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Each of the following chapters presents recommendations for research on the effects of a polluted environment on a specific category of receptors, such as man, materials, or ecosystems. The recommendations in this chapter are more general and apply to research on many or all. of the topics discussed in later chapters. They are ccncerned with insti tutional arrangements and research strategies that will increase the usefulness of research on effects for making environmental protection decisiors, facilitate the conduct cf some important kinds of research, and strengthen the process through which research findings are used in regu- latory decision making. RESEARCH STRATEGIES FOR SCME RELATIVELY INTRACTABLE SCIENTIFIC PBCELEMS Many of the most critical scientific issues related to decision making on environmental problems probably cannot be resolved by research efforts within the next several years. Some fundamental questiors about effects of environmental changes that fall into this category include: • identifying effects of pollution on climate; • identifying no-effect levels in plants, animals, and humans; • predicting changes in whole eccsystems; - 22 -

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• extrapolating from results under controlled lab oratory conditions to ambient conditions; and • obtaining quantitative measures of interactions among multiple ccntaminants. Issues of this kind cannot now be resolved, for reasons that may include the following: • they are intrinsically so complex that scientific methods for solving them have net yet been developed; • they involve effects that may be widely separated from the initial cause or receptcr; • they involve effects that may be qualitatively no different from those produced by natural processes; • they involve effects that may develop over a long time scale; and • they are concerned with the statistics cf rare events. These characteristics often make existing methodologies inadequate for testing assumptions, or make experimental investigations very difficult and expensive. Despite such obstacles, efforts to resolve these questions should con- tinue to have high priority. Some of the effects involved, such as climatic change or long-term perturbations of eco- systems, may be irreversible; and their consequences, such as changes in world agricultural productivity or a decline in the yields of ocean fisheries, might render many current environmental concerns trivial in comparison. Yet, because of the continuing need for information to support a shift- ing array of more immediate decisions, and because the time reeded to produce answers tc most of these currently intractable problems generally cannot be estimated with any confidence, regulatory agencies such as EPA have tended to assign such investigations low priority in the alloca- tion of research funds. Pesearch on these fundamental problems is needed to reduce uncertainties for future environmental decisions, and attempts to resolve them ought not tc be set aside in favor of the more immediate responsibilities of regulatory agencies. long-term funding should be made available, and the work cught to be performed urder arrangements that irake continuity of effort possible. Examples of agencies that might appropriately support research in these areas are the - 23 -

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National Institutes of Health (NJH) cr the Department of the Interior (Dol) for some of the biological research, and the Naticnal Cceanographic and Atmospheric Administration (NCAA) or the National Science Foundation (NSF) for problems rela- ted to climatic change. The global nature of some problems makes an international approach to both research and policy making very important, although such an approach is seldom easy to achieve. IMPORTANCE OF EFFECTS CN NONHUMAN OPGANISMS The National Environment Policy Act calls for a balanced commitment to the protection and enhancement of both huiran health and ecosystems. However, because of the relative ease of recognizing direct threats to human health and the great social weight attached to them, policy decisions are most heavily influenced by evidence of hazards to man, and a large proportion of research has been directed toward assessment of such impacts. Research on ecological effects is usually justified in terms of its value to humans, and work has concentrated on effects on organisms that have important economic or cultural significance (for instance, agricultural crops or vertebrate wildlife species). There is no point to disputing society's right to assign high value to effects on humans and other organ- isms perceived as important to humans. We believe, how- ever, that the well-being and possibly the survival of most vertebrates, including man, depend cn the continued functioning of basic processes of ecosystems, such as the cycling of elements or the conversion of energy into bio- mass. From an ecological perspective, the greatest threats to the life-support system would result from harm to those organisms that play the largest roles in the flows of energy and materials through ecosystems, on scales from local to global. The vast proportion of each of these flows is pro- cessed in most cases by green plants and algae and by decom- posers such as bacteria and fungi (American Association for the Advancement of Science 1967). Vertebrates high in food chains account for only a tiny fraction of energy and nutri- ent flows, and effects on these organisms are therefore less critical to ecosystem functions.

