‘1/‘_/ {K w A '3‘; 1%, INTERAGENCY TASK FORCE ON THE HEALTH EFFECTS OF IONIZING RADIATION: ,4 I / REPORT OF THE WORK GROUP ‘ ON EXPOSURE REDUCTION / DOCUMENTS DEPARTMENT JUL 3 I 1979 LIBRARY UNIVERSITY OF CALIFORNIA DEPOSFTORY JUN 29 ‘979 JUNE 1979 73/454? M 1/5“} é 65/ ii BACKGROUND ‘ 5'2; I777 fast In May, 1§58, the White House directed the Secretary of Health, Education and Welfare to "coordinate the formulation of a program" covering (1) research on the health effects of radiation exposure, (2) public information on radiation, (3) care and benefits for persons adversely affected by radiation exposure, and (4) steps to reduce adverse radiation exposure. To carry out the Presidential directive an Interagency Task Force on the Health Effects of Ionizing Radiation was established comprised of the Departments of Defense, Energy, and Labor, the Veterans Administration, the Nuclear Regulatory Commission, the Environmental Protection Agency and the Department of Health, Education and Welfare as chair. The Task Force completed seven reports over the course of its work: 0 Final Report of the Task Force which reviews the Work Group Reports of the agencies' staffs and recommends a future program. 113?Q@ , ~ f“ L, y’m%¢ 7 Q% J, .~ . . ;./ 1;; Science Work Group Report which describes the health effects associated with radiation exposure, includes an inventory of federally supported radiation research, with particular emphasis on human studies, and recommends areas for future research. Privacy Work Group Report which recommends administrative and legislative changes to permit easier access by health researchers to records while, at the same time, protecting personal privacy. Care and Benefits Work Group Report which examines existing systems for providing care and benefits to persons who may have been injured by radiation exposure and recommends additional guidelines for handling radiation— related claims. Exposure Reduction Work Group Report which reviews present efforts to reduce exposure to radiation and recommends a range of additional measures for consideration. _ ii _ 0 Public Information Work Group Report which outlines public information programs for the general population and particular groups exposed to radiation. 0 Task Force Report on Institutional Arrangements which describes current institutional arrange- ments among Federal agencies concerned with the use, study, and control of ionizing radiation and recommends changes to improve coordination, effectiveness, and responsive- ness among them. Drafts of these seven reports were made available for public comment and were distributed to scientists of varying viewpoints, public interest and environmental groups, representatives of the nuclear power industry and the medical professions, labor unions, veterans' organizations, and State agencies. These groups were asked to submit their views formally and informally, orally and in writing, throughout the Task Force proceedings. The public comments received were considered in the preparation of the final Report of the Task Force and the final Work Group Reports. The - iii - written public comments have been summarized and com- piled in a separate volume. The Work Group Reports contain the proposed recommen- dations of the Work Group members, and the Task Force Report contains the proposed recommendations of the Task Force members. The final recommendations of the agencies will be contained in a report to the White House. - iv _ THE WHITE HOUSE WASHINGTON May 9, 1978 MEfiORANDUM FOR THE SECRETARY OF DEFENSE THE SECRETARY OF HEALTH, EDUCATION ul’ AND WELFARE THE SECRETARY OF ENERGY THE ADMINISTRATOR OF VETERANS AFFAIRS ’7Z3 FROM: STUART EIZENSTAT 37 D2- ZBIGNIEW BRZEZINSKI SUBJECT: _ radiation Exposure Inquiry o The President has approved the development of a coordinated response to the growing agency and Congressional concern about the effects of radiation exposure on participants in nuclear tests and workers in nuclear—related projects. ' The Secretary of Health, Education and Welfare should coordinate the formulation of a program including the following: 1. A study or series of studies which would determine the effects of radiation exposure on participants in nuclear tests, including members of the armed forces and civilian personnel, workers at nuclear facilities and projects, and other persons as indicated. 2. A public information program to inform persons who might have been affected and the general public about the steps being taken and the conduct of the studies. 3. A plan for ensuring that persons adversely affected by radiation exposure receive the care and benefits to which they may be or should be entitled. 4. Recommendations on steps which can be taken to reduce the incidence of adverse radiation exposure of this type in the future. We are aware that the Department of Defense has.initiated' .a study and that the Center for Disease Control has under— taken at least two investigations. Our intent is that these efforts become a coordinated Administration approach to the problem. A proposed plan of action should be prepared for review by June 1, 1978. The staff of the National Security Cauncil, the Domestic Policy Staff and the Officc- of Science and Technology Policy within the Executive Office are available to assist the interagency group. INTERAGENCY TASK FORCE ON THE HEALTH EFFECTS OF IONIZING RADIATION CHAIRMAN: F. Peter Libassi Department of Health, Education & Welfare F. Peter Libassi General Counsel Room 722-A, Humphrey Bldg. 200 Independence Ave SW Washington, DC 20201 Dr. Donald S. Fredrickson Director, National Institutes of Health Room 124, Bldg. #1 9000 Rockville Pike Bethesda, Maryland 20014 Dr. William H. Foege Director, Center for Disease Control Room 2104, Building #1 1600 Clifton Road NE Atlanta, GA 30333 Dr. Arthur Upton Director, National ‘ Cancer Institute Rm II-A—52, Bldg. #31 9000 Rockville Pike Bethesda, Maryland 20014 Dr. Donald Kennedy Commissioner, Food and Drug Administration Room 14-88, Parklawn Bldg. 5600 Fishers Lane Rockville, Maryland 20857 - vii - Linda Donaldson, Project Manager Office of Legal Counsel, OGC Room 706-E, Humphrey Bldg. 200 Independence Ave SW Washington, DC 20201 Dr. Gilbert W. Beebe Clinical Epidemiology Branch National Cancer Institute Room A521, Landow Bldg. 7010 Woodmont Avenue Bethesda, Maryland 21609 Dr. Clark Heath Director, Chronic Diseases Division, Bureau of Epidemiology, CDC Room 5112, Building #1 1600 Clifton Road NE Atlanta, GA 30333 Dr. Charles Land Statistician, Health Environmental Epidemiology Branch National Cancer Institute Room 3C07, Landow Building 7910 Woodmont Avenue Bethesda, Maryland 20014 John C. Villforth, Director, Bureau of Radiological Health, FDA Twinbrook Research Laboratories 5600 Fishers Lane Rockville, Maryland 20857 Department of Defense Vice Admiral Robert Monroe Director, Defense Nuclear Agency 6801 Telegraph Road Alexandria, Virginia Department of Energy Ruth Clusen Assistant Secretary for Environment Room 4228 20 Massachusetts Ave NW Washington, DC 20545 Department of Labor Robert Copeland Director, Office of Health and Disability ASPER Room So. 2121 200 Constitution Ave NW Washington, DC 20210 Environmental Protection Agency David Hawkins Assistant Administrator For Air & Waste Management Rm 937, W. Tower, Waterside Mall 401 M Street SW Washington, DC 20460 Nuclear Regulatory Commission Robert B. Minogue Director, Office of Standards Development Room 120 5650 Nicholson Lane Washington, DC 20555 - viii Dr. James Liverman Deputy Assistant Secretary for Environment Room 4228 20 Massachusetts Ave NW Washington, DC 20545 William Mills Director, Criteria & Standards Division (ANR-460) Office of Radiation Programs 401 M Street SW Washington, DC 20460 Karl R. Goller Director, Division of Siting, Health & Safety Standards Office of Standards Development 5650 Nicholson Lane Washington, DC 20555 veterans AdminiStration Dr. Lawrence B. Hobson Deputy Assistant Chief Medical Director for Research & Development Room 644-E, Veterans Administration 810 Vermont Avenue NW Washington, DC 20420 Staff Kathleen Blackburn, Attorney Office of the General Counsel, HEW Room 672, Parklawn Bldg. 5600 Fishers Lane Rockville, Md. 20857 Mary Pendergast, Attorney Office of the General Counsel, HEW Room 711-E, Humphrey Bldg. 200 Independence Ave SW Washington, DC 20201- June Zeitlin, Special Assistant to the General Counsel, HEW Room 722-A, Humphrey Bldg. 200 Independence Ave SW Washington, DC 20201 K.S. Reagan, Attorney Office of the General Counsel, HEW Room 7ll-E, Humphrey Bldg. 200 Independence Ave SW Washington, DC 20201 V- ix - INTERAGENCY TASK FORCE ON THE HEALTH EFFECTS OF IONIZING RADIATION Task Force Work Groups Science -- Privacy -- Public Information —- Care & Benefits -- Exposure Reduction -— Dr. Clark Health (Chair) Center for Disease Control, HEW Room 512A, Building #1 1600 Clifton Road NE Atlanta, GA 30333 Steven J. Cole (Chair) Office of the General Counsel, HEW Room 706-E, Humphrey Bldg. 200 Independence Ave SW Washington, DC 20201 Nancy Low (Chair) Office of Assistant Secretary for Public Affairs, HEW Room 631-F, Humphrey Bldg. 200 Independence Ave SW Washington, DC 20201 Donald Gonya (Chair) Deputy Assistant General Counsel Room 601 Altmeyer Bldg. 6401 Security Boulevard Baltimore, Maryland 21235 Kathleen Blackburn (Co-Chair) Office of the General Counsel, HEW Room 672, Parklawn Bldg. 5600 Fishers Lane Rockville, Maryland 20857 Mary Pendergast Office of the General Counsel, HEW Room 7ll-E, Humphrey Bldg. 200 Independence Ave SW Washington, DC 20201 Dennis Tolsma (Co-Chair) Center for Disease Control, HEW Room 2035, Building #1 1600 Clifton Road NE Atlanta, GA 30333 "Xi" II. III. Introduction RADIATION EXPOSURE REDUCTION Table of Contents Principles of Radiation Protection ................... A. History OOOOIII.OOIIOOOO'IODOOIIOOOQIOOCCC.0...... B. The Scientific Bases for Principles of Radiation Protection ......IIOOOOIOOI......OCOOIOO C. Application of Radiation Protection Principles ... Radiation Protection Efforts and Opportunities ....... A. General Population Exposure ...................... l. 2. Natural Radiation and Radioactivity .......... Technologically Enhanced Natural Radiation ... a. b. Uranium Mining OIOIOOOICIOOOOOOOOIOno.0... Phosphate Mining, Milling and Fertilizer Production 00...........ICOOOOIOOOOOOCIIOO Radioactivity in Potable Water Supplies... Radioactivity in Construction Materials... Non-nuclear Energy ooooooooooooooocoocoooo Healing Arts (Medical and Dental) ............ a. Background OIO........OQI...ICOOOOIOOOOOOO (l) (2) The Federal Government's Role in Medical Radiation ................... (a) Department of Health, Education, and Welfare ......... (b) Nuclear Regulatory Commission... (c) Environmental Protection Agency IICOIIODOOOOUI.00.0.00... State Health Departments/State Radiation Health Programs ........... - xiii - Page 1 2 2 19 23 23 26 29 31 32 32 34 34 38 39 40 43 43 (3) (4) Congressional Interest in Radiation Health and Safety ................... Non—Governmental Activity Concerning the Medical Use of Radiation ........ Diagnostic Uses of Radiation ............. Therapeutic Uses of Radiation ............ Problem Areas and Recommendations ........ (l) (2) Clinical Judgment ................... (a) (b) (c) (d) (e) (f) (g) Inappropriate Indications....... Medico-Legal Considerations .... Financial Benefit .............. Patient Pressure ............... Screening Asymptomatic Persons COCOCOOOOOOIIIDC'OCQOIOO Duplicate XeRays and Excessive Views ....;........... Inadvertent Medical Radiation Exposure of Pregnant Women ................. Radiological Technique .............. (a) (b) (C) (d) (e) Poor Image Quality ............. Poor User Techniques ........... Inadequate Quality Assurance in Medical Facilities OIOCOCIOOOOOOOOOOI... Credentialing and Education of Users 00......OIIOODIOOOIOOII Poor Maintenance and Use of Therapeutic Equipment ....... — xiv — Page 44 45 46 47 49 49 50 52 53 54 55 57 57 59 60 60 61 62 62 (3) Inadequate or Faulty Equipment....... (a) High Failure Rate .............. (b) Old Equipment COIIOOIOIOOIIOOOOI (4) Insufficient Control For New Technology .......................... (a) Inadequate Criteria for Diagnostic Image Requirements ................... (b) Inadequate Evaluation for New Technology OIIOCIOOOOIOIDOI. (c) Slow Acceptance of Exposure Reduction Improvements ......IDIIIOOOIOOOO (d) Inadequate Coordination of Research ....................... Nuclear Weapons Development and Protection ... a. Atmospheric Testing ...................... b. C,Underground Testing ...................... c. Weapons Development and Production ....... d. Weapons Deployment ....................... Nuclear Energy ............................... a. Research and Development Activities ...... b. Uranium Based Fuel Elements .............. c. Operation of Power Reactors .............. d. Nuclear Waste Management ....;............ e. Decommissioning .......................... Consumer Goods 0.0DOOOIIOOOOOIIOOOOOIOOOOIIIOO Page 64 65 65 66 66 66 67 67 68 68 71 72 77 78 79 80 81 86 89 90 III. occupational Exposure IOU....QIOCIIIOO...IOOOOI.IO 1. 2. 3. 4. 5. 6. 7. Healing Arts CC0.0...IOOOOOOOUOIOCDIIOOOOIOIOC Manufacturing and Industrial ................. Nuclear Energy (Nuclear Fuel Cycle) .......... a. Uranium Mining OOICIOOOOQOOODICCIOCOIOCUOO b. Milling of Uranium Ores .................. c. Fuel Fabrication and Enrichment .......... d. Nuclear Reactors COOIOIOCIOOC.OCCDOIOOOCOO e. Disposal of Radioactive Wastes ..;........ Research .0...6C0.0.00.......OOOODOOOUOOOOOIII Naval Reactors .0...I..OCIOOICOUOIOICOIOOOIIOD Nuclear Weapons Development and Production OO00......U.QIOOOOOIIOIOOOIIIDOQIOO other Occupations .IO...OIOOIOOOIOOOOUOOOOIOIO Cross-Cutting Considerations ......................... A. B. C. The Role of the States IIIOOOIOIOOIIIUOOOOOOOCCOCO Improved Monitoring 0....'0.CIOOCOOOOOICOOIOCIOOO. Transportation OO'OOOOOOOI.OUIOOCIOOOCOIOCOCIIOOOO 1. 2. 3. 4. _Shipment of Low Level Radioactive Material O'CQOCIOIOII.IIOIOOIOOIIIOOIOIOIIIOIO Transportation Personnel Monitoring .......... Transport of Spent Nuclear Fuel and wastes O..00...O..0...’...OIOOIOIIIOQIOOICOOII. Radiological Emergency Response Planning for Transport Accidents ...................... - xvi - Page 95 104 109 114 115 116 117 118 122 124 126 130 131 133 134 135 137 138 139 139 141 D. Worker Involvement in Radiation Reduction I.00....0II.COO00'...CUIOUOIOOCOCUOOOOCOOO E. Reproductive Health .0...UIIIOIOII.COCOOOOOOOOOOOOOI IV. Recomendations 0.000.000.00000000000000CIOCIOIOOIOOIO Appendix 1: Appendix 2: Appendix 3: Appendix 4: Appendix 5: Appendix 6: Appendix 7: Work Group Members cOOOOOOIIIIIOIOOOIOOU0.00... Dose and Frequency of Some Common X-Ray Examinations OOICODOOOCIOIIIIIOCOOOIOIOOOOOOIOO Average Doses from Common X-Ray Examinations I...IOOOOOIOOIOOOOOOOIOOOOCIII... Average Doses from Several Nuclear Medicine and X-Ray Diagnostic Procedures ....;. Summary of Worker Protection Jurisdictions in the Federal Sector ........... Naval Nuclear Propulsion Program Exposure (1960—1977) COO-COIIOOIOOCIIOIIIOIIOI. DOD Checklist of Radiation Exposure Reduction Approaches .......................... - xvii — Page 142 143 145 148 149 150 151 153 155 156 I. INTRODUCTION This Work Group has been asked to review current efforts to reduce exposure to ionizing radiation and to recommend additional measures that could advance this goal still further, in order to avoid adverse genetic and somatic effects in individuals and in the popula- tion at large. The Work Group is composed of thirteen members, l/ each designated by a Federal agency partici- pating in the Interagency Task Force on the Health Effects of Ionizing Radiation. The members of the Work Group have supplied information on the work of their agencies, other agencies and pri- vate groups, and have commented upon the information submitted by others. An attempt has also been made to incorporate into the report information, criticisms, and recommendations made by various groups and indi- viduals concerned with radiation protection. These groups, which include representatives of the nuclear industry, medical professions, unions, environmental and public interest groups, advisory organizations, and State officials, have met with the Health, Education, and Welfare (HEW) coordinators of the Interagency Task ‘ Force, submitted materials to the head of the Work Group, and submitted comments on a draft of this report. Given the time frame within which the Work Group has worked, we have not attempted an exhaustive review of all possible sources of exposure and all potential control measures. Instead, we have surveyed the major known sources of radiation exposure, have indicated, when possi- ble, the relative contribution of each to total popula- tion dose, and have recommended measures for exposure reduction. Because each of the sources of radiation differs from the others in its contribution to total dose, the pathways by which the radiation reaches humans, the purpose of the activity, who benefits from it, who incurs risk, and how it can be controlled, the recommendations vary widely and employ both regulatory and non-regulatory approaches, depending on the situation. None of the recom- mendations has been subjected to detailed analysis of its benefits, costs, and cost effectiveness. Rather, the recommendations are intended to be used for consideration as part of a comprehensive program of radiation reduction, employing the coordinated efforts of Federal agencies, State agencies, and private groups and individuals. l/ For a list of the Work Group members and their agency affiliations, see Appendix 1. The Work Group is aware that a number of particular issues relating to its task have been matters of public concern over the past few years. In particular, attention has been focused on the problems of medical applications of radiation, nuclear waste disposal, transportation of 'nuclear materials, cleanup of mill tailing sites, emis- sions from nuclear facilities, and the long-term effects of atmospheric nuclear testing. Each of these topics is discussed in this report, along with others of similar import. In many instances, comprehensive efforts are underway on the Federal level to deal with these problems. Under such circumstances, we have not attempted to make our own recommendations, but have described the issue and the control activities it has produced. The report is divided into four sections. Part II outlines the history and nature of radiation protection principles and describes broadly how they are applied in particular contexts. Part III surveys the various sources of exposure to the general population and to occupational groups and recommends specific steps that might be taken to reduce existing exposures in the future. Part IV iden- tifies issues that cut across several areas and finally, Part V makes general recommendations for a radiation expo- sure reduction program. II. PRINCIPLES OF RADIATION PROTECTION A. History The need for protection against the hazards of ionizing radiation was recognized almost simultaneously with the discovery of x-rays in the late nineteenth cen- tury. Concern at that time focused on obvious, acute effects such as radiation burns. However, in the late 1920's, cancer was a known effect at high doses and experts in the fields of medicine, radiology, physics, and biology joined to form the precursors of the present International Commission on Radiological Protection (ICRP) and the National Council on Radiation Protection and Measurements (NCRP). These organizations prepared recom- mendations on radiation protection for international and U.S. national use respectively. In 1934, the NCRP and the ICRP first recommended basic standards for use by those who were working directly with radiation or radio— active materials. These occupational standards were intended to reduce to a reasonable level the risk arising from exposure to radiation. During the 1940's, two developments altered the nature of radiation protection efforts. First, the advent of the atomic age meant that the exposure of the general popula- tion to ionizing radiation would increase. Second, as knowledge about radiation accumulated, experts began to recognize more widely that radiation damage was not restricted to acute effects and could be manifested in genetic defects and chronic or delayed somatic diseases such as cancer. This recognition was accompanied by a tacit adoption of a fundamental assumption in radiation protection efforts: in the absence of conclusive data on the effects of ionizing radiation at low doses it is assumed that there is no dose threshold below which indi— viduals are free from risk of harm. Eventually, both of these developments were reflected in the radiation protection guides promulgated by advisory organizations. In 1954, the NCRP introduced the principle that any exposure to radiation should be considered poten- tially hazardous and thus should be kept "as low as prac- ticable" below recommended dose limits. 2/ In 1956, the Committee on the Biological Effects of Atomic Radiation (the BEAR Committee), a panel of experts assembled by the National Academy of Sciences (NAS), assessed the risk to populations and recommended a limit on the average accumu— lated dose to the reproductive cells from man-made sources between conception and age 30, in order to prevent a significant number of adverse genetic effects. g/ In 1957, the NCRP and the ICRP recommended a maximum annual whole-body dose of 0.5 rem to individuals in the general g/ NCRP, "Permissible Doses from External Sources of Ionizing Radiation" (NCRP Report No. 17) (1954). This report has been superseded by NCRP "Basic Radiation Protection Criteria," (NCRP Report No. 39) (1971). ;/ National Academy of Sciences, National Research Council, "The Biological Effects of Atomic Radiation," Washington, D.C. (1956). _ 4 _ population, set at one-tenth the Federal Radiation Protection Guide for occupational doses of 5 rem per year. 4/ In the late 1950's, concern about the impact of ionizing radiation on the general public led to the formation of the Federal Radiation Council (FRC), which was comprised of the Secretaries of HEW, Defense, Labor, Commerce, and Agriculture, and the Chairman of the Atomic Energy Commission. One of the FRC's responsibilities was to recommend to the President radiation protection guides for Federal agencies that used or regulated the use of radiation and radioactive materials. In 1960, the FRC promulgated, with presidential approval, the Federal Radiation Protection Guides, 5/ which were in accord with recommendations of both national and international groups and were based on the available scientific know- ledge regarding radiation exposure and potential bio-. logical damage. Relevant recommendations were: Recommendation 1 There should not be any man-made radiation exposure without the expectation of benefit resulting from such exposure.... Recommendation 2 ...every effort should be made to encourage the maintenance of radiation doses as far below this guide as practicable. 4/ NCRP, "Maximum Permissible Radiation Exposures to Man, A Preliminary Statement of the National Committee on Radiation Protection and Measurement," 68 Radiology 260 (1957); NCRP, "Maximum Permissible Radiation Exposures to Man (April 15, 1958), Addendum to National Bureau of Standards Handbook 59," 71 Radiology 263 (1958); ICRP, "ICRP Publication 2, Report of Committee II on Permissible Doses for Internal Radiation," Pergamon Press (1959). §/ 42 Fed. Reg. 4402 (1960). Recommendation 3 Radiation Protection Guides Type of Exposure Condition Dose (rem) Radiation worker: (a) Whole body, head and Accumulated dose 5 times the number trunk, active blood of years beyond forming organs, age 18 gonads, or lens of ' eye 13 weeks 3.0 (b) Skin of whole body Year 30.0 and thyroid 13 weeks 10.0 (c) Hands and forearms, Year 75.0 feet and ankles 13 weeks 25.0 (d) Bone .............. Body burden 0.1 microgram of radium-226 or its biological equivalent (e) Other organs ...... Year 15.0 13 Weeks 5.0 Population: (a) Individual ...... Year 0.5 (whole body) (b) Average ......... 30 year 5.0 (gonads) In an additional provisidn to Recommendation 3, the PRC provided, as an operational technique, that: ...where the individual whole-body doses are not known, a suitable sample of the exposed population should be developed whose protection guide for annual whole body dose will be 0.17 rem per capita per year. It is to be noted that this FRC Radiation Protection Guide of 0.17 rem applies to "a suitable sample of the exposed population" near a particular radiation facility. In effect, this FRC limit, although numerically identical with the ICRP genetic limit of 5 rems in 30 years (also 0.17 rem per year), is more restrictive than the ICRP value, which applies to average doses within a whole population. This FRC recommendation was implemented in 1964 by an amendment to 10 CFR 520.106. The numeric guides contained in Recommendation 3 were conditioned by the following guidelines: 0 There can be no single permissible or acceptable level of exposure without regard to the reason for permitting the exposure. It should be general practice to reduce exposure to radiation, and positive effort should be carried out to follow the sense of these recommendations. It is basic that exposure to radiation should result from a real determination of its necessity. 0 These 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. Recommendation 7 The Federal agencies apply these Radiation Protection Guides with judgment and discretion, to assure that reasonable probability is achieved in the attainment of the desired goal of protecting man from the undesirable effects of radiation. The Guides may be exceeded only after the Federal agency having jurisdiction over the matter has carefully considered the reason for doing so in the light of the recommendations in this paper. The order of the Guides is purposeful. Exposure to any source of radiation must be justified by some benefit. If benefit exists, the level of exposure must be kept as low as reasonably possible, below the upper limits established in the dose levels of Recommendation 3. The limits for the general public do not apply to medical applications of radiation, nor do they apply to exposures due to natural background sources of radiation. Finally, the Guides can be exceeded only after careful deliberation in light of all the recommendations. Since 1960, considerable effort has been expended in quantifying the health effects of radiation. The ICRP and NCRP have continued to publish analyses of new data and recommendations for protective measures. Both an NCRP Report and an ICRP Publication, based on complete reviews of both technical data and radiation protection philosophy, have basically the same findings as their earlier guidance with respect to maximum individual doses (whole-body), as promulgated by FRC. g/ They have been joined in their efforts by other groups of experts such as the United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR) and the Committee on the Biological Effects of Ionizing Radiation of the National Academy of Sciences (the BEIR Committee), a successor to the BEAR Committee. The fundamental principles of radiation protection promulgated by the FRC remain authoritative today. While the basic FRC exposure guides for workers, other indi- viduals, and the general population have not been changed since 1960, the NCRP (upon which FRC guidance is, in part, based) has since reconsidered the basic exposure guides for workers and the public and promulgated their recommendations which provide, in part, changes to the dose equivalent to the skin, extremities, thyroid, and fetus. 1/ B. The Scientific Bases for Principles of Radiation Protection The scientific data used for the establishment of radiation protection guides come from two basic sources: (1) human data from epidemiological studies of populations g/ NCRP, "Review of the Current State of Radiation Protection Philosophy" (NCRP Report No. 43) (1975) (hereafter NCRP 43); ICRP, "Recommendations of the ICRP" (ICRP Publication 26) (1977) (hereafter ICRP 26). 1/ NCRP 39, supra note 2. exposed to ionizing radiation, notably the survivors of the atomic bomb explosions in Hiroshima and Nagasaki, occupationally exposed individuals (e.g., radium dial painters and uranium miners), and persons exposed to high doses of medical radiation; and (2) data from experiments conducted on various animal species under controlled circumstances. The results of these studies have been reviewed by the Science Work Group §/ and will not be reviewed here. However, it is important to note the con- clusions that have been drawn from this body of knowledge and used in radiation protection. The most comprehensive study, that of the Japanese atom bomb survivors, 2/ involved people generally exposed to doses of radiation significantly higher than those of con— cern today, delivered at relatively high rates in a single dose. In order to set exposure limits, experts used those and other human data to estimate the effects of doses at much lower levels, delivered over time, at a lower rate. In doing so, they used two assumptions, which were grounded in scientific knowledge but which have been generally viewed as conservative: first, that there is no threshold dose level below which radiation exposure pro- duces no harm; and second, that the response to radiation at low doses is directly proportional to the response at high doses, allowing one to extrapolate directly from known effects at high dose levels to unknown effects at low dose levels. It is assumed that the dose/response curve for radiation injury is a straight line running from the point of zero dose/no response to response points at high dose levels derived from available human data (the "linear hypothesis"). lg/ §/ Report of the Science Work Group of the Interagency Task Force on Ionizing Radiation, "Biologic Effects of Ionizing Radiation" (hereafter Science Work Group Report). 2/ See, e.g., Beebe, G., Kato, H., Land C., "Studies of the Mortality of A-bomb Survivors, Mortality and Radiation Dose, 1950—1974," Radiat Res 75: 138-201, 1978. lg/ See Science Work Group Report, supra note 8. The effects of ionizing radiation depend on the amount of radiation interacting with tissue, and the probability that a radiation effect will occur is proportional to the dose received. If the radiation damages the cells that generate sperm and ova, the potential effects are genetic; if it damages other cells, the potential effects are soma— tic, notably cancer. At low dose levels, the specific risk of injury to a particular individual is very low; but if enough individuals are exposed to these low levels, the risk of injury occurring to some individual within the group may be significant. ll/ As a result, a central goal in radiation protection is to reduce the total dose delivered to human tissue-~the popu- lation dose—-and thus to prevent an excess incidence of genetic defects and somatic disease. Maximum permissible dose limits for individuals are intended to ensure that the probability of harm is "negligible" for any individual. As stated by the ICRP: The permissible dose for an individual is that dose, accumulated over a long period of time or resulting from a single exposure, which, in the light of present knowledge, carries a negligible probability of severe somatic or genetic injuries; furthermore, it is such a dose that any effects that ensue more frequently are limited to those of a minor nature that would not be con— sidered unacceptable by the exposed indi— vidual and by competent medical authorities. lg/ On this basis, the permissible dose for occupational exposure was recommended by the ICRP to be 5 (age - 18) rem per year. lg/ In 1957, the NCRP recommended that ll/ The term "low—dose", unless indicated otherwise, refers in this report to exposure levels below the individual occupational exposure guideline, and in most cases to annual exposures lower than 1 rem. lg/ ICRP, "ICRP Publication 2, Report of Committee II on Permissible Doses for Internal Radiation," p. XIX, Pergamon Press (1959). l;/ IQ. p. XXI. _ 10 _ the maximum dose to individuals in the general population should be limited to 0.5 rem per year. 13/ The rationale was that no member of the general public should be exposed to more than one-tenth of the annual permissible occupa- tional dose for the whole-body, head, trunk, active blood forming organs, or gonads. This NCRP recommendation was adopted by the PRC in 1960. lé/ Finally, because all radiation is presumed to cause damage, the actual dose delivered in any context should be kept "as low as reason— ably achievable" (ALARA). 16/ The logic of the linear hypothesis leads to the conclusion that there is some small risk of adverse health effects whenever a large population is exposed to low levels of ionizing radiation. A number of advisory bodies have calculated the sizes of the risks of radiation exposure; because of variations in the assumptions used, these estimates vary from organization to organization. 11/ The general range of estimates for somatic effects, however, based on human data, is that approximately 1 to 2 excess cancer deaths will occur whenever a large population is exposed to 10,000 person-rems of radiation. lg/ Genetic effects have also been estimated, on the basis of data from animal experiments because no conclusive human data exist. 12/ 13/ See note 4 supra. lg/ FRC, "Report No. 1, Background Material for the Development of Radiation Protection Standards, "Washington, D.C. (May 1960). lg/ For a definition of ALARA, see 10 CFR §20.l(c). l—' \l \ Compare ICRP 26, supra note 6, p. 12; UNSCEAR, "Sources and Effects of Ionizing Radiation," (1977), 0 27 (hereafter UNSCEAR 1977) and "The Effects on Populations of Exposure to Low Levels of Ionizing Radiation," Report of the Advisory Committee on the Biological Effects of Ionizing Radiation, NAS/NRC (1972) (hereafter BEIR 1972). 1§/ See Science Work Group Report, supra note 8. 12/ BEIR 1972, supra note 17, p. 1; See also Science Work Group Report, supra note 8. -11.. Recently, a number of studies of populations exposed to very low levels of radiation have been performed, includ- ing studies of occupational exposures at the Department of Energy's (DOE) Hanford facility, 29/ the Portsmouth naval shipyard, 2l/ and a re-analysis of data from a three-state study of leukemia deaths. 22/ The prelimi- nary results of these studies, which have been very extensively criticized and vigorously defended, suggest that the linear hypothesis may, in some instances, under- estimate the risk of somatic harm from radiation expo- sure. 22/ By implying a higher incidence of radiation produced cancer, these preliminary results differ from the results of earlier studies. If confirmed, they may have a significant impact on radiation control activi— ties by further complicating the already difficult task of determining the actual health effects of exposure to low levels of radiation. 25/ Any estimate of the disease incidence and genetic effects produced by levels of radiation below recommended guides implies, of course, acceptance of the idea that activi- ties using radiation and radioactive materials confer 22/ See, e.g., Mancuso, T.F., Stewart, A., Kneale, 6., "Radiation Exposures of Hanford Workers Dying from Cancer and Other Causes," 33 Health Phys 369-385, 1977. 22/ See, e.g., Najarian, T., Colton, T.: "Mortality from Leukemia and Cancer in Shipyard Nuclear Workers," 1 Lancet 10-18-1020, 1978. 22/ Bross, I.D.J., Natarajan, N., "Leukemia from Low Level Radiation. Identification of Susceptible Children," New England g Med 287:107-110, 1972; Bross, I.D.J., "Genetic Damage from Diagnostic Radiation." 237 JAMA 2399-2401, 1977. 22/ See Science Work Group Report, supra note 8. 23/ The NCRP continues to hold the view that there is a high probability of overestimating the probable risk of cancer from low—level radiation if the linear non- threshold hypothesis is used. NCRP 43, supra note 6. The ICRP believes that their risk estimates are realistic. See ICRP 26, supra note 6. -12- sufficient benefit upon individuals and the general population to justify the costs incurred in human health effects. The germ of this concept is implicit in Recommendation 1 of the FRC Radiation Protection Guides. Similar acceptance underlies all human activities that carry risk of injury, from building skyscrapers to driving automobiles. Central questions in any such situation are what levels of risk are unacceptable and who should make that determination. Recently, advisory groups have recommended that government agencies now charged with determining acceptable risks should undertake more detailed and careful balancing of benefits and costs in activities generating radiation exposure and comparison of such activities with alternative methods of accomplish— ing the same goals. g;/ This analysis is advocated not only for situations in which expansion of radiation activities is contemplated, but also for those in which additional control measures have been proposed. 36/ Application of cost/benefit analysis presents many difficulties, particularly when the costs include human suffering and death. 21/ Also, to weigh costs and bene- fits, it is necessary to adopt an estimate of the poten- tial somatic and genetic damage done by exposure to radiation. Health effects of radiation exposure are presently derived from the consensus of scientific groups (such as the BEIR Committee, UNSCEAR, NCRP, and the ICRP) on the basis of scientific evidence, but the cost/benefit analysis must be performed by agencies charged with gg/ BEIR 1972, supra note 17, pp. 2-3; Considerations of Health-Benefit Cost Analysis for Activities Involving Ionizing Radiation Exposure and Alternatives, Report of the Advisory Committee on the Biological Effects of Ionizing Radiation, NAS/ NRC (1977) (EPA 520/4—77-003) (hereafter BEIR II 1977); NCRP 43, supra note 6, pp. 2—3; Egg generally ICRP 26, supra note 6. gg/ For facilities licensed by the Nuclear Regulatory Commission (NRC) radiation risks are included in the impact analysis that is published in the environmen- tal statement issued by the NRC prior to licensing. 