ENVIRONMENTAL POLLUTION AND CANCER AND HEART AND LUNG DISEASES SECOND ANNUAL REPORT TO CONGRESS August 7,1979 TASK FORCE ON ENVIRONMENTAL CANCER AND HEART AND LUNG DISEASE Environmental Protection Agency National Cancer Institute National Heart, Lung and Blood Institute National Institute for Occupational Safety and Health National Institute of Environmental Health Sciences National Center for Health Statist Center for Disease Control Food and Drug Administration ------- ENVIRONMENTAL POLLUTION AND CANCER AND HEART AND LUNG DISEASES Second Annual Report to Congress August 7, 1979 TASK FORCE ON ENVIRONMENTAL CANCER AND HEART AND LUNG DISEASE Environmental Protection Agency National Cancer Institute National Heart, Lung and Blood Institute National Institute for Occupational Safety and Health National Institute of Environmental Health Sciences National Center for Health Statistics Center for Disease Control Food and Drug Administration Prepared with the assistance of GEOMET, Incorporated, under EPA Contract Number 68-01-5773, George R. Simon, Project Officer, Office of Research and Development, Environmental Protection Agency, Washington, D. C. 20460 ------- PREFACE The Task Force on Environmental Cancer and Heart and Lung Disease was established in accordance with Section 402 of Public Law 95-95, enacted August 7, 1977, for the purpose of recommending and coordinating Federal pro- grams concerned with the reduction of such diseases. The Task Force initially included representatives from the Environmental Protection Agency, the National Cancer Institute, the National Heart, Lung and Blood Institute, the National Institute for Occupational Safety arid Health, and the National Insti- tute of Environmental Health Sciences. The Administrator of the Environmental Protection Agency (or his delegate) was designated as Chairman by this law. Subsequent legislation, Section 9 of Public Law 95-623 enacted November 9, 1978, added the Director of the National Center for Health Statistics and tne head of the Center for Disease Control to the membership of the Task Force.* The Task Force is required to report annually to Congress on its progress and problems. This report describes the work of the Task Force in its second year (August 1978 to August 1979) and outlines plans for the future. Chapter 1 is an introduction that delineates the responsibilities of the Task Force and summarizes its first annual report. Status summaries of the Task Force's activities are presented in Cnapter 2. Chapter 3 describes future plans of the Task Force. * In September 1978, the Food and Drug Administration was invited to participate in Task Force activities. -in- ------- Abbreviations of Agencies and Organizations ACDA Arms Control and Disarmament Agency ADAMHA Alcohol, Drug Abuse, and Mental Health Administration CDC Center for Disease Control CEQ Council on Environmental Quality CPSC Consumer Product Safety Commission DHEW Department of Health, Education, and Welfare DOC Department of Commerce DOD Department of Defense DOE Department of Energy DOI Department of Interior DOL Department of Labor DOS Department of State DOT Department of Transportation EOF Executive Office of the President EPA Environmental Protection Agency FAA Federal Aviation Administration FDA Food and Drag Administration FSOS Food Safety and Quality Service HCFA Health Care Financing Administration HRA Health Resources Administration HSA Health Services Administration HUD Department of Housing and Urban Development ITC International Trade Commission IOC Library of Congress MSHA Mine Safely and Health Administration NAS National Academy of Sciences NASA National Aeronautics and Space Administration NCHS National Center for Health Statistics NCI National Cancer Institute NCTR National Center for Toxicological Research NHLBI National Heart, Lung, and Blood Institute NIA National Institute on Aging N1AID National Institute of Allergy and Infectious Diseases NIAMDD National Institute of Arthritis, Metabolism and Digestive Diseases NICHHD National Institute of Child Health and Human Development NIDA National Institute of Drug Abuse NIEHS National Institute of Environmental Health Sciences NIGMS National Institute of General Medical Services NIH National Institutes of Health NIMH National Institute of Mental Health NINCDS National Institute of Neurological and Communicative Disorders and Strokes NIOSH National Institute for Occupational Safety and Health NLM National Library of Medicine NOAA National Oceanic and Atmospheric Administration NRC Nuclear Regulatory Commission NSF National Science Foundation OASH Office of Assistant Secretary for Health OSHA Occupational Safety and Health Administration OSTP Office of Science and Technology SI Smithsonian Institution SSA Social Security Administration USDA U.S. Department of Agriculture VA Veterans Administration -IV- ------- TABLE OF CONTENTS EXECUTIVE SUMMARY Page vii Chapter 1. INTRODUCTION The Task Force Responsibility The First Year 1 1 2 Chapter 2. STATUS SUMMARY Standardization of Measurements and Tests Education of the Public and of Health Professionals Exposure and Metabolic Mechanisms Information Exchange Risk Assessment