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Assessment of the Scientific Information for the Radiation Exposure Screening and Education Program 1 Introduction Beginning in 1945 and continuing through 1962, the United States conducted a series of aboveground nuclear-weapons tests. Many people potentially exposed to radiation from the testing program later became concerned that their health had been adversely affected by those events. The concerned populations included workers and civilian employees who participated onsite in tests involving the atmospheric detonation of nuclear devices within the boundaries of the Nevada, Pacific, Trinity, or South Atlantic Test Sites and others living in the surrounding areas during the testing period. Uranium miners had also been at risk of exposure to radiation from inhaled radon decay products and other airborne hazards in the mine environment that together were presumed to have caused an increase in the incidence of lung cancer and respiratory diseases among the miners relative to the general population. On October 15, 1990, the Radiation Exposure Compensation Act (RECA), PL 101-426, was enacted to provide payments to people who developed particular cancers or other diseases as a result of either exposure to radiation released during aboveground nuclear-weapons tests or employment associated with the uranium-mining industry. The cancers specified as compensable under RECA were those that had been determined to be causally associated with radiation exposure on the basis of epidemiologic studies of populations exposed to low to moderate doses at mainly high dose-rates (NRC, 1980). RECA1 was amended on July 10, 2000. The amendment broadened the scope of eligibility for benefits to include additional categories of people and 1 In this report we refer to RECA with all amendments attached unless otherwise stated.
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Assessment of the Scientific Information for the Radiation Exposure Screening and Education Program modified the criteria for determining eligibility for compensation. The Department of Justice (DOJ) administers RECA as codified by 28 CFR 79. The RECA of 2000 also amended Subpart I of Part C of Title IV of the Public Health Service Act to add Section 417C—grants for education, prevention of, and early detection of radiogenic cancers and nonradiogenic diseases. Section 417C provides the authority for competitive grants to states, local governments, and appropriate health-care organizations to initiate and support programs for health screening, education, medical referral, and appropriate followup services for persons eligible under RECA. Persons eligible for those programs are categorized by the nature of their exposure to radiation as defined by 42 USC 2210 note and Public Law 106-245, the Radiation Exposure Compensation Act Amendment of 2000, Sections 4(a)(1)(A)(i) and 5(a)(1)(A), and in 28 CFR Part 79. The categories are uranium miners, uranium millers, ore transporters, certain downwinders, and onsite nuclear-test participants. The Health Resources and Services Administration (HRSA) of the Department of Health and Human Services administers the grants as part of the Radiation Exposure Screening and Education Program (RESEP). In response to a congressional mandate (Public Law 107-206), HRSA asked the National Research Council’s Board on Radiation Effects Research to convene a committee to assess the recent biologic, epidemiologic, and related scientific evidence associating radiation exposure with cancers or other human health effects. The committee was asked to consider the issues surrounding the implementation of RECA and to make recommendations on the basis of scientific knowledge and principles. The study began in September 2002. The following statement of work describes the task set before the committee (HR 107-593): On the basis of its information, the committee will make recommendations to HRSA regarding: A. technical assistance to HRSA and its grantees on improving accessibility and quality of medical screening, education, and referral services; B. the most recent scientific information related to radiation exposure and associated cancers or other diseases, with recommendations for improving services for exposed persons; and C. whether other groups of people or additional geographic areas should be covered under the Radiation Exposure Compensation Act (RECA) program. The committee considered whether additional geographic areas should be added to the previously defined areas2 on the basis that residents had been simi- 2 The areas previously designated for compensation were: the Utah counties of Beaver, Garfield, Iron, Kane, Millard, Piute, San Juan, Sevier, Washington, and Wayne; the Nevada counties of Eureka, Lander, Lincoln, Nye, and White Pine and the portion of Clark County that consists of townships 13-16 at ranges 63-71; and the Arizona counties of Apache, Coconino, Gila, Navajo, and Yavapai and the part of Arizona that is north of the Grand Canyon.
