‘REPORT OF THE \INTERAGENCY TASK FORCE ON THE HEALTH EFFECTS OF IONIZING RADIATION}, "D'o—‘TT‘E’T’TCUM NT 0 PAR MENT JUL 31 1979 LIBRARY Y UNIVERSITY OF CALIFORNIA ”.3. DMSITOR , JUN 2 7 1979 Printed and distributed by the Office of the Secretary, U.S. Department of Health, Education, and Welfare Washington, D. C. <9 REPORT of the INTERAGENCY TASK FORCE on THE HEALTH EFFECTS 1"‘ OF IONIZING RADIATION‘ June 1979 Wu ‘ §> E r9 , FUEL - iii - DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE THE OFFICE OF THE SECRETARY WASHINGTON. D.C. 2020: E} g 31%! THE GENERAL COUNSEL ‘ M if? , n" F. l in Car 7‘} TO: FROM: W774, Fad; Letter of Transmittal Secretary of the Department of Health, Education, and Welfare Secretary of the Department of Defense Secretary of the Department of Energy Secretary of the Department of Labor Administrator of the Environmental Protection Agency Chairman of the Nuclear Regulatory Commission Administrator of Veterans Affairs Interagency Task Force on the Health Effects of Ionizing Radiation Attached is the final report of the Interagency Task Force on the Health Effects of Ionizing Radiation, prepared in response to the White House Memorandum of May 9, 1978. The Task Force examined: 0 scientific research and knowledge on the health effects of ionizing radiation; legal restrictions on access to records by health researchers; existing care and benefit systems for persons adversely affected by radiation exposure; information programs for the general public and targeted groups; steps to reduce radiation exposure in the future; institutional arrangements for carrying out federal research and protection activities concerning radiation. These issues are considered in greater detail in the Task Force work group reports, which are also attached. _iv.. Page 2 This final report contains our recommendations for a coordinated program concerning the health effects of radiation exposure on participants in nuclear tests, workers in nuclear-related activities, and the general public. To the extent agency representatives on the Task Force hold differing opinions with respect to any recommendation, those differences are reflected in the report. I want to express my appreciation to each of the agency representatives, not only for their cooperation and hard work, but also for their commitment to carrying out this task in an open and collaborative manner. 4. om flaw. 'F. Peter—Libassi Chair of the Interagency Task Force on the Health Effects of Ionizing Radiation General Counsel Department of Health, Education, and Welfare (th ough May 31, 1979) Richard Cotton Chair of the Interagency Task Force on the Health Effects of Ionizing Radiation (from June 1, 1979) Executive Secretary Department of Health, Education, and Welfare M7 R. R. MOWE \ Vice Admiral, U.S. Navy Director, Defense Nuclear Agency Department of Defense Page 3 73%.?“ Ruth Clusen Assistant Secretary for Environment Department of Energy 267% fig? ,/\." David Hawkins Assistant Administrator for Air, Noise and Radiation Environmental Protection Agency WW Robert Copeland, Director Office of Health and Disability ASPER Department of Labor ' Wflfiiw Robert B. Minogue Director, Office of Standards Development Nuclear Regulatorv Commission / flan/41c! fl firnfi/i “Dr: Lawrence B. Hobson 7 Deputy Assistant Chief Medical Director for Research and Development Veterans Administration (:12;4ék-/€:2§22444é2é9¢~£—~ Linda Donaldson, Project Manager Office of General Counsel Department of Health, Education, and Welfare — Vii — THE WHITE HOUSE WASHINGTON May 9,-1078 MEMORANDUM FOR THE SECRETARY OF DEFENSE THE SECRETARY OF HEALTH, EDUCATION ./’ AND WELFARE THE SECRETARY OF ENERGY THE ADMINISTRATOR OF VETERANS AFFAIRS ’fZ: Q FROM: STUART EIZENSTAT 970.0. ZBIGNIEW BRZEZINSKI SUBJECT: _ radiation Exposure Inquiry 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 land 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. 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 this the incidence of adverse radiation exposure of type in the future- We are aware that the.Department of Defense has initiated- _a study and that the Center fpr pisease 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 Council, the Domestic Policy Staff and the OffiC(. of Science and Technology Policy within the Executive Office are available to assist the interagency group. —ix- BACKGROUND In May, 1978, 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. 0 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. 0 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. 0 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. 0 Exposure Reduction Work Group Report which reviews present efforts to reduce exposure to radiation and recommends a range of additional measures for consideration. 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 written public comments have been summarized and com- piled in a separate volume. The Task Force Report contains the proposed recommen- dations of the Task Force members, which are based on the recommendations of the Work Group members contained in the Work Group Reports. The final recommendations of the agencies will be contained in a report to the White House. INTRODUCTION ‘Xi" TABLE OF CONTENTS I. BACKGROUND A. Nature of Ionizing Radiation B. Sources of Radiation Exposure II. FEDERAL AGENCY ACTIVITIES A. Development and Use of Radiation— Related Technology B. Research into Biologic Effects of Radiation C. Radiation Protection Activities 1. 2. 3. 4. 5. 6. 7. 8. User Agencies Environmental Protection Protection of Workers Control of Medical Exposures Regulation of Consumer Products Regulation of Transportation Other Federal Agencies The Role of the States D. Provision of Care and Benefits III. RESEARCH ON THE HEALTH EFFECTS OF RADIATION A. Methodologic Issues B. Health Effects of Radiation C. Recommendations IV. PERSONAL PRIVACY AND RESEARCHERS' ACCESS TO RECORDS A. Legal Restrictions on Researchers' Access to Records Page 10 16 16 17 19 19 19 21 22 23 23 24 24 26 28 29 31 38 45 46 B. - xii - Recommendations V. REDUCING RADIATION EXPOSURES A. B. C. Radiation Protection Principles Specific Issues in Radiation Protection 1. Exposure in the Healing Arts 2. Nuclear Weapon Development and Production 3. Nuclear Power 4. Background and Technologically Enhanced Natural Radiation 5. Consumer Goods 6. Occupational Exposures 7. Transportation Recommendations VI. DELIVERY OF CARE AND BENEFITS A. B. VII. A. B. Sources of Care and Benefits 1. Veterans Benefits 2. Workers' Compensation Programs 3. Back-up Programs 4. Tort Law Remedies Recommendations PUBLIC INFORMATION Basic Information Additional Information for Specific Groups of the General Public Information for Medical or Dental Patients and Health Care Personnel Information for Those Exposed to Radiation on Their Jobs Persons Exposed as a Result of Atmospheric Nuclear Tests Dissemination of Information 47 52 53 56 56 59 61 62 63 64 65 66 68 68 70 72 73 73 74 80 80 81 81 82 83 84 — xiii — G. Recommendations VIII. INSTITUTIONAL ARRANGEMENTS A. Radiation Protection and Coordination B. Care and Benefits C. Research on the Biological Effects of Ionizing Radiation IX. CONCLUSION Table 1: Table 2: Table 3: Figure 1: Attachment 1: Appendix Appendix Appendix Appendix Appendix Appendix Appendix U.S. General Population Collective Dose Estimates Federal research support in FY 1978 ($1000) by supporting agency and research area ,Cancer linked to radiation in A: B: C: particular populations General Dose-response Models List of Task Force and Work Group Members Report of the Science Work Group Report of the Records and Privacy ' Work Group Report of the Exposure Reduction Work Group Report of the Care and Benefits Work Group Report of the Public Information Work Group Report on Institutional Arrangements Public Comments 85 88 89 96 97 103 ‘15 18 34 37 105 INTRODUCTION A number of issues arising in various settings during the past few years have created concern about the health effects of ionizing radiation. l/ Such concern is not new. Since the early years of this century, when x-rays were first used by researchers and radiologists, knowledgable individuals have been aware that radiation can be harmful as well as beneficial. Recently, however, attention has been focused on the possible long-term effects of low levels of radiation on human beings exposed in situations as diverse as medical procedures using x-ray devices and radioactive materials, routine maintenance of nuclear reactors, and military exercises during atmospheric tests of nuclear weapons. Questions have been raised about the adequacy of existing knowledge about these low level effects, the research through which such knowledge is expanded, the methods used to protect persons who are or have been exposed, and the systems designed to deliver care and benefits to those who may be injured as a result of exposure. In May 1978, the White House by memorandum asked the Secretary of Health, Education and Welfare (HEW) to coordinate formulation of a program to address these questions, wOrking with the Secretary of Defense, the Secretary of Energy and the Administrator of Veterans Affairs. 