Funding of Federal Efforts 6 8 13 15 22 23 Chapter 3. TASK FORCE PLANS The Approach to Strategy Development Actions for Next Year 27 27 31 Appendix A. Appendix B. Appendix C. Appendix D. Appendix E. Appendix F. PERTINENT SECTIONS OF PUBLIC LAWS 95-95 AND 95-623 MEMBERS OF THE TASK FORCE, WORKING GROUP AND PROJECT GROUPS MEETING DATES A RESPONSE TO THE FIRST ANNUAL REPORT FROM CONGRESSMAN PAUL G. ROGERS SUMMARY OF RECOMMENDED RESEARCH IN EXPOSURE AND METABOLIC MECHANISMS OF FOUR TOXIC CHEMICALS CATEGORIZATION AND FUNDING OF FEDERAL PROGRAMS -v- ------- EXECUTIVE SUMMARY ------- EXECUTIVE SUMMARY This is the second annual report to Congress by the Task Force on Environmental Cancer and Heart and Lung Disease. INTRODUCTION The Task Force was established in the Clean Air Act Amendments of 1977 to focus efforts by the Environmental Protection Agency and the various branches of the Department of Health, Education, and Welfare on the develop- ment of coordinated, comprehensive Federal research programs and strategies for the reduction of the risks of environmentally related cancer and heart and lung diseases. During its first year, the Task Force defined the problem of environ- mentally related cancer and heart and lung diseases and developed objectives and an organizational capability to address the problem. It also identified Federal resources available and began the exchange of information among its members. The Task Force identified six areas of special concern which war- ranted early action: Standardization of Measurements and Tests Exposure and Metabolic Mechanisms t Early Indicators of Disease Risk Assessment Education of the Public and of Health Professionals Strategies to Protect Public Health. -Vll- ------- WORK OF THE SECOND YEAR During the second year, Project Groups were formed to deal with three of these areas. A Project Group on Standardization of Measurements and Tests examined ways to improve comparability of experimental results, and sub- sequently concentrated on formulating suggested Federal guidelines on the standardization of measurements and tests. A Project Group on Education of the Public and of Health Profes- sionals concentrated on identifying available educational programs of envi- ronmentally related disease. In October 1979, this group will conduct a workshop to explore how health professionals perceive their needs in envi- ronmental education and to consider ways in which the Government can promote educational initiatives to meet these needs and thereby aid in the reduction of environmental disease. The Task Force requested a feasibility report on the utility of interagency study of exposure and metabolic mechanisms. A report was pre- pared by the National Institute of Environmental Health Sciences which addressed the problem in terms of four representative chemicals. A Project Group on Exposure and Metabolic Mechanisms was then established to work in this field. Separate Project Groups were not established for Early Indicators of Disease, Risk Assessment, or Strategies to Protect Public Health. The question of Early Indicators of Disease may be considered by the Project Group on Exposure and Metabolic Mechanisms. The Task Force as a whole reviewed the work done by the Interagency Regulatory Liaison Group in the -vm- ------- area of risk assessment and decided to coordinate activities of other groups in this area rather than establish a separate Project Group. The Task Force views information exchange among it members as the primary basis for establishing coordination and development of interagency programs. Activities this year included creation of a directory of inter- agency groups working in environmental health, publishing a monthly calendar of events, listing data bases for Federal research programs, and assisting the National Center for Health Statistics in its efforts under Section 8 of Public t Law 95-623 to develop plans for the collection of environmental health data. As it did last year, the Task Force identified and classified relevant funding in each of its member agencies. Approximately $270 million were spent in 1978 by the seven agencies on research and strategy planning addressed to Task Force objectives. TASK FORCE PLANS In the coming year the Task Force will continue its information exchange activities and will strengthen ties with such groups as the Inter- agency Regulatory Liaison Group and the National Toxicology Program. In addition, it will move forward in the Project Group areas of Standardization of Measurements and Tests, Education of the Public and of Health Professionals, and Exposure and Metabolic Mechanisms. Each group will identify and recom- mend specific actions appropriate for meeting the objectives of reduction of environmental diseases. -IX- ------- The Task Force will continue and expand its review of the role of risk assessment. An inventory of relevant current and planned programs will be assembled by member agencies as a basis for analyzing emphases and new initiatives. Activities during the year will be directed toward the develop- ment of recommendations to Congress and to the member agencies. -x- ------- Chapter 1 INTRODUCTION ------- Chapter 1 INTRODUCTION THE TASK FORCE RESPONSIBILITY The Task Force on Environmental Cancer and Heart and Lung Disease is composed of representatives from: Environmental Protection Agency (EPA) National Cancer Institute (NCI) i National Heart, Lung and Blood Institute (NHLBI) National Institute for Occupational Safety and Health (NIOSH) National Institute of Environmental Health Sciences (NIEHS) National Center for Health Statistics (NCHS) Center for Disease Control (CDC) Food and Drug Administration (FDA) (observer). The Task Force was established to provide a focus for a concerted attack upon the national problem of environmentally related cancer and heart and lung dis- eases.