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CHAPTER 1 INTRODUCTION Goals of the Planning Study The effects of environmental factors on human health and well-being have attracted increasing attention in recent years.1-3 Environmentally related health problems are of major concern because they may contribute substantially to rising costs of illness, and because most of them are--theoretically--preventable.2-5 But there also is concern about costs of regulations designed to yield a cleaner environment. Although estimates of such costs abound, they are no t balanced by reliable e s timates of potent) a 1 bene f i ts.6-8 In an effort to improve estimations of benefits, Congress enacted Public Law 95-623, the Health Services Research, Health Statistics, and Health Care Technology Act of 1978.9 Section 7 calls for an "ongoing" study designed to improve the information on and methodologies for estimating costs of illness caused by harmful environmental exposures and for estimating benefits of improvements in the environment. The benefits of concern are improved health and decreased costs of illness. Congress recognized that any estimates of such health benefits made with existing data will be very imprecise, and that there is a great need to more accurately evaluate benefits of programs to improve the environment. A recent Supreme Court decision, in which the Court fai led to uphold an Occupational Safety and Health Administration (OSHA) standard for benzene on the grounds that benefits had not been sufficiently demonstrated, is only one example of the need for benefit analyses.l° Even crude estimates of benefits can help policymakers set priorities and choose among alternative strategies. As better data become available and methodologies advance, uncertainties in the estimates should diminish, affording improved policy decisions. Congress asked the Institute of Medicine and the Department of Healtt' and Human Services to conduct an ongoing study which is to address "present and projected future health costs of pollution and other environmental conditions resulting from human activi ty" anyplace in the indoor or outdoor environment, including places of employment and resi dance .9 The ongoing study would provide -15-

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information on sources of environmental hazards, the health effects attributable to those sources, and the costs of these health effects. The law calls for biennial reports that identify deficiencies in the availab le data, recommend corrective actions, and recommend ways to facilitate evaluation of the health effects of environmental hazards. Appropriate government agencies, such as the Environmental Protection Agency, must be involved. Finally, the~law specifies a wide variety of medical and social costs that must be considered. (Sections 7 and 8 of the law are in Appendix A.) Many aspects of environmental effects on health, as encompassed by P.L. 95-623, will contribute to the complexity of the ongoing study. In a broad context, the human environment includes all the activities and outside factors (that is, non-genetic factors) that can affect human health in beneficial or in harmful ways. These may include activities that individuals undertake, such as smoking and exercising, and substances to which people are unknowingly exposed, such as trace substances in food or air. The social environment, which includes socioeconomic factors as well as relationships among family, friends, and work associates, can be included e Exposure to beneficial or harmful environmental agents may occur from a variety of sources and by various routes, singly or in combination.] People may be exposed to agents by inhalation, ingestion, contact with the skin, or through action on the sensory organs, for example, loud noises. As explained later in this chapter, this report recommends that the ongoing study initially emphasize involuntary exposures to potentially hazardous chemical and physical agents resulting from human activi ty. Health effects to be studied also span a wide range. They may include cancers, respiratory conditions, heart and circulatory disorders, mental illness, reproductive disorders, and illness associated with other organ systems. Because of the ongoing study's broad scope, the Institute of Medicine undertook this planning study to assure that the ongoing study proceeds in an orderly and useful way. Major goals of the planning study were to o describe the basic information requirements necessary for - the ongoing study and for the biennial reports o provide a framework for the ongoing study and an assessment of the feasibility of meeting the various requirements of the law o recommend administrative arrangements for carrying out the ongoing study -16-

