- - f ,' … . ** º > - - - -- * •, - - -- A. - - - . . . - +. - •. . . sº * d º ſº United States Environmental Protection Agency SAB-EC-88–040 Science Advisory Board * FUTURE RISK: PUBLIC RESEARCH STRATEGIES # | FOR THE 1990s - .*. September 1988 Cover photo by Steve Delaney FUTURE RISK. RESEARCH STRATEGIES FOR THE 1990s The Report of The Research Strategies Committee Science Advisory Board - United States Environmental Protection Agency to Lee M. Thomas Administrator United States Environmental Protection Agency September 1988 ºli,” if ; : ; ; ; )." : f I “. "'s "** *** * & *} #ſº Q Ç s r \-º *: * pjB C HEA} TH LißRAR'ſ Science Advisory Board U.S. Environmental Protection Agency Washington, DC 20460 September 1, 1988 Mr. Lee Thomas Administrator US Environmental Protection Agency Washington, D.C 20460 Dear Mr. Thomas: In the Spring to 1987, you asked the Science Advisory Board to provide you with advice on ways to improve strategic research planning at EPA. Today we are transmitting to you the results of our investigation. This Report of the Research Strategies Committee has drawn upon the expertise of nearly fifty nationally-recognized Scientists, engineers, and administrators in government, industry, academia, and environmental organizations. We believe that this country's Overall approach for protecting human health and the environment must evolve in response to Changing circumstances, and that EPA's strategy for R&D must evolve to reflect that new approach. In essence, we are recommending that the Agency emphasize the prevention of pollution as its primary goal. This expansion of EPA's traditional role is necessary if we are to harness the energy and resources of Federal, State, and local governments, the private Sector, and individual families in a national effort to reduce the health and environmental risks facing us in the 1990s and beyond. This report, together with its five detailed appendices, provides clear guidance for shaping the strong environmental research program needed to reduce future risk. The recommendations described here, if implemented, would facilitate the successful conduct of that research. We appreciate the opportunity to have Conducted this study, and we look forward to a formal response from the Agency on the advice provided here. Finally, we want to express our appreciation for the assistance we received from Tom Super of your immediate office and from the staff of the Science Advisory Board. All were instrumental in helping us prepare this report. We are very grateful for their efforts. *2. 2’ Alvin L. Alm º Chair, Research Strategies Committee Norton sº w v. 2 w Sººn Chair, Executive' Committee | Contents Members of the Research Strategy Committee . . . . . . . iv Chapter One: Executive Summary. . . . . . . . . . . . . . . . . . . . 1 The Fundamental Importance of Research and Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 The Research Strategies Committee. . . . . . . . . . . . . . . . . 2 Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 The Ten Recommendations . . . . . . . . . . . . . . . . . . . . . . . . 5 Chapter Two: Background . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Chapter Three: The Ten Recommendations . . . . . . . . . . . 8 Recommendation 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Recommendation 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Recommendation 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Recommendation 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Recommendation 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Recommendation 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Recommendation 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Recommendation 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Recommendation 9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Recommendation 10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 U.S. Environmental Protection Agency NOTICE This report has been written as a part of the activities of the Science Advisory Board, a public advisory group providing extramural scientific information and advice to the Administrator and other officials of the Environmental Protection Agency. The Board is structured to provide a balanced expert assessment of scientific matters related to problems facing the Agency; hence, the contents of this report do not necessarily represent the views and policies of the Environmental Protection Agency or of other Federal agencies. U. S. Environmental Protection Agency Science Advisory Board Research Strategies Committee Steering Committee Dr. Ellen Silbergeld Chief, Toxics Program Environmental Defense Fund 1616 P Street, N. W. Washington, D. C. 20036 Mr. Roger Strelow Vice President General Electric Company 3135 Easton Turnpike Fairfield, Connecticut 06431 Sources, Transport and Fate Group Dr. George Hidy, Chairman Vice President Environment Division Electric Power Research Institute 3412 Hillview Avenue Palo Alto, California 94.303 Dr. Anders Andren Water Chemistry Laboratory 660 N. Park Street University of Wisconsin in Madison Madison, Wisconsin 53706 Dr. Jack Calvert National Center for Atmospheric Research 1850 Table Mesa Drive Boulder, Colorado 80303 Mr. Richard Conway Union Carbide Corporation South Charleston Technical Center 3200 Kanawha Turnpike (Bldg. 770) South Charleston, West Virginia 25303 Dr. Robert Huggett Virginia Institute of Marine Science School of Marine Sciences 9 Raymond Drive Seaford, Virginia 23696 Dr. Donald O'Connor 307 Dunham Place Glen Rock, New Jersey 07452 Dr. Barbara Walton Environmental Sciences Division Oak Ridge National Laboratory Post Office Box X Oak Ridge, Tennessee 37831-6038 Dr. Herbert Ward Rice University Department of Environmental Science and Engineering 6100 South Main Room 102, Mechanical Lab Building Houston, Texas 77005 Mr. Al Alm, Chairman President Alliance Technologies Corporation 213 Burlington Road Bedford, Massachusetts 01730 Dr. Stanley Auerbach Senior Staff Advisor Environmental Sciences Division Oak Ridge National Laboratory Oak Ridge, Tennessee 37831-6035 Dr. Anthony Cortese Director Center for Environmental Management Curtis Hall Tufts University Medford, Massachusetts 02155 Dr. Bernard Goldstein Chairman Department of Environmental and Community Medicine UMDNJ-Robert Wood Johnson Medical School 675 Hoes Lane Piscataway, New Jersey 08854-5635 Dr. George Hidy Vice President Environment Division Electric Power Research Institute 3412 Hillview Avenue Palo Alto, California 94.303 Dr. Raymond Loehr H.M. Alharthy Centennial Chair and Professor - Civil Engineering Department 8.614 ECJ Hall University of Texas Austin, Texas 78712 Dr. Norton Nelson Professor of Environmental Medicine Institute of Environmental Medicine New York University Medical Center 550 First Avenue New York, New York 10016 Dr. David Rall “ Director National Institute of Environmental Health Sciences (P.O. 12233) 111 Alexander Drive, Bldg. 101 Research Triangle Park, NC 27709 * Alternate: Dr. James R. Fouts Exposure Assessment Group Dr. Bernard Goldstein, Chairman Department of Environmental and Community Medicine UMDNJ-Robert Wood Johnson Medical School 675 Hoes Lane Piscataway, New Jersey 08854-5635 Dr. Rolf Hartung School of Public Health University of Michigan 3125 Fernwood Avenue Ann Arbor, Michigan 48108 Dr. Brian Leaderer Pierce Laboratory 290 Congress Avenue New Haven, Connecticut 06519 Dr. Morton Lippmann Institute of Environmental Medicine New York University Lanza Laboratory Long Meadow Road Tuxedo, New York 10987 New York, New York 10471 Dr. Donald O'Connor 307 Dunham Place Glen Rock, New Jersey 07452 Dr. Jack Spengler Harvard University HSPH Building #1, Room 1305 655 Huntington Avenue Boston, Massachusetts 02115 Ecological Effects Group Dr. Stanley Auerbach, Chairman Senior Staff Advisor Environmental Sciences Division Oak Ridge National Laboratory Oak Ridge, Tennessee 3783] Dr. Phillippe Bourdeau Director, Environment and Non-Nuclear Energy Research Directorate General for Science, Research and Development of the Commission of the European Communities 200 Rue de la Loi 1049 Brussels, Belgium Dr. Dan Goodman Montana State University Department of Biology Louis Hall Bozeman, Montana 59717 iv Dr. Rolf Hartung School of Public Health University of Michigan 3125 Fernwood Avenue Ann Arbor, Michigan 48108 Dr. Allan Hirsch Health and Environmental Review Division—Dynamic Corp. 11140 Rockville Pike Rockville, Maryland 20852 Dr. Robert Huggett Virginia Institute of Marine Science School of Marine Science 9 Raymond Drive Seaford, Virginia 23696 Dr. John Neuhold Utah State University Department of Wildlife Sciences College of Natural Resources Logan, Utah 84322-5210 Dr. Scott Nixon University of Rhode Island Graduate School of Oceanography Narragansett, Rhode Island 02882-1197 Dr. Paul Risser University of New Mexico 200 College Road Albuquerque, New Mexico 8713] Dr. William Smith Yale University 1502A Yale Station New Haven, Conn. 06520 Dr. Frieda Taub University of Washington 104 Fisheries Center Seattle, Washington 98195 Dr. Richard Wiegart University of Georgia Department of Zoology Athens, Georgia 30602 Health Effects Group Dr. David Rall, Chairman Director National Institute of Environmental Health Sciences lil Alexander Drive, Bldg. 101 Research Triangle Park, NC 27709 Dr. Eula Bingham Department of Environmental Health University of Cincinnati Medical College Kettering Laboratory 3223 Eden Avenue Cincinnati, Ohio 45267 Dr. Bernard Goldstein Chairman, Department of Environmental and Community Medicine UMDNJ-Robert Wood Johnson Medical School 675 Hoes Lane Piscataway, New Jersey 08854-5635 Dr. David Hoel Director, Division of Biometry and Risk Assessment National Institute of Environmental Health Sciences Research Triangle Park, North Carolina 27709 Dr. Jerry Hook Vice President, Preclinical R&D Smith, Kline and French Laboratory 709 Swedland Road King of Prussia, PA 19406 Dr. Philip Landrigan Director, Division of Environmental and Occupational Medicine Mt. Sinai School of Medicine 1 Gustave Levy Place New York, New York 10029 Dr. Donald Mattison Director, Division of Human Risk Assessment National Center for Toxicological Research Jefferson, Arkansas 72079 Dr. Frederica Perera School of Public Health Division of Environmental Sciences Columbia University 60 Haven Avenue New York, New York 10032 Dr. Ellen Silbergeld Chief, Toxics Program Environmental Defense Fund 1616 P Street, N. W. ROOm 150 Washington, D. C. 20036 Dr. Arthur Upton Director, Institute of Environmental Medicine New York University Medical Center 550 First Avenue New York, New York 10016 Risk Reduction Group Dr. Raymond Loehr, Chairman H.M. Alharthy Centennial Chair and Professor Civil Engineering Department 8.614 ECJ Hall University of Texas Austin, Texas 78712 Mr. Richard Conway Union Carbide Corporation South Charleston Technical Center 3200 Kanawha Turnpike (Bldg. 770) South Charleston, West Virginia 25303 Dr. Anthony Cortese Director Center for Environmental Management Curtis Hall Tufts University Medford, Massachusetts 02155 Dr. Anil Nerode Cornell University Department of Mathmatics White Hall Central Avenue Ithaca, New York 14853-7901 Dr. Adel Sarofim Massachusetts Institute of Technology Building 66 Room 466 Cambridge, Massachusetts 02139 Dr. Paul Slovic Decision Research 1201 Oak Street Eugene, Oregon 974Ol Mr. Roger Strelow Vice President General Electric Company 3135 Easton Turnpike Fairfield, Connecticut 06431 CHAPTER ONE Executive Summary The Fundamental Importance of Research and Development The ongoing national debate over the direction of U.S. environmental policy rarely focuses on the basic technical understanding that allows environmental problems to be identified and solved in the first place. Without a substantial investment in research and development, we would not understand the processes and practices that cause pollution, the means by which it is transported, the mechanisms of human exposure, the kinds of risks that pollution poses, or potential ways to reduce those risks. Without our knowledge base, we would be like those people in the Middle Ages who could not correlate lack of sanitation with mortality. Fundamentally, most environmental contaminants are the inadvertent byproducts of a scientifically sophisticated and technologically advanced society; they can only be controlled through the application of the same scientific and technological skills. Our Success at protecting public health and environmental quality in the modern world will be measured by the extent to which we understand and manage those human activities that can affect the environment both for better and for worse. We must have the technical capacity to anticipate environmental problems, whether those problems are birth defects caused by chemical exposures or changes in the global climate. We must be able to estimate the kinds and degrees of environmental risk, whether such risk is posed to segments of populations or to large ecosystems. And we must have the ability to define the most practical and efficient solutions to our environmental problems, whether those solutions are high-temperature combustion technologies for the incineration of wastes or the increased use of carpools and mass transit to reduce air pollution. The longer we remain ignorant of environmental problems and their possible solutions, the greater the risk of adverse consequences to human health and environmental quality. Without our past and continuing research, we would not understand how seriously our children's intelligence and behavior can be damaged by lead contamination. We would not know that stratospheric ozone depletion is threatening the protective layer that shields the earth from the sun's ultraviolet rays. We would not understand the nature of the health risk posed by the naturally-occurring radon that sometimes seeps into people's homes. Even more important, without scientific research we would not have undertaken the different kinds of control actions that already have begun to reduce risk in these—and many other—areas. Moreover, past environmental R&D efforts have proven to be very good investments. For example, the new technologies that EPA has developed to treat wastewater and dispose of hazardous wastes have led to substantial reductions in the cost of controlling pollution. If we are to v’ continue enjoying the enormous health, environmental, and economic benefits of environmental research, then our research investments must be guided by a comprehensive strategy that defines the most efficient and cost-effective approaches to reducing environmental risk in the future. In order to reduce environmental pollution and its associated risks to public health and welfare, we use many tools—national environmental standards, control technology requirements, and enforcement procedures. But none of those tools can be used effectively until research has characterized the environmental problem at hand and helped define and develop the possible controls. Thus research is the most fundamental of the tools that promote environmental quality. Without the strong scientific and technical knowledge that results from research and development programs, standard-setting would not be possible, control technologies would not exist, and there would be nothing to enforce. The Research Strategies Committee Recognizing the overriding importance of research and development, EPA Administrator Lee Thomas asked the Science Advisory Board (SAB) to establish a special committee to advise him on ways to improve strategic research planning at EPA. The Administrator was concerned about an apparent imbalance between the Agency's short-term, program-related research and its longer-term, basic research. He sensed that EPA's immediate regulatory needs were driving its research and development efforts, while longer-term research equally important to achieving EPA's overall risk reduction goals was being neglected. Consequently, he asked the SAB for an independent, objective assessment of EPA's long-term research needs, and advice on how to incorporate those needs into EPA's research planning process. The Research Strategies Committee of the SAB was created in response to the Administrator's request. Headed by Al Alm, former Deputy Administrator of EPA, and composed of nationally-recognized Scientists, engineers, and managers with broad experience in environmental research, the Committee reviewed EPA's R&D program in the context of the nation's continuing need to understand environmental pollution and the risks it poses to human health and ecological systems. As part of its review, the members of the Committee prepared detailed documents in five specific research area.S. • Sources, Transport, and Fate; • Exposure Assessment; • Ecological Effects; • Human Health Effects; and • Risk Reduction. Among other things, those documents suggest directions to EPA for planning and implementing the environmental research needed by this country in the 1990s and beyond. Furthermore, they describe specific types of research that EPA should undertake in order to protect public health and environmental quality over the long term. This summary report to the EPA Administrator is derived mainly from the more detailed findings and recommendations contained in the five Committee documents, which are listed as appendices on the inside back cover of this report. The five individual documents containing the complete findings of the Research Strategies Committee can be ordered from EPA's Science Advisory Board. Conclusions The Environmental Protection Agency is usually understood to be a regulatory agency. EPA indeed has the responsibility to regulate a wide range of Sources—large and Small, mobile and stationary—that emit pollutants into the environment. In the past, the Agency typically has fulfilled its regulatory responsibilities by mandating certain kinds of controls to capture pollutants before they escape into and contaminate the environment. However, the Research Strategies Committee believes that EPA is more than a regulatory agency. EPA is also a research agency responsible, along with other Federal agencies such as , the National Institute of Environmental Health Sciences, for defining the nature of and possible Solutions to—the nation's environmental problems. EPA is a technology transfer agency responsible for sharing with industry and state and local governments all the information, training, and technology needed throughout the country to protect the environment. EPA is an education agency responsible for teaching people how their individual actions can sometimes degrade—or protect—the environment. All these functions depend on a strong R&D program to identify and characterize environmental problems and develop effective solutions. Based on this fundamental belief that EPA is a multi-faceted agency with diverse responsibilities, the Research Strategies Committee concludes that EPA needs to reshape its strategy for addressing environmental problems in the next decade and beyond. In addition to the current emphasis on Federally-mandated controls that are put in place to clean up pollutants after they have been generated, the Agency must develop a strategy that emphasizes the reduction of pollution before it is generated. A strategic shift in emphasis from control and clean-up to anticipation and prevention is absolutely essential to our future physical, environmental, and economic health. Over the first 18 years of its existence, EPA has tended to emphasize the use of pollution control equipment to reduce health and environmental risks. That approach, commonly called "end-of- pipe" control, was appropriate considering the kinds of environmental problems that faced the nation in the 1970s, and the kinds of environmental laws that were enacted during the 1970s. The approach was predicated on a number of factors, including the notion that “the polluter pays". That is, the person/organixation responsible for the problem should bear the brunt of correcting the problem. For example, for the nationwide control of automobiles, powerplants, refineries, and municipal wastewater, Federally- mandated end-of-pipe controls were sensible, targeted, relatively efficient, and reasonably cost-effective, and such controls will continue to play an important role in our future environmental protection efforts. As we move into the 1990s, however, our strategy for reducing environmental and health risks must evolve in response to changing circumstances. For one thing, we are discovering environmental contamination in our homes—e.g., radon—and in the stratosphere— e.g., chlorofluorocarbons—that are not emitted by "pipes" in the traditional sense. Some kinds of environmental contamination, such as run-off from farms and construction sites, are decentralized and therefore not amenable to Federal command-and-control Solu- tions. And because so many new or residual environmental problems, such as indoor air pollution and ground-level ozone, are linked to thousands—if not millions—of Small sources of pollution, traditional approaches to pollution control are not likely to be as effective in the future as they have been in the past. Furthermore, we have learned that traditional end-of-pipe controls have tended to move pollution from one environmental medium to another, not eliminate it. For example, air and water pollutants captured at the end of the pipe usually are disposed of on land. However, land disposal of hazardous pollutants now is being curtailed, and land disposal of non-toxic wastes is increasingly constrained by a scarcity of disposal Sites. The shrinkage of our land disposal capacity will limit the shifting of pollutants between media, thus forcing us to find alternatives to end-of-pipe controls. There is a further reason why we will have to augment our traditional approaches to pollution control with innovative alternatives. Despite the Success of our past efforts, some pollutant loadings are still too high, and they are overwhelming the capacity of the environment to assimilate them. For example, since their introduction in the early 1970s, factory-installed controls on automobile exhausts have proven to be an effective way of reducing the air pollutants—like carbon monoxide (CO) and volatile organic compounds (VOCs)—emitted by individual cars. However, total loadings of CO and VOCs still pose environmental problems in many parts of the country, because the total number of cars, and the total number of miles they are driven, have increased substantially since 1970. Finally, we have to develop a new environmental protection strategy to address future environmental problems that may not be as reversible as past forms of air and water pollution. We may not be able A to add ozone, or subtract carbon dioxide, from the upper atmosphere, no matter how much risk is posed by stratospheric ozone depletion or global warming trends. We will find it extremely difficult to replace estuarine ecosystems, and impossible to replace species of plants and animals, if they are lost. Clearly, the magnitude of these risks requires that we develop and maintain a national environmental strategy that emphasizes prevention, because, in some cases, we will not be able to act after the fact. Besides working to improve the end-of-pipe controls we have relied on in the past, this country has to develop new, less toxic substitutes for the waste products that end up in the environment. We have to redesign our manufacturing processes so they generate less waste. We have to improve the efficiency of our energy use so that total combustion emissions are reduced. We have to educate all our citizens about the actions they can take during their daily lives to reduce pollution. As we modernize our industry in response to the competitive pressures of a global marketplace, we must recognize that less waste and increased efficiency are often two sides of the same coin; our ability to reduce waste and pollution will be one measure of our ability to compete in the international economy of the 1990s and beyond. In short, EPA's R&D program has to be planned and implemented to support the wide range of activities, examples of which are shown in Figure 1, that must be undertaken throughout our society if we hope to protect our health and environment from future risk. This inevitable shift in EPA's long-term environmental protection strategy will have enormous implications for EPA's R&D program. Just as EPA has emphasized command-and-control approaches because of statutory requirements, its R&D program has emphasized short- term, program-related research that supports regulatory development. That kind of R&D emphasis is understandable given the fact that EPA's statutorily-mandated regulatory responsibilities have grown dramatically over the past decade, while its R&D budget has shrunk. However, if EPA's environmental protection strategy is to be refocused on the reduction of pollution at its Source in anticipation of environmental problems, then EPA's R&D program has to be expanded and reoriented to include much more basic, long-term research not necessarily tied to the immediate regulatory needs of EPA's program offices. Moreover, EPA must expand and improve the pool of scientific and engineering talent necessary to identify and solve environmental problems. FIGURE 1 Example Risk Reduction Strategies Individuals Communities and Industry Federal and State Community Groups Governments PREVENT Conserve Reduce Substitute Ban Certain POLLUTANT Energy pesticide use raw materials materials GENERATION and redesign processes RECYCLE Return wastes to Promote Reclaim Purchase AND REUSE recycling centers and operate Solvents recycled products recycling centers TREAT AND Inspect Treat Water Treat Mandate air CONTROL and rem()Ve Supplies hazardous and wastewater asbestos WaSte treatment standards. REDUCE Avoid fishing Operate clean Operate clean Establish high-level RESIDUAL and swimming in sanitary landfills chemical landfills radiation disposal EXPOSURE polluted waters facilities The Ten Recommendations n support of its belief in the I essential value of a strong, coordinated EPA R&D program that has as its long-term goal the prevention or reduction of environmental risk, the Research Strategies Committee makes the following recommendations: 1. EPA should shift the focus of its environmental protection strategy from end-of-pipe controls to preventing the generation of pollution. EPA should use a hierarchy of policy tools that support national efforts to 1) minimize the amount of wastes generated; 2) recycle or reuse the wastes that are generated; 3) control the wastes that cannot be recycled or reused; and 4) minimize human and environmental exposures to any remaining wastes. 2. To support this new strategy, EPA should plan, implement, and sustain a long-term research program. In conjunction with EPA's program offices and the external Scientific community, EPA's Office of Research and Development should develop basic core research programs in areas where it has unique responsibilities and capabilities. 3. EPA needs to establish better mechanisms to ensure that a coherent, balanced R&D strategy is planned and implemented. EPA needs to establish an internal Research Strategy Council to oversee its R&D program; a standing committee of the Science Advisory Board should provide an independent review of EPA's core research program; and the Assistant Administrator for Research and Development should be changed from a political to a career position. 4. EPA must improve its capability to anticipate environmental problems. EPA should explicitly develop and use monitoring Systems that help the Agency anticipate future environmental conditions, and it should create a staff office that would be responsible for anticipating environmental problems and then recommending actions to address them. 5. EPA should provide Federal leadership for a national program of ecological research by establishing and funding an Environmental Research Institute. The Institute would conduct a core ecological research program, monitor and report on trends in ecological quality, and provide a catalyst for ecological research efforts funded by other Federal agencies, state governments, universities, and the private sector. 6. EPA should expand its efforts to understand how and to what extent humans are exposed to pollutants in the real world. To help improve current understanding of human exposure, EPA should place much greater emphasis on the use of personal monitors and biomarkers, and it should validate many of its human exposure models. 7. EPA should initiate a strong program of epidemiological research. Such studies should be designed to support regulatory efforts and to develop information on potential new environmental and health problems. 8. EPA should expand its efforts to assist all those parts of society that must act to prevent/reduce environmental risk. Since state, local, individual, and private sector actions will become increasingly important for reducing the amount of waste and pollution generated, EPA needs to improve the education, training, technology transfer, and research programs that support such actions. 9. EPA needs to increase the numbers and sharpen the skills of the scientists and engineers who conduct environmental research. EPA should increase grant programs and initiate training programs to increase the national supply of technical personnel, and it should use existing mechanisms, such as the Intergovernmental Personnel Act, to bring about a closer collaboration between EPA scientists and engineers and the external scientific and engineering community. 10. EPA's R&D budget should be doubled over the next five years. If the nation is willing to spend $70 billion per year cleaning up and protecting the environment, then it is reasonable—indeed, barely sufficient—to spend one percent of that amount on EPA research that helps determine how the national environmental protection budget can be allocated most effectively. CHAPTER TWO Background EPA's R&D responsibilities were defined in the same broad terms. According to the 1970 Reorganization Message: “The EPA would have the capacity to do research on important pollutants irrespective of the media in which they appear, and on the impact of these pollutants on the total environment. Both by itself and together with other agencies, the EPA would monitor the Condition of the environment— biological as well as physical. With these data, the EPA would be able to establish quantitative 'environmental baselines'—critical if we are to measure adequately the success or failure of our pollution abatement efforts." In the years that followed, the new Agency was given a host of Specific responsibilities beyond its more general mandate. In response to widespread public concerns, Congress passed a series of major environmental laws requiring EPA to protect air quality, water quality, and drinking water, control pesticides and toxic substances, ensure the safe disposal of solid and hazardous wastes, and clean up abandoned hazardous waste sites. In each of these areas of specific responsibility, EPA faced substantial scientific uncertainty. The risks posed by the different pollutants in different media were not well understood. In many cases the technologies needed to control them were unknown or not yet fully developed. Thus, despite its original charter to take a long-term view of human health and environmental quality, EPA has had to devote a larger and larger share of its R&D budget to the support of near-term regulatory development required by environmental law. EPA's emphasis on R&D that supports its specific legislated responsibilities has had two negative effects on its long-term research efforts. First, it has sharply limited the resources available for long-term hen the Environmental Protection Agency was established in 1970, one of its major missions was to integrate the different environmental protection responsibilities then existing in different Federal agencies. Before 1970, those responsibilities had been organized primarily by the different environmental media—air, water, and land—that they were meant to protect. Yet, as President Richard Nixon noted in his message to Congress establishing EPA: "Despite its complexities, for pollution control purposes the environment must be perceived as a single, interrelated whole.” EPA's organization plan recognized the intermedia causes and effects of air, water, and land pollution, and proposed a “far more effective approach to pollution control” which would: • Identify pollutants. • Trace them through the entire ecological chain, observing and recording changes in form as they OCCUIT. • Determine the total exposure of man and his environment. • Examine interactions among forms of pollution. • Identify where in the ecological chain interdiction would be most appropriate. Thus EPA was launched with the explicit assumption that it would be concerned not simply with the effects of particular pollutants in the different environmental media, but with the larger, overarching issues related to human health and environmental quality. The Agency was intended to take a long-term view of the overall condition of the environment and its capacity to support a healthy life for all species, including humans. research. Second, the long-term research that has been planned by EPA often has been subject to funding cuts in favor of projects with more immediate public and political interest. In short, funding for long-term research at EPA is not only very limited, but it is also tenuous from year to year, conditions that tend to undermine the research itself, the morale of the scientists and engineers who conduct it, and the respect and cooperation of the scientific community outside EPA. This situation, which is understandable in terms of immediate public concerns and limited R&D budgets, is very short- sighted in terms of national policy. For a number of reasons, an R&D program shaped almost exclusively by the near-term needs of EPA's program offices will not necessarily provide the scientific and engineering information needed to protect human health and environmental quality over the long term. First of all, EPA's regulatory activities are not necessarily focused on the environmental problems that pose the greatest risks to public health and welfare. Rather, they are focused on the environmental problems defined in EPA's enabling legislation, which in turn reflects public concern about the effects of different contaminants in different environmental media. Yet neither the depth of public concern nor the stringency of environmental law is necessarily an accurate measure of the relative seriousness of the environmental risks facing us today. The public ultimately will understand those risks, just as they are beginning to understand the implications of global warming, but not until unnecessary health and environmental costs have been imposed, or irreversible damages have occurred. Second, the environmental laws that EPA currently administers in most cases require EPA to impose 6 end-of-pipe controls on classes of pollutant sources across the nation as a whole. Those end-of-pipe controls—usually on large pollution sources like powerplants, or on large classes of pollution sources like automobiles—have worked reasonably well, and they have resulted in measurable improvements in environmental quality. However, the steady increase in some pollutant loadings—like solid waste—and the intractability of some pollution problems—like ground-level ozone— despite end-of-pipe controls necessitate that more and more small, decentralized sources be controlled. Controlling such sources will require the use of a number of different risk reduction approaches like materials substitution, redesigned products and production processes, recycling, and lifestyle changes. Yet the kinds of research that would support such approaches are not likely to be initiated by EPA program offices with extensive and immediate Federal command-and- control responsibilities. Third, implementing pollution control alternatives like materials substitution, recycling, and lifestyle changes will require that state and local governments, private industry, and individual families all take steps to reduce the generation of wastes and contaminants. This decentralization of risk reduction responsibilities is positive and necessary in light of our growing recognition that significant environmental risks are linked to the typical activities of our everyday lives. Although the Federal government's role in such circumstances may change, EPA still has the responsibility to conduct research that will help other parts of our Society act to reduce environmental risks. EPA must fulfill that responsibility, because no one else will. The private sector is unlikely to undertake research on risk reduction techniques that will not have wide commercial application. No one company, or industry, is likely to have a unique, sizeable stake in many future environmental issues, thus making basic environmental research hard to justify to management or investors. Municipal governments—one important user of risk reduction research—traditionally have not invested in such research, because they can barely afford the cost of the traditional technologies needed to manage solid waste, treat wastewater, or protect drinking Water. In short, no individual local government or private business is likely to fund research needed by many local governments and private businesses to help reduce their waste streams. Yet, as more and more elements of our society become directly involved in the business of risk reduction, such research clearly is needed. Fourth, the specific regulatory requirements of EPA's program offices often result not in the eradication of a pollutant, but in the transfer of that pollutant from one medium to another. Even though EPA was established explicitly to address the cross-media effects of pollutants, their sources, and their control technologies, the Agency's media-oriented program structure, developed to implement media-oriented legislation, has found it difficult to integrate cross-media concerns. The same media-oriented programs are unlikely to have an immediate interest in research that addresses cross-media issues. Cross-media environmental problems are especially troubling in light of recent concerns over the risks posed by land disposal of Solid and hazardous wastes. In the 1970s air and water pollutants concentrated and collected by end-of-pipe controls were routinely disposed of on land. Now, however, the disposal of wastes on land is strictly regulated. Our growing need to eliminate pollution, not simply move it from place to place, is causing us to look beyond end-of-pipe pollution controls. Yet program-related research is not likely to provide the kind of information needed to develop and implement those new controls. Finally, an R&D program driven by existing policy considerations will be inherently weak to the extent that it fails to anticipate the future. As the history of human disease clearly demonstrates, curing a disease already afflicting large numbers of people is much more difficult and expensive than preventing the outbreak of disease in the first place. Similarly, reducing the presence of a pollutant in the environment in anticipation of an environmental problem, rather than in reaction to an environmental problem, is a more sensible national policy. EPA's program offices must react to the environmental problems that caused their enabling legislation to be passed; consequently, they have insufficient incentive to support long-term research that investigates the fundamental relationships of ecosystem structure and function that can give early warning of possible environmental problems in the future. Yet that kind of research, seen in the perspective of long-term quality of life and long-term costs, may be the most important of all. In summary, although EPA's near-term research provides essential support to the program offices in their efforts to carry out their immediate statutory responsibilities, that research does not support the kind of integrated approach to risk reduction that will be needed to protect human health and the environment over the long term. The long-term research that is critical to the shaping of future national environmental policy is not being adequately planned or funded at EPA today. CHAPTER THREE protection strategy from end-of-pipe controls to I EPA should shift the focus of its environmental preventing the generation of pollution. The Ten Recommendations M. of the most serious environmental problems facing this country will not be solved through the use of end-of-pipe controls alone. In some cases, like ground-level ozone, end-of-pipe controls have already been applied, but more needs to be done. In some cases, like indoor air pollution, end-of-pipe controls simply are not appropriate or practically feasible. And in some cases, like hazardous waste disposal, end-of-pipe controls are becoming more and more expensive. If we hope to protect the environment and human health from environmental problems like stratospheric ozone depletion, hazardous wastes, and surface water and estuarine pollution, we have to begin controlling pollution long before it reaches the end of the pipe. We have to prevent pollution at its SOUITCé. As the Federal agency primarily responsible for protecting human health and environmental quality, EPA should refocus its strategy for controlling pollution. As it has already begun to do in some areas, EPA should encourage the use of a broader array of policy tools, including those that foster changes in individual, community, industry, and institutional behavior. EPA should make a greater effort to apply different policy tools in the following order: • Whenever possible, environmental protection efforts first should be aimed at minimizing the amount of wastes or pollutants generated. Thus waste reduction at its source—for example, through product design changes, industrial process changes, or material substitution—should be a primary objective. • For those wastes or pollutants that are generated, every effort then should be made to recycle or reuse them in an environmentally sound manner. For example, community recycling programs should be an important feature of the nation's solid waste disposal efforts, and industry should be encouraged to reuse as much of its hazardous process wastes as possible. • For those wastes or pollutants that cannot be recycled or reused, treatment, destruction, and disposal technologies should be applied. These risk prevention/reduction tools, like municipal wastewater treatment facilities and automobile emissions controls, are usually the basic regulatory component of EPA's existing programs. • After all reasonable waste reduction options have been applied, human and environmental exposures to any remaining wastes should be minimized. Containment and isolation of radioactive wastes is one example of this approach. Figure 2 illustrates this hierarchy of policy options for reducing risk. There are a number of advantages associated with shifting our pollution control emphasis from the end of the pipe to the source of the pollution. For one thing, it is often cheaper to redesign industrial processes, or separate and recycle Solid waste, than it is to pay for the disposal of wastes in well-controlled landfills or incinerators. They are certainly more cost-effective than the remedial programs that are sometimes necessary to remove wastes or contaminants from the environment. Reducing pollution at its source also avoids the cross-media problems that may result when end-of- the-pipe control of pollution in one medium simply transfers the pollution to another medium. Finally, by reducing the use of materials known to be harmful to human health or the environment, we can reduce the worker and consumer exposures that sometimes occur even if the end of the pipe is well controlled. community or small business will have the incentive or resources to do it. Even though such R&D may not directly support EPA's regulatory activities, it will support this country's broader environmental goals. It also will be an invaluable aid to all the businesses and communities and families across the country that must change their everyday lives if we are to solve some of our most pressing environmental problems. FIGURE 2 Hierarchy for Risk Reduction Research Just as EPA's regulatory role will change as it incorporates this broader approach to environmental protection, its R&D role will change as well. EPA must conduct research that supports materials substitution, industrial process changes, and recycling technologies, because it is unlikely that any individual Prevent Generation Potential Wastes and Contaminants Actual generated Wastes and Contaminants generated Reuse/Recycle Wastes and Contaminants after recycle/reuse =º- Treat/Control Residual Wastes and Contaminants =º- * Minize exposure i To support this new strategy, EPA should plan, implement, and sustain a long-term research program. The Research Strategies Committee has prepared five separate documents—listed as appendices to this report—that examine the current state of environmental research and recommend a number of important core research areas related to: 1) the Sources, transport, and fate of pollutants; 2) the assessment of human and environmental exposures; 3) ecological effects; 4) human health effects; and 5) risk reduction in general. A list of candidate core research areas discussed in the five appendices to this report is shown in Figure 3. EPA should use those suggestions as the starting point in its formal efforts to define a specific list of core research alſea S. S is evident in the language used to establish EPA in 1970, the Agency's responsibilities go beyond the regulatory actions mandated by environmental statutes. EPA is also responsible for supporting in a broader way the basic health and environmental objectives from which its regulatory programs are derived. Therefore, EPA’s R&D efforts have to be targeted not only on short-term, program-related issues, but also on longer-term issues related to risk prevention/reduction in general. EPA should begin immediately to identify those core areas of research where it has unique responsibilities and capabilities, and where long-term efforts are needed to identify, assess, and mitigate serious risks. Those core research areas should be selected according to their ability to: • Address environmental problems that can be expected to persist for a decade or more; • Generate scientific results that are likely to support a number of existing and/or anticipated Federal, state, or local control programs, whether regulatory or non-regulatory; and • Provide Scientific information, engineering innovations, or new technology unlikely to be generated by the private sector, other parts of the Federal government, or state governments. FIGURE 3 Candidate Core Research Areas Sources, Transport, and Fate • Characterizing sources and discharges • Transport, conversion, and interaction in the environment • Models for predicting form and concentration of pollutants • Methods for anticipating future environmental problems Exposure Assessment • Total exposure assessment methodology • Personal monitoring • Models for predicting exposure • Biological markers of exposure Ecological Effects • Assessing risks to ecological systems • Defining the status of ecological systems • Detecting trends and changes in ecological systems • Predicting changes in ecological systems Health Effects • Neurotoxicity • Reproductive toxicity Respiratory system effects Carcinogenicity Biological markers of disease Methods of extrapolating animal effects to humans Epidemiology Risk Reduction • Preventing pollutant generation • Combustion and thermal destruction • Separation technologies • Biological approaches for detoxification and degradation • Chemical treatment of concentrated wastes and residues • Ultimate containment methods and approaches • Exposure avoidance • Risk communication • Incentives for risk reduction • Education and technology transfer • Environmental management and control systems 10 EPA's formal process of defining core research areas should begin with the Agency's senior scientists and engineers in consultation with its program offices. It is important that the program offices be included in the process, so that the Agency's long-term R&D efforts are related to the basic scientific uncertainties that impede EPA's short-term regulatory efforts. Program office involvement in defining core research areas also will help link the two different—but complementary—aspects of EPA's overall R&D program. EPA also should find ways to involve the external scientific community and other affected groups—such as State governments and universities—in defining core research areas and the R&D programs undertaken in those areas. For example, the Science Advisory Board could convene periodic workshops involving EPA's scientists and engineers, EPA's program offices, and external interests in order to build consensus and external Support for EPA's core research programs. EPA needs to establish better mechanisms to ensure that a coherent, balanced R&D strategy is planned and implemented. PA’s Commitment to an R&D strategy that balances short-term and long-term research needs must be institutionalized. Unless an appreciation of the relative value of long-term research is built into EPA's planning and management structure, such research will continue to be underemphasized. EPA should take steps to ensure that long-term research needs and risk reduction opportunities are considered as part of a coherent, balanced R&D strategy. First, EPA should establish a new Research Strategy Council made up of the Administrator, Deputy Administrator, the Assistant and Deputy Assistant Administrators for Research and Development, and the Deputy Assistant Administrators of the program offices. Using their broad Agency experience, the members of the Council would oversee the process of defining core research areas, and they would review and approve the core research programs planned each year. The Council would focus especially on long-term, cross-media environmental problems that are not the specific responsibility of any EPA program office, and they would ensure that R&D funds are available to study such problems. In short, the Research Strategy Council would work to ensure that EPA’s R&D plans respond to environmental concerns beyond those addressed by EPA's statutorily-mandated regulatory programs. In order to assist the Council incorporate a long-term perspective into EPA's research planning process, the Science Advisory Board should establish a standing Research Strategies Committee that would review EPA's core research programs and advise the Research Strategy Council on its content and quality. That kind of external, independent review would bring a broader perspective and wider range of scientific expertise to EPA's R&D planning process. Finally, in order to improve the likelihood that long-term research plans in fact are implemented over the long term, EPA's Assistant Administrator for Research and Development (ORD) should be changed from a political to a career position. Throughout EPA's history, no ORD Assistant Administrator has held the position for more than three years; since 1980, no individual has remained in that position more than two years. Consequently, no leader of EPA's R&D program has stayed at the Agency long enough to implement a sustained, long-term research strategy. If the Assistant Administrator for ORD could expect to stay in office for an extended period, then it is more likely that a long-term research strategy would be carried forward to completion. 11 EPA must improve its capability to anticipate environmental problems. ecause environmental legislation tends to be driven by public concerns about existing environmental problems, EPA's statutorily-mandated regulatory programs tend to be focused on existing environmental problems. EPA's R&D program, in turn, is almost entirely devoted to the definition, assessment, and control of existing problems. Yet, as history has shown again and again, cleaning up chemicals in the environment after biological damage already has occurred is difficult, expensive, or impossible from a practical standpoint. Worker illness led to the discovery of Kepone in the James river; dead and dying cattle led to the discovery of polybrominated biphenyls in feed; malformed oysters led to the discovery of tributyltin in harbors. In each case, the problem was not discovered until substantial health and/or economic costs had been incurred, and each case entailed a long and expensive clean-up program. Clearly, great benefit can be derived from the identification of trends in environmental quality before they begin to cause serious ecological or human health problems. With more lead time, material substitutes can be developed, manufacturing processes redesigned, or traditional end-of-pipe controls put in place at substantially lower cost. Early identification and response to a potential problem can sharply reduce adverse effects on human health and environmental quality. Public discussions of different possible courses of action are likely to be more reasonable and less emotionally charged, if the public does not feel a sense of emergency or catastrophe. There are a number of steps EPA should take to enhance its ability to anticipate environmental problems before public fears are aroused, and before costly, after-the-fact clean-up actions are required. For example, EPA should broaden its data-gathering efforts. Monitoring programs are valuable for their ability to paint a picture of present conditions; if continued, they can help describe what has happened to the quality of an ecosystem over time. But they also are invaluable tools for helping anticipate the future; they can be used to predict the environmental consequences of continued patterns of pollutant loadings. EPA needs to begin monitoring a far broader range of environmental characteristics and contaminants than it has in the past. Although we understand a lot about the handful of chemicals that already are known to cause environmental problems, we know relatively little about the thousands of chemicals used in modern society, and that possibly could cause adverse efects on human health and ecosystems over the long term. Thus EPA should expand its use of monitoring activities that can foretell health and ecological risks. Past analysis of the muscles and adipose tissue have provided invaluable information on a wide range of contaminants actually accumulating in living Creatures. Those kinds of studies should be increased in the future. EPA should take two specific steps sº to improve its anticipatory capacities. First, EPA should undertake research on techniques that can be used to help anticipate environmentalº problems, and it should make a more concerted effort to be aware of and interact with the research efforts of other Federal agencies concerned sº with the identification and anticipation of environmental problems. Such research would involve a retrospective examination of how problems have been identified in the past, and it should utilize emerging techniques for forecasting future environmental conditions. Second, a staff office should be created within EPA for the purpose of evaluating environmental trends. and assessing other predictors of potential environmental problems before they become acute. The primary mission of this office would be to identify potential and emerging ecological and human health problems. The office would analyze potential problems, drawing upon technical expertise within and outside the Agency. The office would also prepare an annual report to the EPA Administrator that describes potentially significant trends in health and environmental data and outlines possible Agency responses. The conclusions and recommendations of that report then would be considered in EPA’s strategic planning for research and development. 12 EPA should provide Federal leadership for a national rogram of ecological research by establishing and unding an Environmental Research Institute. E. systems such as forests, rangelands, and fresh and saltwater wetlands are enormously valuable from both an environmental and economic perspective. Yet we understand relatively little about how those complex, interrelated systems are being affected over time by pollutant loadings. Most past ecological research has investigated the effects of particular pollutants on particular species—for example, the development of single species ecotoxicological test methods to support regulations under the Toxic Substances Control Act. The larger questions related to total pollutant loadings, multimedia effects, and cumulative, long-term effects on interwoven biological communities remain unanswered. A number of Federal organizations besides EPA—for example, the Department of Interior, the Department of Agriculture, the National Oceanic and Atmospheric Administration, the National Institute of Environmental Health Sciences, and the National Science Foundation—carry out research on ecological systems, the ways in which they are affected by environmental pollution, and the potential human health consequences of those ecological alterations, as do private organizations, universities, and state governments. With the exception of the investigation of human health effects, however, there has been little national focus or leadership for those efforts. Furthermore, ecological research in this country is neither coordinated nor comprehensive enough to provide an ongoing assessment of the health of various ecosystems. Because EPA has the primary Federal responsibility for protecting ecosystems, EPA should provide the Federal leadership for an enlarged, < coordinated program of national ecological research. To provide the visibility, stability, and intellectual focus for that research, EPA should establish and fund a new Environmental Research Institute. The Institute should be operated by a contractor, much like the Department of Energy's national laboratories, and it should have several specific functions: • It should conduct a core ecological research program. • It should define the ecological endpoints that need to be monitored to provide an overall picture of ecological health, determine which of those endpoints are not being currently monitored, and support monitoring activities to fill data gaps. • All relevant ecological data, whether generated inside or outside the Institute, should be collected by an Office of Data Systems within the Institute. Those data should be used to define trends in ecological quality, and those trends should be described in an annual report to the nation on the overall quality of the environment. • It should provide a national focal point for ecological research useful not only to EPA, but to other interested parties as well. Thus it should be prepared to conduct research funded by, or in cooperation with, other Federal agencies, state governments, universities, and the private sector. • It should participate with the two EPA Centers of Excellence—at Cornell University and the University of Rhode Island—that are dedicated to ecological research. Because of the excellent resources already functioning in the Public Health Service, especially the National Institutes of Health, the Environmental Research Institute would not engage in health effects research. Nor would it supersede ongoing ecological research efforts. Rather, it is meant to supplement and build on current ecological research in a systematic, coordinated, and collaborative way. The overall goal of the Institute should be to define a comprehensive ecological research program and then implement those parts of it that are not already being carried out either inside or outside the Federal government. In fact, because the Institute would provide centralized leadership for the nation's ecological research efforts, other Federal agencies, state governments, or the private sector may be interested in funding specific kinds of ecological research of particular interest to them. Although EPA should provide the initial administrative impetus and funding, and be prepared to continue its support over the long term, the Environmental Research Institute should act and be perceived as a national institution of national benefit. 