* Congress directed the Task Force to recommend comprehensive programs for quantifying the relationships between environmental pollution and asso- ciated disease and for reducing the risk and incidence of such disease. It also was directed to coordinate relevant research, stimulate cooperation among Federal agencies, and report to Congress annually on its progress and difficulties in reaching these objectives. The Task Force was identified in * Appendix A includes relevant sections from Public Laws 95-95 and 95-623. -1- ------- Section 8 of Public Law 95-623 which requires that the Secretary of the Department of Health, Education, and Welfare, acting through NCHS, consult with and take into consideration recommendations of the Task Force with respect to collection and coordination of environmental health statistics. THE FIRST YEAR The Task Force was formally organized in November 1977. At that time the EPA Administrator assigned staff within the Office of Research and Development to serve as a technical secretariat to the Task Force. Sub- sequently, at the first plenary meeting of the Task Force, a Working Group composed of alternate Task Force members was established to increase the Task Force's capability.* During the first year, the national problem with regard to environ- mentally related cancer and heart and lung diseases was outlined. The Task Force defined pollution as those chemical pollutants present in the ambient and workplace environment which affect humans through various media such as air, water, and soil. It examined information on existing environmental research programs and inventoried and categorized resources available to Federal agencies to combat the problem. The first annual report, submitted to Congress on August 7, 1978, stated: There is evidence that risk and occurrence of cancer and heart and lung diseases increase with environmental pollution, which is broadly defined to include all environmental factors. * Members are listed in Appendix B; meeting dates in Appendix C. -2- ------- t The extent of illness, death, and cost to society from environmentally related cancer and heart and lung diseases is a matter of national concern. There is expectation that levels of illness, death, and cost resulting from these environmentally related diseases could be substantially reduced by preventive measures and current preventive measures are believed to be inadequate to obtain desired reductions of risk and occurrence. t Increased knowledge of pollution-disease relations and improvements in strategies and preventive measures are needed for reduction of risk and occurrence. The Federal Government has a central, critical role to take in research and prevention of environmentally related disease; changes in current Federal efforts may be necessary if reductions of risk and occurrence of environmentally related cancer and heart and lung diseases are to be obtained. In addition, in the first annual report, the Task Force identified a limited set of areas of special concern and interest: t Standardization of Measurements and Tests t Exposure and Metabolic Mechanisms t Early Indicators of Disease Risk Assessment Education of the Public and of Health Professionals Strategies to Protect Public Health. It was decided to examine these subjects through the formation of Project Groups, each charged with determining: (1) the contribution which improved knowledge in each area could make to the achievement of Task Force objectives, (2) the needs for improved knowledge and (3) the feasibility of -3- ------- undertaking interagency activities to assist in resolving problems in these areas. Reports of the Project Groups will constitute a basis for further actions. The establishment of ties with other existing interagency groups working in related fields and the exchange of information among Task Force member agencies were also identified as areas for emphasis. The Chairman of the U.S. House of Representatives' Subcommittee on Health and the Environment acknowledged the first annual report on behalf of the Subcommittee in a letter to the Chairman of the Task Force on September 8, 1978. His letter, which suggested several areas in which further effort and consideration would be desirable, is presented in Appendix D. -4- ------- Chapter 2 STATUS SUMMARY ------- Chapter 2 STATUS SUMMARY A hierarchical approach was implicit in emphasizing the areas iden- tified for detailed examination in the first annual report of the Task Force. The aspects