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o recommend steps to maximize the usefulness of the biennial reports. The Institute of Medicine committee that prepared this report has developed a conceptual framework for the ongoing study rather than a step-by-step plan. This report describes the types of information needed to conduct the ongoing study, discusses the difficulties inherent in the congressional charge, and makes recommendations for improving the data and methodologies needed to provide the estimates Congress requested. Chapter 1 provides an overview of the problem. Chapters 2 and describe the kinds of information needed and available to relate hazards to health effects. Chapter 4 discusses the various costs described in Section 7 of P.L. 95-623 and the methodologies available for estimating them. These last three chapters appraise the difficulties of attempting to arrive at numerical estimates, noting that great uncertainty will attach to any numerical estimates d eve loped . Some of the practical admini strative i ssues of implementing the ongoing study are reviewed in Chapter 5, which also describes how the ongoing study might serve the needs of various groups. Chapter 6 recommends a series of phased activities for the ongoing study and an administrative structure, suggests topics for detailed analysis, and makes additional recommendations for improving available data. Historical Background: Estimating Benefits of Environmental Regulations A brief review of the recent history of environmental regulation indicates the need for benefit estimates.ll The decades of the 1950s, 1960s, and especially the 1970s were periods of major federal legislative activity to control potential environmental hazards, particularly pollutants.6 Appendix B briefly describes major federal environmental statutes. In the periods preceding enactment of virtually all of these laws, data were gathered to define the magnitude of the environmental problem and, in many cases, its qualitative association with health. Once a law was in place, the responsible agency focused on showing improvement or deterioration of pertinent environmental indicators. But the agencies made little attempt to quantify relationships among environmental factors, health effects, and costs of these health effects. Although environmental legislation usually called for research, it seldom provided for research that would help establish data bases to reveal relationships between environmental variables and effects on health. However, agencies have sponsored investigations, such as -17-

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epidemiologic studies,12~13 that have attempted to identify these relationships and to discover mechanisms of action of harmful environmental agents. The agencies' major efforts went towards defining and controlling environmental problems. The data collection systems that evolved from the various pieces of legislation met at least partially the needs for which they were intended, but they were not set up to relate health effects to environmental measures.14 Beneficial health effects were assumed, but not measured.l5 Also, there was no particular attempt made to evaluate costs of these regulations, or to develop cost/benefit estimates. For example, the OSHA Act specifically excludes cost as a reason for obtaining a variance from some provisions of the law.16 Now, however, increased concern with costs of illness and costs of environmental regulations has led Congress to seek evidence for health benefits of these regulatiOns.17,18 Although the legislation calling for this planning study refers to reducing health costs, the aim also can be considered in terms of health bene fi ts that would result from reducing environmental hazards. This is not the only information that decision makers need,l9 but it helps those who must consider the cost effectiveness of regulations or standards intended to improve the environment. However, P.~. 95-623 does not ask the ongoing study to do cost/benefit analyses or cost effectiveness analyses, or to provide data on pollution abatement costs, all of which may be relevant for making policy decisions. Therefore, this planning study is not considering all relevant information, but only information related to estimating health benefits. Benefits of pollution abatement are often more difficult to estimate than costs. One reason is that costs are incurred in the short term, while benefits may appear only far in the future.8~17~22,23 Benefits of a less hazardous environment, besides improvements in health, could include better recreational facilities or improvements in productivity.22 Not all types of benefits are readily expressed in economic teens. Health benefits are particularly difficult to document or to convert to dollars, partially because of problems in attributing a dollar value to human life and its quality. Nonetheless, there have been numerous attempts to estimate the benefits of a cleaner environment. Two recent reviews suggest that, although the health benefits from controlling pollution and other environmental hazards cannot be accurately quantified, they probably are considerable.17~22 For example, if air quality has improved 20 percent from 1970 to 1978--an assumption that is consistent with some analyses--the benefits are estimated at anywhere from $5 billion to $58 billion per year, about 80 percent of which are to health.22 -18-