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Assessment of the Scientific Information for the Radiation Exposure Screening and Education Program larly at risk of exposure to fallout from US nuclear-weapons tests. In its report, the committee considers a range of possible expansions of the current downwinder geographic areas to include other areas exposed to high levels of fallout. In considering task B, the committee focused its review on issues relevant to RECA and RECA populations and did not duplicate nor have access to the detailed final conclusions of the exhaustive efforts of the Committee on the Health Risks of Exposure to Low Levels of Ionizing Radiation (the BEIR VII committee’s report will be published in 2005). Reports on task-related topics published since 1990 in the national and international peer-reviewed literature were identified for review. Reanalysis of existing epidemiologic data with alternative methods or models and the collection and analysis of new epidemiologic data were beyond the committee’s task. HRSA also requested that the National Research Council committee provide an interim report to the agency and its grantees. The six grantees funded by HRSA (see Table 11.1) under RESEP in 2002 and in 2003 were at the Dixie Regional Medical Center, the Miners’ Colfax Medical Center, the Mountain Park Health Center, the Northern Navajo Medical Center, the St. Mary Hospital and Medical Center, the University of New Mexico Health Sciences Center, and the Utah Navajo Health System, Inc. The interim report was organized around items A and B above, and was to assist RESEP staff to develop an action plan that is consistent with best medical and educational practices and the current state of science (NRC, 2003a). The committee provides background information in Chapter 3 on recent developments in radiation dosimetry, radiation biology, and radiation epidemiology that influence the risk-assessment process. That approach was taken to enable the committee to determine whether any of the RECA populations are likely to be at more or less risk of cancer as the result of exposure to radiation than previously estimated and whether additional geographic areas should be recommended for inclusion in RECA. This report constitutes the results of the committee’s assessment and its recommendations. It consists of 11 chapters. Chapter 2 describes the Radiation Exposure Compensation Act, including a brief history which led to its creation and recent revisions (addresses item C in the committee’s statement of task). Chapter 3 reviews the scientific principles of the physics and dosimetry of ionizing radiation, radiation biology, and epidemiologic methods, and provides basic technical background information in support of Chapters 4, 6, and 7. Chapter 4 reviews and summarizes recent data on radiation epidemiology, dosimetry, and biology (addresses item B). Chapter 5 describes probability of causation (PC) and its use in compensation (addresses item C). Chapter 6 provides information about additional geographic areas that might be included under RECA (addresses item C). Chapter 7 provides information about additional diseases and classes of people that might be included as compensable under RECA (addresses item C).
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Assessment of the Scientific Information for the Radiation Exposure Screening and Education Program Chapter 8 discusses an ethical framework as it applies to RECA and RESEP (addresses item C). Chapters 9 and 10 discuss the indications for and implications of screening, both to improve health and to identify persons eligible for compensation (addresses item A). And Chapter 11 addresses education and outreach (addresses item A). To be consistent with the policies of the National Academies and to fulfill its charge, the committee conducted fact-finding activities involving outside parties in public information-gathering meetings. The committee met in closed sessions including conference calls only to develop committee procedures, review documents, and consider findings and recommendations. It met once in 2002, five times in 2003, seven times in 2004, and once in 2005. Eleven of the fourteen meetings included public information-gathering sessions, and the committee also received and considered other public comments and communications. The information-gathering meetings were structured to solicit information from technical experts and the study sponsor on topics related to the study. At those meetings, the committee heard from representatives of HRSA and its RESEP grantees, the Department of Energy, DOJ, the Department of Labor, scientific, medical and other experts from academic institutions, and other interested parties, and it benefited from the information they provided. The committee appreciated and was impressed by the efforts of the speakers to work with it during the project; their cooperation has been important in the committee’s efforts. The committee also held three public meetings dedicated to information-gathering in St. George, Utah; Window Rock, Arizona; and Salt Lake City, Utah. In addition, the Research Council staff held a public meeting in Boise, Idaho, to gather information for the committee. Notices inviting the public to attend those meetings went to the offices of Senators Orrin Hatch, John McCain, and Larry Craig; to the press in Utah and Arizona; to the Navajo Education Center in Arizona; and to the Salt Lake City Library. Each of the four meetings was a full-day open session at which members of the public and technical experts were invited to express their views and concerns, ask questions, and provide information orally or in writing on issues related to the committee’s task. The committee invited those unable to attend the meetings to submit written statements for its information and inclusion in the Research Council’s public-access file, which is available on request. Almost 200 people, including members of the mass media, attended each of the public meetings. We found the public eager to assist us. In particular, they seemed to be supportive of our study, interested in learning more about it, and curious about the answers they hoped the committee would be able to provide to a number of questions. Such interaction with the public provided a formal, yet open, exchange of ideas, questions, and responses and proved useful to us. The oral and written comments, views, concerns, and questions submitted to the committee by members of the public and technical experts were in sev-