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Current research priorities do not adequately account for the relative long-term ecQlsgicgi significance of potential effects on the structure and functions of eco- systems. Realignment of these priorities is needed, but is unlikely to occur until recognition of our dependence on relatively subtle and obscure complex processes is incorporated in institutional definitions of what it is in the environment that needs protection. ECONOMIC MEASUREMENT OF EFFECTS Regulatory decision makers need estimates of the costs of environmental pollution that are properly grounded in economic theory and are based on the most reliable and up- to-date scientific evidence. Although this need has been clear for scme time (see, for instance, NRC 1975), the current level of effort to provide sound economic analy- sis for environmental decision making is, in our judgment, still seriously inadequate. The need for improved eco- nomic analysis in EPA is also examined in the report of the Panel on Sources and Control Techniques cf the Environmental Research Assessment Committee, (NRC 1977a), and in the re- port of ERAC itself (NRC 1977b). Emphasis in those reports is on analysis of the full range of costs and benefits cf different control techniques and regulatory strategies. Our concern here is more particularly with research to estimate the economic value of effects of a polluted environment, or the costs of pollution. The economic analysis of the costs of pollution requires techniques for extending the dollar cr monetary price mea- sure to things that are valued by individuals but that do not pass through markets, in order to provide a basis for comparing the benefits and costs of environmental changes. Not all environmental effects car be captured by these dol- lar measures; only those that directly affect the human activities of consumption and production, broadly defined, can be estimated. For example, those ecosystem changes that do not affect human activity in some way cannot be measured in dollars. This does not mean that these changes have no value or cost, but rather that we have reached the limits of economic analysis. - 25 -

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Pegulatory decision rrakers at present lack reliable estimates of the costs of environmental changes in ironetary terms. This lack is only partially attributable to limita- tions in economic theory. Econcmic theory and models are available that provide a basis fcr defining and measuring many of the significant types of economic effects of envi- ronmental stresses. Some major exceptions are morbidity, mortality, and aesthetic impacts. Qi2§e_c£or.d,in§ti2n_betwe.en._.the Asocial and natural sciences should be pursued in .the^desicm and conduct of research t to research. There are three important reasons fcr the shortage cf reliable estimates of economic ccsts of pollution. First, seme of the studies leading to monetary estimates of such costs have lacked an adequate theoretical justification for the interpretations of the data used. Early estimates of air pollution damages derived from studies of property values are a case in point (Freeman 1974; Polinsky and Shavell 1975, 1976). Second, in soire ether cases, the use of existing economic models would require major efforts to gather data that are not presently collected on a regular basis. If research were designed and carried out tc col- lect primary (scientific) data appropriate for economic analysis, improved estimates of pollution damages cculd be obtained for effects "such as impacts on water-based recreation, deterioration of materials, and damage to agricultural crops. The major constraint on improved data gathering is cost, but expanded efforts to do well- defined case studies in specific geographical regions seem to be justified, such studies might provide a basis for extrapolating to national estimates cf" damages, which would be very important for many regulatory decisions (Freeman 1976) . Probably the most serious barrier to better estimates of the economic costs of pollution is inadequate knowl- edge of the underlying relationships between environmental conditions and their effects on humans, ether organisms, materials, and climate. It is essential, in our view, for cooperative interaction between economists and natural scientists to begin gay^ly. in research on such effects — as early as in the posing of research questions. Such coor- dination would offer the most premise cf casting data- gathering efforts in a frame of reference that would sup- port later economic analysis. - 26 -