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Because methods and assumptions for estimating costs of pollution abatement differ from those for estimating benefits, the results are not necessarily comparable. Estimates of costs of pollution control are more precise. For instance, expenditures for abating pollution and improving environmental quality in the United States totaled about $46.7 billion in 1978, which was about 2 percent of the Gross National Product.6 of those expenditures, approximately $20 billion each went to improving air quality and water quality, and $6 billion went for control of solid wastes. Information Needed by the Ongoing Study P.L. 95-629 enumerates explicitly the kinds of information the ongoing study should provide. Section 7(e)~1~(A-E) calls for an ongoing study that shall, to the extent feasible (A) identify the pollution (and the pollutants responsible for the pollution) and other environmental conditions which are, or may reasonably be anticipated to be,.responsible for causing, contributing to, increasing susceptibility to, or aggravating human diseases and adverse effects on humans; (B) identify each such disease and adverse effect on humans and specifically determine whether cancer, birth defects, genetic damage, emphysema, asthma, bronchitis and other respiratory diseases, heart disease, stroke, and mental illness and impairment are such a disease or effect; (C) identify (on a national, regional, or other geographical basis) the source or sources of such pollutants and conditions and estimate the portion of each pollutant and the extent of each condition which can be traced to a specific type of source; (D) ascertain (i) the extent to which the pollutants and conditions identified under subparagraph (A) are, or may reasonably be anticipated to be, responsible, individually or coil ec t ive ly, for caus i ng, contribut i ng to, i ncreas ing susceptibi lity to, or aggravating the diseases and effects identified under subparagraph (B), and (ii) the effect upon the incidence or severity of specific diseases and effects of individual or collective, as appropriate, incremental reductions in the pollutants and changes in such conditions and (E) quantify (i) the present and projected future health costs of the diseases and effects identified under subparagraph (B), and (ii) the reduction in health costs which would result from each incremental reduction and change referred to in subparagraph (~) (ii). -19-

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To obtain the estimates Congress has requested, it will be necessary to ascertain: o sources and amounts of environmental hazards o their dispersion into the environment levels of human exposure from contact with and absorption of the substances in question health effects, expressed quantitatively, resulting from a given exposure o costs of the resulting health effects. Figure 1-1 depicts these requirements schematically. The chart shows the data needed and methodologies used to derive the relevant information and to develop relationships among the different kinds of information. Chapters 2, 3, and 4 of this report will discuss the chart in greater detail. Sources and Dispersion of Substances Boxes 1 and 2 in the figure represent information related to the sources of a substance and the amounts of it or its derivatives entering the various parts of the environment. Much of this information comes from environmental monitoring activities carried out in response to regulatory requirements.24 Monitoring information is useful for determining pathways of exposure and for taking steps to decrease exposures arising from human activities.* Despite the vast amount of these data available,24~25 there is little information on exposures to individuals from the various sources. Human Exposure Boxes 3 and 3a relate to exposure measurements. Direct measurement of exposure would be most desirable, but such information is rarely available. Instead, exposure calculations often are based on concentrations of substances measured in air, water, food, and pollution and other environmental conditions resulting from human activities," the phrase used in P.L. 95-623, can encompass a broad spectrum of hazards. It is often not possible to distinguish natural hazards from "man-made hazards," and this report does not attempt a sharp distinction. -20-

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FIGURE 1-1. CAT OF INFORMATION NEEDED TO ESTATE THE COSTS OF ENVIRONMENT-RELATED HEALTH EFFECTS AS MANDATED BY PUBLIC LAW 95-623 1. PRIMARY SOURCES OF HAZARDS A NOTE: This chart assumes a simple substance-by- ~ubstance approach, ignoring, for example, synergistic effects ~ , 3a. TYPES OF DATA Direct exposure-- personal monitoring Surrogate measures of exposure 4a. TYPES OF DATA In vitro tests Animal evidence Clinical studies Epidemiologic data (Can include lifestyle. socioeconomic factors) Other 1 1 5a. METHODOLOGIES Output accounting* Willingness-to-pay *Often called human capital Man-made sources Production processes products by-products Natural sources _ _ , ~ 2. DISPERSION INTO ENVIRONMENT, including transportation and transformation processes Concentration of substances, which may vary locally, in: Air Food Water Soil Other materials used by people ___ .~ 3. HUMAN CONTACT AND ABSORPTION (Exposure) —21— Level in people (Amount or concentration) 4. QUANTIFYING HEALTH EFFECTS (Dose-response information) Health problems Cancer Cardiovascular problems Respiratory problems Heritable defects Other 5. ESTIMATING COSTS OF ILLNESS Medical costs Physicians Hospitalization Drugs Lost productivity Lost workdays Bed days Home expenses Pain and suffering Years of life lost Other