21/ BEIR II, 1977, supra note 25, pp. 6-9. -13... specific radiation protection missions, with full public participation. This Work Group will not attempt to balance the costs and benefits of the measures we propose. Rather, we shall identify sources of exposure and, when sufficient data exist, estimate the number of person-rems of radiation associated with each source. We shall iden- tify steps that might be taken to reduce exposures. More detailed weighing of the costs and benefits should accom— pany future evaluations of these recommendations by agencies responsible for their implementation. C. Application of Radiation Protection Principles Two kinds of organizations share the primary responsibility for preventing particular exposures: pri- vate users of radiation and government agencies charged with regulating use. Since the sources and purposes of radiation vary widely, the methods used to control expo— sure and the balance between user and agency responsibie lity differ from situation to situation. gg/ In some areas, such as the use of radiation in the healing arts, government agencies have traditionally exercised minimal control. In other areas, such as nuclear power generation, there has been extensive government regulation. Within the confines of regulatory requirements, users are free to develop their own protective techniques, often assisted by professional associations like the American Dental Association (ADA), by advisory organizations like the NCRP, or by private voluntary standards-setting organizations like the American National Standards Institute (ANSI). The methods used vary from the educa— tion and training of those who use radiation to very specific recommendations on facility and equipment design. gg/ In a number of instances, government agencies both use radiation and regulate its use. For example, the DOE operates facilities in which radioactive materials are used to manufacture nuclear weapons. These facilities are managed by contractors, who are bound to follow standards and work practices established by that department. Similarly, the Navy both operates nuclear propulsion vehicles and regulates exposures to those who maintain them. In such situations, the agencies generally follow accepted recommendations of other agencies. _l4 _. Regulatory responsibility is dispersed among a number of Federal and State agencies, which use a variety of mea— sures to prevent unnecessary exposures. These measures range from public education, to non-mandatory recommenda- tions of good practices, to establishment of regulations. Regulation is the most intrusive measure, but also the one which provides the greatest control if enforced; it has been used extensively in radiation protection. Translation of scientific data into standards that protect individuals from radiation is a lengthy and complex pro- cess. Research results are reviewed and analyzed by scientific groups such as the BEIR Committee, UNSCEAR, NCRP, and ICRP, which estimate the hazards of low-level radiation. The ICRP and NCRP also make specific recommendations for standards and work practices. These organizations differ in their membership, procedures, and the conclusions they have reached, but all accept the fundamental approach to radiation protection outlined in section A. Although all are prestigious and highly respected, they are private groups, not accountable to the public, and serve only in an advisory role. ‘ The reports and recommendations of these groups are used— by government agencies as the basis for radiation protec- tion activities. All of the agencies involved in radia- tion protection are accountable to the public and most employ procedures designed to permit substantial public participation in their decisionmaking. As a result, groups and individuals other than the advisory organiza- tions are also expected to play a role in the development of standards and practices. Different types of guidance are used by Federal agencies to control occupational and environmental exposures. One type, basic limitations on permissible exposures, is exemplified by the Federal Radiation Protection Guides. Several types of Guides have been provided: occupational exposure limits, general population limits, protective action guides for internal exposure due to atomic bomb testing, and occupational exposures to radon daughter products in underground uranium mines. Responsibility for revising and refining these Guides and recommending new guides now rests with the Environmental Protection Agency (EPA), which inherited the FRC guidance authority in 1970. Federal agencies use the Guides to develop standards _ 15 _ adapted to radiation activities within their particular jurisdictions, taking into account the need for the expo- sure, the benefits derived from the practices that are the source of exposure, and the practicality of reducing the allowable dose. Appropriate consideration of these three criteria in the establishment of radiation standards is mandated in the Guides. In addition to its FRC authority, the EPA has various statutory authorities with respect to radiation standards, including the Federal Water Pollution Control Act, Clean Air Act, Ocean Dumping Act, Safe Drinking Water Act, the Resource Conservation and Recovery Act, and the Uranium Mill Tailings Radiation Control Act. The EPA is also involved in the analysis of radiation aspects of environ- mental impact statements for nuclear power plants and other nuclear facilities and responsible for some monitor- ing of radiation levels in the general environment. The primary authority for commercial nuclear power plant safety rests with the Nuclear Regulatory Commission (NRC), which authority is based on the Atomic Energy Act of 1954, as amended. The NRC regulates the design, construction, licensing, and operation of nuclear facilities to protect the public and radiation workers against the hazards of radiation. The Commission sets and enforces safety stan- dards to prevent radioactive contamination from power reactors and also to ensure that any radioactivity released meets the ALARA principle. In addition, NRC is authorized to research and exercise regulatory control over the manufacture, distribution, possession, use, and transfer of products containing by—product, source, and -16- special nuclear material. 22/ Under this authority, NRC regulates a variety of nuclear materials used in industry, medicine, research, and consumer products. The NRC has a program for transfer of some of its regulatory authority to the States. Under section 274 of the Atomic Energy Act, the NRC may relinquish to the States its authority over the use of by-product, source, and special nuclear materials. The NRC is required, how- ever, to retain regulatory authority over the licensing of nuclear facilities such as reactors, exports and imports of nuclear materials and facilities, and larger quantities of fissionable materials. The mechanism for transfer of 22/ By-product materials are radioactive materials (except special nuclear material) yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear materials. Although by-product materials do include activation products from nuclear reactors and pluto- nium - beryllium neutron sources, they do not include activation products from other neutron sources such as Californium-252 or accelerators. Source materials are materials essential to the production of special nuclear materials. This cate— gory includes uranium (including depleted uranium produced as tailings from the enhancement process) and thorium, both of which are naturally occurring and radioactive. Other radioactive materials that occur in nature along with uranium and thorium, such as radium and polonium, are not included under the Atomic Energy Act, presumably because they are not considered to be important to the common defense and security. Special nuclear materials are materials capable of releasing substantial quantities of atomic energy. This category includes plutonium, uranium enriched in the isotope—235, uranium—233, and any material artifically enriched by any of these materials. Baker, R. F. and Tse, AN, "NRC's Regulatory Program on Consumer Products Containing Byproduct, Source, and Special Nuclear Material," in NUREG/CP-0003 "Radioactivity in Consumer Products," August 1978, p. 44. _ 17 _ the NRC's regulatory authority is by agreement between the Governor of a State and the Commission. Before entering into an agreement, the Commission is required to make a finding that the State's radiation control program is compatible with the Commission's, and that the State's program is adequate to protect the public health and safety. Thus far, 25 States have entered into such agreements and have taken over the regulatory authority described above (generally referred to as "Agreement States"). \ The Department of Energy (which includes the former Energy Research and Development Administration) has the respon— sibility, under the Atomic Energy Act, as amended, to encourage the development and use of nuclear power for peaceful purposes "to the maximum extent consistent with the common defense and security and with the health and safety of the public". The Act authorizes research and standard—setting for its own activities, and radiation safety control is accomplished through the use of contract requirements set by DOE for its contractor-run facilities. In addition, DOE is responsible for the production of all nuclear weapons in the United States. The Department of Health, EduCation, and Welfare's Food and Drug Administration (FDA) under the Radiation Control for Health and Safety Act, Medical Device Amendments Act, and Public Health Service Act, as amended, has responsibi— lity over electronic products (such as x—ray equipment) or medical devices which emit radiation. In addition, the Food, Drug, and Cosmetic Act provides FDA with the authority to regulate radiation found in or used in con- nection with food, drugs, cosmetics, and medical devices. The Health Care Financing Administration (HCFA) plays an indirect role in the medical use of radiation by control— ling the reimbursement process for Medicare and Medicaid. Other components of HEW, such as the National Institutes of Health (NIH), conduct research on radiation effects. The Consumer Product Safety Commission (CPSC) under the Consumer Product Safety Act and the Federal Hazardous Substances Act has authority to regulate manufacture and marketing of consumer products containing naturally- occurring or accelerator-produced radioactive materials. Examples of such products are luminous-dial timepieces and smoke detectors, both of which may use radioactive polonium or other naturally occurring elements. -13- Another activity requiring regulation is transportation of radioactive materials or goods. Authority here is shared among the NRC, DOE, the U.S. Postal Service, and several agencies within the Department of Transportation (DOT), now coordinated by the Materials Transportation Bureau. The NRC, DOE, and DoT operate under a memorandum of under- standing to avoid duplication of effort. gg/ The NRC requires its licensees to meet DoT standards and other specifications when preparing radioactive materials for shipment or when transporting those materials. Postal shipments of radioactive materials are regulated by the U.S. Postal Service. Responsibility for protecting several categories of workers exposed to radiation rests with two agencies within the Department of Labor (DOL). The Mine Safety and Health Administration (MSHA) has the authority to set limits upon and to regulate occupational radiation expo— sure of uranium and other miners exposed to radioactive elements. The Occupational Safety and Health . Administration (OSHA) has the authority to set standards restricting exposure of workers other than those protected by the NRC, or other Federal agencies. OSHA coverage, for example, includes industrial radiographers and others exposed to radiation in manufacturing and industry, and health care workers. OSHA standards also govern radiation exposure of construction workers, Federal contractor employees (except those subject to DOE and NRC supervision under the Atomic Energy Act), and workers in general industry. Like the NRC, OSHA has the authority to dele- gate enforcement powers to States that meet OSHA criteria. A number of other agencies have minor regulatory responsibilities or conduct activities that influence radiation. 31/ gg/ This memorandum of understanding was between the Atomic Energy Commission and the DOT. The NRC and DOE now operate under the memorandum pursuant to authorities transferred to their respective agencies. fil/. The Department of Agriculture has authority to control radioactive contamination of crops and use of radiation as a pesticide; the National Bureau of Standards of the Department of Commerce sets standards for radiation measurement; the Interstate Commerce Commission has adjudicated tariff disputes concerning transportation of radioactive wastes. _ 19 _ III. RADIATION PROTECTION EFFORTS AND OPPORTUNITIES The Work Group has organized radiation protection efforts and future opportunities into two basic cate- gories:. exposures of the general public (exclusive of work settings) and occupational exposures. General public exposures have been subdivided further by source of exposure: 0 natural radiation and radioactivity (background radiation) 0 technologically enhanced natural radiation 0 healing arts (medical and dental) 0 nuclear weapons development and production 0 nuclear energy (nuclear fuel cycle) 0 consumer products In addition to general population exposure, certain occupational groups have opportunity for radiation expo- sure. These can be divided into seven occupational categories: 0 healing arts (medical and dental) 0 manufacturing and industrial 0 nuclear energy (nuclear fuel cycle) 0 research 0 naval reactor programs 0 nuclear weapons development and production 0 other occupations Most of the data on occupational exposures relates to workers potentially exposed to radiation who have been issued individual monitoring devices or whose work environment has been monitored. There are, in addition, workers potentially or actually exposed to radiation who are not monitored in these ways, and whose doses -20- therefore can only be inferred by modeling techniques similar to those used to estimate the doses to members of the public. gg/ The total population dose of ionizing radiation in the United States from all of these sources is difficult to estimate. The information needed to identify radiation exposure sources and their levels is not always avail- able, and the data that is available is sometimes out- dated. Consequently, the data presented do not reflect measurements of actual exposures, but are used to illustrate the relative magnitudes of exposure. The estimated relative dose contribution from each source is presented in the following tables. gg/ UNSCEAR 1977, supra note 17, p. 229. _ 21 _ U.S. GENERAL POPULATION EXPOSURE ESTIMATES - 1978 (a) Source . Person-rems pergyear (in thousands) Natural Background 20,000 (b) Technologically Enhanced 1,000 (c) Healing Arts 18,000 Nuclear Weapons fallout 1,000-1,600 weapons development, testing, and production 0.165 Nuclear Energy 20 (c) 36 (C) (5) Consumer Products 6 (a) Total Body. (b) Based on 200 million persons (1970 population value for persons residing in the U.S). (c) Rough estimates of total body equivalent. (d) The 184,000 organ-rems (bronchial epithelium) from radon are expressed as total body dose equivalents. _ 22 _ U.S. OCCUPATIONAL EXPOSURES ESTIMATES - 1975 (a) (M Source Person-rems (in thousands) Healing Arts 40-80 Manufacturing and I 50 Industrial Nuclear Energy 50 Research 12 Naval Reactors 8 Nuclear Weapons 0.8 Development and Production Other Occupations 50 (a) These estimates were derived from the following (b) sources:- Teknekron, Inc., "Occupational Exposures to Ionizing Radiation Within the United States for the Year 1975. A Statistical Data Base." Washington, D.C. (EPA Contract No. 68-01-1953); Moss, C., gt al., "Estimated Number of U.S. Workers Exposed to Electromagnetic Radiation," presented to AIHC Conference, May 26, 1977; "NUREG-0463, Occupational Radiation Exposure, Tenth Annual Report, 1977"; Work Group estimates. Exposures are not strictly additive with respect to health effects risk estimates. -23— A. General Population Exposure The public is exposed to ionizing radiation from a variety of sources, only some of which are controllable. In addition, radiation control efforts might be outweighed by the direct and indirect benefits the public receives from radiation use. However, there are some activities for which public exposures to radiation have not been reduced to a level as low as is reasonably achievable (ALARA). This report will identify activities which should be considered to reduce both present and future levels of exposure. 1. Natural Radiation and Radioactivity At present, the major source of radiation exposure to man is from natural sources of radiation in the environment. Natural background radiation originates from extra—terrestrial (cosmic) sources and from terres- trial radioactivity. In addition, exposure can result from technological activities which handle and process natural substances containing radioactive materials, commonly referred to as technologically enhanced natural radioactivity. Since the exposure from these techno- logical activities can be controlled, they are discussed separately from natural terrestrial and cosmic radiation sources, which are generally considered uncontrollable exposures. Natural radiation contributes approximately 20 million person—rems per year to the U.S. population dose, g;/ and is frequently used as a basis of comparison for exposures from man-made sources of radiation. 23/ Cosmic radiation exposure, originating from the sun and stars, accounts for 7 million person-rems annually. §§/ The exposure to any individual is dependent upon a number gg/ EPA Estimate. gg/ National Council on Radiation Protection and Measurement, Report No. 45, "Natural Background Radiation in the United States," November 15, 1975, p. l (hereafter NCRP 45). §§/ EPA Estimate. _ 24 _ of factors, including location. The average dose equivalent rate per person in the U.S. population is 28 mrem per year (whole body), while the population in Denver, Colorado (1600 meters altitude) receives annually a cosmic dose equivalent of 50 mrem per year per person, and the population of Leadville, Colorado (3200 meters altitude) receives a cosmic dose equivalent of about 125 mrem per year per person from this source. 36/ Travel in airplanes slightly increases cosmic ray exposure. A five hour jet flight can result in a dose equivalent of 2.5 mrem (whole body), and the U.S. population-averaged occupancy time at jet altitudes results in an annual dose equivalent close to l mrem per person. 37/ Cosmic rays also interact with extra—terrestrial and terrestrial matter to form radionuclides, 38/ resulting in an average dose equivalent rate of less than 1 mrem per year per person (whole body). 32/ While cosmic radiation exposure could be reduced by population redistribution, structural shielding, or restricting commercial aviation altitudes, none of these are considered feasible. Terrestrial radiation from naturally occuring radio- nuclides in the earth represents a significant component of the background radiation exposure to the public. 40/ It is estimated that terrestrial radiation accounts for 8 million person—rems annually. 41/ External exposure varies with the concentration of radionuclides in the §§/ NCRP 45, supra note 34, pp. 21-22. The EPA estimates that the annual cosmic—ray whole body dose in the United States is 45 mrem per person. EPA, "Estimates of Ionizing Radiation Doses in the United States, 1960-2000," p. 17 (hereafter EPA Estimates 1960-2000). gz/ NCRP 45, supra note 34, p. 21. The EPA estimates that in 1980 the total exposure from air transport would be 240,000 person-rems (whole body). EPA Estimates 1960-2000, supra note 35, p. 160. pg/ NCRP 45, supra note 34, p. 23. g/ I_d. p. 43. 49/ lg. pp. 60, 90. 31/ EPA estimate based on UNSCEAR 1977, supra note 17. _25_ soil; persons living in areas where the soil contains extensive deposits of uranium, thorium, or phosphates con— taining uranium will receive higher radiation doses. 43/ Internal exposure from the naturally occurring radio- nuclides contributes in excess of 3 million person rems to the public's total dose, g;/ and derives primarily from three main sources -- food, air, and drinking water. 44/ In areas where the background levels of radon are higher than average, exposure might be reduced through increased ventilation and other design features in homes and other structures. 4§/ Land use planning, Federal home loans, and cooperation with builders could be used to accomplish this reduction, with probably little addition to building costs. Foods reflect the levels of radioactivity in soils. For example, foods grown in areas of relatively high radio— activity may show high levels of some radioactive materials such as radium. Currently, the natural radio- activity in foods is not controlled, although HEW (FDA) has this authority under the Federal Food, Drug, and Cosmetic Act.‘ The overall contribution to population dose from controllable sources is probably low in the U.S. because most foods are not grown in areas containing high levels of natural radioactivity. 42/ NCRP 45, supra note 34 p. 68. In the United States, most of the population receives annual external terrestrial doses ranging from 30—95 mrem/year depending upon location with an average of 55 mrem/ year. EPA, "Radiological Quality of the Environment in the United States, 1977," p. 35 (hereafter EPA Radiological Quality). gg/ EPA estimate based on UNSCEAR 1977, supra note 17. .3; .b \ NCRP 45, supra note 34, p. 91. .3: U1 \ In some cases these efforts may conflict with energy conservation efforts such as through tightly sealing homes to conserve energy. _26_ 2. Technologically Enhanced Natural Radiation The exposure from technologically enhanced natural radiation comes from natural radionuclides that have been distributed by some activity or technology. The radionuclides are either brought to the earth's surface where exposures can occur, the earth's surface which pre- viously provided protection is removed, or persons go into the earth in natural caves or manmade excavations where they are exposed. Since some form of technology is involved, the resulting exposure can be controlled. The population dose due to technologically enhanced natural radiation is not well known, but estimates have been made. Some of the sources of exposure that could be considered for control are discussed below, and the EPA estimates that many other technologies may be causing unknown significant exposures. gg/ one major source of technologically enhanced natural radiation exposure is from the extraction industries, i.e., from the mining and milling of ores containing —. uranium and phosphate. a. Uranium Mining Uranium is an essential material for both nuclear power generation and nuclear weapons production, and the population dose due to uranium mining and milling activi- ties properly should be attributed to those uses. The population dose due to uranium mining and milling is not measured, but it has been estimated for a few sites. 41/ It is difficult to apportion the exposure according to the ultimate use of the uranium. It has, however, been esti- mated that exposures caused by the wastes associated with uranium milling will, unless isolated from the atmosphere, become the dominant contribution to planned radiation exposure from the nuclear fuel cycle. gg/ 46/ EPA Radiological Quality, supra note 42, p. 57. .b 7/ See EPA Radiological Quality, supra note 42, p. 5. g_/ Carter, L.J., "Uranium Mill Tailings: Congress Addresses A Long Neglected Problem," 202 Science 191, 191, 194 (October 13, 1978) [hereafter "Carter"]. _27.. Uranium mining activities are concentrated primarily in the States of New Mexico, Wyoming, Colorado, and Utah. While mining activities increase surface uranium and its decay products, especially radon, it does not appear that there are measurable increases in environmental radio- activity except in the immediate vicinity of the mines. 52/ Once the ore is mined, the uranium in the ore is separated and concentrated in milling operations, which result in the accumulation of large quantities of waste product material called tailings. Composed primarily of ore resi— dues, the waste tailings contain almost all of the radio- activity (such as the radon daughters from the uranium _decay) that was present in the ore. Uranium mill tailing piles are categorized currently as active or inactive, depending on whether the mill is processing ore. At pre- sent, there are 27 million tons of tailings at 24 inactive sites, and another 113 million tons have accumulated at active sites. It is estimated that there may be a billion tons of uranium waste tailings by the year 2000. §Q/ At an active site, the tailings are mixed with water (slurry) that is discharged into a pond contained on one or more sides with dikes. While the surface of a tailings pile is covered with water, the tailings material cannot be removed by the wind, and the water will slow up the radon escaping from the solid wastes below. However, the water may seep out of the bottom or sides of the tailings pond, permitting radium to enter the environment. As soon as a tailings pond no longer has water added to it, the surface will dry, allowing the wind to pick up the par- ticulate material and radon gas to enter the atmosphere. The radioactivity contained in waste tailing piles will, if not controlled, contaminate the environment through (1) radon daughter exposures to the lung from inhalation exposure, (2) whole body gamma irridation directly from the pile, (3) deposition of radionuclides in the body because of the ingestion of contaminated food and water, and (4) possible exposure to radon daughters and radium if mill tailings are used in construction materials or 52/ EPA Estimates 1960-2000, supra note 36, p. 27. §g/ Carter, supra note 16, p. 191. -28- in land fill. At the current rate of power development, the 100 year dose commitment from uranium milling (pri— marily tailing piles) has been calculated to be 1270 person—rems per year. él/ As indicated earlier, uranium mill tailings with substantial radium concentrations have been used for con— struction purposes. For example, in Grand Junction, Colorado, tailings were used for land fill beginning in 1953. In 1966, it was first observed that homes built over the fill had elevated radon daughter exposures. In 1970, the Office of the Surgeon General, Public Health Service, HEW provided guidance to the State of Colorado concerning the radiation exposure, and two years later the Congress initiated a multi-million dollar project, paid for out of State and Federal funds, to decontaminate, through recovery of the tailings fill, all buildings exceeding the Surgeon General's guidelines. The decon- tamination effort has proceeded slowly; a recent General Accounting Office Report indicates that less than half of the 700 sites requiring decontamination have been com— pleted, at a cost of $6.5 million. The EPA has also studied this problem. In the past there was little regulatory control over mill tailing sites. The NRC was able to license mills only during the active life of the mill. In addition, the NRC had no regulatory authority over the possession, process- ing, and disposal of ore containing less than .05 percent of uranium and thorium (separately or combined). Most tailings have levels below that limit. The States were the locus of control, but generally did not exercise con- trol measures. Under its limited authority, the NRC was able to take one step to control the waste tailings pro~ blem. In 1977 it adopted a set of performance objectives for waste management and insisted that companies applying for NRC licenses or license renewals implement those objectives. Under recent legislation (Pub. L. 95-604, the Uranium Mill Tailings Radiation Control Act), the NRC has authority to license mill tailings indefinitely, even after a mill becomes inactive, with regulations meeting standards set by the EPA. The legislation also requires NRC Agreement El/ Supplemental Testimony of R. L. Gotchy, NRC, before the Atomic Safety and Licensing Board Panel. -29- States to have controls as strict as NRC's. Furthermore, the States are now required to develop environmental impact statements similar to those required under the National Environmental Protection Act. Pub. L. 95—604 also provides for a remedial action program under which the DOE will undertake the_clean-up of 22 named inactive sites and any other sites meeting the requirements of the Act which DOE determines should be decontaminated. This effort will be financed 90% out of DOE appropriations, and 10% from the States in which the sites are located. The NRC will be involved in DOE's pro- posed cleanup plans, and the EPA is required to set the environmental, health, and safety standards under which the DOE and NRC will control these sources. Finally, the NRC will prepare a generic environmental impact statement on the uranium milling industry with emphasis on tailings disposal. Public hearings will be held on the statement in 1979. Under the Resource Conservation and Recovery Act, EPA is developing regulations that establish exempt quanities of radioactivity in waste products that could be used in construction materials. Following publication of these exempting regulations, the need for additional regulations will be considered. In addition, EPA currently is con- ducting field studies on the levels of radioactivity pre- sent in water effluents from tailing piles. b. Phosphate Mining, Milling, and Fertilizer Production Phosphate rock contains uranium, thorium, and radium. The mining and processing of the phosphate ore redistributes these naturally radioactive nuclides among the various products, byproducts, and wastes, thus dis- persing the radioactive nuclides throughout the environ- ment. The EPA has investigated the radioactivity concentrations in the products and by—products of the phosphate industry, and has found that phosphate industry residues are a sig- nificant source of exposure in parts of the country where phosphate mining takes place. gg/ Calcium silicate slag gg/ EPA Radiological Quality, supra note 42, pp. 68-74, 99. -30— from the production of elemental phosphorus has been widely used in and around Alabama as an aggregate in con- crete block. The slag has also been used in Idaho under some structures and is still widely used there for road paving and several other applications, including the pro— duction of insulation. In Florida, increased levels of radium have been found in water effluents, gypsum wastes (possible by-product materials in wallboard and plaster), in various phosphate products including fertilizer, and most significantly in the use of reclaimed land for build- ings, farming, and cattle raising following extraction of phosphate. The EPA has investigated the exposure levels in homes built on reclaimed phosphate mined land, and plans to pub— lish proposed recommendations to the State of Florida on the control of these exposures in 1979. It also has recommended to the State of Idaho against the use of phosphate slag in building materials. Phosphate mining operations could also be modified to reduce exposures. For example, since the majority of the radium is present in a matrix with the phosphate below an overburden, the phosphate industry is being encouraged to lay aside the overburden and, after extraction, to return the radium bearing residue underneath the overburden soil. EPA currently is considering recommendations on this mat- ter. This could be an effective non-regulatory means of controlling the radioactivity levels on reclaimed lands by industry and could result in exposure levels near those existing prior to mining. Under the Resource Conservation and Recovery Act, EPA has regulatory authority to require exposure reduction steps if non-regulatory efforts fail. Some radioactive air and water effluents released directly from mines could be controlled to prohibit increased local exposure. The EPA could control water effluents under the Federal Water Pollution Control Act either by establishing discharge limits for radioactivity or by requiring a neu- tral or slightly acid pH. The EPA has not established discharge limits for radioactivity, although it has developed proposed guidelines for control of radium by controlling the pH of some discharges. Under the Clean Air Act the EPA is also examining the need for controlling radon emanations from mines. -31— EPA has a report in progress on its sampling of fruit and vegetables grown on phosphate reclaimed land. Although so far insufficient data exist upon which to draw a firm con- clusion, it appears from initial data collected that the amount of radioactivity involved is very low. c. Radioactivity in Potable Water Supplies Studies have indicated that potable ground waters contain measurable quantities of radioactivity (e.g., radium, radon, and other radionuclides), and that high, and in some cases extremely high, concentrations of radio- nuclides exist in some waters used for domestic supplies. Exposure can result when such water is ingested or when the radon is inhaled once the radon in the water is dif- fused into the air. The population doses from this exposure source are not known, but are probably small, although individual doses can be high. The EPA is cur- rently studying this problem and will consider controls if warranted. Limits on the amount of man-made and naturally-occurring radionuclides have been established by the EPA under the Safe Drinking Water Act. EPA has promulgated regulations that set maximum contaminant levels for radioactivity in drinking water that the States are required to meet. g;/ If a State exceeds maximum permissible levels, then EPA can directly control potable water contaminants. Accepta— ble contaminant levels may be reached either by purifying water with excess contaminants or where possible by selecting a water source that does not need purification. In addition, blending is permitted to meet contaminant criteria. These limits exist for a large majority of drinking water supplies, although small water supplies (serving less than 25 persons) are not included. Most of the non-controlled supplies use ground water wells, which as a class have radioactivity levels higher than surface water. Under the Federal Water Pollution Control Act, the EPA could set water quality criteria for radioactivity which would provide guides to the States. Such water quality criteria could also be effective in controlling the radioactivity levels in foods grown in areas having high radium concentration in waters used for agriculture and livestock. It is estimated that about equal amounts _5_§/ 40 CFR 141. -32- of water are consumed as drinking water and in food production, thus they contribute about the same amount to radioactivity intake. d. Radioactivity in Construction Materials In addition to the extraction industry by- products used for construction which cause radiation expo- sure, certain natural residential and commercial construc- tion materials containing radionuclides (e.g., granite) are also a source of gamma radiation and radon decay pro- duct exposures, which exposures are also exacerbated by poor ventilation and increased insulation for energy con- servation. This area of potential exposure has received only limited attention, and the U.S. population exposure is not known with any certainty. e. Non-nuclear Energy It is not generally realized that non-nuclear energy sources, including coal and liquified petroleum (natural) gas, are sources of radiation exposure. Coal originating in deposits with high concentrations of uranium can affect the environment through airborne dis— charges, solid waste materials, and ash utilization (radon will continue to emanate from fly-ash for thousands of years after the coal has been burned). Radioactivity in coal used for power generation has received more attention since utilities have increased their use of Western coals, some of which contain more uranium than Eastern coals. Unfortunately, Eastern coal generally has a high sulfur content, while burning Western coal results in less sulfur dioxide emission. -33— Estimates have been made on the radiologic impact of coal-fired plants and comparisons made with nuclear powered plants. §3/ The results have varied widely, depend ing on the assumptions made. Further assessment of the potential problems appears to be called for. a/ McBride compared coal plants with both boiling water reactors and pressurized water reactors. McBride's calculations, which were based on a number of assump- tions, indicated that the maximim dose commitments from a model coal plant were greater than those from a pressurized water reactor (except for thyroid dose) but less than those from a boiling water reactor (except for bone dose). In general, however, whole- body and organ doses for coal and nuclear plants were in the same order of mangitude. McBride, J.P. gt al., "Radiologic Impact of Airborne Effluents of Coal-Fired and Nuclear Power Plants," Oak Ridge National Laboratory Report ORNL-5315. §eg also McBride, J.P. gt al., "Radiological Impact of Airborne effluents of Coal and Nuclear Plants," 202 Science 1045 (Dec. 1978). Beck has presented a measurement of radioactivity deposited in the area of a large power plant which indicate that McBride's estimates of the radiological impact of coal-fired plants are too high. Beck‘s analysis would indicate that for equivalent power output, nuclear power produces approximately 360 times the population dose commitment of coal power. Beck, H.L. 95 gl;, "Perturbations of the Natural Radiation Environment Due to Utilization of Coal as an Energy Source," presented at DOE/UT symposium, Houston, Texas, April 23-28, 1978. Langer's recent analysis suggests that coal-fired plants, in emitting large quantities of radionuclides in fly ash, cause potential hazards from alpha par- ticle emission. He concluded that the cumulative dose commitment from a coal emission exceed those of nuclear plant emissions. Langer,s., "EPA Regulations and the Radiologic Dose Commitment from Coal-Fired Power Plants," presented at the San Diego meeting of the American Nuclear Society, June 19, 1978. -34- The EPA has recently acted under the Clean Air Act Amendments of 1977 to require scrubbers and precipitators at coal-fired plants. Scrubbers and precipitators remove particulate matter, including radioactive particulates, from power plant emissions. However, radon will continue to be released from this removed particulate matter. Waste disposal therefore remains a problem. The EPA has evaluated the population exposures to consumers from natural gas and liquified natural gas use in unvented kitchen ranges and space heaters. They esti- mate that the population-dose from the radon in natural gas is about 3 million organ—rem per year, §§/ and the population dose from liquified natural gas is 30,000 organ—rem per year. §§/ The EPA has conducted an assess— ment of the radiological health effects from this exposure source and has determined that controls would not be cost effective. Neither the EPA nor any State has guides for the maximum permissible concentration of radon in natural gas. 3. Healing Arts (Medical and Dental) a. Background The second largest source of ionizing radiation exposure to the general public, and the principal source of man-made ionizing radiation exposure, is the purposeful use of diagnostic and therapeutic radiation in medical and dental practice to provide health care benefits. Radiation exposure reduction in the healing arts involves a benefit-risk analysis that must weigh the medical bene- fit to the patient against possible somatic and genetic risks from radiation. §1/ Unlike some other radiation §§/ Critical organ dose -- tracheobronchial tissues, not directly comparable with whole-body dose estimates. §§/ Critical organ dose -- tracheobronchial tissues, not directly comparable with whole-body dose estimates. §Z/ A benefit-cost analysis should also include societal benefits (e.g. the well—being of the individual in society and the society as a whole) and economic costs, services, and resources. s33 BEIR II 1977, supra note 25, pp. 143—187 (discussion of benefit- cost for medical radiation). - 35 _ exposures, most of the benefits from medical exposures flow directly to the person exposed. 