related to standardization of measurements and tests form the basis for much of the work related to the Task Force's responsibilities. Information and knowledge of exposure to pollutants, metabolic mechanisms and early indicators of disease represent the next hierarchical level. The assessment of risks and education of the public and of health professionals forms the next level, while strategies to protect public health is at the apex of this pyramidal structure. In addition to these areas, the develop- ment of an information exchange system was subsequently cited as an impor- tant activity for Task Force consideration. Project Groups were formed in the following areas: standardiza- tion of measurements and tests, education of the public and of health profes- sionals, and exposure and metabolic mechanisms. The Project Groups are composed of representatives from the Task Force agencies and other interested Federal agencies.* The activities of these Project Groups during the past year focused on organizing, determining the exact scope of their activities and gathering preliminary information. In this chapter, the status reports of these Project Groups are given. Activities concerning information exchange and risk assessment are Members are listed in Appendix B. -5- ------- described. A summary of funding of the relevant research programs of the Task Force agencies also appears in this chapter. STANDARDIZATION OF MEASUREMENTS AND TESTS Research in the area of environmentally related disease is conducted under the sponsorship of numerous Federal agencies. To improve the validity, quality and interagency applicability of this research, measurements and tests need to be standardized. A Project Group was established to study ways of improving the intercomparability of test results through the development of common definitions and standard test protocols for the Task Force member agen- cies. Biostatisticians as well as laboratory research scientists participated in the activities of this Project Group. As defined by the Task Force in its first annual report to Congress, standardization of measurements and tests included chemical, physical and bio- logical factors in laboratory, clinical and community conditions. Early dis- cussions among the members of the Task Force and among their Working Group representatives resulted in the suggestion that this definition be narrowed to a more manageable scope during the initial activities of the Project Group. Subsequently, the Project Group defined the scope of its activities to include the standardization of measurements and tests iri chemical, physical, and bio- logical systems and in health data collection systems. This approach was reviewed by the Task Force which recommended that the Project Group concen- trate on the standardization of physical and chemical tests and measurements. To address this more specific charge, the composition of the Project Group was changed and representatives who had more direct involvement and expertise in physical and chemical measurement procedures were appointed. -6- ------- When the members of the Project Group met to reformulate their objectives, they decided to concentrate on policy concerns instead of on the implementation of specific procedures. This decision was based upon the different responsibilities and perspectives of the participating agencies, since some of the participating agencies have regulatory functions while others are primarily research oriented. In addition, the group decided to initially concentrate on providing ways to compare experimental results and to formulate Federal guidelines on the standardization of measurements and tests. In accordance with these new objectives, the following guidelines on the standardization of measurements and tests were developed by this Project Group. Federal agencies conducting research in support of efforts to reduce environmentally related disease shall conduct their research according to the following principles: The experiment, measurement, or test will be designed and conducted according to appropriate statistical experimental designs and with preset statistical sensitivity. To the extent possible, standard test methods will be used. If such methods are unavailable, reliable methods having performance comparable to standard or reference methods will be used. All chemicals, such as reagents and carrier materials, will be identified as completely as possible in terms of source, purity, and any other relevant character- istics. Documentation will be as clear, unequivocal and com- plete as the reporting medium permits. If the docu- mentation appears in professional publications in which length and detail are limited, the necessary complete documentation should be available. -7- ------- Although interagency implementation of these guidelines could be a lengthy process, their development is an important first step toward increasing the reliability and utility of research sponsored by the Federal Government. EDUCATION OF THE PUBLIC AND OF HEALTH PROFESSIONALS The development of an informed citizenry may be the most useful, long-term strategy for reducing both the costs and risks associated