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other materials, combined with estimates of the amounts ingested or inhaled by an average person. In some cases, elaborate models have been developed to estimate exposure. Relating Exposure to Health Effects . . . The step from Box 3 to Box 4 is perhaps the most difficult in the scheme. Information for determining the environmental causes of the health problems in Box 4 comes from several kinds of studies, including in vitro and animal studies and studies in human populations (Box 4a). Many attempts have been made to quantify health impacts of various environmental factors.6~26-29 Table 1-1 and Appendix C indicate the range of environmental factors and health effects that might be considered. Table 1-1 is not comprehensive; it omits, for example, possible environmental factors in mental illness. Quantitative assessment of health effects of the environment is complicated by uncertainty about dose/response relationships, especially at low doses. Much testing for toxic effects employs high doses of single substances in animals, but the environment of human beings constitutes exposures to many substances at-once, and at varying doses and times, during which susceptibility may vary.~30~32 For chronic diseases or those with long latency periods, relating exposure to health effect is particularly difficult. Nonetheless, dose/response information is necessary for meeting the requirements of Pet. 95-623, which asks for the change in health status that would result from various changes in exposure. Estimating Costs of the Health Effects - Boxes 5 and 5a of Figure 1-1 list some of the costs that need to be considered and the two methodologies most often used in cost-of-illness studies. Difficulties in determining these costs are caused by the extensive variety of costs that the law wants evaluated and by the requirement that future health costs, as well as present ones, be quantified. Furthermore, the reduction in health costs that would result from incremental reductions in pollutants and other hazards must be ascertained. Thus, a systematic approach is needed to examine health effects-costs relationships by 0 defining the array of costs, including those mentioned in the law, that can reasonably be expected to derive from a particular health effect -22-

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o determining which of these can be calculated with reasonable accuracy, assessing current methods for calculating costs, and suggesting ways that the methods may be refined or more broadly appl fed o suggesting new sources of data and/or new methodologies for determi ni ng the re levant hea 1 th cos t s . Various procedures exist for estimating costs of illness, none of them entirely satisfactory.23~33 Using the output-accounting (or human-capital) approach developed by Cooper and Rice,34 cost of illness studies estimate direct and indirect health costs. Direct costs are medical care expenses, such as those for hospitalization and physi clans .35 ~ 35 Total direct medical care costs are fairly readily estimated and allocated among the various health services and supplies. Allocating direct costs by disease is much less precise, and attempting to correct for the portion of illness attributed to environmental factors introduces still greater uncertainty. For 1979, national health care expenditures were $212.2 billion, which was about 9 percent of the Gross National Product.37 Indirect costs are more difficult to calculate. They include estimates of the loss of earnings and the assumed market value of unperformed housekeeping services. Table 1-2 shows the estimated direct and indirect costs in 1975 for 16 diagnostic categories, and Table 1-3 ranks them using several burden of illness criteria.35 Thus, diseases of the circulatory system ranked first in potential years of life lost, second in number of inpatient days, and first in total economic burden. The output-accounting method does not encompass such factors as pain and suffering, effects of bereavement on family and friends, or special transportation or clothing costs incurred because of illness. Other methods, such as the willingness-to-pay approach, attempt to develop values for illness and death that include factors not considered by the output-accounting approach,23 but these attempts also introduce new difficulties. Additional Comments Figure 1-1 assumes a substance-by-substance approach, but other approaches exist. For example, the geographical distribution of cancer can be compared to aggregate measures of industrial output, or the health effects of air pollution or other aggregate factors could be examined without definitive information on which substance or substances are responsible for the health effect. Useful information can be derived from the various parts of the scheme without going through the entire set of boxes. At present, the most critical and least available information concerns quantifying human exposure to substances and determining subsequent health effects. -24-

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The difficulties in obtaining the data and performing the estimates depicted in Figure 1-1 should not be underestimated. There seldom are identifiable, isolated cause and effect relationships between environmental factors and health; inadequacies and gaps in information and methodologies exist for measuring health costs. A major purpose of this planning study was to recommend systems of surveillance, monitoring, and data collection to improve the information avai table, enable assessment of hazards that are not now adequately understood, and facilitate assessment of associated costs for known and yet-to-be-identified hazards. Some of the data needed for the ongoing study already exist, both in the federal government and elsewhere.14~35 However, these data usually are collected for a specific purpose, without attempts at coordinating efforts with other agencies or avoiding duplication.14~39 Changes in organization of data and in methods of data collection by agencies and others may be necessary to provide the estimates required by P.J.. 95-623. Early Phases of the Ongoing Study Because the ongoing study cannot cover all environmental hazards, health effects, and costs in each biennial report, this planning study suggests criteria for choosing topics that might receive the greatest attention, although the ongoing study will have to set more explicit priorities. Each biennial report could discuss a single health issue, route of exposure, type of hazard, or related methodology. The relationship between potential environmental hazards and their health effects can be approached by starting with a possible hazard (Box 1 in Figure 1-1) or with a health problem (Box 4 in Figure 1-1~. In choosing a health problem, criteria that are frequently used by health professional s for setting priori ties could be considered. They include 40 o magnitude of health problem, including mortal ity rates, years of li fe lost because of premature death, severity and reversibility of effect, transmissibility of effects to future generations, and other measures such as those in Table 1-3 probability that additional obtainable information would be useful targets of opportunity, even if the problem affects relatively few people -27-