58/ The decision to use a diagnostic or therapeutic radiation procedure is usually made by the physician rather than the patient, who generally acquiesces to the physician' 5 recommendations. Patients may receive radiation externally, by exposure from an x-ray machine or source located outside the body, or internally, by means of ingestion, insertion, or injec- tion of a radioactive substance. Both types of exposure are used in diagnosis and therapy. A patient may be exposed to relatively low doses of radiation from an external source such as an x-ray machine in order to produce an image used by a physician in diagnosing the patient' s medical condition. Much higher doses of radia- tion from x- ray machines, accelerators, or sealed external sources of radiation are used in treating medical condi- tions, usually cancer. Nuclear medicine is the clinical specialty concerned with the diagnostic and therapeutic use of radioactive materials called radiopharmaceuticals. When certain radiopharmaceuticals are administered to a patient they may concentrate, depending upon the drug used, in a par- ticular organ or organ system. The radiation emitted is transformed into images or data patterns that can be interpreted by the diagnostician. Through this means, such information as the size, shape, displacement and functional status of the organ or organ system may be obtained. Alternatively, a patient may receive a sealed radiation source in the treatment of a disease, §;&°r a cesium implant for the treatment of cervical cancer. §§/ Although benefits flow directly to the individual patient, not all risks do. Society as a whole assumes some risk for every radiation exposure. For example, the genetic risk attached to radiation expo— sure is borne by future generations. In addition, future health care costs associated with radiation- induced injury or disease may be spread throughout society by health insurance, Medicaid/ Medicare fund- ing and Health Maintenance Organizations. However, most patients receiving radiation in the healing arts, except for dental radiation, are in an older age group and thus contribute a lesser genetic risk. -35.. The main contributor to the total dose from medical exposures is diagnostic x-rays; the contribution from dental radiation, radiopharmaceuticals, and radiation therapy is far lower. A11 medical and dental uses of radiation account for approximately 90 percent of the total man-made radiation dose to which the U.S. population is exposed. Diagnostic use of x-rays contributes annually 14.8 million person-rems to the population dose (1970 figure); the diagnostic use of radiopharmaceuticals con- tributes an estimated annual population dose of 3.3 million person-rems (1980 projection). gg/ Approximately 145,000 dental x—ray machines and 125,000 medical x-ray machines are in current use. 69/ On the basis of a nationwide x-ray exposure study conducted by HEW, it is estimated that in 1970, out of an estimated population of 200 million persons, 130 million had one or more x-ray examinations. Over 76 million persons had radiographic examinations (which included about 10 million persons having photofluorographic chest examinations) and approxi- mately 59 million had dental x-ray examinations. 61/ The use of diagnostic x-rays presumably has increased since 1970. 62/ It is believed that there has been an increase §g/ EPA Radiological Quality, supra note 42, p. 6, 207-210. The figures cited above do not refer to total body exposures but to doses to limited portions of the body. 62/ FDA 77-8034, Report of State and Local Radiological Health Programs (with extrapolation for non—reporting States).' §;/ FDA (BRH) Population Exposure to X—Rays - U.S. 1970, (FDA) 73-8047 (hereafter BRH Population Exposure). 62/ Surveys of x-ray examinations in 1964 and 1970 indicated an increase of 23 percent during that period, from 173 to 212 million examinations. (Extrapolation of that data would project 269 million examinations for 1977). The 1964-1970 increase was at least partially due to the increased access to medical care caused by the enactment of Medicare as well as an increasing number of older persons in the population. _37_ in x-ray procedures at least partly because of expanded technical capabilities, including the introduction of computerized axial tomography (CT) in 1973. §§/ About two-thirds of medical x-ray examinations take place in hospitals, with the remainder taking place in private physicians' offices, group practices, and health agencies. gg/ Tables of the average patient doses from some common x-ray examinations and the frequency at which they are prescribed are given in Appendices 2 and 3. Therapeutic applications of radiation and the use of radioisotopes occur primarily in hospitals. In 1974, approximately 317,000 new cancer patients were treated with radiation. Another 28,000 patients were treated 'with ionizing radiation for benign disease. §§/ 'Between 110,000 and 170,000 persons operate medical x-ray equipment in the United States. Of these, approximately 80,000 are certified or licensed to practice. §§/ Approx- imately 12,000 nuclear medicine technologists currently are involved in the conduct of nuclear medicine proce— dures; of this number, approximately 7,000 are licensed §§/ At present, approximately 700 CT scanners are being used on approximately 2 million patients annually. Moreover, one analyst has projected a medical demand for one CT scanner for each 100,000 persons in the next three years, a total of 2,200 scanners. Gempel, P.A., "Planning Aspects of CT Scanning", Proceedings of 9th Annual National Conference on Radiation Control. DHEW, Rockville, Md., April 1978, p. 89. 64/ BRH Population Exposure, supra note 61. ._§/ Patterns of Care Study — Pattern Highlights, October 1978. Radiation Oncology Study Center, American College of Radiology, Phila., Pa. gg/ Statement by Donald Kennedy, Commissioner, Food and Drug Administration, before the Subcommittee on Health and the Environment, Committee on Interstate and Foreign Commerce, U.S. House of Representatives, July 12, 1978. -38- or certified. gz/ There is a shortage of trained radiation therapists. Moreover, in 1977, 1336 of the 1964 radiation therapy technologists had received formal train- ing in radiation therapy and were registered. §§/ (1) The Federal Government's Role in Medical Radiation Most of the control over the medical use of radiation is left to the States and the professional societies. Compared to Federal regulation over non- medical radiation exposures, there has been relatively little Federal control over the use of radiation in the healing arts. gg/ There are several Federal agencies with regulatory and non-regulatory responsibilities for some aspects of medical radiation. In several instances, apparent over- laps in authority between agencies have been resolved through memoranda of understanding. gl/ Personal communication to BRH from the American Registry of Radiologic Technologists, The American Society of Clinical Pathologists and the Nuclear Medicine Technology Certification Board. Only two States (New Jersey and California) require licensure of nuclear medicine technologists. §§/ Radiation Therapy Technology Manpower Needs-1977, Applied Radiology, Vol. 7, No. 6, Nov./Dec. 1978. gg/ There are several reasons for the traditional Federal noninvolvement. Because of the large numbers of pro- cedures, institutions and personnel involved, direct Federal control would be expensive and time consum- ing. Further, there has been reluctance to impose Federal controls in an area traditionally left to State law and physician judgment. Medical malprac- tice liability is governed by State rather than Federal law, although the States have delegated much of the responsibility for policing the profession to the profession itself. Also, regulating in the area of medical judgment is very difficult and complex. _39_ (a) Department of Health, Education, and Welfare The Department of Health, Education, and Welfare through the FDA, NIH, and HCFA is involved in regulatory, voluntary, and educational radiation control programs. The Federal Food, Drug, and Cosmetic Act of 1938 (as amended) gives FDA authority to control the introduction into interstate commerce of drugs, including radioactive drugs. 19/ This Act does not provide authority for FDA to control the use of drugs. FDA lacks authority to regulate the way in which a prescription drug is used by a physician (including uses not approved in the labeling). 11/ Under authority of the Radiation Control for Health and Safety Act, 13/ FDA, through the Bureau of Radiological Health (BRH), sets performance standards for the manufac- ture of electronic products that emit radiation, such as x-ray machines and accelerators. FDA does not have authority to regulate how x-ray machines or accelerators are used. The Medical Device Amendments of 1976 gave FDA 19/ Federal Food, Drug, and Cosmetic Act, 21 USC 5301, et seq. (1977). Radioactive biologics are considered drugs for the purpose of the Act. lg. 11/ FDA requires the manufacturer to carry out investiga- tional programs to establish the safety and efficacy of new drugs. It often takes years to substantiate, through clinical trials, a new use for a drug already approved for other uses. However, once a drug has been approved for any use, a physician may prescribe the drug for unapproved uses, without Federal sanc- tion. A manufacturer may not make unapproved claims in the labeling for drugs. 12/ Radiation Control for Health and Safety Act of 1968, 42 USC 263b (1977). _ 4o - additional authority to regulate medical devices, includ- ing medical devices containing a radioactive source. 1;/ Under the Amendments, FDA may subject devices to general control, performance standards, or premarket approval. FDA has authority for research, training, development, and evaluation of new procedures; the conduct of educational programs for radiation users and consumers; and issuance of appropriate voluntary recommendations about radiation. FDA carries on a technical development program to improve radiation instrumentation methodology and to optimize the use of radiation in such areas as diagnostic imaging process. The NIH supports a varied research program in the diagnostic and therapeutic medical uses of radiation. This is done primarily through grants and contracts. HCFA has an indirect effect on the medical use of radiation by controlling the reimbursement process for Medicare/Medicaid. HCFA sets standards for the reimburse— ment of medical services, including diagnostic and thera- peutic x-ray and nuclear medicine procedures. (b) Nuclear Regulatory Commission Under the Atomic Energy Act of 1954, as amended, the NRC and Agreement States regulate the manu- facture, distribution, and use of by-product, source, and 1;/ Medical Device Amendments of 1976, 21 USC 360C (1977). FDA and NRC are drafting a memorandum of understand- ing on the control of medical devices containing a radioactive isotope over which NRC exercises juris- diction. It is expected that the memorandum will set up a working arrangement analogous to that existing between FDA's Bureau of Drugs and the NRC; that is, FDA's Bureau of Medical Devices will evaluate the safety and efficacy of the device for a proposed use and classify it, perhaps subjecting the device to performance standards. NRC will then license a faci- lity to use the device. An example of such a device is a Cobalt-60 sealed source. Cobalt—60 is a by— product material subject to NRC control. Cobalt-60 encapsulated for medical use is a device and, there- fore, under FDA authority. -41- special nuclear materials. 74/ Most radioisotopes used in medical diagnosis and/or— therapy fall within one of the above classes and therefore under the jurisdiction of the NRC and the Agreement States. For the medical use of radioisotopes, NRC licenses institutions and individual physicians. 75/ Through the licensing requirements, NRC can regulate virtually all aspects of the radiation safety of workers and the general public and some aspects of patient safety for the use of and exposure to licensed materials. 76/ The NRC does not have statutory authority to regulate the medical use of naturally-occurring or accelerator- -produced radioactive materials. In 1976 the NRC began reviewing its regulation of the medical uses of radioisotopes. This review focused on the extent to which patient protection should be considered in the regulations and on specific areas of potential regula- tory involvement by NRC. 11/ The NRC has since published a policy statement indicating its intent to regulate the 13/ 42 U.S.C. 2011 et seq. (1977). 75/ See 10 CFR Parts 30, 32 and 35 (1977) (licensing regulations). 16/ Because FDA formerly exempted those radioactive drugs controlled by ABC and because FDA did not regulate radioactive devices, for several years the AEC regu- lated the safety and efficacy of radioactive drugs and devices containing by- product material. In 1975 FDA terminated the exemption for AFC—controlled drugs and subjected the drugs to the safety and efficacy requirements of the new drug provisions of the Federal Food, Drug, and Cosmetic Act. By interagency agreement, NRC defers to FDA‘ 5 decision on the safety and efficacy of a proposed use for a radioactive drug that is also under NRC control. NRC licenses a faci- lity or individual for radioactive drug use only after FDA has approved the safety and efficacy of the drug for the proposed use or has accepted a Notice of Claimed Investigational Exemption for a New Drug (IND) for that drug. 11/ 42 Fed. Reg. 20691 (1977) (meeting notice). - 42 _ radiation safety of patients only where justified by the risk to patients or where compliance with voluntary stan— dards is inadequate. 1§/ The NRC has recently amended its medical licensing regulations to permit physicians greater latitude when using diagnostic radiopharmaceuticals. At present, NRC restricts the majority of their’licensees to diagnostic clinical procedures that have been approved by FDA in the labeling. Under the new amendments NRC will permit licensees to perform procedures not yet approved by FDA as long as they follow the FDA approved chemical form, route of administration, and dosage range. 12/ 1g/ 44 Fed. Reg. 8242 (1979) (Policy statement). The general policy statement further states that 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. 12/ In addition, NRC has formulated positions on specific issues, several of which have resulted in additional proposed rules. For example, the NRC is considering amending its regulations to require licensee reports of serious misadministrations of by-product materials. Human Uses of By-Product Material, 43 Fed. Reg. 29297 (1978). Another NRC rule requires NRC licensees authorized to treat patients with radioactive implants to confirm removal of the implants at the end of the treatment by a source count and radiation survey of the patient. Human Uses of By-product Material, 43 Fed. Reg. 55346 (1978). Failure to account for all implants at the conclusion of patient treatment has resulted in unnecessary radiation exposure to patients and mem— bers of the general public. §£§ NRC Inspection and Enforcement Circular No. 78—10, "Control of Sealed Sources Used in Radiation Therapy" (June 1978); NCRP, "Protection from Radiation From Brachytherapy Sources," (NCRP Report No. 40) (1972). An addi— tional rule applies calibration requirements to teletherapy sources used by NRC licensees. 44 Fed. Reg. 1722 (1979). _43_ (c) Environmental Protection Agency Under authority of the Atomic Energy Act, as amended, 89/ EPA is charged with advising the President with respect to radiation matters directly or indirectly affecting health. This authority includes guidance for all Federal agencies in the formulation of radiation standards and in the establishment and execution of programs of cooperation with the States. HEW cooperated with EPA recently in this area in the promulgation of guidance on the use of x—rays in Federal facilities. 81/ (2) State Health Departments/State Radiation Control Programs Each State licenses individual practitioners of medicine, dentistry, nursing, and pharmacy within its jurisdiction. The preparation of radioactive materials and the use of radiation emitting devices may be affected by these laws. For example, each State's pharmacy laws license individual pharmacies (including nuclear pharma— cies) to prepare and dispense drugs for intrastate distri- bution under prescription orders of licensed practitioners. Two States are planning to license nuclear medicine technologists. Of the 15 States with enabling legislation for the licensing of x-ray technologists, only seven have an active program that requires formal education and examination. Most States have enacted legislation to regulate x—ray equipment and all States have a program to inspect x-ray machines. However, many States lack the personnel and funds to inspect x-ray units with any regu- larity. 83/ For the same reasons, only half of the States regulate naturally-occurring and accelerator-produced radioactive materials although the authority to regulate 82/ 42 USC §2021(h) (1977). 81/ Radiation Protection Guidance to Federal Agencies for Diagnostic X—Rays, 43 Fed. Reg. 4377 (1978). See Executive Order 12088 (October 13, 1978) (implementing radiation guidance). 82/ Miller, L.A., Report of State and Local Radiological Health Programs, Fiscal Year 1976, HEW Publication (FDA), August 1977. _ 44 _ these materials is held by all of the States. 83/ At recent Congressional hearings it was found that less than 5 percent of diagnostic x—ray equipment in use in the U. S. today is subject to annual inspection compliance with existing safety standards. It was further found that State governments lack sufficient resources to conduct adequate inspection programs. §£/ A cooperative effort of the Conference of Radiation Control Program Directors, FDA, NRC, and EPA has resulted in suggested State regulations for the control of radia- tion. §§/. (3) Congressional Interest in Radiation Health and Safety In recent years, the Congress has demonstrated an active interest and oversight role with respect to radiation health and safety. In 1977, the Senate Committee on Commerce, Science, and Transportation held hearings directed at identifying gaps in scientific knowledge regarding health effects, and deficiencies in and duplication of current Federal regula- tory activities. §§/ 83/ Cf. infra note 244. 84/ See Findings and Recommendations on Initiatives for Reducing Unnecessary Human Exposure to Diagnostic X— Rays -- I. General Findings, Cong. Rec., Oct. 14, 1978, pp. H 13575-77 [hereafter Findings and' Recommendations]. §§/ Revised and New Parts Ionizing Radiation Category of the Suggested State Regulations for Control of Radiation. Notice of Availability, 40 Fed. Reg. 29749 (1975). 8§/ The Committee is expected soon to present a report on its findings and recommendations for improving the safety of radiation—emitting devices, the efficacy and conduct of medical radiation procedures, and pro- fessional and public understanding of the health benefits and risks of exposure to radiation sources. -45— In addition, in 1978 the House Subcommittee on Health and the Environment of the Committee on Interstate and Foreign Commerce conducted oversight hearings that addressed the issues of delivery of radiological services, radiological health training of health practitioners who order radia- tion examinations, and State and Federal efforts to ensure optimum performance of diagnostic radiation-emitting pro- ducts. §1/ Several of the recommendations contained in this Work Group Report are similar to those made by Senate and the House Subcommittees. When recommendations are similar, it is noted in the Work Group Report. (4) Non—Governmental Activity Concerning the Medical Use of Radiation In addition to government activities, several non—governmental groups have long played a role in radiation safety and patient protection. The Joint Commission on Accreditation of Hospitals is a private, voluntary organization that establishes standards for the operation of hospitals and other health-care facilities and services, and conducts periodic survey (inspection) and accreditation programs. The Commission has estab- lished general standards for radiology departments. In addition, professional organizations provide various services for their membership, including education, certification, standards development, communication, lobbying, and other special interest activities. gg/ §1/ "Findings and Recommendations, supra note 84, pp. H 13575 - 13577. gg/ Major professional groups in the area of medical radiation include the Society of Nuclear Medicine, the American College of Radiology, the Nuclear Medicine Technology Certification Board, the American Society of Clinical Pathology, the Radiological Society of North America, the American Society of Radiologic Technologists, the American Registry of Radiologic Technologists, the American Association of Physicists in Medicine, the American Dental Association, the American Medical Association and the American Pharmaceutical Association. Some of these groups have a certification or registration program. -46- b. Diagnostic Uses of Radiation Radiation exposure from medical and dental diagnostic x-rays is variable and depends on such factors as the type and extent of the examination, equipment used, patient characteristics, and techniques employed by the individual practitioner or technologist. The dose to the skin from medical x-rays is easily measurable but since usually only a portion of the body is exposed at any one time, whole body or specific organ dose is more difficult to characterize. §g/ Radiopharmaceuticals and radioisotopes are also used in diagnostic procedures. While the individual radiation dose from many nuclear medicine diagnostic examinations has been decreased through the use of shorter-lived radio- nuclides and more sophisticated detection devices, 29/ the number of such examinations has increased markedly over gg/ Typical specific organ doses from radiological diagnostic procedures are available in the litera- ture. §gg, e.g., DHEW Publication (FDA) 76-8015, A System for the Estimation of the Mean Active Bone Marrow Dose, R. Ellis, M. Healy, B. Shleien, and T. Tucker; DHEW Publication (FDA) 76—8030, Organ Doses in Diagnostic Radiology, M. Rosenstein and DHEW Publication (FDA) 76-8031, Handbook of Selected Organ Doses for Projections Common in Diagnostic Radiology. 29/ Use of some of the shorter-lived radionuclides, although beneficial to the patient, may pose addi- tional risks to medical and transportation workers who handle the radioisotope. Due to the short half— life it may be necessary to order larger quantities of material and to receive more frequent shipments. Both of these factors increase the radiation exposure risk to persons involved in the transportation of the material to the health care facility and to medical personnel involved in the preparation and admini- stration of the radioisotope to a patient. -47— the past decade. 21/ A table of comparative exposures from several x-ray and nuclear medicine procedures is given in Appendix 4. c. Therapeutic Uses of Radiation Radiation therapy, in the form of external beams or internally administered radiopharmaceuticals, is used primarily in the treatment of cancer. Various forms of cancer may be treated with radiation doses of up to 6000-7000 rads given to localized areas in order to destroy tumor cells. When radiation therapy is used in the treatment of cancer, it tends to contribute little to the population genetic burden because patients are gener- ally beyond childbearing ages and the radiation exposure is localized. 22/ Benign skin diseases and other nonneoplastic diseases are treated with radiation doses of up to 1000-2000 rads, generally with very energy x-rays. g;/ The use of radia- tion therapy for benign diseases (e.g., bursitis, acne, certain viral warts, peptic ulcer, and arthritis) has decreased in recent years, as other forms of effective treatment have become available. The potential risk of treatment with ionizing radiation for a benign, non-life threatening disease should be recognized. Nevertheless, 21/ It is estimated that approximately 6.7 million in—vivo nuclear medicine procedures were performed in 1975. Health Industries Handbook 1978 at 9552-54. Employing an estimated annual growth rate of 30 per- cent yields 13.8 million in 1978. [BRH estimate]. It should be noted that the kind of diagnostic infor- mation gained from nuclear medicine procedures and x-ray examinations is seldom identical. gg/ BEIR II 1977, supra note 25, p. 177. Younger patients may have significantly increased life expectancies after treatment and radiation damage is of some concern for this group. 2;/ UNSCEAR, 1977 supra note 17, p. 341. -43- ionizing radiation therapy may be considered if other safer methods have not suceeded in alleviating the condi- tion and if the potential consequences of no further treatment are unacceptable. 23/ Quality assurance in radiation therapy has become of increased concern recently. For some tumors, the dif- ference between control of the disease and the failure to cure is a small fraction of the total dose. In addi- tion, there is only a narrow difference in the dose tolerated by normal tissues adjacent to the tumor and the dose needed to destroy the tumor itself. 22/ Too much irradiation of normal tissues can lead to painful and debilitating side effects. In 1974—77, BRH with the National Bureau of Standards (NBS) conducted a nationwide survey of cobalt-60 teletherapy facilities. This type of facility is responsible for about two-thirds of all radia- tion treatments. The study evaluated the ability of the participants to expose a set of dosimeters to a prescribed dose. Analysis of data showed that about four percent of participating facilities were unable to obtain a mean exposure within 10 percent of the prescribed dose. 2§/ In 1976, following a report of teletherapy over-exposure, the NRC issued a warning to its medical licensees on the need for proper calibration of teletherapy units. 21/ After the warning, the NRC conducted a study that showed the calibration of 97.6% of NRC-licensed teletherapy units 25/ NAS/FDA 78-8043, A Review of the Use of Ionizing Radiation for the Treatment of Benign Disease. 2§/ Herring, D. and Compton, D., "The Degree of Precision Required in the Radiation Dose Delivered in Cancer Radiotherapy“, Computers in Radiotherapy, British Journal of Radiology, Special Report No. 5, 1971. gg/ D. Thompson, et al., Int. J. Rad. Oncology, 4, 1065 (1978). 21/ In 1975-76 at an NRC licensee hospital approximately 400 patients treated for cancer with cobalt-60 tele— therapy received radiation doses exceeding the pre- scribed doses by as much as 41%. The increase occurred because the radiation dose rate from the teletherapy unit had not been determined properly. -49.. to be within 5% of the values supplied by the licensees' physicists. NRC, as noted earlier, has since published a rule requiring its licensees to calibrate teletherapy units annually. d. Problem Areas and Recommendations For many medical radiation procedures there is a large potential for reducing unnecessary radiation expo- sure. There are four sources of unnecessary exposure that may result from the medical use of radiation considered in this report: (1) questionable clinical judgment in ordering some x-ray and other radiologic procedures; ' (2) radiological technique (including use and maintenance of equipment); (3) inadequate or faulty equipment; and (4) lack of control for rapidly expanding new technology. Each of these four areas will be addressed separately below. Some of the following problem areas and recommen- dations apply mainly to x— ray procedures and apply only in a general way to nuclear medicine procedures. 98/ The term x— ray is used for recommendations that apply— mainly to x- ray procedures. More general terms, such as diag- nostic radiological procedures, are used for general pro- blem areas and recommendations, applicable to both x-rays and nuclear medicine procedures. (1) Clinical Judgment Clinical judgment is the complex process by which a decision is made to order a radiological examina— tion for a patient. This process may or may not involve a physician in the decision-making. In some cases, the physician personally may see and refer the patient for the radiological examination. However, for example, some hospitals have a routine order that a chest x-ray exami- nation be performed on each patient upon admission to the hospital. gg/ For example, nuclear medicine patients usually do not expect or demand nuclear medicine procedures, such procedures are not used for screening nor are they usually self-referred. -50.. practitioners of the healing arts request approximately 240 million x-ray examinations annually. 22/ In addition, another 14 million nuclear medicine procedures and 345,000 radiation therapy treatments are ordered each year. Although most of these procedures convey health benefits to the patient that outweigh their biological and economic costs, a significant fraction provides no benefit to the patient. Some sources of these unnecessary procedures have been identified in the medical literature. Although several of the factors contributing to the ordering of unnecessary exposures are discussed separately in the following sections, in actual practice it is often impos- sible to isolate and characterize the factors that contri- bute to the ordering of any one examination. (a) Inappropriate Indications One major factor causing the ordering of unnecessary procedures is the lack of scientific data on when x-ray examinations are indicated; i.e., appropriate signs or symptoms that would indicate the usefulness of a particular examination in a certain situation. 190/ For example, a number of x—ray procedures are ordered more out of habit than by application of appropriate clinical judgment in correlating patient signs and symptoms with suspected outcome. 101/ 99/ 1977 BRH Estimate. 100/ The House Subcommittee on Health and the Environment found that there was nearly a total lack of empiri- cally based criteria for determining which patients and symptoms were most appropriately referred for diagnostic x—ray examinations. Findings and Recommendations, supra note 84, pp. H 13575-77. Congressman Rogers and BRH recently cosponsored a National Conference on X-Ray Referral Criteria (November 1978). BRH will publish a transcript of this Conference in Spring 1979. rd 0 l—' \ Hall, F. M., "Overutilization of Radiological Examinations", Radiology 120:443-448, August 1976. gee also Davis, M. "Radiological Overkill", JAMA, 200:999—1.000 (June 12, 1967). -51— In addition, current clinical training of physicians tends to emphasize the use of radiological procedures to make a diagnosis. The biological and economic costs of these procedures are usually of secondary concern because the physician is under pressure from both peers and patients not to miss any abnormality. This pressure exists whether or not the identification of a particular abnormality contributes to actual patient management. In addition, diagnostic x-ray procedures may be ordered to provide the physician with information that may be useful in fur- thering medical knowledge although not necessarily useful to the treatment of the patient undergoing the examina— tion. This attitude is reinforced by the fact that most economic costs are borne by a third party through medical insurance. In the area of radiation therapy, disagreement exists among certain specialists on the appropriateness of the treatment of some categories of benign disease with radiation. igg/ Recommendations The ordering of unnecessary radiological procedures could be decreased if responsible entities: 103/ 0 Develop, test, and promulgate specific referral criteria for diagnostic radiological examinations to guide health practitioners in determining when and how often to refer patients for these pro— cedures. Panels of physicians representing appropriate clinical specialists should develop these criteria with government assistance. Prior to wide scale distribution, referral criteria must be validated through clinical trials. H N \ Department of Health, Education, and Welfare, Food and Drug Administration, “A Review of the Use of Ionizing Radiation for the Treatment of Benign Disease", DHEW Publication (FDA) 78-8043, September 1977. See also Findings and Recommendations, supra note 84, p. H-l3576 (research and professional education recommendations). H o (A) \ -52— 0 Develop and conduct programs, including model curricula, to inform health practitioners, includ- ing their designates and students, about the risks and benefits of medical radiation, and the princi- ples of cost-effective utilization of diagnostic radiological procedures. 0 Promote diagnostic planning as an integral part of the education of medical and dental students and residents so that they may better understand the uses and limitations of diagnostic and therapeutic radiological procedures. 0 Describe and assess the use of x-rays in the practice of dentistry to determine the frequency of their inappropriate use and their quality and utility as diagnostic tools. 0 Provide for data collection of the number, type and amount of exposure from radiological proce- dures. (b) Medico-Legal Considerations The fear of malpractice suits is often cited as a reason for ordering diagnostic tests, including radiological examinations. 193/ There is disagreement, however, on the extent to which radiological examinations are ordered for purely defensive reasons. In medical literature, estimates of the fraction of all x-ray examinations done primarily for defensive purposes range ;_3/ See, e.g., The Medical Malpractice Threat: A Study of Defensive Medicine, Duke L.J., pp. 939—993 (1977); Twine, E., et al., A Dynamic Systems Analysis of Defensive Medicine, Masters Thesis MIT, June 1977; M. Garg, et al., The Extent of Defensive Medicine: Some Empirical Evidence, Legal Aspects of Medical Malpractice at 25 (Feb. 1978). See also, Report of the Secretary's Commission on Medical Malpractice: Appendix, Washington, D.C., DHEW (OS), 73—89 (1973). _53_ from 6 to 40 percent. lgé/ There is agreement, however, that the fear of malpractice suits is a factor present in the ordering of some x-ray exams. One commentator has stated that, "Physicians' decisions are increasingly dic- tated by legal considerations, and defensive medical practice is encouraged by both insurance companies and hospital administrators in an attempt to avoid potential litigation". igg/ Recommendations Concern over malpractice suits could be an obstacle to the widescale use of specific criteria for radiological proce- dures. To overcome this problem, the following actibns are recommended: 0 Initiate evaluation(s) of the impact of existing malpractice concerns on diagnostic radiological ordering practices. 0 Consider amending existing legislation so that physicians using generally-accepted referral criteria are relieved of liability when they do not employ an x-ray examination. (c) Financial Benefit Physicians who refer patients to specialists for radiological examinations generally do not receive direct financial benefit from the procedures. Rather, it is the medical specialists performing and interpreting the examinations (e.g., radiologists and nuclear medicine physicians) who receive direct financial benefit from the procedures. However, physicians who practice self—refer- ral by providing their own x—ray services do accrue direct financial reward and may contribute to overutilization of x—ray examinations. An investigation on the use of x-rays by physicians showed that non-radiologists providing their own x-ray services to patients used those services almost twice as often as physicians who referred patients to 105/ See Findings and Recommendations, supra note 84 p. H 13575. 10 / Hall, supra note 101. -54- O consulting radiologists. 