13 EPA should expand its efforts to understand how and to what extent humans are exposed to pollutants in the real world. enerally accepted toxicological test methods have been developed for determining the adverse health effects of different substances. In assessing risk, however, it is also necessary to know the concentrations and durations to which people are exposed during their daily lives. In fact, there is usually greater uncertainty about the level, duration, and pattern of human exposure than there is about the health effects of a given level of exposure. Although considerable progress has been made in developing effective methods of measuring human exposure, much more needs to be done. Exposure assessment in the past has consisted simply of determining the concentration of a chemical in the immediate vicinity of an individual and then making various assumptions about the levels inhaled or ingested. In reality, however, the important toxicological question is: How much of the chemical actually impinges on the internal target organ? Physical and biological processes can affect the concentration of the pollutant that is absorbed and retained by a particular organ. Alternatively, some processes actually can convert a chemical into a more toxic substance in the body. Recent progress has been made in verifying and quantifying exposure by examining biological tissue for the presence of the chemical of concern or the presence of biochemicals of concern—i.e., investigating tell-tale – “biomarkers.” EPA should act aggressively to improve techniques for assessing individual exposures, validate exposure models, and improve the use of biomarkers as indicators of exposure. The Science Advisory Board enthusiastically supports the Total Exposure Assessment Methodology (TEAM) approach to determining human exposure. This method involves the use of personal monitors that measure an individual's total exposure to different substances during the course of daily activities. The TEAM approach first demonstrated the importance—in Some cases, the overriding importance—of indoor air pollution. This direct way of measuring exposure needs to be utilized more extensively. It not only can measure the exposure of selected individuals (e.g., those expected to be most highly exposed), but it also can be used to define the distribution of exposures throughout a large population. Improved techniques are needed to extend the use of this important tool to a wider range of chemicals. Currently, EPA often measures the concentration of a chemical at some emitting source (e.g., a Smokestack), and then uses mathematical modelling to estimate the conceptration to which different individuals are exposed. Using these computer-driven models, the Agency has been able to estimate exposure levels that would occur under a wide variety of assumed conditions, thus generating data that would have been very difficult, if not impossible, to measure directly. However, the Agency needs to undertake a critical review of the many different available models in order to determine their site-specific applicability and estimate their accuracy and precision. Although model validation is complex and expensive, EPA has an obligation to lead efforts in this area. EPA should develop a priority ranking of models to be evaluated, and establish a schedule for validating the most important ones. The use of biomarkers is an interdisciplinary effort that links physical, environmental, and biomedical scientists in an effort to anticipate and reduce human risk. EPA should expand its efforts in this area. In particular, the Agency needs to explore the increased use of biomarkers as quantitative biochemical indicators of environmental exposure and biological effects. EPA also should make every effort to draw on the expertise and research results found in other Federal agencies—such as the National Institute of Environmental Health Sciences, the National Cancer Institute, and the National Center for Toxicological Research—that already have well-established programs in this rapidly emerging research area. Finally, EPA's Centers of Excellence program has proven to be an effective way of involving the academic community in targeted environmental research, thus generating new scientific knowledge useful to EPA and the nation as a whole. That program should be expanded through the support of a new university-based Center of Excellence dedicated to exposure aSSes Sment. 14 EPA should initiate a strong program of epidemiological research. F. a regulatory perspective, good epidemiological data are invaluable. Because those data are generated through the study of large numbers of real people living in the real world, the conclusions drawn from them are widely accepted and acted upon. For instance, current efforts to limit smoking in public places are being driven by a widespread belief that passive smoking is harmful to health, a conclusion based to a large extent on epidemiological data. EPA also has based some of its most important health regulations on epidemiological data. National standards that limit the concentration of air pollutants, for example, are set at levels to protect against the health effects seen in epidemiological studies. The Harvard-based Six Cities Study, sponsored by the National Institute of Environmental Health Sciences, was extremely valuable to EPA during its recent reviews of its particulate and sulfur dioxide air quality standards. However, to support its regulatory activities, EPA makes much greater use of occupational studies and laboratory studies of animals. Although such studies can provide useful information, the relevance of those results is sometimes questioned. For example, because concentrations of chemicals found in occupational settings are usually much higher than those found in the general environment, adverse health effects found in workers may or may not necessarily translate into health risks for the general population— which also includes children and the elderly—exposed to lower concentrations. Laboratory studies of test animals are sometimes questioned because of differences between the metabolic and regulatory processes of test animals and humans, in addition to the generally large difference in dose levels. Furthermore, the population of test animals used in laboratories are far more homogenous than human populations. Although occupational and animal studies will continue to play an important role in environmental research, EPA needs to increase its use of non-occupational epidemiological studies, which optimally allow the assessment of potential adverse human health effects at exposure levels of concern to the general public. In spite of their limitations, such studies—in combination with well-conducted experimental research—can form the basis for a “weight-of-evidence” that may generate consensus within the Scientific community regarding a given environmental health risk. EPA could improve the cost- effectiveness of its epidemiological research, and broaden the usefulness of the results, by combining its efforts with those of other government agencies. For instance, EPA could add to existing data bases (for example, the National Health and Nutrition Examination Survey), and cooperate with existing studies of the workplace (for example, the Dioxin Registry Study), particularly when such studies are able to relate dose to adverse effect. Within EPA, epidemiological research should be coupled directly with an improved capability to monitor and assess exposures—for example, through the wider use of personal monitors and biomarkers. Furthermore, EPA should expand its cooperative epidemiological research with other countries where existing pollution levels are several times higher than in the United States. In addition to obtaining valuable scientific data for the United States, such an effort could foster environmental protection efforts globally, and enhance U.S. relationships with other nations. 15 EPA should expand its efforts to assist all those parts of society that must act to prevent/reduce environmental risk. four future efforts to protect human health and environmental quality are to be successful, more and more elements of our Society must take steps to prevent/reduce risk. State and local governments, large and small businesses, and individual families must act to reduce the wastes and contaminants that are generated every day as we go about our normal lives. State and local governments have to rethink their zoning laws if we hope to protect our fragile estuarine areas; manufacturers have to redesign their production processes if we hope to control hazardous wastes; families have to separate their garbage if community recycling programs are to Succeed. The prevention/reduction of environmental risk in the future is going to require not only Federal regulations and end-of-pipe controls, but also changes in lifestyle and behavior throughout our Society. EPA needs to do a better job conducting research that will be useful to all the different elements of our society involved in preventing/ reducing risk. Then it must find better ways of transferring the results of that research to the end-users, especially the end-users who are likely to achieve the greatest risk reduction. To control chemical wastes, for example, technology transfer efforts should be targeted initially to industries that use chemicals but have little expertise in the chemistry of waste management. Small- and medium-sized hazardous waste generators could benefit substantially from EPA's technology transfer efforts, because they often are not aware of source reduction and recycling options. State and local governments are an especially important target for the transfer of technical information and training tools, because they are responsible in large part for the implementation and enforcement of existing Federal environmental legislation, and they are likely to play a major role in our national response to future environmental problems. In short, EPA must make a greater effort to generate information about the full range of risk prevention/ reduction techniques and then transfer that information to all the different people who will need to use it in the future. EPA also must ensure that those end-users, especially state governments, are involved in the planning of EPA activities that are intended to serve them. In addition, EPA should support the development and implementation of education programs that teach targeted groups about different kinds of environmental risks and the steps that they can take to prevent/reduce them. Such support should include educational materials, handbooks, audiovisuals, seminars, and training courses. EPA's current information and training related to asbestos removal is a good example of the content and value of that kind of support, and it should be replicated in areas such as lead paint removal and integrated pest management. EPA also should work cooperatively with private industry and universities to incorporate environmental studies and training into academic curricula. Students studying business, chemistry, public policy, economics, medicine, and mechanical, electrical, and petroleum engineering should all be exposed to the concept of environmental risk and the techniques of environmental risk reduction. As with so many other problems, widespread public education is one of the best ways to reduce environmental risk, and EPA must play a major role in environmental education. Finally, EPA should carry out research—including non-traditional research—that will be useful to the universe of end-users. EPA should dedicate R&D funds not only to collect environmental data and develop control techniques useful to a broad spectrum of people, but also to study more effective ways of communicating information. For example, EPA should try to find better ways of defining risk itself, and better ways of educating the public about the nature of risk and the steps they can take to prevent/reduce it. Moreover, many effective actions that reduce environmental risk do not employ traditional control technologies, e.g., restricted activities in wetlands, integrated pest management practices, and right-to-know activities. EPA must have a strong research program to support those kinds of actions at the state and local levels. 16 EPA needs to increase the numbers and sharpen the skills of the scientists and en environmental research. gineers who conduct he single most important element of our national environmental R&D effort are the environmental scientists and engineers themselves. Whether those Scientists and engineers work inside or outside EPA, their numbers, education, skills, and professional experiences must be enhanced if we are to attain our national risk prevention/ reduction goals. Thus EPA must do more to increase the amount and improve the quality of the scientific and engineering talent dedicated to environmental research. To that end, EPA must strengthen the links between EPA and the external scientific community. Those linkages are valuable for a number of reasons. Environmental research is not an activity unique to EPA; it is being conducted in public and private sector laboratories and universities across the country and internationally. EPA's research should take place in that larger context, so that it supports and builds on the environmental research carried out elsewhere. Furthermore, each of the elements of our national environmental research effort will be improved by the cross-fertilization of Scientific ideas inside and outside the Agency. The more the scientific community at large understands about EPA's scientific goals and projects, and the more that EPA's Scientists know about research outside the Agency, the greater the benefit to our national effort as a whole. EPA could improve this intellectual cross-fertilization by encouraging an increased exchange of scientists and engineers between EPA and the external scientific community, both nationally and internationally. Existing mechanisms like the Intergovernmental Personnel Act and the Visiting Scientists and Engineers Program could be used to bring outside talent into the Agency for relatively short, rotational terms. The proposed Environmental Research Institute also could be a source of technical personnel willing to work in EPA laboratories. Similarly, EPA scientists and engineers should be encouraged to broaden their experience through sabbaticals at universities or outside laboratories, and there should be opportunity for EPA personnel to work at the Environmental Research Institute. EPA scientists and engineers also should be encouraged and allowed time to contribute more extensively to peer-reviewed periodicals. EPA also must devote more resources to the development of new scientists and engineers who will expand the pool of technical professionals available to study environmental problems. Without the steady infusion of young talent into university, state, Federal, and private sector laboratories, the country could face a personnel shortage that would cripple our future environmental protection efforts. Thus EPA should expand its support for its investigator-initiated external grants program. Up to ten percent of an expanded EPA R&D budget should be spent on grants to the nation's colleges and universities. Not only do those grants lead to high-quality research, but they also provide training opportunities for young scientists and engineers working on their undergraduate and post-graduate degrees. Those students in time will become the backbone of our national environmental research effort, because they will be capable of providing the broad scientific and engineering expertise needed in the future at the Federal, state, and local levels. Furthermore, EPA should initiate a program that provides training grants to colleges and universities interested in helping to develop young scientists and engineers. 17 1 O EPA's R&D budget should be doubled over the next five years. ver the last ten years, EPA's budget for research and development has declined dramatically. EPA's FY 1980 budget provided $398 million (in constant 1982 dollars) for R&D. By FY 1983, that figure had declined by almost half, and since then it has risen to about $317 million. In other words, during the past decade EPA's R&D resources have shrunk by about 20 percent in real terms. (See Figure 4.) In that same period, EPA's need to better understand environmental risk has grown substantially. Congress has enacted major environmental laws—e.g., Superfund (1980), RCRA amendments (1984), Superfund amendments (1986), Safe Drinking Water Act amendments (1986), and Clean Water Act amendments (1987)—that give EPA broad new regulatory responsibilities in areas clouded with scientific uncertainty. Several new environmental concerns of national and/or international proportions—like acid rain, indoor air pollution, radon, stratospheric ozone depletion, and global warming—have emerged over the past decade. Thus the nation's need for better scientific information on the likely causes and effects of a wide range of environmental problems has been growing at the same time as EPA's ability to fund the research that will generate that information has been shrinking. EPA's R&D efforts must be expanded rapidly, especially in its core research areas, because of the long-term health, environmental, and economic benefits they will bring to the nation as a whole. While the value of EPA's applied research often is apparent, the benefits of basic research may not manifest themselves as quickly or as directly. Yet basic research is equally valuable 18 to our physical and economic health in the long run. Basic research is valuable because it clarifies the nature of chemical processes that may contribute to, and biological processes that may be affected by, the environmental contamination that often results from human activity. Basic research is valuable because it can help us see the long-term subtle changes in ecosystems that foretell serious risks in time for us to use risk reduction options other than expensive, after-the-fact, clean-up FIGURE 4 Funding History (1980-1989) $ in millions 3000 2000 Fiscal Years º 80 81 82 83 84 ºr U.S. GOVERNMENT PRINTING OFFICE: 1988 technologies. Finally, basic research is valuable—indeed, invaluable— because it provides the fundamental knowledge that is essential for innovative, economically-productive applied research within and outside EPA. Therefore, the Research Strategies Committee strongly recommends that EPA's R&D budget be doubled over the next five years. An increase of $375 million may seem extravagant, especially in light of the current Federal budget deficit and strong Constant 1982 Dollars (Constant 1982 Dollars) EPA Operating Budget and Superfund EPA Operating Budget ORD Budget 85 86 87 88 89 - 523-010 - 1302/00421 public pressure to balance the Federal budget. However, the nation invests approximately $70 billion per year in pollution control, and that figure is increasing. We should be willing to invest at least one percent of that amount to achieve the kind of health, environmental, and economic benefits that have resulted from past R&D efforts. Expending a small fraction of our national pollution control budget to fund an EPA R&D program that, among other things, would help determine the most effective ways to invest our national pollution control budget does not seem unreasonable. An expanded national investment in EPA research is even more justifiable in terms of the economic value of the resources that research is meant to protect. It is difficult to put a price on human health or environmental quality. How much are we willing to pay—as either individuals or as a nation—to preclude a single incidence of cancer, or a single birth defect? How much are we willing to pay to save a single wetland, or preserve visibility in a scenic area? Such questions have been debated within EPA and the larger scientific community for many years. And while we have not found a final answer, the stakes continue to go up. For example, the health, environmental, and economic consequences associated with the connection between atmospheric pollution and global warming are staggering. Environmental research can clarify the situation by providing scientific data to guide any actions we may have to take to protect the habitability of the planet. Given the resources at risk, and the investment we willingly make to control risks that are well-defined, a doubling of EPA's R&D budget seems a most appropriate use of national resources. This report has been derived mainly from five detailed documents prepared by the Research Strategies Committee of the Science Advisory Board. The five documents are: APPENDIX A: Strategies for Sources, Transport and Fate Research. (SAB-EC-88–040A). Describes the importance of understanding fundamental environmental processes, improving the accuracy with which they can be modeled, and identifying escalating/emerging environmental problems. APPENDIX B: Strategies for Exposure Assessment Research. (SAB-EC-88–040B). Describes a program which incorporates integrated exposures, indicators of exposure, measures of uncertainties, and cooperative activities across the country. APPENDIX C: Strategies for Ecological Effects Research. (SAB-EC-88–040C). Describes the need for approaches to assess risk to ecological systems, determine environmental status and trends, and predict future changes. APPENDIX D. Strategies for Health Effects Research . (SAB-EC-88–040D). Describes the growing role of environmental factors in the etiology of human illness and disease, the importance of long-term basic research in identifying and resolving health problems, and specific research areas and technologies that appear to offer particular promise for the future. APPENDIX E. Strategies for Risk Reduction Research. (SAB–EC-88–040E). Describes the overall risk reduction concept and specific research areas to support it, including administrative changes, education and technology transfer, and cooperative efforts with the private sector. Copies of these documents can be obtained by writing The Science Advisory Board U.S. Environmental Protection Agency A-101F Washington, DC 20460 * -- United States Office of the Administrator SAB-EC-88-040A Environmental Protection Science Advisory Board September 1988 Agency Washington DC 20460 Final Report &EPA Appendix A: PUBLIC Strategies for Sources, HEALTH º Transport and Fate Research ſº v. 2. Report of the Subcommittee On Sources, Transport and Fate Research Strategies Committee NOTICE This report has been written as a part of the activities of the Science Advisory Board, a public advisory group providing ext ramural scientific information and advice to the Administrator and other officials of the Environmental Protection Agency. The Board is structured to provide a balanced, expert assessment of scientific matters related to problems facing the Agency. This report has not been reviewed for approval by the Agency; hence, the contents of this report do not necessarily represent the views and policies of the Environmental Protection Agency or of other Federal agencies. Any mention of trade names or commercial products do not constitute endorsement or recommendation for use . U. S. Environmental Protection Agency SC i ence Advisory Board Research Strategies Committee Sources, Transport and Fate Subcommittee Dr. George Hi dy Electric Power Research Inst it ute, Environmental Division 34 l 2 Hill view Avenue Palo Alto, CA 94 30 3 Members Dr. Anders Andren - University of Wisconsin, Water Chemistry Laboratory 660 N. Park Street - e. Madison, Wiscons in 53706 Dr. Jack Calvert gº National Center for Atmospheric Research 1850 Table Mesa Drive Boulder, Colorado 80 30 3 Dr. Yoram Cohen University of California at Los Angeles, Chemical Engineering Department BOelter Hall Los Angeles, CA 900 24 Dr. Richard Conway - Union Carbide Corporation, South Charleston Technical Center 3200 Kanawha Turnpike (Blog. 770) South Charles ton, WV 25.303 Dr. Robert Huggett & Virginia Institute of Marine Science, School of Marine Sciences 9 Raymond Drive Seaford, Virginia 23696 Dr. Donald O'Connor Manhatton College, Environmental Engineering and Science Program, Riverdale, New York l O 47 l. Dr. Barbara Walton Oak Ridge National Laboratory, Environmental Sciences Divisit Post Office Box X Oak Ridge, TN 3783 l–6083 Dr. He roe rt Ward Rice University, Department of Environmental Science and Engineering 6 100 South Ma in Houston, TX 77005 Support Staff Dr. Donald G. Barnes * Acting Staff Director, Science Advisory Board U.S. Environmental Protection Agency Ms. Joanna- Foellmer Secretary to the Staff Director, Science Advisory Board U. S. Environmental Protection Agency * Original draft prepared through the support of Dr. Terry F. Yosie, former Director, Science Advisory Board Strategies for Sources, Transport and Fate Research Appendix to FUTURE RISK TABLE OF CONTENTS 1 - 0 Executive Summary 2.0 Importance of Sources, Transport and Fate Research 2. 1 The Role of Sources, Transport and Fate Research 2.2 Key Elements Needs in Sources, Transport, and Fate Research 3.0 Strategy for Sources, Transport and Fate Research 3. 1 FIRST STRATEGIC ELEMENT: - Reduction of Uncertainty in Estimating Environmental Concentrations of Pollutants 3.1. 1 Modeling and Model Validation 3. 1. 2 Source Characterization 3. 1. 2. 1 Chemical Characterization 3.1.2.2 Release Rates 3. 1.2.3 Episodic Releases 3.1.2.4 Source Characterization by Medium 3. 1 . 2.4.1 Air 3. 1 - 2.4.2 Surface Water 3. 1.2. 4.3 Ground Water 3. 1. 2.4. 4 Soils and Sediments l1 l 1 11 l2 l2 l2 13 1 3 3. 1.3 Transport Processes 14 , 3. 1.3.1 Surface Water 3.1.3.2 Ground Water 3.1.2.3 Water-Underlying Bed Interactions 3.1.2. 4 Soils 3. 1 .. 4 Fate Processes 3.2 SECOND STRATEGIC ELEMENT: Early Detection of Environmental Problems 3. 2. 1 New Stressor Identification: The Need for Early Warning 3. 2.2 Early Warning Data Sources 3. 2. 2. 1 Chemical, Biological and Physical Monitoring 3.2.2.2 Societal, Economic and Technological Changes 3. 2. 2.3 Literature Reviews and Expert Workshops 3.3 Implementation at EPA 4.0 Recommendations 4. 1 Recommendation I: Emphasis on STF Models 4.2 Recommendation II: Leadership by Risk Assessment Council 4.3 Recommendation III: Establishment of an Early Warning Group 15 15 16 16 17 17 17 18 18 21 22 22 23 23 24 24 STRATEGIES FOR SOURCES, TRANSPORT AND FATE RESEARCH 1.0 Executive Summary Sources, transport and fate (STF) research explores the interconnections between sources of environmental pollutants, their transport and transformation through the environment, and their ultimate fate. These research findings allow measurement or prediction of pollutant concentrations at points distant from the source. These exposure data are coupled with toxicity information to assess risk. In other cases, STF research can be used to identify sources of environmental risks. For example, previously unsuspected pollution sources fortuitously have been identified through field measurements (e.g., chlorinated dibenzo-p-dioxins from pulp and paper mills), and mathematical models have successfully related suspect source emissions to particular environmental findings (e.g., stratospheric ozone depletion). In addition to risk assessment purposes, STF research is being looked to as a generator of "early warning" information on potential, emerging, and/or escalating environmental problems. * * In order to meet these growing demands, STF research strategy in the 1990's should have two major elements, which are central to this report: a. Strengthening EPA's capability for predicting environmental form and concentration of pollutants, with a known level of uncertainty, through measurements and modelling. º b. Utilizing STF knowledge to provide an early warning vehicle for anticipating issues that are likely to become priority concerns for EPA. g The first element of the strategy calls for expansion of the knowledge base on transport and transformation processes in order to develop and validate models needed in the assessment and management of environmental risks. The second element is designed to raise Agency and public awareness of environmental problems at a stage early enough to permit adoption of a cost-effective approach to risk reduction. Regarding the first strategic element, much of the success of STF research depends upon the development and validation of mathematical models, specifying their degrees of uncertainty. While the basic principles applicable to many of these models are known, site-specific conditions, process data needs and differing scale requirements (e.g., local vs. regional vs. global, or short-term vs. long-term) limit the current successful application of these models and introduce uncertainties which — 1 – need to be identified, quantified, and narrowed. Models are predicated on mass conservation and, necessarily, require data on source characterization, media transport and chemical conversion processes, and deposition or media removal processes, which are sometimes called "fate" terms. A broad range of known and potential sources in all media (e.g., air, surface water, ground water, and soils) should be characterized through a core program examining the chemical characterization, release rates, . and frequency of releases from the sources. This source information, coupled with fundamental knowledge of transport and transformation processes, should feed into the mathematical models which predict the behavior and ultimate fate of the pollutant (s) in various media and generate estimates of exposure. - Regarding the second major element of the strategy -- the need for early warning --, great benefits can be derived from early identification of problems; i.e., reasoned risk reduction actions can be implemented to correct a situation before it requires a costly crisis response. The ability to detect problems before they would traditionally appear is related to foresighted collection and judicious use of key environmental data. Chemical, biological and physical monitoring activities, a major source of such data, need to be strengthened considerably. In addition, a shift in strategic thinking is needed in the basic approach to environmental monitoring. Currently, the Agency focuses on a limited number of selected pollutants, adopting a "feedback" strategy. That is, if certain pollutants are found in excess of some existing standard or limit, the information is fed back and regulatory action is taken. In the future, the Agency should adopt a "feed forward" strategy that involves monitoring a much broader range of compounds and other environmental stressors of potential interest, many of which do not have regulatory standards. The resulting data would provide an increasingly realistic and complete estimate of the total toxic burden in the environment and a context within which to . determine more easily the extent to which chemically transformed products or new, unregulated compounds enter the environment. It would also highlight situations in which the distribution of chemicals change, perhaps indicating significant changes in environmental conditions; e.g., global air (climate) warming from the increased presence of radiation- absorbing gases in the atmosphere. . Such information would be fed forward and analyzed, possibly leading . to the development of a regulatory or other risk reduction response. Careful consideration of societal, economic and technological trends could also be helpful in anticipating--and possibly avoiding—-environmental problems. Measurements alone will not suffice to provide an anticipating framework. A forward looking analysis also will be needed. The Agency should assign the task of achieving this "early warning" goal to a group –2– charged with discerning the implications of emerging observations and knowledge in the context of past knowledge. This group would submit an annual report on their findings and projections, or a special alert of findings as necessary. This Report contains three specific recommendations: a. Recommendation I: Improved STF Models EPA should strengthen its research on STF model development, evaluation and validation, as a means for reducing uncertainty in risk assessment and risk management. b. Recommendation II: Leadership by the Risk Assessment Council The Agency's Risk Assessment Council should take steps to insure that STF research is integrated into EPA's approach to exposure assessment analyses. c. Recommendation III: Establishment of Early Warning Group The Agency should establish a group of senior scientists and engineers to identify potential, emerging, and/or escalating environment health and ecological problems using systematic, long term measurements and their interpretation. 2. O Importance of Source, Transport and Fate Research 2. l. The Role of Sources, Transport and Fate Research The study of the sources, transport and fate (STF) of pollutants is an essential part of environmental research. This type of work has served three major roles in environmental assessment, resulting in the ability to estimate exposure concentration levels and to relate excessive exposure levels to sources needing emission reduction. The roles are: a. Generation of fundamental knowledge about the physical and chemical characteristics of emissions from pollution sources. b. Clarification of the nature of transport, conversion and media loss processes (e.g. deposition and absorption) that lead to exposure. - c. Highlighting of chemical conversions leading to . pollutants that differ from the direct emissions; e.g. , the conversion of sulfur dioxide into sulfuric acid in the atmosphere. In the first instance, an expanding inventory of compounds or radioactive substances has emerged that potentially affect the environment. In some research the interpretation of temporal and spatial distributions of ambient measurements has led to the identification of sources otherwise not considered (e.g., polychlorinated dibenzo-p-dioxins from pulp and paper mills). Accurate source identification information is important for the development of cost-effective control strategies. Second, STF research has provided the principal basis for developing mathematical models to relate source emissions to ambient conditions, yielding exposure estimates. Such models provide a critical element of exposure estimation in space and time to assess the impact of both existing and new sources. Particularly notable accomplishments of modeling that have not only provided regulatory tools but have advanced the understanding of source-receptor relationships include multiple source air dispersion models and chemical fate models for ground water contamination. - º Specially designed measurement programs have been required to provide data to investigate environmental processes and to verify and test the reliability of such models. These measurements are distinct from monitoring and surveillance for existing regulatory requirements. A third role of STF research involves understanding large-scale environmental phenomena, using basic knowledge of chemical processes, results from laboratory experimentation, development of mathematical models, and critical measurements in the field. Examples of major contributions in this category – 4– include: a. Tropospheric ozone prediction schemes employing meteorological factors and highly complicated chemistry. • b. An explanation of the role of chlorofluorocarbons in modifying stratospheric ozone, c. The discovery of organic chlorine compounds in treated drinking water. d. The exploration of complex bio-geochemical factors affecting the speciation of heavy metals such as mercury, chromium and selenium. - An additional emerging role of transport and fate research concerns the identification, analysis and interpretation of certain long-term trends that can alert policy makers to significant environmental issues in the future. Those have included inferences from long-term monitoring that emerged through ecological and biological effects, acid deposition and long-range transport, the build-up of greenhouse gases to produce climate change, surface hydrogeological concerns in the storage and land disposal of wastes, and identification of global contamination of the oceans from certain pesticides. The past successes of STF research in raising scientific and public awareness on a wide range of environmental issues indicates that the public investment in this work is well founded. The area should continue to be an important component of EPA efforts in research and development. 2. 2 Key Elements Needed in Sources, Transport and Fate Research An important factor in risk assessment is knowledge of the sources of pollutants and the processes that subsequently govern the dispersal of a pollutant into the environment. This relationship can be conceived as links in a chain beginning with pollutant emissions followed by transport, transformation and media removal (deposition or sorption). Understanding these relationships contributes scientific insight as to how pollutants, through space and time, reach humans and other receptors. In addition, definition, of source-receptor relationships aids decisionmakers in targeting specific sources for risk reduction efforts. Failure to address these questions can result in environmental policies and regulations that are cost-inefficient, spending too little on some problems and too much on others. EPA's research has contained a substantial component of STF work in the past. However, the effort frequently has been poorly defined and, consequently, has not always focused on issues central to the Agency's needs. For the l990's, STF research strategy should have two major elements: a. Strengthening the capability of predicting environmental form and concentration of pollutants, with a known –5- level of uncertainty, through measurements and modeling. © b. Utilizing STF knowledge to provide an early warning vehicle for anticipating issues that are likely to become priority concerns. for EPA. The first strategic element would expand the base of knowledge on transport and transformation processes in order to develop and validate mathematical models for assessing and managing environmental risks through exposure estimation and identification of significant sources and their relative contributions. The second goal would use a combination of measurements, theory and analysis to contribute to raising Agency and public awareness of issues potentially harmful to public health and the environment at a stage early enough to permit adoption of a cost-effective approach to risk reduction. Section 3 discusses these key elements of the STF research strategy. Section 4 offers specific recommendations. 3.0 Strategy for Sources, Transport and Fate Research Environmental risk assessment and management requires reliable means for estimating exposure in space and time, as well as estimating the contribution of sources to those exposure patterns. Exposure to humans and to ecosystems can occur through respiration, ingestion, direct contact, or the food chain. Exposure generally is defined in terms of an ambient concentration or bioaccumulation concentration over time, a deposition rate to a collector, or a total medium burden (amount of material in a defined volume). In the absence of direct measurements of exposure, estimation of concentration, deposition or burden can be carried out through interpolation or extrapolation of results of mathematical calculations based on the principles of mass and energy conservation. Continuing research is needed on both direct measurement of exposure and predictive models, as discussed in the report of the Exposure Assessment Subcommittee. In general, projections of source contributions to exposure at a receptor (source-receptor relationships, or SRRs) presently can be done only through mathematical models. Inherent in either the interpretation of field observations or mathematical modeling are uncertainties in exposure or SRRs that are seldom known. A scientifically supportable risk assessment requires an accurate and precise exposure estimate. Therefore, determination of uncertainty in estimates. is as important as the estimate itself. This is also true in risk management where a balancing among cost, technological effectiveness and reliability, and other factors is often required or used for selecting among determining emission control options. Inherent in the improvement of risk methodology is reduction of uncertainty in estimates of the attribution of exposure to specific sources. Uncertainty in exposure estimation derives from two factors. The first concerns a mismatch in the spatial or temporal scale of calculations relative to receptors. The second uncertainty stems from errors in the models themselves, the input data to the models, and computational errors inherent in numerical techniques which are employed in the execution of the model. Models calculate concentrations or burdens in a relatively coarse or macro-scale. An individual receptor generally is much smaller than this resolution and often is mobile. These factors make it necessary to use population mobility and statistical factors to relate measurements at fixed stations and model calculations to receptor exposure. Little research has been done to reduce uncertainty in these factors or in estimation of target tissue doses resulting from environmental exposure. This subject is more fully discussed in the report of the Exposure Assessment Subcommittee. — 7– Work has been done to define uncertainties in model º calculations but, in general, models and interpolation schemes are not well tested for reliability or validated for the quality of their simulations. º The validation of theoretically based models is often defined at two performance levels. The first is determined by a suitable comparison of its predictions with ambient concentration measurements for given physical or chemical input conditions. However, close correspondence between model prediction and a few, selected environmental measurements does not necessarily constitute adequate model validation. Thus, a second validation criterion is needed that tests the model for its integrity in simulating media processes that link source emissions to ambient conditions. Testing models at this level is far more demanding than the first evaluation, but it needs to be an integral part of STF research. Experimentation with models at this level leads to advances in basic knowledge as well as added confidence in the model performance. 3 - 1 FIRST STRATEGIC ELEMENT: Reduction of Uncertainty in Estimating Environmental Concentrations of Pollutants. 3. 1. l Modeling and Model Validation Effective risk assessment begins with an attempt to estimate the environmental concentration of contaminants within an acceptable margin of error, followed by exposure assessment that assumes a reasonable level of confidence in estimates of contact with these environmental pollutant concentrations. Three factors significantly affect the accuracy of estimates of environmental concentration: a. Specification of source location, chemical characteristics and emission rates. b. Description of transport and chemical conversion processes. c. Description of fate or removal processes. Information on these factors is used to construct models to represent the phenomena believed to be involved in the movement and transformation of chemicals in the environment, and computer codes are developed to facilitate what are frequently very complex calculations. The EPA requires reliable data on concentrations in environmental media in order to determine exposures to target organisms and populations for risk assessment. The Agency also requires data on the contribution of specific sources to pollutant concentrations (i.e., SRRs) as a means of identifying which sources to target for reducing risk. In the absence of sufficient data on exposures, source data may be combined with transport and transformation models to provide estimates of –8– exposure. In such cases, it is critical that the models be capable of providing exposure estimates within acceptable (or at least defined ) bounds of uncertainty. Uncertainty is determined by the suitability of the model (i.e. , whether it includes appropriate terms for all of the important variables, such as dispersion and meteorological conditions) and by the accuracy of coefficients and other input data associated with each variable or connecting mathematical term. In an ideal world, each model would be fully validated before it is used for risk assessment or risk management decisions. However, the high costs and long lead times required for model validation inhibit the validation effort in a regulatory agency such as EPA. In reality, a model can prove useful, even without a full validation, provided that it can be empirically verified for a range of conditions comparable to those in the situation for which it is to be applied. Furthermore, as it is applied more widely and tested periodically against available environmental data, it can be refined and/or modified, based on operating experience. Thus, iterative applications of models have served the EPA in several ways. They help to define the bounds of uncertainty associated with use of the model in risk assessment or risk management, thereby increasing confidence in the results. At the same time, the data generated provide a basis for refining the model and/or extending the bounds over which it can be used. Although STF models primarily have been structured to address a single medium of the environment--air, surface water, ground water or soil--, it is increasingly apparent that intermedia and multi-media models are also necessary to analyze certain problems. In any case, the most general and appropriate structure of a model is based on the conservation of mass or continuity principles, incorporating source, transport, transfer and transformation components. The basic principles that underlie any modeling effort are at least qualitatively understood and the numerical coefficients relating to the above mentioned components often can be estimated. The application to a particular problem, however, often requires more detailed qualitative descriptions of transport and transformation processes; e.g., resuspension of aerosols from soils and the role of wet scavenging of reactive organics. In addition, more accurate quantitative measures of the coefficients which model these processes may be required in order to obtain projected estimates that are of practical use to the risk manager. Thus, there arises the need for model calibration and validation specific to the problem and region, the degree and extent of which should be guided by the significance of the question and the environmental and economic consequences. EPA should continue to establish a systematic procedure and a specific schedule to validate key environmental models. This effort should include documenting underlying assumptions, updated modeling procedures and protocols, and estimating uncertainties in prediction capability for a range of –9– conditions . The verification of models to a defined uncertainty requires a combination of special data acquisition, including source emission and field tests, laboratory experiments, and theoretical or mechanistic studies of media processes. These generally involve progressive and incremental design considerations based on a continuing improvement in our knowledge. The model components to be quantified are source characterization, media transport and conversion processes, and ultimate disposition ("fate") processes. Each of these components and their associated uncertainties are discussed in the following sections. 3.1.2. Source Characterization In deriving estimates of environmental concentrations of póllutants, quantification of sources, their strengths, and interactions is potentially one of the larger sources of uncertainty. Because of legislative mandates, source inventory and characterization have been directed toward release into - specific environmental media such as air, surface water, ground water and soil. Great strides have been made on emissions estimation in the last lº years; however, source characterization should continue to be high in priority because a. Historical sources such as abandoned waste pits and dumps have been inadequately characterized as to the presence of particular pollutants or to releases. b. More recently acknowledged sources, such as contaminated sediments, present additional assessment problems c. Advances in emission control technology and evolution of industrial processes and activities require progressive re-evaluation of emissions inventories d. Multi-source and multi-media interactions have been inadequately characterized. The sources to be studied will change according to the prioritization of current and projected environmental problems and introduction of new technology. Within a given problem area, the sources studied should not be limited to those addressed by current Federal regulations. Rather, the outlook should be as comprehensive as possible to define the magnitude of current and emerging problems. In studying ground water pollution sources, for example, municipal landfills should be included as well as RCRA Subtitle D facilities and the use of agricultural chemicals. Source research should address area, as well as point, sources and both mobile and stationary sources. A continuing core research program in this area is recommended both to develop generic methodology and to apply it to critical environmental problems. Three aspects of a core program are addressed in this report: chemical characterization, release rates, and episodic releases. Emphasis also should be placed on emerging — 1 0– technologies and new chemicals entering the environment. 3. 1. 2. 1 Chemical Characterization The objective of chemical characterization is to develop and apply efficient methods that adequately define problem sources and point to solutions. Accuracy, precision, detection limits, matrix effects, cost, and time are all critical factors. Besides the identity and concentration of chemical constituents, tests are needed to predict the mobility of materials under various scenarios and to provide data for selection/design of control techniques. 3.1.2.2 Release Rates Emissions from point sources often can be directly measured, while the flux of contaminants from various area or diffuse sources into the environment is estimated by applying a mathematical model to either source characterization data or ambient monitoring data. Each approach is associated with levels of uncertainty that need to be established and then reduced when greater accuracy and precision is required. For example, many exposure estimates assume a nominally steady discharge of a pollutant, when in fact, variation in emissions rate may be critical to an accurate estimate of exposure. Also, there is a need to develop approaches which utilize all available data sources, be they NPDES reports, air permits or RCRA Part B applications. Improved release rate models need to be soundly conceived and adequately verified for a variety of applications. 3.1.2.3 Episodic Releases In many situations EPA may emphasize the regulation of emissions under stable, steady conditions while serious environmental and/or human health problems are caused by sudden releases or "upset" conditions. Formal procedures are needed for : a. Identifying specific potential hazards; i.e. situations that could result in a sudden release. b. Estimating probability of that hazard occurring. c. Predicting the magnitude and chemical or physical form of the release. Projections of equipment failure and handling or transportation accident rates are needed. Acceptable standards of practice need to be established and tested. One approach for hazard identification is to divide operations into segments and compare possible risks against a hazard checklist, including combustible mixtures, mechanical stress, vapor cloud release and over-pressurization. The potential for natural disasters, like a sudden gas release (e.g. carbon dioxide or hydrogen sulfide) from -1 1 – a volcanic disturbance or a deep lake sediment should be investigated. - 3.1.2.4 Source Characterization by Mediuſ 3. 1 , 2.4.1 Air Although air quality research is said to be more advanced than research for other media, a continuing effort will be needed to refine and improve knowledge of emissions for regulatory decision making. Over the past decade there has been considerable effort to characterize emissions of criteria pollutants and certain hazardous chemicals from stationary and mobile sources. Data acquisition for source characterization will be needed for air regulatory analysis at a modest level of priority for at least the next decade. Continuing work will be required to maintain and update the inventories. Characterization of emissions from new or rebuilt facilities will be required, as will the estimation of pollutant forms not previously considered. Additional research will continue to be needed to provide improved emission factors and to define the uncertainties and limitations in available data. With such refinements, high priority should be assigned to upgrading estimates of emissions of nitrogen oxides and volatile organic compound emissions for use in source-receptor modeling and control strategy analysis of oxidants and air toxics. 3. 1. 2.4.2 Surface Water In many instances non-point sources are the major contributors to freshwater surface problems; e.g., toxics in Lake Superior and Lake Michigan. Risk reduction efforts will increasingly turn to non-point sources because of the large fraction of surface water pollution problems they may represent and since point sources have been more effectively controlled. Potentially important non-point surface water pollution sources include the following: run-off and leachates from agricultural and other land uses, deposition of wind-borne volatile organic chemicals and heavy metals, groundwater inflow and sediment releases. At this time source models for predicting organic loadings are much further developed than models for inorganic loadings. Also, agricultural run-off is considered to be better characterized than is urban run-off. Research should be balanced between monitoring (direct measurements for use in identifying/defining problems, as input data to models, and in model validation) and development of predictive run-off models. Specific models need couple the source information with hydrodynamic and process kinetic models, describing sediment -12– transport, and elucidating biologically mediated reactions, metal speciation kinetics, and hydrophobic compound transport. Reconstructive models based on concentrations in receptor organisms, including humans, also are useful. Balanced funding of field measurements and predictive modeling is recommended. 3.1.2. 4.3 Ground Water Contamination of ground water from human activities frequently originates from surface impoundments, landfills, agriculture, leaks and spills, septic tanks, mining, petroleum and gas production, and underground injection of wastes. EPA's l977 "Report to Congress on Waste Disposal Practices and Their Effects on Ground Water" (Premier Press, Berkley, CA, 1980) identified the disposal of wastes at industrial impoundments and other solid waste disposal sites as the most important sources of groundwater contamination. It estimated that approximately lS$ of the liquid and solid industrial wastes generated in the United States can be classified as hazardous. Such wastes represent potential sources of groundwater contamination, depending on the method of disposal. Most of the past land-disposed wastes were not managed by means that comply with more recent Federal regulations, and, therefore, they may threaten groundwater quality in many areas. In addition to industrial wastes, the l877 report identified so-called secondary sources of national importance including septic tanks, municipal wastewater, mining, and petroleum exploration and production residues. Although concentrations of toxic material from these sources are generally lower than from industrial wastes, they can be significant on a regional basis. In an area of substantial manufacturing activity containing large numbers of people, there exists a potential for pollution of groundwater resources, especially from products such as gasoline, fuel oils, and solvents. Areas where mining, agriculture, and/or petroleum production are prevalent are also at potential risk. 3.1.2.4.4 soils and sediments Soils and sediments can retain organic and inorganic chemicals released to the environment. Therefore, they can become sources for release and subsequent contamination of air, ground water, and surface waters through resuspension, vapor losses, leaching, and removal of particulates containing sorbed compounds. Defensible risk assessments and risk management strategies require reliable information on the amount of contaminants accumulated in soils at sites and knowledge of how to predict contaminant persistence, transformation, and transport to other media. - The spatial distribution of chemical contaminants in soils is often extremely heterogeneous. Consequently, extensive core — 1 3– sampling and/or exhumation to delineate zones of contamination can be time-consuming and expensive. In situ and remote assay equipment and sampling methods are needed to determine concentrations of chemicals in surface and subsurface soils. Among approaches that show promise are those that couple recent advances in laser technology with those in fiber optics in order to improve the detection of organics and the development of portable gas chromatographs for analysis of volatile organics in the field. In addition, neutron and scintillation probes may prove useful for in situ detection of transuranic and gamma-emitting radionuclides, respectively. Development of these and other techniques to detect and quantify contaminants will require a significant research effort, but one that would yield a high payoff in monitoring capability. In order to adequately assess soil sources, there is a need for appropriate leaching test (s). Improved methods are needed to evaluate contaminated soils and wastes to account for variability in leach rates of constituent chemicals over a long period of time at specific sites. Such methods could be used to improve cleanup and closure of RCRA and CERCLA sites, as well as to serve as guidance for management of land treatment and landfill facilities. t - 3. 1. 3 Transport Processes There is general acceptance of the basic principles of the transport component of STF models. The fundamental equations of fluid (air and water) motion which follow from these principles are reasonably well-established and have been utilized for calculations. The principal limitations of these models often lie with certain empirical transfer coefficients that are media specific. The mixing and dispersion associated with the fluid motion, although understood, has less of a research base to support it. Nevertheless, empirical relations, based on field and laboratory data, provide important insight into the nature of transfer coefficient variability. The recent advances in turbulence theory increase scientific understanding of this important mixing mechanism. At the present time, the development and application of fluid dynamic models incorporating this theory reside primarily with the research scientists. Transferring this knowledge to the environmental analyst is an important need for the future development and application of air and water quality models. Certain specialized areas; e.g., underlying sediment bed failure, remain as more fundamental challenges for environmental modellers. Analytical and numerical solutions and the associated codes are available for surface and ground water transport models. Stochastic or Monte Carlo techniques have also been used to define the uncertainty of the various elements in these models. Different research groups should test a selected group of models in order to determine those which are most appropriate for use in – 14- environmental quality analysis. This testing should be followed by a comparison of model performance with sets of observations from various air regimes and water systems. 