with environmental cancer and heart and lung diseases. The lack of awareness and understanding of environmental factors among health professionals has long been identified as a serious deficiency in the prevention of environmental disease. Recognizing these two factors, a Project Group on the Education of the Public and of Health Professionals was established. The Project Group classified the public in two broad areasworkers and the general public. The first group consists of unionized and nonunionized workers. The second consists of all members of the public interacting with the environment in nonworkplace conditions, including workers away from their work, housewives, retired persons, and most students. The health professionals area includes physicians, osteopaths, nurses, nurse-practitioners, physician assis- tants, dentists, health scientists and students in these fields. Within this framework, the Project Group developed the following objectives: Classify existing programs for the medical profession and public into categories of information, education, or training Identify the material currently directed toward the medical profession both in formative and continuing education programs -8- ------- Identify the material currently being disseminated in major newspapers and journals concerning the relation of environmental pollution to cancer and heart and lung diseases Identify the available resources and the role of various Federal, state, local and professional organizations and agencies in education of the public and health profes- sionals regarding environmentally related disease Determine the status of communication between agencies and organizations involved in environmental education and the extent of duplication or gaps Examine documents from environmental education programs and evaluate program results'to identify appropriate strategies for educating the public and health professionals. Highlights of information obtained by the Project Group are presented below. Education of the Public Workers The education of workers exposed to occupational hazards is addressed through direct channels. Numerous agencies provide support to both industry and unions in the area of occupational and environmental hazards. Examples of this support are presented below: Through a series of contracts funded by NCI, and managed by OSHA, the Cancer Alert Program was developed to inform and alert workers to the risks from known and suspected carcinogenic substances encountered in the workplace. As a result of this program, the National Academy of Sciences developed broad guidelines for a public information program on occupational cancer. In addition, funds provided through the Cancer Alert Program have contributed to the development of educational materials on the recognition and control of occupational cancer hazards for use in training programs with employees and employers at high-risk facilities. -9- ------- OSHA, through NCI, awards grants to labor unions, trade associations, educational institutions, and other non- profit organizations to develop capabilities for providing training, education, and related assistance to employees. Within a 5-year period, it is intended that most recipient organizations become centers of competence that can pro- vide an extensive range of workplace safety and health activities and services. OSHA, Mine Safety and Health Administration and NIOSH work closely with employee groups and unions to develop safety and health training and awareness programs. NIOSH not only develops and disseminates Criteria Docu- ments for substances considered to be a hazard in the workplace, it also publishes a Current Intelligence Bulletin, sent out to industry and labor, dealing with current industrial hazards. Through its Health Hazard Evaluation Program, NIOSH formally advises employees and employers of health hazards in workplaces. Research supported by NCI, NIEHS, NIOSH and other agen- cies is aimed at investigating the exposure of workers to such environmental hazards as asbestos, textile dusts, and printers' ink. This information is often dissemi- nated to the workers by the individual researchers. EPA sponsored the development of a modular training program for auto emissions inspection and maintenance mechanics, with the assistance and support of auto manufacturers and unions of auto mechanics. A modular training program is a self-contained instructional unit designed to address the specific requirements of a given population. General Public A literature search combined with communications and visits to Federal agencies, news media representatives, educational institutions, consumer interest groups, and other organizations revealed that there is much information available to the public on environmental pollution and its relationship to cancer and heart and lung diseases. Segments of this informa- tion are disseminated through newspapers and magazines throughout the country, -10- ------- but access to information by media editors is not systematic. The majority of editors and health writers who were interviewed believe there is a need for an official clearinghouse where they could obtain updated or