591/ In addition, certain standing orders for x—ray examinations may be regarded as a subtle form of self-referral by the medical facili- ties for financial benefit. For example, the routine chest x—ray examination performed upon hospital admission at an average charge of $25 could provide substantial revenue to the medical institution. Recommendations The above problem can be ameliorated by overcoming the financial incentive to over-order medical imaging proce- dures. The following actions are recommended: 0 Disseminate validated referral criteria to third-party carriers and Professional Standards Review Organizations for implementation through utilization review and reimbursement mechanisms. 0 Encourage cost—awareness training for medical students. (d) Patient Pressure Patients frequently expect or demand radiological procedures because they believe them to be a necessary component of a thorough medical evaluation. Physicians may acquiesce to these demands in order not to jeopardize their relationship with the patient or to promote the psychological wellbeing of the patient. A survey of patient attitudes toward upper gastrointestinal x—ray examinations found the following: 65 percent of the patients indicated that they wanted the examination very much; 51 percent stated that if their doctor had l_1/ Childs, A. W., and Hunter, E. D., "Non-Medical Factors Influencing Use of Diagnostic X-Ray by Physicians", Medical Care, July-August 1972, Volume X, No. 4, p. 331. _55_, not ordered the examination, they would have requested it; and 64 percent believed that better doctors order more diagnostic tests. 108/ Recommendations Recognizing that patients should exercise an active role in health care decisions that affect them, the following action is recommended. 0 Conduct programs to inform patients/consumers about the risks and benefits of medical radiation exposure. These educational programs should be linked to parallel educational programs for health personnel. igg/ 0 Conduct programs to educate patients to request that their films be forwarded when they change physicians or see a consultant and to keep a record of the radiological procedures they have received at different facilities. (e) Screening of Asymptomatic Persons X-ray screening examinations of sympton—free individuals, either in the general population or in specific groups, are conducted for a variety of reasons. Examples of screening procedures include mammography screening for the early detection of breast cancer and pre-employment chest and lumbar spine x—rays. Frequently, programs using these examinations fail to take into account factors such as the minimum acceptable yield of the examination, the consequences if an abnormality is detected (i.e., the true usefulness of detecting the disease state), and the radiation risk from the survey. Examination of these factors resulted in the 1972 policy statement jointly prepared by HEW, the American College 108/ Marton, K., Alexander J., and Sox H., "Patient Attitudes Towards Tests: The UGI Series", Annual Meeting of the American Federation for Clinical Research, April 29 — May 1, 1978, San Francisco, CA. 109/ See Findings and Recommendations, supra note 84, p. H#l3576 (public education and information recom- mendations). _56.. of Radiology, and the American College of Chest Physicians discouraging the use of mass chest x-ray screening of the general population for tuberculosis and other cardiopul- monary diseases. llg/ Recommendations Radiographic screening is performed by a wide variety of public and private organizations and there is no single mechanism to deal effectively with all of these. However, the following items are recommended: lll/ O Routine x-ray screening examinations, in which no prior clinical evaluation of the patient is made, should not be performed unless exception has been made for specified groups of people on the basis of a careful consideration of the magnitude and medical benefit of the diagnostic yield, radiation risk, economic, and social factors. Federally funded mass screening programs should be initiated only after careful consideration of cost—effectiveness, risks, and benefit. Such screening programs should also be required to develop ongoing data to justify continuance. The efficacy and utility of routine hospital admission x-ray procedures should be investi- gated, and appropriate criteria for their use developed and disseminated, if necessary. Model State legislation should be developed to address population screening by private organiza- tions. The Chest X-Ray As a Screening Procedure for Cardiopulmonary Disease: A Policy Statement, DHEW Publication (FDA) 73-8036 (April 1973). See also Findings and Recommendations, supra note 84, p. H 13577 (recommended legislation governing mass x-ray screening programs). -57- (f) Duplicate X-Rays and Excessive Views The failure of some physicians and medical institutions to use x-rays taken at other institutions or by other physicians is another source of unnecessary duplicative exposures. Most x-ray examinations consist of more than one radiograph (i;g., more than one view of the patient's anatomy). It has been proposed that for many examinations the number of views taken could be reduced without compromising the accuracy of the diagnosis. llg/ Reduction of the number of views would reduce not only the radiation exposure of the patient but also the economic cost of the examination. Recommendations Duplicative x—rays and excessive views for x-ray procedures increase patient exposure and health-care costs without a concomitant improvement in diagnostic effective- ness. Thus, the following recommendations are made: 0 Support administrative controls and physician training to prevent the ordering of duplicate and standing order x—rays. o The number, sequence, and types of standard views for x-ray examinations should be clinically oriented and kept to a minimum. 0 Radiologists should monitor closely the perfor— mance of radiological examinations and, where practicable, tailor examinations to obtain the diagnostic objectives of the referring physicians through appropriate deletion, substitution, or addition of prescribed views. (9) Inadvertent Medical Radiation Exposure of Pregnant Women In 1970, an estimated 805,000 pregnant women in the United States (23 percent of those who were 112/ Rigler, Leo G., "Is This Radiograph Really Necessary?" Radiology 120:449-450, August 1976. _ 53 _ pregnant that year) received x—ray examinations. llé/ Experimental studies with animals as well as some human epidemiological studies and case reports have indicated that abdominal x—ray exposure of the mother can represent a hazard to the unborn child. The magnitude of the hazard depends upon the radiation dose received and the stage of fetal development when exposure occurs. llfi/ Radiation increases the risk of damage to a fetus during all stages of pregnancy. In the first week or two of pregnancy, radiation can increase the risk of spontaneous abortion. Subsequent exposure, especially during weeks two through six, increases the risk of malformation. There is also some evidence suggesting that fetal irradiation can increase the subsequent risk of leukemia and other child- hood cancers. An examination of the trends in maternal x—ray exposure practices showed that 49% of physicians interviewed did not routinely ask female patients if they might be pregnant prior to performing abdominal x-ray procedures. llé/ Such practices might lead to inadvertent exposure of an embryo or fetus and the consequent risk of adverse health effects for the child. Recommendations Since medical radiation exposure of the embryo or fetus is known to present a risk of injury, the following actions should be taken to minimize those risks: [.1 __§/ Boice, J. and Burnett, B., "Considerations of Possible Pregnancy in the Use of Diagnostic X-Rays". Presented at Health Physics Seventh Mid-Year Topical Symposium, San Juan, Puerto, Dec. ll-l4, 1972. DHEW Pub. (FDA) 75-8029 (1973). l_é/ "Clinical Methods of Avoiding Medical X-Ray Exposure of the Human Embryo and Fetus: A Technical Overview," November 1976, 0.8. Department of Health, Education, and Welfare, Public Health Service, Food and Drug Administration, Bureau of Radiological Health. 115/ Asire, A.J., Murray J.L., and Linton, O.W., "Trends l in Maternal X-Ray Exposure Practices in the San Francisco Bay Area,“ unpublished report available from O.W. Linton, American College of Radiology, 6900 Wisconsin Avenue, Chevy Chase, Maryland 20025. -59.. o Clinicians should ascertain the likelihood of pregnancy when considering nonemergency radio- logical examinations that place the uterus of a women of childbearing age in or adjacent to the radiation beam. 0 Develop and implement appropriate programs to advise health care practitioners, allied health personnel, and students about the risks of radia- tion exposure during pregnancy and about measures they can take to minimize those risks. 0 Inform patients about the risks of radiation expo- sure during pregnancy and about preventive mea- sures they can take to minimize those risks. 116/ (2) Radiological Technique The improper use and maintenance of equipment is another source of unproductive radiation that may result in radiation exposures to patients that are unnecessarily high or that result in poor quality films. For diagnostic procedures, FDA's Nationwide Evaluation of X-Ray Trends (NEXT) program has demonstrated that a patient undergoing the same x-ray examination may receive more than 100 times as much radiation in one hospital or clinic as in another. lll/ ‘ While the diagnostic radiologist strives to obtain a quality image with the lowest possible dose to the patient (typically less than 1 rad), the therapeutic use of radiation requires a massive dose. The beam must be aimed precisely to include the entire tumor while exclud- ing as much of the surrounding normal tissue as possible. 116/ Patient Exposure from Diagnostic X-Rays: An Analysis of 1974 NEXT Data, HEW Publication (FDA) 77—8020, Wochos, J. F., and Cameron, J.R., April 1977. 117/ See Findings and Recommendations, supra note 84, p. H 13576 (puglic education and information recommendations). - 60 _ Reasons for unnecessary exposure include: (a) Poor Image Quality 'In many cases diagnostic radiology facilities do not always produce high quality images. llg/ The effect of poor image quality is twofold. First, if the quality of the radiograph is so poor that the exami— nation must be repeated, the patient receives additional radiation exposure. Second, if the image is of poor qua- lity the chance of a wrong diagnosis or of not detecting an abnormal condition is increased and the radiation dose to which the patient was subjected was in vain. (b) Poor User Techniques The improvement of user techniques is an important exposure reduction effort. For example, the size of the x—ray beam should be restricted so that the area of the body exposed is no larger than needed, and shielding devices (such as gonad shields) should be used under certain circumstances. 112/ Furthermore, the beam should be accurately aimed at the area of interest. These steps aid in reducing unnecessary exposure to radiosensitive organs (e.g., testes, ovaries and bone marrow). In addition, improved grids, film processing and film viewing techniques, as well as improved diag- nostic x-ray receptors (screens and films), reduce the exposure necessary for an examination. Repeat procedures in nuclear medicine may be caused by equipment malfunction, technical problems, or radio- pharmaceutical defects, but an analysis of the relative importance of each of these factors remains to be done. 118/ Diagnostic Radiology Facilities Quality Assurance Programs 43 Fed. Reg. 18207 (1978). 119/ Radiation Protection Recommendations Specific—Area Gonad Shield, 41 Fed. Reg. 30327 (1976). -61— (c) Inadequate Quality Assurance in Medical Facilities , Quality assurance lgg/ programs carried out by the staff of an x-ray facility can also help reduce the problems of poor image quality and unnecessary patient exposure. A BRH study conducted in cooperation with the radiology department of the Public Health Service Hospital in Baltimore showed that a quality assurance program limited to automatic film processors reduced by 30 percent the number of retakes required because of poor image quality. 121/ Other studies also have shown that quality assurance programs would be expected to reduce unproductive radiation exposure to the patient by decreas- ing the number of repeat examinations. 123/ It is reason- able to assume that a program which reduces the need for retakes would also reduce unnecessary exposure and improve the quality of the radiographs actually taken. 1_Q/ Quality assurance means the routine testing and, if necessary, corrective action that enable a medical radiation facility to produce consistently high quality diagnostic images with minimum radiation exposure. 121/ "Automatic Processing QA: Impact on a Radiology Department", Radiology, 125:519-595 Goldman, L., et al., 1977. 122/ Economic Analysis of a Quality Control Program, Application of Optical Instrumentation in Medicine, VI Proceedings of Society of Photo—Optical Instrumentation Engineers, 1977; A Comprehensive Quality Assurance Program: A Report of Four Years Experience at the University of Alabama in Birmingham, Application of Optical Instrumentation in Medicine, V, Proceedings of the Society of Photo-Optical Instrumentation Engineers, 1976; Personal Communication from Dr. James A. Merchant, Director, Application Laboratory, National Institute for Occupational Safety and Health, to John C. Villforth, Director, Bureau of Radiological Health, dated September 11, 1978 (recorded as C00094 response to 43 FR 18207). -62- (d) Credentialing and Education of Users Improved and expanded education for x-ray, nuclear medicine, and radiation therapy technologists and clinicians is a most important aspect of technique improvement. Few States require education, training, and certification of all medical radiation workers (those working in the diagnostic x-ray, nuclear medicine, and radiation therapy fields). Professional societies have made some efforts to encourage the use of trained personnel and some credentialing by professional organization has taken place. (e) Poor Maintenance and Use of Therapeutic Equipment BRH has found significant problems with respect to the maintenance and use of therapeutic equip- ment. Although the BRH/NBS survey of the ability of therapy equipment to deliver accurate cobalt-60 doses did not allow the identification of the source of error, it may be surmised that these differences are due to poor calibrations, inaccurate exposure setups, or equipment malfunctions. NRC's rule requiring annual calibration of teletherapy units applies only to cobalt—60 and cesium-137 units. The introduction of electron accelerators for radiation therapy has intensified the need for good qua- lity control and maintenance programs. Recommendations Recommendations for radiation exposure reduction in the radiological technique area are: 0 Develop patient radiation exposure guidelines for common examinations. 0 Study the feasibility of expanding the "postcard" survey program beyond the current Dental Exposure _63_ Normalization Technique and Breast Exposure Nationwide Trends programs. 123/ 0 Encourage use of up to date techniques and equipment for all radiologic examinations and treatments. 0 Develop guidelines for facility based quality assurance programs for all types of x-ray and therapy facilities. 0 Encourage State participation in quality assurance programs by grants, contracts, and/or the use of Medicare/Medicaid reimbursement. 124/ 0 Promote improvement in the education, training and proficiency of medical radiation technologists (§;g., x—ray, nuclear medicine and radiation therapy) by supporting the development of cur- ricula, educational materials, testing materials, and methods of clinical competency measurement. igg/ In carrying out the two programs, called Dental Exposure Normalization Technique (DENT) and Breast Exposure: Nationwide Trends (BENT), the State agency sends a special postcard containing an inexpensive radiation measurement device to each hospital or office in its jurisdiction performing mammographic or dental x-ray examinations, with instructions to expose the cards according to normal practice and mail them back. By "reading" the cards, the State can pinpoint problem facilities quickly and at minimum expense. The BENT program, now in operation in 42 States, has resulted in a drop in radiation exposure of 10 percent in the par- ticipating States. The DENT program, now opera- tional in 34 States, has reduced exposure by 30 percent. The data from these two programs have not yet been published but are available for review. In February 1978, the Secretary of DHEW sent letters to the States to encourage participation in these pro— grams. Since that letter four States have imple- mented DENT and 14 have started BENT. 24/ See Findings and Recommendations, supra note 84, p. H 13577 (recommendations quality assurance programs). - 64 _ 0 Develop model licensure or credentialing guidelines, including periodic retraining and recertification for medical radiation techno— logists and provide assistance to the States in adopting and implementing them. 0 Conduct and support continuing education programs for all operators of medical radiation equipment. 125/ 0 Develop an equipment and technique testing program for diagnostic nuclear medicine. (3) Inadequate or Faulty Equipment Another source of unnecessary exposure from medical radiation is the use of inadequate or faulty equipment. FDA is responsible for developing and promul— gating performance standards for the manufacture of radiation-emitting electronic products. The performance standard for diagnostic medical and dental x-ray compo- nents and systems became effective on August 1, 1974, and applies to products manufactured after that date. Confor- mance with this standard is enforced by the FDA through reviews of manufacturer reports, plant inspections, laboratory testing, and field testing of equipment in current use. Field test data have shown a noncompliance rate of over 30 percent, primarily due to problems in the assembly of the equipment. To deal with this problem, an FDA inspection program has been expanded through addi— tional testing by State agencies. More stringent enforce— ment of the requirements on assemblers is in process. Federal law requires the recall of noncompliant equipment. Since the standard became effective, 72 recalls of medical and dental x-ray systems, involving more than 38,000 non- compliant products have occurred. The defect provisions of the Radiation Control for Health and Safety Act of 1968 apply to all diagnostic x-ray equipment manufactured after l 5/ See Findings and Recommendations, supra note 84 p. H 13576 (recommendations for professional education). -65.. October 18, 1968. 126/ Twenty-six recalls, including more than 35,000 products, have been initiated under this authority. There is no Federal regulatory control over equipment manufactured before October 1968. (a) High Failure Rate There exists an unacceptably high rate of failure to comply with the diagnostic x-ray equipment performance standard. (b) Old Equipment The FDA performance standard only applies to diagnostic x-ray equipment manufactured after August 1, 1974, and there are varying State requirements on equipment manufactured before that date. Thus the following recommendations are made: 121/ Recommendations 0 Assemblers should be required to test diagnostic x-ray equipment, e.g., at the time of installa- tion. 0 More frequent inspection should be performed either by the FDA or the States (with Federal grant or program support). 0 Use the new civil penalty provision of the Act as it applies to noncompliant assemblers. ;g_/ A product which uses radiation to accomplish its primary purpose (e.g., diagnostic x—ray equipment) is considered defective if it does not meet its design specifications relating to radiation emis— sions or if it emits radiation unnecessary to accomplish its primary purpose 9E if it does not accomplish its intended purpose. lgl/ §g§ Findings and Recommendations, supra note 84, p. H 13576 (recommendations for performance standards for electronic diagnostic radiation equipment and systems). -66- 0 States should re—examine x-ray machines at a prescribed frequency depending on the use, com- plexity, and type of equipment. 0 X—ray equipment, under a system of State inspections, should be required to conform to Federally prescribed minimum standards. These standards should apply to all x-ray equipment in current use regardless of the date of manufacture. (4) Insufficent Control for New Technology In recent years the medical radiation field has been characterized by rapid changes in technology that proceed quickly from the research laboratory to clinical application. At the Federal level, action in dealing with these changes from the standpoint of dose reduction or cost containment has been largely reactive. There has been no strong Federal focus in directing the thrust of research into new medical technology or in evaluating its impact. (a) Inadequate Criteria for Diagnostic Image Requirements As new advances in diagnostic radiation technology are made, it is increasingly important to understand how much diagnostic information is really used under various clinical circumstances. Often a new and improved diagnostic radiation technique carries with it, in addition to a better image (e.g., one which is sharper or contains more information), increased radiation expo— sure and cost. The best balance of diagnostic information and radiation exposure and cost can be made only after the characteristics of the image, which is clinically needed, have been identified objectively. The problem is complex in that the optimum image is different for different diagnostic procedures. For example, the quality of the image from a chest x-ray needed to detect tuberculosis may be far different from that required to diagnose pneumoconiosis or asbestosis. (b) Inadequate Evaluation for New Technology Today's accelerated rate of technological change is accentuated in the field of diagnostic imaging because of the application of modern electronic and -67... computer-based technologies to this field. Recent experience shows that rapid clinical acceptance of new diagnostic instrumentation can occur without adequate assessment of its benefit and effect on health care delivery, costs, and potential risk to patients. On the other hand, new technological developments have occurred which, if properly applied, could result in improved diagnostic imaging, reduced health care costs, better information retrieval, and decreased patient exposures. (c) Slow Acceptance of Exposure-Reduction Improvements Technological improvements that relate only to exposure reduction and that do not offer collateral diagnostic, time saving, or economic advantages have been slow to gain acceptance and wide application. (d) Inadequate Coordination of Research There is no formal mechanism within the Federal government to ensure that Federal research pro- grams in the area of diagnostic imaging are coordinated and that the most critical research needs are addressed adequately. To address several of the problems presented by inadequate evaluation of new technology the following recommendations are made. 128/ - 0 Review various Federal research programs relating to diagnostic imaging to ensure adequate coordina— tion of these various research efforts. 0 Make available adequate resources to encourage research which will lead to optimization of diagnostic imaging process. 0 Evaluate new techniques for diagnostic testing which do not involve ionizing radiation, e.g., ultrasound and thermography. When found safe and effective, these techniques should receive appropriate encouragement. 128/ See Findings and Recommendations, supra note 84, p. H 13575 (research recommendations). -68— 0 Encourage the use of standardized quality assurance procedures which could easily be incorporated into the software package now being offered for use with computer controlled imaging devices. ' 0 Make available resources to permit development of standardized test methods and regulatory perfor- mance standards to assure adequate image quality. 0 Encourage research in developing newer radio- pharmaceuticals that deliver less radiation to the patient and provide increased diagnostic information. 0 Encourage research to develop more sensitive instrumentation to reduce the amount of radiation needed for an examination. 4. Nuclear Weapons Development and Production The potential sources for general population exposure from nuclear weapons production and nuclear explosions, will be presented in terms of the nuclear weapons (and peaceful uses or "plowshare" related) test "cycle", including the research and development phase, testing, production, transportation, routine deployment, and storage. Potential expoosures from the use of a nuclear weapon in a ware are excluded. All of the steps in this cycle are accomplished in DOE and DOE-contractor facilities which are regulated by the DOE, except for the transportation, storage, and routine maintenance of finished nuclear weapons which are controlled by DOD. a. Atmospheric Testing By fare the largest dose commitment to the public associated with the nuclear weapons and peaceful uses of nuclear devices cycle is from the fallout of atmospheric nuclear tests which were conducted by the United States from 1945-1962 and by other countries both _69_. during and since that time, and to a much lesser extent from U.S. underground testing from 1961 to the present. 129/ Atmospheric tests introduce radioactive material into the stratosphere, some of which is later deposited on the earth's surface. A portion of the small amount of material remaining in the stratosphere continues to be deposited. Thus fallout from current tests, that remaining in the atmosphere from past tests which is still being being deposited, as well as that previously deposited from past tests contribute to the annual popu— lation dose. Fallout contains both short—lived radionuclides and radionuclides with much longer half-lives and, like natural radiation exposure, exposure from radioactive fallout can be both external and internal. A number of short-lived radionuclides (e.g., iodine-131 with a half- life of 8 days) can contribute significantly to both external and internal doses within a few months of their production. The accumulation of long-lived radionuclides, such as cesium-137 (30 year half-life), deposited from past nuclear tests remains a source of external gamma radiation for a much longer period of time. Internal exposure from radioactive fallout results from inhalation and from the ingestion of contaminated water, food grown in contaminated soil, and from other food chain pathways (e.g., milk from cows which have eaten contaminated igg/ Of the 320 announced underground tests conducted by the U.S., only 18 have released small quantities of radioactivity sufficient to be detected at offsite locations. The largest off site whole body exposure from one of the largest accidental releases (the BANEBERRY test, December 18, 1970) was 36 mrem. Baneberry Summary Report U.S.A.E.C., May 1971. The most recent release of detectable gaseous activity from an announced test was on November 24, 1971. Underground Nuclear Testing Program: Nevada Test Site WASH - 1526/ (Supl), September, 1975. Summary Information on Accidental Releases of Radioactivity to the Atmosphere from Underground Nuclear Detonations Designed for Containment, August 1963- June 1971, Robert E. Allen, WASH - 1183 U.S.A.E.C., June 1971. -70.. pasture grass). Most doses are received within one year after exposure. However, the doses from strontium— 90 and plutonium will be received over a person's lifetime following inhalation or ingestion because of their long physical and biological half-lives. Many assumptions have to be made in calculating population doses due to fallout. Annual doses have varied remarkedly by location depending on the test pattern, and measure— ments have been made only in limited locations. There- fore, in calculating population doses some estimates are made and combined with actual data. Furthermore, it is necessary to decide how far into the future the effect of a given long lived radionuclide from fallout is to be calculated. Dose commitments are calculated for a period determined by a combination of factors, which may include the lifetime of the individual, biological halflife of the nuclide in an individual, and halflife of the nuclide itself. A dose commitment then, is the dose to an indivi— dual calculated for the period over which he or she would be affected by a particular radionuclide. It is estimated that for the years 1960-2000, the total annual whole-body dose for the U.S. population due to all atmospheric tests around the world is l-l.6 million person-rems. igg/ While little can be done at this point to modify the population exposures associated with past atmospheric testing of nuclear weapons, a few exposure reduction or prevention efforts should be considered, including: 0 Continued adherence to the Atmospheric Test Ban Treaty 0 Diplomatic efforts to dissuade other nations from atmospheric testing l3 / The range of values reflects changing dose commit- ments over a 30 year period due both to physical and biological processes and to the assumption of the continued limited atmospheric testing. NCRP 45, supra note 34; EPA Estimates 1960-2000, supra note 36. The two 1976 tests in China gave a U.S. population thyroid dose of 68,000 person—rads. Strong et al., EPA, "Assessment of Fallout in the U.S. from Atmospheric Testing on September 26 and November 17, 1976, by the People's Republic of China," EPA-520/5-77-002, August 1977. _71_ b. Underground Testing Following cessation of atmospheric testing, by the United States, a program of underground testing of nuclear explosives has been conducted to: (1) develop optimum technology in weapons development; (2) protect the safety of the workers, public, and the environment; and, (3) comply with the Atmospheric Test Ban Treaty. Since 1963, all U.S. testing of nuclear devices has been done underground. A panel comprised of experts from major DOE laboratories and consultants is an integral part of the safety considerations associated with the underground testing program. This Containment Evaluation Panel. examines each factor which may contribute to unwanted escape of radionuclides to the atmosphere during or after the detonation. Such reviews consider in detail, among other things, the device yield, depth of burial,‘geology, hydrology, location of the emplacement site (including the proximity to and the success of previous test locations), closure methods, stemming design, and the drilling and construction history. It is the function of the Panel to undertake this comprehensive and thorough review required by the DOE before approval can be given to proceed with the test. There have been no dynamic ventings since the BANEBERRY test, December 18, 1970, and no lesser releases of radio— activity since the DIAGNAL LINE event of November 24, 1971. The underground testing program is conducted in accordance with the DOE Safety "Orders". The DOE requires periodic visits to certain key areas related to safety of opera- tions at the Nevada Test Site. Matters appraised are management overview, health protection, industrial safety and fire protection, occupational medicine, environmental -protection, emergency preparedness, and nuclear explosives safety. There are also interim visits between formal appraisals. Members of the group performing these appraisals are organizationally separate from those who conduct operations at Nevada Test Site. Findings and recommendations are presented to the DOE Manager of the Nevada Operations Office. -72.. Additional efforts that could be explored include: 0 Increased air, soil, and water monitoring to detect fallout from tests conducted by other nations or from an accidental venting from U.S. underground test locations, and the development of response efforts (e.g., decontamination of food, evacuation or sheltering of persons). c. Weapons Development and Production The research and development aspects of nuclear weapons development take place primarily in DOE facilities and DOE contractor facilities at universities, and pri- vate, commercial, and government installations. An addi- tional phase of the cycle is the production of weapons- grade fissionable materials. The two fissionable isotopes predominantly used in nuclear weapons are uranium-235 and plutonium-239. Uranium-235 constitutes 0.715% of naturally occurring uranium which must be mined and refined to produce the pure uranium metal. The weapons grade uranium—235 is then separated from natural uranium in a process called enrich- ment. Plutonium-239 is produced in nuclear reactors where naturally occurring uranium-238 is converted to plutonium by the neutron capture process. The plutonium is then extracted from the uranium using chemical processes. The enrichment of uranium-235 and the production of plutonium-239 take place in DOE facilities, e.g., the Savannah River Plant near Aiken, South Carolina. lgl/ (At present, there is no weapons grade enriched uranium being obtained from enrichment activities. Current weapons needs are being supplied from the recycle of obsolete weapons.) These fissionable elements are sent to other DOE facilities (uranium to the Y-12 Plant, Oak Ridge, Tennessee and plu- tonium to the Rocky Flats Plant, Golden, Colorado) where the nuclear components of fission weapons components are fabricated. The warhead components from various facili- ties are shipped to other plants where they are assembled prior to being deployed by the Department of Defense (DOD) 131/ The Oak Ridge Gaseous Diffusion Plan, Oak Ridge, Tennessee used to provide weapons grade enriched uranium for the weapons program. -73... to bases and missile sites. Outdated weapons are returned to the DOE assembly plants where the weapons are dis— mantled, and the plutonium removed and shipped to a fabri- cation plant where it is recycled for new weapons. There is potential for population exposure from the uranium mining and milling operations, because of the waste tailings (discussed under technologically enhanced natural radiation); from effluent discharge from the DOE and DOE-contractor facilities which enrich the uranium, produce and separate the plutonium, fabricate and assemble the components; from the storage of wastes; and from the transportation of the radioactive materials in railroad cars, trucks, and airplanes, including the accidental ‘release of weapons from their air and surface transports. There is a growing accumulation of both high and low level nuclear wastes from military programs which are stored at a number of DOE-contractor facilities. At present there are more than 74 million gallons of high level nuclear wastes (liquids and associated wet solids) from military programs, and an additional 2.7 million gallons are pro— duced each year. Most of these wastes are stored at the Hanford Reservation near Richland, Washington; other storage facilities are located at the Idaho National Engineering Laboratory near Idaho Falls, Idaho, and Savannah River near Barnwell, S.C. These high—level wastes are either in liquid form or the liquid has been converted into wet solids and are stored in tanks made of stainless or carbon steel. The anticipated life expec- tancy of the stainless steel tanks is more than 50 years. However, leaks of radioactive liquids have occurred because of mechanically and chemicaly induced stresses and heat, possibly accelerated by radiation damage. At Hanford, over 423,500 gallons of high—level wastes leaked from 16 carbon steel tanks. The largest leak occurred on June 8, 1973, when one tank leaked a total of 115,000 gallons. The Savannah River site (carbon steel tanks) has recorded at least one leak, while the Idaho site (stainless steel tanks) has recorded none. The AEC (now DOE) was responsible for these sites at the time of the ’leaks and undertook remedial action. According to the AEC, no contamination of the environment, other than the ground immediately below the tanks, and no exposure to members of the public occurred as a result of those leaks because the radioactive materials were immobilized in the -74.. soil. 132/ To reduce the chance of future leaks, the AEC began a program to transform the liquid wastes into solid form, which is less mobile and safer. 133/ In addition to these high level wastes there are presently 54 million cubic feet of low level and transuranic nuclear wastes from military programs, which inventory increases by approximately 1.5 million cubic feet per year. Major burial or storage sites are maintained by DOE for these wastes at Hanford, Savannah River, the Oak Ridge National Laboratory in Tennesee, and the Los Alamos Scientific Laboratory in New Mexico. Some offsite contamination has been occurring at Oak Ridge for the past 15 years. In adddition, early in the nuclear weapons program low-level wastes were dumped in the ocean. Because of the high costs, the United States no longer uses this disposal method, although several European countries continue ocean dumping. 133/ Recent investigations by the EPA indicate that some leakage (including plutonium) may have taken place at two former U.S. dumping sites located off the Maryland-Delaware Coast and in the Pacific Ocean near the Farallon Islands. 135/ It has been estimated that no exposures to the public have resulted from these leaks. The problems associated with the management of these wastes and the Federal efforts to date are discussed in the section of this report on nuclear power plants. 13_/ ABC, (prepared by Atlantic Richfield, Hanford Company) 241-T-106 "Tank Leak Investigating", November 1973. See also, ERDA—1538, Final Environmental Statement -— Waste Management Operations (Hanford Reservation), December 1975; ERDA-1537, Final Environmental Statement -- Waste Management Operations (Savannah River Plant), September 1977. 