2/ A. Congressional Interest Several of the problems that the agencies were asked to consider have been the subjects of Congressional interest over the past few years. é/ Among the issues highlighted by Congressional hearings are: _l/ Radiation may be divided into two major categories-- ionizing and non—ionizing. See Section I.A. Throughout this Report, the term "radiation" will be used to refer to ionizing radiation, unless otherwise noted. _3/ The White House memorandum is found on p. vii. _§/ The Congressional committees which have investigated such issues since 1974 include, in the Senate, the Governmental Affairs Committee, the [cont. on p. 2] 0 Scientific uncertainty about radiation health effects: A few recent studies have raised ques- tions about the nature, frequency and magnitude of health effects produced by low levels of radiation. 0 Federal management of research: Members of Congress have voiced concern over how federal agencies have managed radiation-related research, particularly agencies that use or promote nuclear technologies. 0 Adequacy of standards: A few recent studies on radiation health effects have raised questions about the adequacy of exposure standards and other measures used to protect individuals exposed to radiation in the course of their employment, since those measures are premised on the results of earlier research. 0 Medical uses of radiation: Evidence suggests that a significant portion of the radiation used for medical diagnosis of disease and injury in the United States may be unnecessary and could be avoided. [cont.] Committee on Commerce, Science and Transportation, the Subcommittee on Nuclear Regulation of the Committee on Environment and Public Works, and the Subcommittee on Health and Scientific Research of the Committee on Human Resources. In the House of Representatives, they include the Subcommittee on Health and the Environment and the Subcommittee on Oversight and Investigation of the Interstate and Foreign ' Commerce Committee, the Subcommittee on the Environment and Atmosphere of the Science and Technology Committee, the Subcommittee on Environment, Energy, and Natural Resources of the House Government Operations Committee, and the Subcommittee on Energy and the Environment of the Committee on Interior and Insular Affairs. A number of other committees, such as the House Armed Services Committee and the Veterans Affairs Committees of both Houses, maintain an interest in particular aspects of radiation use. 0 Consequences of weapons tests: Exposure to radioactive materials released during atmos- pheric weapons tests conducted by the Atomic Energy Commission (AEC) between 1945 and 1962 may have subjected participants and people living downwind from the test sites to increased risk of cancer and other adverse health effects. 0 Nuclear wastes: Permanent disposal sites have not yet been located for the large amounts of radioactive wastes, ranging from uranium mill tailings to spent fuel elements, produced by the nuclear fuel and weapons cycles. 0 Federal agency coordination: Many have questioned the adequacy of past efforts to coordinate the activities of the numerous federal agencies involved in aspects of radia- tion protection. All of these issues have stimulated substantial controversy. Many individuals believe fervently in positions that are flatly contradicted by others whose beliefs are held with equal conviction. Testimony before the committees and the comments of committee members themselves indicate significant skepticism about the effectiveness of present federal agency activities. The need is apparent for a program that improves the agencies' capacity to handle these issues, taps the interest and expertise of numerous concerned groups in the private sector, and affords members of the public an opportunity to make their views known directly to responsible officials. B. The Interagency Task Force on the Health Effects of Ionizing Radiation The White House memorandum asked federal agencies with major jurisdiction over issues relating to radia- tion to formulate a coordinated program that would respond to the problems identified by the Congress, the public and the agencies themselves. To carry out this directive, the Secretary of HEW established an Interagency Task Force under the direction of the General Counsel of HEW. The Task Force included a high level official from each of seven agencies, HEW, the Department of Defense (DoD), the Department of Energy (DOE), the Department of Labor (DoL), the Environmental Protection Agency (EPA), the Nuclear Regulatory Commission (NRC), and the Veterans Administration. 5/ Acknowledging the problems identified by Congress, the Task Force sought to conduct its activities in a cooperative, responsive, open manner. The objectives of the Task Force have been: 0 To review current knowledge about the nature and extent of health effects caused by radiation exposure; to present an inventory of federally- supported radiation research; and to recommend a research program to seek resolution of ques- tions about the health effects of radiation. 0 To examine legal restrictions on health researchers' access to records necessary for epidemiologic research on radiation and to recommend appropriate changes. 0 To review present efforts to reduce exposure to radiation and to recommend additional measures, if needed. 0 To examine existing systems for providing care and benefits to persons possibly injured by radiation exposure and options for improving these systems, and to recommend changes if necessary. 0 To design and to recommend a public information program. 0 To recommend institutional changes that would improve effectiveness, responsiveness, and coordination on radiation-related issues within the federal government. To accomplish the first five objectives, five Work Groups were established to consider different categories of issues. Each Task Force agency participated fully on the Work Groups, which were thus able to draw upon the extensive expertise and experience of agency staffs. §/ _g/ A list of Task Force members is found in Attachment 1. _§/ The Department of Labor participated only on the Work Groups concerned with compensation and expo— sure reduction. Since the agencies have for some time been addressing several of the problems that the Task Force was asked to consider, the Work Groups were able in some instances to draw upon work that was underway. Each Work Group was chaired by a staff member from HEW and each has produced a report which has provided the basis for the analysis and the recommendations in this Report. g/ Work Group members supplied necessary information, drafted portions of the work papers and reviewed the work done by the chair or by other members of the group. The final subject, the need for improved coordination and leadership within and among the federal agencies concerned with radiation and methods for achieving these goals, was examined in a paper reflecting the views of the Task Force representatives themselves. 1/ The leadership of the Task Force has also made every effort to open the decisionmaking process by consulting extensively with interested members of Congress and their staffs and with groups and individuals who have an interest in various aspects of the project. A series of informal meetings has been held with scientists of varying viewpoints, public interest and environmental groups, representatives of the nuclear power industry and the medical professions, labor unions, and veterans' organizations. These groups have been asked to submit their views formally and informally, orally and in writing, throughout the Task Force proceedings. They have reviewed and commented upon the work papers and many of their comments are reflected in this Report §/ and in the Reports of the Work Groups. _§/ The five Work Group reports are Appendices A-E of this Report. _1/ The Report on Institutional Arrangements is Appendix F of this Report. _§/ Because of their volume, not all public comments could be included in this Report. The Task Force therefore, chose to indicate instances in which the comments presented a particularly useful idea, or pointed out matters overlooked or underemphasized by the work groups, or confirmed, directly or indirectly, a point made by the work groups. All public comments have been collected and are published as Appendix G to this Report. The Task Force Report that follows was drafted by HEW, based on the six work papers and on public comments. The recommendations represent the views of the partici— pating agencies, except where disagreement is speci- fically cited. The Report is divided into nine sections. The first gives background on the nature and sources of radiation. The second outlines the roles of Federal agencies with jurisdiction over radiation—related issues. The third reviews what is known about the health effects of radiation as a result of numerous research studies, focusing on the question of effects produced by low doses, and recommends a research program. The fourth reviews the restrictions on access to data faced by researchers doing radiation-related research and recom- mends changes that would ease restrictions without threatening individual privacy. The fifth indicates measures that could be taken to reduce unnecessary radia- tion exposures and recommends a number of steps to be taken. The sixth reviews current programs designed to