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ESTABLISHMENT OF QCICK-RESPONSE STUDY TEAMS of outbreaks of illness or other effects §Sfei§nt _en y ir o nmen t . Som« changes in environmental quality result from pollution incidents with sharply defined onset times and spatial boundaries. Such episodes often lead to clusters of cases of adverse effects, which present opportunities to gather important information on the effects or to identify the causes (which may be un- " known) . Examples of such incidents include the acci- dental introduction of polybrominated biphenyls into cattle feed in Michigan (Isleib and Whitehead 1975) ; the intense pollution of the area around Hopewellr Virginia with the pesticide Kepore; and the severe episodes of urban air pollution produced by unusually stable weather conditions in different parts of the country on several occasions in recent years (Storer 1975). In such cases, the usefulness of what can be learned from an incident often depends cn how quickly needs for specific data can be identified and the nec- essary measurements made. Evidence gathered long after the event is. likely to be more difficult to obtain, less complete, and of less obvious value for demon- strating cause-effect relationships. Public health departments have developed some very effective capabilities for rapid study of outbreaks of infectious diseases and food poisoning. Broader applica- tions of the same techniques to environmental problems are being developed, but are not yet available for rou- tine use. The essential ingredients of such a program include: • . developing a sequence of procedures to be followed, ranked in order of the iitmediacy of needs for certain data; • assembling and training multidisciplinary teams to conduct field investigations, and providing the flexibility tc mobilize the teams on very shcrt notice; and • providing strong laboratory support. Investigations of pollution incidents ought to include measurements of the distribution and concentration of con- - 27 -

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taminants in the environment (if the identity of these is known) and examination of a wide range of receptors for potential effects. Depending on the nature of the episode, humans, domestic animals, wildlife, plants, and critical ecological organisms (e.g., soil bacteria) may need to be studied to determine what effects, if ary, are occurring. Where effects are present but the cause is unknown, their manifestations must be carefully recorded, and samples cf tissues of affected organisms and of the air, soil, water, cr food to which they are exposed must be obtained and analyzed. The complexity of the investigations that need to be conducted requires that the team assembled include diverse specialists, such as a clinical physician, an epidemiologist, a veterinarian, a plant pathologist, an analytical chemist, and so on. EPA and other agencies conducted scme studies of this sort in the Hopewell (Kepone) incident, and some siitilar investigations, primarily involving outbreaks of suspected pesticide poisoning, have been conducted by the Epidemic Intelligence Service of the Center for Eisease Control (CDC) of the U.S. Public Health Service. The capabilities that exist now should be strengthened and called upon in response to future incidents. EPA is in closest touch with reports of most pollution-related outbreaks of disease and other damage, and is best equipped to measure and assess a bread range of environmental conditions and consequences. CDC has the best expertise and capability to perform rapid iredical evaluations in the field. The most effective investigations of future incidents will require active and coordinated par- ticipation by both CDC a'nd EPA, as well as other appropriate agencies. To date, the desirable level cf interaction has rarely been achieved, tte recommend strongly that more for- mal institutional arrangements be developed to provide for joint rapid-response efforts by EPA and CDC to study the effects of future pollution incidents. PUBLICATION OF THE EASIS FOR SCIENTIFIC JUDGMENTS ^he bgs 4g for _its_scient if ^,g_ judgments jeg§rding_the_guality._cf_evidence_of ign Scientific evidence of actual or potential adverse effects on man or on the environment carries great weight in EPA's regulatory decisions. For example, evidence of possible carcinogenicity was critical in the decision tc - 28 -