5.; 0) w \ "Plan For The Management of ABC-Generated Radioactive Wastes," Wash-1202 (73), July 1973. igg/ This continued dumping is under limits and procedures provided by the International Atomic Energy Agency pursuant to an international agreement. H (A) \ EPA, "Environmental Surveys of Two Deep Sea Radioactive Waste Disposal Sites using Submersibles", IAEA-SM—207/65. _ 75 _ The research and production facilities operated under DOE authority and control are monitored by DOE to measure the levels of radioactivity and other effluents emitted, igg/ in order to (1) determine whether the facility, its pro— cesses and operations are functioning as they were designed and planned, relative to containment, waste treatment, and effluent control; (2) detect and provide early warning of unplanned releases so that appropriate corrective actions can be taken when necessary; (3) deter— mine the degree of compliance with applicable Federal, State, and local standards and requirements and with self imposed operating limits for pollutants and radioactivity; and (4) identify the most promising areas for improvement in containment or operations to minimize environmental impacts. In addition, the EPA as well as State and local agencies adjacent to DOE facilities monitor areas adjacent to DOE facilities to verify that guideline levels of radioactive release are not exceeded. In 1976, the total whole body annual population dose commitment from all weapons-related DOE production and research facilities is estimated to be no greater than 165 person—rems. 131/ Although radioactivity levels in the air and water in the vicinity of the Rocky Flats Plant routinely have been well within (less than 0.1% of) applicable radiation standards, igg/ public concern has developed about this plant because of its proximity to Denver. Two contami- nating incidents prompted this concern. In the first incident, due to leakage of plutonium, contaminated cut- ting oil from drums stored in the southeast corner of the plant from 1958 until 1968 produced elevated plutonium levels in soil near the plant. The contamination was then spread in an east-southeasterly direction by the 186/ DOE maintains two computer-based management systems to track environmental releases and compliance with exposure standards, the Effluent Information System and the Onsite Discharge Information System. 137/ Environmental Monitoring at Major U.S. Energy Research and Development Administration Contractor Sites, Calendar Year 1976, ERDA 77-104/1. 1 8/ Annual environmental monitoring reports prepared and issued by the Rocky Flats Plant and by the Colorado Department of Health. _76_ prevailing winds. The highest levels of contaminated soil on the plant site have since been covered by a layer of asphalt to decrease additional dispersion. 139/ In the second incident, which occurred in 1973, tritium was inadvertently released from the plant to the Great Western Resorvoir, the source of drinking water for approximately 13,000 people in the Bloomfield, Colorado, community. The EPA investigated this incident and con— cluded that the total population dose commitment approxi- mated 80 person-rem and that the total committed dose to a typical Bloomfield resident would approximate 6 mrem. ggg/ Administrative and procedural controls were established to prevent further tritium releases and a water recycle pro- ject was initiated to provide zero liquid discharge by 1979 from the plant. lgl/ A project has also been initiated to provide for control, impoundment, and analy- sis of storm run-off prior to release off—site. Calculations in 1977 based on actual effluent and environmental monitoring data indicate that continued operation of the Rocky Flats Plant, with no further cleanup operations or systems improvements, will result in an annual dose commitment of 5.9 and 51 personerems respectively to the whole body and to the lungs of the Denver population. The maximum dose to a single indivi- dual is estimated at 0.18 and 0.54 mrem respectively to the whole-body and to the lungs. The 0.18 mrem dose assumes a person resides at the boundary of the site, drinks water from the Great Western Reservoir, and eats fish from the reservoir. igg/ igg/ Plutonium in Soil Around the Rocky Flats Plant, HASL-235, August 1, 1970; Radioactive Contamination in the Environment near the Rocky Flats Nuclear Weapons Plant, Colorado Department of Health, Sept. 1977; Draft Environmental Impact Statement, ERDA-lS45—D, September 1977 (herafter ERDA Draft). 140/ Investigative Report of the 1973 Tritium Release at the Rocky Flats Plant in Golden, Colorado, Region VIII, EPA, March 1974. H as i—‘ \ ERDA Draft, supra note 139. ._a .5 \ Id. _ 77 _ Environmental groups have suggested that additional prevention and reduction efforts need to be taken with respect to the Rocky Flats and other DOE facilities, including: 0 Land use restrictions on areas near weapons production facilities. 0 Increased soil, water, and air monitoring in areas near weapons production facilities. 0 Back—up water sources for areas near weapons production facilities. 0 Development and adoption of emergency response evacuation plans. 0 Promulgation of proposed Federal guides for plutonium contamination in the environment (EPA). o Cleanup of contaminated land near DOE and DOE- contractor facilities. 0 Relocation of production facilities to low- density population areas. 0 Requiring warnings to be given to home buyers near production facilities. All of these issues have been or are presently being addressed by the responsible Federal agencies and several actions have been taken in response to the concerns ’ expressed. For example, HUD in cooperation with the EPA is considering requiring notification to appropriate home buyers in developments near the Rocky Flats facility in Colorado, of the Plant's existence and of the Colorado emergency response plan for the plant. Also, funds have been transferred from DOD to DOE to provide the town of Bloomfield, Colorado with an emergency water supply if discharge from the Rocky Flats facility contaminates the Great Western Reservoir, that city's present water source. d. Weapons Deployment Once nuclear weapons are released to DOD, the monitoring of potential exposures from these weapons and their control is the responsibility of the DOD. Although -78... some occupational exposures occur in the storage, maintenance, and transport of these weapons, the only radioactive release to the environment which could result in exposure to the public have been in connection with transportation accidents during military operations. Two incidents have resulted in significant contamination (in Greenland and Spain). igg/ Both incidents resulted in cleanup operations. 5. Nuclear Energy The production of electricity by nuclear means involves research and development activities, the mining and milling of uranium, fabrication of uranium-based fuel elements, the operation of power reactors, and the trans- port and disposal of radioactive wastes (current govern— ment policy does not permit fuel reprocessing for nuclear energy purposes although other countries are continuing their reprocessing programs). The collective exposure to the population of the United States from these activities in the nuclear fuel cycle has been calculated by the NRC to be approximately 400 person- rems of U.S. population annual dose commitment (total body dose) and 3600 organ-rems to their bronchial epithelium per 1000 megawatt electric year of power production. 155/ This includes doses from radioactive effluents from all uranium fuel cycle facilities, including normal opera— tions, anticipated operational occurrences, and accidents, and from radon and its daughters from mining and milling. In 1978, the 51,000 megawatt electric power production would result in approximately 20,000 person—rems (total body) and 184,000 organ-rems of annual dose commitment from the uranium fuel cycle. igg/ A similar event in Goldsboro, N.C. did not expose the public. DOD's policy is not to release informa- tion that an accident has occurred unless news of the accident reaches, or is likely to reach, the public from other sources. l—‘ b \ The calculations are partially contained in Table 8-3 of 10 CFR Part 51; NUREG-0332; and the NRC Staff response to the Honicker Petition (SECY 78-560, October 26, 1978). -79... a. Research and Development Activities Research and development activities relating to the production of electrical power through nuclear energy involve the use of research and test reactors. These reactors can contribute to environmental radioactivity and hence contribute to the population dose, either from direct radiation from the reactor or through discharges of radioactive gaseous and liquid wastes resulting from reactor operations. At the end of 1975, the NRC licensed and regulated 68 research and test reactors. The NRC will not issue construction or operating licenses to a research or test reactor until the NRC staff determines that the reactor has met the requirements of 10 CFR Part 50, Licensing of Production and Utilization Facilities. This includes an analysis of the safety and the environmental impact of the proposed facility, including the effect of radioactive effluents and radiation from the facility. The effluent releases and radiation doses to the popula- tion must meet the requirements of 10 CFR Part 20, Standards for Protection Against Radiation. A reactor is also required to satisfy regulations concerning its effluents and radiation output during operation. Licensees must monitor effluents and the environment, and submit annual reports on the results of this monitoring. Many States in which the reactors are situated monitor the environment near each site. The DOE also owns research and test reactor facilities, which are operated by contractors. In accordance with ERDA Manual Chapter 0513, these contractors prepare annual reports containing data on levels of radioactive and non- radioactive pollutants in the environs of each site and an interpretation of the sampling results in relation to the DOE's dose standards for the public, which are based on the Federal Guides. These reports include estimates of offsite population exposures and summaries of effluent releases. The population dose due solely to research and development activities (including weapons programs) at DOE contractor facilities is approximately 370 person—rems per year. igg/ 45/ See, EPA Radiological Quality, supra note 42, p. 201 et seq. (doses from all DOE contractor facilities). -80— b. Uranium-Based Fuel Elements As discussed in the section of this report on technologically enhanced natural radiation, the uranium mining and milling steps of the nuclear fuel cycle (including the resulting waste tailings) can be a source of radioactive air and water pollution and they can be used as a by-product or be disposed of in a manner that causes increased exposure to humans. However, milling is licensed by the NRC and has to meet its regulatory requirements. igg/ Once the uranium ore is mined and milled, DOE contractor facilities use gaseous diffusion technology to increase its percentage of uranium-235 in a process called enrich— ment. Enrichment plants are covered by EPA standards for the uranium fuel cycle. lgl/ Radiation doses to indivi- ‘duals and to the population from various exposure pathways have been estimated by DOE for annual releases of radio- active effluents from normal operations of enrichment plants. While gaseous effluents are the primary contri- butors to population total body dose from the enrichment process, DOE data indicate that diffusion operations are unlikely to increase significantly levels of exposure to the general population over that caused by natural back- ground radiation. In the final fuel fabrication step, the uranium is fabricated into fuel rods which are assembled into fuel elements prior to their installation in the reactor core. The NRC has estimated dose data from fuel fabrication facilities by various exposure pathways, which data indi- cate that it is unlikely that fuel fabrication activity would increase levels of exposure in the general environ- ment. Fuel fabrication facilities must meet NRC require- ments. igg/ 146/ See 10 CFR Parts 20, 50 and 40 CFR Part 190. 14 / 40 CFR 190. l 8/ See 10 CFR Parts 20, 50 and 40 CFR Part 190. _ 81 _ c. Operation of Power Reactors Radiation from commercial nuclear power reactors may reach the environment through discharges of airborne and liquid wastes containing low level radio- activity. 149/ The evaluation of population dose due to the operation of power reactors must take into account both normal operations, including anticipated operational occurrences, and the consequences of postulated accidents. Under normal operations, nuclear power plants emit very low levels of radionuclides into the environment. Because of the long half-lives of some of these radionuclides, the calculation of the dose commitment to the U.S. population is made by the NRC as follows: evaluation is made of the distribution of radionuclides in the environment surround- ing the nuclear facility, including the buildup of certain deposited radionuclides in the soil for fifteen years (half of the estimated plant life). An individual is assumed to take up such material for one year of release, and then the 50 year dose commitment is calculated, allow- ing for both biological and radionuclide decay as a func— tion of each nuclide. This is the 50 year dose commitment per year of reactor operations. Nuclear power plants, which are regulated by the NRC, have operated with low releases of radioactive effluents in conformance with NRC regulations. 150/ The NRC prepares both a Safety Evaluation Report and an Environmental Impact Statement for each nuclear power plant prior to issuing a construction permit and an operating license. These documents contain, among other things, estimates of the radiation dose to the public that would result from normal plant operation. The NRC also sets, as part of the operating license requirements, emission standards with which the licensee must comply. These standards are based on the ALARA design objectives and limits of NRC regulations. 151/ Radioactive waste treatment systems are designed for each plant to assure that no member of the public will receive more than 3 mrem (total body) per year H 4 / This report does not address the possibility of exposures caused by the sabotage of a power plant. H U1 \ 10 CFR Part 20 and 50, App. I. See See Appendix I to 10 CFR Part 50 and 10 CFR Part 20. H U1 1.4 \ -82— through liquid effluent pathways, 10 mrad per year through gaseous effluent pathways, and 15 mrem per year to the thyroid from radionuclides through the cow-milk pathway. Current NRC regulations set an absolute upper limit of of 500 mrem per year for any radiation pathway and 170 mrem per year as the average population exposure. l§g/ These regulations will be modified to meet the new limits pro- mulgated by the EPA. igg/ It has been determined that at least three reactors that meet NRC standards of 10 CFR Part 50, Appendix I, on a given site, would meet the individual dose criteria of 40 CFR Part 190. Each additional nuclear facility pro— poSed on or near a nuclear facility site would be evaluated for its contribution to individual dose, and would be licensed only if it meets applicable regulations. The EPA has recently promulgated a standard, lég/ to go into effect in 1979, whereby no person is to receive more than 25 mrem per year from planned discharges from all facilities licensed by the NRC in the nuclear fuel cycle. (This standard excludes exposures from the radon from mining and milling and waste disposal operations, trans- portation of radioactive materials, and DOE facilities other than enrichment plants). Additional standards may be set by the EPA under the Clean Air Act Amendments of 1977 which require the EPA to determine if radioactive elements shall be declared hazardous within the context of the Act. If radioactive air pollutants are to be so controlled by this Act, the EPA can set standards applica— ble to NRC licensees and other discharges (mines). In establishing and implementing these standards, the EPA and NRC are required by statute to operate under a Memorandum of Understanding. lgé/ The Amendments also permit States to set equally or more stringent standards. Some sectors of the public and scientific community believe that existing radiation protection standards are not sufficiently strict. This belief may be based on the 152/ 10 CFR Part 20. 153/ 40 CFR 190. 154/ g. |—' U'l \ See Clean Air Act Amendments of 1977. _ 83 _ fact that most activities result in radioactivity levels that are a small fraction of the existing standards, so that lower standards appear feasible. Usually people liv- ing in the vicinity of a licensed nuclear facility do not receive more than a 5 to 15 mrem radiation dose per year, or less than 10% of the current population standard of 170 mrem per year. lég/ However, there will be instances when operating conditions will result in fluctuations of dose above the usual operating range, necessitating flexibility in the standards as recognized by EPA in establishing a limit of 25 mrem per year to an individual. In addition to normal operations, population exposure can be caused by accidental occurrences in nuclear power_plant operation. In its draft report, the Work Group had reviewed accident assessment and emergency planning. As a result of the accident at the Three-Mile-Island nuclear power plant on March 28, 1979, studies of the many issues raised by that accident are underway by many organiza- tions. Numerous changes to current procedures will result from these studies. Critics have raised other issues concerning reactor operations: (1) the failure to calculate the radiological impact of power plant operations on the fetus; (2) the adequacy of monitoring; and (3) plant siting. When evaluating the impact of nuclear power plant operations, the NRC calculates doses for infants, children, teenagers, and adults, but does not calculate fetal dose on the grounds that not all radiation exposure pathways are appropriate for the fetus, and because the fetus is not likely to be at the location of maximum dose (the site boundary). The Environmental Policy Center has suggested that the fetal dose should be calculated and used as the basis for radiological impact standards because a fetus is more radiosensitive than an infant, child, or adult, and could therefore be harmed even if present standards are complied with. NRC staff members have calculated fetal dose for the major pathways of con— cern, and find that for most nuclides, the fetal dose is not greater than the maximum receptor -- which may be the 156/ This situation reflects application of the principle that radiation exposure be limited to levels as low as reasonably achievable. -84- infant, child, teenager, or adult depending in which nuclide and which pathway is being calculated. Even where the fetus may be the maximum receptor, the dose is small, and not greatly different from other older receptors. The NRC requires that power plant licensees monitor all of the effluent release pathways and all the environmental pathways of consequence outside their facilities and sub- mit the results of their monitoring to the NRC annually to show compliance with NRC regulations. The NRC and the EPA supply guidance to the licensees on how and what they should monitor. In addition, seventeen of the States which have nuclear power plants have extensive programs operating under specific statutory authority with con- tracts from NRC to confirm licensee data. The NRC also makes at least an annual effluent and environmental radiological monitoring inspection at the regulated reactors and conducts research on the effectiveness of monitoring programs and the transport of radioactivity in the environment. The EPA's radiation program collects and analyzes data on radioactivity in air, water, milk, and soil, prepares dose summaries from all radiation sources, and compares them with standards. The core of EPA's radiation program has been the Environmental Radiation Ambient Monitoring System (ERAMS) in which some State and local governments collect samples in areas around nuclear facilities and send them to the EPA for analysis. The ERAMS monitoring results have been published yearly since December 1974 (prior to that time they were published monthly). Other EPA pro- grams that have been dropped or reduced because of fund- ing cuts and which might be reinstituted include: (1) an increased funding program for State radiation surveillance protection, and (2) laboratory capacity expansion, and (3) a more extensive ERAMS. ' The DOE requires its contractor facilities to monitor radioactivity in effluents and in the environment and to prepare and submit annual environmental monitoring reports. The reports include summaries of radioactivity in effluents and in environmental media and assessments of dOSe to the public. DOE reviews the reports for adequacy and accuracy, and through appraisals and site visits assures the quality of the monitoring programs. Copies of the annual environmental monitoring reports and annual tabulations of radioactivity in effluents are provided to EPA and State and local Environmental and health agencies. - 85 _ Some environmental groups have voiced the concern that the NRC and the DOE rely too heavily on the licensees and contractors to monitor facilities without sufficient independent monitoring or assessment. The EPA and the States have exercised their authority to monitor for radioactivity in the vicinity of nuclear facilities to confirm operators' monitoring. For example, the State of Colorado routinely samples air, water, and other media on— and off—site at the Rocky Flats Plant. The monitoring programs have also been criticized for failure to provide a central and publicly accesible information source on radioactive pollutants. These concerns have for the most 'part been covered by (l) the issuance by DOE of an annual compendium (to be replaced effective 1979 by an annual summary report) of site environmental monitoring reports, (2) the issuance by NRC of annual effluent reports for major nuclear facilities, and (3) the issuance by EPA of an annual report entitled "Radiation Protection Activities." lél/ Land use policies and demographics are an important aspect of nuclear power plant siting, since the NRC will not per— mit plant siting if many people live nearby. According to NRC regulations, the licensee must maintain an exclusion area beyond the site in which it has the authority to prohibit or remove persons or property that might be harmed by radioactive release. Beyond the exclusion area a low population zone must be identified in which there is a reasonable probability that appropriate protective. efforts could be taken to assist residents in the event of a serious accident. The approved size of the plant site, exclusion area, and low population zone varies for each nuclear power plant that receives a license. The NRC considers demographics for a nuclear plant only at the time it approves a con- struction permit although factors regarding radiological impact have to be updated annually, as a condition of the technical specifications required as part of the license: for the five to seven years of construction and for the 30 to 40 years of operation the protection of the public is split (sometimes unclearly) between Federal, State, and local authorities as well as resting primarily with the 57/ The most recent report is EPA—52074—78-003 for CY 1977. -86- licensee. For example the NRC and the Oyster Creek nuclear power plant licensee are concerned that the plant's low population zone (near Toms River, N.J.) is filling up with residential subdivisions, but they have no control over local zoning. Local authorities do not wish to hamper development of the surrounding seaside area. The State, which has authority to limit developments of 25 units or more along the coastline, imposed a moratorium on the construction of such large units in 1976 while it studied the issue, but developments of up to 24 units con- tinue to be added. NRC regulations require that a licensee must stay informed about post—construction events that would have made the site unacceptable if known before licensing, such as sub- divisions, ammunition plants, and liquified natural gas terminals, lég/ but the NRC has no controls over what goes on near the plant after the site is approved. It does, however, have continuing control over effluent releases, since the technical specifications require annual updating of the release criteria. d. Nuclear Waste Management The operation of nuclear power reactors results in the production of large amounts of highly radioactive waste materials. One of the most controversial issues in the development of nuclear energy is the disposal of the high-level radioactive wastes from used nuclear fuels. The disposal of other, less radioactive waste materials has also generated concern and criticism. Several states have banned new nuclear plant construction until the Federal government determines how to dispose of the waste safely. The most serious disposal problems are presented by the high—level wastes, which would be generated if spent fuel from reactors were to be processed at fuel reprocessing plants or by the need to dispose of the spent fuel rods lég/ A liquified natural gas terminal has been constructed near the Calvert Cliffs plant in Maryland, and the NRC is concerned about proposed liquified natural gas facilities near the Diablo Canyon and San Onofre reactors in California. -87.. themselves without processing. At reprocessing plants, the uranium that remained unburned and the plutonium that was created would be separated as much as possible from the fission products (343., cesium and strontium) that were formed as the fuel was burned up. The separated uranium and plutonium would be recycled in new fuel rods. These facilities and their operations would be licensed by the NRC under many of the same regulations and regula— tory mechanisms described above. Fission products, which form the bulk of the high-level wastes, have relatively short half-lives (30 years is typical), and 700 years can be used as the end point of practical concern for them. However, mixed with the fis- sion products will be a certain amount of plutonium and other transuranic elements which remain radioactive for long periods of time. Plutonium, for example, has a half— life of almost 25,000 years. It is therefore important to keep the wastes out of the environment for extremely long time periods. On April 7, 1977, President Carter announced a policy of deferring "indefinitely" commercial reprocessing of spent fuel and the recycling of plutonium as a nuclear fuel, on the grounds that commercial use of plutonium would contribute to the proliferation of nuclear weapons. If this policy continues, waste management would involve the disposal of spent fuel elements containing the fission products, plutonium, and unused uranium. A commercial reprocessing facility at West Valley, N.Y., was operated by Nuclear Fuel Services, Inc. from 1966 to 1972 before it was shut down for modification and expansion. During that period, 612,000 gallons of liquid high—level waste were produced. This material is cur— rently stored at the site. Nuclear Fuel Services has abandoned its plans to reopen the West Valley reprocessing facility, and the State of New York is faced with the pro— blem of dealing with the waste. The State has asked DOE for assistance. The handling of commercially produced high-level wastes is currently regulated by the NRC, although the DOE is responsible for the development and operation of a Federal -88... repository to receive the wastes. l§2/ In addition, the EPA has proposed general criteria for radioactive waste management (all wastes) and is developing proposed environmental standards for high-level wastes. In addition to the high-level wastes, commercial nuclear operations produce other wastes that are slightly contami- nated with various radioactive materials, such as paper, rags, plastic items, and discarded equipment. Another low-level waste is the radioactive reactor coolant. Highly contaminated cooling water is removed from the reactor core, allowed to cool and evaporate while short- lived radioactive byproducts decay, and is then mixed with cement and solidfied in barrels which are buried. There are at present approximately 9 million cubic feet of low level wastes, and the DOE estimates that there will be 50 million cubic feet by the year 2000. At present, low—level wastes are buried at six commercial sites. Responsibility for regulating these sites resides ultimately with the NRC, although agreements with five of the six State governments have resulted in direct regula- tion by the NRC of only one site. Agreement States must have regulatory programs which are acceptable to the NRC, and which are therefore consistent with the NRC's regu— lations. The major requirement for the disposal of radioactive waste is that the radioactive material remain where it is placed and not migrate into the environment. A Federal Interagency Review Group on Nuclear Waste Management, comprised of representatives from fourteen Federal agencies, has studied alternative approaches to solving the radioactive waste disposal problem and has l§_/ For NRC's regulations, see 10 CFR 50, Appendix F. A special, more extensive, waste facility licensing regulation, 10 CFR Part 60 is currently under development by NRC. The DOE has issued a Draft Environmental Impact Statement —- Management of Commercially Generated Radioactive Waste, which addresses the environmental impacts associated with alternative methods for the treatment, storage, transportation, and final disposition of commer— cially generated high-level and transuranic radio- active waste. DOE/EIS-0046-D (April 1979). -89- recently submitted its report to the White House after considering public comments. The Interagency Review Group report presents findings, policy considerations, and recommendations on radioactive waste management. e. Decommissioning Parts of major nuclear power plant facilities and some of the equipment they contain become radioactive wastes at the end of their useful life, and thus present opportunities for exposure to the population. The proce- dure of taking a major facility out of service is termed decommissioning. The decontamination procedures vary according to the facility, and might include the "entomb— ment" or sealing off of the facility, the dismantling and removal of equipment and cell liners for storage in a waste depository, and the monitoring of all services to assure adequate decontamination of the potentially hazard- ous radioactive material. Both the public and Congress have shown interest in decommissioning. The General Accounting Office has reported to Congress on this issue, and there have been Congressional hearings on the issue. 161/ The NRC has issued regulatory guidance on acceptable methods of _69/ “Cleaning Up the Remains of Nuclear Facilities — A Multibillion Dollar Problem," EMD—77-46, June 16, 1977. The Environmental and Atmosphere Subcommittee of the House Committee on Science and Technology held hearings in June 1977, on decommis— sioning. This was done in connection with proposed Bill H.R. 6181 April 6, 1977, which was intended to provide for a study of certain sequences of the decommissioning disposal, and decontamination of elements involved in the use of nuclear energy. -90.. decommissioning and has sponsored studies on the mechanisms, effectiveness, and costs of various methods of decommissioning nuclear facilities. 161/ 6. Consumer Goods Certain consumer goods commercially available to the general public contain radioactive materials and thus emit ionizing radiation. lgg/ Some relatively common pro- ducts that emit ionizing radiation are watches and clocks with luminous dials, color television receivers, smoke detectors with radioactive sensor elements, dental porce- lain, opthalmic glass (eyeglass), and ceramic glazes. 1§1/ NRC, Regulatory Guide 1.86, "Termination of Operating Licenses for Nuclear Reactors," June 1974; NRC, NUREG0278, "Technology, Safety, and Costs of Decommissioning a Reference Nuclear Fule Reprocessing Plant, "Battelle Pacific Northwest Laboratory for NRC October 1977; NUREG/CR—0130, "Technology, Safety, and Costs of Decommissioning a Reference Pressurized Water Reactor Power Station," Battelle Pacific Northwest Laboratory for NRC, June 1978. See also NUREG/CR—0131, "Decommissioning of Nuclear_ Facilities - An Annotated Bibliography," Battelle Pacific Northwest Laboratory for NRC, October 1978. The NRC Has also received a petition for rulemaking from an environmental group, which requested the NRC to initiate rulemaking to require nuclear power plant operators to post bonds prior to each plant' s operation, to insure that funds will be available for proper and adequate isolation of radioactive materials upon each plant' 8 decommissioning. The NRC has not acted on this petition, although it is studying the costs involved in decommissioning and has published a notice of proposal rulemaking on the issue. 1 2/ See NRC, "Radioactivity in Consumer Products," NURE6/CP—0001, Aug. 1978. GD -91.. The average annual population dose equivalent from these products varies with the number of persons exposed, the dose equivalent from the product, and the area of the body exposed (some products contribute exposure mainly to localized tissues or organs). The total average annual contribution to the U.S. population dose equivalent (whole body) from these products is relatively small. Doses to individuals are also very small. In a 1972 report, the EPA estimated that the annual whole—body dose to the U.S. population in 1980 from consumer products would be 6,000 person-rems. ;§;/ The risks from the small ionizing radiation exposure caused by consumer products and the benefits derived from those products normally inure to the same person, who can make a decision on use if he or she is aware of the possi- ble radiation hazard involved. However, very few members of the general public using these products are aware that they contain radioactive materials or produce radiation during operation. In addition, consumer products contain— ing radioactive materials may have an environmental or public health impact after they are disposed of as waste. For these reasons, manufacturers and governmental control agencies must take measures to inform and protect the unsuspecting public, ensuring that the products are useful, that use of alternative materials has been con- sidered, and that the products are designed and engineered so that they do not result in an adverse impact on public health during their use or in any significant long-term environmental dose commitment after they are thrown away. Four Federal agencies have authority over consumer products: the NRC, HEW (FDA), EPA, and the Consumer Product Safety Commission (CPSC). In addition, twenty- five States (the "Agreement States") have promulgated regulations applicable to all sources of radiation, and l 3/ EPA, Radiological Quality, supra note 42, p. 7. This figure combines doses from television receivers and other consumer products. -92— an additional five States have promulgated comparable regulations covering only the naturally occurring and accelerator-produced radioactive materials (NARM). 