additional infor- mation. Such a clearinghouse could also provide explanations, analyses and summaries of environmental issues. In addition to the materials distributed by the mass media, education material is developed and disseminated to the public through Federal agencies and other organizations such as cancer, heart and lung associations. Education of Health Professionals In assessing educational programs designed for health professionals, the Project Group found that it is impossible to isolate professional educa- tion on environmentally induced cancer and heart and lung diseases from the broader category of environmental and occupational diseases. Furthermore, much of the educational material is fragmented or incorporated into more gen- eral topics, offered on an informal basis, or classified as elective rather than as part of a core program. Therefore, it is difficult to catalog all ongoing educational programs in the area of environmental cancer and heart and lung diseases. The following examples describe some of the Federal Government's efforts to provide environmental education to health professionals: NIOSH funds 12 Educational Resource Centers and awards training grants to other educational institutions having a total of 1472 full-time students in training for FY 1979. Training categories include occupational medicine, occupa- tional health nursing, occupational safety, industrial hygiene, occupational safety and health technician work, and others such as toxicology and epidemiology. -11- ------- EPA (Office of Education and Manpower Planning; Office of Pesticide Programs) and DHEW (Health Services Admin- istration) jointly sponsored the development of a modular training program entitled "Pesticide Protection" for specialized health professional groups. The strategy of developing and incorporating modules into the training cycle of health professionals has proven to be effective in the view of those associated with the program. DHEW (Health Resource Administration) is developing and implementing occupational/environmental training modules at medical schools for primary care physicians, residents, and medical students. In addition, HRA is awarding special initiative project grants to medical schools to support the development of undergraduate curricula in occupational and environmental medicine. DOD is extensively involved in providing education and training in environmental health to its personnel. As an example, the Department of the Air Force provides in-depth training in occupational health and environmental pollu- tion to physicians, nurses, and health technicians. NIEHS supports nine university-based Environmental Health Sciences Centers. The staffs of these centers, with their highly specialized and closely related research interests, permit a multidisciplinary approach to research and research training in environmental health sciences. These centers have also proven to be especially effective in attracting and training medical and nonmedical pre- and postdoctoral students for research, academic, and medical careers in environmental health sciences and related areas. Workshops Deficiencies exist in the environmental education of the public and of health professionals as a result of inadequate information dissemination and a lack of understanding of the problem. As a result, the Project Group plans to sponsor workshops aimed at promoting a coordinated approach to edu- cating both the public and health professionals. The first workshop, scheduled for October 15 and 16, 1979, will be held in Washington, D.C. Workshop participants, representing various health -12- ------- professional organizations, will be asked to identify the needs of health professionals in environmental medicine and to recommend ways in which the Federal Government and these organizations can work together. Prior to the workshop, each participant will receive a set of docu- ments consisting of background material, workshop objectives and an agenda. This material will preclude extensive introductory sessions. The planned composition of the workshop includes representation from physician, osteopath, nurse, nurse-practitioner, and health scientist communities. These special- ties will be divided into working teams so as to allow a more detailed review and documentation of their perception of the needs of health professionals regarding diagnosis and preventive management of environmentally related diseases. The output of each working team will be shared with the entire group to allow for interaction. The Project Group believes that this workshop will provide not only a clearer understanding of health professional needs regarding environmental education but will lead to recommendations for a coordinated approach to improve education of health professionals in diagnosis and management of environmentally related cancer and heart and lung diseases. EXPOSURE AND METABOLIC MECHANISMS Currently, information on human exposure to specific environmental factors associated with cancer and heart and lung diseases is limited. There is even less information on how these substances enter the body and are metabolized. An improved understanding