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o public perception of importance o need for information for policy purposes. For purposes of the ongoing study, another criterion would be o strength of evidence linking a health problem to particular environmental factors. In choosing a hazard to investigate, criteria could include o potency of the hazard o amount of the substance involved o number of people exposed o magnitude of the resulting health effects. Various attempts have been made to set priorities for testing toxic substances and pesticides according to these criteria.41~42 Areas of Initial Emphasis The remaining chapters of the report will discuss the ongoing study, taking into account the topics that the study committee believes warrant early attention. The committee suggests that initial emphasis be given to adverse health consequences of involuntary exposures resulting from man-made changes in the physical and chemical composition of the environment, including some effects of noise and radiation. Consideration of life-style factors, such as diet, exercise, smoking, and alcohol consumption, would largely be deferred, as would the social environment, accidents, most aspects of infectious diseases, and side effects of therapeutic actions. Issues associated with particularly susceptible populations would receive early attention. Nonetheless, data related to these additional factors should be collected whenever possible for future analyses. Also, the possibility of detecting beneficial effects of environmental factors should be considered. The suggestion that study of certain areas be deferred is not intended to imply that they lack importance, but rather derives from the committee's belief that such deferral will make the study more workable, or that these areas are dealt with adequately in other ways. In some cases the language of P.L. 95-623 and the report of the House Committee on Interstate and Foreign Commerce guided these decisions.9~18 As time, money, and personnel permit, the additional areas could be treated. Those areas not receiving major attention in the first few biennial reports could be included in later reports. -28-

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In the broad areas of initial emphasis, several specific questions arise. For example, should smoking and alcoholism, which create a huge burden for society, be included in the study ' s scope? Although exposure to alcohol and cigarette smoke is partially voluntary, there are many cases of involuntary exposure. For instance, exposure of the fetus is involuntary, and smoking and alcohol consumption each adversely affect fetal growth and development.2,43~45 Synergistic effects between smoking and exposure to other environmental hazards magnify harmful effects.46~47 Furthermore, recent studies indicate that measurable physiologic changes occur in non-smokers in an environment with smokers.48~51 The committee would not propose to deal with all cigarette and alcohol problems, but only with those aspects that relate to involuntary exposure and to potentiating effects of other conditions. However, attempts to study effects of particular environmental factors on individuals also require information on their lifestyle, such as smoking habits, and other possible influences on health. (See Chapter 3 for a fuller discussion.) In the long term, the ongoing study could encompass the social environment and the health effects resulting from social changes during the past few decades. However, because addressing the social environment at present might dilute the study's efforts toward collecting and analyzing data related to the physical and chemical environment, the committee would not advise concentration on it at present. Certainly, the social environment influences both physical and mental health. Areas that could be studied in greater detail for health effects include socioeconomic status , changes in family structure, social aspects of the occupational environment, and the influence of television, movies, and other communication media. Effects of bereavement, geographic mobility, and presence or lack of social supports also require much s tudy . With respect to nutrition, the study would not initially investigate adverse effects of natural constituents of the diet, notwithstanding their obvious importance in health and disease. Fat content, total numbers of calories, overnutrition, and undernutrition would not be studied in detail. However, effects of contaminants, pollutants, and additives would fall early within the ongoing study's purview. Accidents and infectious disease also are generally deferred, although they are important public health problems.2,52 Because exposure to some environmental conditions may increase susceptibility to infectious agents, this aspect of infectious disease could be considered early. Accidents accounted for more than half of the deaths that occurred among people aged 1-24 in 1978 in the United States, and were the fourth leading cause of death in the country o~rerall.53 Particularly in occupational settings, accidents are a ma-; or cause of d i sabi 1 i ty . 54 ~ 5 S Furthermore, exposure to taxi c chemicals may increase the probability that accidents will occur. —29—