deliver care and benefits to those injured by radiation, indicates options for improving those systems, and recommends certain improvements. The seventh outlines a public information campaign. The eighth recommends changes in federal institutional arrangements, to improve interagency coordination and responsiveness. The ninth is the conclusion. In reviewing the Report, two additional points should be kept in mind. Members of the Task Force have been aware from the beginning that radiation represents only one of the numerous physical and chemical hazards found in our environment. More is known about radiation than is known about most other hazards. In addition, largely because of the federal government' 5 historical role in the development of nuclear weapons and nuclear power, control measures intended to protect workers and members of the public have been in place for many years. Yet, the problems of radiation exposure are similar in many respects to problems created by exposure to other toxic agents, many of which we know little about. These similarities raise several issues. First, measures recommended in this Report may later be useful as models for handling other hazards. Such action should be care- fully considered, however, since application in other areas may or may not be appropriate, depending on the situation. Second, and closely related, problems associated with radiation may in some instances reflect fundamental inadequacies in the way our society has responded to environmental hazards. To remedy these problems may require reforms that extend far beyond the question of radiation. The Task Force has identified several areas where the issues seem to fit this description. Such reform must be undertaken from a perspective broader than that of a single hazard. Also, since all of these hazards compete for the personnel and funds necessary to control their effects, efforts spent on radiation control may draw resources away from control of agents which are, at present, more dangerous to human health. The Task Force has not tried to make judgments about these issues, which are well beyond the scope of its assignment. Decisions on the allocation of resources among environmental hazards must be made else- where. Finally, since much of this Report and the Work Group reports emphasize the potential dangers of radiation exposure, it is important to note that radiation and radioactive materials are used only because they provide benefits to members of our society. These benefits include diagnosis and treatment of disease, national defense, and generation of electrical power. Many other activities, ranging from driving an automobile to con- struction of a skyscraper, also create risks while providing benefits. We as a society consciously or unconsciously balance these benefits against the risks they create whenever we undertake such an activity. In contrast to some other activities, however, the nature and magnitude of the risks associated with radiation and other environmental hazards are not always readily apparent, and the balance scales are unsettled by uncertainty and political controversy. We must determine how much more of our resources we are willing to devote to learning about radiation, how much real or potential risk we are willing to incur in order to enjoy its bene- fits, and what we are willing to do for those who may suffer the economic and health consequences. I. BACKGROUND Certain basic information concerning the nature and sources of radiation is necessary before one can effec— tively consider current questions surrounding existing scientific knowledge, research needs, radiation exposure reduction efforts and illness compensation. The follow— ing sections provide this background. A. Nature of Ionizing Radiation Ionizing radiation, as opposed to non-ionizing radiation, has sufficient energy to ionize atoms or molecules in biological and other systems. An atom is ionized when one or more of its electrons is separated from the atom. The resulting ions are chemically reactive and the reactions they undergo can damage tissue. Ionizing radiation may be divided into two types: (a) electromagnetic radiation (x-rays and gamma rays) which is similar in form to kinds of non-ionizing radiation such as visible light, microwaves, and radiowaves, and (b) particulate radiation, which may either be electrically charged (e.g., alpha and beta particles) or have no charge (neutrons). Both electromagnetic and particulate radiation can be produced by radionuclides, whether naturally occurring (e.g., uranium, radium, and thorium) or artificially produced (e.g., plutonium 239, cesium 137). Each radio- nuclide emits radiation during a process of radioactive decay. Some radionuclides are unstable and may trans— form themselves into other elements. The term "half life" refers to the time it takes for half of a given amount of a radionuclide to decay. The radioactive decay of each radionuclide has unique characteristics in terms of its energy, the types of radiation emitted, and its half life. Some radionuclides decay directly into stable non—radioactive.materials. Others go through a given decay chain of successive radionuclides (decay products), each with its own half life and type of radiation emission, before reaching a stable condition. The biological effects of all types of ionizing radiation are similar and derive from ionization of molecules that are essential for the normal function of living cells. When radiation strikes an individual cell, one of four events may occur: (1) the radiation may pass through the cell without doing damage; (2) it may damage the cell, but the cell repairs the damage; (3) it may damage the cell so that the cell not only fails to repair itself but also reproduces in damaged form over a period of years; (4) it may kill the cell. 2/ The most important effects are the last two. The killing of a few cells is often harmless to the body, but will create a serious problem if enough cells in a particular organ are killed so that the organ no longer functions. lg/ Incompletely or incorrectly repaired cell damage may over time produce delayed health effects such as cancer, developmental abnormalities, or genetic damage. These delayed effects are the focus of the Work Group reports. . Degree of radiation damage depends critically on which organs and tissues are irradiated. Total body radiation involves exposure of all organs. Most background, environmental and occupational exposures are of this form. Alternatively, radiation may be directed at only a portion of the body, as in medical x—ray procedures. Similarly, when radioactive particulate matter, such as alpha particles, is ingested or inhaled, most of the dose and resultant tissue exposure is confined to one or a few organs, as in exposure to radon gas. Degree of damage from such an organ dose depends upon the vulner- ability of the organ to the type of radiation in question. A common unit for describing radiation dose is the "rem." This unit combines the concept of absorbed tissue dose with the fact that some types of radiation produce more biological damage than others for a given amount of absorbed radiation energy. ll/ As used in this summary, a "low dose" of radiation refers to a dose of about 5 rems or less annually. Because the rem is an inconveniently large unit for many purposes, doses are often expressed _2/ See Testimony of Dr. Karl 2. Morgan before the Subcommittee on Health and the Environment of the Committee on Interstate and Foreign Commerce of the House of Representatives, Jan. 24, 1978. lg/ Cell killing may also benefit the individual. 'Radia- tion therapy in medicine consists of using radiation to destroy cancerous or otherwise abnormal cells. ll/ Other commonly used terms are "Roentgen" and "rad." See the Report of the Science Work Group, pp. 58-59, for an explanation of each term., -10— in "millirem" (mrem). One rem equals 1,000 mrem. Both "rem" and "mrem" are commonly used to express the dose received by an individual. When reference is made to the collective dose received by a large group of people, the dose may be expressed in "person—rems," a figure calculated by multiplying the total number of people exposed times their average individual dose (or the distributidn of individual doses) in rems. For example, 10,000 person—rems is the dose received collectively by 5,000 persons each exposed to an average individual dose of 2 rems, or by 10,000 persons each exposed to l rem, or by 20,000 persons each exposed to 500 mrem. Estimates have been made to quantify the risk of con- tracting cancer over the course of a lifetime as a result of exposure to radiation, based on research per- formed over the last 50 years. lg/ Estimates have ranged ' from 68 to 621 fatal cancers per million persons per rem of whole body radiation. (The variation reflects differences in underlying risk models.) One commonly accepted risk estimate for low level radiation is 100 fatal cancers per million persons per rem of exposure. The expected incidence of fatal cancer from all causes over a lifetime in a population of one million persons, without such exposure, is 160,000. g;/ B. Sources of Radiation Exposure Many sources of radiation exposure exist. The most ubiquitous and least controllable source is background radiation from cosmic rays and terrestrial radioactivity, to which human beings have been exposed throughout their existence. The personal dose level from this source varies from place to place, according to altitude, diet, and soil content, but averages 130 mrem per person per year in the United States. Because everyone on earth is exposed to background radiation, the collective population dose is very high. Background radiation accounts for approximately 50% of the total U.S. annual population dose of 40 million person-rems. lg/ Because background radia— lg/ For further discussion of the scientific basis of risk estimates, see p. 31 et seq. below. lg/ See the Science Work Group Report, p. 22. 