164/ Under the authority of the Atomic Energy Act, as amended, the manufacture and distribution of consumer products using by-product, source, and special nuclear materials is controlled by licensing by the NRC and its Agreement States. The NRC does not have authority over radium, polonium, x-rays, or accelerator-produced radioactive materials. At present, the NRC relies on criteria pub- lished by the Atomic Energy Commission in 1965 with respect to the approval of consumer products. The cri— teria state that approval of a proposed product will depend on several factors: the usefulness of the pro— duct, the radiation exposures that will be associated with the product, and the extent to which the radiation contributes to the product's apparent usefulness. The NRC is presently reevaluating these criteria in light of current technology and radiation protection philosophy. The NRC has authority to exempt from regulatory licensing consumer products containing source, by-product, and special nuclear materials under certain conditions. The exemptions are based mainly on a determination by the Commission that the exempted classes or quantities of radioactive material or the kind of uses or users will not constitute an unreasonable risk to the common defense and security or to the public health and safety. Of par— ticular interest are the exemptions for small quantities of certain radioisotopes when incorporated in specified products. The manufacture and distribution of these pro- ducts are generally subject to specific licensing require- ments, but the possession, use, and transfer may be exempted. For example, the manufacture of luminous watch dials is specifically licensed, but the possession, use, and transfer of these watches are exempted. In compari- sion, all U.S. manufacturers of smoke detectors containing igg/ NARM sources are not controlled by the Federal government (except for the CPSC's authority to regulate NARM in consumer products), but are regulated at the discretion of each State. In non-agreement states, NRC directly regulates source, by-product, and special nuclear materials, used in consumer products. -93.. americium-24l operate under license from the NRC and must therefore comply with its requirements and regulations for manufacturing and distribution of their products. Certain public health and environmental groups have expressed con- cern over the lack of regulatory control over the ultimate disposal of radioactive smoke detectors which have poten- tial for long-term environmental dose commitment after they are thrown away by consumers. Under the Public Health Service Act, as amended by the Radiation Control for Health and Safety Act of 1968, HEW (FDA) has authority to establish an electronic product radiation control program including development of perfor- mance standards and recommendations. Performance stan- dards for television receivers, cold cathode gas discharge tubes, and cabinet x—ray systems for airport inspections have been prescribed. While FDA has the authority under the Food, Drug, and Cosmetic Act, as amended, to regulate devices such as dental porcelain, opthalmic glass, and ceramic glazes, they have chosen a non-regulatory approach. The FDA has requested the dental industry to follow the voluntary American Dental Trade Association standard and develop nonradioactive substitutes for the uranium used in dental porcelain. The FDA conducts a general surveillance of opthalmic glass as a potential problem. On the basis of adverse publicity and the threat of regulatory controls by the FDA, manufacturers of ceramic glazes no longer use uranium as a color addi- tive. The CPSC has authority under the Federal Hazardous Substances Act and the Consumer Product Safety Act over naturally occurring radiation sources in consumer products and has the authority to prescribe labeling for radio- active consumer products or to ban them. Their jurisdic- tion does not extend to consumer products which contain by-product, source, or special nuclear materials which are under the NRC's authority. The CPSC has considered regu- lating radium-dialed time pieces, but since they found this use of radium was disappearing from the marketplace they took no action. The CPSC has also considered the regulation of smoke detectors with radioactive sensor elements. However, since most of these smoke detectors use man-made radioactive elements (e.g., americium) which are under the NRC‘s jurisdiction, the CPSC considered regulations unnecessary. It has however, encouraged voluntary activities to reduce the use of some of the natural radioactive isotopes, primarily radium. _ 94 _ The International Atomic Energy Agency, has prescribed criteria for population protection from consumer products containing radionuclides, lgé/ and the National Council on Radiation Protection and Measurements has evaluated con— sumer products on the basis of whether the radioactive element serves a useful purpose and whether non-radio- active substitutes are available and economic. igg/ Federal agencies could use the recommendations developed by these entities when evaluating the public health acceptability of radiation and radionuclide use in con— sumer products. Alternatively, the EPA could develop Federal guidance for use by Federal agencies under their Federal Radiation Council authority. The three Federal agencies with regulatory authority (HEW, NRC, CPSC) could conduct dose evaluations and surveillance to assure that exposure from these sources are kept low. Cigarette smoking is a special case of consumer product radiation exposure. The inhalation of polonium—210 in tobacco results in both whole body and lung doses and has been implicated as a potential health hazard, including induction of lung cancer in smokers. Because of the con- troversy surrounding how much the polonium increases the hazards from smoking, no action is being taken to reduce the radioactivity in tobacco. Anti-smoking campaigns should be continued, and radioactivity removal efforts, if found to be necessary and feasible, could be effective in further reducing this unnecessary health hazard. l 5/ Nuclear Energy Agency, "Basic Approach for Safety Analysis and Control of Products Containing Radionuclides and Available to the General Public“ (1970). National Council on Radiation Protection and Measurements, Report No. 56, "Radiation Exposure from Consumer Products and Miscellaneous Sources." l-‘ 0‘ \ -95.. B. Occupational Exposure Ionizing radiation has many uses in industry, commerce, and research, and has therefore become a part of a variety of work environments. Federal, State, and industry activities have evolved to control and reduce the associated exposures to workers. As discussed in the Introduction, existing standards and reduction approaches are based on Federal Radiation Protection Guides. lél/ While no activity is without some risk and the benefits of some activities may necessitate that some risks be taken, there are legitimate questions as to (1) how much risk is acceptable, (2) how well workers understand the risks they are taking, what choices workers realistically have, and (4) whether the risks workers are asked to take are really necessary. These questions are not unique in the radiation area but are also applicable to many other occupational problems. The maximum dose limit for workers has been the subject of significant controversy, both scientific and regula- tory. The Natural Resources Defense Council, Inc., filed a petition two years ago requesting that EPA and NRC reduce occupational exposure limits to 0.5 rem annually. In a supplemental petition, they cited the reports by cer- tain scientists which suggested risk is underestimated for low levels of radiation. lgg/ OSHA has also been asked to change its standard. igz/ These standards assume that workers have to be treated differently than the general public. How— ever, the AFL—CIO asserts that workers should be protected at the same level as the general public. Natural Resources Defense Council petitions have been filed with EPA, NRC, and OSHA to reduce occupa- tional exposure limits to 0.5 rem annually, which would bring occupational standards more in line with those for individual members of the general public. igg/ In contrast, Scientific Committee 40 of the NCRP and the UNSCEAR, 1977 supra note 17, both suggest that risk may be overestimated at low levels. This scientific question is discussed in the report of the Science Work Group, supra note 8. -96— Several reviews of dose limits and cooperative hearings are planned by Federal regulatory agencies. Once the Report of the Committee on the Biologic Effects of Ionizing Radiation of the NAS (BEIR III) is published, EPA is expected to publish proposed revisions of current Federal Guides in the Federal Register. NRC staff has proposed some changes in current standards, to agree more closely with the January 1977, recommendations of the ICRP. For example, the NRC Staff recommends elimination of the 5(n-18) formula. ggg/ The NRC staff also has recommended a public hearing, once the BEIR III report is published, on the adequacy of present occupational radia- tion dose standards in response to the NRDC petition. OSHA and MSHA are both considering changes in their stan- dards. Their standards would also need to address any coverage loopholes that may exist as well as medical monitoring of exposed workers. 112/ A ten-fold or greater reduction in the individual dose-limitation standard raises several important ques- tions on which there is disagreement. Both the Atomic Industrial Forum, which represents the nuclear industry, and NRC staff suggest that a large reduction in individual dose limit could increase the collective dose for reactor operations. They argue that the lower standards would probably have to be met, at least initially, in reactor facilities almost entirely through use of larger numbers of workers. Additional exposures caused by involving more workers and health physicists in a given task would raise the collective dose and thus not be consonant with ALARA. In addition, short-term shortages of certain skills would increase reliance on transient workers and possibly less efficient workers. Proponents of reducing the dose limiting standard to 0.5 rem annually believe that this will reduce individual risk which, in their view, is greater than that implied under the linear, non-threshold hypothesis. They argue that the additional costs to licensees to meet lower exposure limits will provide great incentive to apply 169/ See note 219, infra. 170/ DOL health standards must provide for worker monitoring, 29 U.S.C. 655. -97- radiation reduction approaches more vigorously and to develop new technology which could be retrofitted to existing facilities. An alternative approach is to reduce the dose limiting standards but to make exceptions for certain essential procedures with unavoidable radiation exposure. Another approach would be tiered standards based on the proven specific job requirements. lZl/ These approaches would require fully informing the workers of their higher expo- sure risks. Possibly, differential pay rates would need to be developed. However, there is a danger that such approaches would act as disincentives to workers to keep their exposure levels low. Organized labor does not have a uniform position on this question. One union repre— senting nuclear fuel cycle workers, the International Brotherhood of Electrical Workers, does not support major reductions in the current standard. Other unions -- the Oil, Chemical, and Atomic Workers and the AFL-CIO —— have endorsed the proposed lower exposure standard. Workers apparently feel torn between job protection and health protection. A second question is how well workers understand the risks they are taking. Some workers, especially those directly involved in the production and use of nuclear power under- stand that they are experiencing risks in their jobs. For these workers, the degree of control and monitoring has tended to be relatively high and the average individual exposure is fairly low. Other workers may be less well informed and less well protected. The ICRP has calculated that the estimated risk for occupational radiation exposure is in line with the risks associated with other industries generally regarded as lll/ For example, one essential license requirement is to conduct in-service inspection of primary coolant system components, in order to monitor the safe condition of reactor and steam systems, but these inspections are also a source of collective expo- sures. (NRC has instituted an internal effort to balance these interests and is funding a research project to quantify the comparative risks). -98— safe. 172/ Based on calculations by UNSCEAR, lzg/ there may be_25—50 cancer deaths annually from current estimated occupational doses. 115/ For comparison, a recent HEW study estimated that 20 percent or more of all cancer deaths are occupationally related. 115/ Of the 365,000 U.S. cancer deaths in 1975, therefore, approximately 75,000 p... U1 \ ICRP, "Problems Involved in Developing An Index of Harm" (ICRP Publication 27) (1977). See note 18, supra. This Work Group on radiation exposure reduction estimated a total of 250,000 person-rems of occupa— tional exposure annually. This estimate is reason- ably congruent with extrapolations from monitoring data by NRC (164,000 person-rems for 772,000 workers) and Teknekron, Inc. (185,000) since these two estimates do not include certain categories of workers not routinely monitored. Bridbord, K., De Coufle, P., et al., Estimates of the Fraction of Cancer in the United States Related to Occupational Factors, (mimeo), National Cancer Institute, National Institute of Environmental Health Sciences, and National Institute for Occupational Safety and Health, Washington, DC, September 15, 1978. However, a recent editorial in the British medical journal, The Lancet, criticized this analysis. It characterized the HEW extrapola— tion of limited epidemiologic studies to an overall quantification of occupational cancer risk as an "insubstantial framework." Editorial, What Proportion of Cancers are Related to Occupation?, Egg Lancet, No. 8102, ii:1238-1240, December 9, 1978. _99_ may be occupationally related. izg/ Thus, if the ICRP and 1972 BEIR Committee risk estimates for radiation expo- sure are correct, the risks to workers from radiation are less than many risks presently existing in industry. One consideration bearing on the question of occupational radiation exposure reduction is the separation of risks from benefits. Unlike necessary medical exposures, in which the person encountering the risk also accrues the benefit, the worker exposed to radiation is at risk, while the economic and social benefits are received primarily by others. The worker may accept risks because he or she needs to work and there is no realistic alternative. The central questions then become (1) whether workers' have adequate knowledge of the extent of their risks and (2) how to provide technology and practices to control, reduce, and minimize those risks. Although the Occupational Safety and Health Act of 1970 establishes the worker's right to know about workplace risks, unions and environmental groups believe that industry practice is deficient in this area. Although training is required for workers exposed to radiation in regulated industries, some employers do not explain ade— quately the nature of occupational risks from radiation. Thus, some NRC-regulated or OSHA-regulated radiation workers may not in fact fully understand the nature of their occupational risk. Educating workers, however, is a complex undertaking which cannot be fully covered l7 / The HEW report, using published relative risk data, calculated excess mortality for a variety of indus— trial exposures. Selected examples include: Estimated Workers Excess Substance Currently Exposed Mortality Asbestos (lung) 1,600,000 13,900 cases/year Arsenic (lung) 1,500,000 7,300 cases/year Benzene (leukemia) 2,000,000 1,400 cases/year lg. Table 2 and notes to Table 2. - 100 - here. 177/ The NRC has met with union representatives who asked IKE NRC to develop a tutorial document on risks for workers. NRC staff has initiated a proposal to begin this task. A book on this subject is about to be published and, in addition, the Atomic Industrial Forum plans to issue a pamphlet, "Radiation Risk for Nuclear Workers," in early summer 1979. llg/ One proposal which could improve some workers' knowledge of their risks is to establish a registry of all workers exposed to radiation, to record their cumulative doses, or to require uniform monitoring and recordkeeping for all individual exposures. While these approaches might be most helpful as epidemiological research tools, they could also provide a mechanism for workers to monitor their own exposures. The cost and complexity of a registry may be considerable, and less cumbersome approaches should be explored. $12/ A similar but more limited proposal, NRC's Notice of Proposed Rulemaking, to assure that transient workers in nuclear power plants have prompt access to their exposure records when they terminate employment, is discussed below. As discussed in the Introduction, worker protection in the United States is controlled under Federal Radiation Protection Guides which establish exposure limits. How- ever, regardless of quantitative limits incorporated into standards, pertinent regulations require that no radiation IZZ/ See National Institute for Occupational Safety and Health, "The Right to Know. Practical Problems and Policy Issues Arising from Exposures to Hazardous Chemical and Physical Agents in the Work Place," Rockville, MD. July 1977. izg/ See also the Report of the Work Group on Public Information, which recommends development of Federal Worker Education program for persons occupationally exposed to radiation. 1,9/ Data records systems are discussed in Appendix 8 of the Science Work Group Report. - 101 - dose be permitted which is practical and feasible to avoid. This principle, called the ALARA concept, is the keystone of contemporary radiation reduction efforts. 180/ ALARA involves both a philosophical approach to radiation protection and a defined set of technologies which mini— mize exposure at acceptable cost. ALARA is a moving tar— get; as better approaches emerge, or as radiation safety practices are developed further, lower exposures can be attained. While the ALARA principle is generally accepted by radiation professional, and management, many feel it is not always aggressively pursued in some occupational settings. Radiation reduction in the United States is based on a mix of regulatory and non—regulatory programs at both the Federal and the State level, including: (1) development and implementation of safety procedures, guides, and stan- dards; (2) inspection and enforcement programs; (3) ALARA programs in nuclear industry; (4) training of radiation safety personnel; (5) information and education materials for workers; (6) applied research and research dissemina- tion activities; (7) quality assurance programs; (8) sup- port for voluntary efforts by trade groups and unions; and (9) agency technical assistance and consultation. In the course of statutory development of regulation and enforcement in the United States, different occupational groups have become the responsibility of different agen- cies. While a large group of radiation workers is covered under the Atomic Energy Act of 1954, as amended, nearly all other workers exposed to radiation are covered under the Occupational Safety and Health Act of 1970 or the Mine Safety and Health Act as amended in 1977. Under the Occupational Safety and Health Act, OSHA has jurisdiction 1_Q/ The principle of maintaining radiation exposure "as low as practical" (ALAP), was introduced by the National Council for Radiation Protection and Measurement in 1954. This concept was subsequently adopted by the ICRP and termed "as low as is reason- ably achievable" -- ALARA. Application of ALARA must take into account the state of technology, the economics of improvements in relation to benefit to the public health and safety, and other societal and socioeconomic considerations. See 10 CFR 20.1(c). - 102 - of workers not otherwise explicitly covered by other Federal statutes. Certain specific groups of employees are covered by other authorities. There are different approaches taken under the various statutes which are a function of the requirements of the enabling legislation and the worker protection philosophy of the responsible agency. Simplistically, these can be contrasted as the use of ALARA versus the use of regula- tions requiring mandatory compliance with specific expo- sure standards. These approaches will be discussed further in the manufacturing industrial section. The current statutory scheme is summarized in Appendix 5. A brief review of important responsibilities includes: 0 Basic radiation protection limits for all workers are promulgated in Federal Guidelines. This is the responsibility of the Federal Radiation Council authority transferred to the EPA in 1970. 0 Workers in nuclear energy and nuclear weapons research and development carried out in DOE facilities or by DOE contractors are covered by the Atomic Energy Act amendments of 1974 and the Energy Reorganization Act of 1974. The DOE nuclear program establishes its own health and safety requirements (based on appropriate authori- tative sources —- i.e., NCRP, ICRP, and FRC) which are promulgated through a management directive system in the form of "Orders". 0 Workers in nuclear power reactors and other uranium fuel cycle facilities licensed by the NRC, as well as other radiation workers employed by by-product, source, and special nuclear material licensees are regulated by the NRC under 10 CFR Part 20. The categories of licensees in which the largest collective doses occur are power reactors, industrial radiography, nuclear fuel processing and reprocessing, medical use of by-products, and certain other categories of by-product use. 0 Transportation workers are generally covered by other authorities--specifically the Department of Transportation, which has a memorandum of under- standing with NRC, and the U.S. Postal Service. - 103 - o Civilian employees working in jobs relating to National security may be excluded from OSHA coverage. For example, naval nuclear propulsion workers are the responsibility of the Department of Defense. 0 Each Federal agency is charged with controlling radiation exposures of its own employees, with OSHA overview, under the Occupational Safety and Health Act and Executive Order 11874. 0 State and local government employees are covered only in the 24 states operating under an OSHA- approved program. 0 OSHA currently accepts State jurisdiction over workers employed by NRC licensees using x-ray equipment or accelerators in the 25 Agreement States. However, the Occupational Safety and Health Act technically preempts State authority in this area. 0 Miners are regulated by MSHA. Non-Federal observers have expressed concern over the amount of self-regulation by Federal agencies with respect to protecting their own employees and those of organiza- tions acting on their behalf (e.g., Federal researchers using radiation and DOD shipyard, naval propulsion, and weapon deployment personnel). lgl/ Some public interest groups also recommend simplifying the current worker protection structure by reassigning NRC occupational _§l/ Data on research exposure in other than DOE facilities is not adequate to identify significant exposures. The work group estimates that all research exposure, both Federal and non—Federal, totals about 12,000 person-rems annually. DOD naval propulsion data indicates that average individual dose is relatively low and declining. - 104 - regulation enforcement to to OSHA. ggg/ The primary advantage of this proposal is the establishment of a single, standard program for all workers who may be occupationally exposed to radiation administered by an agency whose sole mission is worker protection. However, other groups argue that these proposals would result in duplication and increased expense since NRC-regulated facilities would have to be inspected by both agencies -- NRC for nonworker responsibilities and OSHA for worker protection. Also, OSHA does not have a licensing program for radiation and few OSHA inspectors are specially trained in radiation safety at this time. 1. Healing Arts Medical, dental, and related uses of radiation are the largest sources of occupational exposure l§§/; it is estimated that 550,000 healing arts personnel are exposed annually in clinical settings. igg/ These per- sonnel are exposed when performing diagnostic and thera- peutic procedures on patients, e.g., when giving an x-ray examination, radiation therapy treatments, or preparing and injecting diagnostic radiopharmaceuticals into a patient. 1§§/ l_3/ The Health Research Group has formally asked Dr. Eula Bingham, Assistant Secretary of Labor for OSHA, to reduce the current dose limits for OSHA- covered workers, and HRG believes that NRC occupa- tional regulation should be transferred to OSHA as well. 1 3/- EPA Estimates 1960-2000, supra note 36, pp. 150, 170. 184/ Personal Communication from Ralph Bunge, Chief of Analysis and Evaluations Branch, BRH, FDA, HEW. l 5/ In addition to these personnel, whose radiation exposure takes place primarily in clinical settings, there are also occupational exposures in medical and dental research and in the transportation and handling of the radioactive materials. - 105 - UNSCEAR (1977) has noted several difficulties in collecting and assessing doses to medical workers: (1) doses received by various parts of the body are often quite different while reported doses do not always indi- cate what organs are exposed; (2) dose monitoring is carried out by a large number of establishments ranging from individual hospitals to large commercial or govern— mental units; and (3) medical workers are employed in small numbers in a large number of establishments rather than concentrated in a few easily identified centers (as in the nuclear power industry). igg/ The total dose received by all healing arts personnel is estimated to be 40,000 to 80,000 person—rems annually, for an average individual dose of 60 to 120 mrem per year. lgl/ Some studies, focusing on specific types of workers, have estimated individual doses of between 300-600 mrem per year. 188/ Regulatory jurisdiction over medical workers exposed to radiation is spread among several Federal agencies and the States. NRC licenses medical facilities in the use of source, by-product, and special nuclear materials and has authority over radiation safety for workers exposed to those materials. In the past, NRC medical licensees were not required to report the results of employee monitoring. Starting in 1979, however, on a two year experimental basis, medical licensees will be required to submit annual statistical summary reports on workers' radiation exposures. |‘-" 00 m \ UNSCEAR 1977 supra note 17, p. 242. | I—' 00 \l \ Personal communication from BRH, FDA, DHEW. BRH's estimate is based on an extrapolation of exposure monitoring data collected on PHS and HEW healing arts personnel. Estimates based on data from additional monitoring systems, including commercial dosimetry and an analysis by HEW's National Institute for Occupational Safety and Health indi— cate total exposure may be as high as 80,000 person- rems. l UNSCEAR 1977 supra note 17, p. 243. H 00 (I) \ l - 106 - NRC has recently published a guide to implement the ALARA concept at medical institutions. 182/ The guide and other guides published by OSHA and FDA contain information on radiation safety programs applicable to all sources of ionizing radiation used in the healing arts. 129/ NRC inspects all licensed medical institutions, except those in Agreement States where the States carry out the inspections. NRC inspections are carried out on a one to three year frequency, depending on the potential for radiation exposure in the particular facility. Under the Occupational Safety and Health Act, OSHA has umbrella jurisdiction over worker health and safety, including radiation safety. 121/ OHSA's standards, like the NRC's, follow the Federal Guidelines, and its radia- tion program includes monitoring and inspection. However, OSHA has relatively little equipment and few people trained in radiation safety- AEZ/ OSHA's jurisdiction l§_/ NRC, Regulatory Guide 8.18, Information Relevant to Ensuring That Occupational Radiation Exposure at Medical Institutions Will Be As Low As Reasonably Achieveable. See also NRC, "Principles and Practices for Keeping Occupational Radiation Exposures at Medical Institutions as Low as Reasonably Achievable," (draft) NUREG-0267, 1978. H O \ NRC, BRH, OSHA and EPA, are trying to develop a program encouraging use of these or similar guide- lines to promote compliance with Federal standards and the ALARA concept at additional institutions and for additional radioactive emitters, such as x—ray machines, accelerators and some naturally occuring and accelerator-produced radioactive material. 191/ Occupational Safety and Health Act of 1970, 29 U.S.C. 651 et. seq. (1977). H N \ Personal communication from R. Copeland, DOL. When an employee complains of a suspected radiation hazard, OSHA will send qualified personnel to inspect. However, there is no specific educational effort to promote employee awareness of radiation safety. -107— does not extend to working conditions for employees under statutory authority of other Federal agencies or to State or local government employees at, for example, state hos— pitals or universities. In addition, OSHA enforcement powers have been limited through the appropriation process so that they do not apply to small business, (e.g., pri— vate dental or medical practices). There are 24 states operating under an OSHA approved program. In these States, State and local government employees are, in effect, subject to OSHA standards through the State inspection program. In other States, State employees are covered only by State worker safety regulations. Virtually all States have regulations requiring inspection for radiation safety in the work- place. igg/ Federal agencies are required to conform to standards for their employees that are consistent with OSHA's stan— dards. DOD adheres to OSHA standards for personnel in militrary and health facilities. In government-owned DOE facilities, where medical research or treatment is con- tracted, DOE retains jurisdiction over worker safety. In nongovernment-owned facilities where, for example, DOE merely funds medical research or treatment, jurisdiction over worker safety in the handling of radiation lies with the NRC for source, by-product, and special nuclear material and with OSHA and the States for other types of radiation. Certain efforts to reduce patient exposure have also resulted in reduced occupational exposures, e.g., innova- tions in equipment design to reduce radiation leakage. _g§/ Personal communication from Alice Dolezal, Chairperson of the Conference of Radiation Program Directors. Many states have adopted part or all of the recommended model regulations for control of radiation. See Suggested State Regulations, supra note 85. The model state regulations are a joint effort of the Conference of Radiation Program Directors, NRC, FDA and EPA. In addition, OSHA and the National Bureau of Standards review the proposed regulations. However, inadequate funding and a lack of trained personnel also hinder state inspection efforts. - 108 - In addition, there have been direct efforts to reduce personnel exposure. The NCRP has developed and published shielding and room design factors. igg/ The NRC has pub- lished guidelines for employee radiation protection at medical licensees and has made adherence to certain NCRP guidelines a necessary part of a license application. lgé/ Most States have adopted licensing procedures that address some of the exposures associated with radionuclides, sealed sources, x-ray machines, and accelerators. Radiation inspec— tion and compliance surveys have been emphasized by State agencies. Both State and Federal agencies conduct limited training courses on good radiological practices for healing arts per— sonnel. Professional society generally encourage continuing education in the use of radiation but it is not a requirement. There are approaches in three areas which would retain the necessary quality of diagnostic images or information yet would reduce personnel doses: exposure modifications, process modifications, and worker actions. Exposure modifications offer a number of opportunities for worker protection: 0 In order to define exposure problems and possible solutions, studies could be carried out including: (1) assessment of all examinations, rating them according to potential worker exposure; (2) time and motion studies of procedures with high expo- sures; (3) research into the contribution of scat- ter radiation to worker exposure; and (4) research into exposure levels in unique settings (e.g., veterinary medicine) for reduction opportunities and (5) a quantitative examination of facility, igg/ NCRP, "Medical X-ray and Gamma—Ray Protection for Energies up to 10 MeV Equipment Design and Use," (NCRP Report 33) (1968). These data have been updated in NCRP "Structural Shielding Design and Evaluation for Medical Use of X-rays and Gamma Rays of Energies up to 10 MeV," (NCRP Report 48) (1976). H \D \ See also, Regulatory Guide 10.8, "Guide for the Preparation of Applications for Medical Programs, "U.S. Nuclear Regulatory Commission, January, 1979. 2. - 109 - equipment and procedure factors used in hospital radiation safety programs to reduce radiation exposures to patients, staff, visitors and the public. Standards and guidelines for medical care personnel (such as NRC's Regulatory Guide 8.18) could be developed for promulgation through pro— fessional groups or the regulatory process. Examples include the use of personnel dosimeters to raise worker risk consciousness and to measure exposures, and worker rotation schedules (or other exposure limiting practices). Process modification could reduce worker as well as patient exposures. The efficacy and relative hazards of medical imaging techniques not involv- ing ionizing radiation should be researched, docu- mented, and their use encouraged if acceptable. A technology transfer effort could be conducted though professional societies and professional school curriculums. Further research should also focus on work simplification techniques for high exposure procedures. Modification of human factors is often the hardest goal to accomplish, yet has great potential. Training in radiation safety should be given to all health professionals, and should be supported by a Federal program to train people to teach -radiation safety. In addition, the mandatory training or credentialing, periodic retraining, and testing of healing arts personnel who use radiation would help to ensure that radiation safety knowledge is adequate before a worker is allowed to practice. Manufacturing and Industrial There are an estimated 50,000 person-rems of occupational exposure from manufacturing and industrial sources. lgg/ Occupational radiation protection in indus- try and manufacturing is partially the responsibility of NRC, partially that of OSHA, and it also involves State 96/ Work Group Estimate. - 110 - radiation control and/or occupational safety and health programs in States with OSHA approved programs. 121/ Industrial radiation use not requiring NRC licensure or not under DOE controls is generally covered under the Occupational Safety and Health Act. OSHA inspects workplaces for compliance with standards for whatever hazards or exposures, including radiation, may be applic- able in that industry. It has been estimated that approximately 7 million workers may be exposed to ionizing radiation. igg/ With the exception of some State and local workers, all are covered by the Occupational Safety and Health Act provisions. There have been some important contrasts in NRC and OSHA regulatory approaches to worker protection, although pro- posed refinements in these approaches are drawing them closer together. For example, NRC and DOE emphasize the ALARA concept in occupational settings subject to their ‘licensure or supervision. Under the ALARA approach, dose— limit standards provide an upper limit on exposure, but applicants commit themselves to all cost-beneficial steps to reduce exposure to ALARA in the light of technological and economic factors. Licensing, inspection, and enforce- ment reinforce this goal, although NRC licensees are not yet required to make commitments to specific ALARA actions which are inspectable and enforceable. OSHA's approach to worker protection is primarily operational compliance with standards and regulatory requirements, enforced through periodic workplace inspec— tion and citation of violations. OSHA inspectors visit workplaces to apply all applicable safety and health standards, not just radiation protection. Standards are typically comprehensive, including both exposure limits and a variety of other requirements, such as worker notification and medical examination requirements. l9 / There are 25 NRC Agreement States, which carry out certain regulatory enforcement activities in lieu of NRC actions. Twenty-fdur states have OSHA-approved plans. |-‘ \D \ Moss, C.E., 2; il- "Estimated Number of United States Workers Potentially Exposed to Electromagnetic Radiation." Presented at the New Orleans Conference of AIHC, May 26, 1977. - lll - Currently, some OSHA inspectors have specific training in radiation protection, and some inspectors with indus- trial hygiene backgrounds have some knowledge of in radiation control approaches. NRC is able to apply the ALARA concept partly because of the relatively small number of workplaces it licenses and their basic similarity in purpose and facility design. NRC also carefully defines both the design and operational aspects of ALARA at the categories of facilities it licenses. Thus ALARA can mean a relatively constrained set of techniques, control measures, and engineering specifications on which health physics professionals can agree. OSHA, on the other hand, must deal with a multi— tude of workplaces, producing many different items by many different processes, in which radiation exposure may be essential, incidental, or even accidental. Since regula- tion under the Occupational Safety and Health Act depends on inspectable and enforceable standards, the ALARA philo- sophy has not been viewed as a practical means to regulate worker protection. igg/ At this point, OSHA has not aggressively enforced radiation protection in the sense that it has not been viewed as one of the most hazardous problems demanding priority attention and the commitment of OSHA's limited resources. Industrial use of radiation is primarily for nondestructive testing. The primary pathway of exposure is external radiation, either whole body or to the extremities. Workers in industrial facilities are exposed to industrial radiography, x—ray crystallographic machines, accelerators, radium, and other sources. 229/ Accidents and overexposure are rare in industrial use today; however, some radiation incidents have been l_g/ Since enforcement with most physical standards is based on the idea that exposures within the standard limits are "safe", compliance with the Federal Guide dose limits for radiation seems different from other OSHA compliance activities. However, defined ALARA guides for all workplace exposures settings is not achievable. 00/ The most prevalent types of accelerators used are ion implanters, Van de Graaff generators, neutron generators, and linear accelerators. - 112 - reported—-primarily in industrial radiography and x—ray crystallography. 291/ Lens opacities associated with improper accelerator beam alignment have been reported, although not recently, as well as serious whole body expo- sure through improper interlock procedures. Studies have shown that operator errors constitute the most frequent cause of overexposure. 222/ Moreover, the prevalent factor in overexposure incidents is the operator's failure to use the safety devices or procedures provided. Industrial radiography using gamma radiation sources is useful when external power sources for x—ray machines are unavailable, inconvenient, or not as effective. By—pro- duct materials, such as cobalt-60, are generally used as the source, and hence require licensing by NRC. Indus— trial radiography is one of four NRC licensee categories which are required to report personnel monitoring data. In 1977, 10,569 workers were monitored, of whom 6,197 had measurable exposures. A total collective dose of 3,159 person-rems was received, for an average measurable dose of 510 mrems. In 1977, 10 overexposures were reported in this category. 293/ 201/ EPA Radiologic Quality supra, note 42, p. 222. 202/ Cohen, S.C. 25 al., "Evaluation of Occupational Hazards From Industrial Radiation: A Survey of Selected States." DHEW Publ. No. (NIOSH) 77—142, p. 176. 