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However, after extensive discussion, this committee concluded that accidents and infectious disease generally do not readily fall into the category of environmental factors referred to in P.L. 95-623. Known adverse effects of therapeutically administered treatments and drugs would not be studied initially. Many medical treatments have potential side effects, and physicians consider the risks and benefits when they decide to use a particular treatment. Unintended side effects of medical treatments could fall within the purview of the ongoing study, but the Food and Drug Administration is responsible for pre-market testing and post-market surveillance of drugs and medical devices, and the committee believes that the ongoing study may not have to study this area in detail. In a related matter, effects of medical radiation would not receive early consideration, in contrast to effects of other human activities, such as use of nuclear power, that may increase background radiation. However, total radiation exposure is relevant for assessing health consequences. Susceptible Populations Interactions between factors related to individual susceptibility and factors in the environment may largely determine health outcome in many cases. Individuals may be more susceptible because of hereditary factors, because they are in a particular stage of life, or because of life-style and occupation, for example, smokers who work with asbestos. Genetic factors are important in the way individuals metabolize drugs, and many genetic conditions predispose people to various cancers.56~61 The committee finds that the issue of individual susceptibility cannot be ignored in doing risk estimates or quantifying costs. Usefulness of the Ongoing Study This Institute of Medicine committee and the Congress recognize that there will be great uncertainty in any estimates of the costs of health effects--however expressed--that the ongoing study develops. although no final or precisely quantitative attribution of health costs to environmental factors is likely to be attained in the near future, the ongoing study should help reduce uncertainties in the values. If the estimates, however crude, contain a clear indication of their limitations, the estimates will help Congress and federal agencies make decisions that use limited regulatory and data collection resources more effectively than is now possible. -30-

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PEFERENCES U.S. Department of Health, Education, and Welfare. Human_Health and the Environment--Some Research Needs. Report of the Second Task Force for Research Planning in Environmental Health Science. DHEW Publication No. (NIH)77-1277. Washington, D.C. U.S. Government Printing Office, 1977. U.S. Department of Health, Education, and Welfare. Healthy People. The Surgeon General r S Report on Health Promotion and . Disease Prevention. DHEW Publication No. (PHS)79-55071. Washington, D. C. U. S . Government Printing Office, 1979 . 3. Nightingale, 17.0., Cureton, M., Kalmar, V., and Trudeau, M. Perspectives on Health Promotion and Disease Prevention in the United States. Washington, D.C.: National Academy of Sciences, 1978. Higginson, J. and Muir, C.S. Environmental carcinogenesis: misconceptions and limitations to cancer control. Journal of the National Cancer Institute 63:1291-1298, 1979. 5. Elinson, J. and Wilson, R.W. Prevention. In Health--United States 1978, pp. 21-45. DHEW Publication No. (PHS)78-1232. Washington, D.C. U.S. Government Printing Office, 1978. 6. Council on Environmental Quality. Environmental Quality, 1979. Tenth Annual Environmental Quality Report. Washington, D.C.: U.S. Government Printing Office, 1979. National Research Council. Commission on Natural Resources. Environmental Studies Board. Chloroform, Carbon Tetrachloride, . and Other Halomethanes An Environmental Assessment. Washington, D.C.: National Academy of Sciences, 1978. 8. U.S. Environmental Protection Agency. Economics in EPA. A report by the Subcommittee on Economic Analyses, Science Advisory Board, July 22, 1980. 9. Health Care Services Research, Health Statistics, and Health Care Technology Act of 1978. Public Law 95-623. 42 USC 201. 10. Industrial Union Department, AFL-CIO v. American Petroleum Institute et al. No. 78-911. Decided by the Supreme Court the United States July 2, 1980. . 11. Eisenbud, M. Environment, Technology, and Health: Human Ecology in Historical Perspective. New York New York University Press, 1978. -31-

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