12/ See the Exposure Reduction Work Group Report, p. 23. _ 11 _ tion cannot easily be controlled, one must assume that each individual will receive a dose of background radia- tion in addition to whatever he or she receives from man-made sources. By far the most significant exposure to man—made radiation occurs during the purposeful exposure of medical patients to radiation for diagnosis and therapy. Diagnostic uses of x-rays and radiopharmaceuticals contribute 18 million person-rems each year to the U.S. population dose, an amount that approaches the contribution of background radiation. The great bulk of these exposures occur in the form of low-level doses to particular organs or parts of the body. Therapeutic doses, which are also localized to an organ or part of the body, are much higher for individual patients, but involve a much smaller number of people, each of whom generally suffers from a life- threatening disease. The majority of medical exposures confer benefit directly on the person being exposed, by permitting health care professionals to diagnose and treat injury and disease. However, a source that con- tributes such a large proportion of the total population dose and is under human control must be carefully scrutinized for opportunities to reduce unnecessary exposures. All other sources contribute much less to the total U.S. population dose. One of the most significant of these other sources is technologically enhanced natural radia- tion, that is, radiation from naturally-occurring radio- nuclides redistributed and thereby made more hazardous by human activities. For example, uranium mining makes radioactive materials more accessible in the environment for the exposure of people to uranium and its decay products. Activities that enhance naturally-occurring radiation include phosphate mining and milling, coal mining and burning, and use of construction materials containing radionuclides (e.g., granite, brick). Such activities contribute approximately 1 million person-rems to the collective population dose. Many of the exposures are concentrated in a particular population, workers who mine and mill materials and persons living in surrounding areas. When uranium has been mined and milled, it can then be further processed to produce either nuclear weapons or fuel components for nuclear power reactors. At this time, most of the uranium produced is used to manufacture weapons. Low-level radiation exposures occur throughout _ 12 _ the weapons cycle, from research and development, through testing, to production, transportation, deployment, and storage. Most of these exposures are to individuals who work with the radioactive materials or with weapons compo- nents containing them. Exposure to the public is normally very low. The most extensive exposures associated with nuclear weapons have originated from atmospheric weapons tests conducted by the U.S., the U.S.S.R., the U.K., France and China. lg/ These tests have produced world- wide fallout, which will continue to irradiate the world's population at low levels at a decreasing rate for many years. This source has produced the highest collective dose of any exposure connected with the atmospheric weapons tests. U.S. exposures from these tests are widespread geographically and not related to proximity to U.S. test sites. The U.S. atmospheric testing program was conducted by the Atomic Energy Commission between 1945 and 1962 at the Nevada Test Site and in the South Pacific. Two categories of exposures have resulted from these tests in addition to the world-wide exposures described above. First, localized, off-site fallout produced exposures to populations located in eastern Nevada, southwest Utah, northern Arizona, certain South Pacific islands, and other areas downwind from the test sites. Because only environmental monitoring and not personnel moni- toring was conducted, the external and internal doses received by these groups over the course of the testing program are not known with certainty. Second, on-site participants in the testing program also were exposed to radiation from the tests. Because of personnel and environmental monitoring and attempts lg/ Since the Atmospheric Test Ban Treaty of 1963, the United States and the Soviet Union have tested under- ground, where exposures result only from accidental releases and are extremely small. Although most atmospheric testing has ceased, a few nations con- tinue to test above ground. Between 1972 and 1977, 20 atmospheric tests were conducted. Report of the United Nations Scientific Committee on the Effects of Atomic Radiation. “90 (United Nations 1977). -13- to reconstruct patterns of irradiation, exposures to this group are known with greater confidence than those of the preceding two groups. Approximately 400,000 personnel either supported or participated in the on-site activities, and measures were taken to assure that exposures were in accordance with accepted radia- tion protection guidelines. About 225,000 military personnel were involved, some 60,000 of whom conducted military exercises in the vicinity of the tests. DoD has calculated that of the 225,000 military partici— pants, almost half received no recorded dose, and over 99 percent received external doses of less than 5 rem. A very small number of participants were exposed to levels of radiation that exceeded the permissible guidelines. DoD has found no indications of any signi- ficant inhalation or ingestion of radioactive particles by BOB test participants, but is still actively research— ing this possibility. The Navy's use of nuclear reactors to propel submarines and surface vessels constitutes another military use of radioactive materials. This activity results in low level radiation exposures to military personnel on board ship and to civilian workers engaged in maintenance and repair activities. Another source of exposure is the nuclear fuel cycle, the process by which uranium is refined, fabricated into fuel, and used in nuclear reactors to produce energy for electricity. This source contributes very little to total population dose; the low-level exposures that do occur are concentrated in the worker population and, to a far lesser degree, in the populations near facili- ties. All activities in the cycle are regulated to control and to reduce exposures during daily operation and to prevent accidents that might result in release of large amounts of radioactivity. Both the weapons cycle and the uranium fuel cycle produce high—level and low—level radioactive wastes, which require disposal. Certain of these wastes create particular concern, because of their high toxicity and long half lives. Radiation sources are also used in industries other than those in the nuclear fuel cycle. Both x—rays and radio— nuclides are used for various purposes such as testing pipe welds. A number of consumer products emit radiation or contain minor amounts of radioactive materials, but they are a relatively insignificant source of exposure. -14- Examples are: luminescent watch or clock dials contain- ing radium, smoke detectors containing radioactive materials, color televisions, and some ophthalmic glass. In sum, the two most significant sources of exposure in terms of population dose are background radiation and medical use of x-rays and radiopharmaceuticals. The next highest population dose comes from radioactive fallout from atmospheric testing of nuclear weapons and from technically enhanced natural radiation. Other sources of exposure result in much smaller doses, but these tend to be localized in particular groups of workers and, to a lesser extent, in populations residing near facilities that process radioactive materials or store by-products and wastes. The contribution from all sources is summa- rized in Table 1. It should not be assumed that the health risks to all of the exposed populations are directly comparable. Each of the sources described above contributes or has contributed doses within the range termed "low" in this report, about 5 rems or less per year. However, there are differences in the doses received and in our knowledge about them, the rate at which and manner in which they are or were received, and the type of radiation involved. For example, participants in the weapons testing program received low doses in one or a few whole body exposures at a high dose rate. By contrast, individuals exposed during work at nuclear power plants or in other occupational settings generally receive very low, whole body doses, in many low—rate exposures over time. By further contrast, individuals