3.1.3.1 Surface Water The transport of pollutants in freshwater bodies is predominantly advective (moving with the mean flow), rather than dispersive (associated with the eddying). Given the knowledge of the hydrologic balance of a drainage area and empirical correlation of the dispersion, transport of pollution in freshwater systems can usually be determined with greater accuracy than some other components of the mass balance; i.e. sources and transformations. The hydraulic interaction (e.g., caused by fluctuating levels) between the surface and ground water deserves further attention as it relates to estimating contamination. The dispersive component in estuarine and coastal systems is more significant than in fresh waters. In the former, the effects of density stratification on vertical and lateral dispersion and the distribution and disposition of sediment and organic particulates needs to be further developed. Given the intensive computational manipulations required to solve multi-dimensional fluid dynamic/quality models, a significant effort is needed to enable these models to interact for long-term, time variable simulations and projections. Much remains to be done on transitions for coastal systems both on the east and west coast of the country. The eddies from the Gulf Stream in the Atlantic have marked effects on the transport within the region north of Cape Hatteras and notably in the New York Bight. The Gulf Stream has not been successfully modeled in spite of the advanced state of knowledge of the field and aforementioned developments. Wind and temperature effects are important factors in defining transport in marine systems, as well as in lakes and reservoirs. The latter have frequently been modelled in a simplistic fashion by assuming complete mixing. For long term projections this approximation has been successfully applied in many cases. For the more refined, multi-dimensional analysis, —however, much needs to be done in applying turbulence theory to the analysis of transport phenomena in lakes and reservoirs so that detailed concentration patterns can be estimated. In addition, intermedia transfer phenomena (e.g. , the role of the surface microlayer in pollutant transport across the water/atmosphere interface and critical factors in water/sediment transfer) need additional study. 3. 1.3.2 Ground Water As in the case of surface water, the basic equations of – 15– fluid motion in the saturated zone of ground waters are generally well established and understood. Qualitatively, fluid transport in some important ground water media has successfully been modeled. Similarly, the dispersive effects, referred to as dispersivity, have been empirically defined to s, tº a degree, but site-specific evaluation of this component is us ly required. By contrast, knowledge of the transport in the u a turated zone is inadequate, and further development in this area is needed. A major source of uncertainty in groundwater modelling is the inherent heterogeneity of the soil media and underlying rock structure, which must be addressed on a site-specific basis. 3.1.3.3 Water-Underlying Bed Interactions The exchange between the water and the underlying sediment bed acts as both source and sink of dissolved and particulate forms of pollutant constituents. In some cases, the transfer rates from or to the bed far exceed the current mass inputs from point and non-point sources. Two general constituent categories are considered: nutrients and toxic substances. The former affects the bacterial and algal levels in the water column. In many locations this interaction is the major factor in a dissolved oxygen budget. There is a pressing need for the analysis of dissolved oxygen and eutrophication to better characterize the flux of nutrients at the water-underlying bed interface. - Many organic chemicals and heavy metals partition to particulate matter, particularly to the organic and clay fraction of the solids. The degree to which the contaminated particulates accumulate in the sediment depends on the characteristics of the solids and the turbulence and shear at the water—underlying bed interface. Estuaries, lakes or reservoirs are net sedimenting systems and accumulate these toxic substances in the bed. The broad area of sediment interaction with the water column in all systems requires a significant effort in order to understand the phenomena of sediment transport, settling, resuspension and bioturbation affecting water quality. 3.1.3. 4 Soils Current methods are inadequate to predict accurately conditions in soils (e.g., moisture and temperature fluctuations) or the transport of organic and inorganic contaminants in this medium. Studies are needed to refine the conceptual models for organic and inorganic mobility and to provide for the influence of soil heterogeneity and other environmental variables on these processes. Structure-activity analyses should be explored to improve predictions based on physicochemical properties of specific compounds. Pollutant transport through soils is often viewed simply as –1 6– a single chemical chromatographic process. This view fails to account for the influence of soil structure (e.g., macropores), rainfall events, contaminant interactions in waste mixtures, and the possibility of movement via colloidal transport and adsorption to mobile microparticulates. Studies are needed to delineate the extent to which these additional processes affect rates of contaminant transport in soils. 3. 1 .. 4 Fate Processes The environmental fate of a substance depends on physical dispersion processes as well as on its physical, chemical, and biological properties or interactions with substrates. Information required for future predictions of the fate of chemicals in air, soil, or water includes such basic data as aqueous solubility, vapor pressure, air-water partition coefficient (Henry's Law constant), molecular diffusivity, phase partition coefficient, melting point and absorbtivity. There has been progress in acquiring data in pure homogeneous systems. This fundamental information is needed in order to understand the effects of cosolvents, unicelles, and colloids on these properties. In addition, many chemicals hydrolyze, photolyze or participate in additional abiotic or biotic degradation processes, such as electron transfer reactions. An increased effort is needed to produce thermodynamic and kinetic data for heterogeneous systems as well; e.g., the influence of metal oxides and microorganisms on the persistence of chemicals in soils. - Since economic and logistical constraints prohibit laboratory measurements for all these properties and rate constants, an alternative predictive tool is recommended: investigation of chemical structure-activity relationships. These estimated parameters are then adapted for appropriate fate models. Such an approach has been used with great success in chemical engineering to design unit processes for chemical manufacturing and in pharmacology to construct pharmacokinetic drug transport models. º 3.2 SECOND STRATEGIC ELEMENT: Early Deteetion of Environmental Problems 3.2.1 New Stressor Identification: The Need for Early Warning Early identification of potential, emerging and/or escalating environmental problems should take its place along with risk assessment and risk management as a central part of EPA's mission. The current research program provides no funds specifically earmarked toward this objective. This is disappointing in view of the number of issues (e.g., radon, stratospheric ozone depletion and global climate change) that have only recently risen to priority in EPA's policy agenda but – 17- which have been known to the scientific community for a number of years. It is also surprising because of relatively high perceived risks and the rising priority for these "newer" problems which are discussed in EPA's February, 1987 report entitled "Unfinished Business: A Comparative Assessment of Environmental Problems" (EPA/230/2-87/025a-e). While admittedly not a scientific study, the "Unfinished Business" report provides a rationale for follow-up investigations that need to be pursued, if only to minimize future surprises and to ensure a better match between research expenditures and significant sources of public health and environmental risk. The benefits of early identification of stressors to human health and ecological systems include: a. Cost reduction: more orderly conduct of the research vs. expensive crash programs. b. Improved regulation: more time is available to develop data bases for scientifically supportable regulations. C. Risk reduction: steps can be taken early to reduce or prevent risk either by non-regulatory and/or regulatory means. Initiation of a program to identify new or potential risks, which can complement the Agency's ongoing efforts to assess known risks, is strongly recommended. 3.2.2 Early Warning Data Sources 3. 2. 2. 1 Chemical, Biological, and Physical Monitoring Many of the environmental stresses that concern this nation and the world are caused by anthropogenic chemicals. Often a crisis is first detected through the direct observation of a . biological effect caused by pollutants rather than by earlier prediction or detection of the release. There are numerous examples of this pattern, including: a. Kepone in the James River detected by the observation of worker illness. • b. Tributyltin in harbors detected by the observation of malformed oysters. c. Polybrominated biphenyls in Michigan cattle detected by the observation of dead and dying animals. d. Polynuclear aromatic hydrocarbons in areas of the Puget Sound detected by the observation of fish with Carºl Celºſ S = Often by the time a problem is detected, biological damage has already occurred and remediation is difficult, expensive or impossible from a practical standpoint. In other words, the anticipatory regulatory systems have been inadequate. Improved anticipation can be promoted through an improved surveillance system. Such a system would continue to include a - 18- chemical monitoring program designed to quantify a preselected set of compounds already of regulatory interest. This approach has been the thrust of most environmental monitoring to date. An improved surveillance system should, in addition, provide qualitative identification of additional chemicals of concern. This latter approach has been haphazard in deployment, but has proven important. - There are advantages and disadvantages to the first, directed approach. One advantage is that the qualitative aspects of chemical analyses are simplified. Analytical methodologies can be selected or developed for specific compounds, decreasing the possibility of false identification. The quantitative outputs of the analyses are usually more accurate and precise because the methodologies employed are optimized for the preselected compounds. These outputs are particularly important if the objective of monitoring is to determine compliance with some regulatory program or permit. A disadvantage of the directed approach is that only the preselected compounds are surveyed even though other compounds may also be detected. The data for the latter compounds are generally ignored and even lost. New compounds, which may later prove to be damaging to human health or the environment, are not systematically tracked. Examples exist where chemical problems have been needlessly overlooked. Among these are the impacts of such organic chemicals as polychlorinated biphenyls in the l960's, Kepone and dioxins in the l870's. In other words, potentially valuable chemical data have not and are not being . utilized specifically for environmental assessment because of a narrow focus on chemical-specific monitoring. Another way of describing most existing monitoring systems for toxic chemicals is to describe them as "feedback" programs. Such feedback programs are keyed by error signals. For example, if a permit allows a certain amount of a specific compound in an effluent, a concentration that exceeds the permitted level by an established margin constitutes an exceedance; i.e., a violation. Detection of this violation may feedback, initiating regulatory action. Compounds not specified in a permit and, therefore, not analytically sought, cannot trigger an warning alert even though these "new" compounds may be detrimental to the biological communities in the receiving media. T Technologies and expertise now exist to reduce such oversight through improved design of broad-based chemical monitoring programs and the use of biological endpoints in monitoring. The use of techniques such as gas chromatography (GC) and gas chromatography-mass spectrometry (GC-MS) provide effective means for efficient, anticipatory monitoring. Through the use of various columns and detectors, these methods yield signals for essentially all of the compounds present, both those which are analytical targets and those which are unexpected. Even though many of the output signals are not essential to a — 19- feedback system, they can be collected, stored, and analyzed through the use of data handling systems. This broad-based record can be examined historically for chemicals of possible concern and for apparent shifts or trends that may signal an accumulation of material. In such a program, data systems could be linked together to create networks. Software could be developed to query the networks to determine whether new chemicals have appeared between samplings and whether a compound is increasing or decreasing over time. The network could provide efficient access to the areal distribution of a compound (s) of potential interest. This alternative to targeted chemical monitoring would sacrifice some quantitative aspects of the analyses in order to maximize the qualitative outputs. That is, this added information would be obtained at the cost of somewhat higher limits of detection. The results of these refinements to chemical monitoring would be progress toward "feed forward", rather than feedback, monitoring. Feed forward monitoring, in this case, is defined as monitoring designed to determine when new, unregulated or unselected compounds enter a system and when shifts in the distribution of chemicals in the environment occur. Feed forward monitoring has the advantage of determining many more compounds, which in turn provides a much more realistic estimate of the total toxic burden to which organisms are exposed. Such information would be "fed forward" and analyzed, possibly leading to the development of a regulatory or other risk reduction response. Although feed forward monitoring programs may be less cost-effective in the short-term than routine feedback monitoring for regulatory compliance, the long-term benefits of avoiding a future kepone-type event justify the costs associated with the development and maintenance of such an early warning system. Further, judicious application of knowledge about what biological and physical processes are possible can increase the efficiency with which feed forward monitoring is conducted. Plants and animals can also be used to gain important information about the sources and availability to biota of chemical contaminants and their resulting effects. Insight can result from analyses of tissue that may not be possible from chemical analyses of abiotic components of ecosystems. Another advantage of biological monitoring is the extremely high sensitivity of certain biochemical endpoints, such as enzyme induction, that can supply evidence of the presence of chemicals at concentrations below thresholds for chemical analyses. Recently published studies have shown that biomedical tests derived from research on mammals are useful when applied to aquatic systems. The detection of chemical stresses on aquatic biota by utilizing histopathological and immunological techniques –20– is now possible. The observation of tumors in fish from Puget Sound, the finding of lesions and depressed immune systems in fish from the Elizabeth River, Virginia, and the determination of elevations in metallothionein concentrations in fish from Prickley Pear Creek, Montana, are examples of the use of such technologies. Also, non-specific indicators of toxicant exposure can be valuable monitoring tools in broad-scale screening programs. For example, deviations from normal ratios of single-stranded to double-stranded DNA reflect exposure to a broad array of genotoxic chemicals. - There is no doubt that the ability to analyze environmental samples will improve and become more comprehensive in the future. There is also no doubt that the need for long-term monitoring data will increase as technology and human populations expand. Both of these developments support the concept of collecting and storing environmental samples to be analyzed in the future as new techniques become available or other needs dictate. The Agency now participates in such a program, the Environmental Specimen Bank. Consideration should be given to expanding the effort. The availability of documented samples on which to perform retrospective analyses could be extremely advantageous for determining temporal or spatial trends. Similar efforts should continue with the National Human Adipose Tissue Survey (NHATS). - Monitoring efforts should also address risks caused by stresses on humans and ecological systems other than direct toxicity of anthropogenic chemicals. These stresses include global warming, increased UV-B radiation, physical modification of habitat, radon, pathogenic and engineered organisms, and natural chemical emissions. * 3. 2.2.2 Societal, Economic and Technological Changes Clues as to potential and emerging public health or ecological stressors (risk) can be gained by periodically examining societal, economic and technological trends. For example, energy conservation scenarios developed in the l870's because of rising energy prices could have predicted the rising importance of indoor air pollution problems heightened by increasing insulation and resulting decreased ventilation. Similarly, more recent estimates that approximately 70% of the American people will live within 50 miles of a coastal area by the year 2000 strengthen the urgency for protecting estuarine and marine ecosystems. Other examples of trends which can be studied are the significance of superconductors, climate change and urban population changes. Some aspects of such an effort were included in a l 280 ORD report entitled "Environmental Outlook 1980" (EPA-600/8-80-0003, July 1980). Potentially useful procedures of identifying the environmental impact of trends in energy supply/demand, demographics, human activities, economics, regulations, natural –21 – cycles, international activities, and technology are described. However, the thrust of the report was not on identification of new risks or rapidly escalating risks; rather, the report was directed at determining the effects of such trends on existing efforts to assess and control known risks. In order to make this risk-identification effort successful at a reasonable cost, greater emphasis needs to be on the identification of new, emerging, and rapidly escalating stressors/risks. 3. 2. 2.3 Literature Reviews and Expert Workshops Selected literature should be monitored with the aim of searching for signals of new stressors. Also, workshops should be held at least annually to solicit the thinking of outside experts on potentially significant environmental problems. Possible mechanisms include utilizing units of the National Academy of Sciences, the National Academy of Engineering, the Office of Technology Assessment, professional societies or other Federal agencies to host or co-sponsor such workshops. Working with EPA, these and other institutions; e.g., NIEHS, can organize leading scientists, engineers, sociologists, economists, and others to identify potential and emerging ecological and health Stresses. 3.3 : Implementation by EPA Essential to the development and success of an early warning system is the formation of a, group of people within EPA that includes, at a minimum, staff drawn from the Office of Research and Development and the Office of Policy, Planning and Evaluation. The group would prepare analyses and studies of potential problems, draw upon other Agency expertise, as appropriate, and fund certain outside studies in the data source areas cited above. These people should be experienced individuals who can discern the implications of existing and new information and be able to assess its importance. Inclusion of Visiting scientists from academia, industry or private groups would assist this effort by adding external inputs to the Agency. Each year this group would prepare an annual report to the Administrator, Deputy Administrator and Assistant Administrators of new, emerging, and/or escalating health and environmental problems. The Assistant Administrator for ORD would develop a mechanism to ensure that the conclusions and recommendations of this group receive formal consideration in the research planning process. –22– 4.0 Recommendations 4. 1 Recommendation I: Emphasis on STF Models EPA should maintain its research on sources, transport and fate (STF) model development, evaluation and validation, and continue improving its methods for reducing uncertainty in risk assessment. To implement this recommendation, EPA should take the following actions: a. Continue to formalize the mechanism and criteria for acceptability of STF models for all media, using methods such as the current procedures of the Office of Air Quality Planning and Standards (OAQPS). b. Evaluate and validate on a priority schedule widely used STF models (single medium or multi-media), using a combination of field measurements and laboratory data to determine the level of uncertainties predicted by the models and to provide guidelines for reducing these uncertainties. c. Continue research on media processes to ensure the quality of model input data in order to improve the detection and prediction of chemical transport and transformation in environmental media. - d. Adopt a systematic review schedule for STF model progress, including target milestones to achieve reduction in predicting uncertainties. These four actions will facilitate the preparation of an orderly and focused Agencywide effort to advance the development and use of STF models in risk analysis. - Currently there exists a profusion of numerical codes that are exposure estimators. However, in general, they are not validated or tested, nor have they been ascribed specific quantitative uncertainties. The methods adopted by OAQPS serve as a useful Agency! guide for placing a more uniform certification process on these types of models for regulatory analysis. Validated models are essential for this use so that public confidence in the reliability of risk assessment results can be increased. To achieve the goal of systematic and continued improvement of STF models, research funds should be provided to improve model input data for source emissions, fluid flow estimation, and physicochemical rate parameters. Improvements in these components need to be assimilated progressively into models to ensure that the models reflect the current state of knowledge. Comparisons between older and newer models should also be attempted a regular basis to evaluate progress in reducing uncertainty. These comparisons should also be incorporated into a systematic review process to update the STF models recommended for regulatory applications. - –23– 4.2 Recommendation II : Leadership by Risk Assessment Council EPA's Risk Assessment Council (Council) should ensure that STF research is integrated into EPA's approach to exposure assessment. Specifically, the Council should : a . Initiate the development of Agency wide guidelines for STF model performance criteria and their acceptability, following methods adopted by OAQPS. b. Endorse and promote the coordination and use of interagency STF research as part of an effective research strategy for EPA. 4.3 Recommendation III: Establishment of an Early Warning Group EPA should establish a formal and continuing group of senior scientists and engineers who would be drawn from the Office of Research and Development, the Office of Policy, Planning and Evaluation, and extra-Agency groups. These individuals, representing a number of disciplines, would be charged with identifying potential, emerging, and/or escalating public health and environmental problems. Such a group would, at a minimum, perform the following functions: - a. Survey early warning data sources which can be found from modest refinements to existing chemical, biological and physical data monitoring systems. Such refinements lead to feed forward monitoring, which can determine when new, unregulated or unselected compounds enter a system or when shifts in the distribution of chemicals in the environment occur. Methods for for analyzing such data should be developed. b. Identify potential human health and environmental risks that are currently not classified as major EPA priorities. The process for identifying such risks should include an examination of social, economic and technological changes that can create new risks, use of existing models and measurement data, and sponsorship of periodic expert workshops to survey expert judgment on trends and risks. c. Prepare an annual report of potential new problems to be submitted to the Administrator, Deputy Administrator, and the Assistant Administrators. The Assistant Assistant for ORD should ensure that this report is formally considered in each year's research planning process. –24– 4.2 Recommendation II : Leadership by Risk Assessment Council EPA's Risk Assessment Council (Council) should ensure that STF research is integrated into EPA's approach to exposure assessment. Specifically, the Council should : a. Initiate the development of Agency wide guidelines for STF model performance criteria and their acceptability, following methods adopted by OAQPS. b. Endorse and promote the coordination and use of interagency STF research as part of an effective research strategy for EPA. 4.3 Recommendation III: Establishment of an Early Warning Group EPA should establish a formal and continuing group of senior scientists and engineers who would be drawn from the Office of Research and Development, the Office of Policy, Planning and Evaluation, and extra-Agency groups. These individuals, representing a number of disciplines, would be charged with identifying potential, emerging, and/or escalating public health and environmental problems. Such a group would, at a minimum, perform the following functions: - a. Survey early warning data sources which can be found from modest refinements to existing chemical, biological and physical data monitoring systems. Such refinements lead to feed forward monitoring, which can determine when new, unregulated or unselected compounds enter a system or when shifts in the distribution of chemicals in the environment occur. Methods for for analyzing such data should be developed. b. Identify potential human health and environmental risks that are currently not classified as major EPA priorities. The process for identifying such risks should include an examination of social, economic and technological changes that can create new risks, use of existing models and measurement data, and sponsorship of periodic expert workshops to survey expert judgment on trends and risks. - c. Prepare an annual report of potential new problems to be submitted to the Administrator, Deputy Administrator, and the Assistant Administrators. The Assistant Assistant for ORD should ensure that this report is formally considered in each year's research planning process. - –24- United States Office of the Administrator SAB-EC-88–040B Environmental Protection Science Advisory Board September 1988 Agency Washington DC 20460 Final Report &EPA Appendix B. PUBLIC Strategies for Exposure HEALTH |. Assessment Research .E. à 1488 v.3 Report of the Exposure Assessment Subcommittee Research Strategies Committee NOTICE This report has been written as a part of the activities of the Science Advisory Board, a public advisory group providing extramural scientific information and advice to the Administrator and other officials of the Environmental Protection Agency. The Board is structured to provide a balanced, expert assessment of scientific matters related to problems facing the Agency. This report has not been reviewed for approval by the Agency; hence, the contents of this report do not necessarily represent the views and policies of the Environmental Protection Agency or of other Federal agencies. Any mention of trade names or commercial products do not constitute endorsement or recommendation for use . l. 0 2.0 3. O 4. 6. 7. O O O TABLE OF CONTENTS EXECUTIVE SUMMARY . . . l. 1 Overview l. 2 Recommendations INTRODUCTION O O © © O • T Overview and Examples Definition of Exposure Goal Statement i : RATIONALE FOR EXPOSURE ASSESSMENT APPROACHES TO HUMAN EXPOSURE ASSESSMENT 4. l Overview 4 - 2 Methodologies Modeling Biomarkers 4. 3 Intermedia Concerns ELEMENTS OF EXPOSURE © O *g © O O O © © O © O © O O Q • 1 Overview • 2 Components 2^ 5. 2. 5. 2. 5. 2. ; Averaging Times 5. 2.4 EXAMPLES OF EXPOSURE ASSESSMENT RESEARCH NEEDS Pesticides i BIOMARKERS OF EXPOSUIRE Personal Monitoring Time-Activity Patterns Volatile Organic Compounds Time Activity Patterns and Behavior Factors Exposure Assessment - General Acidic Aerosols and Gases Exposures to Biological Aerosols Environmental Tobacco Smoke Categories of Exposure Determinations and their Limitations Selection of Representative Samples Defining Sample Sizes Sampling, Monitoring Methods, and lO l O lO ll ll ll l2 l2 l2 l2 l3 l3 l4 8 . O l6 STRATEGIES . . . . . . . . . . . . . . . 9 ... O 8 8.2 : • 1 i Assessing Environmental Exposure : i i Interfaces Accountability Long Term Commitment Other Federal Research Educational Training Exposure Assessment Planning : : i Research in Exposure Assessment Coordination and Technical Support Development of Agency-wide Program Outreach MONITORING AND RISK ASSESSMENT . . . . . Importance l6 l6 l6 l? l? l? l8 l3 l8 l 3 l.9 l9 l9 Tools What Can be Done Now Research Needs l9 2O 2 O U. S. ENVIRONMENTAL PROTECTION AGENCY SCIENCE ADVISORY BOARD RESEARCH STRATEGIES COMMITTEE Exposure Assessment subcommittee Chairman Dr. Bernard Goldstein, Chairman, Department of Environmental and community Medicine, UMDNJ-Robert Wood Johnson Medical School, Piscataway, New Jersey Members Dr. Rolf Hartung, School of Public Health, University of Michigan, Ann Arbor, Michigan Dr. Brian Leaderer, Pierce Laboratory, Yale University, New Haven, Connecticut Dr. Morton Lippmann, Institute of Environmental Medicine, New York University, Tuxedo, New York Dr. Donald O'Connor, Civil Engineering, Manhattan College, Mahwah, New Jersey Dr. Jack Spengler, Harvard University, Boston, Massachusetts Invited EPA Participants Dr. Michael Callahan, Exposure Assessment Group, Office of Research and Development, U. S. EPA, Washington, DC Dr. Wayne Ott, Air and Toxic Radiations Monitoring Research Staff, Office of Research and Development, U. S. EPA, Washington, DC Science Advisory Board Staff Mr. A. Robert Flaak, Environmental Scientist and Executive Secretary, Science Advisory Board (A-l.0 l F), U. S. Environmental Protection Agency, Washington, DC 20460 Ms. Carolyn Osborne, Staff Secretary, Science Advisory Board (A-lClF), U. S. Environmental Protection Agency, Washington, DC 2 O 4 6 O l. O EXECUTIVE SUMMARY l. 1 overview Reducing uncertainty in environmental risk assessments is a major problem facing the U. S. Environmental Protection Agency (EPA). A critical factor in understanding those risks is the amount of available information concerning the number of people exposed to environmental pollutants and at what doses. Although there are efforts underway within EPA to develop such information, a clearly defined research strategy is required to focus the scarce resources available to the Agency. Strategies for assessing environmental exposures should be based on the need for exposure characterizations in quantitative risk assessment. Such a strategic approach is essential for EPA to effectively carry out its risk assessment functions. At a minimum, the overall strategy should address: interfaces between the three principal methods of exposure assessment (personal monitoring, modeling, and biomarkers) ; accountability of specific research efforts to overall needs; long-term research commitment; closer ties with other Federal agencies doing similar research; and educational efforts. In this report, we identify examples of research needed to support a strategic research effort in exposure assessment. These include research on acidic aerosols and gases, , biological aerosols, environmental tobacco smoke (ETS), pesticides, volatile organic compounds (VOC), and time-activity patterns and behavior. We also identify the development of biological markers as a promising form of research into determining human exposure. 2 l. 2 Recommendations The following recommendations represent the most critical issues that we believe the EPA should consider in developing its research strategy for exposure assessment. l. 2 - 1 Establishment of an Agency-wide research program to provide a basis for improved capabilities for quantitative exposure assessment. Research needs which should be addressed include: a) development of sampling and analytical instruments and techniques, b) exposure models and their validation, c) selection criteria for human populations and other target species for exposure evaluations, d) protocols for quality assurance of exposure data, and f) systems for exposure data management and access to data banks. l. 2 - 2 Development of methods to optimize and facilitate utilization of indirect indices of exposure, such as environmental monitoring data (e.g., ambient air, drinking water) and effects data (e.g., biomarkers, impacts on ecosystems). l. 2. 3 Establishment of methods to derive the uncertainties of exposure estimates based on both direct and indirect indices. l. 2 .. 4 Use of the concept of total exposure, recognizing all exposure pathways. Therefore, research should incorporate three principal methods of exposure assessment - personal monitoring, modeling, and biomarkers. l. 2 .. 5 Utilization and development of resources in the academic community to facilitate technical innovation and more universal application of developments in exposure technology. l. 2.6 Establishment of a data management resource on exposure data and encouragement of contributions and utilization by program offices, other governmental agencies, the academic community, and other interested groups. l. 2. 7 An increased commitment to extramural research including targeted requests for proposals to increase efficiency, and greater use of the EPA Centers of Excellence program, providing greater support to those Centers which assist the Agency in achieving the goals laid out in its Research Strategy. 2 . O INTRODUCTION 2 - 1 Overview and Examples The development of a strategy for research on exposure assessment requires the definition of goals, a recognition of constraints, and the examination of options for achieving the goals. The choice of options should allow for contingency plans which would permit adjustments in the strategy as conditions change. A good example of a long term research effort with significant payoff for EPA is the . Total Exposure Assessment Methodology (TEAM) study. The success of this study has been dependent upon basic approaches to: a) analytic methodology capable of measuring relatively minute levels of air pollutants, b) technical developments leading to personal samplers, c) fundamental improvements in sampling strategy related to assessing individual and community exposures, and d) the recognition that EPA's focus should be on an individual's total exposure to environmental health hazards. Successful TEAM products could have been achieved far earlier by EPA scientists if there was a recognition of the importance of long term funding in this area by other EPA offices and by the office of Management and Budget (OMB). The relevance of TEAM study findings includes the ability to measure actual human exposure to volatile organic compounds and to assess the relative importance of indoor vs. outdoor exposures; including the recognition that for most toxic air pollutants the home is the major source of exposure. It has provided techniques permitting EPA and state agencies to be responsive to questions concerning extent of exposures in local communities. Much more support of long-term studies of this nature is necessary. Another example of successful long term research in the development and effective use of tools for exposure assessment, is the study of lead exposure. This has increased understanding of the multiple routes of entry of a single source. EPA in essence has conducted a natural experiment by lowering airborne lead through markedly decreasing allowable gasoline lead content. This has produced a clearcut decrease in lead inhaled directly from automobile exhaust. The larger part of the reduction in body burden was due to a reduction in lead in automobile exhaust which settles as dust on the ground where it can be eaten by children who lick their fingers, where it can be stirred up by human activities and inhaled, and where it can enter the food. chain through deposition on edible foliage, and through soil from which it is taken up by growing plants. - Finally, we note the recent completion by EPA staff of the draft of an extensive Strategic Plan for Research on Total Human Exposure to Environmental. Pollution. While the document is misnamed in that it is really not focused on the strategic level, it contains a good road map which lays out important options for the approach to short term and long term research needs and can profitably serve as a blueprint for agency actions. We understand that a revised draft of the strategic plan is under preparation. Although these are good examples of relevant long-term research efforts, there have been many opportunities missed because of the relative paucity of long-term research in the area of exposure, an area which is so central to EPA's mission. The Agency has a need to develop a clearly focused centralized program of long term research aimed at improving exposure assessment. In part because of the relative lack of past efforts, and in part because of the many exciting new advances in basic science pertinent to improved exposure assessment, we are highly confident that a long term research program of this nature will lead to major advances of great value to EPA's regulatory decision making. 2.2 Definition of "Exposure" The term "exposure" is often used without clear definition. For the purposes of this strategy statement, exposure is defined as the environmental concentration of a substance in immediate contact with an organism. Exposure is not synonymous with "absorbed dose". To convert exposure measurements into absorbed dose could require additional information on bioavailability, uptake, and the efficiency of absorption. 2. 3 Goal Statement The Agency's goal for research in exposure assessment should be to develop a system which will provide the most accurate determinations of exposure possible for any given set of constraints. Central to all aspects of research into exposure is the definition and reduction of uncertainties of the determination arising from the assumptions in the conceptual framework for making the determinations. 2.4 Categories of Exposure Determinations and Their Exposure determinations are made up of qualitative and quantitative components, as described in more detail below. The exact methods selected have a significant impact on the list of chemicals which will be included and excluded from analysis. The Agency needs to develop an assessment system which differentiates between the inital reconnaissance stage, where qualitative analyses should receive emphasis, and the definitive stage where quantitative analyses should receive primary attention. Determinations of exposure may be made by measurements, by reconstruction, or by the use of mathematical models. The uncertainties associated with each of these approaches can differ greatly, and in many instances they have not been appropriately defined. Measurements taken in the immediate proximity of an exposed organism are subject to the variabilities of local concentrations, as well as errors introduced as part of measurement techniques. When measurements are no longer made in the immediate proximity of the organism, then additional uncertainty accrues. Thus, the concentrations measured at an ambient air monitoring station may have only a remote connection with actual human inhalation exposures, which are mostly due to indoor air. Similarly, concentrations of contaminants at the municipal potable water plant may be poor predictors of actual exposures from ingested liquids. A further complication is that contamination of one medium can lead to exposure through another medium ; thus, contamination of potable water by volatile compounds can lead to inhalation exposures. Exposures may be inferred on the basis of observed retention or effects in humans, using concentrations of substances or their metabolites in body fluids or tissues, or using other biological markers. These approaches directly estimate absorbed dose, rather than exposure. In addition, they are often unable to distinguish between shorter exposures at higher concentrations and longer exposures at lower concentrations. Exposures may be reconstructed by duplicating chemical releases and measuring the resulting concentrations, or by modeling their transport and fate from source to receptor. Lastly, exposures may be derived from transport and fate models which stipulate. source terms, environmental conditions and the location of the receptor organism. Source terms may be based upon measurements or may be assumed. Both the costs and the uncertainties associated with these various exposure determinations can greatly differ. Important constraints for exposure assessment include: available resources, area and duration of exposure assessment, exposure assessment methods applicable to a specific problem, uncertainties associated with a specific approach, and the precision and accuracy requirements of the user of the exposure assessments. These constraints impose opposing forces on the selection of specific protocols for exposure assessments. For instance, under certain conditions the available resources may allow only the application of a very simple mathematical model, with a resulting uncertainty which would make the exposure assessment valueless for a subsequent risk assessment. 3.0 RATIONALE FOR EXPOSURE AssessMENT Exposure assessments are integral requirements for risk assessment, they are required to identify populations and ecosystems at risk, and they are necessary to determine compliance with certain standards. They are also important components in the development of regulatory strategies. The accuracy and precision of the exposure assessments obviously has a major influence on the reliability of decisions which depend upon such exiosure assessments. During his second tenure as Administrator (1983 - 1985), Mr. Ruckelshaus promoted the use of uniform, agency-wide risk assessment procedures in the exercise of its regulatory responsibilities. This approach has been highly successful in some areas, but much less so in others. It has frequently been limited by the lack of reliable information on exposure to targets and receptors, i.e., to people, vegetation, fish, etc. Experience has demonstrated that exposure assessment techniques are at a relatively less advanced state than are techniques for toxicity assessment, and that a sustained research program will be needed to facilitate and encourage their use in the EPA's risk assessment program. A long-term commitment to research in this area will have immediate as well as long-term benefits to EPA. This is based upon our belief that much of the exposure technology that has already been developed has not been utilized by EPA, but could be after review and evaluation. In the longer term, newer techniques and approaches can be developed, validated, and applied. * - 4. 0 APPROACHES TO HUMAN EXPOSURE ASSESSMENT 4.1 overview Exposures to a variety of environmental contaminants have been shown to be associated with adverse health and comfort responses in humans. Assessing human exposures to a single environmental contaminant or group of contaminants is necessary in utilizing a risk-based environmental management approach directed toward determining the cause (s) of human health risks and formulating cost effective mitigation efforts to reduce or minimize those risks. Efforts to assess total human exposure to environmental contaminants, and to develop effective measures to reduce those exposures need to be guided by a theoretical framework or methodology., Central to the design of a human exposure assessment effort is the identification of the health or comfort effect under study, the ascertainment of the individual contaminant or general category of contaminants thought to be associated with that effect, and specification of the contaminant exposure on a time scale corresponding to the effect. The impact of exposure to environmental contaminants should, , ideally, be evaluated in terms of the dose of the contaminant or its metabolites received. Dose can be considered as the internal dose (amount of the contaminant deposited or absorbed by the body) or biologically effective dose (amount of the contaminant deposited or absorbed which contributes to the dose at the cells where the effect occurs). The use of dose (particularly the biologically effective dose) in assessing the impact of exposure to environmental contaminant (s) is, however, often not practical since it can seldom be measured directly. Exposure is generally the only direct link available to the effect ºf interest. In fact, for regulatory and control strategies the relationship between exposure and concentration in air, water, soil, and food is of primary interest. 4. 2 Methodologies Assessment of total human exposures to environmental contaminant (s) must consider concentrations that occur in one or more of the possible media of exposure (air, water, food and soil), or through rates of uptake via routes of exposure such as skin, ingestion, or inhalation. This approach is much broader than the traditional EPA approach which considers exposures from only one route of exposure and typically from only one microenvironment within that media (e. g. air exposures with specific focus on ambient air). Human exposures across all environmental media can be assessed by three complementary methods: personal monitoring, exposure modeling, and biological markers. 4.2.1 Personal Monitoring Personal monitoring provides a direct measure of total human exposure to environmental contaminant (s) of interest. This approach involves the direct measurement of the pollutant concentrations reaching the individual or population through all media (air, water, food, and soil) integrated over some time period. The emphasis in this approach is to directly measure total exposure at the target to contaminant (s) emitted from multiple sources and traveling along multiple routes of exposure. Personal exposures are monitored over the course of normal activity for appropriate periods of time ranging from several hours to several days. Integration over inappropriate times can obscure toxicologically significant excursions in exposure. 4.2.2 Modeling This approach conceptually combines monitoring of contaminants in the media they occur, activity time budgets or food or water consumption patterns and questionnaries to estimate (model) the average exposure of an individual or population as the sum of the levels of contaminant (s) in each media weighted by time in an environment or quantity of food or water consumed. When personal monitoring or media concentrations are not available or possible, it may be necessary to model personal exposure from statistical and/or physical models based on sources, transport and transformation of constituents. However, models are based on mathematical representations of physical and chemical processes. The more complex the system, the greater the uncertainty of the results of the predicted exposures. w Questionnaires provide information on the media in which the exposure takes place (e.g. physical properties of indoor environment - sources, source use, ventilation, etc.) as an input to the predictive model. The development of a predictive exposure model attempts to measure and understand the basic .. relationships between causative variables and resulting exposures. Such models, once validated, can then be used to estimate population exposures of a wide range of potential mitigation efforts to reduce or minimize exposures. It is the modeling which provides the essential link between the exposures, the microenvironments or media in which the exposures take place, and the factors which determine the contaminant levels in the media and micro- environments. Environmental contaminant levels are the result of a complex interaction of several interrelated variables in each medium (e.g. air pollutant concentrations are a function of sources, source use, meteorology, chemical reaction processes in air, etc.). It is essential that exposure models incorporate data on the factor controlling the exposures, so that cost efficient and effective mitigation (risk reduction) can be instituted. 4. 2. 3 Biomarkers The term "biomarker" includes a large array of measurable molecular constituents in humans. Such markers include residues of chemicals and their metabolites in body tissues and fluids, products of molecular changes such as DNA adducts and chromosome aberrations, changes in levels of endogenously produced molecules, and genetically determined biochemical susceptibilities that vary among individuals. Such markers can be used as indices of exposure, current disease state or susceptibility to disease. Biomarkers of exposure can theoretically integrate total intake to the body from multiple sources of exposure to environmental contaminants. If they are stable over time they can be used to indicate levels of steady-state exposure. They can be useful tools in elucidating mechansims of disease, or for extrapolations between internal doses, routes of exposure, species or tissues. They do not, however, necessarily provide the direct link between environmental exposure and disease. Biomarkers may be measures of the contaminant or its metabolites that are directly related to the specific contaminant associated with the effect outcome (e.g. lead) or may only be a surrogate for exposure to a complex source of environmental contaminants (e. g. cotinine). The sole use of biomarkers to assess exposure to environmental contaminants, like the sole use of personal monitoring, can provide only limited guidance in the selection of effective mitigation measures to reduce exposures since biomarkers do not provide information on the factors controlling exposure to the contaminant (s) in the physical environment. t e It is important that the Agency develop a system that can effectively respond to information needs for risk based decision making. One part of such a general system would be a sub-system concerned with exposure determinations. Research problems in exposure determinations are strongly linked to scientific problems in transport and fate, and research on effects and risk assessments. Important linkages also extend to areas such as pollution control research. These linkages result in an interdependence, so that decisions made in one area can have strong effects on other areas. Deal ing with these complex relationships, as well as the constraints mentioned previously, requires a systems approach in which exposure assessment is one aspect of the entire environmental assessment and management structure. Within the area of exposure assessment, it is important to develop an optimization among resources, uncertainties, and utilities. 4. 3 Intermedia Concerns An obvious and well-documented problem in EPA's approach to environmental pollutants is the strong tendency toward looking at a pollutant in one medium only. Sometimes this has led to regulatory approaches which control a pollutant in one medium by releasing it into another. The physicochemical characteristics of the overwhelming majority of common pollutants permit them to distribute in all media — air, water, soil and food. Work done at an EPA research center readily allows the prediction that leaky underground storage tanks leading to groundwater pollution may result in greater human exposure by inhalation due to offgassing from water than by contamination of drinking water. Any attempt to ascertain the potential impact of an environmental chemical should include assessment of the extent of exposure in all relevant media. This supports development of a centralized integrated approach to exposure which can consider long term needs in exposure assessment. 5. O ELEMENTS OF EXPOSURE 5. l Overview The studies of human exposure provide information that can fill a basic need in risk assessment and risk management. These studies can identify: - a) relative importance of different exposure pathways. b) quantify sources and or activities that contribute to exposures - c) identify populations at differential risk This information is essential to the design of public health and cost effective strategies. For instance, the risk may be unequally distributed across the population due to the influence of specific sources or activity patterns. A mitigation strategy aimed at a nation-wide reduction of emissions may be ineffective. for the highest risk groups. 5. 2 Components In order that exposure studies be useful to future decisions, some basic components must be adequately addressed. These components will determine not only the general ability of results but the specificity of possible subsequent actions. Included in these elements are: a) Selection of representative sample, b) Defining sample size, c) Sampling, monitoring methods, and averaging times, and d) Defining time-activity patterns. Obviously these items are interrelated. The percent of people conforming to the specifications of the sampling protocol is in part dependent on the details and complexity of the studies. 5. 2. 1 Selection of Representative Sample There are well established methodologies for survey research. The Agency has used proven survey techniques in the VOC and carbon monoxide (CO) exposure studies. However, the participation rate in exposure monitoring studies has been only approximately 50%. The issues of selection bias must be addressed in future studies. Experience indicates that both upper and lower economic groups are less likely to participate. Studies do not have to be designed to represent the entire U.S. or urban population, but should include a suitable representation from a broad representative cross section of the population. Depending on the contaminant and distribution of sources, target groups may be selected. Nevertheless, even these exposure studies should use established survey research methodologies. At this time, the difficulty with sample selection is the lack of knowledge about the distribution and use of contaminant sources. Without some prior knowledge, investigators must speculate on how to over-sample low frequency categories. Therefore, a variety of survey studies will be necessary. 5.2. 2 Defining Sample sizes Determination of the number of participants in an exposure study is a critical component. Representativeness and cost are obvious tradeoffs. Microenvironmental models are useful in determining sample size by calculating the uncertainty in representing exposures in the mean as well as percentiles. Microenvironmental exposure and dose models must be developed and tested. In some cases, targeted studies might be needed to develop the input conditions. Statistical methodologies should be improved in the current microenvironmental models. For some contaminants, the concentrations co-vary with activities and for source use. Air pollution dose will vary with activity level and anatomical structure of the respiratory tract. among other factors. These relationships must be better understood to advance microenvironmental models. 5. 2. 3 sampling. Monitoring Methods, and Averaging Times Conducting human exposure studies will require the development of new equipment and methods. Currently, information or actual human exposures is limited, in part, because appropriate equipment and methods do not exist for many contaminants. The exposure times of interest can vary from a single breath to multi-year averages. It is not practical to develop instruments and methods to cover all averaging times and still have them inexpensive, light-weight and durable for personal monitoring studies. However, EPA's engineers and chemists should interact more closely with health scientists lO to define instrument needs with the appropriate time resolution. This does not imply that exposures studies could not continue. A combination of personal measurements with portable equipment and fixed location microenvironmental measurements can provide needed exposure data. 5.2.4 time-Activity Easterns our population is very mobile. More is known about the movements of working adults than of other groups. The time-activity patterns of youth, retired individuals or people in general during different seasons, climates, and weather conditions are not well described. The interactions or co-location of people and pollution sources also are not adequately known. These are more than subtleties. Knowing the indoor/outdoor concentration of pollutants such as ozone and acid particles, and knowing the outdoor time patterns of people with their activity levels allows the calculation of exposure and possible dose on time scales consistent with clinical studies. For some physiological responses, exposures with time frames of minutes to hours are more relevant than either our current standards or long-term averages. In general, human exposure studies need more carefully defined averaging times. Studies of indoor, outdoor, and personal exposures can be misleading if careful attention to averaging times are not considered. It may be true that indoor concentrations are highly correlated to personal exposures when considering 24-hour or longer integrations. However, short-term concentrations may be more relevant to a particular physiologic effect. Formaldehyde in homes illustrate a similar point. A combination of increased emissions (because of thermal heating) and decreased ventilation may result in transient sensory irritation and odor. Averaging formaldehyde over 24-hour or a week with the current survey instruments may indicate low average concentrations, which may suggest that problem concentrations do not exist. Time variation in indoor radon concentrations presents a similar monitoring problem. Short-term charcoal grab samples may misclassify a home where the longer term integration would be more appropriate. 6. O EXAMPLES OF EXPOSURE ASSESSMENT RESEARCH NEEDS 6. l Exposure Assessment - General - a) Develop better understanding of time use patterns in our society, how people spend time indoors and outdoors, and activity levels associated with microenvironments. b) Develop better understanding of ingestion of food, water, and soils by segments of society. ll c) Population exposure studies, e. g., for criteria pollutants, drinking water, pesticides, to determine relationships among control strategies and public health benefits, and to develop new exposure reduction strategies. d) Where sources are indoors - understand patterns of use, repair, maintenance and how these factors affect exposures. 6.2 Acidic Aerosols and Gases The primary means of exposure to acid aerosols and gases is through inhalation of their concentrations in the ambient air. Although research has been conducted in this area, information on the following is not well known: a) Distributions of Hydrogen ion (H+) concentrations across the United States in aerosols and vapors. b) Deposition velocities. c) Importance of facial and nasal deposition to sensory irritation. 6. 3 Exposures to Biological Aerosols Evidence indicates that inhalation of aero allergens, and aeropathogens may be important contributors to respiratory symptoms and illnesses. Investigations might lead to: a) Quantifying relationships among questionnaires and actual indoor concentrations of spores and other antigenic materials. b) Khowledge about the variations in species and concentrations within homes, offices, etc. and between structures. 6.4 Environmental Tobacco smoke (ETs) Evidence indicates that exposures to ETS may lead to increased respiratory symptoms in children, decreased lung performance and perhaps lung cancer in adults. Nevertheless, there are still many unresolved exposure issues. a) Distribution of population ETS exposures is not known. It would be worth while identifying high exposure group in addition to characterizing factors influencing exposures. b) Relationship between ETS environmental concentrations and the deposited dose is important. The lung retention in children as a function of age and activity would be important. 6 - 5 Pesticides Pesticides are widely used in commercial buildings and residences. Yet, the exposure to people in these settings by l2 inhalation, contact or ingestion is not well characterized. 