports -- Subpart N-Exemptions and Additional Requirements -- Subpart O-Enforcement -- Subpart A-General Provisions -- Subpart B-Radiation Protection Programs -- Subpart C-Occupational Dose Limits -- APPENDIX A TO PART 34 -- PART 35-MEDICAL USE OF BYPRODUCT MATERIAL -- Subpart A-General Information -- Subpart B-General Administrative Requirements -- Subpart C-General Technical Requirements -- Subpart D-Uptake, Dilution, and Excretion -- Subpart E-Imaging and Localization -- Subpart F-Radiopharmaceuticals for Therapy -- Subpart G-Sources for Brachytherapy -- Subpart H-Sealed Sources for Diagnosis -- Subpart I-Teletherapy -- Subpart J-Training and Experience Requirements -- Subpart K-Enforcement -- Subpart A-General Information -- Subpart B-General Administrative Requirements -- Subpart C-General Technical Requirements -- Subpart D-Uptake, Dilution, and Excretion -- Subpart E-Imaging and Localization -- Subpart F-Radiopharmaceuticals for Therapy.

Subpart G-Sources for Brachytherapy -- Subpart H-Sealed Sources for Diagnosis -- Subpart I-Teletherapy -- Subpart J-Training and Experience Requirements -- Subpart K-Enforcement -- PART 36-LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS -- Subpart A-General Provisions -- Subpart B-Specific Licensing Requirements -- Subpart C-Design and Performance Requirements for Irradiators -- Subpart D-Operation of Irradiators -- Subpart E-Records -- Subpart F-Enforcement -- E Nuclear Regulatory Commission Agreement and Non-agreement States -- AGREEMENT STATES -- NON-AGREEMENT STATES -- F Regulatory Chronology -- G History of Radiation Regulation in Medicine -- PROFESSIONAL SELF-REGULATION -- GOVERNMENT REGULATION -- NUCLEAR REGULATORY COMMISSION -- Atomic Energy Act -- Other Federal Agencies -- Federal Radiation Council -- Other Executive Agencies -- PHS Radiological Health Program -- Environmental Protection Agency -- STATE REGULATION -- REFERENCES -- H Public Meeting Documents -- ORGANIZATIONS FORMALLY CONTACTED FOR PUBLIC MEETING PARTICIPATION -- COMMITTEE FOR REVIEW AND EVALUATION OF THE MEDICAL USE PROGRAM OF THE NUCLEAR REGULATORY COMMISSION -- PUBLIC MEETING ANNOUNCEMENT AND REQUEST FOR WRITTEN TESTIMONY -- Background -- Providing Testimony -- Guide to Preparing Testimony -- TOPICS -- Regulation -- Data/Risk -- Quality Management/Quality Assurance -- Education -- Other -- PUBLIC HEARING OCTOBER 12, 1994 ORGANIZATIONS AND INDIVIDUALS SUBMITTING TESTIMONY -- QUESTION SUMMARIES -- I Quality Management Technical Panel -- LIST OF PARTICIPANTS, TUESDAY, OCTOBER 11, 1994 -- Speakers -- Observers -- Subcommitee Members -- J Commissioned Papers -- K The Linear, No-Threshold Model -- ADOPTION OF THE LINEAR, NO-THRESHOLD MODEL -- Divided Scientific Opinion, 1958-1966 -- Joint Committee on Atomic Energy Hearings, 1957-1960s.

The BEIR Report and the Code of Federal Regulations, 1972.