exposed for most diagnostic medical purposes generally receive low doses, at high rates, and at intermittent intervals, directed at a small portion of the body. The implications of some of these differences will be described below. -15— TABLE 1 U.S. General Population Collective Dose Estimates — 1978 Person-rems per year Source :/ (in thousands) Natural Background 0 20,000 Technologically Enhanced 1,000 Healing Arts 18,000 Nuclear Weapons Fallout 1,000-1,600 Weapons development, testing and production 0.165 Nuclear Energy 56 Consumer Products 6 U.S. Occupational Exposures Estimates - 1975 j' Person-rems per year Source ' (in thousands) HealingNArts 40 - 80 Manufacturing and Industrial 50 Nuclear Energy 50 Research 12 Naval Reactors 8 Nuclear Weapons Development and Production 0.8 Other Occupations 50 :/ See the text for a description of the specific sources that contribute to each category. -16... II. FEDERAL AGENCY ACTIVITIES At least 15 federal agencies engage in activities relating to the use and control of radiation. lg/ In this section, several Of these activities are described and agencies whose missions give them major roles are identified. A. Development and Use of Radiation-Related Technology The Atomic Energy Act of 1954 required the Atomic Energy Commission (AEC) to conduct research and develop- ment for both military and peaceful uses of atomic energy. These functions include development of weapons systems for defense and security purposes and development of pro- cesses, materials and devices that can be used to produce nuclear energy to generate electricity. When the AEC was divided by the Energy Reorganization Act of 1974 into the Nuclear Regulatory Commission (NRC) and the Energy Research and Development Administration (ERDA), these functions were transferred to ERDA. They were then transferred with other ERDA authorities to the new Department of Energy (DoE) under the Department of Energy Organization Act of 1977. Under this authority, DOE develops and produces nuclear weapons systems for the Department of Defense (DoD). Both development and production are generally conducted in facilities that are owned by DoE, but are operated under contract by private companies or by universities. Among the best known of these facilities are two National Laboratories, Los Alamos Scientific Laboratory and Lawrence Livermore Laboratory, where weapons systems are developed, and facilities like Rocky Flats and Pantex, where they are manufactured. DoE also tests the weapons, detonating them in underground test sites. Once weapons have been produced, they are deployed and maintained in readiness for use by DoD. After some time, they become obsolete or inoperative and are taken out of deployment, disassembled, and the weapons—grade radioactive material is removed and used again. lg/ Committee on Governmental Affairs, U.S. Senate, Study on Federal Regulation, Volume V: Regulatory Organization, S. Doc. No. 95~9l, 95th Cong., 2d Sess. 327—28 (1977). -17- Another program related to defense activities is the Naval Nuclear Propulsion Program, operated jointly by DoE and DoD. Under this program, the United States main— tains a fleet of 113 nuclear submarines and 11 nuclear- powered surface vessels. In addition to defense-related activities, DoE supports and promotes peaceful applications of nuclear energy and technology. DoE and its predecessors have long been involved in development of nuclear fission power in cooperation with and often by contract to the private companies that supply generating equipment, fabricate nuclear fuel, and operate the 72 nuclear power reactors now producing electricity. DoE also sponsors the development of radioactive isotopes for use in nuclear medicine and in industrial applications. Application of radiation-related medical technologies occurs at health care facilities operated by BOB, the VA, HEW, and other federal agencies. There, x-rays and radiopharmaceuticals are used for diagnosis and therapy as in other health care facilities. The President has recently promulgated guidelines recom— mended by EPA and HEW for the use of diagnostic x—rays by federal agencies. HEW also funds extensive medical use of radiation in both governmental and private health care institutions through its Medicaid and Medicare programs. The National Aeronautics and Space Administration is responsible for the development of nuclear aerospace applications. B. Research into Biologic Effects of Radiation. In FY 1978, the federal government spent approximately $76.5 million for research into the biologic effects of radiation. This research may be broadly divided into three categories: epidemiologic studies of the health effects of radiation on human beings, examining human populations exposed to radiation in the past ($17.5 million); experimental studies of the biologic effect of radiation on living systems, generally animals ($43.5 million); and studies of the environmental distribution of radioactive materials and the pathways by which they reach human beings ($15.5 million). See Table 2. -18- Table 2 Federal research support in FY 1978 ($1,000) by supporting agency and research area Research Category Agency Human Experimental Pathways Total DOE 13,618 23,479 10,982 48,079 HEW 1,710 13,624 - 15,334 DOD 1,600 4,912 - 6,512 NRC 350 1,128 2,327 3,805 EPA 185 218 2,263 2,666 VA - ' 108 - 108 Total ' 17,463 ’43,469 15,572 76,504 Sixty-three percent of the funding for this research ($48.1 million) came from DoE, which is authorized under the Atomic Energy Act to conduct research relating to the protection of health and safety during its develop- ment and production operations. DoE funded 78% of all federally-supported human health effects research ($13.6 million), 54% of the experimental research ($23.5 million) and 70% of the pathways research ($11 million). Seventy percent of its research was performed at National Laboratories like Oak Ridge and Brookhaven, which are owned by DoE, but operated by contractors. The remainder of the research was done by universities and/or by other research institutions, with DoE support. HEW funded 20% ($15.3 million) of the research on the biologic effects of radiation as part of its health research budget. Most of these funds were spent on experimental research and were dispensed by the National Cancer Institute (NCI) of the National Institutes of Health (NIH). Eighty-seven percent of NIH—supported research was performed at universities or hospitals and 10% was performed at DoE's National Laboratories. Other agencies within HEW that fund research are the Bureau _ 19 _ of Radiological Health (BRH) of FDA and the National Institute of Occupational Safety and Health (NIOSH) within the Center for Disease Control (CDC). Other departments and agencies supported a much smaller proportion of the research. DoD funded about 8.5% of federal research in this area, concentrating on experi- mental work on acute, high-dose health effects. NRC and EPA funded about 5% and 3% respectively, concen- trating on environmental distribution and pathways, which are of particular concern to these regulatory agencies. Some research was also supported by the Veterans Administration (VA), the Federal Aviation Administration, the National Aeronautics and Space Administration, and the Department of Agriculture. C. Radiation Protection Activities Most federal agencies with radiation-related responsibilities are engaged in protecting individuals from the effects of radiation use, primarily through regulation. Broad guidelines for many of these activi— ties are provided by the Environmental Protection Agency (EPA), which advises the President on radiation matters and prepares guidance to other federal agencies on the formulation of radiation protection standards. 1. User Agencies Agencies with programs that involve radiation exposure to their own workers or to the public, such as DoE, DoD, HEW, and the VA, regulate and supervise their own operations and/or those of their contractors, and are responsible for ensuring that proper measures are taken to keep exposures low. These agencies generally follow the guides that have been issued by the EPA or by its predecessor in this guidance role, the Federal Radiation Council. 2. Environmental Protection The other agencies engaged in radiation protection activities are regulatory agencies charged with control- ling uses of radiation in private industry and among the general public. The EPA has the authority, under Reorganization Act Plan No. 3 of 1970 and the Atomic _ 20 _ Energy Act, to establish generally applicable environmental standards for protection of the general environment from radioactive materials covered by that Act, which are "source material" (uranium and thorium), "special nuclear material" (plutonium and uranium enriched in the isotope 233 or in the isotope 235) and "by—product material" (radioactive material, other than special nuclear material, made radioactive during the production or use of special nuclear material). These standards are enforced through the NRC licensing process and are applied directly by DoE and DoD in their own operations. Some radioactive materials, notably such naturally-occurring radioactive elements as radium and accelerator-produced materials, are not covered by the Act. EPA's jurisdiction over Atomic Energy Act materials is limited to areas outside the boundaries of power reactors and other facilities subject to the regulatory control of the Nuclear Regulatory Commission. 