6. 6 volatile organic compounds (voc) Investigations of VOC's, particularly EPA's TEAM studies, have revealed that for many compounds, exposure is dominated by the indoor air contribution. a) Repeat measures are needed to determine within-structure variation. b) The influence of source use on personal exposure needs to be determined for many VOC's. c) Transportation among other microenvironments needs to be studied. d) Compounds studied must be expanded to include irritants, immuno-toxic and neurotoxic materials. 6 - 7 Time-Activity Patterns and Behavior Factors Extrapolating from a relatively few time-activity studies the average employed person spends their time in the following manner: 28% at work, 63% at home, 6% in transit, lik in other indoor locations and only 2% outdoors. For women not working out of the home, the total indoor time is 94.1% with 4.2% in transit and only l. 7% outdoors. Obviously on any given day, individuals will deviate substantially from these average numbers. However, there are substantial gaps in understanding the time-activity patterns in our society. - - Knowing these patterns and the potential exposures to sources and/or harmful substances would benefit environmental management and policy decision. Time-activity surveys should be designed to resolve behavioral patterns relevant to discerning human exposures to environmental contaminants. Factors that should be considered include: a) Cross-section of population by age, sex, income, job classification b) Ethnic differences c) Regional differences by season d) Temporal differences by weather conditions e) Level of activity (metabolism, minute ventilation) f) Physical condition g) Intra-regional differences by degree of urbanization l3 7. O BIOMARKERS OF EXPOSURE Biological markers of exposure and/or effects are one of the most promising avenues of research. A National Academy of Sciences (NAS) Committee is in the process of evaluating the use of biological markers in environmental health research. They have defined biological markers as indicators of variation in cellular or biochemical components or processes, structure, or function that are measurable in biological systems or samples. Markers can be divided into those reflecting exposure, effect, or susceptibility. There is a continuum between exposure and effect extending to overt human disease. The goals of research into biological markers are the prevention and early detection of human disease. Markers of exposure are particularly valuable in reflecting the earliest steps in the process by which environmental agents lead to adverse effects. Perhaps the ideal marker is one which accurately indicates both exposure and effect. A reasonable example is the formation Of carboxyhemoglobin (COHb), which provides an integrated measure of exposure to carbon monoxide ànd is also the mechanism which is responsible for the toxic effect of this gas. A marker of this nature appears to be particularly suitable for what is now being called biochemial epidemiology or molecular epidemiology. In the past, occupational and environmental epidemiological studies have generally used surrogates for exposure, e.g. job description, geographical proximity to superfund site. Marked improvement in the precision and effectiveness of epidemiological studies can be obtained through the use of molecular markers of . exposure in conjunction with outcome variables, if there is a well defined association between actual exposure and the biological marker. The availability and development of biological markers stems in part from rapid advances in our understanding of biological processes, particularly in the exciting field of molecular biology. Such techniques as the use of monoclonal antibodies, recombinant DNA technology or Potassium-32 post-labelling to detect DNA or prote in adducts open whole new approaches to biological markers for exposure and effect. These new developments appear to promise the ability to determine the extent of exposure of individuals to relatively low levels of environmental chemicals. For example, it would not be surprising to find through the use of sensitive biomarkers of exposure that the bulk of a population living in the vicinity of a hazardous waste site has no more evidence of exposure to chemicals at that site than does a control population; yet a few individuals, through their activities at the site, or an unexpected exposure route, will be found to have markedly elevated exposure. Of particular importance will be studies to validate any markers used in human studies. Furthermore, ethical issues raised by the use of biological markers of exposure must be care fully addressed. - The importance to EPA of improvements in biomarkers of exposure is evident. EPA has invested heavily in the process of risk l4 assessment as a tool for environmental decisionmaking and for priority setting within the Agency. While there is much focus on uncertainties on the hazard side of the risk assessment equation, the uncertainties concerning exposure can often be greater. The failure to appropriately perform exposure assessment at EPA has perhaps nowhere been more evident than in the Tacoma smelter situation. In the summer of 1983, EPA was faced with a specific decision concerning instituting control technology on a smelter which produced a substantial burden of arsenic to the local community. The smelter was a major employer with much of the local economy dependent upon its operation. Owners of the smelter claimed that they would close it down if they were forced to spend substantial sums for air pollution control. William Ruckelshaus, who had only recently returned to head EPA, decided in essence to make this situation into a test case for the policy of carefully communicating risks to the community so that the community could discuss these risks intelligently and participate appropriately in the decision process. Risks as high as one in loo were computed for the immediate vicinity of the smelter with lower risks for surrounding communities depending upon their distance and the wind patterns. Unfortunately, the exposures were estimated by a model in which arsenic emissions were based upon the performance of a similar smelter in another state. A wind rose was placed around this point source, with the public assumed to be standing at their front door breathing this arsenic level for 70 years. Not only were ambient measurements not made, no advantage was taken of the fact that urinary arsenic levels are an. excellent indicator of arsenic exposure and body burden. In fact, urinary arsenic, which already had been obtained by local authorities, clearly demonstrated that EPA's exposure assessment had overestimated the local exposure by a factor of about li . In other words, when Administrator Ruckelshaus told local people that their risk was one in loo, an appropriate exposure assessment based upon a biological marker would have led him to clearly state this upperbound risk as being one in l900. - It should be emphasized that the exposure assessment in the Tacoma case was performed by the Program Office, without any input from the Office Of Research and Development (ORD). It reflects an Agency-wide problem in that much exposure assessment is actually performed within the various program offices, using disparate approaches and unvalidated and unpublished models. The SAB has frequently been critical of such efforts, including the exposure assessment which forms a central portion of the Integrated Environmental Management Program (IEMP) of the Office of Policy, Planning and Evaluation. There are numerous long range research opportunities for EPA in the biomarkers area. It is important that as research proceeds rapidly in assessing biomarkers of effect, e.g. the value of DNA adducts in predicting cancer, that concomitantly research is performed to link adducts of interest to exposure. Such lº biomarkers would be of particular value in determining the slope of the lower end of the dose response curve for the effect of chemicals, such as carcinogens, for which epidemiology or standard laboratory animal 'safety assessment studies are inherently inadequate. Obtaining improved biomarkers of exposure is dependent primarily upon long-term relatively basic research providing the mechanistic understanding of the process by which exogenous agents produce adverse effects. 8 . O STRATEGIES 8 . l Assessing Environmental Exposure Strategies for assessing environmental exposures to environmental contaminants should be based, in part, upon the need for exposure characterizatons in quantitative risk assessment. For an agency with as broad a range of mandates, responsibilities, and capabiities as EPA, a strategic approach to exposure assessment is essential for the effective execution of its risk assessment functions. Adoption of such an approach will have the further advantage of improving and unifying program office applications of such assessments. The overall strategy will need to address the following major issues: interfaces, accountability, long-term commitment, other Federally funded research, and education. 8. l. l. Interfaces Efforts to assess exposures to environmental contaminant (s) need to recognize the role of the three principal methods of exposure assessment (personal monitoring, modeling and biomarkers) and incorporate into their study design, where feasible and practical, several of the methods in order to more accurately assess exposure and estimate dose. Such studies need to determine the factors in the physical environment responsible for the environmental concentrations, the multimedia routes of exposure (air, water, etc.) and the number of microenvironments in which exposures take place so that efficient and effective mitigation measures to reduce exposure can be identified and evaluated. Exposure studies should explore the use of nested designs for exposure assessment which utilizes all three methods to a varying degree. Such efforts will require a fundamental change in the EPA's current compartmentalized approach to exposure assessment. 8. l. 2. Accountability Research efforts to develop: a) new or improved monitoring methods; b) physical/chemical models for exposure assessment, and l6 c) biomarkers, should be evaluated within the context of their usefulness in an overall exposure assessment. Existing information on environmental contaminant exposures should be integrated into the process of setting research priorities for all environmental contaminants. Funding decisions should be tied to such a review and evaluation. 3.1.3. Long-term commitment Long term research on instrumentation for characterizing the particle size distribution and the variation of chemical composition with particle size at the University of Minnesota's Particle Technology Laboratory, largely with extramural support from EPA, led to a marked improvement in our understanding of particulate matter source contributions, long-range transport and transformation, human exposure, and the factors influencing atmospheric visibility. The contribution of the atmospheric concentration data base, made possible by the development of this new instrumentation, was a key factor enabling the EPA to develop a new and better index of particulate air pollution which has been incorporated in the 1987 PMlo National Ambient Air Quality Standards (NAAQS) . * Research in biocentration provides another example of valuable returns from a long-term committment. The U. S. EPA developed many of the basic concepts for the prediction of the bioconcentration of important classes of organic compounds by fish. This work contributed significantly, to exposure assessments for consumers of fish. - 8. l. 4 • Other Federally Supported Research Research pertinent to exposure assessment is being performed at or under the auspices of a number of different Federal agencies, ranging from the U. S. Geological Survey to the National Institutes of Health. It is imperative that EPA establish closer communication with these agencies, so that each can assist the others in incorporating state-of-the-art knowledge in exposure assessment. EPA's scientists need to attend national meetings and keep in close contact with scientists who are performing the basic research pertinent to long term improvements in exposure assessment. e 8. l. 5. Educational Training A Research Strategy should consider the establishment of a policy to address the gaps and lack of synthesis in present approaches to various environmental issues. This proposal is directed to the establishment of educational programs and/or re-organization of existing research centers focussed on environmental assessment; both within the Agency and in academia, to integrate the knowledge of specific disciplines. Given the multiple-faceted nature of problems in all phases of l? the environment (air, water and land) and the multiple effects on both humans and the ecology, and the relatively specialized character of academic programs in health, science and engineering, we recommend that EPA sponsor an academic Center of Excellence (Research Centers Program) to serve as a focus for both research and academic training in exposure assessment. This would provide an ideal setting for multidisciplinary input from various departments and schools within one or more Universities. 8.2 Exposure Assessment Planning Strategic planning for exposure assessment will occur only when agency staff with appropriate skills are provided with clearly stated responsibilities and budgets commensurate with the agency's needs. Considering the breadth and diversity of these needs, and the relatively primitive state of the art, the program should be located within the Office of Research and Development and should include the following major components: research, coordination and technical support, development of an Agency-wide program, and an outreach program. 8. 2. l. Research in Exposure Assessment l A laboratory based program is needed to investigate and develop: a) equipment and techniques for sampling and analysis of environmental toxicants, b) models for environmental transport and transformation of ..chemicals, and procedures for periodic model validation, c) selection criteria for human populations and other target species in the environment whose exposures may need to be defined, d) models for determining total exposure of populations to environmental concentrations, e) protocols for quality assurance of data from environmental measurements and models, and f) systems for data management and its accessability to agency staff. 8.2.2. Coordination and Technical support A headquarters based program is needed to develop exposure assessment skills in ORD, program office, and regional personnel and to provide technical support for the performance of quantitative exposure assessments. 8. 2. 3. Development of Agency-wide Program A headquarters based program is needed which would: l8 a) identify agency needs in exposure assessment not being addressed, and recommend action, programs to the Administrator, b) identify use of exposure assessment techniques in agency offices, and evaluate them for consistency and reliability, and c) set up, maintain, and promote the utilization of agency- wide data base on exposure. 8. 2.4. Outreach - Cy A headquarters based program is needed to exchange information on exposure assessment techniques with other federal agencies and state and local agencies and groups with interests in exposure assessment. This could include, but should not be limited to sponsorship of symposia and workshops, publication and distribution of a newsletter, and preparation of published Guidelines. 9.0 MONITORING AND RISK AssessMENT 9. l Importance When exposure assessments for risk assessments are needed, they can sometimes be based on available data such as concentrations in ambient air, drinking water, food, etc. Unfortunately, data on concentrations in environmental media relevant to the specific population or target of interest are. seldom available, even for chemicals with established concentration or tolerance limits. In such cases, reliance is placed on less direct and reliable indices of exposure, such as estimates of locations of employment or residence, combined with estimates of inhalted and ingested amounts and patterns of activity. Indirect human exposure data based on tissue burdens of samples collected at autopsy have been of great value to exposure estimation for pesticides, PCBs, and other lipid soluble chemicals. However, the recent decision to terminate the adipose tissue surveillance network will greatly diminish the ability of the Agency to detect trends in population exposure to a variety of toxic chemicals, such as pesticides, dioxins from increasing incineration, and/or new toxic chemicals entering the environment, or to determine the efficacy of the implementation of controls. g 9. 2 Tools The tools of exposure assessment are quite varied. They include personal and portable monitors and samplers, highly sensitive analytical procedures for trace concentrations in air, water, food, excreta, blood, tissue specimens, etc., time-activity and dietary diaries, data on dietary habits, and models to relate such information to total or integrated exposure. 19 9 - 3 What Can Be Done Now For some airborne chemicals there are relatively inexpensive and reliable passive monitors which can be used to determine cumulative exposure (nitrogen dioxide, formaldehyde, radon). Continuous measurements of exposure can be made with larger, more complex, and more expensive personal monitors, such as for carbon monoxide. Battery powered personal samplers can collect integrated samples for a broad Trange of gases, vapors, and aerosols. Personal and other portable samplers can collect air samples in selected micro-environments representative of human occupancy. Market-based survey techniques can be used to collect samples on a statistically reliable basis to determine ingestion exposures to a variety of chemicals. What can be done now is generally limited by the costs of carrying out the studies. Exposure to ecologic systems and other receptors for welfare effects can often be measured by conventional techniques for sampling air, precipitation, surface waters, and sediments, and these samples can be analyzed by conventional techniques for trace analyses. Indirect indices of exposure include pathogenic changes in receptors such as leaves which are characteristic for known exposures. Exposures producing both health and welfare effects which are not readily measured involve short-lived reactive chemicals such as sulfuric acid, nitric acid, hydroxy radicals, and photosensitive organics which may be difficult to collect on sampling substrates, or which react, evaporate, or sublimate between sampling and analysis: - - Indirect measures of exposure, especially analyses of blood (e.g. carboxyhemoglobin, lead) can be excellent indicators of human personal exposure. Biomarkers utilizing new knowledge in molecular biology are beginning to be useful in indicating exposure to mutagens and may become very useful and sensitive indices of exposure. 9. 4 Research Needs { Research is needed on sampling and monitoring techniques for chemically unstable and reactive materials, and for materials lost by volatilization between sample collection and analyses. Research is also needed on time-activity patterns, dietary patterns, and behavioral factors which can strongly modify exposures within human microenvironments. Finally, research is needed on exposure models which can utilize a variety of available data on concentrations within environmental media, time-activity and dietary patterns and yield total exposures to individuals and populations. Further research is also needed to validate such models and to determine their residual uncertainties in quantitative terms. 2O United States Office of the Administrator SAB-EC-38-0.40C Environmental Protection Science Advisory Board September 1933 Agency Washington DC 20460 Final Report &EPA Appendix C. PUBLIC Strategies for Ecological º Effects Research É 1488 v. H Report of the Subcommittee On Ecological Effects Research Strategies Committee NOTICE ; This report has been written as a part of the activities of the Science Advisory Board, a public advisory group providing extramural scientific in formation and advice to the Administrator and other officials of the Environmental Protection Agency. The Board is structured to provide a balanced, expert assessment of scientific matters related to problems facing the Agency. This report has not been reviewed for approval by the Agency; hence, the contents of this report do not necessarily represent the views and policies of the Environmental Protection Agency or of other Federal agencies. Any mention of trade names or commercial products do not constitute endorsement or recommendation for use . U. S. Environmental Protection Agency Science Advisory Board Research strategies Committee * tº-e T - - - - - - - - - - - - - - - - - - E 5 = 2 - - s -- * ~ * * * * * ~ - - - - - - - - - - - * * * ams was ºf s = - - -- ~~ - * = a sºme - * * Chairman e Dr. Stanley Auerbach, Environmental Sciences Division, Oak Ridge National Laboratory, Oak Ridge, Tennessee 3783 l Members Dr. Philippe Bourdeau, Director, Environment and Non-Nuclear Energy Research, Directorate General for Sciance, Research and Development of the Commission of the European Communities, 200 Rue de la Loi, l049 Brussels, Belgium Dr. Dan Goodman, Montana State University, Department of Biology, Louis Hall, Bozeman, Montana 597 l'7 Dr. Rolf Hartung, Professor of Environmental Toxicology, school of Public Health, University of Michigan, Ann Arbor, Michigan 48 l O 9 Dr. Allan Hirsch, Vice President, Health and Environmental Review Division, Dynamac Corporation, lll:40, Rockville Pike, Rockville, Maryland 20.852 Dr. Robert Huggett, Professor of Marine Science, Virginia Institute of Marine Science, College of William and Mary, Gloucester Point, Virginia 23062 Dr. Harold Mooney, Professor of Ecology, Department of Biological Sciences, Stanford University, Stanford, California 94 3 O 5 2 Dr. John Neuhold, Department of Wildlife Sciences, College of Natural Resources, Utah State University, Logan, Utah 84.322 Dr. Scott W. Nixon, Professor of Oceanography, University of Rhode Island, Narragansett, Rhode Island 02882 -ll 97 Dr. Paul G. Risser, vice President for Research, University of New Mexico, Albuquerque, New Mexico 87 l.2 l Dr. William H. Smith, Professor of Forest Biology, School of Forestrº and Environmental Studies, Yale University, 370 Prospect Street, New Haven, Connecticut 0.65 ll Dr. Frieda Taub, Professor, School of Fisheries, University of Washington, Fisheries Center WH-10, Seattle, Washington 93 l 95 Dr. Richard G. Wiegert, Professor of Zoology, Department of Zoology, University of Georgia, Athens, Georgia 30602 ii Invited EPA Participants & º ºr “sº sº. * * *- -, e a • " . , r a snington, D.C. 2 C 4 6 J Dr. David G. Davis, Director, office of Wetlands Protections, office of Water, EPA, 40 l. M Street, S. W., Washington, D. C. 204 60 - science Advisory Board Staff Ms.T.Janis C. Kurtz, Environmental Scientist and Executive secretary, EPA, Science Advisory Board, (AlOl-F), 4 Ol M Street, S. W. , Washington, D. C. 20460 Mrs. Lutithia V. Barbee, Staff Secretary, EPA, Science Advisory Board, (Alol-F), 401 M Street, S. W., Washington, D.C. 20460 2. i * * o * * * * Table of Contents * * * * E sºme /* ºp * sº sº * – tº ~ - &=º - * - -- - --- . gºe - F & - The Role of Ecolcsical Effects Research at EPA . 2 Status of Ecological Effects Research 3 Needs and opportunities for Strategic Ecological Effects Research Assessing risk to ecological systems Defining the status of ecological systems Detecting trends and changes in ecological systems - l. 3. 4 Predicting changes in ecological systems : : ; INTRODUCTION: ECOLOGICAL RESEARCH AND EPA " S MISSION 2. l EPA's Responsibilities in Ecological Assessment and Research 2. 2 Relationship of EPA's Ecological Research Program to those of other Agencies 2. 3 Mission of an Ecological Research Program for EPA 2. 3. l Providing a strong scientific basis for ecological considerations in Agency decision- making 2. 3.2 Moving EPA into a leadership position among agencies with environmental responsibility 2. 3. 3 Developing the organizational and intellectual capabilities that will enable EPA to advance ecological science RISK AssEssMENT As A UNIFYING GoAL FOR F2SEARCH PROGRAM 3. l What is an Ecological Risk Assessment? 2 3. l. l Definition - 3. l. 2 Benefits 3. 2 Shortcomings with Present Approaches to Ecological Risk Assessment 3. 3 Present Approaches to Environmental Risk Assessment 3. 4 Information Needs for Ecological Risk Assessment 3. 4. l. The endpoint problem 3. 4. 2 Ecological dose-response relationships 3.5 Recommendations for Specific Approaches MAJOR RESEARCH AREAS FOR ADDRESSING THE INFORMATION NEEDS 4. l. cosystem Classification and Inventory l. l Ecosystem components and mapping . l. 2 Inventory design l. 3 Recommendations :l 3 4 : l O l O ll l2 l2 l2 l3 . i iv Ecosystem Monitoring ls. 4. 2. l Historical deficiencies 4.2.2 Ecological status assessment 4. 2. 3 Con clºsions and recommendations 4. 3 Predicting Ecosystem Change 4. 3. l. Limitations in predictive ability 4.3.2 Considerations needed for ecosystem effects predictions 4.3.3 Recommendations for advancing predictive capability INSTITUTIONAL CONSIDERATIONS 5. l Organizational Issues 5. l. l Research committees 5. l. 2 office of monitoring 5. l. 3 Staffing Extramural vs. Intramural Research Professional Development Facilities and Equipment Resources i : l6 l? * * l 8 l 2 l.9 2 l 2 3 2 3 24 24 25 25 26 26 27 l. O EXECUTIVE SUMMARY l. 1 The Role of Ecological Effects Research at EPA EPA was created in l970 specifically as the regulatory agency responsible for protecting the environment. The l870 reorganization creating EPA transferred responsibilities for conducting research on ecosystems from the Council on Environmental Quality (CEQ) to EPA. In this capacity EPA has both executive and legislative mandates to conduct ecological research upon which other responsibilities related to its mission depend. Congress has enacted l3 statutes, ll enforced by EPA, that are aimed at protecting the environment from anthropogenic insult, such as those from chemicals, solid waste and other toxic substances. Virtually all of the environmental statutes enacted by Congress require EPA to protect ecological values, ultimately requiring preparation of ecological risk assessments. Among the important components of the environment to be protected are both biotic and abiotic components ranging from endangered species to biogeochemical cycling. l. 2 Status of Ecological Effects Research Several other Federal agencies conduct or support ecological research related to their individual missions. Much of this ecological research contributes information that is important to EPA's mission and responsibilities; however, this research falls short of providing a focused and systematic answer to many of EPA's needs. . - EPA's ecological research program has been constrained by limited resources. Therefore, the preponderance of the Agency's research effort has been concerned with questions that directly support immediate decision-making activities. Short-term decisions have dominated and defined research needs; for example, the development of single-species, toxicological test methods for implementing the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Efforts of lesser priority have generated tools for predicting acute toxicity based on chemical structure, and methods to extrapolate from acute to chronic effects or from species to species, especially in aquatic communities. l. 3. Needs and opportunities for Strategic Ecological Effects Research Recognition is growing in the U.S. and elsewhere that the scope of ecological research must be broadened to accommodate the spectrum of decisions concerning environmental quality that must be made at present. A broadened scope of research is also needed to provide for acceptable environmental conditions in the future. Current, identifiable limitations of scope unequivocally demonstrate that a full recognition of the need for ecological risk assessment has not been attained. Also, the structure of ecological risk assessment has not incorporated current ecological knowledge and concepts. In particular, critical areas of resource management, population theory, and knowledge of the mechanisms of ecosystem processes need to be incorporated into a research effort that is directed towards ecological risk analysis. Broadening the scope of ecological research is necessary to provide the opportunity for strategic ecological effects research. Building on past studies of effects on individual organisms, effects on appropriate populations of organisms, interactions in multiple media and effects on communities or ecosystems, new studies are needed to provide a comprehensive understanding of environmental processes and the consequences of human activities. Studies of these ecologically realistic effects must relate the impacts of pollution to key characteristics of ecosystem function, such as physical habitat loss or species diversity. General risk assessment guidelines should emphasize investigating and assessing effects that are cumulative, long- term, and of regional or global scale. Research pathways that lead toward answers to these questions will provide the understanding necessary to anticipate and evaluate both the magnitude and consequence of ecological effects. To build appropriate methodologies, a knowledge base, and a data base for evaluating ecological risks and effects, and to provide the information required to meet the overall needs of the Agency, a research strategy with the following four components is recommended: - - - l. 3. l Assessing risk to ecological systems Interrelated research activities are required to refine and improve environmental risk assessment procedures including: a) identifying appropriate protocols, b) identifying meaningful endpoints, c) characterizing and quantifying exposures, and d) analyzing and quantifying uncertainty. These refinements should be applied as terms in and as structures of models, when determining appropriate assumptions or conditions of application, and via the parameters to be measured to perform environmental risk assessments. l. 3. 2 Defining the status of ecological systems Understanding the degree to which the quality of the environment may decline as a result of human activities or improve as a result of environmental management and remediation activities depends upon a valid and accurate assessment of environmental characteristics. Ecosystem status measurements and analyses of these data provide the fundamental information that is needed to characterize and understand the environmental resource that EPA is charged with protecting. l. 3. 3 Detecting trends and changes in ecological systems Monitoring allows detection and quantification of changes in specific parameters that are judged to be either critical in themselves or that serve as indicators of changes. Monitor-ing is also necessary to assess the effectiveness of environmental management and mitigation practices, and to provide future generations with reference statistics. l. 3. 4 Predicting changes in ecological systems Developing new and expanded predictive methods and assessment techniques requires considerations of complexities, such as impacts of indirect and long-term effects, responses to multiple insults, variability between ecosystems, and differences in spatial and temporal scale. Developing a predictive capability will require predictive studies, experiments in natural ecosystems and the development and validation of models. 2. O INTRODUCTION: ECOLOGICAL RESEARCH AND EPA'S MISSION 2. l EPA's responsibilities in ecological assessment and research EPA was created in 1970 specifically as the regulatory agency responsible for protecting the environment. In this capacity EPA has both executive and legislative mandates to conduct ecological research in support of other aspects of its mission, responsibilities transferred to EPA from CEQ. Congress has enacted 15 statutes, li enforced by EPA, that are aimed at protecting the environment from anthropogenic insults such as those from chemicals, solid waste and other toxic substances. Many of the environmental statutes enacted by the Congress explicitly require EPA or other agencies to prepare ecological risk assessments. Appendix I identifies these statutes and their provisions. Aspects of the environment to be protected include fish and wildlife resources, food webs serving human consumption, aesthetic and recreational values, and rare and endangered species. EPA's mission also entails maintaining basic biotic and abiotic life support systems, such as long-term productivity of aquatic and terrestrial ecosystems and biogeochemical cycling. The Agency's past emphasis with respect to anthropogenic stresses has been on human health. This emphasis has translated into a capability to perform human health risk assessments. This capability far surpasses the Agency's ability to perform environmental risk assessments, primarily due to our relative lack of knowledge of effects other than those on human health. The importance of maintaining viable, healthy ecosystems for. human welfare and health is increasingly recognized by the public and private sectors. In a recently completed exploratory review of environmental problems, EPA identified thirty-one major environmental problem areas and characterized them in terms of their relative importance. Twenty-two of these problem areas were identified as important because of effects mediated by ecological impacts [l] . These problem areas involve l6 particular types of ecological systems; some involve entire geographic regions, while others represent cases where the entire biosphere is at risk. - 2.2 Relationship of EPA's Ecological Research Program to those of other Agencies A number of other Federal agencies conduct or support ecological research, including the Fish and Wildlife Service (FWS/Department of the Interior), the Forest Service (FS/U.S. Department of Agriculture), the National Oceanic and Atmospheric Administration (NOAA/Department of Commerce), the Department of Defense, the Department of Energy, and the Bureau of Land Management. Respective ecological research programs are related to the statutory missions of those agencies. More fundamental research in ecology is supported principally by the National Science Foundation (NSF). While much of the ecological research conducted by other agencies contributes information that is important to EPA's mission, it falls short of providing a focused and systematic answer to many of EPA's needs. Since each Agency has a specific mission, it is not surprising that many direct concerns to EPA may not be addressed at all by the other agencies. The result is that no one agency is collecting, integrating and synthesizing ecological information in a way that supports EPA's need to measure the status of ecological systems and to anticipate and detect potentially unfavorable trends and changes. of course, EPA should keep abreast of related ecological research programs at sister Federal agencies, and special efforts should be made to encourage coordinated research wherever feasibility and efficiency warrant. Such coordination will complement and enhance the impact of the Agency's own strong, independent effort, which is necessary to meet its specific goals and obligations. 2.3 Mission of an ecological research program for EPA In response to limited resources, EPA has concentrated its research effort on immediate and obvious questions that directly support decision-making. Of necessity, past research has supported decisions needed in the short-term. For example, research efforts have focused on single-species, rapid toxicity test methods for regulatory permitting processes. These efforts shorten the time and expense of testing at the sacrifice of correctly identifying the hazards of slow acting toxicants or those that will cause problems by indirect mechanisms. - There is growing recognition that the scope of research must broaden. This recognition is prompted, for example, by cascading effects seen in response to acid deposition, and in far-reaching effects seen as a result of stratospheric ozone depletion. A broadened scope must accommodate the full spectrum of decision- making, in both the near- and long-term. The ecological effects of complex mixtures (as opposed to single chemicals) are now being considered, and risk assessment methods are being explored that can be applied at the population, community and ecosystem levels, as well as the single organism/species level. Regional and global scale, as well as long-term ecological problems are being given increased attention, although little administrative or budgetary support is apparent. -- Some ongoing EPA research programs do reflect this broader emphasis and they include investigations into effects of acid deposition, protection of wetlands, effects of global climate change, and questions of microbial ecology/biotechnology. Even in these forward-looking programs, there are identifiable limitations of scope which suggest that a full appreciation of the needs for ecological risk assessment has not been attained. With the exception of newer approaches described above much of the research involves testing for toxic effects on ecological components, rather than considering the ecological system as a whole. The focus of research programs generally remains on effects of individual pollutants on individual organisms, although some projects take a multimedia, community assessment approach . . Additionally, focus is typically placed on knowing the pollutant, rather than on knowing the environment that we seek to protect. • * The Subcommittee on Ecological Effects envisions three main goals for EPA's ecological research program. They are, in order of priority: a. Providing a strong scientific basis for ecological considerations in Agency decision making. b. Moving EPA into a clear leadership position among agencies with environmental responsibility. c. Developing the organizational and intellectual capabilities that will enable EPA to advance ecological science. 2. 3. l Providing a strong scientific basis for considerations in Agency decision-making In planning and conducting ecological research, EPA mst remain continually aware of the need to integrate research findings and assessments into the regulatory responsi-bilities which are manifest as its policy framework. This framework, derived from current statutes and regulations, generally consist of a set of linked questions, the answers to which should develop from ecological considerations. These key questions include: a. Status How extensive is ecosystem change, and how does it affect the human component of the ecosystem, e.g. human values and activities? b. Causality What are the relationships between environmental stresses and the effects observed? c. Risk What consequences are posed to ecosystems from pollutant stresses? d. Mitigation What ecological improvements can be brought about by various choices among options for mitigating environmental impact and at what additional or alternative ecosystem risk? e. Recovery What rate and degree of ecosystem recovery can be f. Prognosis What is the probability, source and magnitude of ecological effects anticipated in the future? simple consideration of direct effects (such as single species toxicity) will not suffice to provide adequate answers for these questions. Therefore, EPA should develop the capability to address broader ecological questions. Such capability will allow EPA to progress towards solutions to the 22 ecological problems that the Agency has identified [l] . The incorporation of ecological data into the decision- making and the regulatory process can enhance the Agency's performance and the safety of the environment by : a. Identifying reasonable goals and facilitating determination of the degree to which environmental goals are being met. b. Providing a sound scientific basis for setting priorities, ranking environmental problems and allocating resources. . c. Optimizing selection of methods for preventing, detecting, solving or mitigating environmental ' problems. & d. Expediting the clear communication and integration of research results to EPA, state and local governments, and the public. 2. 3.2 Moving EPA into a leadership position among agencies with environmental responsibility At the moment, no one agency has undertaken the task of compiling and making available the full spectrum of environmental data or of coordinating the plans for gathering needed data. There is an obvious need for centralized coordination, and EPA is the logical choice for the role, both in terms of having the greatest needs for this information and the breadth and availability of expertise in matters of environmental quality. 2. 3. 3 Developing the organizational and intellectual capabilities that will enable EPA to advance ecological science The answers to many of the questions that EPA must address are likely to require the development of new theories and concepts, as well as simply new data. To ensure the growth of that knowledge base, it is necessary for EPA to participate in the progress of the science of ecology. The Federal support of fundamental ecological research is primarily the province of NSF. However, NSF's research program is primarily predicated on the interests of the Nation's researchers, and there is no guarantee of complete congruence between the needs of EPA and the priorities of the scientific community at any particular time. Thus, to encourage development of ecological science in the direction it requires, EPA should allocate a reasonable fraction of its research effort to fundamental research, particularly in areas where the scientific community is not adequately addressing the needs of EPA. 3. O RISK ASSESSMENT AS A UNIFYING GOAL FOR THE RESEARCH PROGRAM 3. l What is an ecological risk assessment? E_-gº-ºº: c 3 - 1 - 1 Cefinition An ecological risk assessment is an estimate of the likelihood severity and extent of ecological effects associated with an exposure to an anthropogenic agent or a perturbational change, in which the risk estimate is stated in probabilistic terms that reflect the degree of certainty. The steps in ecological risk assessment may include: a • Hazard identification Demonstrating the plausibility of a specific adverse environmental effect and the mechanism linking the effect to a particular human action. Determination of the population at risk Identifying the extent of the landscape that can potentially be affected. Source inventory Determining the potential intensity of the activity that generates the factor creating a hazard usually via an environmental survey. Exposure assessment Measuring the ambient intensity of the causal factor adjusted for transport, dispersal ecological interactions and vulnerability patterns which modulate the effective dose. Dose-response determination Relating the magnitude of the effect and the intensity of the exposure to the causal factor. Risk characterization Putting together all of the pieces to obtain an estimate of the probability distribution of a range of outcomes. Quantification of uncertainty Documenting the uncertainty about the estimate due to potential uncertainties in measurement and prediction through the process. 3. l. 2 Benefits Risk assessment is simply a systematic and formal application cf all the in formation that is available for predicting cutcomes under actual or hypothetical conditions. The outcome is expressed as the probability of some unit of "effect" and the hypothetical conditions have to do with alternatives about which decisions can be made. The objective is to process information in such a way that the most accurate prediction possible is provided. The predictions must be suitable for deciding among alternatives, while keeping track of the degree of uncertainty so that the decision-maker can have some indication of how firm the prediction is. The formal methodology of risk assessment accomplishes this objective in a comprehensive and logical manner. Risk assessments are designed to promote better decisions. A focused ecological research program can provide for more certainty in environmental risk assessments, both in terms of effect and assumptions, thereby offering three major types of benefits: $ a. The quality of the advice given in support of decisions will improve, so that subsequent environmental management and regulations will be improved. b. The potential for making more accurate predictions will be enhanced. Predictions can trigger preventive action, reducing the need for costly and after-the-fact mitigation, recovery and clean-up programs. c. Risk estimates will be more reflective of actual risk - posed allowing for narrower "margins of safety" and potentially less restrictive regulation. The accumulated procedures used to assess risk have a modest track record in evaluating human health questions related to environmental pollutants, but have been applied more tentatively to ecological questions. Given the need for ecological risk assessment at EPA, concerted emphasis should be placed on vigorous development of ecological risk assessment methods. 3 - 2 Shortcomings with some present approaches to ecological risk assessment Present ecological risk assessment practices commonly fall short of their potential in three ways: a. The risk assessment may fail to consider all the ramifications in a complex causal network, so that it presents an assessment of only some of the risks. b. The risk assessment may fail to provide adequate estimates of uncertainty, so the user has little or no l0 basis for evaluating its results compared to those of any other prediction methodology. c. The knowledge base and data base may be so weak that the uncertainty estimate associated with the risk assessment renders the conclusion tentative, unusable or indefensible. If the measured uncertainty is enormous, that fact is extremely important. In such cases the decision-maker (and the affected constituency) need to be aware of the magnitude of the uncertainty, both to allow for appropriate caution in the decision and to document the need for improved information. 3. 3 Present approaches to environmental risk assessment The field of ecological risk assessment continues to evolve as the method is applied to a variety of environmental problems. Such applications have served to identify areas of uncertainty in risk assessment and aid in defining areas for additional research. EPA's Ecological Risk Assessment Program has the primary goal of formalizing and systematizing scientific knowledge of ecological risks in order to provide both guidance and models for decision-makers. For example, in EPA's Office of Pesticides and Toxic Substances environmental risk assessments assist decision-makers in making at least two kinds of decisions: a. Predicting environmental impacts without access to any . . observational data (the Premanufacturing Notification requirement of the Toxic Substances Control Act). b. Extrapolating observed behaviors from single ecosystems (at best) to all other ecosystems that conceivably might become exposed through, for example, the expanded use of pesticides. Because of experimental and observational tractability, most of EPA's ecological risk assessment approaches have focused at the level of single organisms. These techniques have proven valuable, especially for certain species about which much is known, but serious uncertainties exist in our ability to assess broader ecological risk, which impact on the quality of decisions. When risk assessments are based just on extrapolation from acute or chronic dose responses of individual organisms, potentially important indirect effects can be missed. Current single-species tests can indicate reductions in life span, health, and reproductive rate. However, in complex communities, populations under stress may increase because of reduced competition or prediction. An example of such indirect effects occurs with algae blooms, which may occur after insecticide treatments have removed the consumers that normally keep the algae population at lower levels of abundance. Overall, these efforts indicate a serious interest in ll ecological risk assessment at EPA, but the full potential of ecological risk assessment is not being realized, both for lack of an agreed upon systematic methodology for a complete risk assessment and a lack of fundamental knowledge in the science of ecology. - 2.4 Information needs for ecological risk assessment 3. 4. l. The endpoint problem There are no obvious ecological equivalents of "human cancer rate" or "reactor-core meltdown probability" to serve as the common currency for a quantitative statement of the magnitude of the outcome where risk is of concern. This common currency is sometimes called the "endpoint". For the purpose of communication, it may be necessary to find an analog to the situation in human health risk assessment; however, non-health ecological concerns are more difficult to reduce to a simple one- dimensional functions. There are numerous types of ecological effects, many of which are not interconvertible or self-evident in terms of environmental quality or human welfare. These include: a. Effects on the biosphere as a life support system b. Effects on agricultural productivity c. Effects on productivity of harvested wild lands d. Effects on aesthetics/amenity functions e. Effects on endangered species f. Symbolic indices of our care for the environment. To the extent that these endpoints are genuine matters of concern for some substantial constituency, they are all legitimate endpoints. However, they are qualitatively diverse, difficult to compare or relate quantitatively, and not recognized by a universal constituency. To improve the risk assessment process, meaningful endpoints that relate to causal factors must be found. 3.4.2 Ecological dose-response relationships Dose-response relationships are not only applicable to toxicity testing of individuals but can also be extended to the measurement of responses at the population, community, and ecosystem levels. Often, the dose-response information is based on the results of controlled laboratory experiments. But simplified conditions in laboratory tests (and some modest scale field plot tests) may not adequately mimic behavior of the real system. Discrepancies and inconsistencies arise due to effects of scale, complexity, boundary processes, and missing or unrecognized factors. Further, the available laboratory data are l2 usually quite restricted with respect to the number of species, life cycle stages, and genetic strains studied, and frequently ignore effects of multiple stresses, and population, community, and ecosystem level effects. For these reasons, it is essential that dose-response relationships used in risk assessments be verified in intact systems. Unfortunately, much of the available dose-response data represent those systems that have been considered scientifically interesting and convenient, so this "sample" cannot be counted on to represent the real distribution of possibilities. Thus, we cannot assume that means or variance in dose/response data from this "sample" are adequate for extrapolating to a risk assessment for a system with components other than those covered in the data base. Even more limiting, this data base by itself is insufficient for estimating the uncertainty of the extrapolation. 3.5 Recommendations for specific approaches The logical, systematic framework of risk assessment offers a means for organizing the relevant factual information that is available which bears on predicting the outcome of some contemplated action (or inaction) with respect to environmental regulation, policy, and management. Risk assessment offers a methodology for making these predictions under conditions of uncertainty when available data are incomplete of dubious quality. More importantly, risk assessment allows the consequences of this uncertainty in the input data to be traced to the resulting uncertainty in the prediction. The sections to follow describe examples of the types of research activities that must be carried out to improve our information base; thereby improving our ability to perform more certain ecological risk assessments. * l3 4.0 MAJOR RESEARCH AREAS FOR ADDRESSING THE INFORMATION NEEDs 4. l Ecosystem classification and inventory Inventory and classification measurements provide an information base for estimating the extent and location of specifically inventoried resources that are potentially at risk. These measurements also provide a means for extrapolating risk factors from small scale to larger scale. systems thiat are potentially at risk. Effects on or hazards to resources supported by these ecological systems can also be evaluated. Any indication that environmental change is imminent or has taken place, must first be addressed by determining whether the change has actually taken place, or is currently taking place. The magnitude of the change and the extent of the landscape that is affected must be determined. 4. l. l Ecosystem Components and Mapping In order to extrapolate risk functions or effects from small to large 'scale, the landscape can be divided into natural units with coherent ecological processes, rather than political units. The structure of the ecosystem is currently reflected by measurements based on species diversity, importance indices, or selection ratios. Chemical compartmentalization is also measured to reflect the state of ecosystems using measurements of standing biomass or distribution and availability of nutrients. Research is needed to guide selection of proper divisions. Some examples of useful mapping projects are discussed below. a. Eco-Region Concept The eco-region concept used by EPA provides an example of a useful mapping project and also provides an excellent foundation for the studies described above. The concept is based on the observation that within a region the landscape is a mosaic of patches which form the components of pattern. The eco-region project shares this concept with landscape ecology, a relatively new ecological discipline, dedicated to improving our understanding of the development and dynamics of patterns in ecological phenomena. Research related to eco-regions and landscape ecology contributes to our capabilities in ecological classification and inventory. b. LANSAT Mapping Another ecological mapping project is represented by the on-going LANSAT project. This project produces maps that depict rainfall, temperature and geomorphology and are subjected to ground truth measurements to control accuracy. LANSAT maps may also show the state of vegetative sere development to reflect succession, and depict biomass measurements to reflect ecosystem state variables in terms of trophic level or vegetation types. l4 4. l. 2 Inventory design Several specific factors should be considered in designing the inventories used to establish landscape mapping units. These factors include determination of the error rate for classification of sites, determinations of within-class heterogeneity, and determination of uncertainty in extrapolation applications, including the assignment of site vegetation potential. Data accuracy should be consistent with decision-making demands for variables that are related to identified issues. Furthermore, data accuracy in inventory design must be consistent with the design of future trends-monitoring, which will be compared to the initial inventory when making assessments. 4. l. 3 Recommendations In addition to the recommendation for approaches that can provide a.. firm foundation for extrapolation, studies documenting or describing the major life support services or values of various types of ecosystem should be conducted. The mapping and inventory projects designed to provide this foundation should include ecosystem status indicators that can be correlated with ecosystem function and value. Experimental studies are also needed to quantify ecosystem responses to major environmental and anthropogenic per-turbations and to test the utility of the parameters selected to measure ecosystem status in one or more systems. 4 - 2 Ecosystem Monitoring Strategic monitoring elements are essential for determining changes or trends in ecological systems or environmental parameters influencing these systems. These strategic elements may be carried out as programs that involve repeated measurements of selected biological functions in conjunction with physical and chemical variables over time. Monitoring information is of critical importance to hypothesis formulation, hypothesis testing, ecological prediction and ecological risk analysis. Spectral analysis and other approaches involving data aggregation and pattern recognition techniques are proving useful. Such advances lead to a more complete understanding of ecological and environmental phenomena and cycles. The long-term ecological research program of EPA should include provisions for both biological and chemical monitoring. Extended term monitoring is needed to track environmental pollutants such as ozone, SO2, and NOx and to reveal whether ecological systems are improving, deteriorating or remaining stable over time. 15 4. 2. l Historical deficiencies As important as monitoring efforts are, they. have histori- cally been characterized by numerous limitations and deficiencies. The following are some of the most important: a • Monitoring programs frequently lack clear definition and long-term justification. Monitoring efforts commonly fail to recognize reflevant temporal and spatial dimensions or scale. - Data sets from uncorrelated monitoring programs may not be compatible nor comparable. Mathematical characteristics, e. g. sensitivity, thresholds, correlation, indices, efficiency and uncertainty, all influence comparability of monitoring data. Protocol standardization, quality assurance and quality control measures must be coordinated in order to achieve compatibility. . - Monitoring programs are inherently costly, and main- taining continuity of effort in mission, motivation, manpower and money is a sizable challenge. Feasibility, utility and scientific validity must be carefully evaluated along with expense and manpower requirements to ensure a successful strategy. Monitoring efforts directed at documenting change in biological systems do not adequately distinguish changes induced by natural forces from changes induced by anthropogenic forces. - Much of the environmental monitoring being undertaken by state and federal agencies appears to be designed solely or primarily to determine compliance with regulations. Existing environmental monitoring programs, such as the air compliance monitoring program, are not well utilized in ecological effects programs. There is no research effort to determine the most appropriate physical parameters, chemical species and biological measurements to monitor, although. significant literature on this determination exists. Implementation of a research program dedicated to the identification of the most useful and cost-effective biological parameters to monitor is needed. Long term ecological monitoring should be an integral part of the EPA's strategy for ecological research and risk assessment. There are a number of unknowns which make optimal design of such monitoring programs difficult. However, enough is l6 known to initiate research programs which could be highly productive, generating observations about system status which will also serve as the basis for hypotheses and hypothesis testing. 4, 2, 2 Ecological status assessment EPA is the most logical and appropriate organization to carry out a regular and systematic assessment of the status of the American environment. As a first step, the Subcommittee on Ecological Effects recommends that the Administrator establish a group specifically charged with and funded to carry out this important mission. The efforts of this group should include the following: a. Assessment of existing and historical monitoring efforts b. Storage, synthesis, and interpretations of available monitoring results & c. Identification of important gaps in the present acquisition of environmental monitoring data d. Analysis of major environmental perturbations, both natural and experimental, that will assist in the design of future monitoring programs or in the interpretation of changes already observed e. Development of a coordinated system for the collection and interpretation of ecological and environmental monitoring data within EPA. Numerous monitoring programs have been in place for varying periods of time in a variety of Federal, state, regional and local agencies. Examples include the Status and Trends program and the Mussel Watch project in NOAA, the collection of commercial fisheries landing data by NMFS, the breeding bird count at the National Audubon Society, and the National Timber Inventories of the U. S. Forest Service. Numerous research programs are associated with existing monitoring projects; for example, the NSF Long-Term Ecological Research (LTER) sites forest watershed research programs (e. g. Coweeta, NC; Hubbard Brook, NH, Walker Branch, TN), estuarine sites (e.g. Narragansett Bay, Chesapeake Bay) and the National Acid Precipitation Assessment Program efforts. & At present, there is no systematic and comprehensive collection, synthesis and interpretation of the results of these efforts. EPA ventured into such an effort in 1980 with publication of their "Environmental Outlook," but the effort was not sustained. While it may never be practical or possible to obtain and summarize all of these data, we presently lack even the general overview that was represented by the EPA document and formerly provided by the Council on Environmental Quality. l? It is likely that an important finding from the first effort will be that there are major gaps in all of the existing monitoring programs. Based on a benchmark review, decisions can then be made about reducing redundancy in programs and embarking on new ones that may be carried out by EPA or other agencies. 4. 2. 3 Conclusions and recommendations Current deficiencies in basic ecological research impede our abilities to design and implement a comprehensive ecological monitoring program. Nevertheless, the correct approach is to start a monitoring program based on our best available understanding, while at the same time initiating research programs which will yield knowledge to be incorporated into new and modified ecological monitoring designs. In other words, the Agency's ecological monitoring program must be designed to evolve for at least the first decade. - An ecological monitoring research program, taking advantage of existing ongoing monitoring programs, such as the National Surface Water Survey Phase IV, should be funded and implemented. The program's design should include quality assurance, and standardization of protocols, as appropriate. The statistical design selected should address EPA's research and predictive needs, as well as its regulatory requirements. In addition, EPA should conduct a regular and systematic assessment of the status of the American environment, applying this knowledge to determine the status of representative ecological systems, as well as reaching such conclusions on regional and local scales. Finally, long term environmental monitoring should be an integral part of the EPA's ecological research strategy. Q 4.3 Predicting ecosystem change Many of the decisions that EPA must make involve predicting and preventing environmental damage, rather than cleaning up existing pollution. These range from discrete, relatively short- range decisions, such as establishment of water quality criteria for the protection of aquatic life, to long-range, even global decisions, such as limiting chlorofluorocarbon emissions in order to protect stratospheric ozone depletion. The Agency needs a predictive capability to anticipate and prevent emerging problems. 4. 3. l Limitations in predictive ability For many issues of concern to EPA, the ability to predict ecological consequences is limited for several reasons. First, serious deficiencies exist in our understanding of the ecological effects of environmental perturbations. A CEQ Report on Long-Term Environmental Research and Development stated, "Our capacity to estimate ecological and environmental risks is not sufficient to ensure against either costly, and possibly irreversible, damage to essential biogeochemical cycles or preventable extinctions of endangered species and ecosystems" [2]. l8 Second, many ecological problems are multi-faceted and interactive. Various stresses may be operating on a system simultaneously. These include both man-induced 'stress and extreme natural events, such as drought cycles, floods and other variations in climate. The interactive, cumulative and long-term influences of both natural and human influences on ecosystems means that their conditions often cannot be assessed in pollutant specific or project specific terms. Third, experimental and observational approaches to develop predictive power need to be emphasized. EPA's research has focused on individual, short-range problems, rather than on the sustained and rigorous combination of approaches to ecological research that is necessary for the development of explanatory theory and fact to support predictive capabilities. The ability to predict environmental changes depends on the predictive power of the underlying science ; and by strengthening this foundation, EPA can make significant advances in predictive capability while still carrying out its statutory responsibilities. 4.3.2 Considerations needed for ecosystem effects predictions Developing the necessary next-generation of predictive methods and assessment techniques requires explicit incorporation of some important scientific considerations, including the effects of scale, both spatial and temporal, ecological interactions and resultant indirect effects, responses to multiple stresses, long-term effects and ecosystem variability. These considerations are discussed below. - a. Effects of scale, spatial and temporal Ecological problems occur on various spatial scales: global (e.g., climate modification), regional (e.g., estuarine degradation), and local (e.g., site-specific fish kills. Scale is extremely important. For example, small scale elimination of species allows rapid replacement by immigration while large scale elimination does not. Extrapolation of results from one scale to another is difficult and must be done with caution. In addition to spatial scale, consideration must also be given to temporal scale. Ecological systems may undergo natural change on time scales of hours to centuries. Ecosystems founded on primary production by plankton, such as open ocean systems, experience hourly diurnal fluctuations in dissolved oxygen. In contrast, forest ecosystems undergo community changes that occur over decades or centuries. Basic aspects of biological systems that are responsible for natural cycling and variability must be understood in order to clarify and predict the effects of perturbants. l9 b. Ecological interactions and indirect effects Interacting communities of organisms have recovery capabilities and redundancies that individual organisms lack. Some populations may have extensive compensatory capabilities in one circumstance, but be driven to extinction in another. In ecosystems, actual effects of chemical exposure may be different from predictions that are based on individual organism responses. Exposure may be increased by bioconcentratioſh processes or decreased by changes in bioavailability. Exposure to pollutants may cause a population to proliferate as a result of the elimination of its competitor or predator population, or as a result of complex interactions. Thus a direct effect on one population (the predator/competitor) causes an indirect effect on another population. Such interactions points to the need for study of effects in complex ecosystems; that is, a study of the characteristics and behavior of the receiving environment, as opposed to the behavior of pollutants themselves. c. Responses to multiple stresses Episodic events, such as storms, droughts, and floods are naturally occurring events that cause variable responses in ecosystems. Pollutants also cause variations in response due to their chemical characteristics, source and route of exposure (e.g. point or non-point source). Physiologic stresses such as pH, UV or temperature also induce ecosystem responses. Traditionally, these stresses have been studied in isolation, to determine the mechanism of toxicity or physiological effect. However, ecosystems often experience multiple forms of stress, cumulating impacts over time, which cannot be elucidated by isolated or specific approaches. Understanding the effects of multiple stresses requires a more holistic approach in research design and data analysis. d. Long-term effects Long-term impacts may occur over time and over regions far removed from their source. Such responses may vary seasonally and from year-to-year, as well as by random a processes; therefore, they must be examined over long time frames to understand the significance of trends. Ecosystem level effects, such as chronic or cumulative degradation in river basins and estuaries, and impacts of intensive agricultural development may only be revealed by commitments to long-term investigation. e. Ecosystem variability Despite their similarities, not all ecosystems respond in a similar manner to perturbation. Many ecosystems are similar 20 in overall structure, but differ considerably in species composition. Therefore, it is necessary to evaluate the effects of stress on several ecosystems. Ecologists need to investigate degrees of appropriateness for extrapolation among different ecological communities. Predictions are best if extrapolations are between similar systems and explicit knowledge of the differences between ecosystems will enhance extrapolation between ecosystems of different types. 4.3.3 Recommendations for advancing predictive capability EPA's ecological research strategy must contain a minimum of three elements which, taken together, comprise a total approach to developing a predictive capability. Research projects themselves may deal with individual organisms, populations or subcomponents of the ecosystem; however, the strategic elements of the recommended research are focused on ecosystem-level questions. These three strategic elements are predictive studies, field experiments, and models. The most fundamental element of the ecological research strategy involves predictive studies. Operational-level hypothesis testing with short-term experiments provide the advantages of maintaining control over experimental conditions, yet allowing study of system-level effects. Studies of processes such as transport, persistence, and bioaccumulation/bioconcentra-. tion yield basic data on effects of chemicals, mixtures or other perturbations at the ecosystem level. Microcosm research, as an example of such studies, is still in its early stages, yet offers great potential for advancing our understanding of system level effects while providing the basic inputs needed for predictive capability. A second strategic element consists of longer-term experiments and observations of large-scale, natural ecosystems. In such systems, conditions are not controllable but instead reflect reality. Field studies serve to validate and expand on the conclusions and principles determined by short-term, simplistic experiments. EPA has some experience with this scope of research through whole-lake and watershed experiments designed to investigate delayed and direct responses to acid deposition. Opportunity for this type of research is provided via the Long- Term Ecological Research (LTER) Program of the National Science Foundation which provides the vehicle for collaborative investigation on ecosystem mechanisms and responses for a number of key ecosystems. The last element of the recommended strategy is a modeling component. Fundamentally, models are used in ecosystem research in two ways. g a. Models provide a formal means for hypothesis development and testing along with a means for organizing and understanding the resultant observations and data. 2l b. Models can be used to extrapolate observations and the results of experiments to new or different situations. This combination of capabilities make models powerful instruments for predicting environmental impacts. They may range from relatively simple, informal constructs that use prior experience to forecast change, to models that are complex, mathematically sophisticated, and capable of integrating and quantifying the facets that characterize environmental problems. They may be experiential, drawing on system measurements f empirical, extrapolating from statistical relationships; or qualitative process models, which incorporate some causal relationships. A key part of mathematical model development is field verification and validation. Before such predictive tools can be applied to anticipating future ecosystem effects or ecological risk assessment, careful correlation of model predictions to actual field conditions must be made. The validation steps enable appropriate application of developed models to decision- making, and priority setting problems that the Agency faces routinely. Ultimately, integration between ecological models, economic cost/benefit models, and resource management will be needed to facilitate policy or regulatory actions that are most effective in meeting societal needs. - © 22 5. O INSTITUTIONAL CONSIDERATIONS 5. l organizational issues As the Agency develops its long range ecological research program, it should formulate plans to transfer the knowledge gained to users outside the Agency. These plans should include mechanisms that allow EPA to take advantage of the data and * knowledge that has been gathered outside of the Agency, incorporating these advances and eliminating duplication. States, localities, industries and other nations will benefit from and need to be apprised of research and monitoring findings in the Federal government. This is not only to assist them in their regulatory functions but also to allow them to evaluate the conclusions drawn relative to their own data and experience. Recently an EPA task force explored the need for technology transfer and evaluated several options to facilitate such transfers. They formulated two basic conclusions: "EPA, working in partnership with the states, must take action to legitimize the importance and integral nature of technology transfer and training to its mission. As the Agency continued to evolve and mature, technology transfer and training must become core elements in supporting the Agency's operations and interactions with states and local government, industry and academic. . . Further, the task force believes that failure to incorporate such an emphasis throughout the Agency will undermine the effectiveness of the Agency's regulatory and enforcement efforts and related activities at the state and local levels" [3] . Significant changes will have to take place if the above goals are to be met, and the recommendations are to be effectively implemented. An enhanced ecological research program would enable EPA to achieve the following goals [4] . a. Give greater consideration to ecological impacts in the Agency's ongoing regulatory programs -- e. g., bio- technology, Superfund, and natural resources damage assessment. b. Play a broader leadership role as the nation's principal environmental agency, by assessing and responding to emerging large-scale or long-term environmental problems not directly covered by existing EPA regulatory activities -- e. g., global warming and decreased biodiversity. - c. Contribute to the advances in the state-of-the-science of applied ecology that will be necessary to anticipate, 23 detect, and deal with future environmental problems, particularly those areas not being addresses by other Federal agencies. O 5. l. l Research committees The current Research Committee vehicle for determining research priorities can address the first of the goals outlined above. However, it would be much less effective addressing the second and third goals. The immediate regulatory pressures confronting the EPA program offices will inevitably dictate short term research to supply information needs. Therefore, the Administrator of EPA should designate a given level of funding or percentage of EPA' research budget as available for long-term research, outside the purview of the Research Committees. At this stage, we are not in a position to recommend what the specific level or percentage should be. At the same time, the relationship between Research Committee short-term research and independently directed long- term research must be sensitively handled by ORD leadership. First, there are important interrelationships and mutual contributions between the two types of effort. In that sense, the overall research program, although prioritized through two separate vehicles, should be managed as somewhat of a "seamless whole". Second, to assure continued Agency support, it will be important for ORD to constantly emphasize and demonstrate that the long-term effort is relevant to the Agency's larger goals. It is the special responsibility of research management to assure that the long-term research is not only of top scientific quality, but also focused and relevant to the Agency's overall Ill SS l OIl , 5. l. 2 office of Monitoring The Subcommittee on Ecological Effects recommends that the EPA establish an Office of Monitoring (or redirect the existing Office of Monitoring within ORD) to solve identified problems and implement the recommendations herein. This Office would: a. Review existing monitoring programs and the information generated by such programs for relevance to EPA's objectives. b. Identify important gaps in our present acquisition of environmental and ecological monitoring data. c. Design and implement an EPA monitoring system, which considers quality assurance, standardization of protocols as appropriate, and relevant statistical design and analysis. Target this monitoring system specifically to addressing EPA's research, prediction, environmental and ecosystem assessment requirements. 24 5. l. 3 Staffing It will be necessary to make significant changes in staffing to implement the recommended program. . Specifically, there is a need to add additional applied ecologists to EPA's staff at both Headquarters and at the laboratories to complement the current cadre of environmental scientists. There are a number of outstanding ecologists on EPA's staff; however, they are relatively few in number and unevenly distributed among the various research locations. It will be difficult to incorporate some of the recommended research concepts and rationale recommended in this report without expanding the number of researchers and broadening the disciplinary mix. Hiring limitations of civil service personnel could make it difficult to implement this recommendation. However, there are a number of vehicles already utilized by EPA which can be given greater emphasis to achieve this goal. These include the Visiting Scientists and Engineers Program, Interagency Personnel Agreements (TPA), and fellowships through the American Association for the Advancement of Science (AAAS). Particular emphasis should be placed on vehicles for rotating a small cadre of nationally known ecologists into EPA's Office of Environmental Processes and Effects Research (OEPER). These ecologists could be given significant assignments to incorporate a range of ecological approaches -- e.g. landscape ecology, adaptive environmental assessment -- into the Agency's research thinking. Recent organiza-tional changes in OEPER, specifically incorporation of the Agency's Acid Deposition research responsibilities, should facilitate this broadening of staff capability. 5. 2 Extramural vs. intramural research As in the case of staffing, focused use of extramural resources can broaden scientific participation in the research program. The current Acid Deposition research program demonstrates that ORD can bring such resources to bear in a focused way to address Agency needs. We also endorse continued use of the Center of Excellence concept. While not specifically evaluating the programs of the two existing ecologically-oriented Centers (Cornell and University of Rhode Island), we would point out that these Centers have provided EPA with continuing access to necessary academic input. We would recommend continued management attention to the most effective use of those Centers and particularly to continuity and increased levels of funding. EPA should play a stronger role in support and participation in such activities as the Man-in-the-Biosphere Program, and related programs within the appropriate professional societies. With relatively modest efforts, sometimes requiring only effective liaison or limited support of workshops or similar 25 efforts, EPA can benefit from and influence the direction of these groups. In addition, more explicit attention should be given to liaison and cooperation with related federal programs such as the National Science Foundation's LTER, the ecological research of the DOE National Laboratories, and relevant research of such agencies as the Forest Service and Fish and Wildlife Service. Major benefits can be achieved through such efforts. 5.3 Professional development Implementing the foregoing strategy for ecological research will require a high level of professional ecological competence. Two forces are at work, which are creating a professional manpower problem within the Agency. One such force is the high attrition rate of an already dilute ecological talent pool. The age structure of the Agency's professional staff is inexorably moving upward. In excess of 40% of the professional staff will be , eligible for full retirement benefits by l990 and 75% will be eligible by 2000. * The second force is the need to ensure that there are enough students are in the academic pipeline to fill the spaces vacated by the retiring professionals, let alone to meet the manpower needs of an emerging program. Together the two forces, if left unchallenged, pose a problem that will rapidly reach crisis proportions. The obvious way to challenge these forces is to counter with the resources necessary to support programs for professional development. In the short run, use can be made of . existing mechanisms (IPA, Cooperative Agreements, etc.) to bring talent into the Agency for relatively short (l-2 years) rotating terms. In the long run, however, a permanent, continuing supply of young talent can only be provided by supporting training programs designed to produce MS and Ph. D level scientists not only for the Agency, but for the Nation in general, since any surplus talent produced will find its way into state, municipal and industrial programs thus enhancing the Agency's technology transfer effectiveness. A training program similar to the one implemented by the Federal Water Quality Administraton (FWQA) and later dropped by EPA is strongly recommended. 5.4 Facilities and Equipment In addition to its own unique laboratory and field facilities and equipment, ecological research needs strong analytical and computing support. The Agency's Environmental Research Laboratories were constructed twenty or more years ago during an era emphasizing single species toxicity and water quality testing. The equipment sufficient to accommodate that kind of activity has aged into marginal service ability if not become outmoded. Upgrading existing facilities and equipment is necessary in order to maintain the integrity of existing laboratory output. It is essential if quality ecological work is to be performed. 26 5. 5 Resources Substantial financial resources are required to fully implement the recommendations of the Subcommittee. This will pose significant difficulty under current budget constraints, yet several approaches are possible for initiating the proposed strategy. First, some of the recommended measures can be implemented with modest resource increments. These include strengthening and broadening ecological staffing, strengthening support for Research Centers, and increasing liaison and participation in relevant ecological activities. While these efforts will not substantially increase the level of new long- range research within EPA, they will greatly increase EPA's awareness of and access to relevant work and scientific input. Second, the Agency could decide to redirect a portion of its research budget from short-term, Research Committee prioritized research to long-term efforts, rather than seeking entirely new resources. Such redirection could have an adverse impact on Program Office priorities and support for research, but it could be justified in relation to the Agency's broader goals. Finally, It may be possible to redirect some of the Acid Deposition resources. This will allow the Agency to begin to address other closely related issues, such as global warming and stratopheric ozone deletion. Even if all of these steps for initiating the proposed strategy are taken, successful implementation of, the ecological research strategy will still require a significant infusion of new funds and manpower. Anything less will serve only to compound the uncertainties we are trying to reduce. 27 References l. 2. U. S. EPA. 1987. Unfinished Business: A Comparative Assessment of Environmental Problems. Washington, D. c. Council on Environmental Quality. l.985. Report on Long- Term Environmental Research and Development. Washington, O. C. U. S. EPA. l.987. Report of the Administrator's Task Force on Technology Transfer and Training. Washington, D. C. NAS/NRC. 1977. Research and Development in the Environmental Protection Agency. Washington, D.C. 28 APPENDIX I 29 . APPENDIX I STATUTES REQUIRING AN AUTHORIZING ECOLOGICAL RISK ASSESSMENT STATUTE Clean Air Act (CAA) Clean Water Act (CWA) SECTION l54 (c) l64 (d) l64 (b) l65 (e) 30 l (g) 30 l (h) 3.03.(c) 304 (a) 305 (b) 307 (a) 3 ll (b) 3 lo (a) 320 (b) ACTIVITY FOR WHICH ERA IS AUTHORIZED Studies by the National Science Foundation Studies by the Secretary of Agriculture Redesignation of areas as Class I, II, or III Preconstruction requirements for major emitting facilities Determinations on requests for water quality variances Determinations on requests for modification of secondary treatment requirements for POTWS Development of State water quality standards and designated uses for receiving water Development of Federal water quality criteria and guidance Development of State water inventories Determinations regarding additions to, or revisions of, the list of priority pollutants Designation of hazardous substances Establishment of efficient limitations for thermal discharges Development of estuary protection program 3 O 403 (c) Development and provision of ocean discharge criteria 404 (c) . Determination of the effect of dredge and fill activites prior to authorization to discharge to surface waters comprehensive Environmental Response, Compensation and Liability Act (CERCLA) lC5 (a) (8) (A) Revision of the National Contingency Plan lo 5 (d) Petition to conduct a pre- liminary assessment of the effects of the release or threatened release of hazardous substance lC5 (g) Addition of facilities to National Priorities List l2 l (b) & (d) Assessment of alternative remedial actions and degree of clean up required 3 ll (a) Research on hazardous substances Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 3 (c) (5) Approval of registration of pesticide 3 (d) (l) (B) Classification of pesticides for general use 3 (d) (l) (C) Classification of pesticides for specific use 5 (d) Experimental use permit studies 2 O Research and Monitoring 25 Development of Regulations 3 l Marine Protection, Research and Sanctuaries Act (MPRSA) Safe Drinking Water Act (SDWA) Toxic substances Control Act (TSCA) l O2 (a) lC2 (c) l()4 (h) lo4 (i) 202 (a) (2) 303 (b) l427 (d) 4 (a) 4 (b) 5 (b) Criteria for reviewing permits for ocean dumping Designation of sites and times for dumping Establishment of permitting criteria for low-level radioactive waste dumping Establishment of permitting criteria for general radioactive waste dumping Research on ocean dumping Designation of National Marine Sanctuaries Development of criteria for identification of critical aquifer protection areas Testing to develop data with respect to environmental and human health effects of substances manufactured, dis- tributed, processed, used or disposed of Establishment of standards for the development of test data Notification and submission of test data required for manufacture of a new chemical substance or the processing of a chemical substance for a rºle.W UlS e - Evaluation of application for exemption from notification requirements for test marketing purposes 32 6 (e) l2 (a) Authorization of manufacture or use PCBs in a not totally enclosed manner Application for export of a substance being manufactured processed, or distributed 33 Summary of Statutory Authority Implicitly Authorizing an Ecological Risk Assessment STATUTE Coastal Zone Management Act of lo 72 (CZMA) Marine Mammal Protection Act of lo 72 (MMPA) National ocean Pollution Resea and Development and Monitoring Planning Act of l978 (NPERDA) SECTION 3 O 3 3 O 5 3 (a) ACTIVITY FOR WHICH ERA IS AUTHORIZED Declaration of policy Management Program Development Grant Moratorium and Exceptions lC3 (a) & (b) lo 3 (b) (3) rch 4 (a) 4 (b) (l) (A) 4 (b) (l) (B) Promulgation of regulations on taking of marine mammals Consideration of the marine ecosystem and related environmental concerns Preparation of comprehensive 5 year plan for the overall Federa effort regarding ocean pollution research, development and monitoring Identification of the national needs and problems related to the specific effects of ocean pollution, including the effect: on the environmental value of the ocean and the coastal Iº e SOUllº CeS Prioritize, with respect to value and cost, the national needs related ocean pollution which must be met Submit annual report to Congres which estimates environmental 34 Resource Conservation and Recovery Act (RCRA) Wild and Scenic Rivers Act lC 08 (a) 3004 (b) 3 O Ú4 (d) 3004 (g) 300.4 (m) 3005 (j) 800 l (a) impact of increased importing of foreign oil, evaluates the Federal government's ocean pollution research and monitorin capability, and summarizes the efforts undertaken to coordinate federal programs related to such research and monitoring Development and revision of guidelines for solid waste management Authorization for placement of hazardous waste (e) Authorization for land disposal of hazardous waste Land disposal prohibitions of hazardous waste Development of waste treatment standards Study and Report to Congress on existing surface impoundments Research, demonstration, and training relating to hazardous waste management Special waste studies 3 O O2 Act in general 35 United States Office of the Administrator SAB-EC-88-040D - * I ºf P - S = ce c \ry Toa ^ - mber 1088 Vasilington DC 20460 ºnal Report Appendix D. REVISED OCTOBER 24, 1988 Strategies for Health Effects Research Report of the Subcommittee on Health Effects Research Strategies Committee NOTICE º This report has been written as a part of the activities of the Science Advisory Board, a public advisory group providing extramural scientific information and advice to the Administrator and other officials of the Environmental Protection Agency. The Board is structured to provide a balanced, expert assessment of scientific matters related to problems facing the Agency. This report has not been reviewed for approval by the Agency; hence, the contents of this report do not necessarily º represent the views and policies of the Environmental Protection Agency or of other Federal agencies. Any mention of trade names or commercial products do not constitute endorsement or recommendation for use . U. S. Environmental Protection Agency Science Advisory Board Research Strategies Committee Health Effects Group Chair Dr. David Rall Direct Or National Institute of Environmental Health Sciences ll l Alexander Drive, Blog. 10 l Research Triangle Park, NC 27709 Member Dr. Dr. Dr. Dr. Dr. Eula Bingham Department of Environmental Health \,, University of Cincinnati Medical College Kettering Laboratory 32.23 Eden Avenue Cincinnati, Ohio 4.5 267 Bernard Goldstein Chairman, Department of Environmental and Community Medicine UMDNJ - Robert Wood Johnson Medical 675 Hoes Lane P is cataway, New Jersey 0.8854–56.35 David Hoel Director, Division of Biometry and Risk Assessment National Institute of Environmental Health Sciences Research Triangle Park, North Carolina 27709 Jerry Hook Vice President, Preclinical R&D Smith, Kline and French Laboratory 709 Swed land Road King of Prussia, PA 1940 6 Philip Landrigan Director, Division of Environmental and Occupational Medicine Mt. Sinai School of Medicine l Gustave Levy Place New York, New York 100 29 Donald Matt is on Director, Division of Human Risk Assessment National Center for Toxicological Research Jeffers on , Arkansas 720 79 Dr. Frederica Perera School of Public Health Division of Environmental Sciences Columbia University 60 Haven Avenue New York , New York l () 032 Dr. Ellen Silbergeld Chief, Toxics Program Environmental Defense Fund l6 l 6 P Street, N. W. Room 150 Washington, D. C. 20036 Dr. Arthur Upton Director, Institute of Environmental Medicine New York University Medical Center 550 First Avenue New York, New York l O 0 l 6 Science Advisory Board Staff Dr. C. Richard CO thern Executive Secretary Environmental Protection Agency Science Advisory Board 40 l. M Street, S. W. Washington, D. C. 20460 (Al 0 l) Ms. Renee' Butler Staff Secretary Environmental Protection Agency Science Advisory Board 40 l M Street, S. W. Washington, D. C. 10460 (AlO 1) Ms. Mary Winston Staff Secretary Environmental Protection Agency Science Advisory Board 40 1 M Street, S. W. Washington, D. C. 20460 (AlOl) Chapter Abstract Chapter 1 Chapter 2 Chapter 3 Chapter 4 Chapter 5 Chapter 6 HEALTH EFFECTS WORK GROUP REPORT OF THE AL ALM COMMITTEE Title Environmental Factors and Human Health Kinds of Long-Term Research Research Advances in the Toxicology of Lead Newer Basic/Long-Term Research with Application to Environmental Health Problems Population Risk/Risk Reduction Summary Author Arthur Upton James Fouts Kathryn Mahaffey Marshall Anderson Frederica Perera Lawrence Reiter Morrow Thompson Michael Luster Donal d Mattison Alan Wilcox David Hoel Michael Hogan ABSTRACT This document attempts to delineate the long-term health effects research needs (both basic and applied) considered most supportive of EPA programs. Chapter l provides a historical perspective , describes the nature and sources of environmental determinants of health and disease, touches on the underlying mechanisms of toxicity with implications for risk assessment and disease prevention, and indicates some of the areas where research support is clearly inadequate. Chapter 2 draws a distinction between the basic and applied long-term health effects research needs of EPA programs by providing specific examples that illustrate the need for research addressing "generic" issues as well as various research activities that have application to specific problems and specific settings but which must be carried on over a period of several years. An attempt has been made to explain how EPA uses/depends on basic research of the type conducted by other Federal Agencies, particularly as it relates to the regulatory mission of the Agency. In Chapter 3 the toxic metal lead is used as the paradigm to illustrate the place of and necessity for long-sustained, basic research activity in the development of a foundation for constructive action in important problems in environmental health. Continued long-range and basic research investigations on lead toxicity are at one and the same time perhaps among the more justifiable and yet less supportable of such activities in the entire field of environmental health Sciences. A number of leading-edge/long-term basic research activities with potential application to environmental health problems are described in Chapter 4. It attempts to highlight those activities which perhaps have the greatest promise in this area. Many of these include various aspects of the "new molecular biology" research field, such as the study of oncogenes and proto-oncogenes, the development and use of biomarkers to determine internal dose and exposure and for relating exposure to disease. Other newer developments in neurotoxicology, immunotoxicology and reproductive toxicology are described. An important area of basic research includes methods development and validation. Magnetic resonance imaging is discussed as a very promising new technique that should find many useful applications in studies of the internal structures, states, and compositions of various biological systems. Finally, in Chapter 5 the problem of estimation of population risks is addressed, particularly as it relates to the role of animal data in the quantification of possible human health risks. Factors considered here include choice of mathematical model or extrapolation procedures, primary versus secondary or indirect modes of action and threshold mechanism, problems in species extrapolation and determination of biologically effective dose. Some specific problems in human epidemiologic studies and population risks analysis are also described. Factors affecting the –2- balance of basic research on cancer and non-cancer endpoints within any Federal organization are also discussed. Long-term, basic research into both cancer and non-cancer endpoints is recognized as being essential if the EPA is to formulate a broad regulatory policy in the most accurate manner possible. º Chapter l ENVIRONMENTAL FACTORS AND HUMAN HEALTH Arthur Upton HISTORICAL PERSPECTIVE The past century has seen the conquest of those diseases which have caused the greatest morbidity and mortality in previous generations. In the developed countries of the world, the average life expectancy has doubled, now surpassing the biblical ideal of "three score and ten" years (Figures l and 2). This transformation, which would have seemed miraculous to our great grandfathers, has resulted from advances in our untierstanding of the relationship between health and the environment, broadly speaking. These advances, and the resulting improvements in agriculture, nutrition, sanitation, public health, and medicine, have all but eliminated infectious and parasitic diseases as major causes of death in the industrialized world. Replacing such afflictions as major causes of death in the industrialized world are abnormalities in early growth and development, chronic degenerative diseases, and cancer (Figure 3). These diseases, viewed until recently largely as hereditary or inevitable accompaniments of aging, are now attributed increasingly to environmental causes. Our challenge is to identify the causes and to control them (4). NATURE AND SOURCES OF ENVIRONMENTAL DETERMINANTS OF HEALTH AN DISEASE The "environment", defined broadly, encompasses all external factors that may act on the human mind and body. Many of the factors are produced or altered by man himself. They include chemical and physical agents in air, food, water, drugs, cosmetics, consumer products, the home, and the workplace. The "environment" is thus complex and constantly changing. Inevitably, moreover, it contains a myriad of agents in varying combinations and from multiple sources. Furthermore, because the effects of different agents interact in various ways, the ultimate impacts of any given environmental agent may depend on the effect of other agents and the conditions of exposure (4). Air Acute episodes of atmospheric pollution, such as those listed in Table l, have been observed to cause transitory increases in morbidity and mortality. The effects of chronic exposure, however, are less well documented and may vary, depending on the pollutants in question and their concentrations in the atmosphere (4). On chronic exposure at relatively high concentrations in the workplace, a variety of pollutants are known to cause toxic effects. Examples include various gases (e.g., carbon monoxide, vinyl chloride, coke oven emissions, -4- radon), metals (e.g., lead, mercury, arsenic, nickel) and dusts (e.g., asbestos, silica, cotton fibers, coal) (5). Also well documented are the effects of chronic exposure to cigarette smoke. The incidence of lung cancer has risen precipitously, in parallel with the antecedent increase in cigarette consumption (Figure 4). In smokers, furthermore, there is a systematic relationship betweecn the amount of smoke inhaled and mortality from lung cancer (Figure 5), other cancers, heart disease, and respiratory diseases. Lesser effects have been tentatively attributed to passive inhalation of cigarette Smoke in chronically exposed nonsmokers. - The ultimate effects of chronic low-level exposure to other widely prevalent combustion products and their derivatives (such as sulfur dioxide, ozone, nitrogen dioxide, benzo(a)pyrene, and various suspended particulates) are less well understood. * Although the air pollution produced as a result of coal combustion is a direct cause of respiratory fatalities, there is no exact measure of their number; however, several estimates have been made of the number of fatalities attributable to the combustion of coal in generating electricity (where about 70% of coal combustion occurs). Inhaber (8), for example, estimated that between 5 and 500 fatalities result per 1000 Mwe of electric power produced each year from pollution generated by coal fired plants. A more recent survey by experts in this area puts the estimate between zero and 1000 fatalities per year per 1000 MWe gf electric power produced (9,10). On the basis of a value of 7 x 10° Mwe of electric power produced in the U. S. by the consumption of coal, the estimates imply that up to 700,000 fatalities per year may result from combustion of coal in the U. S. Within the uncertainties of this estimate, it agrees well with a recent inference by Wilson that "50,000 among the 2 million persons who die each year in the United States may have their lives shortened by air pollution" (11). One may question, therefore, the extent to which current ambient air standards provide adequate protection against the potential long-term health effects of coal combustion products, which cannot be specified with certainty on the basis of existing knowledge (12). It is noteworthy in the above context that indoor pollution with combustion products may lead to health effects in the chronically exposed, especially children. Of increasing concern is the extent to which elevation of the radon concentrations within houses and buildings, by weather-stripping and other heat-saving measures, may enhance the risk of lung cancer in their occupants (13–15). Other air-borne pollutants with potential health effects include allergens of various kinds. Although susceptibility to such agents differs widely among individuals, sizable populations are at risk (4). The full significance of air-borne agents as causes of disease is far from established and strongly merits continued study (4). Water In the third world microbial contamination of drinking water still –5– constitutes a major cause of death. Although this type of pollution no longer exists on a significant scale in developed countries, the chemical composition of drinking water has been implicated tentatively in the two leading causes of death in the U. S.; cancer and cardiovascular disease (4,11). It is also noteworthy that water supplies have been found to be polluted in a growing number of areas (Figure 6), owing to contamination by metals, toxic wastes, pesticides, agricultural chemicals, and products of chlorination or ozonization. The health impacts of small quantities of chemicals in drinking water cannot be assessed precisely on the basis of existing knowledge. Research is needed to elucidate the relevant causal relationships and to clarify the pathways through which compounds affecting human health may enter the water Supply (17). Food There is some truth to the adage, "you are what you eat". Overall health is undoubtedly influenced by the total intake of calories in the diet, the relative intakes of different types of foods (protein, fat, ..carbohydrates), the nutritional value of the various foods that are ingested, the presence in food of certain naturally occurring constituents or contaminants, and the presence of man-made additives or pollutants (18). In general, more is known about the nutritional requirements for normal growth, maturation, and reproduction than about the optimal diet for long life and vigor. - In the case of cancer, for example, there appear to be many ways through which the diet may affect the probability of the disease (Table 2); however, the relative contributions of any of these hypothetical mechanisms to the pathogenesis of a particular form of human cancer remains to be established (18). In this connection it is noteworthy that some dietary factors may exert protective effects which are of equal or greater importance than the carcinogenic effects of others. Hence, the net effects of the diet may reflect the balance between the two types of influences. Because of the importance attributed to the diet in the pathogenesis of cancer, heart disease, and other leading causes of death in the modern world, the role of dietary factors strongly merits further study. 0ccupation As noted above, occupational exposure to diverse physical and chemical agents at relatively high dose levels has been observed to cause various diseases. Collectively, the health impacts of these agents and of work-related stresses may approach those caused by occupationally-related accidents (5). - Occupational diseases are also significant in pointing to risk factors that may affect other populations at lower levels of exposure. In addition, occupational disease represents a category of health effects that is relatively amenable to preventive strategies. To lessen the health -6- impacts of occupational risk factors, research of several types deserves further emphasis: 1) more systematic and quantitative monitoring of physical and chemical agents in the workplace; 2) more complete surveillance and recording of work-related health effects; and 3) development of clinical and laboratory tests for ascertaining prior exposure to disease causing agents, for identifying high-risk groups, and for detecting work-related diseases at early stages, when they are most readily arrested, or reversed (4). Toxic Wastes Love Canal and Times Beach, to mention only two of many recent examples (Tables 3 and 4), testify to the need for more adequate disposal of toxic wastes. Although it is clear that disposal practices have been deficient in many instances, the development of optimally safe and cost-effective techniques will require further research, as will precise assessment of the magnitude of the risks posed by prevailing levels of contamination around existing dump sites (21-23). The assessment of risks cannot depend on epidemiological approaches -alone. This would be tantamount to making guinea pigs of exposed populations. Instead, comparative toxicological methods involving laboratory assays and animal models must be exploited insofar as possible in view of the paucity of toxicological data for most chemicals in the human environment (Figure 7). This will necessitate research to advance the state-of-the-art, in view of existing uncertainties about species differences and the interactive effects of the many chemicals that are characteristically present at dump sites. MECHANISMS OF TOXICITY: IMPLICATIONS FOR RISK ASSESSMENT AND DISEASE PREVENTION Toxicological Research As noted above, many of the impacts of environmental agents result from the combined effects of multiple factors, each of which may contribute differently to the total. Furthermore, the effects of a given agent, or combination of agents, may vary, depending on the conditions of exposure as well as the dose. In addition, although some chemicals exert their effects directly, many act indirectly, through the formation of biological active metabolites or through effects on the metabolism of other substances (4). Because of the complexity of these processes, it is difficult or impossible to assess the effects of a given agent without some understanding of its metabolism and mode of action. Knowledge of the comparative toxicology and mechanisms of action of a substance is also essential in assessing its potential risks for humans on the basis of extrapolation from its observed effects in laboratory animals, since choice of the appropriate extrapolation model cannot be made without assumptions about the relevant dose-effect relationships and mechanisms of action (25-26). With respect to the dose-effect relationship, it must not be forgotten that for some types of environmental insults no thresholds are known or –7– presumed to exist. These include the mutagenic, carcinogenic, and some of the teratogenic effects of ionizing radiation (14) and certain chemicals (4). Noteworthy in this connection is the growing evidence that exposure to lead during prematal life and early infancy may cause permanent impairment in the development of the brain, the dose-effect relationship for which extend down to doses hitherto considered montoxic and may conceivably have no threshold (27). In addition, since it is not always feasible to eliminate a toxic agent from the environment, the most practical approach for mitigating its noxious effects may be to arrest or reverse them in exposed individuals. For this purpose knowledge of the mechanisms of such effects may be crucial, as well as the ability to identify, affected individuals at early enough stages for effective protective intervention. Methods for monitoring exposed populations, as well as for monitoring the environment, are thus needed. * Social and Behavioral Factors Any consideration of the role of environmental factors in health should not neglect the influence of social and behavioral influences (28). Among these, socio-economic status is one of the most important since it may affect many, if not all, other environmental influences, directly or indirectly. Mortality from many of the common causes of death tends to vary inversely with socio-economic and educational levels (29). The poor who live in urban ghettos exemplify the problem in their high incidence of malnutrition, congested and stressful living conditions, vermin infestation, chronic exposure to dusts and other air pollutants, and relegation to hazardous working conditions, . Poverty also breeds deviant behavior, including alcoholism, drug addiction, and crime, which have enormous impacts on health. The importance of wholesome daily living habits in those who are not economically disadvantaged also deserves comment. Such simple hysical exercise, adequate hours of sleep, control of body weight, abstinence from smoking, and avoidance of excessive intake of alcohol are correlated with marked reductions in overall morbidity (30). In Mormons (31) and Seventh Day Adventists (32), who generally practice these habits, mortality from cancer and many other diseases is appreciably lower than in the population at large. Also noteworthy is the inverse correlation between level of educational attainment and cigarette consumption (33), which points to the importance of education in motivating people not to smoke or to stop smoking. The large numbers of people at all educational levels who continue to smoke, however, attest to the need for further efforts to solve the problem completely. The cigarette problem -- which accounts for more than 300,000 deaths per year in the U. S. from cancer, respiratory ailments, and cardiovascular disease (33) -- exemplifies the importance of behavioral factors, socio-economic influences , and political forces in shaping the environment for better or for worse. -8- UNDER-RECOGNITION AND UNDER-DIAGNOSIS OF ENVIRONMENTAL DISEASE As noted above, environmental diseases encompass an extremely broad range of human illnesses. They include, for example, emphysema in persons chronically exposed to acid air pollution, leukemia in persons exposed to benzene, lung cancer and mesothelioma in individuals exposed to asbestos, chronic kidney disease and neurologic impairment in persons exposed to solvents, impairment of brain development in children exposed early in life to lead, heart disease in individuals exposed to carbon monoxide, and impairment of reproductive function in men and women exposed to lead and certain pesticides. Such illnesses afflict millions of persons in the United States. Because such environmental diseases arise from man-made conditions, they can be prevented through the elimination or reduction of hazardous exposures at the source; i.e., through primary prevention. They are also amenable to secondary prevention -- i.e., early detection in presymptomatic stages when they can still be controlled or cured; this depends, however, on efficiently and effectively identifying populations at high risk. Finally, their impacts may be lessened by tertiary prevention; i.e., the prevention of complications or disability by application of appropriate diagnostic and treatment strategies. Prevention at all three levels requires adequate information about the effects of specific environmental exposures and adequate data on the places and populations affected. Laws enacted in the past two decades are intended to prevent environmentally-induced disease. These include, for example, the Clean Air Act, the Safe Drinking Water Act, the Resource Conservation and Recovery Act, and the Superfund legislation. In spite of this legislation, however, environmentally-induced disease remains widespread in American society. Given that such illnesses are important and highly preventable, why do they still persist? A series of factors interact to maintain this situation. 1. Despite at least two decades of regulatory and scientific awareness and effort, relatively little is known about the potential health effects of most synthetic chemicals. Most attention and research have been focused on a small number of relatively well known hazards, such as asbestos and lead, and their associated diseases. Wirtually no information is available on the toxicity of approximately 80 percent of the 48,000 chemical substances in commercial use (Figure 7). Even for groups of substances which are most closely regulated and about which most is known -- drugs and foods -- reasonably complete information on possible untoward effects is available for only a minority of agents (Figure 7). Premarket evaluation of new chemical products is notably inadequate. 2. Physicians are not trained to suspect the environment as a cause of disease. Most physicians do not routinely obtain histories of environmental exposure for their patients, which would allow them to identify an environmental origin of disease. Recent surveys indicate that environmental histories are recorded on fewer than 10 percent of hospital charts (34). In consequence, many diseases of environmental origin are mistakenly assigned to other causes, such as old age or cigarette smoking, and opportunities for early prevention or treatment –9– are lost. This problem of inaccuracy in diagnosis is compounded by the fact that disease of environmental origin are typically not clinically or pathologically different from those caused by lifestyle and other factors. * 3. Physicians do not receive adequate training in environmental medicine. Very little time is devoted in American medical schools to teaching physicians in training to recognize the symptoms of known toxins, or to understand the known associations between environmental exposures and disease outcomes. The average American medical student receives only four hours of training in environmental and occupational health during the four years of medical school (34). º 4. Persons are typically exposed to more than one toxic substance in the environment and often do not realize that they have been exposed at all. Further, the symptoms of many environmental conditions develop only many years after onset of exposure during this long latency (incubation). Persons may change addresses, may be exposed to a variety of environmental exposures, may suffer various environmental exposures, and finally may forget exposures which they had many years ago. All of these issues compound the difficulty that physicians and environmental scientists face in attempting to deduce the etiology of environmentally induced illness. 5. The U. S. Environmental Protection Agency (USEPA) and State environmental agencies are empowered to investigate hazardous and environmental conditions; however, severe resource limitations have reduced the capacity of these agencies to undertake necessary inspection and enforcement actions. 6. Fragmented, unreliable and outdated surveillance systems for environmentally related disease produce significant underestimates of the actual number of cases of environmentally induced illness in our society. As a result, the picture they produce does not convey an appropriate sense of urgency about reducing the burden of environmental disease. s In summary, a profound lack of information on the toxicity of the majority of commercial chemicals, insufficient and inappropriate education of physicians, and inadequate surveillance impede all efforts to reduce the impact of environmentally induced disease in the United States. A coherent plan to improve the surveillance, prevention, diagnosis, and treatment of environmental disease is sorely needed. Models which have recently been developed for the detection, treatment and prevention of occupational disease in states such as New York, New Jersey, and California might serve as useful models for undertaking such an effort (35). INADEQUACY OF RESEARCH SUPPORT From the foregoing it is evident that much of the burden of illness in the U. S. today is attributable wholly or in part to environmental risk factors. Thus, of the more than $400 billion annual health expenditures in the U. S., a major part is spent on illnesses that are related directly or -10- indirectly to environmental causes (36) and that are thus potentially preventable. Although the economic impact of such illnesses cannot be reckoned precisely without more adequate information, it is obviously enOYTIOU. S. * Viewed in the light of the enormous costs of illness to the U. S. population, the sums spent on research to prevent such illness are relatively small. In 1985, for example, only $1,180,370 of the $5,121,557 R&D funds obligated by NIH went specifically to support research on disease prevention (37). This sum amounted to less than 0.25% of the total cost of health care in the U. S. that year (37). The sum spent for the same purpose by all other federal agencies combined was far smaller (37). Hence, in view of EPA's mandate to protect, the U. S. population against environmental pollutants, it is clear that the Agency's strategies and budget for the purpose need to be greatly strengthened. Y. SUMMARY The major diseases in modern life result in large measure from the influence of environmental causes. Defined broadly, these causes encompass all external influences that may act on the human mind and body. Included, among other influences, are physical and chemical agents in food, water, air, the home, and the workplace, many of which are produced by man and/or subject to his modification. Although some such agents produce adverse effects only at high dose levels, others may cause effects at lower dose levels, conceivably without a threshold. In practice, furthermore, the observed impacts on human health frequently result from the cumulative effects of combinations of agents, in which additive or multiplicative interactions among causal agents are involved. Hence, although environmental factors have been implicated as major causes of disease, the precise role of any one causal factor in the occurrence of a particular disease cannot always be specified. By the same token, it is difficult to predict the potential risks to health that may result from a given agent at any particular dose level. In our present state of knowledge, assessment of such risks is especially uncertain when direct human evidence is lacking and estimates must be based on extrapolation from observations in laboratory animals or other assay systems. To advance our understanding of the role of environmental factors in health and disease, priority must be given to research on the following: l) more systematic monitoring and characterization of the human environment; 2) more adequate recording of human morbidity and mortality rates, with record-linkage systems to enable the frequency of specific disease to be related to possible environmental causes; 3) further development of methods for detecting indices of exposure to toxicants and for identifying high-risk subgroups; 4) refinement of laboratory tests for characterizing the biological activity of chemical and physical agents, especially at low doses and in combinations; 5) improvement in techniques for human risk assessment with particular reference to comparative toxicological methods and extrapolation from animal data; and 6) better understanding of the mechanisms of environmentally-related health effects, as needed for improvements in risk assessment and in the primary and secondary prevention of environmentally-related diseases. In addition, more -11- vigorous efforts should be directed toward the application of existing knowledge, through: 1) public and professional education, 2) standards-setting, 3) implementation of new and existing legislation, 4) law enforcement, and 5) research to evaluate the efficacy of such measures. In pursuit of its mission EPA in coordination with other agencies and institutions must have a long-range research strategy addressing each of the above needs. -12- REFERENCES l. 10. 11. 12. 13. 14. Jones, H. B. A Special Consideration of the Aging Process, Disease, and Life Expectancy.TUniversity Of CăTTfornia, Radiation Laboratory, Berkeley, California, 1955. Fries, J. F. Aging, Natural Death, and the Compression of Mortality. New England J. Med. 303: 130-135, 1980. Donabedian, A., Axelrod, S.J., Swearingen, C., and Jameson, J. Medical Care Chart Book, 5th Edition. Bureau of Public Health Economics, University of Michigan, Ann Arbor, Michigan, 1972. Second Task Force for Research Planning in Environmental Health Science. Human Health and the Environment - Some Research Needs. U. S. Department Of Health, EdUCăţīOTänd WeTFăre, DHEWTPub. No. NIH 77-127, Washington, D. C., 1977. Levy, B.S. and Wegman, D. H. (Editors) Occupational Health: Recognizing and Preventing Work-Related Disease. Little, Brown and Co., Boston, I983. Cairns, J. The Cancer Problem. Sci. Amer. 233:64-78, 1975. Doll, R. An Epidemiological Perspective of the Biology of Cancer. Cancer Res. 38:3573–3583, 1978. - Inhaber, H. Risk of Energy Production, ACEG-ll 19/REV-1, Atomic Energy Control Board, Ottawa, Canada, May 1978. Morgan, M. G., Morris, S.C., Henrion, M., Amaral, D. A. L., and Rish, W. R. Technical Uncertainty in Quantitative Policy Analysis - A Sulfur Air Pollution Example. Risk Analysis 4:201-216, 1984. Morgan, M. G., Henrion, M., Morris, S.C., and Amaral, D. A. L. Uncertainty in Risk Assessment. Environ. Sci. Technol. 19:662-667, 1985. Letter to the Editor. Chernobyl Public Health Effects. Science 238:10-11, 1987. Task Force on Environmental Cancer and Heart and Lung Disease. Environmental Cancer and Heart and Lung Disease, 3rd Annual Report to Congress. U. S. Environmental Protection Agency, Washington, D. C., 1980. Committee on Indoor Pollutants. Indoor Pollutants. National Academy of Sciences, Washington, D. C., 198T. Advisory Committee on the Biological Effects of Ionizing Radiation. The Effects on Population of Exposure to Low Levels of Ionizing Radiation. National Academy of Sciences, Washington, D. C., 1980. -13– 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. National Council on Radiation Protection and Measurements. Evaluation of Occupational and Environmental Exposures to Radon and Radon Daughters in the United States.TNCRPTREDOFETNOTE.TNationäT Council on Radiation Protection and Measurements, Washington, D. C., 1984. Dickson, D. Toxic Synopses: United States. Lessons on Love Canal Prompt Clean Up.. Ambio ll:46-50, 1982. Committee on Safe Drinking Water. Drinking Water and Health, Vol. 4. National Academy of Sciences, Washington, D. C. T982. Committee on Diet, Nutrition, and Cancer. Diet, Nutrition, and Cancer. National Academy of Sciences, Washington, D.TC. T982. Doll, R. The Epidemiology of Cancer. In: Accomplishments in Cancer Research, 1979 Prize Year General Motors CancerTResearch TFoundation, edited by J.G. Fortner and J.E. Rhoads, J. B. Lippincott Co., Philadelphia, 1979, pp. 103–121. Weiss, B. and Clarkson, T. Toxic Chemical Disasters and the Implications of Bhopal for Technology Transfer. Milbank Quarterly 64:216-240, 1986. Office of Technology Assessment. Technologies and Strategies for Hazardous Waste Control. U. S. Congress, Washington, D.TC. T983. National Materials Advisory Board. Management of Hazardous Industrial Wastes. National Academy of Sciences, Washington, D. C., 1983. Committee on Response Strategies to Unusual Chemical Hazards. Assessment of Multichemical Contamination. National Academy of Sciences, Washington, D. C., 198T. National Academy of Sciences - National Research Council. Toxicity Testing. Strategies to Determine Needs and Priorities. National Academy Press, Washington, D. C., T984. Committee on Chemical Environmental Mutagens. Identifying and Estimating the Genetic Impact of Chemical Mutagens. TNational Academy of Sciences, Washington, D. C., 1982. Omenn, G. S. Environment Risk Assessment: Relation to Mutagenesis, Teratogenesis, and Reproductive Effects. J. Amer. Coll. Toxicol. 2:113-123, 1983. Bellinger, D., Leviton, A., Waternaux, C., Neddleman, H., and Rabinowitz, M. Longitudinal Analyses of Prenatal and Postnatal Lead Exposure and Early Cognitive Development. N. Engl. J. Med. 3.16:1037-1043, 1987. -14– 28. 29. 30. 31. 32. 33. 34. 35. 37. Eisenbud, M. Environment, Technology, and Health. Human Ecology in Historical Perspective. New York University Press, New York, 1978. Occupational Mortality: England and Wales, 1970-1972. (Decemial Supplement). Her Majesty's Stationery Office, London, 1978. Belloc, N. B. Relationship of Health Practices and Mortality. Prev. Med. 2:67–81, 1973. Lyon, J. L. Gardner, J. W., and West, D. W. Cancer Incidence in Mormons and non-Mormons in Utah During 1967-1975. J. Nat. Cancer Inst. 65:1055-1062, 1980. Phillips, R. L., Garfinkel, L., Kuzma, J. W., Beeson, N. L., Lotz, T., and Brin, B. Mortality Among California Seventh-Day Adventists for Selected Cancer Sites. J. Natl. Cancer Inst. 65:1097-1108, 1980. Surgeon General. Smoking and Health. Department of Health, Education, and Welfare, Washington, D. C., T979. Levy, B. S. The Teaching of Occupational Health in United States Medical Schools: Five-Year Follow-Up of An Initial Survey. Amer. J. Public Health 75:79-80, 1985. Markowitz, S. B. and Landrigan, P. J. Occupational Disease in New York State. Mount Sinai School of Medicine, New York, TT987. . Institute of Medicine. Costs of Environment-Related Health Effects: A Plan for Continuing Study. National Academy Press, Washington, D. C., 198]. National Institutes of Health. Data Book. U. S. Printing Office, Washington, D. C., 1986. -15- Table 1. Some Place Meuse Walley, Belgium Donora, Pennsylvania London, England New York, New York London, England Selected Acute Air Pollution Episodes Date December 1930 October 1948 December 1952 November 1953 December 1962 Estimated Nos. of Attributed Excess Deaths 63 20 4,000 200 v. 700 —16- Table 2. Ways in Which Diet May Affect Incidence of Cancer 1. By providing source of carcinogens or precarcinogens: -- Natural components of plants -- Products of chemical, bacterial or fungal action during processing or storage -- Products of cooking -- Contaminants (products of fuel combustion, pesticide residues) 2. By affecting formation of carcinogens: -- Provision of substances for formation of nitrosamines (secondary amines, nitrates, nitrites) -- Inhibition of formation of nitrosamines as in stomach (Vitamin C) -- Alteration of excretion of bile salts and cholesterol into large bowel (fat) -- Alteration of metabolism of carcinogens (enzyme induction by meat, fat, indoles in vegetables, antioxidants) -- Alteration of enzyme formation (trace elements) -- Affect on formation of estrogen (fats, total calories) 3. By modifying effects of carcinogens: -- Through transport (alcohol, fiber) Through effect on concentration in bowel (fiber) Inhibition of promotion (Vitamin A, beta-carotene) (From Reference 19) – 17- Table 3. Some Acute Environmental Pollution Episodes Toxic Pollutant Location Year Mercury Minimata Bay, Japan 1959 PCBa Kyushu, Japan 1968 PBBa St. Louis, Michigan 1973 Lead Kellogg, Idaho 1976 Dioxina Seveso, Italy 1976 DBCPa Lathrop, California 1977 Kepone Hopewell, Virginia 1978 Multiple Agents Love Canal, New York 1978 Dioxin Times Beach, Missouri 1983 Dioxin Newark, New Jersey 1983 © *PCB defined as polychlorinated biphenyls, PBB as polybrominated biphenyls, dioxin as 2,3,7,8-tetrachlorodibenzo-p-dioxin, and DBCP as l,2-dibromo-3-chloropropane. -18- Table 4. Examples of Outbreaks of Mass Human Poisoning From Toxic Chemical S Date" Location Chemical No. Affected 1930 U.S. A. Triorthocresyl phosphate 16,000 1934 Detroit Lead g 4,000 1952 London Air pollutants 4,000 1952 Japan Parathi on 1,899b 1952 Moringa (Japan) Arsenic 12, 159 955 Minamata (Japan) Methylmercury l,000 1956 Turkey Hexachlorobenzene 4,000 1958 Kerala (India) Parathi on 828 l 959 Morocco Triorthocresyl phosphate 10,000 1960 Iraq Ethylmercury 1,022 1964 Niggata (Japan) Methylmercury 646 1967 Qatar Endrin 69 l 1968 Japan Polychlorinated biphenyls 1,665 1971 Iraq Methylmercury 50,000 1976 Pakistan Malathion - 7,500 1981 Spain Toxic oil 12,600c 1984 Bhopal Dimethyl isocyanate 2,000 *Year of onset. *These were the estimated number of exposed babies. It was stated that several thousand were poisoned and 131 died. “Deaths. The full scale of lingering and permanent morbidity remains unknown. (From Reference 20) -19- Figure l *: 1-I-T-I-T-I-T-I-T-I-T-T—t G Indig, 1900 soo & Mºxico, Yºo e Thoslord, 1947 E.G. Jopon, 19CO, Wºo | &ºs United States, 1900, 1940, 1930 •e England, 1900 Geo of inford, 1949 ©Geºgurn, 1980 | :so 25 wº wº AF -.-: . Age-Specific Death Rates in Warious Countries and Years (From Reference 1). –20- O 2 > > C- -) (M) |- 22 Lll O C- Ull GA- 0 10 20 30 40 50 60 70 80 90 100 AGE Figure 2 The Increasingly Rectangular Survival, Curve in the U.S. About 80 percent (stippled area) of the difference between the 1900 curve and the ideal curve (stippled area plus hatched area) had been eliminated by 1980. Trauma is now the dominant cause of death in early life. (From Reference 2). –21– Percent of all deaths 1900 1967 Cause of death 10 O . 1O 2O 30 40 Diseases of the heart Malignant neoplasms Vascular lesions affecting central nervous system All occidents Influenza or pneumonio Diseases of early infancy General arteriosclerosis Digbetes mellitus Other diseases, of circulatory system Other broncho- pulmonic diseases Tuberculosis Gastrics, etc. Chronic nephritis Diphtheric Cz 1900 Cºx, 1967 42 sº Figure 3 Leading Causes of Death in the United States, 1967, as Compared with 1900. (From Reference 3). –22- Figure 4 1 Lº * 50 1,000 y /_p^ O { & & º - {} LUNG CANCER 100e 0. 1909 10 0 1940 e 1900 Time-Trends in Lung Cancer Mortality and Cigarette Consumption in England and Wales. (From Reference 1 * 6). –23– soor dº tº ANNUAL *} º ; : : |NCIDENCE : : : standardized . * - for age : : : rºº ºl * ſº MEN w” : : . ; : º 200 || ve : 0. f : # * de # 100 . ; : - $ i “–– A– -*——º- O 20 30 40 Dose RATE (cigarettes smoked per day) Figure 5 Incidence of Lung Cancer in Regular Cigarette Smokers in, Relation to Number of Cigarettes Smoked Per Day. (From Reference 7). –24- Shaded areas = Reported pollution areas Open areas = Areas that may not be problem-free, but the problem is not considered major. 0 Industrial chemicals other than chlorinated hydrocarbons Heavy metals, such as mercury, zinc, copper, cadmium and lead Chlorinated hydrocarbons from treatment processes & energy development * Coliform and other bacteria Saline Water General municipal and industrial waste Figure 6 Drinking Water Problem Areas (As Identified by Federal and State Regional Study Teams). Source: U. S. Water Resource Council. (From Reference 16). -25- Black bars Dotted bars 34ae ºf ºatiated ºn Pereºat £atºr. Pesticides -d Laert 3, 330 N - Lugredients ºf Pesticide N - Perºnalatises NN E. 19 24 2 24 Cee-tie agredients 3.410 2 14 19 10 3& Drugs ºd ºasipients 1.813 used in Breg Peºlatises Feed A444t4vº 0, 627 Che-deals in Cº-ree: 12,000 Creater than of equal to 1,000,000 lb/ye 11 11 - 70 Chºsals a Cº-ºrest 13,911 §4 Leae thº- N % Z 1,000,000 le/yr - º 12 12 70 Chºicals tº Cº-ree: 21, 732 N/ Productise val- or § - taaesessible N 7. 10 0 º Complete health hazard assessment possible Partial health hazard assessment possible Slanted line bars = Minimal toxicity information available Horizontal line bars = Some toxicity information available Open space bars Figure 7 (but below minimal) = No toxicity information available Adequacy of Available Data on Chemicals of Different Categories for Health-Hazard Assessments. (From Reference 24). -26- Chapter 2 J KINDS OF LONG-TERM RESEARCH James Fouts LONG-TERM HEALTH EFFECTS RESEARCH SUPPORTIVE OF EPA PROGRAM NEEDS I. Basic Research Basic research needed in EPA programs may or may not be directed specifically at support of certain applied research programs. Such basic research may seek only to understand deeper levels of the general universe of problems attacked in the specific, discrete long-term, applied researches (such as described just below). The general basic research philosophy is that understanding more about the ways chemicals Cause disease can lead to earlier detection or better tests for adverse health effects (and better designs of epidemiology studies), better analytical methods, etc. All of this can and often does lead to better bases for regulation and, thus, better regulation. (See Section III below) Some of this basic research can be directed at using some of the "new biology" to advance our ability to assess exposure or to better identify and quantify specific bad effects of (or bad actors in) complex mixtures of chemicals occurring "naturally". Overall though, the distinguishing feature of this basic research is that it addresses more "generic" issues, and that it not necessarily be tied into any one specific problem nor seek "quick" answers. As such, it must be supported for several years to be effective and to give the kinds of findings that will be most useful to many "applied" research programs. It is, however, true that often the most useful facts and new approaches needed in resolving any environmental emergency have come from turning to laboratories doing good basic research. There are many examples here of the kind of research that probes deeper (and is more risky) than any of the applied programs. Some of these might be: A. New methods to detect and quantify dioxins Basic research has identified and characterized an intracellular "receptor" for dioxins and related compounds. Studies carried out over many years resulted in the partial purification of this receptor, and better understanding of the mechanisms, and specificity of several of the biological effects of dioxins. Recently, using the "new biology" techniques, this "dioxin" receptor has been cloned and can now be made available to "methods" (and other) research. Basic research in such areas/uses has pointed to one possible application of these studies--the use of this cloned dioxin receptor to isolate/separate and identify small amounts of dioxins and, at least, some dioxin-like materials in complex mixtures--particularly of the dioxins in soils, waste site effluents, etc. The research on the "dioxin" receptor is the kind of basic research effort which may now come to "fruition" (e.g., in the new methods –27- for assaying dioxins in mixtures). But it has stretched over many years, and although never without some merit to the most practical/applied of objectives, has not been of immediate value to most of the EPA needs. B. New methods for detecting exposure to some toxic chemicals The cytochrome P-450s are a component of steroid, lipid, and xenobiotic metabolizing enzyme systems found in a variety of living systems (from yeast to humans). Much basic research over at least 35 years has led to some understanding of the diversity and responsiveness of these systems in many species. The "new biology" again has given us some new tools for quantifying and identifying many of these pigments. It is now possible to "fingerprint" the kinds and amounts of many different isozymes of P-450 in tissues of many animals (including humans) and plants. Basic research has described in some detail the responsiveness of these P-450s to various environmental stresses (including chemical exposures). Taken all together then, this long-continuing, basic research program may now be giving us tools for looking at the exposures of plants, animals, and humans to many environmental chemicals--e.g., the amounts and types of P-450s seem to reflect exposures to things like pesticides, smoke, solvents, etc. Further, basic research work (especially in pharmacokinetics) may even give us a tool for assessing both acute and cumulative/chronic toxic exposures (of species ranging from fish to humans) using these monoclonal antibodies for specific P-450s. II. Applied Research There are several types of research activity which have application to specific problems and specific settings, but which must be carried on over a period of several years. These can be divided into 3 major categories: 1) research programs with discrete and sequential parts/steps--where one part must usually be done before another can be initiated/planned, 2) research programs that often take a long time, but parts of which can be carried on concurrently, and 3) methods development and validation. A. Long-term research programs best done in sequential steps This is usually a series of several, discrete projects, each of which generates data useful/needed in other related projects--either in their design or execution. There are many examples here, but the key feature in each is that this is a long-lasting program with several stages, and each stage feeds into/sets up the next action: 1. The ozone layer and ozone depletion This is a program which has continued for many years. The human and ecological health effects implications of this are enormous. Human health effects of the ozone-layer depletion include possibly large increases in UV light-induced cancers and other serious skin diseases. Ecological effects on agriculture/crops may be equally human –28- life-threatening, though less direct. There have been many stages in this overall program: a. The first studies looked at the issue--Is there any evidence that we are actually losing stratospheric ozone? The answer to this (data supporting this) is still being gathered and debated (at least in some quarters), but the first indications were that evidence existed to Suggest a loss; therefore, step 2 was needed. b. The second step seemed to be: What might be causing this loss of ozone? Is there any human contribution (e.g., chemical) which can destroy ozone and which is likely to get to the ozone layer? Data about the chemistry and interactions of light, ozone, and hydrocarbons had to be generated here first. Some experiments are still being carried out at this stage. * c. The next step was to gather data about the presence of ozone-destroying materials/chemicals (e.g., halogenated hydrocarbons) in the upper layers of the atmosphere. New methods for measurement, collection of samples etc. had to be developed, validated and used. d. Then real-life sources of these hydrocarbons had to be sorted out and evaluated for their possible contributions to the problem. e. Then decisions as to which steps would be most effective in changing the amount of hydrocarbons at the ozone layer had to be decided. - - Thus, many types of research were/are involved here---chemistry, biochemistry, ecology, climate, stratospheric, marketing, sociological/psychological, and political. However, the steps to be taken next in the overall strategy of dealing with this problem depended on the outcome of those studies made just before and on most of those preceding. 2. The ecologic and health effects of acid rain A number of issues have been raised here, but they all concern whether acid rain or another source of pollution has caused the effects, and what these effects really are. Acid rain is believed to be formed primarily from industrial sources, though others are also possible and constitute another subset of evolving issues. One example in this problem area is whether the damage to trees (and other flora, here and in Europe) is due to acid rain from factories and electric power generation or is caused by pollutants from cars/traffic, etc. A series of studies has been made and others are continuing. It is becoming obvious from some of the results that the answer is "yes" to both; tree damage (and crop effects/human health effects) may result from acid rain and car exhaust. This answer comes from a series of sequential and evolving researches carried out over several/many years. One of the most recent reports on all this (including some limited assessment of human health effects of acid aerosols) is probably the National Acid Precipitation Assessment Program report issued in September 1987. Human health effects of acid aerosols were recently re-assessed at an EPA-NIEHS sponsored symposium held at NIEHS –29- in October 1987. The report of this will be published in Environmental Health Perspectives in 1988. This research effort in both ecoſogy and human Thea Tth effects of acid rain has gone on for years/decades, and some answers are only now becoming barely visible. B. Long-term studies with concurrent steps These are studies that just take a long time--the objectives are such that the study just can't be done in short time frames. Many "purely" epidemiology studies fall here--where the questions concern health effects of low level, chronic exposures or seek to determine endpoints resulting only years after exposure or in populations that must "age" to have detectable effects. Most studies on possible causes of cancer or on carcinogenic effects of chemicals are here. So are evaluations of the causes of many other slowly developing effects/diseases (e.g., emphysema, kidney failures, liver damage, and CWS or CNS effects). These evaluations involve multiple studies done at the same time but continuing for a long time on the same populations. Chronic toxicity studies in animals are a subset of this kind of approach. There are many examples here: 1. The "Six Cities Studies" of health effects of air ‘pollution--comparing various indices of health in persons living in 6 cities of widely varying degrees of pollution. This Study has been going on for years now. Some part of the increasing clarity in this Study results from more data--accumulated now over more than 10 years, but some part is the adding of new tests and better data analysis to the screens for health effects. The point is that this Study required/used repeated studies of the same populations/regions over several years to establish effects and to clearly associate these health effects with the changes in air pollution (which occurred during the years of the study) in these 6 "regions". The principal effects now being seen are those on the lung (lung function decrements), but other systems (e.g., kidney, CWS) may be shown to be affected as these studies continue. 2. The effects of maternal polychlorinated biphenyl (PCB) exposures on childhood development. This began with séveral accidents both in the U.S. and elsewhere (e.g., cooking oil contaminations in Taiwan and Japan and accidents like the dumping of waste oil contaminated with PCBs along highways, and the exposures of persons living near, or walking along these highways). From both short- and long-term animal studies it was known that many serious effects of PCBs were not seen acutely but were instead delayed in onset and subtle. Therefore, several epidemiology studies were begun to follow (for several years) health in populations of PCB-exposed persons and especially in any children they might have. The effects of various levels of maternal exposure to PCBs on childhood development are now being described in some detail but only because these accidentally-exposed populations and a large number of "less-exposed" and "normal"/unexposed women and children were followed for many years. 3. The effects of polybrominated biphenyl (PBB) exposure. Again, this began with an accident--the mixing of PBBs into animal feed and the spread of this chemical/mixture among many farms and into many parts of the food chain in Michigan. Heavily-exposed persons are still being –30– monitored for effects, since again, animal studies show that these effects are delayed and subtle. C. Development and validation of test methods In many cases the methods for detecting and quantifying new environmental toxins/problem chemicals do not exist at the time such "problems" are first discovered. This set of "long-term" research activities is vital in any program seeking to understand and affect environmental health hazards. There are many examples here, but only a few can be given: 1. Dioxins (PCDDs) and dibenzofurans (PCDFs) Chemical methods for detecting, separating, and quantifying these "families" of toxic materials did not exist when the first "poisoning" episodes in humans occurred. The amounts of these materials present in samples from most accidents is very small, and yet, in animals, these chemicals show toxic effects at extremely low concentrations. We are only now getting the methods needed to detect, quantify and selectively identify and separate the wide variety of these chemicals found in most real life exposures. Some of the newest in analytical techniques were developed to meet this problem/series of problems. The best of separation and analytical methods were required to identify the dibenzofurans as contaminants of the PCBs and dioxin mixtures and also as contributors to some of the toxicological effects/problems associated with these mixtures. This long-term research has stretched over at least twenty years and is not ended yet. Walidation of all these methodological advances is still occurring. 2. Lead With/in several environmental problems we need some measure of the toxic material in "deep" body tissues. Getting at these without painful surgery/biopsy or the use of autopsy material is a must if the amounts of information we need are to be generated--particularly for long-term studies, or for uncovering chronic effects (although this information may also be vital for acute emergencies). Lead, like several other metals, tends to stay only briefly in readily accessible body tissues and fluids. Stores of lead and several other chemicals occur in relatively inaccessible tissues like bone, teeth (or deep fat, etc.). Methods to measure these "deep" stores of toxic chemical are urgently needed. Non-invasive methods are especially useful/attractive for screening/repeated measurements. Newer methods for this in the case of lead may be possible now with X-ray fluoroscopy. Walidation of this method is now taking place--total time from concept to use will be about –31– ten years if all goes well--a long-term effort typical here of several Others. III. How EPA Uses/Depends on Basic Research Conducted by Other Federal Agencies Health research within the EPA is ultimately directed toward the regulatory mission of the Agency. While such research is often of an "applied" and/or "immediate" nature which answers specific problems that the Agency must deal with in an expeditious manner, sound basic or fundamental research is the only method of improving the scientific rationale underlying regulatory decisions. It is vital that the EPA Scientific staff maintain current awareness of relevant basic research by performing such research within the Health Effects Research Laboratory and by closely following the latest developments in toxicological research. The Agency cannot effectively accomplish its research mission without Scientists who have competence in and knowledge of the tools of basic research. Without this competence and knowledge health scientists within the Agency would be unable to effectively translate the findings of fundamental research into the applied research areas most supportive of the Agency's regulatory mission. However, since basic research performed by EPA represents only a small fraction of that which is necessary to support its regulatory mission, the Agency must rely heavily on basic research information developed by other Federal agencies particularly by the various Institutes of the Department of Health and Human Services. These organizations have been reponsible for many of the scientific breakthroughs in molecular biology, genetics, biochemistry, immunology, and cancer research that have enabled development of applied methods for exposure monitoring, dosimetry, toxicological testing, and biochemical epidemiology. Basic research performed through programs developed at the National Institutes of Health has substantially impacted the Agency's regulatory approaches and policies. Research on the molecular basis of mutation, xenobiotic metabolism, pharmacokinetics, and molecular dosimetry performed at the National Institute of Environmental Health Sciences has found applications at EPA in genetic bioassay development and improved metabolic activation systems for in vitro test systems, molecular techniques for exposure monitoring, and advanced methods for human biochemical epidemiology. Fundamental research by the National Cancer Institute on mechanisms of carcinogenesis and immune surveillance has contributed directly to the development of toxicological test methods and guidelines for cancer risk assessment promulgated by the EPA Office of Health and Environmental Assessment. EPA is benefiting directly from widely and federally-funded basic research in the area of neurotoxicology. The discovery of biochemical differences among various cell types within the central nervous system (and their concomitant differential vulnerability) is leading to an improved understanding of mechanisms of neurotoxicity and improved methods for the assessment of adverse neurotoxicologic responses. These methods will undoubtedly contribute to future Agency guidelines for neurotoxicity testing. In addition to the use which the Agency makes of basic research information generated by other Federal agencies through indirect means –32– (information appearing in the literature and discussed at scientific forums), the Agency also depends upon active research collaborations which take advantage of basic findings and/or expertise. EPA scientists frequently engage in collaborative studies with scientists in other governmental agencies as well as their colleagues in academia who may be funded by these agencies. These research efforts often take advantage of expertise in new technologies and new findings that may have applications to the regulatory mission of the Agency. As an example, research on mechanisms involved in the successful fertilization of the oocyte has led to interagency collaborative research to improve methods for the evaluation of male fertility. Other research efforts delineating the fundamental factors involved in dermal absorption have led to joint interagency research projects centered on the development of improved methodologies for the assessment of the kinetics of such exposure. Clearly, it would be possible to extend this list of relevant examples since much of the scientific information utilized by the Agency for regulatory decision-making and guidelines formulation rests on a foundation of basic research. –33– Chapter 3 g RESEARCH ADVANCES IN THE TOXICOLOGY OF LEAD Kathryn Mahaffey PREAMBLE The place of and necessity for long-sustained basic research activity in the development of a foundation for constructive action in important problems in environmental health could be illustrated by reference to any of several current problem areas. We have chosen the story about lead and its dangers or toxicity to serve this purpose. Lead as a public health problem has been recognized for years (if not centuries). Yet how, what, and when to do something about both preventing its health effects and treating those not prevented have been obvious only recently, and only as a result of long-continuing basic research. For one thing, only long-range, multidisciplinary, continuing basic research has given us the varied tools we need to detect some of the more subtle (yet extremely important) effects of lead. We have moved from counting dead bodies to worrying about things like changed behavior and nerve damages in lead-exposed children--but only because we now have some good tests for such effects of lead. This then is the story of an environmental health research success--made possible only because such slow-moving (and sometimes hard to explain) studies were pursued and supported by far-sighted people who believed that long-range research was and would continue to be extremely cost–benefit positive. Background Understanding the range of adverse health effects produced by lead exposure has advanced markedly in this century. Research into the toxic effects of lead provides a paradigm that has guided the entire discipline of clinical and laboratory toxicology for the past five decades. Fundamental multidisciplinary laboratory research in such areas as biochemistry and physiology has been a major key to this progress. Lead has long been recognized to be acutely toxic at high-dose exposure. In addition, we now recognize, based on reearch findings in the 1970's and 1980's, that lead toxicity reflects two patterns of lead exposure. Adverse neurobehaviorial effects of lead on infants occur at levels within one standard deviation of the mean concentration of the United States population. Superimposed on the general population lead exposure is an additional severe problem of high-level lead exposure concentrated among young children from lower socioeconomic families, particularly those from urban areas. In children, high-dose exposure to lead, such as results from ingestion of lead-based paint, has been shown to cause a profound neurologic syndrome characterized by coma, convulsions, and in severe cases death. In adults with high-dose exposure to lead, abdominal cramping, a syndrome termed "wrist and ankle drop," and end-stage renal disease are the well-recognized consequences. -34- The challenge has been to understand that the range of health problems caused by lead was much more extensive than the clinically-obvious disease. What has made this challenge especially difficult is that environmental lead pollution has been at very high levels, producing an elevated body burden of lead in a sizable portion of the population. During the 1970's in metropolitan areas, young children frequently had blood lead concentrations greater than 40 g/dl; a concentration now associated with several neuropsychological impairments. The challenge is to perceive the etiology and severity of health problems that are so common they are considered "normal." In the paradigm of lead public health and preventive medicine have progressed from enumerating mortality and morbidity (i.e., case reports) to understanding the disease process. This progress reflects and has been possible only because of long-range support of environmental research. Among the most exciting recent findings with respect to understanding of the toxicology of lead is the realization that lead is capable of producing toxic effects in adults and children at relatively low levels of exposure, i.e., levels that are insufficient to produce grossly clinical symptoms. Only a decade ago such levels of lead exposure were considered "safe". Lead is now recognized to produce a syndrome of subclinical toxicity. Recent research has demonstrated that this subclinical toxicity of lead is a many-faceted syndrome involving multiple organ systems. The developing red blood cells, the nervous system, and the kidneys are the organ systems in which these toxic effects have been more intensively Studied. - In the early 1900's lead exposures were so high that occupational records routinely reported lead-induced mortality statistics. For example, Hoffman (1935) reported that the number of deaths attributed to lead poisoning for the United States registration area between 1900 and 1933 was in excess of 3400. The number of deaths among children, who are more susceptible to the effects of lead exposure, remains largely unknown. In the 1940's through the 1960's descriptive reports of clinical aspects of the disease dominated the literature. Prior to the introduction of chelation therapy, severe lead poisoning with encephalopathy had a mortality rate of 65% (NRC, 1972). Among survivors of lead poisoning profound neurological damage is the predominant, reported effect. For example, Byers and Lord (1943) and other clinicians showed long-term residual sequelae of acute pediatric lead poisoning which included mental retardation, seizures, optic atrophy, sensory motor deficits, and behavioral dysfunctions. Perlstein and Attala (1966) reported such sequelae in 37% of children who suffered lead poisoning without evidence of encephalopathy. Through screening programs to identify children with lead toxicity before they become symptomatic, and through legal requirements to monitor occupational exposures of workers to lead, severe clinical cases of lead toxicity have been brought under a degree of control; however, they have not been eliminated. These case reports, describing clinical aspects of intoxication, have identified which organ systems are most affected at –35- high-dose exposures. The limited reversibility or irreversibility has been documented in many of the clinically-reported, neurologic effects. Using these clinical studies as a guide, long-range, multidisciplinary research has extended the understanding of lead toxicity to the current emphasis on biomarkers of exposure, dose-response relationships for specific effects, and identification of susceptible subgroups for these effects. Research Findings in the 1970's and 1980's The general picture of adult and pediatric lead poisoning has changed in recent decades. The overall pattern is identification of significant adverse health effects at progressively lower exposures. These can be arbitrarily separated into neurobehavioral, hematopoietic, renal/endocrine, and reproductive effects. As a part of this effort, differential sensitivity of various subpopulations has been revealed. Identification of effects occurring at environmental exposures once considered "normal" has coincided with reducing environmental exposures to lead. Only through reduced exposures can the results given by toxicology and epidemiology research be evaluated in general human populations. © I. Neurobehavioral Effects Recognition that neurobehavioral effects in children are produced by lead exposures considered "normal" in earlier decades (e.g., blood lead concentrations of 20-50 g/dl) has been among the most significant research findings in the 1970's and 1980's. Longitudinal studies during the past 10–15 years built upon early case reports and cross-sectional studies. The longitudinal prospective designs have permitted gathering improved information on exposure histories. Information on exposure levels and patterns is clearly important in assessing effects of a cumulative toxicant on endpoints such as neurobehavioral function that may reflect changes induced at far earlier, but critical, developmental periods. The most consistent finding of the prospective studies is that an association exists between low-level lead exposures during developmental periods (especially prematally) and later deficits in neurobehavioral performance. This latter is reflected by indices such as the Bayley Mental Development Index, a well-standardized test for infant intelligence. Blood lead concentrations of 10-15 g/dl constitute a level of concern for these effects (EPA, 1986). In addition, impaired neurophysiological function has been associated with increasing blood lead concentrations among children. These functional deficits include changes in the auditory brainstem evoked potentials and evidence of lead-related reduced hearing acuity (Robinson et al., 1985, 1987). These subclinical toxic effects of lead on the central nervous system are generally considered to be permanent and irreversible, and they are associated with permanent loss of intelligence and irreversible alteration in patterns of behavior. Bellinger et al (1987) reported significantly lower post-natal development scores on the Mental Development Index of infants from an upper-middle class population when maternal blood lead levels were in the rnage of 10–25 g/dl. Among adult women ages 20-40 years mean, blood lead levels were between 10 and 12 g/dl. based on the NHANES II general –36- population data for the period 1976-1980 (Mahaffey et al., 1982). Thus, it must be emphasized that these neurobehavioral changes are associated with blood lead levels within one standard deviation of the mean blood lead level of the United States' population reported in the NHANES II data. The peripheral nervous system is also affected by lead. Typically, adults are likely to demonstrate peripheral rather than central nervous system effects. In the early 1960's investigators began to call attention to "subclinical" neuropathy manifested by changes in peripheral nerve conduction velocity in lead workers not having overt neurological involvement (Sessa et al., 1965). In the 1970's Seppalainen et al. (1972, 1975) reported the slowing of the maximal motor conduction velocity of the median and ulnar nerves and other electromyelographic abnormalities in workers whose blood lead concentrations never exceeded 70 g/dl. Investigations of the behavioral effects of lead uncovered an increased hearing threshold, decreased eye-hand coordination, and other physiological and psychological changes in workers with blood lead concentrations below 80 g/dl. (Repko et al., 1975). II. Hematopoiesis Anemia has been a symptom of severe clinical lead poisoning in both children and adults. Anemia (increased prevalence of hemotocrit values below 35%) is now recognized to become evident in one-year-old children at blood values of 30 g/dl. Lead interferes with synthesis of heme and the formation of hemoglobin at a number of metabolic steps. In the developing red blood cells lead inhibits the enzyme -aminolevulinic acid dehydratase to increase levels of erythrocyte protoporphyrin in children. The threshold for this effect in children is associated with a blood lead concentration of 15-18 g/dl (Piomelli et al., 1982). Impaired heme biosynthesis produces effects in addition to anemia. The accumulation of protoporphyrin IX (measured as zinc protoporphyrin or as protoporphyrin in erythrocytes) is not only an indicator of diminished heme biosynthesis but also signals general mitochondrial injury. The final step of heme biosynthesis occurs in the mitochondria. Such injury to the mitochondria can impair a variety of subcellular processes including energy metabolism and homeostasis. Health implications of such impairment include: reduced transport of oxygen to all tissues; impaired cellular emergetics; disturbed immunoregulatory role of calcium; disturbed calcium metabolism; disturbed role in hematogenesis control; impaired detoxification of xenobiotics; and impaired metabolism of endogenous agonists (e.g., metabolism of tryptophan). III. Renal Effects Acute high-dose lead exposure in children produces a Fanconi-type syndrome with glucosuria, phosphaturia and aminoaciduria secondary to poisoning of the proximal convoluted tubule. High-dose exposure to lead in childhood has been associated with glomerular nephritis and renal disease in adults. Among occupationally-exposed adults, an increased rate for mortality from all causes, from all neoplasms (specifically, cancers of the stomach, liver, and lungs), from chronic nephritis, and from other hypertensive disease (i.e., hypertension due to kidney damage and not heart –37- © disease) were observed in a longitudinal study of workers in lead battery plants and lead smelters (Cooper, 1985). A statistically-significant relationship has been reported between increases in systolic and diastolic blood presures and increases in blood lead among 40-to-59 year old, white males from the NHANES II survey population (Pirkle et al., 1985). Impairment of the endocrine functions of the kidney have been reported to occur at much lower lead exposures. Recognition of these effects required development of several areas of research: A. Understanding the metabolic activation of Vitamin D to 1,25-dihydroxyvitamin D. This metabolite is critical to regulation of calcium metabolism. * B. Recognition that lead impairs various steps in both biosynthesis and function of 1,25-dihydroxyvitamin D. Currently, the most studied site at which these metabolic pathways converge is the proximal convoluted tubule of the kidney. Here 25-hydroxyvitamin D, formed in liver from Vitamin D, undergoes a second hydroxylation which is catalyzed by the enzyme l , , 25-hydroxyvitamin D hydroxylase. Research using in vitro techniques (following in vivo exposure of chickens to lead)Thas demonstrated that lead inhibits the activity of this enzyme. Findings from a clinical investigation among young children indicated that plasma l,25-dihydroxyvitamin D levels were depressed in proportion to blood lead concentration. Chelation therapy to reduce body burden of lead, resulted in increasing serum concentrations of 1,25-dihydroxyvitamin D up to levels similar to those present in children serving as controls (Rosen et al., 1980). Additional epidemiological research has shown that 1,25-dihydroxyvitamin D concentrations were decreased with increasing blood lead concentration over a broad range of blood lead concentrations, 12 to 120 g/dl (Mahaffey et al., 1982b). IV. Reproductive Effects Early in the century a number of adverse effects of lead on reproduction were reported among women with occupational lead exposures. These included increased spontaneous abortion rate, increased still-birth rate, and a higher, post-natal and early childhood mortality rate among children of such exposed women. Exposures associated with these adverse outcomes were very high. However, longitudinal, prospective studies, designed to evaluate neuropsychological effects of lead, have provided important information on reproductive effects at the upper range of current environmental levels. McMichaels et al. (1986) found that the incidence of preterm deliveries (before the 37th week of pregnancy) were significantly related to maternal blood lead at delivery. When late fetal deaths were excluded, the strength of the asociation increased. The relative risk of preterm delivery at exposure levels reflected in blood lead concentrations of 14 g/dl or higher was 8.7 times the risk at blood lead concentrations up to 8 g/dl. Reduction in gestational age at delivery with increasing blood lead concentrations were also reported by Dietrich et al. (1986), Bellinger et al. (1984), Moore et al. (1982), and Bornschein et al. (1987a, –38– b). The data from Bornschein indicate that for each 10 g/dl increase in blood lead concentrations birth weight decreased between 58 and 60l grams depending on the age of the mother. The findings of McMichaels et al. (1986) also identified an excess in miscarriages and still births in the high-lead exposure areas. In contrast, data from this study show that average, maternal blood lead concentration was lower for still births than for live births. Placental response to lead remains an unanswered question. Basic research in the toxic effects of lead at low doses is of profound importance for the fields of preventive medicine and public health. Until recently, blood lead concentrations of 25 g/dl and below were considered safe, and indeed, only five years ago the Centers for Disease Control (CDC) stated that 25 g/dl should constitute a threshold level indicative of increased lead absorption in children. Now, on the basis of recent research it is evident that lead produces toxic effects in children at levels below this guideline. Thus, recent research into the toxicity of lead at low doses is about to force a total re-evaluation of current standards for assessing the exposure of American children to lead. The importance of these basic research findings stems from the fact that lead exposure remains extremely widespread among children in the United States. Data from the Second National Health and Nutrition Examination Survey (NHANES) indicated that in 1980 9.1% of all preschool children in the United States - 1.5 million children – had blood lead concentrations of 25 g/dl or more (Mahaffey et al., 1982a). Among black preschool children the prevalence of increased lead absorption (high blood lead concentrations) was 25%. These findings on the high prevalence of increased lead absorption (high blood lead concentrations), when taken in conjunction with the data on subclinical lead toxicity, carry a message of chilling significance. These findings suggest that 9% of all children in this nation, and 25% of minority children, may be suffering irreversible neurologic, intellectual, and behavioral impairment as the result of chronic, low-dose exposure to lead. The impl ſcations of these basic research data for public health and environmental medicine are enormous. This then has been a very condensed story about one of the many pervasive and important environmental health hazards. It is a story that continues beyond the present findings and their implications. It will reach even more successful conclusions only if the kind of studies which brought us to this stage are continued. Continued long-range and basic research investigations on lead toxicity are at one and the same time perhaps among the more justifiable and yet less supportable of such activities in the entire field of environmental health Sciences. So much has been done before in lead research that in comparison, no other (few at least) of all the current health hazards has received this much emphasis. Yet it is obvious that this sustained effort in lead research has paid off handsomely and is still needed. It is this "apology" for long-range, basic research that we feel can stand for the entire field of environmental health science, whatever may be the specific stage of development of this research for any one hazard. –39– REFERENCES l. 10. 11. Bell inger D.C., Neddleman H. L., Leviton A., Waternaux C., Rabinowitz M. B., Nichols M. L. (1984). Early Sensory-Motor Development and Prematal Exposure to Lead. Neurobehav Toxicol Teratol 6:387-402. Bellinger D.C., Leviton A., Waternaux C., Neddleman H. L., Rabinowitz M.B. (1987). Longitudinal Analyses of Prenatal and Postnatal Lead Exposure and Early Cognitive Development. New England Journal of Medicine 3.16:1037-1043. - Bornschein R. L., Succop P. A., Dietrich K. N. , Krafft K., Grote J. , Mitchell T., Berger 0., Hammond P. B. (1987a). Prenatal-Lead Exposure and Pregnancy Outcomes in the Cincinnati Lead Study. In: Linberg S.E., Hutchinson T.C., eds. International Conference: Heavy Metals in the Environment, W 1: September: New Orleans, LA: Edinburgh, United Kingdom: CEP Consultants, Ltd., pp. 156-158. Bornschein R. L., Grote J., Mitchell T., Succop L., Shukla R. (1987b). Effects of Prenatal and Postnatal Lead Exposure on Fetal Maturation and Postnatal Growth. In : Smith M., Grant L. D., Sors A. , eds. Lead Exposure and Child Development: An International Assessment. Lancaster, United Kingdom: MTP Press. Byers R. K., Lord E. E. (1943). Late Effects of Lead Poisoning on Mental Development. Am J Dis Child 66:471-483. Cooper W. C., Wong 0. , Kheifets L. (1985). Mortality in Employees of Lead Battery Plants and Lead Production Plants, 1947-1980. Scand J Work Environ Health l l :331-345. Dietrich K. N. , Krafft K. M., Bier M., Succop P.A., Berger 0., Bornschein R. L. (1986). Early Effects of Fetal Lead Exposure: Neurobehavioral Findings at 6 Months. Int J. Biosoc. Res. 8:151-168. U. S. Environmental Protection Agency (1986). Air Quality Criteria for Lead. Research Triangle Park, NC: Office of Health and Environmental Assessment, Environmental Criteria and Assessment Office: EPA Report No. EPA-600/8-83/028af-df. 4v. Available from: NTIS, Springfield, WA: PB87–142378. Hoffman F.L. (1935). Lead Poisoning Statistics for 1933. Am J Public Health 25(2; Supply:90-100. Mahaffey K. R., Annest J. L., Robert J., Murphy R. S. (1982a). National Estimates of Blood Lead Levels. United States, 1976-1980. NHANES. New Engl J Med 307:573–579. Mahaffey K. R., Rosen J. F., Chesney R. W., Peeler J. T., Smith C.M., DeLuca H. F. (1982b). Association Between Age, Blood Lead Concentration and Serum l ; 25-dihydroxycholecolciferol Levels in Children. Am J Clin Nutr 35: 1327-1331. –40– 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. McMichaels, A. J., Wimpani G.V., Robertson E.F., Baghurst P.A., Clark P.D. (1986). The Port Pirie Cohort Study: Maternal Blood Lead and Pregnancy Outcome. J Epidemiology Community Health 40:18-25. Moore M. R., Goldberg A., Pocock S.J., Meredith A., Stewart I.M., Maconespic H. , Lees R., Low A. (1982). Some Studies of Maternal and Infant Lead Exposure in Glasgow. Scott Med J 27:ll 3-122. National Research Council (1972). Airborne Lead in Perspective. Washington, D.C. Committee on Medical and Biological Effects of Atmospheric Pollutants. Perlstein M.A., Attala R. (1966). Neurologic Sequelae of Plumbism in Children. Clin Pediatr 5:292-298. Piomelli S., Seaman C., Zullow D., Curran A., Davidow B. (1982). Threshold for Lead Damage to Heme Synthesis in Urban Children. Proc Natl Acad Sci USA 79: 3335-3339. Pirkle J. L., Swartz J. , Landis J. R., and Harlan W. R. (1985). The Relationship Between Blood Lead Levels and Blood Pressure and Its Cardiovascular Risk Implications. Am Jr of Epidemiol 121:246-258. Repko J. D., Morgan B. B., Nicholson J. (1975). Behavioral Effects of Occupational Exposures to Lead. U. S. Department of Health, Education and Welfare. National Institute for Occupational Safety and Health. Washington, D. C. Robinson G., Baumann S., Kleinbaum D. , Barton C. , Schroeder S.R., Musak P., Otto D. A. (1985). Effects of Low to Moderate Lead Exposure on Brainstem Auditory Evoked Potentials in Children. Copenhagen, Denmark: WHO Regional Office for Europe: pp. 177-182. (Environmental Health Document 3). Robinson G. S., Keith R.W., Bornschein R. L., Otto D. A. (1987). Effects of Environmental Lead Exposure on the Developing Auditory System as Indexed by the Brainstem Auditory Evoked Potential and Pure Tone Hearing Evaluations in Young Children. In: Lindberg S.E., Hutchinson T. C., eds. International Conference: Heavy Metals in the Environment, VI: September, New Orleans, LA: Edinburgh, United Kingdom: CEP Consultants, Ltd., pp. 223-225. Rosen J. F., Chesney R. W., Hamstra A., DeLuca H. F., Mahaffey K. R. (1980). Reduction in 1,25-dihdroxyvitamin D in Children with Increased Lead Absorption. New Engl J Med 302:1128-1131. Seppalainen A.M., Hernberg S. (1972). Sensitive Technique for Detecting Subclinical Lead Neuropathy. Br J Ind Med 29:443–449. Seppalainen A.M., Tola S., Hernberg S., Kock B. (1975). Subclinical Neuropathy at "Safe" Levels of Lead Exposure. Arch Environ Health 30: 180-183. –41- 24. Sessa T., Ferrari E. , Colucci d'A.C. (1965). Welocita de Conduzione Nervosa Nei Saturnini. Folia Med. (Napoli) 48:658–668. –42– Chapter 4 NEWER BASIC/LONG-TERM RESEARCH WITH APPLICATION TO ENVIRONMENTAL HEALTH PROBLEMS PREAMBLE In this Chapter a number of authors discuss some of the newer basic/long-term research with possible applications to current environmental health problems (especially in humans). This does not represent the whole universe of possible basic/long-range research which will or could be of great benefit to such environmental issues. It is, however, an attempt at careful choices of those studies which have required such long-term support for the reaching of this stage where their applications could have great impact on environmental health. As such then, this is a look at the many and more probable benefits of supporting such long-range research more adequately than has been done in the past. –43– ACTIVATION OF PROTO-ONCOGENES BY CHEMICALS Marshall Anderson INTRODUCTION Proto-oncogenes are cellular genes that are expressed during normal growth and development processes. These genes were initially discovered as the transduced oncogenes of acute transforming retroviruses (1). Recent studies have established that proto-oncogenes can also be activated to cancer causing oncogenes by mechanisms independent of retroviral involvement (2-4). These mechanisms include point mutations or gross DNA rearrangements such as translocations or gene amplifications. Jhe activation of proto-oncogenes by genetic alterations results in altered levels of expression of the normal protein product, or in normal or altered levels of expression of an abnormal protein. ACTIVATION OF PROTOONCOGENES The activation of proto-oncogenes in spontaneous and chemically-induced rodent tumors and in human tumors has been studied in great detail during the past several years. Investigations in rodent models for chemical carcinogenesis imply that certain types of oncogenes are activated by carcinogen treatment and that this activation process is an early event in tumor induction (5-6). Alternatively, analysis of some human and rodent tumors suggests that oncogene activation is involved in neoplastic progression (7-9). The number of proto-oncogenes that must be activated in the multistep process of neoplasia is unclear at present. The concerted, low level expression of at least two oncogenes, ras and myc, are needed for the partial transformation of primary rodent cellſs in vitro (10). Furthermore, in addition to the activation of proto-oncogenes, the loss of specific regulatory functions such as tumor suppressor genes may be a distinct step in neoplastic transformation (11). The implication of activated oncogenes in rodent tumor will be discussed in terms of extrapolation of rodent carcinogenic data to human risk assessment. The activation of ras proto-oncogenes appears to represent one step in the multi step process of carcinogenesis for a variety of rodent and human tumors (5,6). The activation of ras by point mutations is probably an early event in tumori genesis and may be the "initiation" event in some cases. Thus, a chemical that induces rodents tumors by activation of ras proto-oncogenes can potentially invoke one step of the neoplastic process in humans exposed to the chemical. Is this property alone enough to classify the chemical as a potential human carcinogen? Dominant transforming oncogenes other than ras have also been detected in chemical-induced rodent tumors (6). TThe involvement of these oncogenes in the development of human tumors is unclear at present, as well as whether the non-ras genes detected in human tumors can be activated by chemical S or radiation (6). º –44– ONCOGENE ANALYSIS Most chemicals are classified as potentially hazardous to humans on the basis of long-term carcinogenesis studies in rodents. While these rodent carcinogenesis studies are often designed to mimic the route of human exposure in the environment or workplace, the dose of a given chemical is usually higher than that which actually occurs in human exposure. Coupled with the appearance of species- and strain-specific spontaneously occurring tumors in vehicle-treated rodents, this complicates the extrapolation of rodent carcinogenic data to human risk. Oncogene analysis of tumors from spontaneous origin and from long-term carcinogenesis studies should help determine the mechanisms of tumor formation, at a molecular level. For instance, the finding of activating mutations in different codons of the H-ras gene in furan-induced liver tumors versus finding activating mutations in only one codon of the H-ras gene in spontaneous liver tumors suggest that the chemical itself activated the H-ras proto-oncogene by a genotoxic event (12). In general, comparison of patterns of oncogene activation in spontaneous versus chemically-induced rodent tumors, together with cytotoxic information, should be helpful in determining whether the chemical in question is mutagenic, cytotoxic, has a receptor mediated mechanism of promotion, or some combination of these (and other) modes of action. This type of analysis might be of particular importance for compounds such as furan and furfural (12,13) which are negative for mutagenicity in short-term bioassays. APPLICATION TO STUDY OF CARCINOGENICITY Another approach which should be helpful in species-to-species extrapolation of risk from carcinogenic data is to examine oncogene activation and expression in tumors from different species induced by the same agent. For example, K-ras oncogenes with the activating lesion in codon 12 were observed in both rat and mouse lung tumors induced by tetranitromethane (14). Even though little is known about the DNA damaging properties of this chemical, these data suggest that this compound is acting in the same manner to induce tumors in both rats and mice. The role of chemicals and radiation in the activation of proto-oncogenes by gene amplification, chromosomal translocation, and other mechanisms which can alter gene expression, is currently being investigated by several groups. Also, as human life span increases, it becomes more important to study chemical-induced enhancement of the progression of benign to malignant tumors. These and similar approaches to explore the mechanisms by which chemicals induce tumors in animal model systems may remove some of the uncertainty in risk analysis of rodent carcinogenic data. –45– REFERENCES 1. Bishop J.M. 1985. Wiral Oncogenes. Cell; 42:23–38. 2. Warmus HE. 1984. The Molecular Genetics of Cellular Oncogenes. Annual Rev Genet; 18:553–612. 3. Weinberg RA. 1985. The Action of Oncogenes in the Cytoplasm and Nucleus. Science; 230:770–776. 4. Bishop J.M. 1987. The Moleuclar Genetics of Cancer. Science; 235:305-311. 5. Barbacid M. 1987. Ras Genes, Ann Rev of Biochem 56, in press. 6. Anderson M, Reynolds S. Activation of Oncogenes by Chemical Carcinogens in: The Pathology of Neoplasia. A Sirica, ed., Plenum Press, N.Y., N.Y. (In press 1988). 7. Brodeur GM, Seeger RC, Schwab M, Warmus HE, Bishop J.M. 1984, Amplification of N-myc in Untreated Neuroblastomas Correlated with Advances Disease Stage; Science 224:1121-1124. 8. Seeger RC, Brodeur GM, Sather H, Dalton A, Siegel SE, Wong KY, Hammond D. 1985, Association of Multiple Copies of the N-myc Oncogene With Rapid Progression of Neuroblasts, The New England Journal of Medicine; 313: 1111–1116. 9. Slamon DJ, Clark GM, Wong SG, Levin WJ, Ullrich A, McGuire WL. 1987, Human Breast Cancer: Correlation of Relapse and Survival With Amplification of the HER-2/neu Oncogene; Science 235:117-182. 10. Land H, Parada LF, Weinberg RA. 1983. Tumori genic Conversion of Primary Embryofibroblasts Requires at Least Two Cooperating Oncogenes; Nature (London) 304:596–602. & 11. Barrett JC, Oshimura M, Koi M. 1987. Role of Oncogenes and Tumor Supressant Genes in a Multistep Model of Carcinogenesis, In: Symposium on Fundamental Cancer Research. Volume 38 (F. Becker, ed., ), in press. 12. Reynolds SH, Stowers SJ, Patterson R, Maronpot RR, Aaronson SA, Anderson MW. 1987. Activated Oncogenes in B6C371 Mouse Liver Tumors: Implications for Risk Assessment, Science 237: 1309-1316. 13. Tennant RW, Margol in BH, Shelby MD, Zeiger E, Haseman JK, Spalding J, Caspary W, Resnick M, Stasiewica S, Anderson B, Minor R. 1987. Prediction of Chemical Carcinogenicity in Rodents from In Vitro Genetic Toxicity Assays, Science 236:933–941. *º-sº 14. Stowers SJ, Glover PL, Boone LR, Maronpot RR, Reynolds SH, Anderson MW. 1987. Activation of the K-ras Proto-oncogene in Rat and Mouse Lung Tumors Induced by Chronic Exposure to Tetranitromethane, Cancer Res 47: 3212-3219. –46- CARCINOGEN-DNA AND PROTEIN AODUCTS: RESEARCH PERSPECTIVES Frederica P. Perera INTRODUCTION Advances in basic research in molecular biology and biochemistry have permitted the development of innovative methods applicable to studies of human populations exposed to chemical carcinogens. These highly sensitive techniques can detect and sometimes quantify the internal dose of carcinogens (the amount of the carcinogen or its metaboſite in body tissues and fluids) or the biologically effective dose (the amount that has interacted with cellſUTâr İmäCTOmoſéCITES Such as DNA, RNA or protein) in target tissue or a surrogate. This latter type of dosimetry data could be especially valuable in studies of cancer etiology by providing "a mechanistically relevant link between external exposure data on the one hand and clinical disease on the other. Comparable molecular dosimetry data in rodents and humans have the potential to improve interspecies extrapolation of risk in addition to providing early warning of a carcinogenic hazard to humans. Successful applications of such "adducts research" could directly address major programs/needs at EPA for better estimates of exposure and risk to humans. Various methods are available to monitor chemical-specific lesions (such as immunoassays for DNA and protein adducts) as well as non-chemical specific biologic alterations (such as cytogenetic effects or somatic cell mutations). Table 1 gives examples of currently available methods for measuring the biologically effective dose of carcinogens. As can readily be seen, all pertain to endpoints associated with carcinogens that exert genetic toxicity. Moreover, almost all available methods depend on readily es for the actual target tissue itself. Despite these limitations, biological markers have significant potential usefulness in cancer etiology and risk assessment. –47- Table 1. Examples of Human Biologic Monitoring Methods" Sites & End Point Method Fluids!") Biologically effective dose Adducts (DNA) Immunoassay, postlabeling, fluor- WBC escence spectrometry Adducts (protein) Mass spectrometry, ion-exchange RBC amino acid analysis, HPLC, gas chromatography Excised adducts HPLC, fluorescence * Urine UDS Cell culture, thymidine incorporation WBC SCE Cytogenetic WBC Micronuclei Cytogenetic BM, WBC Chromosomal aber- Cytogenetic WBC rations Somatic cell mutation Autoradiography, light microscopy WBC (HGPRT) Somatic cell mutation Immunoassay RBC (glycophorin A) Sperm quality Analyses of count, morphology, motility Sperm (a) (b) Source: See Reference 1 (as modified) RBC=red blood cells; BM=bone marrow; WBC=white blood cells; UDS=Unscheduled DNA Synthesis; HPLC=High Performance Liquid Chromatography; SCE=Sister Chromatid Exchange; HGPRT=Hypoxanthine Guanine Phosphoribosyl Transferase –48- ADDUCTS Carcinogen-DNA and carcinogen-protein adducts have been the focus of considerable research in the past 5 years and illustrate a number of strengths and limitations common to biological markers in general (2,3). Biological Basis The biologic rationale for measuring DNA adducts is that these lesions, if unrepaired, can produce a gene mutation. There is considerable evidence that gene mutation in somatic cells "initiates" the multistage process of carcinogenesis (4,5); but it may also result in conversion of tumors to the malignant state (6, 7). Carcinogen-DNA adducts resulting in gene mutation may also activate certain oncogenes instrumental in carcinogenesis (8,9,10). Yº Protein such as hemoglobin can, in theory, act as a more readily available surrogate for DNA. Proportionality between protein and DNA binding has been demonstrated for a number of carcinogens (11,12,13). © Adducts are generally monitored in peripheral blood cells rather than target tissue. However, for only a few carcinogens (e.g., benzo(a)pyrene and cis platinum) is there actual experimental and/or human evidence that comparable levels are formed at both sites (14,15). METHODS Techniques to measure carcinogen-DNA adducts include immunoassays using adduct-specific polyclonal or monoclonal antibodies, synchronous fºuorescence spectroscopy, HPLC fluorescence spectrophotometry, and P-postlabelling. Carcinogen-protein adducts may be determined using antibodies and gas chromatography-mass spectrometry. The sensitivity Of the DNA to adduct methods is in the range of one adduct per 10°-10 nucleotides. Those methods aimed at carcinogen-protein adduct quantification also appear to have adequate sensitivity for environmental studies (16). However, unambiguous identification of particular DNA adducts at low levels is difficult with present analytical methods. Moreover, cross-reactivity of antibodies (such as the BPDE-I-DNA antibody which also detects closely related polycyclic aromatic hydrocarbon (PAH-DNA adducts) presents problems in definitive characterization of adducts (17). ANIMAL AND HUMAN STUDIES Experimental studies involving acute and/or chronic exposure to diverse carcinogens have shown that the relationship between administered dose and macromolecular binding is generally linear with few exceptions (12, 2, 18,3). With respect to humans, carcinogen-DNA and -protein adducts have been investigated in human populations with exposures such as cigarette smoke, PAHs, tobacco and betel nut, dietary aflatoxin and N-nitrosamines, cis platinum, psoralen, 4-aminobiphenyl, propylene oxide, vinyl chloride and ethylene oxide (3). –49– While results thus far support the feasibility and adequate sensitivity of the methods in terms of human studies, they are frequently limited by technical variability in the assays, small sample size, lack of appropriate controls, and inadequate data about exposure. However, they consistently illustrate that there is significant variability in the formation of carcinogen-DNA and -protein adducts between individuals with comparable exposure or administered dose (15,19-25). Another consistent finding in the human studies involving environmental exposure, is that measurable levels of adducts are seen even in so-called "unexposed controls" (19–20, 26-29). Both of these observations have obvious implications for risk assessment. - Although still largely in the validation stage, methods to monitor DNA and protein adducts in experimental animals and humans have considerable potential in a number of areas. These include: hazard identification, understanding of mechanisms involved in carcinogenesis, interspecies risk extrapolation and improving the power and timeliness of epidemiology (19,26,30–32). Research Needs Research is needed in the following areas: A. Interlaboratory validation of methods as has been undertaken recently for PAH-DNA immunoassays (33). B. Research on the stabililty of adducts in stored tissues. C. Investigation of intra- and inter-individual variation in adduct levels. D. Research on the persistence of adducts in various cells and tissues. E. Comparison of adduct levels in DNA versus protein as well as in surrogate versus target tissue for a number of different classes of compounds. F. Identification of critical sites or "hot spots" on DNA with respect to the carcinogenic effectiveness of adducts. G. Interspecies comparisons of DNA and protein adduct formation (e.g., humans and rodents with acute and chronic exposure to the same compound(s)). H. Experimental and human studies on the relationship between adduct formation, gene mutation, and oncogene activation. I. Longitudinal studies (experimental and human) on the relationship between adduct levels and tumor incidence/cancer risk. Examples would be molecular epidemiological studies in model populations (such as patients exposed to high dose chemotherapy and who experience a high rate of secondary cancer, or heavily-exposed –50– worker groups). Biologic samples could be drawn at the outset and stored for future analysis. Sample banks to serve as archives of human blood, urine, and tissue for retrospective analysis. -51- REFERENCES 1. 10. 11. 12. 13. Perera F. 1987. Molecular Cancer Epidemiology: A New Tool in Cancer Prevention, J Natl Cancer Inst, 78, 887–898. Wogan GN, Gorelick NJ. 1985. Chemical and Biochemical Dosimetry of Exposure to Genotoxic Chemicals. Environ Health Perspect, 62, 5-18. Perera F. The Significance of DNA and Protein Adducts in Human Biomonitoring Studies. Mut Res (in press). Weinstein IB, Gattoni-Celli S, Kirschmeier P, Lambert M, Hsiao W, Backer J, Jeffrey A. 1984. Multi stage Carcinogenesis Involves Multiple Genes and Multiple Mechanisms, Cancer cells 1. The Transformed Phenotype, Cold Spring Harbor Laboratory. New York, pp. 229–237. Yºr Harris CC. 1985. Future Directions in the Use of DNA Adducts as Internal Dosimeters for Monitoring Human Exposure to Environmental Mutagens and Carcinogens. Environ Health Perspec, 62, 185-191. Hennings H, Shores R., Wenk ML, Spangler EF, Tarone R, Yuspa SH 1983. Malignant Conversion of Mouse Skin Tumors is Increased by Tumor Initiators and Unaffected by Tumor Promoters. Nature (London), 304, 67-69. Scherer E. 1984. Neoplastic Progression in Experimental Hepatocarcinogenesis. Biochim Biophys Acta, 738, 219–236. Beland FA, Kadlubar FF. 1985. Formation and Persistence of Arylamine DNA Adducts In Vivo. Environ Health Perspect, 62, 19-30. Marshall CJ, Wousden KH, Phillips DH. 1984. Activation of c-Ha-ras-1 Proto Oncogene by In Vitro Modification with the Chemical Carcinogen, Benzo(a)pyrene Dioſ-epoxide, Nature (London), 310, 586–589. Hemminki K, Forsti R, Mustomen R, Savela K. 1986. DNA Adducts in Experimental Cancer Research. J. Cancer Res Clin Oncol, 112, 181-188. Ehrenberg L, Moustacchi E, Osterman-Golkar, Ekman G. 1983. Dosimetry of Genotoxic Agents and Dose Response Relationships of Their Effects. Mutation Res 123, 121-182. Neuman HG. 1984a. Dosimetry and Dose-response Relationships, in: Berlin A, Draper M, Hemminki K, Wsainio H (Eds.), Monitoring Human Exposure to Carcinogenic and Mutagenic Agent, IARC Sci, Publ No 59, Lyon, pp. 115-126. Neuman HG. 1984b. Analysis of Hemoglobin as a Dose Monitor for Alkylating and Arylating Agents, Arch Toxicol, 56, 1–6. –52– 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. Stowers SJ, Anderson MW. 1985. Formation and Persistence of Benzo(a)pyrene Metabolite-DNA Adducts. Environ Health Perspect, 62, 31–39. Reed E, Yuspa SH, Zwelling LA, Ozols RF, Poirier MP. 1986. Quantitation of Cis-diamminedichloroplatinum II (cis platin) -DNA-intrastrand Adducts in Testicular and Ovarian Cancer Patients Receiving Cisplatin Chemotherapy, J Clin Invest, 77, 545–550. Tannenbaum SR, Skipper PL. 1984. Biological Aspects to the Evaluation of Risk: Dosimetry of Carcinogens in Man. Fund Appl Toxicol, 4, S367–S370. Santella RM. Application of New Techniques for Detection of Carcinogen Adducts to Human Population Monitoring. Mutation Res (in press). Y’ Poirier MC, Beland FA. 1987. Determination of Carcinogen-induced Macromolecular Adducts in Animals and Humans, Prog Exp Tumor Res, 31, 1-10. Perera F, Santella R, Fischman HK, Munshi AR, Poirer M, Brenner D, Mehta H, Wan Ryzin J. 1987 a. DNA Adducts, Protein Adducts and Sister Chromatid Exchange in Cigarettee Smokers and Nonsmokers. J Natl Cancer Inst, 79:449-456. Perera F, Hemminki K, Young TL, Brenner D, Kelly G, Santell RM. 1987b. Detection of Polycyclic Aromatic Hydrocarbon-DNA Adducts in White Blood Cells of Foundry Workers. (Accepted). Shamsuddin AKM, Sinopoli K, Hemminki, Boesch RR, Harris CC. 1985. Detection of Benzo(a)pyrene-DNA Adducts in Human White Blood Cells. Cancer Res, 45, 66–68. Haugen A, Becher G, Benestad C, Wahakangas K, Trivers GE, Newman MJ, Harris CC. 1986. Determination of Polycyclic Aromatic Hydrocarbons in the Urine, Benzo[a]pyrene Diol Epoxide-DNA Adducts in Lymphocyte DNA, and Antibodies to the Adducts in Sera from Coke Owen Workers Exposed to Measured Amounts of Polycyclic Aromatic Hydrocarbons in the Work Atmosphere. Cancer Res 46, 4178-4183. Bryant MS, Skipper PL, Tannebaum SR, Maclure M. 1987. Hemoglobin Adducts of 4-aminobiphenyl in Smokers and Nonsmokers. Cancer Res 47, 602–608. Dunn BP, Stich HF. 1986. 32p Postlabeling Analysis of Aromatic DNA Adducts in Human Oral Mucosal Cells. Carcinogenesis 7, 111-5-1120. Phillips DH, Hewer A, Grover PI. 1986. Aromatic DNA Adducts in Human Bone Marrow and Peripheral Blood Leukocytes, Carcinogenesis 7, 2071-2075. Bridges B.A. 1980. An Approach to the Assessment of the Risk to Man from DNA Damaging Agents. Arch Toxicol, Suppl 3:271-281. 27. 28. 29. 30. 31. 32. 33. –53– Wright AS. 1983. Molecular Dosimetry Techniques in Human Risk Assessment: An Industrial Perspective, in: Hayes AW, Schnell RC, Miya TS (Eds.). Developments in the Science and Practice of Toxicology. Elsevier, Amsterdam, pp. 311-318. Tornqvist M, Osterman-Golkar S, Kautiainen A, Jensen A, Farmer PB, Ehrenberg L. 1986. Tissue Doses of Ethylene Oxide in Cigarette Smokers Determined from Adduct Levels in Hemoglobin. Carcinogenesis, 7, 1519–1521. Everson RB, Randerath RM, Santella RM, Cefalo RC, Avitts TA, Randerath R 1986. Detection of Smoking Related Covalent DNA Adducts in Human Placenta. Science 231, 54–57. Bridges BA, Butterworth BE, Weinstein IB. Banbury Report 1982. Indicators of Genotoxic Exposure; Report No. 13. Cold Spring Harbor Lab, Cold Spring Harbor, NY. NAS Briefing Panel. 1983. Report on Human Effects of Hazardous Chemical Exposures. National Acad Sci, Washington, DC. Sobsel FH. 1982. The Parallelogram: An Indirect Approach for the Assessment of Genetic Risks from Chemical Mutagens. In: Progress in Mutation Research (Bora KC, Douglas GR, Nestmann ER. eds.). Elsevier, Amsterdam, pp. 323-327. Santella Rm, Weston A, Perera F, et al. 1987. Interlaboratory Comparison on Antibodies and Immunoassays for Benzo[a]pyrene Diol Epoxide-1 Modified DNA. (Submitted). –54- NEUROTOXICOLOGY Lawrence Reiter INTRODUCTION Epidemiological studies in Europe indicate that long-term exposure to solvents can produce neurobehavioral disorders which, depending on the length and severity of exposure, can range from loss of concentration and memory impairment to mood and personality changes to severe and apparently irreversable dementia. Indeed, cognitive impairment appears to be an early sign of solvent neurotoxicity. These studies have led the international neurotoxicology community to call for improved methods for identifying and characterizing solvent neurotoxicity both in animal models and in human clinical populations. Y- NEUROBIOLOGY OF LEARNING AND MEMORY An area of long-term research which promises to produce powerful * applications to this problem is the neurobiology of learning and memory. The goal of this field is to understand how normal memory function is carried out by the nervous system as well as how various neuropathological conditions, such as Alzheimer's disease and Korsakoff's syndrome, produce cognitive dysfunction. Interest in this area of neuroscience research is very intense. By some estimates, fully a quarter of all research in the basic neurosciences is concerned with the neurobiology of learning and memory. It is not surprising then that progress in this area is occurring at a very rapid rate. This paper will briefly highlight some specific recent developments in this field which should have a major future impact on neurotoxicological assessment. Analysis of the neurobiology of learning has been organized around three general areas: (1) key brain regions i.e., which brain regions are essential for different forms of memory; (2) memory "circuits" in the brain, i.e., the delineation of neural pathways through which sensory information results in the production of learned behavioral responses; and (3) synaptic mechanisms, i.e., the nature of the synaptic changes that occur during learning, and the biochemical and cellular processes which underline them. The first of these areas has had, as one of its major concerns, the problem of how to extrapolate from animal models of cognitive dysfunction to human dementia. The latter two areas have been concerned primarily with analyzing the animal model systems at more molecular levels. In the past 5-7 years, dramatic discoveries have been made in all three of these areas. NEUROTOXICOLOGICAL ASSESSMENT Attempts in the area of extrapolation have taken two forms. One has been to develop behavioral tests in animals which are more analogous to those which are used to assess cognitive function in humans. The other form, and the one which we will emphasize here, has been to apply -55- behavioral tests to humans which are analogous to those which are well understood, both behaviorally and neurobiologically, in animals. For example, it has recently been shown that delayed-non-matching-to-sample, a task which is a sensitive indicator of memory impairment associated with limbic system and frontal cortical damage in rats and primates, is also a Sensitive indicator of dementia associated with similar neuropathology in human clinical populations. Another example is the successful use of human eyeblink conditioning to detect learning deficits, associated with aging and Alzheimer's disease, which were predicted by neurobiological studies of eyeblink conditioning in rabbits. These recent developments in basic behavioral neuroscience establish a direct neurobehavioral link between the experimental analysis of cognitive dysfunction in animals and its assessment to humans. Neurotoxicological research, aimed at validating the application of these new animal models to the problem of risk assessment will substantially advance progress on the question of how animal studies can be used to characterize risk to human populations, following exposure to solvents and other environmental pollutants. The second important development which could greatly increase the Sophistication of neurotoxicological assessment is the identification of neural circuits subserving learning. The best example of this is the neurobiological study of rabbit eyeblink conditioning. This Pavlovian conditioning preparation has many advantages for neurotoxicological assessments, including: (a) the wealth of knowledge of its behavioral properties, which makes it possible to study anything from simple associative reflexes to complicated cognitive-perceptual processes in a single experimental preparation; (b) the ability to directly compare quantitative measures of both learned and unlearned behavior, on-line and in real time; (c) the ability to directly compare the same type of conditioning in animals and humans; (d) the ease of arranging concurrent electrophysiological recording from discrete brain loci (or, in the human, brain EEG activity recorded from scalp electrodes). However, the most important advantage offered by this recent research development is the wealth of knowledge that we now have about its essential neural circuitry in the brain stem and cerebellum. We also know a good deal about the effect of pharmacological agents on this type of conditioning and this greatly improves our ability to integrate the various aspects of neurotoxicological assessment. If an unknown compound produces a behavioral effect, we have a good idea of where to look for its neurochemical and neuroanatomical effects, and ultimately its mechanism(s) of action. Conversly, if a compound produces an effect on a neurochemical or neuroanatomical system, we know what functional consequences to look for in terms of the types of behavioral or cognitive processes which might be impaired. Some investigators have already begun to use Pavlovian techniques of this kind as animal models in the neurotoxicological assessment process. Just this year (1987), the rabbit eyeblink preparation has been applied to the study of dementia associated with aluminum toxicity. One final development which is worth mentioning is the use of the in vitro brain slice technique to study neural plasticity. Electrophysiological studies of hippocampal slices have uncovered a phenomen, termed long term potentiation (LTP), which has become very influential as an experimental model for studying the synaptic mechanisms –56– of learning. In LTP there is, in effect, an increase in synaptic efficacy that occurs with repeated use. Investigations of the cellular and biochemical mechanisms of LTP have revealed a special role of a particular receptor type (the N-methyl-D-aspartate or NMDA receptor). Pharmacological antagonists of the NMDA receptor may prevent the induction of LTP, and may disrupt cognitive function in rats. What is true of drugs may also be true of other compounds with neurotoxic potential (eg., environmental chemical s). It is likely that with continued research in this area, hippocampal slice preparations may be used as a means of screening unknown compounds for their potential ability to produce cognitive dysfunction, and of characterizing the neurobiological mechanisms of any neurotoxic effects which are found. SUMMARY Y’ In summary, these three general areas of long-term research in behavioral neuroscience create a framework for the analysis of neurobehavioral function which is integrated at both a conceptual and, perhaps more importantly, a practice level. With this framework, it is possible to use information from diverse scientific subdisciplines, including cell biology, neurochemistry, neuroanatomy, neurophysiology, and both animal and human psychology, in a very direct and real way to either (a) identify the risk that compounds with neurotoxic potential may pose to normalTcognitive function or (b) characterize the risk of classes of compounds, such as the solvents, which are known to produce memory loss, dementia and other neurobehavioral disorders. –57– USE OF MONOCLONAL ANTIB0DIES IN NEUROTOXICOLOGY Monoclonal antibodies provide another example of long-term research which has promise for application to a wide variety of environmental problem (See Chapter 2 for some others). This section will describe some new applications in neurotoxicity. Background Exposure to a foreign substance often elicits an immune response characterized by production of antibodies. Antibodies are serum proteins that react with antigens (antigens are foreign substances capable of inducing antibody formation). Such antigenic substances can include viruses, bacteria, proteins, or even complex molecules like environmental chemicals. Antigen-antibody reactions are highly specific, indeed, among the most specific known to biology. It is this specificity of the antigen/antibody complex that has been exploited by the biomedical scientist with applications ranging from curing Polio to understanding the molecular basis of enzyme catalysis. Antibodies are produced in the body by B lymphocytes (B-cells), each of which produces its own unique antibody. In theory, as many as 10 million antibodies can be produced by a mouse in response to a single antigen. Each antibody reacts with a unique antigenic site (termed an epitope) and each antigen contains several epitopes. Because one B-cell can form antibodies against only one epitope but there are many B-cells producing antibodies against each epitope, this is referred to as a polyclonal (many cells) antibody. The lymphocyte fusion technique of Kohler and Milstein, for which they received the 1984 Nobel Prize, was designed to overcome the limitations associated with the use of polyclonal antibodies (e.g., contamination, heterogeneity, limited supply). The antibodies produced by Kohler and Milstein were referred to as monoclonal because they were produced by a single (mono) B-cell line (clone). Monoclonal antibodies have several advantages including: 1) inherent specificiy (each clone produces only one specific antibody); 2) unlimited supply (clones produce large amounts of antibody and can be kept indefinitely); and 3) purified antigens are not required for the production of pure antibodies (monoclonals by definition recognize only a single antigenic determinant). Monoclonals have been used to define, localize, purify, quantify, and modify antigens. The main distinction between the use of monoclonals, as opposed to polyclonal antibodies, is that monoclonals confer far greater precision and accuracy and are available as essentially immortal, off the shelf reagents. Thus, it is now possible to define antigens with a greater degree of certainty than ever before. This inherent trait of monoclonals has made it far easier to identify rare antigens both in vivo and in vitro (e.g., nervous tissue cell types and tissue typing in cellſ Culture). TOne example of the application of monoclonals that is relevant to the EPA is the use of specific monoclonals to identify dioxin congeners in contaminated soils. True purfication of antigens from heterogeneous sources (e.g., serum, tissue) also is now possible with monoclonals. Thus, rare factors or hormones, such as interferon, can now be easily obtained in –58- bulk pure form. Likewise, quantification of antigens in complex mixtures is also easier to achieve with monoclonals than with polyclonal antibodies, an example being human chorionic gonadatrophin for pregnancy tests. By targeting specific antigens with monoclonals, modification of toxicity or disease states also may be realized. Examples are treatment of digoxin overdose (with antibody to digoxin), and cancer therapy with anticancer agents linked to monoclonals targeted to tumor cell antigens. Applications of Monoclonals to Neuroscience/neurotoxicology The years of research on monoclonal antibodies that followed Kohler and Milstein's original report in 1975 are now beginning to revolutionize neurobiology by providing the tools with which to understand the complex cellular and subcellular organization of the nervous system. Thus, the major impact of monoclonal antibody technology on neuroscience has been the unambiguous identification of different cell classes in the nervous system. Indeed, monoclonals have now been produced which identify previously unknown subsets of neurons and glia (the major cell types of nervous tissue) which otherwise would not appear to be different using classical techniques of light or electron microscopy. Monoclonals have also proved crucial for the identification and characterization of unique macromolecules, and have been even shown to reveal important differences • within the same molecule. For example, monoclonal antibodies have now been produced that reveal phosphate-containing versus nonphosphate-containing neurofilaments, the major structural (filament) component of all neurons. The significance of this subtle difference, i.e., the absence or presence of a single phosphate, is that this substitution may be related to a variety of neurological disease states, including Alzheimer's disease, and also may represent a general response to injury of the nervous system. In neurotoxicology, it is known that toxicant-induced injury to the developing or mature nervous system often is manifested by alterations in the cytoarchitecture of specific neuroanatomical regions. Furthermore, within an affected region, the response to injury may encompass several cell types. Because antigens that distinguish the diverse cell types comprising the mammalian nervous system have been revealed by monoclonal antibodies, these same antibodies can be used to detect, localize and characterize cellular responses to neurotoxic exposures. This can be accomplished by a technique known as immunohistochemistry, where antibodies are used as specific probes for microscopically localizing specific antigens within tissue obtained from toxicant–exposed animals. Quantitative data are obtained with the same antibodies by using monoclonal-based radioimmunoassays. Thus, through the use of monoclonal antibodies an integrated morphological/biochemical evaluation of neurotoxicity may eventually be achieved. The possibility also exists that the sensitivity and specificity of monoclonal antibodies can be applied to the detection and measurement of antigens released into the cerebrospinal fluid and blood as a consequence of neurotoxic exposures. Theoretically, it would them become possible to develop inexpensive monoclonal-antibody based test kits for detecting neurotoxicity in the exposed human population. In summary, it is clear that current advances in the neurosciences will continue to reveal the extensive cellular and subcellular heterogeneity of the nervous system based on the use of monoclonal antibodies. The EPA, by –59– actively participating in long-range research, will benefit by having the tools with which to assess and predict environmentally-induced neurotoxicity. -60– MAGNETIC RESONANCE IMAGING Morrow Thompson INTRODUCTION A major problem in environmental health sciences is the non-invasive detection of small adverse effects or adverse effects at early stages. Research applications of magnetic resonance imaging hold promise for just such advances. In the few years since Lauterbur's (1) paper was published, magnetic resonance (MR) imaging has evolved rapidly into an accepted clinical technique and, also, a research tool of enormous potential. Systems with high field, superconducting magnets (1.5 to 4.7 Tesla) are available commercially and are designed for human beings and laboratory animals (separate systems). Sophisticated techniques that modulate the effects of proton density, relaxation times, and motion permit the acquisition of 3-dimensional images that optimize differences between normal tissue types, define pathologic structures of areas, and allow the measurement of blood flow or perfusion (2-5). For reasons of abundance and signal intensity, the hydrogen nucleus (proton) is probed for the "production of 23ractically all MR images. The abilities, to image alternate nuclei (e.g. **Na) and chemically shifted nuclei (e.g. *H in water versus fat) have been demonstrated and show the versatility and undeveloped potential of the technology. Present day proton MR images of human beings and laboratory animals contain superb anatomic detail that, in some applications (biologic specimens and small animals), approaches microscopic levels. In recent publications (6, 7), images of frog eggs and plant stems have been shown with volume elements (voxels) of 0.2 and 12.0 L, respectively. Perhaps more impressive are experiments being conducted at Duke University in which chemically induced hepatic lesions as small as 100 L in volume have been imaged in rats. The ability to detect such small lesions in live animals requires long imaging sessions (as long as 6 hours), strong magnetic fields and gradients, sophisticated pulse sequences, and little or no relative motion. Because respiratory motion is transferred through the diaphram to the liver, the last issue (no motion) is accomplished by intubating the animal, using a gaseous anesthetic, and synchronizing signal acquisition to respiratory motion (8,9). Some of the advantages of MR imaging are common to those of other techniques, and other advantages are unique. Similar to computerized tomography (CT) scans, MR imaging is non-invasive and may be performed multiple times on the same animal or patient. In toxicology experiments, for example, the incorporation of MR imaging of a group of animals could provide important information concerning target organs, time to lesion (e.g., tumor) development, and response to continued or modified treatment (e.g., progression or regression of lesions). MR imaging uses fewer animals per exepriment compared with conventional means for gathering similar information. While imaging techniques based on ionizing radiation are well established, rapidly produced (a distinct advantage compared to MR imaging -61- at its present state of development), and excellent for demonstrating some anatomic structures or abnormalities (e.g., bone lesions containing calcium deposits, recent hemorrhage), MR imaging has some distinct and important advantages. With current and anticipated magnetic fields, gradients, and RF signals, and with the proper precautions MR imaging is considered safe for patients and technicians (10). Additionally, the MR signal, unlike the penetrating beams of ionizing radiation, contains information in addition to that of tissue (in this case, proton) density. The signal is also determined by the rates at which protons relax in relationship. to the molecular lattice (T1, spin-lattice, longitudinal relaxation) and to each other (T2, spin-spin, transverse relaxation). Because these time constants are influenced by the chemical composition of the tissue (probably by the amount and motional freedom of water molecules), the resulting image can permit distinction of tissues that are similar in proton density but differ in relaxation times. * Although not a consistent finding, malignant tumors frequently have T1 and T2 relaxation times greater than those of benign tumors or normal tissue. Recent disappointments concerning the apparent inability of MR imaging (relaxation times) to distinguish between pathologic entities have been expressed (11). This may be partially related to the acquisition of the Signal from tissue slices that, because of slice thickness, include degenerative and normal areas within and adjacent to the lesion of interest. In animal experiments at Duke University, this possibility is being explored by excising very thin (only 1.25 mm thick) tissue slices in rats. While signals from such thin slices are weak, and imaging sessions are relatively long, the thin sections with high resolution greatly improve the selectivity, and, hopefully, the discriminating ability of the method. CURRENT AND FUTURE APPLICATIONS In clinical medicine, MR imaging compliments and frequently exceeds the performance of other imaging methods. MR imaging excells in demonstrating neoplastic, demyelinating, and degenerative processes of the central nervous system. Because of the suscetibility of the thyroid and parathyroid glands to ionizing radiation, MR imaging is a preferred method for examination of these tissues. Respiratory and cardiac gating have been used to produce excellent diagnostic images of the heart, thoracic blood vessels, and lungs. MR images of liver, kidney, reproductive organs, and pelvis routinely demonstrate a variety of neoplastic and non-neoplastic processes. Current and future developments will incorporate the use of faster scanning sequences, 3-dimensional imaging, measurement of perfusion and flow, contrast agentil imaging gºmbinfg with in vitro spectroscopy of different nuclei (e.g., *P, **C, Nā; F), chemicalſTshift imaging (e.g., permitting separate proton images of #1 in #3ter verses fat), and, possibly, multinuclear imaging (e.g., **P, “’N). These developments, in addition to improving the sensitivity of detecting lesions, will allow imaging to be combined with in vivo metabolic studies that can characterize biochemical activities in a region of interest. In toxicologic experiments, techniques have been developed that allow prolonged anesthetization of rats (as long as 6 hours) associated with respiratory and cardiac scan synchronization for thoracic and abdominal –62– imaging. High field systems (300 MHz, 7 Tesla) are being developed and tested that have a theoretical resolution of 10 M. Areas of active research include the improvement of RF coil designs, and the use of stronger field gradients, surface and implanted coils, and contrast agents. Within a few years, increases in resolution should permit, for example, the visualization of renal glomeruli, preneoplastic hepatocellular foci, and nuclei in the brain. With such developments, Lauterbur's closing statement in his 1973 paper would seem remarkably prophetic, "Zeugmatographic techniques should find many useful applications in studies of the internal structures, states, and compositions of microscopic objects." –63– REFERENCES 1. 10. 11. Lauterbur PC. Image Formation by Induced Local Interactions: Examples Employing Nuclear Magnetic Resonance. Nature 1973; 242:190-1. Morgan CJ, Hendee WR. The Evolution of Nuclear Magnetic Resonance. In : Introduction to Magnetic Resonance Imaging. Denver: Multi-Media Publishing, Inc. 1984:1-12. Andrew ER. A Historical Review of NMR and Its Clinical Applications. Br Med Rev 1984; 40: 115-9. Damadian R. Tumor Detection by Nuclear Magnetic Resonance. Science 1971; 17.1:1151-3. Yº- Lauterbur PC. Cancer Detection by Nuclear Magnetic Resonance Zeugmatographic Imaging. Cancer 1986;57: 1899–1904. Aguayo JB, Blackband SJ, Schoeniger J, Mattingly MA, Hintermann M. Nuclear Magnetic Resonance Imaging of a Single Cell. Nature 1986; 322:190-1. Johnson GA, Brown J., Kramer P.J. Magnetic Resonance Microscopy of Changes in Water Content in Stems of Transpiring Plants. Proc Natl Acad Sci USA 1987;84:2752–5. Hedlund L, Dietz J, Nassar R, Herfkens R, et al. A Ventilator for Magnetic Resonance Imaging. Invest Radiol 1986; 21:18-23. Hedlund L, Johnson GA, Mills G.I. Magnetic Resonance Microscopy of the Rat Thorax and Abdomen. Invest Radiol 1986; 21:843–6. Saunders RD, Smith H. Safety Aspects of NMR Clinical Imaging. Br Med Bull 1984; 40:148–54. & Johnston DL, Liu P, Wismer GL, Rosen BR, et al. Magnetic Resonance Imaging: Present and Future Applications. Can Med Assoc J 1985; 132:765-77. –64- IMMUNOTOXICOLOGY Michael Luster In a broad sense immunotoxicology can be defined as the study of adverse (inadvertent) effects of environmental chemicals, therapeutics or biologicals on the immune system. The types of effects that may occur include immunomodulation (i.e., suppression or enhancement), hypersensitivity (allergy) and, in rare instances, autoimmunity. A large body of information has developed over the past 10 years that exposure to certain chemicals or therapeutics can produce immune dysfunction and alter host resistance in experimental animals following acute and subchronic exposure. Examples of these are listed in the attached table. The most extensively studied class of environmental chemicals is the polyhalogenated aromatic hydrocarbons (PHAs), including polychlorinated biphenyls, polybrominated biphenyls, chlorinated dibenzofurans and the prototype of this class, chlorinated dibenzo-p-dioxins. Despite the species variability associated with the toxic manifestation of these compounds, studies in laboratory animals exposed during neonatal or adult life with PAHs and, in particular, dibenzo-p-dioxins have indicated that the immune system is one of the most sensitive targets for toxicity. These effects are characterized by thymic atrophy and severe and persistent suppression of cell-mediated (T cell) immunity and share many features of neonatal thymectomy. Laboratory studies have further indicated that the target cell for immunosuppression by PHAs is the thymic epithelium which is necessary for T cell maturation. Although only a limited number of reports indicate immune dysfunction following human exposure to PHAs, the effects have been found to be remarkedly similar to these which occur in animals. For example, suppression of a delayed hypersensitivity response and increased susceptibility to respiratory infections have been found in patients who accidentally ingested polychlorinated biphenyl/dibenzofuran-contamined rice oil. Another example of this immune dysregulation by PHAs has been reported in Michigan farm residents who inadvertently ingested polybrominated biphenyls. These individuals also demonstrated persistent suppression of cell-mediated immunity with increased numbers of null cells, possible reflecting the presence of immature cells. Although long-term deleterious consequences of polybrominated biphenyls remain to be determined in humans, early data indicate a correlation between immune alterations and increased tumor incidence. Thus, it appears that early laboratory studies in rodents have provided a very accurate account of the immunological dysfunction that is observed in humans following inadvertent exposure to these compounds. –65– EXAMPLES OF IMMUNOLOGICAL ABNORMALITIES Associated WITH CHEMICAL EXPOSURE IN RODENTS AND HUMANS gº Laboratory Chemical Iſºmune Human Immune Class Example Abnormality Abnormality Polyhalogenated TCDD + + Aromatic Hydrocarbons PCB + + PBB * + HCB + N. S. Heavy Metals Lead + º Cadmium º tº e Methyl Mercury + º Aromatic Hydro- Benzene *}” * carbons \ (Solvents) Toluene * N. S Polycyclic DMBA +H: ER : tº * * Strategic Risk Reduction Research contains many inter-related components. Each concern or problem requires a different set of activities and outputs to reduce specific risks to human ... health and the environment. one 'sseurſsna Tupoleuuoo 'suopanqpasup ereo unIgell "upuppeoe "auſauruIenob entºs pue IBaeped C TTu Ka peſotdue eq'ugo "tropaea resuoo Kfireue ** 5° e 'sepbeaterns eseun go Kuew • I JageM palaaoq as euo:Ind uOHeIIHuañ fuTp IInd aedo Id seale XIOM eaig axious uopaeop|dde epropºsed palſTOIAuCO sepfotoutloan UOIsreds]p qugqn IIod IITſpueT TeoTurauſo aimoes suransKS TOTAuCo pue appme "KIonuſeau'ſ TeoTurauſ) rºueur, Ge:II, Ten EM33s leM eqsum pH TOs pue efgnIs furpasodiudo-CO Torquoo uofanitod rºw uopaenau Foup ensura snopiezeu pue pH IOS fuTIOKoal aeded uOHeuſe [oei Aurantos saomosai Teopapao 3oanoud Oa fuTuoz • 830mpord uOpana Pasquis UNOH Baxesuoo eIQepeafepopc, go as euornd Tapianuu Muth fuTTood reo aeaen pug Afraug estorial IJSNI biºIHIO X\{LSſ)OlNI zsänoid SIVIMCIIAIGINI iseſ]1Anovuoſionpa: Msis e; du'a?:3 : 1 elde i sdnorfi Mapuruluido *sapapuruuro 'z uopaoe IIoo easeM snopiezou pſoulasnoi. fupuue Id esn puu'ſ III gpueſ KIgq]ues redoid SI33">M. pean UICd up us Hj 3, uOKI seopaap uOHui-II, Haapſa Guoh sanons suf ’uoper Iog uopae||auſan Guoh sungifold uopauaaaad aurappoon seopaep fupddpup poora III gpug"I futascaro Mapuruuxxo aueunuara KIddris raavºſ eoueuanupuu uransAs fºup3 gali eouguayupuu pua uopaoadsurf oanti Teacular sonseqsw JezTTTHIag IOJ BaseM preſſ passodunoo asſ) Burr Tokoal sseIf, Teporauroo furpleu d'Ind up Kraaooar Mfixaua pue TeoTuraup Iog SGeoOud 33 eryl fu pſeum Teans up uOII deros go esm fuTToMoax easura snopiezou Kapuruuno fºup IoMoar ITO fºup IoMoer 935um pHIOs Kapuruuno auraunredap QIe IOOups on 3upud pasnun e3vuoq separenaud Two pasm up sper], - grouge.To quTud go esnati snonpoid pelokoea go as euornd uffseper 35mpoïd ufipsepal sseoord uopaoanoid Ignuauruo IPaua Iog uOHIST mixxo pug"I 3usuafuuuuu 38ed paauxfeau.I 5upueprufi opuefixo g35mpoïd profesnoq snopiuzuli-uou egguſoxnd "TWIYIISCRH &ICOOCRH CRNW JN&WIVºIRAL CNW StuTOKOGM NOIJºrcinºcº) JNWIMYTIOd 5NLIN3A&Rid - 7 - 4: Example involvements of Research Strategy Council and core Area Workshops in Risk Reduction Planning and Implementation Figure RESEARCH - RESEARCH COMMITTEES STRATEGY "FOR IMPLEMENTATION COUNCIL - - A - PLANNING AT LABs AND ORD OFFICES office of RESEARCH —A - AND DEVELOPMENT EPA OFFICE AND EVALUATION POLICY OFFICES workshops plan 10-year program for core areas *-NON-EPA - *Non-EPA chair of workshops to advise on whether the key items from the workshops get to the Research Strategy Council - - 8 - The EPA research and development strategy should focus on problems and areas where there is the greatest potential for reducing risk to human health and the environment. This strategy will allow EPA to prevent or control wastes, residues and contaminants as efficiently as possible while focusing the limited resources of EPA on situations where these items cause the greatest impact and where the greatest reduction of risk can be accomplished. It is clear that risk reduction is a critical aspect of the EPA mission and can serve as an overall coordinating strategy. Research and development must support the risk reduction role of the Agency. Soundly conceived and properly managed, an EPA risk reduction strategy would use all available information and studies within and outside EPA to: a. identify the scientific and technical approaches that have the greatest opportunity for reduction of risk to human health and the environment, - b. prioritize these approaches on the basis of relative risk reduction, c. provide the logic for resource allocation that is consistent with relative risk reduction, and d. provide a sound basis for regulations. 1.3 Risk Reduction Research Concepts Research at EPA can be considered as: a. supporting the specific programs and priorities of the regulators, or and b. more broadly supporting the basic objectives of the statutes from which the regulatory programs are derived. Research that is limited entirely to direct support of current regulatory programs and priorities may fail to accomplish maximum feasible risk reduction. Current regulatory activity may not always be focused on the highest risk associated with the pollutants or activities in question. Rather, such activity may merely fill gaps in regulations adopted years earlier. In addition, control of some risks either is not yet, or perhaps cannot be, dealt with primarily through regulations. Risk reduction research cannot ignore the needs of ongoing regulatory . programs; however, it should address the needs in a broader, more comprehensive framework. The total research program helps to reduce environmental risks in complementary ways: a. by supporting and facilitating implementation of regulations aimed at reducing risk, gº -- - – 9 - b. by defining the risk at issue and/or developing technology needed to comply with risk-prevention rules, and c. by demonstrating the feasibility of risk reduction actions that, although consistent with regulatory requirements, may be undertaken independently of regulations. Therefore, an appropriate research and development program directly reflects and supports the Agency's risk reduction strategy. Specifically, planning as described in Figure 4 would determine what research and development activities are needed to reduce the risk to human health and the environment posed by wastes, residues and contaminants. Such planning would also indicate the proper timing of that research and development. Most importantly, by identifying the extent to which the research (if successful) will reduce risks to human health and the environment, such a program provides clear and firm logic for EPA research and development activities. This facilitates the balancing of competing research needs. Provision of information to state and local government and to the public can accomplish risk reduction goals; education and technology transfer, therefore, has an important place in the research strategy. 1.4 Risk Reduction Strategy 1.4.1 Hierarchy of Strategies -- EPA should develop a national environmental protection policy based upon preventing environmental pollution and thereby reduce risks as early as possible. This policy can be described as a hierarchy of strategies (Figure 5 on page 10) for risk reduction consisting of: preventing the generation of wastes and contaminants, recycle/reuse, treatment, and minimizing exposure through containment, and avoidance (for further illustrative examples, see Table 1 on page 6). As noted above, the EPA research program should also reflect this same hierarchy of - strategies. - - a. Preventing Waste and Contaminant Generation - The most effective strategy to reduce risk to human health and the environment is to prevent the production of waste and contaminants. Such a strategy eliminates potential environmental problems, Example: Substitution of water-based paint for solvent-based paint in automaking - - b. Recycling and Reuse - Strategies to recycle and reuse wastes and contaminants can eliminate their release to the environment thereby avoiding the need for treatment or disposal, Example: Recycling waste oil C - Destruction, Treatment and Control: Strategies to destroy, treat, detoxify or control environmental contaminants in order to eliminate or minimize their release should be employed for all wastes which cannot be eliminated or recycled, and Example: Incineration of hazardous wastes * - 10 - Figure 5: Hierarchy for Risk Reduction Research potential waste, residue, and contanninant generation prevent generation actual waste, residue. and contanninant generation reuse / recycle Wastes reduced by -> recycle/ f O USO residues and treat contaminants residual wastes and contaminants contain avoid –Lºs- minimal exposure to wastes and contaminants - 11 - d. Minimization of Residual Exposure - Once the generation of wastes and contaminants has been reduced and the release of the wastes and remaining wastes and contaminants has been controlled to the optimum extent, any remaining risk must be addressed by avoiding or minimizing exposure. Example: Building ventilation While risk reduction research must focus on all of these major areas; source control, source reduction and recycling should receive greater emphasis to reduce to a minimum those waste streams and contaminants that require treatment and ultimate disposal. Research on environmentally sound and cost-effective methods of treatment and disposal also must continue since there will always be wastewaters, sludges and residues that require sound treatment and disposal. Research on other methods of exposure avoidance should be initiated. 1.4.2 Continuum of Activities -- A risk reduction strategy must recognize that the possible risk reduction approaches are all part of continuum of activities (Figure 3 on page 5). Many terms are frequently used to identify the various aspects of this continuum. However, terms such as research, development, demonstration and technology transfer are artifical distinctions and separations. Research and development programs for risk reduction must be based on what will best reduce risk, and should not be limited by artifical or traditional distinctions. Adhering to this principle will greatly enhance the perception of EPA by all interested parties, Congress, the public, and EPA's own staff. The radon program is an example of a well-regarded non-regulatory program for risk reduction. Not all environmental problems require effort all along the continuum. Where pertinent knowledge exists but is not widely known or disseminated, educational and technology transfer efforts may be the most appropriate stategies. For technologies and management approaches that appear technically and economically feasible, large-scale demonstration efforts may be most appropriate. In some situations, fundamental scientific and technical knowledge must be broadened before the extent of a problem and better solutions are identified. The time required for these efforts can vary depending on the available knowledge base and the success in obtaining and utilizing more pertinent information. Understanding where in the continuum of activities it is appropriate. to utilize resources to reduce risk is a key aspect in implementing of a risk reduction research strategy. 1.5 Risk Reduction Research at EPA The question of whether the private sector, and not EPA, should fund and be responsible for control technology development is frequently asked. - 12 - Risk reduction strategies encompass much more than treatment technology (see Figure 5 on page 10 and Table 1 on page 6). Risk reduction research includes research on all of the topics noted in the hierarchy shown in Figure 5 on page 10. The private sector is unlikely to take responsibility for risk reduction research efforts (2, 3, 4). For several reasons, EPA must perform risk reduction research if the nation is to achieve its environmental goals. Research and development is in part a "public good" as evidenced by studies which demonstrate that many successful innovations come from ideas generated outside the firm which develops the innovation. There are also insufficient economic incentives for the private sector to perform basic risk reduction research. Such research has a low chance of commercial success. Short deadlines for compliance with regulations encourage the use of existing technology. No one company or industry is likely to have a unique, important stake in many environmental issues, thus making individual action hard to justify to management or investors. Industry is not monolithic; there are so many sectors involved that they will not get together to sponsor generic research. The industrial sector has little economic incentive to develop technologies which significantly reduce the emissions of pollutants to below regulatory levels, knowing that such technology may result in lower emission standards for all industry. In addition, most pollution control companies do not have the financial strength to devote significant resources to research and development. Moreover, municipal wastewater and drinking water treatment are most often performed by municipal governments which can hardly afford existing technology and have traditionally invested very little in research and development. Finally, EPA risk reduction research can provide large economic, health and environmental returns. Recent studies by EPA indicate that successful risk reduction technologies developed by EPA have saved the nation from $30 to over $1,000 for every dollar spent by EPA. See Tables 2 and 3, pages 13 and 14. Other agencies such as the National Science Foundation, Department of Energy, Department of Defense, and the Department of Health and Human Services could conduct risk reduction research. However, the charters for these agencies are not the same as for EPA. Although these agencies support research which is technically and scientifically sound, it is unlikely that such research would obtain the type of data needed by EPA to make regulatory decisions or provide the research results in a timely fashion to focus directly on and meet the EPA needs. Divorcing research needed for risk reduction from the regulatory decision making process would breed inefficiency and frustration and likely would result in regulatory decisions being made on incomplete knowledge. EPA needs to conduct risk reduction research to assure the Agency's credibility. EPA is the agency charged with protection of human health and the environment. EPA is expected to be and needs to be the "authority" in the broad area of environmental risk reduction. Therefore, it is imperative that EPA have a strong risk reduction research strategy and adequate resources to implement that strategy. - *- - 13 - Table 2: Examples of Benefits EPA's Office of Research and Development has supported research on technologies which have improved treatment effectiveness, reduced risk, and resulted in savings of energy and costs. Successful technologies include: For Wastewater Treatment trickling filter/solids contact process which achieved suspended solids and BOD of 10 mg/l without effluent filtration secondary clarifiers with flocculator center wells which produced average effluent suspended solids and BOD of 5 mg/l top-feed vaccum filtration for sludge dewatering which yielded higher cake solids than bottom-feed vacuum filters bor Hazardous Wastes - a Superfund Innovative Technology Evaluation (SITE) of infrared incineration used for the decontamination of soils on-site treatment for liquid wastes contaminated with dioxins and furans using potassium polyethylene glycolate (called the APEG on KPEG process). microbial treatment for both in situ and on site treatment See Appendix A for details. - 14 - Table 3: value of Benefits - * * - Benefit-to-cost Technology Expenditure for Research National Cost Savings Katio Secondary S 70 000 $ 380 000 000 1400 to 1 Clarifiers with Flocculator Center Wells Trickling S 290 000 $ 280 000 000 1000 to 1 Filter/ Solids Contact Process Oxygen S 3 200 000 $ 14 000 000 3.3 to 1 Aeration - - APEG - - Treatment S 212 000 $ 3 100 000 10 to 1 See Appendix A for details º - - – 15 - In summary, the suggestion that private industry or other agencies will undertake the risk reduction research needed to protect the nation if EPA does not, is fiction. Protection of human health and the environment is a public good, and a public agency should have lead responsibility for and undertake risk reduction research, development and demonstration. The basic mission of EPA is to reduce the level of risk to human health and the environment. Therefore, it is appropriate for EPA to have a significant and serious health and environmental risk reduction research effort. 1.6 Core Areas for Risk Reduction Research Certain types of pollutants have a large impact on human health and the environment and thefore require continuing attention and new technical approaches. Risk reduction research in EPA should be organized by core areas. 1.6.1 Criteria for Selection -- Selection of core areas should be guided by the following criteria: 3 * problems of high risk that can be expected to persist for a decade or more, b. areas in which generic research can support a number of existing and anticipated EPA and state programs, - c. areas in which inadequate information exists for sound regulatory decisions and guidance, and d. areas where research is unlikely to be conducted by others. 1.6.2 Core Areas for Research - Examples of initial or candidate core risk reduction research areas are: a. preventing pollutant generation, b. combustion and thermal destruction, c. separation technologies, d. biological approaches for detoxification and degradation, e. chemical treatment of concentrated wastes and residues, f. ultimate containment methods and approaches, g. exposure avoidance, h. risk communication and perception, and i. incentives for risk reduction. Other research strategy group reports discuss additional potential core areas which can contribute to risk reduction. The development of test methods and the conduct of risk assessments, for example, may support the risk reduction effort. - - 16 - 1.6.3 Nature and Benefits of Core Areas -- Risk reduction research in each core area ultimately may include the full continuum of activities illustrated by Figure 3 on page 5. The challerige for EPA is to determine at what point in the continuum to utilize available resources in each of these core areas. Research in each of these areas also should focus on: a. minimizing cross-media transfer of contaminants, b. clarifying the technical and scientific fundamentals (see Figure 6 on page 17), and c. identifying the economics of feasible source reduction, recycling, & treatment and disposal options. Risk reduction research addresses the needs of ongoing regulatory programs in a broader, more comprehensive framework. Core areas focus on those problems whose solutions require an on-going research program which will support both current and future Agency programs aimed at reducing risks to human health and the environment. Strength in the core areas benefits the program offices by placing EPA in a sound position to develop guidance and approaches for problems that place human health and the environment at risk. Investing in risk reduction research reduces current and future risks to human health and the environment, thereby increasing the quality of life and productivity. Such research is an investment that protects not only present but also future generations. - If the world were ideal, a risk reduction strategy could focus primarily on the concerns and problems that are arising. However, a realistic strategy must address simultaneously diverse problems that have resulted from past and current activities: a. residues from past actions such as abandoned sites and contaminated groundwater, b. currently generated wastes and residues that are affecting soil, air and water and are modifying ecosystems, and c. control of activities such as release of chlorofluorocarbons (CFCs) that increase the future risks to human health and the environment. Risk reduction research in the noted core areas can address these diverse problems. 