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ban EDT.i To make equitable decisions, the Administrator cf EFA must have scientific information that is thorough, balanced, accurate, and based on a rigorous and objective assessment of .the quality of available evidence and the remaining scientific uncertainties. In the introduction to this report, we recommend extensive peer review of scientific data as one method of ensuring the quality of the scientific input to EPA's decisions. We feel that fcrmal policies should be adopted that would foster such peer review. Such measures are particularly needed where critical evidence has been developed by a party in an adversary context, either by EPA itself cr by industry or other interested parties. Regulatory decisions clearly are based on social consid- erations, as well as on scientific evidence. Nevertheless, the process would be improved by more detailed and explicit statements cf the scientific judgments that support such decisions. For example, where contradictory evidence can be cited on a scientific point, it is important to know what the scientific basis is for accepting scme studies as valid, and rejecting others. Decision documents have tended to cite only the evidence that supports the decision. In seme cases, it has net been possible for an outside observer to know what evidence EPA has reviewed, whether uncited (ccn- flicting) research data were examined, or why only certain studies were considered valid. This problem is compounded when information is used that has never been published in the open literature, as is sometimes the case with both EPA and industry data. The problems created for EPA and for others by the lack of more explicit statements of scientific judgments can be seen clearly in the records of judicial review of some of EPA's decisions. For example, the Federal Court cf Appeals for the 3rd Circuit in 1975 remanded effluent limitations guidelines for the iron and steel industry to EPA because "other information available to the agency", cited,in the Administrator's decision document, was not specified, and consequently meaningful judicial review cf the Administrator's decision was impossible.2 Similarly, the Federal Court of Appeals for the ttth Circuit in 1976 reversed EPA's effluent limitations for the tanning in- dustry, and castigated the agency: "The record, however, implies that these conclusions are the product of guess- work, and not of reasoned decision-making... No scientific data or other demonstrative evidence was given to substan- tiate these final effluent levels11.3 Such conclusions by the courts are, unfortunately, net isolated; many of these EPA decisions that have been reversed have been faulted for improper or inadequately supported use of scientific information.* - 29 -

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EPA takes pride (with some justification) in being an "open" agency; that is, the public has extensive access to the decision process ard opportunity to partic- ipate in it. Nevertheless, EPA's decisions continue to be attacked, often with assertions that the Agency consid- ered only selected data, or erred in its assessment of the quality of available research. A more complete and explicit statement of the scientific basis for decisions would have salubrious effects on public awareness of and confidence ip the scientific rigcr of EFA's assessment process, and ultimately, perhaps, would improve the pro- cess itself. Vie recommend, therefore, that EPA establish a policy along the following lines: before a regulatory action is taken, information should be published that would list all studies deemed relevant to the proposed action, identify the scientists who performed the research and their sources of funding, and summarize the results of each study. The studies that are to be relied upcn to support proposed regu- lations should be identified and the reasons for rejecting the conclusions of studies that came to materially different results should be stated. Vie believe that a policy of this sort should be fol- lowed at all stages of the sequential processes of decision making, adjudicatory hearings, ard judicial review of EPA actions. - 30 -