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Assessment of the Scientific Information for the Radiation Exposure Screening and Education Program eral broad categories. The committee considered each of those in preparing its report: Personal testimony on the adverse health effects attributed by individuals and families to the activities defined by RECA and on the hardships experienced by them in their treatment and disease-management efforts. Argument in favor of expansion of RECA coverage to include northern Utah counties, all Utah counties, and other areas, such as Idaho, Montana, New York state, and all the United States, based on maps from the National Cancer Institute (NCI), indicative of counties in which the total dose to the thyroid was estimated to be at least as great as that estimated in areas currently covered by RECA. Argument in favor of expansion of RECA coverage to include additional diseases for one or more of the eligible populations. Argument from the Navajo Nation that miners can use affidavits under some circumstances to establish employment history but that millers and ore transporters cannot. Argument from the Navajo Nation that an affidavit should be allowed as proof of presence or residence for downwinder claimants. Argument to expand RECA coverage to residents of Guam who were potentially exposed to fallout and to radiation from the decontamination of naval vessels associated with nuclear tests conducted in the Pacific. Recommendation to support an update of the study of leukemia in the downwinder populations. Reports of immediate-family members (same or different generation) or close relatives with multiple similar or diverse types of cancer (such as breast cancer and thyroid cancer), often among individuals or families with no known history of cancer. Interest in the PC approach to compensation that uses individual doses estimated with the NCI algorithm (difficulty with on-line access to the NCI-PC algorithm was described). Inequity within RECA and among the various federal radiation compensation programs. National or universal health care as a solution (posed as the only equitable solution) to the problem. Concerns about the possibility of the resumption of nuclear testing at the Nevada Test Site (NTS) and elsewhere. Support of full and comprehensive epidemiologic studies among the Navajo Nation. A proposal that the federal government put more money into a trust fund for compensation. The idea that the federal government should conduct more research into the health effects of fallout from nuclear testing.
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Assessment of the Scientific Information for the Radiation Exposure Screening and Education Program Reports (by medical and other professionals and other citizens of Idaho) of apparent excesses of cases of some radiogenic diseases and others perceived to be attributable to radiation exposure. Appendix A lists the names of invited speakers, representatives, and other persons who have interacted with the committee through correspondence, by providing information at meetings, or by providing their statements for our use. More than 1,400 people have interacted with the committee. The type of interaction—for example, e-mail, fax, letter, phone call, and attendance at meetings—is also noted. SCIENCE, VALUES, AND DECISION-MAKING The review of scientific research, evidence-based medical knowledge, and studies of effective educational strategies presented in this report provides new information, some of which was developed since RECA was enacted and later amended. Applying this new scientific knowledge may require additional societal value-based decisions. In addition, not all the issues presented to the committee fell strictly within its charge. Some issues, such as citizens’ concerns about the possibility of the resumption of nuclear testing at the Nevada Test Site (NTS) and elsewhere, clearly fell outside the charges that HRSA put to this committee. Other issues, although intertwined with the scientific recommendations the committee provides in this report, require debate and deliberation among citizens and their congressional representatives. The committee offers relevant scientific recommendations, but the attendant policy decisions must come from the larger body of citizenry. Whom to compensate is one such decision. The method that the committee thoroughly discussed by which a person is eligible, on scientific grounds, to qualify for RECA compensation, will require that Congress make some additional decisions. For example, it calls for further determinations as to whether compensation is to be based primarily on estimated dose or on a composite measure taking both estimated dose and uncertainty into account (see Chapters 5 and 6). These difficult policy decisions lie outside of science per se, but science has valuable information to offer in support of them. The decisions are societal judgments based on the acceptance of some scientific consequences over others (Rudner, 1953; Beauchamp and Childress, 2001). Other decisions about compensation include how to compensate; an example is whether to focus on communities or individuals. In the latter case, a further decision is whether to establish a sliding scale of compensation or to apply a flat rate of compensation to all. These are all societal decisions. At best, the committee will make transparent, in Chapters 5 and 6, the consequences, values, and assumptions embedded in the various criteria that Congress could adopt to establish eligibility for compensation. The decision rests with Congress.
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Assessment of the Scientific Information for the Radiation Exposure Screening and Education Program Citizens’ concern to achieve equity occupied much of the committee’s deliberations. In providing a scientific basis for establishing justice, the committee still is limited to making recommendations within or directly related to its charge. The committee was not asked to comment on the use of any new criteria for eligibility for compensation for persons in existing RECA-eligible geographic areas. The committee recognizes that reforms never rest simply on the scientific recommendations of experts. Committee members understand that many other considerations play a role in crafting policies and laws; these include pragmatic consequences, budgetary realities, and competing political goals. The committee intends that its scientific recommendations remain within the parameters of its initial charge and that they are consistent with principles of ethics.
Representative terms from entire chapter: