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Project History and Organization ANN Y. WATSON Health Effects Institute Rationale The Health Effects Institute (HEI) is an independent nonprofit corporation that, ac- cording to its charter, is "organized and operated ... specifically to conduct or support the conduct of, and to evaluate, research and testing relating to the health effects of emissions from motor vehicles." Because resources are always limited, fund- ing decisions need to be made in the con- text of the most important scientific needs. Formulation of a research strategy that takes into account current problems as well as long-range goals provides a mechanism for resource allocation. Accordingly, the HEI undertook a major endeavor to iden- tify specific research problems within auto- motive air pollution and toxicology. The Institute recognized the need for a compre- hensive, integrated research strategy and committed the resources to develop the necessary intellectual input and to make available this information to the scientific and regulatory communities. The focal point of the project was to identify and explain obstacles that prevent the quantifi- cation of risk and to propose future re- search to solve these problems. Although the Institute, as the name im- plies, focuses primarily on health effects, the identification of pollutants and quanti- fication of exposure are essential when de Air Pollution, the Automobile, and Public Health. (it) 1988 by the Health Effects Institute. National Academy Press, Washington, D.C. 11 termining the dose at which effects may occur. Hence, the Institute chose to evalu- ate topics relevant to exposure analysis and biological effects. The project had two pri- mary goals: (1) to assess the pattern and extent of population exposure to automo- tive air pollutants; and (2) to assess the toxicity to humans including unusually susceptible persons so that societal risk can be estimated. Organization Implementation of this project called for the formation of a parent Steering Com- mittee and two Subcommittees (the mem- bers of which are listed at the end of this chapter), one for Exposure Analysis and the other for Biological Effects. The Steer- ing Committee, chaired by Donald Ken- nedy and composed of members from the HEI's Research and Review Committees and staff, established policies and approved of the plans and reports of the two subcom- mittees. The Exposure Analysis and Bio- logical Effects Subcommittees, chaired by Robert Sawyer and Gerald Wogan, respec- tively, included members of the Institute's Research and Review Committees and other scientists with expertise in some of the topics studied in the project. The Sub- committees developed plans for evaluating research needs, selected topics for investi- gation, recruited specialists to write back- ground documents, and guided their efforts.

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12 Project History and Organization It was not feasible to commission papers on every aspect of automotive emissions and their potential health effects. One cri- terion used for selection was the topic's relevance to the goal of the project and the information available. Because inhalation is the primary route of exposure and the lung represents the first line of defense, asthma, cancer, chronic obstructive pulmonary dis- ease, and respiratory infection were chosen for study. Consideration of other physio- logical systems or health outcomes, how- ever, was not as clear. For example, ath- erosclerosis was evaluated because of its prevalence in society and its association with cigarette smoke, another air pollutant; however, birth defects or kidney disorders, also very important conditions, were not studied because their connection to auto- motive emissions has been less clearly es- tablished. Available expertise was used as another criterion for determining which topics to include. For example, the investi- gation of neurotoxicology uses behavioral as well as biological approaches. The iden- tification of a single author equally familiar with both of these approaches was difficult. The decision was made to explore the relationship between behavioral effects and automotive emissions as this relationship may relate to issues of the quality of life. Finally, an effort was also made not to duplicate ongoing Institute studies. For ex- ample, carbon monoxide was not chosen as a topic for evaluation because the Institute is currently conducting a multicenter study of this pollutant. The development of each paper was fol- lowed by one member of the appropriate subcommittee and by either Richard Bates or Ann Watson. Early in the project, au- tumn 1985, a meeting was held in Dear- born, Michigan, at which the authors pre- sented outlines of their chapters to the Steering Committee and Subcommittees, the scientific staffof the Institute, the spon- sors of the Institute, and to each other. After brief presentations, comments were invited from the audience. The- authors then prepared initial manuscript drafts, which were submitted for external peer review (colleagues serving as peer review- ers are acknowledged at the end of this chapter) and internal review by subcom- mittee members. Suggestions from review- ers and subcommittee members were trans- mitted to the authors for their use in the preparation of their final manuscripts. Messages To and From the Authors In order to produce a series of focused papers, a set of guidelines was distributed to the authors. They were asked to concen- trate on two questions: (1) What do we need to know to be able to quantify levels of risk? and (2) How do we get the neces- sary information? Papers were to be writ- ten as concise and critical reviews, to iden- tify gaps in our knowledge, and to propose research directions necessary to fill those gaps or resolve controversies. These papers were not to be comprehensive reviews, and, much to the concern of some of the authors, extensive bibliographies were dis- couraged. The authors were encouraged, however, to evaluate creatively the most important and feasible research opportuni- ties in their areas of expertise. The authors were also asked to write in a style that would be appropriate for a broad readership. It was the Institute's desire to make this information available to an audi- ence that included scientists in fields other than the authors', policymakers, and in- formed citizens of public interest groups, among others. It was not easy for special- ists to step back and realize that what had become his or her first language was often beyond the grasp of many even fellow scientists in different fields. It was some- times a struggle to strike a balance between insulting the experts and informing the interested persons. Within these guidelines, the authors had the freedom to present their own interpre- tation of the problems and, most impor- tantly, their solutions. "Solutions" are pre- sented in the form of recommendations of specific research projects. Recommenda- tions and their rationale are described in the text and are ranked in priority by the authors at the end of each chapter.