1.7 Implementation Strategies 1.7. 1 Research Management Process - EPA needs a new research management process for risk reduction research to ensure that: (a) the most important present and future risk reduction issues and problems are acted upon, (b) research outputs are relevant and (c) the research supports program office risk reduction goals. The new process, depicted by Figure 4 on page 7, – 17 - Figure 6: Fundamental Research Applies to Environmental Risk Reduction. ~ ZZZZZZZº ERVOlPS 32 e-sº > J W PERCOLATION SLOW PERCOLATION DIRECT REPLENISHMENT REQUIRED UNDERSTANDING <º INSIGHT /ATELY SPONSORED % % RESERVOIR <> Ž - - 2/ UNDAMENTAL RESERVOIR © 4 ef - OF INSIGHT AND UNDERSTANDING ON GENERIC PROBLEMS DIRECTLY APPLICABLE TO EPA'S INTERESTS - 18 - would expand the role of the existing research committees to include all the elements of risk reduction research programs. The jurisdiction of the research committees would include some elements which have not been high priorities or a traditional part of the ORD mission, (e.g., chemical accident prevention strategies, risk communication). The process would also involve mechanisms for periodic active involvement of the external scientific community and other affected and interested groups in defining core areas of research and programs within these research areas. One such mechanism of involvement is the use of periodic workshops convened by the SAB involving ORD, program offices and the community outside EPA. Such mechanisms can give EPA access to additional expertise which will assist the agency in targeting the research efforts to the most important problems and can build external Support for its research effort. The proposed workshops will recommend the relative resources that should be allocated to core areas and the appropriate administrative structures for carrying out the research. These workshops probably will redefine the core areas. A Research Strategy Council consisting of senior administrators and career executives from all major EPA programs would oversee the process to provide a continuing, high level management mechanism for the scope and direction of risk reduction research. The Council would focus on the cross-cutting issues that need attention and on how to structure approaches that would assure that adequate resources would be available for the designated core areas. The purpose of the Council would be to elevate the shaping of each year's research program above the level of simply responding to separate and perhaps uncoordinated regulatory or program office demands. The Council would assure that adequate vision and support is provided to : a. identify broad problems areas of high risk that are characterized by a lack of scientific understanding, b. address problems in ways that generate timely research results for decision-makers, c. assemble and retain a qualified group of scientists, engineers and other researchers, and d. forecast new and escalating problems which will require research and development efforts. - The Council would meet once or twice annually to review past efforts and focus on major policy issues involving risk reduction programs which require significant continuing research efforts. Such a body would also provide a structured mechanism for high level input from research administrators into the Agency's other programs. - 19 - The outside scientific community can develop and articulate technical consensus opinions on a variety of issues for EPA to use in managing research. One mechanism for the development of technical consensus is workshops as illustrated in Figure 4 on page 7. º Problems for such workshops to address can be predioted in ways analogous to those used for technological forecasting (16): a. intuitive forecasting either by a committee of experts or by a Delphi technique of separately and iteratively polling experts, b. scenarios, or rich descriptions of assumed future conditions; these are useful in looking at possibilities not defensible with traditional logic and can examine extremes, and C. monitoring or searching for signals of new concerns and for better approaches to reduce or eliminate current and future COIlce ITS e - - - 1.7.2 Education and Technology Transfer -- One of the greatest difficulties in a risk reduction strategy is getting pertinent information to the institutions, organizations and people who can use it. This is a particular problem for small and medium sized industries, for state and local governments and for consultants and design engineers. These groups and individuals look to EPA for the needed expertise and knowledge. . The current EPA mechanism for education and technology transfer is an ad hoc system of individual contacts and occasional seminars, training courses and conferences. Education and technology transfer is a legitimate function of EPA and of research and developinent at EPA. Private industry, academia and EPA should work cooperatively to provide the education and technology transfer to assure that the risk reduction research information is adequately disseminated and used (Figure 7, page 20). 1.8 Industry-Government—Academia Partnership -- It is important that EPA include other sources of expertise as part of its risk reduction strategy. Researchers outside EPA have much to bring to the endeavor that EPA often cannot duplicate internally. EPA must lead a broad-based, multi-party risk reduction research effort. For example, a risk reduction research . partnership that includes industry is critical for sourge control, source reduction and recycling studies. Such studies can involve research on process redesign, product substitution and control technology. There should be a strong extramural risk reduction research program to complement the EPA intramural risk reduction research program. This is important to encourage fresh interdisciplinary ideas and to make best use of the talent that exists in the nation. The partnership can consist of support for studies, technology transfer, use of facilities, joint use of personnel and training. Investigator initiated research should be a significant component of the effort. - Figure 7: Education and Technology Transfer are Important to the Reduction of Risks to Human Health and the Environment EDUCATION AND - RISK REDUCTION TECHNOLOGY USERS - ACTUAL RESEARCH TRANSFER - REDUCTION OF RISK prevent generation B- a regulators H- 3...an control residual - HEALTH AND and exposure - G Industry - THE C better education º G public - ENVIRONMENT hr3 Ol - - *...* ogy Research and c academia In for nation Needs – 21 - 2.0 BACKGROUND INFORMATION AND DETAILS 2. 1 Risk Reduction: A Central Goal of Environmental Research and Development - 2.1. 1 Risk Reduction Research and EPA's Mission - EPA's basic mission Gy is to reduce the level of risk to human health and to the environment posed by waste, residues and contaminants. In carrying out that mission EPA must carry out the programs mandated by law as a first priority. However, EPA is also viewed by state and local government, industry, the general public and by people and institutions in other nations as a world leader in all pollution caused problems affecting public health and the environment. In this context EPA is viewed as an organization which must provide leadership on scientific and policy issues involved in environmental protection and must balance environmental goals with other societal goals. A major responsibility in carrying out this mission is to provide information to state and local government, industry and the public about risk reduction strategies that will achieve human health and environmental goals. Further, EPA is expected to develop and evaluate risk reduction strategies in the legal, scientific, political, cultural and social context in which it operates. In the past, EPA's work on developing risk reduction strategies has largely addressed the specific programs mandated by Congress. More recently, EPA has assumed a broader leadership role by sponsoring research on global problems including stratospheric ozone depletion and indoor air pollution problems such as radon contamination. However, EPA's research effort has been focused on cleaning up existing pollution problems with primary emphasis on pollution control technology. Moreover, the risk reduction work has been oriented to problems in specific environmental media such as control of water pollution control rather than generic research oriented toward minimizing problems across environmental media. The orientation of EPA's risk reduction research is a result of the Agency following the narrow statutory mandates with tight deadlines for applying risk reduction strategies. These statutory mandates use a command and control regulatory approach designed to meet environmental quality standards as a means of rectifying existing environmental problems. Very little effort is expended on waste, residue and contaminant prevention across all environmental media, the most effective means of future risk reduction. This is not surprising. The EPA risk reduction research program is a microcosm of the way in which society has approached environmental - protection problems. Pollution control has been reduced to a kind of programmed thinking and a way of shaping questions and answers about environmental management. As stated by Joel Hirschhorn of the Office of Technology Assessment, "the entrenched, rigidly adhered to, and unquestioned perception of pollution control as the way to achieve environmental protection defines the paradigm and undermines pollution prevention." (15) – 22 - In addition to not fostering waste, residue and contaminant prevention, the pollution control strategy has become extremely expensive and caused intermedia environmental problems, e.g., scrubbers which reduce air pollution create a noxious sludge for land disposal. In addition, the current strategy has not achieved the broad environmental goals desired by the public and mandated by Congress and State legislatures. 2.1.2 A New Environmental Policy - It is time for EPA to establish a new national environmental policy based on a hierarchy of strategies for risk reduction for all environmental media. The policy would establish preventing waste, residue and contaminant generation as the primary method of risk reduction. Preventing the generation of wastes, residues and contaminants through source reduction or by natural resource management would yield the greatest risk reduction because it eliminates or reduces. exposure to public health and the environment. As evidenced by the large cost of remediating problems from inappropriate hazardous waste management, prevention is often the most cost effective risk reduction strategy. After exhausting these methods, strategies to recycle or reuse wastes and prevent or reduce the release of contaminants would be applied. Next, treatment, destruction, accident prevention and other control techniques would be utilized to minimize the quantity and toxicity of substances released into the environment. Recognizing that such a policy cannot be fully implemented for all environmental problems in the short run, it will also be necessary to look at other exposure reduction techniques. Strategies such as containment, pollutant dispersion or protecting individuals from exposure would be employed as a last resort in controlling or avoiding any residual exposure from potential polluting activities. Figure 5 on page 10 describes the conceptual idea of this environmental policy. Table 1 on page 6 describes a number of actions individuals, groups, industry and other institutions can take to reduce risks in the framework of this new environmental policy paradigm. 2.1.3 A Strategy for Risk Reduction Research - Such a national Policy would provide EPA's Office of Research and Development (ORD) with a consistent conceptual framework for developing its risk reduction research strategy. This research and development strategy should focus on scientific and technical areas having the greatest potential for reducing risk to human health and the environment. This strategy will allow EPA to control pollution efficiently by focusing the limited resources of EPA on situations where wastes, residues and contaminants have the greatest impact and where, therefore, the greatest reduction of risk can be accomplished. Such a research strategy should be based on a systematic way to evaluate the risks to health and the environment and must consider: a. assessment of sources, transport to a receptor and transformation during the transport and ultimate fate of the contaminants, – 23 – b. evaluation of the exposure that humans or the environment receive, c. determination of the effects that result from that exposure, d. measures to reduce the risks that result, and e. characterization of risk to humans and the environment. This system is depicted in Figure 1 on page 2. Risk reduction measures can occur at many locations in the cycle and are a key component in EPA decision-making and in the mission of EPA. º EPA's research and development strategy should identify and quantify the links in the risk assessment-risk reduction scenarios for specific major problem areas. Problem areas within EPA and state responsibilities and mandates should be considered as well as emerging problems such as global climate change. The identification and quantification would: a. more clearly identify scientific uncertainty, b. indicate where more knowledge would reduce that uncertainty and reduce risks to human health and the environment, c. provide a better logic base to allocate limited resources, and d. provide better information on which to base regulations. The risk reduction part of the research strategy would focus on determining what research and development activities are needed to reduce risk to human health and the environment and what is the proper timing of that research and development. Most importantly, the clearer, firmer logic for EPA research and development activities should make it easier both to prioritize competing research needs and to balance them based on the extent to which the research will reduce risks to human health and the environment. 2. 2 Defining Core Areas Within The Elements Of Strategic Risk Reduction Research Selection of core areas for long range risk reduction research should be guided by the following three criteria. The core areas should address problems that are expected to persist over a period of a decade or more; problems where generic research will support a number of existing and anticipated EPA programs; and problems which are unlikely to be addressed by the private sector. - 24 - Workshops involving the appropriate experts, from both ORD and academia, with representatives from the program offices and industry would establish both the core areas and the comprehensive research program directions within each area. In this manner, programs of high scientific quality relevant to EFA's goals can be formulated. EPA would also convene periodic workshops to review the relevance of the core areas and to update their programs. EPA should maintain strong scientific programs in the core areas. "Having a research program of high quality could pay off for EPA also by enabling it to work with other agencies as a leader, not as a 'lead agency' in the way OMB uses that term, but as a scientific leader." (13) EPA should encourage researchers in the EPA laboratories to become world-class investigators in their areas by publishing in premier journals and by presenting papers at international society meetings. The active involvement of EPA researchers at the frontier of their fields would enhance the EPA's credibility, and provide to EPA early access to research being done in other laboratories. Examples of core areas, to be identified and refined by the workshop process defined above, follow. The EPA OEETD report on strategic risk reduction research and development (5) identified research needs which are listed in Appendix C, categorized by the core area into which they might fit. * * r 2.2.1 Defining the Universe of Risk Reduction Techniques - Traditional environmental protection programs have employed a variety of technology-based strategies for risk reduction. Most such strategies employ devices to collect, store, convert, destroy or block the movement of contaminants to meet environmental standards and/or to cut down on unsafe exposures. For a variety of reasons, risk reduction techniques and strategies which reduce or prevent the production or release of contaminants to the environment without employing treatment or control technology are being increasingly utilized. However, research on these techniques has been meager and has suffered from having an inadequate conceptual framework to evaluate efficacy, potential implementation problems or long term costs. Because of the increasing interest in these techniques and their potential to have both positive and negative impacts on a broad range of societal values it is imperative that EPA have a strong, coordinated research program on these techniques. Many of these risk reduction strategies, such as, prohibition of hazardous substance production, product substitution or aquifer protection zoning are often considered to be policy oriented or "soft science" and have been developed and evaluated by EPA program and policy offices. The - 25 - EPA Office of Research and Development (ORD) has concentrated largely on technology-based risk reduction strategies. However, non-technology-based techniques are extremely important and deserve the same systematic, rigorous development and evaluaton as is traditionally applied to scientific and technology-based strategies. Accordingly, EPA should consider expanding the role of ORD to include research on these strategies. While this would cause some minor organization disruptions it could greatly enhance the credibility and use of those strategies. 2.2.2 Preventing Waste and Contaminant Generation The most effective strategy to reduce health and environmental risks is to prevent the generation of environmental contaminants. This strategy has two components: a. Source reduction, defined as changing industrial production input materials and processes, substitution of products using different raw materials, changing energy production methods and fuels, and resource conservation which eliminates or reduces the release of contaminants into all environmental media - air, water and land, and - b. management of potentially polluting activities through strategies such as local or regional land-use zoning to protect. critical resources, land purchase and acquisition, and watershed management to effectively limit the generation or release of contaminants in critical resource areas or population centers. Source reduction should be applied to all potential environmental contamination sources, from pesticides and toxic substances to air and water pollution and hazardous and solid wastes. - The research strategy should address both components of the waste and contaminant prevention strategy. The current waste minimization strategy should be expanded to cover all environmental media programs, including pesticides and toxic substances. In this context, waste should be defined as any non-product substance (solid, liquid or gas) that leaves a production process or site or that is released into the environment in handling, use or storage. The research program should be oriented toward: a. understanding and developing strategies to overcome barriers to and create incentives for source reduction. Priorities include development of improved methodologies for costing waste management alternatives, including life cycle costs, and potential legal liabilities, - - 26 - b. improving technology transfer, technical assistance and education programs designed to promote source reduction, c. quantitative measurement of source reduction and recycling accomplishments relative to production output and other benchmarks of progress, d. improving production and use of materials which can result in environmental contamination, e. improving, refining and developing better natural resource management strategies such as local and regional land-use zoning controls to protect critical resources, land purchase and acquisition, and watershed management, f. integrated pest management to reduce pesticide and fertilizer use, g. strategies involving substitution for and prohibition of the use of harmful substances, and h. energy conservation strategies. 2.2.3 Recycling and Reuse - Environmentally sound methods of recycling and reuse of potential contaminants can eliminate or greatly reduce the release of contaminants to the environment, reduce the amount of waste to be treated or disposed of, and reduce the generation of pollution from the use of virgin materials. For example, the recycling of solvents in an industrial facility can eliminate air pollutant releases and hazardous waste which must be incinerated or landfilled. The research strategy should include the following elements: a. expansion the recycling component of the current waste minimization strategy to all environment media, b. research on strategies to create adequate markets for recycled goods (secondary materials), c. understanding and developing strategies to overcome barriers to and create incentives for recycling, d. development of improved methodologies for costing waste management alternatives, including life cycle costs and potential legal liabilities, and e – 27 - e. research on ways to recycle specific products and pollutants which create the most significant problems when released or disposed of, e.g., plastics, solvents, batteries, tires, inks, pigments, autoS . 2.2.4 Treatment and Control -- Strategies to prevent the generation of contaminants and/or strategies for recycle should be the first choices for risk reduction. When these strategies have been exhausted, strategies and techniques which destroy, treat, detoxify and reduce either the volume or toxicity of environmental contaminants should be applied. This approach will reduce and, if applied vigorously, minimize the release of environmental contaminants. There are a number of strategies for controlling environmental releases to reduce or minimize the potential for release of and exposure to harmful substances. These include: a. facility management programs such as o accident and spill prevention systems o information, audit and control systems O plant risk analysis, b. auto emissions inspection and maintenance programs, c. environmental monitoring and surveillance systems, and d. labelling of products to ensure safety of use, recycling and proper disposal. EPA should develop a coordinated, systematic research program to evaluate and further develop such strategies as an important component of risk reduction research. Further combustion and thermal destruction research can contribute to treatment and control of wastes, residuals and contaminants. The products of combustion of fossil fuels are pervasive in our industrial society. This source accounts for the emission of 90 tons/capita per year of combustion products in the U.S., is the dominant source of the criteria pollutants, and is the cause of current concerns with pollution on a local (NO and CO in hones), regional (NOx and SOx), and global (CO2 and N2O) scale. This source has the potential of being of continuing concern into the forth- coming decade and beyond into the 21st century as fuel consumption and combustor designs change. In addition, the high temperature processes in – 28 - combustors for fossil fuels, in wood stoves, in municipal and hazardous waste incinerators, and in a number of the high temperature pyrolysis and other thermal destruction methods proposed for Superfund sites have much in coſmon. a • Ce Generic research areas could include the following: The chemistry of high temperature reactions: Models of the reactions in flames and pyrolysis units, together with mixing models, will be of benefit for defining products of incomplete combustion (PICs) in incinerators or for anticipating the conditions that lead to the formation of previously unsuspected pollutants such as N20 in furnaces. Mixing: thuch can be gained from a more fundamental understanding of the mixing process in order to reduce emissions from a wide range of combustors. For example, the effectiveness of destroying NO in furnaces by hydro- carbon injection (reburning) or the burnout of primary pyrolysis products in the secondary combustion chamber of hazardous waste incinerators or above the grates in a municipal incinerator depend upon attaining mixing of the reactants at a molecular level. Aerosol generation and elimination: The vaporization of trace metals from the incineration of municipal sludges, municipal solid wastes, and hazardous wastes as well as from the inorganic constituents of coals and oils results in the formation of fine aerosols that are difficult to collect. Understanding of the mechanism and the rates governing the processes could both better guide the field monitoring programs designed to evaluate this mode of mobilization of heavy metals, as well as suggest improved combustor operation to minimize emissions. Gas-solid reactions: Problems that will certainly continue to be of concern over a decade include the capture of sulfur by limestone, the burnout of a solid residue in an incinerator, the development of advanced sorbents for gasifiers with the potential for high temperature applications. These problems are part of a wide class of gas-solid reactions, the understanding of which could lead to improvements in processes such as acid gas removal or the reduction of the formation of a throwaway by-product. - 29 - e. Development of real-time monitors: Mcnitors for continuously measuring the emissions from incinerators would, by providing a means of rapidly responding to process upsets, enable the reduction of emissions of products of incomplete combustion and, hence overcome some of the objections to the use of this technology. A number of options exist, but require the development of toxicological and risk correlations between the compounds of concern and compounds that are readily ‘. measureable. This partial listing illustrates the potential for defining areas of research in combustion that pertain to several classes of problems which fall in EPA's purview. Combustion is an area of research pertinent to other agencies. EPA's role should be the development of a long range research program built around topics, such as mixing and kinetics, that can serve short-term goals on identification and destruction of PICs or acid rain precursors, as well provide information that would be relevant to potential future problems. Physical and chemical treatment can be used to destroy, treat, detoxify and reduce either volume or toxicity. Among the ſpore pervasive environmental problems is the treatment of waste streams containing very low concentrations of pollutants. The pollutants may be dispersed in a gaseous, liquid, or solid stream either in a molecular form or as fine particles (aerosols. or colloids). The challenge is to achieve high removal efficiencies at low concentration levels, while minimizing the formation of undesirable by-products, and to develop cost-effective technologies in process. These problems have been of importance throughout the history of the EPA. Many of the problems are site-specific and are being adressed by the private sector. There are, however, a large number of medium and small companies utilizing chemicals that do not have the technical resources to recognize the environmental problems to which their effluent streams may be contributing or to develop and implement an appropriate control strategy. The EPA has an important contribution to make in conducting the risk reduction research for these smaller and medium sized companies. Additionally, EPA needs to conduct risk reduction research for problems generated by households, by municipalities, and by other parts of the public sector. Air toxics illustrate these problems since a major fraction of the organic molecules in urban atmospheres comes from a wide variety of dispersed and currently unidentified sources. Another example is the contamination of both drinking water and effluents from municipal wastewater treatment systems, where traditional treatment methods are often found to be inadequate. - 30 - Suggestions for the type of core research that could be done include: a • Ce Fine Particle Controls: The control of the emissions of toxic metals requires the development of improved under- standing of the control of the fine particles produced by vaporization/condensation. Particles in the 0.1 to 1.0 micron size range are of special concern. Absorption/Desorption: Better understanding of the absorption and desorption by high surface area porous solids would be of benefit for both the better design of filters, such as activated carbon, and for the possible development of more economical means of removing trace contaminants from soils. Concentration of Wastes: Economies can be achieved by reducing the volume of the waste stream. Innovative methods such as supercritical extraction, liquid membranes, and reverse micelles are providing new directions in separation technology. - Advanced Chemical Treatment: Detoxification of wastes by chemical treatment is very cost-effective. The method must be tailored to the waste in question since the chemical reactions are specific to a compound or class of compounds, and the method of application depends upon the physical . nature of the waste. The on-site dechlorination of compounds in soils (the APEG and KPEG processes) is a good example of the potential of such technologies. By far the most versatile, cost-effective approach for treating most organic pollutants at low concentration is through use of biological systems for controlling pollutant release. A continuing core research program is needed to take full advantage of such systems. A research initiative EPA proposed in this area in March 1987 (17) should be supported; however, more emphasis should be placed on utilizing naturally occuring organisms than was originally proposed. Key generic research activities in this area of include the following: a • Identify and characterize biotransformation processes occurring naturally in surface waters, soils, and aquifers. Establish optimal conditions to enhance transformation rates. - - 31 – b. Evaluate the utility of genetically engineered organisms in effecting transformations not achievable by natural organisms at reasonable rates. C - Develop new biosystem concepts for incorporating natural and engineered organisms and conditions to effect desired transformations. Include in situ treatment as well as centralized treatment facilities. Develop improved mathematical models to describe biological treatment 9perations. . Initial emphasis may be on cleanup of Super- fund sites, but the program should have broad pertinence to wastewater treatment, land treatment, and aquifer restoration. Include research on anaerobic and aerobic systems for wastewater treatment and sludge stabilization, on enzymatic reagents and delivery systems for treatment of contaminated soils, and on treatment of combined sewer overflows. d. Determine the environmental fate and effects of the treatment residuals, including engineered organisms. Develop means for proper communication of risk (or lack thereof) to the public. - e. Develop means to mitigate adverse consequences of the release of engineered organisms. f. If not covered under other programs, include research on pathogen inactivation. e 2.2.5 Reducing Exposure After Optimum Pollution Prevention, Treatment and Control -- Once the generation of environmental contaminants has been reduced and the release of the remaining contaminants has been controlled to the optimum extent, any remaining risk must be addressed by avoiding or minimizing exposure. This can be accomplished by strategies such as proper land containment, pollutant dispersion, use of home water treatment devices, buffer zones and risk communication. An important part of the EPA risk reduction research strategy must be a viable, strong research program that investigates sound approaches for the land containment and disposal of wastes and residues. Land disposal will continue to be a very important risk reduction activity. There are only three major ultimate disposal locations: air, water and land. Although other options exist and will be used, land disposal has a continuing, inevitable and important risk reduction role for EPA and for the nation. Land disposal options will continue to be needed, and as part of meeting overall EPA needs, land disposal research can help assure that such disposal will be protective of human health and the environment. – 32 - Environmentally sound land disposal practices will be needed even more in the future for: municipal solid waste, household hazardous wastes, very small quantity generator hazardous wastes, residues resulting from treatment of hazardous wastes; high volume wastes such as fly ash, bottom ash and mining wastes; CERCLA remediation and removal wastes; incinerator residues; demolition wastes; and contained wastes that have no other technically feasible or economic disposal alternative. In addition, technology is needed to retrofit existing land disposal facilities and for future facilities. EPA needs a strong land disposal research program (LDRP) to address these issues. - Another need that can be met by a strong LDRP is to evaluate and understand the long-term performance of what are now considered environmentally sound and technically appropriate land disposal practices and the associated monitoring methods to assure that they are environmentally sound over many decades. In spite of the research conducted to date, it remains very difficult to predict that improved land disposal practices, such as "secure" landfills, will protect human health and the environment in future decades. Without such an understanding, the nation will never have permanent verified solutions to the proper management of the above wastes and may find itself caught with the need of continuing to clean up waste disposal sites, because of no cohesive, viable LDRP. A recent review (6) of the current EPA LDRP concluded that EPA does not have a waste management strategy that clearly defines the continuing role of land disposal and that recognizes the need for a strong and vital LDRP. Unless this is corrected, EPA and the nation will lack the scientific and technical knowledge necessary to the ongoing development of scientifically sound land disposal guidance and regulations. - w This situation appears to have occurred because, as with almost all EPA programs, the LDRP is driven by immediate and legitimate program office needs for information to support Congressional mandates and court deadlines to develop regulations. As a result of changing program office direction, the research focus has shifted during the past decade. In the 1970's, the LDRP emphasized municipal solid wastes in response to the needs of the Solid Waste Disposal Act. With the passage of the Resource Conservation and Recovery Act (RCRA) in 1976, the focus began to change to the control of hazardous wastes. In recent years, the LDRP has evaluated whether hazardous waste land disposal methods are protective of human health and the environment. With the current (RCRA) emphasis on alternative technologies to land disposal (needs that resulted from the requirements in the 1984 RCRA Amendments), the perceived need for hazardous waste land disposal research efforts has declined. These funding reductions cripple the program's ability to meet future technical requirements in regard to the use of environmentally sound land disposal methods. The net effect of these cumulative individual decisions results in EPA being left with a LDRP that does not meet the Agency's overall long-term needs. - 33 - The Science Advisory Board review (6) recommended numerous efforts that should be Part of a land disposal research strategy. These included: a. identification of changes in the characteristics of wastes likely to be land disposed in the future, - b. field scale research to have a technical understanding of the Performance of cover and liner systems. The emphasis on land disposal closure and post-closure operations and monitoring should be increased because many land disposal facilities recently have closed, and others will close, c. research on approaches and designs that facilitate liner and cover repairs, d. evaluation of monitoring data at permitted facilities to evaluate containment designs, and e. an increase in cooperative efforts with the private sector to develop better analytical and evaluation methods for constructing and defining the performance of land disposal components and systems. Assuming that opportunities to mediate those environmental processes which transport and transform the contaminants are uncommon and also that personal protective devices are an undesirable last resort, then a promising area of research concerns education of the public on personal exposure avoidance. - Research into human exposure avoidance embodies sociological, cultural and psychological issues. Learning what motivates people to take action concerning their health and how to prepare and deliver educational materials to be effective are essential elements. Exposure avoidance, by personal action, deserves its place along with source reduction and control as an important element in a strategy of risk reduction. A companion research program in total human exposure would provide the technical information used in the exposure avoidance. Other programs in risk reduction through exposure avoidance relate to protection of pesticide applicators and asbestos abatement workers; drinking water treatment (central and at point of use); providing alternative sources of drinking water, indoor air ventilation, and land use planning (e.g. industrial buffer zones). Of these, continued core research programs are recommended on drinking water treatment (particularly at point of use) and on the reduction of indoor air pollution from passive smoking, asbestos, solvents, combustion products and radon. - 34 - Proper, siting of noxious facilities is an important strategy in reducing public exposure and environmental contamination from harmful substances. EPA's research strategy should address both technical and non-technical strategies to improve government decision-making on siting potentially noxious and polluting facilities. The research should focus on improving the use of Siting as a strategy to minimize public exposure and environmental contamination and on Overcoming barriers to siting, :*s, treatinent and disposal facilities needed to reduce environmental T].SKS • 4.2.6 Selecting Risk Reduction Strategies -- The selection of risk reduction strategies to achieve desired risk reduction goals will involve a variety of legal, scientific, economic, political and social factors. However, one critical element in making these decisions is the communication between decision-makers, parties affected by the decisions and others, e.g., the news media and academics, who report, chronicle and evaluate these decisions. Indeed, some would argue that risk communication is the most critical element in such decisions. Because it is newly emerging as a defined subject area of intellectual organization and because of its importance, EPA should expand and develop a strong research program in risk communication. The importance of risk communication to risk reduction efforts was recently expressed by Milton Russell, former assistant administrator for Policy, Planning and Evaluation at EPA. Russell observed that: - "Real people are suffering and dying because they don't know when to worry, and when to calm down. They don't know when to demand action to reduce risk and when to relax, because health risks are trivial or simply not there. I see a nation on worry overload. One reaction is free floating anxiety. Another is defensive indifference. If everything causes cancer, why stop smoking, wear seat belts or do something about radon in the home? Anxiety and stress are public health hazards in themselves. When the worry is focused on phantom or insignificant risks it diverts personal attention from risks that can be reduced." Implicit in Russell's statement are two basic functions served by risk communication. One is the provision of basic information and education in order to help people understand risk and put it in perspective so that they will know "when to worry and when to calm down." Communications about the risks from eating flour contaminated with EDB or drinking water containing radioactive fallout from Chernobyl are examples of this category of information. The second function is to communicate in order to motivate necessary risk-reducing actions such as renovating a home that has high radon levels or disposing of household chemicals properly. – 35 - The goal of informing people about risk and motivating behavior change sounds easy, in Principle but is surprisingly difficult to accomplish. To be effective, risk communicators must recognize and overcome a number of obstacles. , First; doing an effective job of communicating means finding comprehensible ways of presenting complex technical material that is cloaked in uncertainty and is inherently difficult to understand. To further complicate matters, risk information may make a hazard seem more frightening, even when the aim of the message is to calm public concerns. When public attitudes and perceptions are well established, as with nuclear power, they are hard to modify because new information is filtered in a way that Protects established beliefs. However, when people lack strong prior views, the opposite situation exists--they are at the mercy of the way that information is presented or "framed." In such cases, subtle changes in the ways that risks are expressed can have a major impact on perceptions and decisions. Understanding risk perception is critical to clearly "framing" and communicating risks to the public. Many risk analysts have argued that health risks can best be understood and appreciated by means of comparisons with risks from other (often more familiar) activities. Such comparisons are thought to provide a "conceptual ruler" that is intuitively more meaningful than absolute numbers or numerical probabilities. Yet, to date, there is little specific knowledge about how to formulate such comparisons and determine whether or not they communicate effectively. There is a need for creative new indices and analogies to help individuals translate risk estimates varying over many orders of magnitude into simple, intuitively meaningful terms. The task will not be easy. Ideas that appear, at first glance, to be useful, often turn out, upon testing, to make the problem worse. For example, an attempt to convey the smallness of one part of toxic substances per billion by drawing an analogy to a crouton in a five-ton salad seems likely to enhance one's misperception of the contamination by making it more easily imaginable. The proposal to express very low probabilities in terms of the conjunction of two or more unlikely events (e.g., simultaneously being hit by lightning and struck by a meteorite) also seems unwise in light of experimental data showing that people greatly overestimate the likelihood of conjunctive events. Perhaps public understanding of quantitative risk can be improved by studying their understanding of commonly used measures, such as distance, time and speed. The sensitivity of risk communications to framing effects points to another avenue for research. We need a better understanding of the magnitude and generality of these effects. Are public perceptions really as malleable as early results suggest? If so, how should the communicator cope with this problem? One suggestion is to present information in multiple formats--but does this help or confuse the recipient? Finally, the possibility that there is no neutral way to - 36 - present information, coupled with the possibility that public preferences are very easily manipulated, has important ethical and political implications that need to be examined. Because of the complexity of risk communications and the subtlety of human response to them, it is extremely difficult, a priori, to know whether a particular message will adequately inform its recipients. Testing of the message provides needed insight into its impacts. In light of the known difficulties of communicating risk information, it could be argued that an agency which puts forth a message without testing its comprehensibility and effectiveness is guilty of negligence or at least of short sightedness. This assertion raises a host of research questions. How does one test a message? How does the communicator judge when a message is good enough in light of the possibility that not all test subjects will interpret it correctly? Risk communication is closely linked with risk perception. To communicate effectively, we need to understand the nature of public knowledge and perceptions. Thus, a ccmprehensive research program on risk reduction also needs to include research on risk communication and perception. Some general research questions dealing with research on risk communication and perception are: - a. What are the determinants of "perceived risks?" What are the concepts by which people characterize risks? How are those concepts related to their attitudes and behavior toward environmental hazards? b. What steps are needed to foster enlightened behavior with regard to risk? What sorts of information do policy makers and the public need? How should such information be presented? What indices or criteria are useful for putting diverse risks in perspective and motivating desirable behavior change? How should uncertainty be explained to the public and to policy makers? - c. What makes a risk analysis "acceptable?" Some analyses are accepted as valuable inputs to risk management decisions, whereas others only fuel controversy. Are these differences due to the specific hazards involved, the political philosophy underlying the analytical methods, the way that the public is involved in the decision-making process, the results of the analysis, or the incorporation of social values into risk analysis? - 37 - d. How can polarized social conflict involving risk be reduced? How can an atmosphere of trust and mutual respect be created among opposing parties? How can we design an environment in which effective, multi-way communication, constructive debate, and compromise can take place? - e. Are certain contexts of risk communication more or less conducive to the processing of risk information? The information-theoretic model of risk communication has been useful to a limited degree, but it is too constraining. In addition to looking at information flow, channels and receivers, we have to look at the social and cultural contexts within which scientific information gets transmitted. f. In dealing with public perceptions of risk, we need research that examines now people come to an understanding of risk in real time, under actual conditions. Ethnographic case models are important. Laboratory models of risk perception have provided an important conceptual framework, but they need to be complemented by analytic case studies. g. How do we get consensus in the expert community? What are the factors that impede consensus? We need to know more about the problem of risk communication between experts. h. How should lack of scientific consensus be transmitted to the lay public? We need to clairfy and describe the issues in an understandable manner for public consumption. Risks can be defined as threats to people and things they value (their health, their finances, the quality of their environment). Considerable research has been directed toward assessing values associated with human mortality and morbidity, so that these values could be factored in to risk benefit analyses. Much less attention has been given to the valuation of environmental features such as clean air and water, protection of plant and animal species, etc. Typically these valuation efforts have been approached from an economic (e.g., cost-benefit or willness to pay) perspective. For instance, the public and policy makers are asked to assume that a market exists for trading such "goods" and they are asked to estimate appropriate "prices" expressed in terms of "willingness to pay" to save (or to avoid the loss of) a human life, to clean up a polluted lake, to preserve an animal species, and so on. - 38 - The market approach to valuing goods for which no market actually exists has come under severe criticism, however, on the grounds that it is biased at best and invalid at worst. It appears that many outcomes associated with environmental protection may simply not be able to be evaluated in terms of well-defined dollar values that can be compared with nonetary values for traded goods or services. People may care about maintaining a clean environment, reducing perceived risks, protecting their health, or preserving a threatened animal species without realiy being able to express the importance of such outcomes in terms of monetary values: Instead, , their values may reflect a complex mix of aesthetic, moral, political, psychological, social and economic concerns that need to be measured by innovative new methods. The methodology of multi-attribute utility theory, for example, might be used to construct overall values from the component dimensions of value. Thus, despite modest research efforts in the past, we still lack the ability to evaluate many outcomes associated with environmental protection. We need a fresh approach, one that starts by looking beyond economic components of value, which are important but are only part of the story. Research is needed to determine what the components of "value" really include and how they can be measured in a manner that is reliable enough and valid enough for input into policy decisions. Such research will need to proceed from an interdisciplinary base in which the efforts of psychologists, ethicists, economists and others are closely coordinated. 2.2.7 Incentives for Risk Reduction -- Risk reduction strategies will only be effective if properly implemented. Although taken for granted, seldom is the implementation strategy considered in evaluating and chosing a risk reduction strategy. Most risk reduction strategies are mandated by legislative, executive and judicial branches of government. However, it should be realized that risk reduction strategies are aimed at influencing the behavior of individuals, groups and institutions to reduce environmental risks. Creating incentives to change behavior is what most environmental law and regulation aims to do. There are strategies other than government command and control and market-place factors to create the proper incentives for risk reduction. EPA should develop a coordinated systematic research program on such alternative strategies. The research program should include factors motivating behavior. Priorities should be given to: a. Economic incentives through fees, taxes, grants, loans, etc., - b. Evaluating the incentives and disincentives to applying risk reduction strategies, and c. Understanding motivations of individuals, groups and institutions to foster changes in behavior which will result in risk reduction. - 39 - 2.3 Education and Technology Transfer One of the greatest difficulties in implementing innovative risk reduction strategies is getting the information in the hands of institutions and people who can implement the strategies. For example, they are often faced with a proposal for a new facility which wishes to employ a new technology for risk reduction. In addition to checking the literature and consulting professional colleagues, state and local officials often call EPA and sometimes other states for advice. They do so for several reasons. They assume EPA has or should have the expertise to evaluate the technology, and that EPA and other states may have been faced with similar issues. Moreover, state and local governments feel that they are on firmer ground with the backup of EPA or another state which condones, has approved or utilized the technology or strategy. State and local governments also perceive the value of technology transfer activities to their communities and local economies. EPA assistance that enables communities to achieve environmental goals more cost-effectively is clearly beneficial. The current mechanism for obtaining this assistance is an ad hoc system of individual contacts with occasional seminars, training courses and conference by EPA. -- The problem is not unique to state and local government. Business and industry (particularly small and medium sized) also need a better mechanism for obtaining information about risk reduction technologies and strategies. For reasons of competition and lack of expertise or other resources, small and medium sized industries do not often have access to the latest information to reduce risks. An important example of this is getting information to (and acceptance by) farmers on integrated pest management to reduce risks from pesticide exposure. Similarly, the public which is demanding and having a larger role in government and private decision-making on environmental protection needs information on the effectiveness and application of risk reduction strategies and technology. Moreover, academic programs at universities and other institutions must have access to information on innovative risk reduction strategies to ensure that educational programs will be providing the personnel who can implement risk reduction programs. To date, EPA has not had a coordinated, comprehensive strategy for communication and education on risk reduction strategies. This is especially true for the Office of Research and Development which has been unable to budget resources for technical assistance, technology transfer and communication, except in a few specialized cases. - EPA should develop a comprehensive, regular program for communication, education and technology transfer across all environmental media. The report of the Administrator's Task Force on Technology Transfer and Training is an important step forward for EPA; its recommendations should be fully implemented. 2.3.1 Education ºng Tºaining Programs -- it is irportant for EPA, private industry, Erade and professional associations, and universities to wºrk cooperatively to incorporate training in environmental issues into the curricula of a number of disciplines relevant to environmental management. It is critical that much more integrated views of product design, production processes, waste generation, product handling and use, non-engineering approaches, cost effectiveness, and pollution control that relate to all risk reduction strategies be developed in such fields as civil, environmental, chemical process, mechanical, electrical and petroleum engineering; business; public policy; economics; medicine; public health and law. As an example, pollution control -- much less environmental protection --- cannot continue to be thought of only as an "end-of-pipe" treatment of wastes. A sound integrated curricula would not require separate courses on topics such as source reduction and waste audits. Rather, the curricula would teach the implications for pollution generation of actions not traditionally associated with polluticr. An example is to incorporate waste elimination as a goal of a design problem on manufacturing computer chips. - - EPA should work actively with groups such as the National Research Council, the National Science Foundation, the American Institute for Chemical Engineers, the Association of Environmental Engineering Professors, the Accreditation Board for Engineering and Technology, the American - Academy of Environmental Engineers, the American Medical Association, the American Public Health Association and the American Bar Association to advocate such changes. º º - - In addition, EPA should support the development and implementation of such education programs. Such programs could include education and training materials, handbooks and other written and audiovisual materials and also seminars and training courses. The success of the existing regional asbestos training and information centers sponsored by EPA are an excellent example of the value of such programs that should be replicated for other risk reduction strategies. Priorities for consideration should include a. lead paint removal, b. radon mitigation, c. integrated pest management, d. chemical accident risks, e. hazardous waste management, f. support of curriculum development at universities in environmental management and risk reduction, and -- --- • , , , , ; ; ; -ºº: - - . . ; *...*. * at:--~~~~ --e're-ºrient of improved waste load all. Scation models to compute the risk in Tultidischarge settings and seasonal permitting programs. -> Control of Toxics in Sludge -- There is a need for research on treatment and control methods for toxics in sludge to reduce risk. Proposed research topics include: º-> Development of strategies to reduce the risk of surface sludge impoundments (lagoons). º Charaterization of sewage sludge pathogens at various stages in the treatment system to determine treatment and disposal strategies to reduce pathogens. © R&D on new sludge stabilization strategies for microbial destruction and pathogen reduction. sº Determination of the fate of pathgens in sludge-amended soil controls. Reducing Risks from Toxic Metals Pollution of Soils, Sludges, and Surface Waters -- Toxic metals (i.e., lead, mercury, chromium, and cadmium) are mobile in the environment, bio- accumulate, and can leach into sensitive water supplies. Proposed research topics include: º Further development and field testing of innovative technologies for reducing the pollution of land and water resources by toxic metals. Various methods to be investigated include biological reduction. <--> R&D on the uptake of toxics by crops grown on sludge-amended soil. cº- Research on plant uptake and the leaching of contaminants on sludge disposed strip-minded lands. Biological Detoxification/Destruction of Organic Pollutants in Soilº. Studges, and Surface Waters. TBioIogical degradation offers the potential for safe, effective, and inexpensive cleaning of hazardous waste. However, much more information is required. Proposed research topics include: tº º Definition and characterization processes in various media. « » R&D on new organisms for the treatment of specific pollutants including the bioengineering method, the delivery system, the environmental fate of the organisin, and methods to mitigate adverse effects from accidental releases. - 5 - --> Development of an adequate technology transfer method on promote the use of biodegradation. --> Characterization studies on the pathogen contents of septic tank pumping (septage). Containment and Disposal O Reduction of Releases from Subtitle D Landfills and Surface Impoundments -- the development of Low level gas release and leachate control technologies for Subtitle D landfills and surface impoundments are needed to produce an appreciable reduction in risk without significantly increasing the cost or skill required for implementation. 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