11/ Under its Atomic Energy Act authority, the EPA has promulgated a standard to limit planned releases of radiation from all facili- ties in the uranium fuel cycle combined; exposures from radon in mining, milling and waste disposal activities, transportation of radioactive materials, and DoE facilities other than enrichment plants are excluded. EPA also has authority under the Federal Water Pollution Control Act to regulate the discharge into navigable waters of radioactive materials, like radium, not covered by the Atomic Energy Act. Under the Safe Drinking Water Act, EPA establishes national drinking water standards and can protect drinking water supplies directly when states fail to do so. The Resource Conservation and Recovery Act gives EPA regulatory authority over recovery and disposal of all radioactive wastes not covered by the Atomic Energy Act and obligates it to plan a national system for the storage and disposal of such wastes, along with other hazardous wastes. Under the Clean Air Act and its amendments, EPA also has the power to regulate air— borne emissions of radioactive materials. Other acts provide EPA with additional relevant authority. 11/ A major exception is that EPA has authority to set standards for atmospheric releases from these facilities under the Clean Air Act. The NRC then implements those standards. -21- The NRC is the successor to the ABC's broad authority under the Atomic Energy Act to regulate the possession and use of source materials, special nuclear material, and byproduct material. The principal power given to the NRC is to issue, to enforce or to withdraw licenses of those who wish to produce, use, or possess these regulated materials. Conditions tied to the issuance of licenses are meant to ensure that facilities are conStructed and operated with proper attention to the health and safety of workers and the public. Among those licensed by the NRC are nuclear power reactors, private reactor fuel_producers, industrial users of Atomic Energy Act materials, manufacturers of products containing Atomic Energy Act materials, and medical institutions that use Atomic Energy Act materials for diagnostic and therapeutic purposes. The NRC issues both mandatory regulations and regulatory guides that tell its licensees how to meet regulatory requirements. The NRC has the authority to relinquish some of its regulatory powers to a state by written agreement, so long as the state's radiation control program is adequate and compatible with the NRC' 5 program. The NRC may not relinquish its authority over facilities in the uranium fuel cycle (including power reactors), over export and import of regulated materials and facilities, over quan- tities of special nuclear materials sufficient to form a critical mass, and over certain disposal functions for regulated materials. At present, agreements have been signed with 25 States, which regulate 11,000 licensees. The NRC regulates 9000 licensees, including 72 power reactors and about 40 fuel cycle facilities. The FDA has authority to protect the public against ingestion of radionuclides in food, by regulating and restricting the distribution of food containing exces- sive amounts of radioactive substances. 3. Protection of Workers Several different agencies have authority to set and to enforce standards and other measures for protec- tion of workers from exposures to radiation. As in other areas of radiation protection, in establishing operational standards these agencies follow the basic guides originally set down by the Federal Radiation Council and now by the EPA. Federal user agencies are _ 22 _ responsible for ensuring that occupational doses in their own facilities are kept low, consistent with EPA's guidance and the exposure standards set by OSHA. Regulation of occupational exposures in the private sector is performed by three federal agencies. lfi/ The NRC regulates its licensees' workers' occupational expo- sures to radiation emitted by regulated materials. Such workers include health care workers and industrial radio- graphers as well as workers in nuclear fuel cycle facili- ties. Responsibility for protecting workers exposed in other contexts or to other forms of radiation rests with two agencies within the DoL. The Mine Safety and Health Administration (MSHA) has the authority to set upper limits upon and to regulate occupational radiation expo- sure of uranium miners, phosphate miners, coal miners, and other miners exposed to radioactive elements, and workers in the uranium milling industry. The Occupational Safety and Health Administration (OSHA) has the authority to set standards restricting exposure of workers other than those protected by the NRC and MSHA, including industrial radiographers and others exposed to radiation in manufacturing and industry, and health care workers. OSHA standards are in effect to 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 delegate enforce- ment powers to states that meet OSHA criteria. 4. Control of Medical Exposures Although two agencies, the FDA and the NRC, have authority relevant to control of radiation exposure to patients in medicine, no federal authority exists to regulate use of radiation in medical practice directly. Major regulatory responsibilities reside in the FDA. Under the Federal Food, Drug and Cosmetics Act and other laws, the FDA has authority to regulate the manufacture lg/ Worker health is also affected by standards estab- lished and enforced by other agencies, including the Department of Transportation, which regulates transportation of radioactive materials, and FDA, which regulates electronic products, like x-ray machines, that emit radiation. See sections 4 and 6 below. -23- and distribution of radiopharmaceuticals and medical devices containing radioactive materials. It shares part of this authority with the NRC, which has similar powers when the drugs or devices contain material governed by the Atomic Energy Act. The two agencies have worked together in the development of regulations. The FDA also sets basic performance standards for x-ray machines and other electronic products manufactured after 1974 that emit radiation. The standards ensure that the products emit the smallest amount of radiation consonant with effective operation; products must satisfy the cri- teria before they are marketed. In furtherance of this authority, FDA also issues recommendations for use of x—ray machines and other radiation emitters, conducts education programs for professionals and others, and assists the states with their activities in this area. 5. Regulation of Consumer Products. Three agencies, the FDA, the NRC, and the Consumer Product Safety Commission (CPSC), are involved in the control of consumer products that may emit radiation. The FDA's authority over electronic products extends to consumer products, such as color television receivers, that emit radiation. The NRC's authority over Atomic Energy Act materials extends to consumer goods, such as certain smoke detectors, that contain such materials. Related authority is held by the CPSC which, under the Consumer Product Safety Act and the Federal Hazardous Substances Act, can 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 that contain radioactive materials not covered by the Atomic Energy Act. 6. Regulation of Transportation Another major activity requiring regulation is transportation of radioactive materials or goods con- taining them. Authority here is shared among the NRC, the Postal Service, and several agencies within the Department of Transportation (DoT) that are now coordi— nated by the Materials Transportation Bureau. The NRC and DoT operate under a memorandum of understanding to avoid duplication of effort. DoT requires shippers, freight forwarders, warehousemen, and carriers to meet _24_ packaging, labeling and transporting standards when shipping on land, by air and on navigable waters. The NRC requires its licensees to meet DoT standards and its own specifications when preparing radioactive materials for shipment or when transporting those materials. The Postal Service regulates shipment of radioactive materials in the mail. 7. Other Federal Agencies A number of other agencies have minor regulatory responsibilities 12/ or conduct activities that influence regulation. 32/ In sum, a number of different agencies are directly and substantially involved in regulation related to radiation exposure; others play minor roles. Jurisdictions do not neatly coincide, but rather overlap and diverge in com- plex ways, creating potential conflicts that must be resolved by arrangements between agencies or leaving gaps that have yet to be filled. 31/ 8. The Role of the States State activities parallel those of the federal government in many respects. Like federal agencies, some state agencies conduct research into the biological effects of radiation. States may have operations, notably health care delivery, which result in radiation exposures. 12/ The Department of Agriculture has authority to control radiation contamination of crops and use of radiation as a pesticide. 39/ The National Bureau of Standards of the Department of Commerce is concerned with standardization and physical measurement of radiation; the Interstate Commerce Commission has adjudicated tariff disputes concerning transportation of radioactive wastes. 31/ One example of a gap in regulation has been control over accelerator-produced and some naturally-occurring materials. See Study on Federal Regulation, Vol. V, Regulatory Organization, note 16 above, pp. 335- -37. Another is protection of state workers in states without an OSHA-approved plan. -25... The major area of state activity and interaction with the federal government, however, is in regulation. Most states have authority under specific radiation control laws or under general public health laws to regulate activities using radiation. Since the federal government is so extensively involved in this area, states operate within the federal legislative framework and are occa- sionally preempted by federal activities. For example, some federal statutes, such as the Safe Drinking Water Act, empower federal agencies to take certain steps if a state fails to act. Other statutes, such as the Atomic Energy Act, permit federal agencies to delegate certain of their functions to states with adequate and compatible programs. Some states have assumed regulatory responsi— bilities under these statutes, while others have not. Many states try to fill the gaps in the federal regulatory structure. Most states regulate to some degree the pos- session and use of naturally—occurring radioactive materials such as radium, which are not heavily regulated by the federal government. Also, some states attempt to regulate the use and safety in continued operation of x-ray machines; the federal government is authorized only to set performance standards for manufacture. In order to achieve uniformity in their regulatory activities, states have generally tried to follow "Suggested State Regulations for Control of Radiation," guidelines prepared by joint state and federal effort in 1962. These guidelines are periodically updated by federal and state authorities, working in concert. In a few recent instances, states have begun to assert a role in regulatory areas that come within the statutory authority of federal agencies. For example, a number of states and some localities have expressed concern or issued regulations on the transportation of radioactive materials through major population centers. Several states are also concerned about the problem of disposal of high-level and low-level radioactive wastes. Because of their traditional jurisdiction over questions of land use, states also have an interest in the siting of nuclear power plants. These issues and the complicated network of federal-state interaction described above suggest that the states will play a significant role in future radia- tion use and control. The national Conference of Radiation Control Program Directors, whose membership includes all states and territories, is one organization through which this role can be carried out. _26_ D. Provision of Care and Benefits Several federal agencies administer programs that are potential sources of care and benefits to persons who may be injured as a result of exposure to radiation. These programs may be broadly divided into those that require a claimant to demonstrate some connection between irra- diation and injury (primary benefit programs) and those that dispense benefits to anyone who meets entitlement criteria, regardless of the cause of injury (back-up programs). Two major primary benefit programs are of interest here. The first, administered by the VA, is the veterans' dis- ability compensation program, which compensates veterans for service-connected disabilities. The second, adminis- tered by the Office of Workers Compensation Programs at DoL, is the Federal Employees Compensation Act, which compensates federal employees for work-connected injuries. DoL also administers the Longshoremen's and Harbor Workers' Compensation Act, a source of benefits to private shipyard employees. Back-up programs include Social Security Disability Insurance, an insurance program funded by employers and employees, and Supplemental Security Income, a social welfare program for the disabled poor, both administered by the Social Security Administration of HEW. They also include Medicare, which provides only medical benefits, primarily to the elderly, but also to those receiving SSDI benefits. Medicare is administered by the Health Care Financing Administration of HEW. Government agencies like the VA, the Public Health Service of HEW, and DoD also provide direct medical services to specific groups. None of these programs is designed to compensate for radiation- related injury in particular, but each might provide assistance to eligible individuals. The federal government is not the only source of care and benefits. Each state administers a workers' compensation program, which should be the primary benefit program for most workers injured by radiation. Some states also have back-up programs, such as Medicaid, which is partly financed by the federal government. Many people, particularly members of the public, will not have recourse to a primary benefit program and may seek to obtain compensation for injury through the courts. If an individual attempts to recover from the United -27- States, he or she must first file a claim with the agency connected with the exposure. If the claim is not resolved, the claimant may choose to file a lawsuit against the United States, which would be defended by the Department of Justice. _ 28 _ III. RESEARCH ON THE HEALTH EFFECTS OF RADIATION Numerous studies conducted since World War II have vastly expanded knowledge about the health effects of radiation. The results of these studies have been compiled and analyzed repeatedly by prestigious groups such as the Committee on the Biological Effects of Ionizing Radiation of the National Academy of Sciences (the BEIR Committee), the United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR), The National Council on Radiation Protection and Measurement (NCRP), and the International Commission on Radiological Protection (ICRP). 23/ While these studies have allowed experts to place an upper limit on the risks produced by exposure to relatively high doses of radia- tion, they have not provided data sufficient to permit definitive estimates of risks at low doses. g;/ The Task Force's Science Work Group reviewed studies bearing upon the question of low—dose effects, examined various hypotheses that could explain the data, and concluded that existing knowledge is insufficient to provide an unequivocal answer to the low—dose question. The Group also concluded that inherent methodological problems may prevent scientists from ever finding a definitive answer. It recommended pilot studies of several research projects which, if feasible, could further narrow the scope of uncertainty about low dose effects. This section describes methodological problems encountered by researchers, outlines the health effects of radiation as revealed in past research, discusses the present controversy over low—dose effects, and presents the Group's recommendations. 23/ The BEIR Committee issued a new analysis of research findings on May 2, 1979, "Effects on Populations of Exposure to Low Levels of Ionizing Radiation" (National Academy of Sciences 1979) (DRAFT) [hereafter BEIR III]. g;/ The term "low dose", unless indicated otherwise, refers in this report to dose levels of about 5 rems or less per year of external, whole body radia- tion or its equivalent. _ 29 - A. Methodologic Issues Knowledge about the health effects of ionizing radiation is derived primarily from epidemiologic studies of human populations exposed to radiation under nonex- perimental conditions, laboratory animal populations exposed to radiation under controlled experimental condi- tions, and studies of cellular and subcellular components of biological systems exposed to radiation. The majority of epidemiologic studies have been cohort studies, which involve comparing the incidence of disease in a group exposed to radiation with the incidence in a nonexposed group to determine the excess of disease attri— butable to radiation. Groups studied include persons exposed to atom bomb radiation and fallout; persons exposed to radiation for medical purposes, generally for therapy but in a few studies for diagnosis; and persons exposed occupationally. Numerous problems, attributable in part to the fact that exposures generally do not occur under controlled conditions, contribute to the impreci- sion of these studies' results, particularly when the researcher is tracing the effects of radiation at low doses and wishes to ascertain the relationship between dose level and incidence of disease (the dose/response relationship). Among these problems are: 0 Dosimetry: It is often impossible to determine the dose received by an individual, although researchers usually attempt to estimate it. As a result, it may be difficult to determine whether an observed response indicates a greater-than— expected effect of a low dose of radiation or a predictable effect of a higher—than-expected dose of radiation. 