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Ann Y. Watson 13 An integrated response to the authors' recommendations is provided in the fol- lowing chapter, entitled "Motor Vehicle Emissions: A Strategy for Quantifying Risk." This chapter attempts to put to- gether a more overall approach to their recommendations. Surprisingly, even though a wide range of disciplines were represented in this project, several consist- ent themes emerged and are highlighted in the overview. The authors have responded to our re- quest to share their knowledge. Now it is up to the scientific and regulatory commu- nities, among the ultimate consumers of this project, to use this information. Acknowledgments The realization of such an endeavor from inception to published form required the . . . , ~ participation ot numerous, too often un- derthanked, individuals: Richard Bates ini- tiated this project, and then convinced the Institute of the necessity of defining future directions in research in order that the proper scientific data base could be ob- tained for quantification of risk; Linda Bu- chin assisted in the massive task of admin- istration; Ellen Williams helped to translate technical expertise into discussions appro- priate for the intended audience; Richard Maurer transformed hand-drawn sketches and computer printouts into illustrations and advised on book design; and Virgi Hepner coordinated and proofed the final stages of production. The Executive Direc- tor of HEI, Thomas Crumbly, supported the project enthusiastically from beginning to end, and provided the necessary re- sources. From the National Academy Press, Virginia Martin recognized the po- tential contribution of this project, and she was instrumental in encouraging the Press to publish a work unrelated to Academy reports. In addition. numerous individuals at the Press worked with and guided us through the intricacies of the publication process. Finally, the Institute is indebted to the authors for their enthusiasm and coop- erat~on. Steering Committee Donald Kennedy (ChairmanJ Stanford University Richard R. Bates Health Effects Institute Thomas P. Grumbly Health Elects Institute Robert I. Levy Columbia University Walter A. Rosenblith Massachusetts Institute of Technology Robert F. Sawyer University of California, Berkeley John W. Tukey Princeton University Arthur C. Upton New York University Medical Center Gerald N. Wogan Massachusetts Institute of Technology Exposure Analysis Subcommittee Robert F. Sawyer /(Chairman) University of California, Berkeley Richard R. Bates Health Effects Institute Glen R. Cass California Institute of Technology David E. Leith Harvard Medical School Roger 0. McClellan Lovelace Inhalation Toxicology Research Institute Ken Sexton Health Effects Institute Werner Stoeber Fraunhofer Institute of Toxicology and Aerosol Research, Federal Republic of Germany Ann Y. Watson Health Effects Institute Arthur M. Winer University of California, Riverside

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14 Biological Effects Subcommittee Gerald N. Wogan (ChairmanJ Massachusetts Institute of Technology David V. Bates University of British Columbia Richard R. Bates Health Effects Institute Earl P. Benditt University of Washington Joseph D. Brain Harvard University School of Public Health Curtis C. Harris National Cancer Institute Donald E. McMillan University of Arkansas Medical School Sheldon D. Murphy University of Washington Mark I. Utell University of Rochester School of Medicine Ann Y. Watson Health Effects Institute Peer Reviewers Zoltan Annau The Johns Hopkins University Anne P. Autor University of British Columbia John C. Bailar III Harvard University School of Public Health Goran Bondjers University of Goteborg Goteborg, Sweden Jack G. Calvert National Center for Atmospheric Research Julius S. Chang National Center for Atmospheric Research David P. Chock General Motors Research Laboratories Steven D. Colome University of California, Irvine Project History and Organization Ramzi S. Cotran Harvard Medical School James D. Crapo Duke University Medical Center Jack H. Dean Chemical Industry Institute of Toxicology Kenneth L. Demerjian State University of New York, Albany Donald L. Dungworth University of California' Davis Bruce A. Egan Environmental Research and Technology, Inc. Ludwig A. Engel Westmead Hospital Sydney, Australia Hugh L. Evans New York University Medical Center James E. Fish Jefferson Medical College Inge F. Goldstein Columbia University School of Public Health Daniel Grosjean Daniel Grosjean and Associates, Inc. Joachim Heyder Gesellschaft fur Strahlen-und Umweltfors- chung mbH Frankfurt, Federal Republic of Germany Millicent Higgins National Institutes of Health John R. Hoidal University of Tennessee Center for the Health r~ ~ ~clences George J. Jakab The Johns Hopkins University School of Hygiene and Public Health Fred F. Kadlubar National Centerfor Toxicological Research Samuel S. Lestz Pennsylvania State University Richard B. Mailman University of North Carolina School of Medicine Kevin T. Morgan Chemical Industry Institute of Toxicology

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Ann Y. Watson 15 Paul Nettesheim National Institute for Environmental Health rot . Sciences Gunter Oberdorster University of Rochester Wayne R. Ott U.S. Environmental Protection Agency Robert F. Phalen University of California, Irvine Charles G. Plopper University of California, Davis Gerald M. Saidel Case Western Reserve University Peter W. Scherer University of Pennsylvania Dennis Schuetzle Ford Motor Company Bernd Seifert Institute for Water, Soil, and Air Hygiene, Federal Health Office Berlin, Federal Republic of Germany John H. Seinfeld California Institute of Technology Dean Sheppard University of California, San Francisco Thomas I. Slaga The University of Texas System Cancer Center lames A. Swenberg Chemical Industry Institute of Toxicology Ira Tager University of California, San Francisco Thomas R. Tephly University of Iowa Lance Wallace Harvard University School of Public Health Peter A. Ward University of Michigan David Warshawsky University of Cincinnati Medical Center I. Bernard Weinstein Columbia University George T. Wolff General Motors Research

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