203/ NRC "Occupational Radiation Exposure Tenth Annual Report, 1977," NUREG—0463, October, 1978, pp. 4, 33. - 113 - Accelerator workers are not covered by the Atomic Energy Act. However, exposure of workers at DOE and DOE- contractor facilities is covered by DOE worker protection orders. 293/ In 1976, DOE reported that 2,766 individuals were monitored, of whom half (1384) had measurable expo- sure. The total collective dose was 670 person-rems, for an average measurable dose of 480 mrems. ggg/ Worker exposure in manufacturing facilities is mainly from radionuclides, an area covered by Federal and State regulatory programs. There are also external exposures from radiation used for nondestructive testing of manu— factured products. Meaningful decrease seems achievable. There are several potential actions that can help t0' reduce manufacturing and industrial exposures: 0 Industry could adopt more intensive monitoring, closer management, supervision, safety, control procedures, and enforcement measures. 0 Conduct research into better waste handling and disposal. 0 Select and use isotopes that give lower exposures. 0 Develop accurate and uniform methods of reporting and documenting information on radiation sources and worker exposures, for those not already covered. 295/ Naturally occurring and accelerator-produced radioactive materials (NARM) are regulated by the Occupational Safety and Health Act and the States. An NRC task force has recommended that NRC seek legislative authority to regulate these materials. s93 NUREG—0301 and SECY—78-667, December 18, 1978. A Task Force of the Conference of Radiation Control Program Directors has developed 12 NARM guides for use by States. 05/ DOE, "Ninth Annual Report of Radiation Exposures for DOE and DOE Contractor Employees, 1976," DOE/ - 114 - 0 Develop, as an adjunct to current training courses, a clear and concise training manual for industrial radiation device operators. The manual should list practical safety measures in clear and understandable language. 0 Conduct more unannounced inspections of facilities to stimulate management's safety consciousness. 0 Consider further studies of the magnitude of unreported incidents and unregistered facilities, and, if a significant source of hazard, devise incentives for workers to report incidents and penalties for failure to register equipment. 0 Institute mandatory training requirements and develop training programs. 0 Develop programs to control, at point of manufacture, emissions from accelerators used in industry--e.g., voluntary pre-market testing or regulatory controls. 0 Stimulate more widespread State control over accelerators as in South Carolina's "Title C" program, which uses compliance with standards prepared by the National Bureau of Standards as a licensure requirement. 3. Nuclear Energy (Nuclear Fuel Cycle) The primary control over worker exposures during the nuclear fuel cycle is NRC licensing. As has been discussed earlier, before licensing nuclear fuel cycle facilities, NRC analyzes the safety of the facility and prepares a Safety Evaluation Report. One aspect of the safety review, performed before facility construction and reactor operation, is radiation protection for workers. The NRC radiation protection review emphasizes conformance with all applicable regulations, such as 10 CFR Part 20, Standards for Protection Against Radiation, and assurances that occupational radiation exposures will — llS - be ALARA. 296/ MSHA is also responsible for uranium mining and milling, and DOT and NRC operate under a Memorandum of Understanding with respect to transportation where the Atomic Energy Act and DOT hazardous materials authorities overlap. a. Uranium Mining Uranium ores were initially mined as a source of radium-226 for medical and industrial uses. Since 1948, however, almost 300,000 tons of uranium compounds have been produced, most for nuclear fuels. The most important source of exposure in underground mining is the inhalation of radon daughter products (alpha emitters). External radiation (gamma) exposure also occurs. MSHA data (based on mine operator data) indicate that in 1976, 4300 active miners received an average annual lung dose of 1 Working Level Month (WLM). 291/ However, other limited MSHA data suggest that the average annual radon daughter exposure may reach 4-5 WLM (20-25 rems to lung tissue). 298/ The current Federal Guide for underground uranium miners is 4 WLM per year. Total worker exposure is estimated to be 10,000 person-rems (internal alpha) and 6,000 person—rems (whole body gamma) in 1976. _g§/ Regulatory guidance in this regard is provided in part in NRC Regulatory Guide 8.8., Information Relevant To Ensuring That Occupational Radiation Exposures at Nuclear Power Stations Will Be As Low As Is Reasonably Achievable (1978); NRC Regulatory Guide 8.10, Operating Philosophy For Maintaining Occupational Radiation Exposures As Low As Is Reasonably Achievable (1977) and NRC Regulatory Guide 8.19, Occupational Radiation Dose Assessment In Light-Water Reactor Power Plants Design Stage Man-Rem Estimates (1978). 07/ One WLM exposure is the approximate equivalent of 5 rems exposure to lung tissue, according to BEIR I calculations. 08/ MESA (1976) "Administration of the Federal Metallic and Non—Metallic Mine Safety Act ... A Report to the Congress by the Secretary of Interior." - 116 - Lung cancer is the major consequence of long-term radon daughter exposure. Epidemiological studies by HEW's Center for Disease Control (National Institute for Occupational Safety and Health), estimate that 34-excess lung cancers result from every million WLM. 292/ The effect of smoking has not been thoroughly investigated but may shorten the latent period of the cancer. Currently, MSHA inspects underground uranium mines at least four times a year to ensure compliance with its standards. However, these standards have been mandatory only since the 1977 amendments to the Mine Safety and Health Act became effective early in 1978. Enforcement efforts with regard to radiation dose reduction are sup- posed to emphasize better ventilation of the mines, sealing off unused areas, and the design and use of better respiratory protection. The Federal Guides for under- ground uranium mines of 4 WLM/year may require re-exami- nation after publication of the BEIR III report. 219/ Additional monitoring may also be needed to assess more frequently the routine levels of exposure received in mines. b. Milling of Uranium Ores Under the Atomic Energy Act, the possession, processing, or disposal of ore containing uranium or thorium in concentrations that equal or exceed 0.05 per- cent requires the processor to be licensed by the NRC. There were 17 active uranium mills in 1976, with a nominal capacity of 28,450 tons of ore per day. For 1975, seven of these reported a collective dose of 166 person-rems 209/ Archer, V. Personal communication. 210/ The National Academy of Science Committee on the Biological Effects of Ionizing Radiation is expected to issue its third report in summer 1979. -117- for 437 monitored workers. NRC estimates a total collec- tive whole body dose for uranium mill workers of 400 person-rems per year. 211/ Milling operations are also subject to MSHA under the 1977 amendments to the Mine Safety and Health Act (which became effective in 1978). However, MSHA has incomplete radiation standards for milling. To the extent that the MSHA standards are incomplete, they should be reviewed and appropriate new ones issued. MSHA and NRC are working on a Memorandum of Understanding which, as currently drafted, would continue some overlapping jurisdiction in this area. c. Fuel Fabrication and Enrichment Gaseous diffusion technology is used to enrich the uranium-235 content in fuels. Inhalation of uranium and its naturally occurring daughters is the important exposure pathway. Fuel fabrication involves the process— ing of uranium compounds into pellets of uranium dioxide which are loaded into rods, and then assembled into fuel elements to be installed in reactor cores. Most of the waste compounds in fuel fabrication plants are in solid form. Both DOE and commercial plants are involved in the enrichment, conversion, and fabrication, of nuclear fuel. Some 12,838 DOE and DOE-contractor employees in 1976 received a total of 1741 person-rems. Of this number, 10,307 had measurable exposure, an average of 170 mrems per individual. Fuel processing accounts for the largest individual exposure, averaging 540 mrems. 212/ _11/ Reporting is mandatory for uranium mills under 10 CFR Part 20, when the mill processes or uses certain special nuclear materials in quantities exceeding ‘5000 grams. For the seven mills reporting, 404 “workers had a measurable dose, for an average mea— surable dose of 410 mrems per year. 2 2/ DOE Ninth Annual Report of Radiation Exposures, supra note 205, p. 9. - 118 - In 1977, some 23 NRC licensees (commercial plants) reported that 11,496 workers received a total of 1725 person-rems of exposure associated with fuel processing and fabrication. Some 7004 had measurable exposures, for an average of 250 mrems per individual. This is a reduc- tion from 560 mrems per person in 1975. 218/ d. Nuclear Reactors As is the case for all nuclear fuel cycle licensees, power reactor operation requires the applicant, as part of its license application, to submit to the NRC a variety of data and worker protection commitments. NRC places great emphasis on this phase of the fuel cycle, and it is being regulated with growing intensity. Applicants' commitments are reviewed for eventual NRC staff approval at both the construction permit and operating license stages of the application. Licensees are inspected for compliance with regulatory requirements as well as their commitments. 212/ Regulatory enforcement centers on the maximum dose limit and on the ALARA requirement for occupational exposures. NRC uses a Standard Review Plan to describe the NRC staff review requirements and process. 215/ Important methodo- logical elements include control of source strength; methods to reduce the number of people, length of time, and frequency of work in the radiation field; and design, equipment, and procedural aspects of worker protection. NRC‘s revised ALARA Guide is applied to all new power reactor license application. gig/ Thus, all currently 213/ NRC, Occupational Exposure Tenth Annual Report, supra note 203, p. 8. 213/ This discussion is focused on commercial power generation. DOE has responsibility for DOE and contractor-operated reactors (both for weapons development and for energy research purposes). 215/ NRC, "Standard Review Plan for the Review of Safety Analyses Reports for Nuclear Power Plants -- L.W.R. Addition," NUREG—78/087, September 1975. (Revised in 1978). 21 / NRC Regulatory Guide 8.8, supra note 211. - 119 - licensed power reactors have passed an ALARA review as a condition of licensure; however, once licensed, operating reactors do not receive a systematic ALARA program review. NRC staff have recommended a stronger ALARA program to the NRC Commissioners, which would require licensees to submit an ALARA program and to make commitments to specific ALARA actions which would be inspectable and enforceable. 311/ The occupational exposure limit for nuclear workers covered under DOE orders is 5 rems (whole body) annually and 3 rems (whole-body) in a quarter. NRC also limits exposure to 3 rems (whole body) per quarter, but permits 12 rems (whole body) per year in certain instances. gig/ The current standards are based on a calendar quarter. Several unions representing reactor workers have argued that the standard should be based on a running quarter. One of their concerns is that workers could conceivably receive their full quarterly dose late in one quarter and early in the next--i.e., six rems in a few days time——if high-exposure tasks were grouped near the end of the calendar quarter. However, among monitored 211/ NRC Policy Session Item, "Further Actions to Control Risks Associated with Occupational Radiation Exposure in NRC-Licensed Facilities," SECY-78-415, August 1978. This would apply not only to power reactors but to all NRC licensees. glg/ The cumulative lifetime occupational exposure limit is determined by the formula 5 (worker age - 18). The effect of this formula is to permit whole body external doses as high as 12 rems annually provided that the dose averaged over the worker's lifetime does not exceed 5 rems per year. The 3 rem/quarter limit may only be used in instances where the worker's cumulative dose records are available to the licensee; where it is not known, the quarterly limit is 1.25 rems (10 CFR Part 20). In addition to the permissible limit for whole body external radiation of 12 rem per year for individuals whose average accumulated dose is controlled by the 5(n-18) formula, there can be an organ dose as high as 15 rem per year as a result of inhalation or ingestion at a rate equivalent to the maximum permissible concentrations of 10 CFR Part 20, Appendix B, Table 1, Column 1. - 120 - workers, only a small proportion (approximately 129 out of 71,904 nuclear power plant workers) experience doses greater than 6 rem even in a year. 212/ The average dose of reactor workers with measurable doses has stayed relatively constant (600-800 mrems annually) and the per- cent of exposures under 2 rems has remained at about 95 percent of the total workers. 332/ The running quarter concept has been considered by standard setting organiza- tions and regulators but is not viewed as a workable or useful means to reduce radiation exposures. Another concern raised by some unions, public interest groups, and environmental groups is the adequacy of current radiation dose monitoring. NRC requires extensive monitoring as a condition of licensure; this is primarily the responsibility of the licensee, with some NRC over— view. Some groups have suggested that monitoring activi— ties should not be performed solely by licensees, because of their possible conflict of interest. 32;/ Alternatives which have been suggested include monitoring by an inde— pendent agency, such as OSHA, or State radiation control programs, or the unions (on the theory that unions would have a primary commitment to worker safety). A special problem of worker monitoring involves recordkeeping on workers who move from one plant to another, such as subcontractor personnel, "moonlighting" 219/ NRC, Occupational Exposure Tenth Annual Report, supra note 203, p. 8. g_g/ In 1977, there were 71,904 person monitored in 65 NRC licensed nuclear power plants, of whom 44,233 had measurable exposures. Their average annual dose was 740 mrem, a collective dose of 32,731 person-rems. (ggg NRC, Occupational Exposure Tenth Annual Report supra note 208. In DOE reactor faci- lities, 8886-workers were monitored in 1976. The 5861 with measurable exposures averaged 420 mrem, a collective dose of 2436 person-rems. §gg DOE Ninth Annual Report of Radiation Exposure supra note 205. 221/ NRC is currently developing a requirement that monitoring results be checked against standard sources and standard techniques. - 121 - workers, and other transient workers. Transient workers may receive allowable doses at more that one facility during a calendar quarter or year, thus exceeding the maximum allowable doses at more than one facility. Some of these workers are highly skilled and are therefore called upon to do high exposure special maintenance work. Others who are skilled may be used in high radiation areas when the employers have already exposed the normal workforce to their maximum permissible doses or when they choose to save their exposures for other work. ’The NRC has published a Notice of Proposed Rulemaking which would require licensees to give any employee a prompt estimate of dose upon termination of work if the employee so requests and to obtain information on prior exposures for new employees. 332/ The system proposed by NRC would improve controls on exposures. However, it might be feasible to design alter— native systems which do not place a burden on the worker to maintain and transmit the records. There may be an economic incentive for a worker to falsify his or her exposure status, since the worker would not be able to work if the dose limit had already been accumulated. Since there are a known and finite number of licensees, it might be a stronger system if it placed the burden on the licensee to obtain the exposure information from the other licensees rather than the worker. However, the NRC rule is stated in its present form to minimize delays in employment and loss of pay for workers who might other- wise have to wait for exposure records to be obtained by prospective employers. The nuclear fuel cycle, and power reactors in particular, are among the more thoroughly supervised industrial sectors in the United States. ggg/ However, a number of dose reduction possibilities can be identified, in addi- tion to the NRC staff recommendation for an enforceable N N N \ 43 Fed. Reg. 4865, (1978). N N w \ In addition to licensure, inspection, and enforcement, NRC issues numerous regulatory guides to describe methods acceptable to NRC to meet Commission regulations. - 122 - ALARA program. 223/ One possible approach would require licensees to perform cost—benefit analyses and provide all additional protection shown to be cost—effective (e.g., by establishing a dollars-per—person—rem criterion). Another would be to establish a total collective dose objective for various types of licensees. The NRC has evaluated these alternatives and has decided, for the time being, that these approaches would not be cost-effective. In NRC's view there is an inadequate data base on which to establish such a program. In recent years the NRC has taken several actions to reduce occupational radiation exposure in licensed nuclear facilities to ALARA including: (1) constant review, revision of, and additions to regulations; (2) the promul- gation of guidance on good practice, design, equipment, and operations; (3) increased plant inspection, including a resident inspectors program; (4) strengthening of the exposure reduction review, inspection, and enforcement functions for licensees and applicants; (5) meeting with industries, other government agencies, research organiza- tions, and others; (6) support of research projects (con- ducted by the National Laboratories, industry, Electric Power Research Institute, and the Atomic Industrial Forum); (7) preparation and presentation of technical papers and sessions (particularly through the American Nuclear Society and the Health Physics Society). NRC has studied exposure experience in recent years through examination of required monitoring data and research projects. Routine and special maintenance workers are the most exposed occupational group, because of the increase in maintenance work and the increase of radiation dose rate near reactor equipment as reactors age. Build-up of activated corrosion products on the inner surfaces of reactor primary coolant systems is one important source of this exposure due to the increase in exposure from older plants, and is an important area for prevention efforts. e. Disposal of Nuclear Wastes The transport and disposal of nuclear wastes are sources of occupational exposure. NRC has estimated that occupational exposure from the transportation of fuel and 24/ See supra note 217 and accompanying text. - 123 - waste to and from one lightwater-cooled nuclear power reactor is 4 person-rams per reactor year, distributed over 200 workers. (The range of individual exposure is estimated to be 0 to 300 mrem). ggg/ In 1975, NRC received data from the four licensees engaged in waste disposal by burial. While only 65 workers had measurable doses, the average dose was relatively high—-1260 mrems per worker, a collective dose of 81 person-rems. 235/ A number of actions warrant consideration to achieve further reduction in occupational exposures in the nuclear fuel cycle: 0 Encourage timely action by EPA on its proposed revision of occupational guidelines. 0 Conduct a review of radiation exposure standards, with a public hearing, as proposed in the NRC staff paper of August 17, 1978, and include con- sideration of alternate approaches described in that paper. 221/ 0 Carry out a comprehensive ALARA program review: By NRC, for all licensed operating nuclear fuel. cycle facilities (as recently recommended by NRC staff), and by DOE, for their similar contractor facilities. This would include but not be limited to training programs, management ALARA responsi- bility, worker involvement in radiation protec- tion, radiation exposure record keeping, exposure analysis, written procedures, and independent audit of radiological control requirements. Provide additional guidance in this regard, as is currently being prepared by NRC. N N w \ EPA Radiologic Quality, supra note 42 pp. 164-166. This estimate, however, does not clearly define the potential impact of accidents, in EPA's view. N N m \\ Cool, W., "Occupational Radiation Exposure at NRC Licensed Facilities, 1975." NRC Publ. NUREG-0419, p. 11. - N N 4 \\ NRC, Policy Session Item, supra note 217. 4. - 124 - Develop the basis for an improved and more elaborate radiation exposure monitoring system including, where economically justifiable, com- puterized data keeping and exposure data recall. Carry out a feasibility study of various options to involve workers more extensively in radiation exposure protection activities. Carry out or stimulate and support additional research in areas of activated corrosion product reduction, including chemical cleaning, high- temperature—high-flow filtering, water chemistry control, and operational control, whenever iden- tified effective measures can be shown to be con- sistent with the cost benefit philosophy embodied in the ALARA principle. Support additional research in radiation dosimetry and instrumentation (especially assessment of neutron exposure); establish uniform methods for testing and calibrating all radiation protection instrumentation to achieve optimum precision and uniform reporting. Continue to strengthen regulations and regulatory guidance in the areas where the identified mea— sures will have the greatest potential for collective exposure reduction in licensed nuclear energy facilities. This is an ongoing effort of NRC, with input from other agencies. Carry out proposed re-examination of the Federal Guide of 4 WLM/year for miners. Research Research-related occupational exposure to ionizing radiation can occur in university and college laboratories, hospitals, industrial research laboratories, and private and public research organizations. It is estimated that as many as 100,000 workers are potentially exposed to sources such as electron microscopes, x-ray diffraction units, accelerators, x-ray machines, reactors, and radionuclides. The population dose due to occupa- tional exposure in research settings is approximately - 125 - 12,000 person-rems per year. 328/ It is impossible to know how much collective dose might be added from expo- sure to low-radiation sources used in science education-- 143., teachers and high school and college students. In addition, numerous graduate students, research assistants, research associates, and post-doctoral fellows work with radiation in research projects. Little or no data exist on these exposures. Although some of these research facilities are subject to NRC regulation and all are subject to OSHA regulation, as well as having some State and local control, the preven- tion and reduction of occupational exposures in research settings has not been a high priority. States normally require that radiation-emitting machines be registered and subject to inspection, but they often inspect them less than once per year. Research facilities usually have a radiation safety officer who is responsible for radiation protection, and the reduction and prevention efforts of the facility are related to the officer's incentive, know- ledge, and ability to influence the researchers' controls. Unfortunately, too many investigators tend to place inadequate emphasis on the radiation protection aspects of their experiments, due to either lack of proper training or carelessness due to lack of proper motivation. The magnitude of individual doses from this source is unknown, and it may be a significant problem. A number of actions could be taken which could reduce occupational exposures in research facilities: _g§/ Work Group estimates. DOE carries out and supports weapons—related and other nuclear research in the National laboratories such as Oak Ridge, and in contractor facilities, such as the University of California. In 1976, monitored workers in the cate- gory, General Research, had low individual doses (190 mrem) per individual with measurable dose. Of 34,258 individuals monitored, 14,186 had measurable doses, with a collective dose of 2,698 person-rems. Other specialized research is not separately inden- tifiable in certain DOE monitoring classifications-— e.g., accelerators. gee DOE Ninth Annual Report of Radiation Exposure, supra note 205, p. 9. - 126 - 0 Encourage research centers to make exposure reduction the specific responsibility of principal investigators and provide assurances of adequate safety training to their personnel. 0 Use radiation protection emphasis as one criterion in selecting projects eligible for radiation research funding. 229/ 0 Alternatively, Federal grant and contract guide- lines could be developed, along the lines of NIH's DNA recombinant research guidelines (43 Fed. Reg. 33042, July 28, 1978) to encourage all facilities to adopt stringent radiation safety procedures. 0 Conduct studies and personnel monitoring to ascertain whether significant, currently unrecog— nized exposures are occurring in research settings. 5. Naval Reactors Radiation exposure to personnel in the Naval nuclear propulsion program can occur during pressurized water reactor operation, during support activities (ELE'I personnel on tenders), and during reactor maintenance work at naval shipyards. 239/ The Navy has an active program to control these exposures. The policy of the Navy with respect to radiation exposure is to reduce exposure to ALARA. Results of their efforts to reduce radiation exposure are shown in Appendix 6.- _22/ Recommendations on areas of research which are likely to have useful findings could be developed by NIH or the National Academy of Sciences. However, perception of these as a restriction on subject matter suitable for study may lead to resistance by the academic community. N w o \ In 1978, the U.S. Navy operated two submarines bases, ll3 nuclear submarines, and 11 nuclear powered ships. Six naval shipyards and three pri- vate shipyards (all manned primarily by civilian personnel) were engaged in the construction, overhaul, and refueling of these ships. -127- Over the last twelve years the total radiation exposure has been reduced to less than half of the amount in the peak year of 1966, even though the number of nuclear powered ships nearly doubled during that period. In all shipyards, a total of about 100,000 individuals have been monitored for exposure to radiation since 1955. The annual exposure rate of monitored workers has averaged somewhat less than 10,000 person-rems. In 1978, 14,984 personnel were monitored at shipyards, and 22,403 were monitored aboard ships and at submarine bases. 33;/ The collective dose was approximately 6000 person-rams, with individual doses ranging from 0-3 rems per monitored worker. The mean exposure of each person monitored has 'been about 250 mrem per year. The total lifetime exposure from radiation associated with Naval nuclear propulsion plants to date for all personnel monitored since 1954 has averaged about one rem per person. ~No personnel have ever received more than one-tenth the Federal annual occupational exposure limit from internal radiation exposure caused by radio- activity associated with Naval nuclear propulsion plants. Since 1967 no person has exceeded the Federal limit on external exposures, which allows up to three rem per quarter, nor in this ten—year period has anyone exceeded the Navy's selfimposed limit of 5 rem per year for radia- tion associated with Naval nuclear propulsion plants. Several approaches are combined in Naval radiation protection. Control of radiation during reactor plant operation is based on shielding and ship design. Control of radiation in support facilities incorporates specially designed and shielded facilities, controlled access, and radioactive material accountability systems. Shipyard training is stressed to assure each person understands his or her duties and responsibilities. Nuclear power training is provided to all military personnel who operate naval propulsion plants as well and to commanding officers of nuclear-powered ships. 321/ Department of the Navy, "Occupational Radiation Exposure from U.S. Naval Nuclear Propulsion Plants and their support facilities," Report NT—79—2, February 1979, p. 19, 20. - 128 - Monitoring is emphasized. All workers are issued dosimetry equipment and are required to know their own exposure. Shipyards typically produce computer printouts of dosimetry data for all personnel twice daily and dis- tribute this data to all worksites. Workers are also extensively monitored for internal radiation using sensi- tive scintillation detectors. ggg/ Internal radioactivity is controlled by measures to control airborne radioactivity, radioactive surface con- tamination, food and water, and wound contamination. Internal and external radiation exposure reduction is achieved by a combination of factors involving planning, training, and operational procedures. ggg/ The Navy believes that checks and cross-checks and audits and inspections of numerous kinds are essential in minimizing radiation exposure. Each worker is specially trained in radiological control as it relates to his or her own job. Written procedures exist which require ver— batim compliance. Radiological control technicians and their supervisors oversee radioactive work. Personnel independent of radiological control technicians are responsible for personnel radiation exposure records. A strong independent audit program is required covering all radiological control requirements. In all shipyards this radiological audit group is independent of the radio- logical control organization and its findings are reported regularly to senior shipyard management including the shipyard commander. This group performs continuing surveillance of radioactive work. It conducts in-depth audits of specific areas of radiological control. This group checks all radiological control requirements at least annually. DOE assigns to each shipyard a representative who reports to the Director, Division of Naval Reactors at DOE headquarters. One assistant to this representative is ggg/ In 1978, nine shipyards monitored 11,701 workers. Two workers were found to have internal radio- activity in their lungs, both from work outside Naval programs. 33/ See Appendix 7 for a DOD checklist of radiation exposure reduction approaches. - 129 - assigned full time to audit radiological controls, both in nuclear-powered ships and in the shipyard. The Naval Sea Systems Command also conducts periodic inspections of radiological control in each shipyard. Similarly, there are multiple levels of audits and inspections for the other Navy shore facilities, tenders, and nuclear- powered ships. Recently, a report of excess cancer mortality among workers in the Portsmouth, NH, naval shipyard was pub- lished ggg/ and extensively reported in the Boston Globe. NIOSH and DOE are conducting epidemiologic studies of workers in Portsmouth to ascertain whether or not these reported findings represent a true excess in radiation- induced cancer deaths over those expected in this population. ggg/ Worker exposure may also come from transportation of radioactive wastes (see Nuclear Energy, above). Expo— sures of Naval personnel are included in the figures cited above. Solid low-level wastes are shipped to burial sites licensed by the NRC or States, shipments are made in accordance with DOT regulations, in approved containers. Spent fuel and associated material is shipped from refueling shipyards by DOE under NRC, DOT, and DOE requirements. ggg/ Worker exposure in transit is estimated at 3 person rems per year. 331/ Exposures at the receiving site are included under the nuclear fuel cycle. 234/ Najarian, T. and Colton, T, "Mortality from Leukemia and Cancer in Shipyard Nuclear Workers", Lancet Vol. i, 1978, pp. 1018-1020. 235/ See Science Work Group Report, supra note 8. 236/ Department of the Navy, "Environmental Monitoring and Disposal of Radioactive Wastes From U.S. Naval Nuclear Powered Ships and their Support Facilities", Report NT—79—l, January 1979. 37/ Estimates derived from NRC, "Final Environmental Statement on the Transportation of Radioactive Materials By Air and Other Modes," NUREG 0170. Vol. 1, Dec. 1977. - 130 - 6. Nuclear Weapons Development and Production Sources of occupational radiation exposure due to the nuclear weapons cycle can be related to the same phases as those discussed earlier for population exposure. All fabrication, testing, and development operations are conducted at DOE facilities. In 1976 a total of 814 person-rem (i.e., about 8% of all DOE activities) was due to occupational exposure in this area. 238/ Of this, 25 person-rems are related to underground testing. 239/ The vast majority of the exposure occurs during development and fabrication. All DOE operations are subject to Chapter 0524 (Standards for Radiation Protection) which includes a detailed program for radiation exposure reduc- tions. Facility and equipment design, operating proce- dures, monitoring and personnel protective equipment, and aspects of radiation safety management are addressed in detail in this chapter. The collective dose equivalent for all DOE operations has been reduced by a factor of three over the last 10 years. Further reductions will probably be achievable only by detailed examinations of each operation within the framework of existing radiation programs and by continued management emphasis of this effort. Radiation doses received within DOD, related to nuclear weapons deployment, are generally very low. Programs designed to maintain weapon readiness and effectiveness help to maintain these exposures at a very low level. Exposure levels are low enough that the associated mili— tary personnel are not considered radiation workers by the definition of Federal regulations. 240/ There are a few specific exceptions to this because of the special nature of a particular type of deployment. These opera— tions are under constant review so that if conditions change the radiation protection measures can be reevaluated and updated if necessary. 238/ DOE Ninth Annual Report of Radiation Exposures, supra note 205. 2 9/ This estimate is based on the assumption that all doses received by personnel involved in the program were associated with the testing. 40/ 10 CFR Part 20. - 131 - Past activities involving personnel in the Atmospheric Nuclear Tests Programs resulted in exposures to a sizable population over the seventeen-year period 1945 through 1962. Approximately 225,000 military and civilian per- sonnel were involved in the test activities. A massive effort is currently underway to assemble as completely as possible all identifying information and radiation exposure data on all persons present at each United States atmospheric nuclear bomb test. 251/ The populations of some communities near the test site received relatively high thyroid doses: A study of young people in southwest Utah and adjacent Nevada exposed to fallout estimates that the average cumulative individual thyroid dose during 1952—1955 was over 100 rad. 352/ Exposures of personnel involved in the clean-up and' rehabilitation of one of the Pacific sites (i;g., Enewetak Atoll) are very low. In general, exposures are below the rather sensitive detection levels of the radiological monitoring systems used. Therefore, the collective dose equivalent can only be estimated. On the basis of moni- toring data, this is less than ten person-rem annually, distributed over about 1000 individuals. 7. Other Occupations Radiation exposures also occur to workers in other occupations who are not usually considered radiation workers. These workers include metal ore miners, ore millers and processors, transportation and cargo handlers, some construction workers, workers in caves (including storage and record vaults), and aircrews in jet aircraft. Most of these workers are not well monitored, consequently their exposure levels are difficult to estimate. The Work Group estimates that this wide variety of occupational exposures may reach 50,000 person-rems annually. Mining (excluding uranium), with relatively small individual exposures but a relatively large number of workers, is the largest single source of exposure in this group—-approxi- mately 20,000 person-rems. 241/ Science Work Group Report, supra note 8. 242/ g. - 132 - Because of the relationship established between underground uranium mining and lung cancer due to exposure to radon decay products, there is concern over the radon decay product exposure to non-uranium (i.e., metal ore) miners. Metal ore mines are presently regulated by MSHA under the same exposure standards as uranium miners (4 WLM per year). However, the mandatory Federal standards only became effective in March 1978, the effective date of the 1977 amendments to the Mine Safety and Health Act. The NAS is expected to include the risks due to radon decay products exposure in its forthcoming BEIR III Report. It is recommended that: 0 Maximum exposure limits for miners (including open pit miners and milling workers) be revised if the BEIR III assessment of radon decay expo— sure supports this action. Construction workers have been identified by some as potentially exposed to radiation when involved in con- struction near operating nuclear facilities. Also, long— term association with construction materials (such as phosphate-mined gypsum) which contain low-level radio- activity may create special situations of excess exposure. Calculations of exposures from mathematical formulations of exposure level, or a field survey, might be useful in assessing these potential risks. It is recommended that: o The exposure levels of construction workers be evaluated. Fossil fuels used in power generation have had almost no study. It is therefore unknown whether significant radiation exposure occurs among workers in coal-fired plants, although the potential for at least some exposure exists. ggg/ It is recommended that: 0 Studies be conducted of potential occupational hazard from radiation for workers in coal—fired power plants, ash disposal, etc. With the exception of persons engaged in the manufacture and distribution of consumer products designed speci- fically to contain radioactive material, it is generally 43/ See discussion under General Population Exposures, supra . - 133 - assumed that most workers are not significantly exposed. However, there are indications that some occupations or industries may have more significant amounts of exposure than is currently recognized. Currently, the OSHA stan- dards for radiation exposures do not contain provisions dealing with medical surveillance or training. The following recommendations are therefore made: 0 Identify and classify as radiation workers persons potentially exposed during the manu— facture of any products containing radioactive materials. 