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NQ2ES Committee on Principles of Decision Making for Pegulating Chemicals in the Environment, Environmental Studies Board and Committee cn Toxicology, National Pesearch Council. Unpublished case studies on the decision to ban the use of DDT include papers by Angus A. Maclntyre, Eoctoral Candidate, University cf California at Davis; Max Sobelman, Vice President of Operations, Montrose Chemical Corporation of California; and Charles F. Wurster, Associate Professor, State University cf New Ycrk at Stony Erook. These papers are available in limited numbers upon request from the Environmental Studies Eoard of the National Research Council, 2101 Constitution Avenue, Washington, E.C. 20418. _____ v. EPA, 526 F.2d. 1027 (3rd Cir. 1975). See page 1063. v. l£ai£' 8 ERC 1881 (4th Cir. 1976). See page 1884. For other examples cf cases in which the courts held that EPA had not provided an adequate scientific explanation for its decisions, see HC2kg£_ghem4ca3. s and Elastj.cs Corp% v. Jjain, 537 F.2d. 620 (2nd Cir. 1976), [pages 636-637}; A,m€.r.ica.n_Meat_Jnstitute v. j_p£r p. 2d. 442 (7th Cir. 1975) [pages 459 and 466]; Igternatigpal £§I2§SiS]L.£2S!E3Si v. BU£k.£lS£.3u.§, **78 F.2d. 615 (D.C. Cir. 1973),"[page 648"]; IieII§£hia.c £ower_Co. v. E£A, 477 F.2d. 495 (4th Cir. 1973), [p. 507]; Environmental E§feDse_Fun.d v. ££A, 465 F.2d. 528 (D.C. Cir. 1972), [page~541 ];~P2£tia2d_Cgment_A§§u.. v. Ruckeishaus, 486 F.2d. 375 (D.C. Cir. 1973), £er.t._den.. 417 U.S. 921; FMC CSIE* v. TJZain, 8 EPC 1731 (4th~Cir. T976) , [pages 1737~ and 1739]; Ethyl_£oj£ v. EPA, 7 ERC 1353 (D.C. Cir. 1975), and 8 EPC 1785 (1976)", Cejt^^deQi 8 EPC 2200; Fen.n.e£2tt_C2EEe.r v. EPA, 3 EFC T682~(D.C. Cir. 1972); T.ex,as vT E£A, 6~ERC 1897 (5th Cir. 1974) ; South Terminal £2liir§tion~v. £PA, 6 EPC 2025 (1st Cir. 197477 £EE§l2£hian_£2wer v. T£§in, 9 ERC 1033 (4th Cir. 1976), [page 1052"]; CPC^Internatlonal v. Tr§in, 9 EPC 1301 (8th Cir. 1976), [pages 1309-10]; 5uEQnt_de Nemours and Cc^ v. TraiQ, 541 F.2d. 1018 (4th Cir7~l976) ""cert..~iranted 96 S. Ct. 3165, [pages 1033, 1035, 1036, 1039]7 - 31 -

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REFERENCES American Association for the Advarcement of Science (1967) Symposium on Primary Production and Mineral Cycles in Natural Ecosystems, sponsored by the Ecological Society of America. Orono, Maine: University of Maine Press. Freeman, A.M., Ill (1974) On estimating air pollution control benefits from land values. Jcurnal of Environmental Economics and land Management 1(1) :74-83. Freeman, A.M., Ill (1976) Benefits cf pollution control. Pages II/1-II/55. Criticial Feview cf Estimating Benefits of Air and Water Pollution Control, edited by A. Hershaft. Washington, E.G.: C.£. Environmental Protection Agency. Isleib, D.R. and G.L. Whitehead (1975) Fclybrominated biphenyls: An agricultural incident and its conse- quences. I. The agricultural effects of exposure. Pages 47-55, Proceedings of the 9th Annual Conference cn Trace Substances in Environmental Health, edited by E.D. Hemphill. Columbia, Mo.: University of Missouri. National Research Council (1975) Decision Making for Regu- lating Chemicals in the Environment. Environmental Studies Board, Commission on Natural Resources. Washington, D.C.: National Academy of Sciences. National Research Council (1977a) Sources of Residuals and Techniques for Their Control: Research and Cevelopaent Needs. A Report cf the Panel on Sources and Control Techniques to the Environmental Research Assessment Committee, Environmental Studies Board, Commission on Natural Resources. Washington, D.C.: National Academy of Sciences. - 32 -

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Naticral Research Council (1977b) Research and Development in the Environmental Protection Agency. Analytical Studies for the U.S. Environmental Protection Agency. Volume III. A Report of the Environmental Research Assessment Committee, Environmental Studies Board, Commission on Natural Resources. Washington, D.C.: Rational Academy of Sciences. Pclirsky, A.M. and S. Shavell (1975) The air pollution and property value debate. Review cf Economics and Statistics 57(1):100-104. Pclinsky, A.M. and S. Shavell (1976) Amerities and property values in a model of an urban area. Journal of Public Economics 5(1-2):199-299, Storer, J.B. (1975) Testimony. Pages 150-157, Costs and Effects of Chronic Exposure to Lew-level Pollutants in the Environment. Hearings befcre the Subccmittee en the Environment and the Atmosphere, Committee on Science and Technology, D.S, Congress, House. 94th Congress, 1st Session. - 33 -