0 Records: If doses were measured at the time of exposure, they may not have been recorded, or the records may have been lost or destroyed. Health outcome records may be unavailable, incomplete, or inaccessible. 35/ o Competing causes: Populations under study may have been exposed to other physical or chemical gg/ Legal barriers to health researchers seeking access to records are discussed in Section IV. ..30.. agents that could have caused the observed effect. Often, information on these variables, beyond the fact they may have been present, does not exist. 0 Sample size: In order to demonstrate a particular effect, a researcher needs a minimum number of research subjects. The smaller the dose whose effect is measured, the larger the group must be. In the case of low doses of radiation, conclusive demonstration of effects might require studying a population of a million or more. None of the populations studied to date reaches this magnitude and most are sub- stantially smaller. 0 Comparison group: Usually, a researcher must match the exposed group with a comparison group that shares most of its characteristics except radiation exposure. Assembly of such a group is often difficult or impossible. 0 Population and exposure factors: Numerous variables may affect the observed response. In the case of radiation, these include: the particular type of radiation; dose level, dose rate, and dose fractionation; and the age, sex, and health status of the subjects. Since some or all of these problems affect every epidemiologic study, whether or not concerned with radia- tion, study results are always open to debate. Experimental animal studies indirectly confirm the results of human studies and also provide basic knowledge about radiation effects, notably dose/response relation- ships, synergistic effects with other agents, and mecha— nisms of cell damage, repair and carcinogenesis. Although the experimental setting permits control of several of the problems noted above, animal studies can- not avoid the problem of sample size. The largest animal population studied to date is comprised of 250, 000 mice, an enormous population to maintain under laboratory con- ditions. This study has produced useful information on the biological effects of radiation. Nonetheless, even this animal population is not large enough to provide conclusive information on low dose effects. Also, response patterns vary from species to species, leaving _ 31 _ uncertain the question how study results should be applied to humans. gg/ B. Health Effects of Radiation Despite methodologic difficulties, both human and animal studies have provided substantial information about the health effects of radiation. These effects may be divided into four types: (1) acute somatic effects, (2) developmental effects, (3) genetic effects, and (4) late somatic effects. Acute somatic effects are various forms of illness that occur in individuals within days or weeks of their exposure to penetrating radiation. They usually result from single whole body doses of over 100 rem; single whole body doses of 500 rem or more are often fatal in the absence of medical support. Bone mar— row cells and the cells lining the intestinal tract are particularly vulnerable to such large doses of radiation. As a result, acute somatic effects include anemia, hemorrhage, and infection on the one hand and nausea and diarrhea on the other. Other cells are more resistant, but may also be affected as with neural cells at higher doses. At the cellular level, a prominent effect is chromosomal damage, most commonly studied as chromosome breakage in white blood cells. The significance of such damage for the delayed health effects described below is not known at present. Developmental effects are abnormalities that occur in individuals who were exposed to radiation while in the womb or as young children. Animal experiments suggest that doses as low as 5 rem in early pregnancy may produce increased incidence of skeletal, nervous system and other malformations. Doses from 10 to 19 rem to human fetuses have been shown to produce small head size, and doses above 150 rem have been associated with mental retarda- 3§/ One commentator criticized the Science Work Group Report for not placing enough emphasis on the con- tribution made to our knowledge about radiation by experimental animal studies. See Public Comments, Appendix G, [hereafter, Pub. Comm.) doc. 28. The focus of the Report was on human epidemiologic studies, partly because those studies are the focus of greatest concern and controversy at present. This emphasis does not reflect any belief that experimental studies are of lesser importance. -32— tion. gg/ Doses in the 0.2 to 20 rem range appear to increase the risk of childhood cancer. When reproductive cells are exposed to harmful agents, mutations can occur that may result in genetic effects in the children of those exposed or later descendants. To determine whether radiation produces such effects, a study would have to follow a very large population for many generations. Such studies have been completed on short—lived animal species, and they indicate that radiation produces gene mutations and that such mutations can result in genetic abnormalities in later generations. Although similar genetic changes may also be induced in humans, none has yet been demonstrated, perhaps because the effect is too small to see with the data resources available or with present methods of observations. 21/ The study of Japanese survivors of the atomic bombs at Hiroshima and Nagasaki, the largest and one of the oldest studies, has so far produced no evidence of an increase in genetic effects as a result of radiation. Nonetheless, the BEIR Committee in 1972, basing its calculations on extensive animal data, did estimate, within a broad range, potential human genetic effects resulting from exposure to low doses of radiation. gg/ Late somatic effects are effects that may become clinically evident many years after an individual has been exposed to radiation. The major and most con— clusively demonstrated late somatic effects are various forms of cancer, which have been shown to be associated with radiation exposure in numerous studies. Some forms of cancer, notably leukemia and thyroid, breast and lung cancer, have been linked firmly to radiation, while the association is more problematic for others. Table 3, gg/ Miller, R. w., and Blot, w. J., "Small Head Size Following In Utero Exposure to Atomic Radiation", Lancet 2: 784—87, 1972. 21/ This conclusion was challenged by one of the researchers on the Tri-State study, which suggests that low-dose radiation may be associated with immunodeficiency in the children of irradiated parents. Pub. Comm., doc. 49, p. 4. For further discussion of this study, see pp. 36-38, below. 3§/ See Science Work Group Report, p. 6. The 1979 estimates of the BEIR Committee do not differ significantly from the 1972 estimates. _33_ which is taken from the Report of the Science Work Group, summarizes the findings of the major studies. 22/ Most of the studies have involved exposures at relatively high doses of radiation (50 rem or more), either delivered at a high rate in a single incident or perhaps in a few incidents within a short period of time. Some have involved high doses of internally-deposited radionuclides or repeated doses which produced extensive exposures to the organs at risk. The man-made radiation exposures that occur most frequently today are medical diagnostic expo— sures and doses at low levels, resulting in accumulations of 50 rem only after many years, if at all. The question arises whether these fractionated, low dose and generally low rate exposures produce health effects comparable to those produced by the higher dose, high rate exposures that have been studied. Providing answers to this question is made difficult by the methodologic problems noted earlier. Because cancer has a long latent period and because clinical features of cancer do not reveal its cause, it is impossible to determine whether any given case of cancer was caused by radiation or by another factor. Associations are dis— covered by comparing the incidence of particular forms of cancer in a population exposed to radiation in excess of natural background with the incidence in a non—exposed population. Everything else being equal, excesses in the exposed population are presumed to reflect the effects of radiation. Yet, in some populations under study, confounding variables (e.g., a chemical carcinogen like benzene) may produce at least some of the observed effects. Moreover, the number of excess cases is generally a small fraction of the total incidence of 22/ Triple asterisks (***) indicate strong associations, usually confirmed repeatedly in multiple studies and often with evidence that cancer risk increases with radiation dose. A double asterisk (**) indicates associations that appear meaningful but are less striking. A single asterisk (*) indicates sugges— tive associations, usually from quite recent work in single sets of data, not confirmed by other studies and often based on very small numbers or question- able study design. The numbers following the study titles indicate references found in the Science Report. flywfim N. 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