0 Modify existing OSHA standards to provide for better monitoring and control of exposures. 0 OSHA and NIOSH should do further work to identify workers who may use radioactive materials or be exposed to them. Findings should be publicized to employees and workers and built into OSHA enforcement activities, as appropriate. Air crews on jet aircraft at relatively high altitudes have increased exposure to cosmic radiation; their expo- sure is dependent on in-flight time, altitude, route, and the presence of solar flares. The annual doses received are on the average less than 1 rem but for supersonic air— craft the dose could be slightly higher. To alert pilots so that aircrafts altitude can be lowered, in-flight radiation monitors are used on supersonic flights to detect excessive radiation levels during solar flares. This system is also an alert system for fallout contamina- tion from atmospheric nuclear testing. Although no addi- tional regulatory action is required, other activity could be warranted: 0 Conduct systematic annual assessments of radiation exposures for air crews to define the actual doses received by these workers. IV. CROSS-CUTTING CONSIDERATIONS In the course of considering specific actions in Part II, a number of issues emerged which relate to more than one source of exposure. The most important of these cross-cutting considerations are (l) the role of the - 134 - States, (2) the need for improved monitoring, (3) transportation, (4) complementing regulatory approaches with voluntary compliance and incentive approaches and worker involvement, and (5) reproductive health. A. The Role of the States State radiation protection programs have an important role in radiation exposure reduction efforts. Many of these programs are underfunded. The States have had difficulty retaining trained staff in order to mount and maintain comprehensive programs. About half are located in state natural resource or environmental protection agencies and half are located in human resources agencies or health departments. Twenty-five States are recOgnized as Agreement States by the NRC and carry out regulatory inspection programs in their jurisdictions. There is, however, a potential problem in that these programs deal to some extent with workers covered by OSHA. Thus, they may technically have been preempted by the Occupational Safety and Health Act unless that State is operating under an OSHA-approved plan. The State agencies conduct inspections, enforce Federal regulations and State statutes, and carry out environ- mental monitoring programs. Some states are active in controlling naturally occurring and accelerator—produced radioactive materials (NARM). 353/ State emergency response plans are often the responsibility of these pro— grams. Finally, a number of States maintain education and public information programs. The annual budgeted expenditures (Federal and State monies) for State and local radiologic health activities average 6.5 cents per capita, ranging from 0.5 cents to 16.8 cents per capita. ggg/ Because of their experience and expertise, _55/ However, present controls over NARM are fragmentary and non-uniform at both the State and Federal level and these materials present significant radiation exposure potential. §g§ "Regulation of Naturally Occurring and Accelerator—Produced Radioactive Materials," NRC Task Force Review, NUREG 0301 (July 1977). 245/ Miller, L.A., "Report of State and Local Radiological Health Programs. Fiscal Year 1976." HEW Publication (FDA) 77-8034. August 1977. - 135 - any major national program to reduce radiation exposures would probably need to be performed in concert with these State programs, or at least with those States most able and willing to participate. However, the States would need additional capacity and power to extend and broaden their activities, assuming they are willing to do so. Several actions can be taken to assist the States in achieving this goal: 0 The States, in conjunction with the appropriate Federal agencies, could establish guidelines for the conduct of State Radiation Control Programs. (A task force of the Conference of State Radiation Program Directors is currently working on this). 0 Minimum standards could be adopted and a joint monitoring system set up to assure the overall quality of the program. 0 The States could be encouraged to adopt uniform standards and regulations which are consistent with current Federal regulations. 0 Financial assistance could be made available to students specializing in radiation protection at both undergraduate and graduate levels with funding provided by appropriate Federal agen- cies. In return the students receiving aid would be required to serve internships in State programs. 0 Additional Federal financial and technical assistance and training to State Radiation Control Programs could be provided for recruit- ment and retention of competent professional and technical personnel as well as maintenance of properly equipped facilities. Restoration of Federal short-term training programs would be very useful to States. B. Improved Monitoring Although monitoring can be costly, and many of the samples taken will not show radioactivity, public concern about radiation suggests that there is a need to estab— lish quantitatively how much exposure of the public is - 136 - occurring. Credibility in the sensitive area of public concern may be better served if monitoring is not con— ducted solely by the entities that produce the potential exposures. The value of monitoring data comes from a variety of uses. Personal dosimetry data is a prevention tool and it is also an important research resource. Negative environ- mental data confirms that protection programs are meeting their objectives, while adverse findings trigger evidence of break-downs in protection. Human exposure monitoring is also often of critical importance in establishing eligibility for compensation. Credibility of government radiation reduction efforts may demand a greater commit— ment in monitoring. The psychological impact of visible monitoring can be an incentive to management and to workers to consider reduction actions more carefully, as well as a reminder that all radiation has risks. This is true in medicine as well as in industry. While considerable environmental monitoring is being done, there is probably less environmental monitoring done now than in earlier years. There is also less publication of data. During the years of high fallout, the FDA's Bureau of Radiological Health and its predecessor agencies issued a monthly publication, Radiological Health Data Reports. This publication has been terminated by EPA and replaced with a limited annual report, but environmental groups have argued that it should be reestablished to be more comprehensive and timely. EPA's Environmental Radiation Ambient Monitoring System (ERAMS) is an important source of data on environmental radioactivity. The States once received considerable Federal support for monitoring, but that support has diminished over time in the face of grow- ing costs to States for monitoring. NRC receives reports of personnel monitoring from the most important categories of licensees and has some voluntary sample reporting of exposure data from other licensees. NRC has promulgated a rule changing the exceptions to the mandatory reporting requirement. DOD and DOE also have environmental and personnel monitoring programs. BRH monitors medical radiation use but has inadequate data sources. There is limited monitoring of radiation expo- sure from transported materials. - 137 - The following recommendations could expand and improve current monitoring: 0 Additional monitoring by the States both of ambient radiation and radionuclides in the environment and of human exposures (e.g., medical exposures, research, and consumer products). 0 Development of improved measuring technology for greater validity in measured beta and neutron doses. C. Transportation Transportation of radioactive material involves potential exposure both for the general public and for workers, and cuts across the nuclear industry, medicine, military, and other uses of radioactive materials. Annual transport of radioactive materials increased from 200, 000 packages in 1961 to approximately 2. 5 million today. 246/ There is considerable concern from transportation per- sonnel, environmental groups, and the general public over the potential hazards of radioactive material transport. Recent accidents involving the transport of radioactive substances have increased this concern. DOT regulates the safety aspects of the transportation of hazardous materials. 247/ The NRC regulates the pos- session, use, or packaging of radioactive materials that 246/ R.F. Barker, Statement Before the U.S. Senate Committee on Commerce, Hearings on the Transportation of Hazardous Materials, June 12, 1974. An estimated 40% of packages containing radioactive material travel by air, primarily on passenger-carrying aircraft. 222/ DOT regulates safety aspects of transportation in interstate and foreign commerce on land, on civil aircraft and on vessels in navigable water not operated by public agencies. DOT safety regulations apply to shippers, freight forwarders, warehousemen, and private contract and common carriers of radio- active materials. - 138 - are by—product, source, or special nuclear material. 248/ DOT and NRC operate under a Memorandum of Understanding to avoid overlap. The regulations for the transportation of radioactive material seek to limit radiation exposure during transport through containment of the radioactive material and pro- tection of people (and film) from radiation emitted from packages in transport. DOT, often with NRC, engages in several non—regulatory efforts at transport safety. Efforts include joint emer- gency planning with States, information dissemination, deVelopment of cargo handlers safety guides, training and State surveillance programs. 1. Shipment of Low Level Radioactive Material The NRC and DOT have undertaken a joint study of the adequacy of existing requirements for transportation of low-level radioactive materials. This study followed a highway accident in September 1977 in Springfield, Colorado, in which several tons of uranium concentrate (yellow cake) were spilled, necessitating an extended clean-up involving State, local, carrier and shipper resources. 332/ The NRC and DOT studied several possible actions including routing and advance notification _§§/ Exempt from NRC regulations are common and contract carriers, freight forwarders, and warehousemen when transporting or storing, as a part of the transpor- tation process, a shipper's by-product, source, or special nuclear material and when subject to DOT regulations. 332/ Congressman Wirth of Colorado requested a study of the regulations and actions related to package integrity and emergency response to transportation accidents involving radioactive materials. - 139 - requirements. 250/ In a draft report from the study group, relatively few of the actions studied have been approved. The study group cited a low benefit to risk ratio for most of the proposals. There is some concern, however, that citizen and environmental groups should have an opportunity to present their views on the proposals. 2. Transportation Personnel Monitoring There is no routine personnel monitoring data available on transportation related exposures. A recent surveillance conducted by several States showed that some employees of freight forwarders who handle packages con— taining radioactivity receive more than the permissible annual radiation dose for the general population. 251/ Transport workers who handle packages containing radio- activity are not classified as radiation workers by the regulations. Thus, these workers are not monitored for radiation exposure. The Department Of Transportation plans to issue a Notice of Proposed Rulemaking which would impose occupational radiation exposure requirements on those specialized carriers or freight forwarders hand- ling specified volumes of radioactive material packages. 3. Transport of Spent Nuclear Fuel and Wastes During the past two years, there have been two separate proceedings before the Interstate Commerce Commission (ICC) involving exemptions from tariff provi- sions for the handling of rail shipments of spent fuel g_g/ Other actions considered were: modification of NRC rules to require licensee shippers to maintain emer— gency procedures for transportation accidents; changes in the method of shipping low specific activity materials; requiring that an information packet accompanying each shipment; clarification of Federal, State, local, carrier, and shipper finan- cial and other responsibilities and responses for an accident; and development of a system for obtain— ing up—to—date transportation data (e.g., types, quantities, etc. ). 51/ NRC, "Summary Report of the State Surveillance Program or the transportation of radioactive materials," NUREG-0393, March 1978. - 140 - and wastes. The ICC has ruled against the railroads in each of the cases, in effect ordering the railroads to carry the radioactive material. ggg/ In a related pro— ceeding, the nuclear industry and DOE filed complaints with the ICC against certain eastern railroads holding themselves out not to be common carriers of irradiated spent fuel. In this case also the ICC issued a ruling against the railroads' position. ggg/ In a separate pro— ceeding the ICC has ruled against a requirement of a special train to carry radioactive material. gég/ Several environmental groups advocate a moratorium on the transhipment or off-site shipment of spent fuel from nuclear reactor sites until safe permanent disposal is found. géé/ Environmental commentators have noted that movement of spent fuel from one reactor to another or to off—site storage increases the danger of a transport acci- dent without gaining permanent safe storage. These groups further argue that there should be a uniform policy on the disposal of nuclear waste rather than ad hoc responses to problems as they develop. gég/ See ERDA v. Akron, CAnton and Youngstown Railways et al., ICC Docket No. 36312 (spent fuel and irradiated waste) (stay granted pending appeal); ERDA v. Akron, Canton and Youngstown Rwys., Civ. 18-3 425 6th Cir., (August 3, 1978). See also Missouri-Kansas-Texas Railway Co., ICC No. 36307 (radioactive waste material). 2;;/ Department of Energy, Department of Defense v. [18 Railway Companies], ICC No. 37076, pending, filed Nov. 9, 1978 (irradiated waste from nuclear reactors). 54/ Radioactive Material Special Train Service Nationwide, ICC No. 36325 (March 8, 1978). géé/ Some nuclear plants are reaching storage capacity for on—site storage of spent fuel. Among the options available to nuclear power companies at or near maximum storage are transhipment to another reactor or shipment to off-site storage. - l4l - \. 4. Radiological Emergency Response Planning for Transport Accidents The subject of emergency response planning for nuclear transport accidents has evolved as an important issue in the public forum. Recent accidents, such as the Colorado "yellow cake" spill and the derailment of a freight train carrying several uranium hexafluoride cylinders near Rockingham, North Carolina, in March 1977, have served to heighten the issue and raise pressing questions on the need for coordinated emergency response planning. An interagency group has issued a guidance manual on development of State emergency response for transportation related accidents and developed programs of operational training in radiological emergency response planning. DOT is developing a gudiance manual on handling transport accidents and a training course for emergency services personnel on handling nuclear transport accidents to sup- plement the 20-hour course already developed on handling of all types of hazardous materials transport accidents. However, as the recent emergency responses to transport accidents show, more needs to be done to help the States develop and implement responsive plans. Local concern over transport and particularly over the routing of such transport is shown by New York City's passage of a regu— lation forbidding certain radioactive material transport across the city and by the large attendance at NRC hear- ings held in New York on this issue. ggg/ DOT recently announced a Notice of Advanced Rulemaking inviting comment on the need to establish routine requirements for highway transportation of radioactive material. 321/ Recommendations for reducing radiation exposure during transportation are: ggg/ gee also DOT No. HM—l64, Advance Notice of Proposed Rulemaking, 43 Fed. Reg. 36492 (1978) (inquiry to ascertain whether federal action necessary following New York City's routing ordianance). 257/ I_d. - 142 - 0 Consider developing routes to minimize travel through heavily populated areas, and issuing advance notice to State and local governments involved. National security is a factor which must be considered before issuing advance notification of some shipments. 0 Consider restricting certain radioactive material cargoes to freight-only vehicles, when slower modes would not causer greater exposures or loss of activity (e.g., short half-life nuclides). 0 Consider establishing permanent surveillance programs, perhaps with grant support, through State radiation programs to detect transport exposure trends at an early stage and to evaluate additional shielding requirements. 0 Consider consolidating Federal authority over the transportation of nuclear material now held by DOT, NRC, and the DOE. D. Worker Involvement in Radiation Reduction Increasingly, Federal enforcement of physical standards alone as a worker or consumer protection mecha- nism is seen as an incomplete approach to State and National goals in preventing disease and injury. Alternatives ranging from advocacy to negotiations have been proposed as complementary mechanisms to seek volun- tary compliance with standards. Incentives —- e.g., tax credits, pay bonuses, and non-economic stimuli, have also been promoted as supplementary approaches. Regulation enforcement through inspections can not cover all possible violators. Moreover, the right of entry for inspectors is being limited in some instances. Informed workers could be one of the most effective means to alerting both management and government to unhealthy workplace condi- tions. However, there would need to be adequate safe guards to protect their jobs or maintaining their wages. Worker protection need not require Federal or State enforcement actions if management and labor can find non- adversarial means to collaborate and the collaboration does not involve risky tradeoffs between work and health. In the radiation area, management voices a commitment to - 143 - ALARA, but it is not clear that the worker is always informed and used in radiation reduction. For that matter, there may be some tension in the role of health physics personnel -- some work for management yet are charged with protecting the workers against exposure. This tension might be reduced by increased worker and union involvement. In medicine, protection is almost totally the role of the workers (i.e., the technologists) but their knowledge and skills may not be assured by cur— rent education and lack of credentialling. Additional study of this aspect of radiation protection is recommended: 0 Explore collaborative activities involving all agencies responsible for occupational radiation control that could increase the involvement of workers in their own protection. E. Reproductive Health The ALARA principle is also important in the complex area of reproductive effects. Effects are known to result from exposure of the fetus in the womb (teratogenic effects). Less certain are effects from exposure of the male and female reproductive cells to radiation before conception (genetic effects). g§§/ The radiation exposure limits that are imposed as a result of the Federal Radiation Protection Guides include consideration of genetic effects. ALARA practices have primarily stressed procedures to prevent potential genetic effects from medical irradiation. Males are now routinely provided with shielding over the gonadal area when abdominal x-rays are taken. Procedures have also been recommended to prevent teratogenic effects from medical irradiation. For example, since the most serious teratogenic effects will be initiated during early pregnancy, when the woman may not know that she is pregnant, the ICRP has recommended that women receive diagnostic radiation only during the ten days between menstruation and ovulation. 258/ See the discussion of these isues in the Science Work Group Report, supra note 8. - 144 - The issue of teratogenic and genetic effects has arisen most recently in the context of occupational exposures. It has been suggested that women of childbearing age should nOt be permitted to work in situations where they may be exposed to radiation. Women's rights groups have argued that their right to equal employment opportunity must not be abrogated and that measures other than bar- ring them from employment must be adopted to protect future generations. The issue is complicated by the fact that the individual who may suffer injury (the child) has no choice about accepting the risk. ggg/ Less emphasis has been placed on the prevention of potential genetic effects through exposure of men, although it is also of public concern, as evidenced in the Natural Resources Defense Council petition to the EPA and NRC to lower dose limits for men in their reproductive years. Similar issues are being raised with respect to occupational exposures to other toxic agents. There is a pressing need to establish a carefully considered national policy in this area, balancing competing rights and interests. Therefore, it is recommended that: o a national policy be developed and implemented concerning reduction of the risks of radiation- induced teratogenic effects. This policy should consider the following aspects: - the risk of teratogenic effects and a determination of what level of risk should be deemed unacceptable - measures that would reduce the risk of teratogenic effects below an unacceptable level by controlling or preventing exposures to pregnant women, while recognizing the right of women of childbearing age to equal employment opportunity 25 / See also summary discussion of these issues in NRC, Regulatory Guide 8.13, "Instruction Concerning Prenatal Radiation Exposure", Nov. 1975 (Revision 1). - 145 — o The risk of genetic effects, a determination of what level of risk should be deemed unaccept— able, and measures that would reduce the risk of genetic effects below the unacceptable level consonant with national goals on employment rights be included in the broad review of the nation's existing radiation exposure standards. V. RECOMMENDATIONS The Work Group has presented a series of opportunities for radiation exposure reduction, intended to "obtain reductions of risks and effects of radiation as low as is reasonably achievable". This ALARA principle includes consideration of the state of technology, the economics of improvements in relation to benefits to public health and safety, and other societal and socioeconomic conditions. All identified opportunities are believed to have some impact; however, it is not clear they are all feasible, affordable, or implementable. In the limited time avail- able to the group, it would have been impossible to assess comprehensively the value of all of the potential oppor- tunities. Nevertheless, the group believes such assess- ment is imperative before embarking on important new directions. There are several opportunities that the Work Group considers sufficiently compelling to commend them as candidates for early action. 1. Each potential opportunity for radiation exposure reduction should be reviewed, in terms both of its feasibility and its risks and benefits to individuals and society, as part of an aggressive National commitment to reduce radiation levels using the ALARA concept. 2. The United States should undertake a concerted program to achieve radiation exposure reduction in the healing arts. Medical exposure reduction appears achievable without loss of diagnostic or therapeutic benefits, and in some‘cases may result in enhanced benefits. Such a plan would include these elements: 0 it would develop, test and disseminate medical radiation referral criteria, in cooperation with medical professional organizations, for specific diagnostic radiological examinations - 146 - it would develop appropriate methods of monitoring the implementation and effective- ness of the referral criteria it would explore and evaluate various incentive approaches to supplement the volun- tary approaches -- e.g., third-party payment incentives to encourage the use of new lower-* exposure or alternate imaging technology, Professional Standards Review Organization monitoring, selective Medicare/Medicaid screening and reimbursement criteria and/or the stimulation of State programs to broaden and intensify radiation control activities it would study the availability of trained personnel, and means of alleviating any cri- tical personnel shortages it would recommend guidelines for the training, testing, credentialing or licensing and continuing education of medical x-ray, nuclear medicine, and radiation therapy tech- nologists, and the granting of assistance to the States for their adoption and implementa— tion of the above it would seek to ensure full implementation of the President' 5 Guidelines on Diagnostic X—ray Examinations in federal programs and extend to all sectors of medicine the underlying philo- sophy and principle of medical and dental x—ray use embodied in Guidelines it would encourage voluntary compliance with Quality Assurance guidance through profes- sional medical organizations. it would make available adequate resources to encourage research leading to optimization of the diagnostic imaging process and evaluation of imaging modalities not involving ionizing radiation. it would evaluate and limit where indicated the screening of asymptomatic patients by radiological examinations O - 147 - it would develop and conduct informational programs to inform medical and dental practi- tioners and their designates, students, medical facility administrators and patients about the risks and benfits of mediCal radia- tion, and to educate them about ways of min— 'imizing the risks and maximizing the benefits it would develop Federal minimum performance guides for x-ray equipment manufactured before 1974 and would assiSt the States in enforcing these standards. State radiation control programs should be strengthened, including grant support if appro— priate, to help them take on more responsibility for radiation exposure reduction, including: 0 radiation control in areas not covered by Federal programs more frequent inspection and testing of radiation-emitting electronic machines intensified monitoring both in the vicinity Of nuclear power plants and in other areas during transport of radioactive materials asSistance to recruit and retain additional skilled staff and restoration of Federal short—term training programs. An expanded National program of environmental and human exposure monitoring, including tech— nical improvements (i.e., better measurement technology) should be undertaken. The planned Federal review of existing exposure standards should be carried out fully, openly, and expeditiously. The review should include: 0 participation by each Federal agency represented on the Work Group consideration of alternative approaches ample hearings to permit all interested parties to present arguments. ,APPENDIX 1 Work Group on Radiation Exposure Reduction Kathleen Blackburn Health, Education, and Welfare William H. Blahd Veterans Administration Robert Copeland Department of Labor William E. Kreger U.S. Nuclear Regulatory Commission Murray E. Miles Department of Defense William A. Mills Environmental Protection Agency Eugene Moss Health, Education, and Welfare Mary K. Pendergast Health, Education, and Welfare Donald Ross Department of Energy Bernard Shleien . Health, Education, and Welfare Lester Slaback Department of Defense Dennis Tblsma Health, Education, and Welfare Edward J. Vallario Department of Energy APPENDIX 2 Dose and Frequency of Some Common X—Ray Examinations Mean Active Bone Marrow Dose I I I 1 l Annual : High : Medium : Low Per Capita Rate : (250-1000 mrad) : (50-250 mrad) : (less than 50 mrad) (mrad) : : : High 0.10 : : : Dental, Radiographic : : : Chest Intermediate 0.04— : Upper GI Series : :-Photof1uorographic 0.10 : : : Chest Intermediate 0.01— : Lumbar Spine, : Skull, Cervical: 0.04 : Barium Enema, : Spine, Gall— : : IVP, Lumbosacral: bladder, : : Spine : Pelvis : : : Abdomen (KUB) : Low '0.01 : Small Bowel : Thoracic Spine,: Femur : Series, : Ribs, Hip : : Pelvimetry : : Shleien, B., Tucker, T., Johnson, D., "The Mean Active Bone Marrow Dose To The Adult Population Of The United States From Diagnostic Radiology", Health Physics Vol. 34 (June 1978) pp. 587—601. APPENDIX 3 Average Doses from Common X-Ray Examinations (1) Entrance Skin Dose Per Examination (rads) Exposure Per Film Mean Mean (2) Active Bone Gonad Examination (Roentgens) Marrow Male Female Radiographic ; ; : ; Chest : 0.04 (PA) : 0.01 : 0.0005 : 0.001 Photofluoro- ; g ; ; graphic Chest : 0.38 (PA) : 0.04 : 0.002 : 0.003 : : : : (4) Dental : 1.1 : 0.009 : 0.0001 : 0.0001 : z (3) = (5) 2 Upper GI Series : 0.90 (AP) : 0.53 : 0.001 : 0.17 : : (3) : (5) : Barium Enema : 1.0 (AP) : 0.87 : 0.17 z 0.90 l. Shleien, 3., Tucker, T., and Johnson, D., HEW Publication (FDA) 77-8013, Data for 1970. 2. Exposure in Roentgens; radiographic view designated in parentheses. 3. Also includes dose from fluoroscopic portion of examinations. 4. Population Dose from X—Rays, U.S. 1964, PHS Pub. No. 2001 5. Radiographic portion only, HEW Pub. (FDA) 76-8034. APPENDIX 4 Average Doses frcm Several Nuclear Medicine and X-Ray Dignostic Procedures Radiation Dose Per Examination (Rads) Mean : : Active Bone (2) Organ in : Procedure : Target Marrow (1) Gonads Imaging : : Organ Male Female Procedure : : Brain : X—Ray : : Angiography : 12.49 (3, 5) (lens of eye) : CT : 1-5 (4, 6) (head surface) : Nuclear Medicine : : 99m Tc pertechnetate : 0.75-3.75 (stomach) (7) ___ Lung : X-Ray : : Chest radiograph : 0.01 0.0005 0.001 : Nuclear Medicine : : 9911 Tc—Macro Aggregated : : Albumin : 0.8 (lung) (8) : 133—Xe : 0.25 (lung) (8) Bone : X‘Ray : : Pelvis : 0.09 0.36 0.21 : Lumbar Spine : 0.35 0.22 0.72 : Lumbo Sacral Spine : 0.45 : Nuclear Medicine : : 99m Tc ghosghate : 0.8 (bone) (8) ___ Kidney : X-Ray : : Abdaninal radiograph : 0.15 0.10 0.22 : Intravenous pyelograph : 0.42 0.20 0.59 : Nuclear Medicine : : 131-I—ortho-iodohippurate : 0.3 (kidney) (8) : 99m 'nc DI‘PA : 0.1 (kidney) (8) Liver : X-Ray : : Abdominal radiograph : 0.15 0.10 0.22 : Gallbladder : 0 . l7 0 . 0005 0 .08 Nuclear Medicine 99m Tc sulfur colloid 1 (liver) (9) 5. 6. 7. Shleien, B., Tucker T., and Johnson D., The Mean Active Bone Marrow Dose to the Adult Population of the United States from Diagnostic Radiation, Health Physics 34:587-601, June 1978 (1970 data). Gonad Doses and Genetically Significant Dose From Diagnostic Radiology, U.S. 1964 and 1970 HEW Publication (FDA) 76-8034 (1970 data). Radiation Dose to Eye Lens and Gonads. During 'Transfemoral Cerebral Angiography, Quisling, R., Exposure to Patient and Personnel in Computed Axial Tomography, Shrivastava, P., Lynn, 8., and Ting, J., Radiology 125:411—415, November 1977. Mean of right and left lens doses. See n.4 supra. Range of exposure in Roentgens. See n.5 supra. MIRD Dose Estimate No. 8, J. Nucl. Med., Vol. 17, p. 74, January 1976. MIRD Dose Estimate, J. Nucl. Med., Supplement No. l, p. 7, February 1968. MIRD Dose Estimate No. 3, J. Nucl. Med., Vol. 16, p. 1082, January 1975. 2. APPENDIX 5 Summary of WOrker ProteCtion Jurisdictions in the Federal Sector AGENCY Federal Regulatory Agencies- Direct worker Protection Environmental Protection Agency Nuclear Regulatory Comnission Department of Labor Occupational Safety and Health Administration Mine Safety and Health Administration Department of Transportation Federal Aviation Administration Federal Railroad Administration Federal Highway Administration Coast Guard Postal Service Federal Regulatory Agencies- Indirect Wbrker Protection Department of Health, Education, and welfare Food and Drug Administration RESPONSIBILITY Federal Guides-all workers workers for NRC licensees: Source material By-product material Special nuclear material Production and utilization facilities All non-mine occupational safety and health radiation exposures_ not otherwise regulated by —other Federal authorities All mining radiation expo- sures Exposure from transport of radioactive materials- workers, passengers, and general public Exposure from mail transport of radioactive materials Emissions from radiation-emit- ting machine sources, food, drugs--Consumer protection also protects the worker APPENDIX 5 (cont '6!) AGENCY Environmental Protection Agency Consumer Products Safety Commission 3. Federal Non-Regulatory Agencies- Direct Worker Protection Department of Defense Department of Energy Veterans Administration Department of Health, Education, and Welfare National Institutes of Health Center for Disease Control Food and Drug Administration CDC/National Institutes for Occupational Safety and Health RESPONSIBILITY General environmental air and water quality measures—-radio- activity Federal Radiation Council Authority Consumer products which use radioactive materials (except certain by-product, source, and special nuclear materials) Naval propulsion, weapons deployment and maintenance, radiation safety for military personnel, research All DOE contractors and DOE ernployees-—weapons development, fuel fabrication and enrich- ment, reactors, accelerators, research Radiation safety for medical radiology, nuclear medicine, and research by VA employees Responsible, under OSHA over- sight, for radiation safety of agency employees using radiation in research, service delivery Research on occupational exposure and criteria docu- mentation for transmittal to OSHA and MSHA TOTAL MAN-REM PER YEAR 20000 ‘ 15000 10000 5000 APPENDIX 6 ‘p’ ./"' /0/\NUMBER OF SHIPS . 60 6I 62 63 64 65 66 67 68 69 70 71 72 73 74 75 FIGUREI TOTAL RADIATION EXPOSURE RECEIVED BY MILITARY AND CIVILIAN PERSONNEL IN THE NAVAL NUCLEAR PROPULSION PROGRAM 1960 - I977 ofl“. 76 110 100 90 8O 70 60 50 . 40 30 20 10 NUMBER OF SHIPS IN OPERATION APPENDIX 7 DOD Checklist of Radiation Exposure Reduction Approaches The following is a brief checklist which has been in use for years in maintaining personnel radiation exposure as low as practicable during maintenance, overhaul, and repair. Operations, maintenance, and repair personnel are required to be involved in this subject; it is not left solely to radiological control personnel. Preliminary Planning 0 O 0 Plan in advance Delete unnecessary work Obtain expected radiation levels Preparation of Wbrk Procedures 0 0 00000 0 000 O 0 Plan access to and exit from work area Provide for service lines (air, welding, venti- lation, etc.) Provide communication (sometimes includes closed-circuit television) Remove sources of radiation Plan for installation of temporary shielding Decontaminate WOrk in lowest radiation levels Perform as much work as practicable outside radiation areas State requirements for standard tools Consider special tools Include inspection requirements (these identify steps where radiological control personnel must sign prior to work proceeding) Minimize discomfort of workers Estimate man—rem Temporary Shielding O O O 0 Control installation and removal by written procedure Inspect after installation Conduct periodic radiation surveys Minimize damage caused by heavy lead temporary shielding Prohibit use of lead shot for temporary shielding APPENDIX 7 (cont'd) Balance radiation exposure received in installation against exposure to be saved by installation Shield travel routes Shield components with abnormally high radiation levels early in the maintenance period Shield position worker occupies Perform directional surveys to improve design of shielding by locating sources of radiation Use mockups to plan temporary shielding design and installation Rehearsing and Briefing Workers OOOO Rehearse Use mockups duplicating working conditions Use photographs Brief workers Performing Work 0 0 0 Post radiation levels Keep excess personnel out.of radiation areas Minimize beta radiation exposure (anticontami— nation clothing effectively shields cobalt 60 betas) Supervisors and workers keep track of radiation exposure Workers assist in radiation and radioactivity measurements Delegate radiological control monitoring respon— sibilities when necessary to minimize radiation exposure Evaluate use of fewer workers Re-evaluate reducing radiation exposures WNW cw, BERKELE WI DEPARTMENT OF HEALTH. EDUCATION. AND WELFARE POSTAGE AND FEES PAID WASHINGTON, o.c. 20201 u.s. DEPARTMENT or H.E.W. HEW 391 OFFICIAL BUSINESS PENALTY FOR PRIVATE USE. $300