of these areas will also provide the -13- ------- basis for identification and possible use of early indicators of disease. A feasibility report* reviewed information on the problems of human exposure by examining the production, use pattern, and environmental transport of four industrial pollutants. It described the metabolic processes for each of these pollutants by considering retention, accumulation, and elimination of these chemicals from the human body. The report identified areas in which inform- ation is inadequate and where more research is needed. Specific recommenda- tions were made for each of the four chemicals. The ability to make these recommendations strongly suggested that the approach taken in the feasibility study has a utility for the Task Force. The recommendations of the feasibility report appear in Appendix E. In reviewing the feasibility report the Task Force recognized that the area of exposure and metabolic mechanisms is important to their responsi- bilities, and may provide a basis in the future for the identification and use of early indicators of diseases. It recognized that many Task Force agen- cies are involved in research related to pollutant exposure and metabolic mechanisms and that an interagency approach is desirable. Therefore, in May 1979, the Task Force established a Project Group on Exposure and Metabolic Mechanisms. The Project Group will identify research needs in the area of exposure and metabolic mechanisms and to propose research strategies to address these needs. The detailed description of the charge appears in Chapter 3. * Piver, W.T., W. Jurgelski, T. Damstra, H. L. Falk, and J. Bernheim. "Exposure and Metabolic Mechanisms of Four Important Industrial Pollutants: Benzene, Toluene, Carbon Disulfide and Methylene Chloride." Pre- pared for the Task Force on Environmental Cancer and Heart and Lung Disease. NIEHS, Research Triangle Park, NC. December 1978. -14- ------- INFORMATION EXCHANGE Information exchange has been an integral part of the Task Force activities since its establishment. A unified, comprehensive, Federal strategy for dealing with environmental health hazards necessitates the exchange of information concerning research results and regulatory decisions. To more fully utilize information currently available within the Federal Government, the Task Force decided to collect, classify, and disseminate information on the numerous coordinating committees and conferences sponsored by the Government. The Task Force also agreed to review information bases with an initial emphasis on those which are relevant to the three Project Groups. Interagency Committees Many interagency committees and groups within the Federal Government address various aspects of environmentally related disease, ranging from causes of environmental diseases to regulatory action. A directory of such committees is being completed; a summary appears in Table 1. Two criteria are used to select committees for inclusion in the directory: the committee should be comprised of representatives from two or more Federal agencies, and the committee's mandate should be in the area of environmental health. For each committee, the fpllowing information is being compiled and will be periodically updated: Title Roster of principal (lead) agency members i Name of Chairman Name and telephone number of the Executive Secretary or principal contact -15- ------- Table 1. Intcragency Committees of Relevance to Task Force Work Committee Name Chemical Selection Working Croup Authority Memorandum Agreement to Establish an NCI Working Croup Reports to Director of NCI Chairperson Herman Krayblll, NCI Information Contact A. F. Douglas, NCI (301 .496-5591) Members' NCI, NIEHS, FDA, EPA, NLM, USDA, DOL, CPSC, NIOSH, CDC, DOE, U.S. Army Purpose Is to make selection and recommendation, of chemicals for consideration in the bloassay carcinogen testing program. Committee on Health and Medicine of the Federal Coordinating Council for Science, Engineering, and Technology (FCCSET) Subsection 401(b) of the National Science and Technology Policy, Organization and Priorities Act of 1976 Chairperson of FCCSET Donald S. Fredrlckson, NfH Joseph C. Perplch, ND-I (301-496-3152) NIH, USDA, DOC, DOD, FDA, HCFA, DOE, EPA, EOP, DOL, NASA, NSF, DOS, VA, DHEW Purpose is to increase the overall effectiveness and productivity of Federal ROD efforts in health and medicine by. ( 1) addressing Interagency rocs relating to major national problems concerned with health and medicine, (2) reviewing Federal policies related to blomcdic.l research, health care, and health promotion; (3) faclUutlns cooperation and coordination among Federal programs and activities relating to health and medicine; and (4( providing reviews, analyses, advice and recommendations to the Chairperson of the FCCSET on Federal policies and programs concerned with health and medicine. DHEW Committee to Coordinate Environmental and Related Programs (CCERP) Directive from DHEW Assistant Secretary for Health, May 1979 DHEW Assistant Secretary for Health David P. Rail, NEKS Raymond E. Shapiro, NIEHS (919-S41-3S06) NIEHS, CDC, DHEW, FDA, NCI, NCTR, NICMS, NIOSH, CEQ, CPSC, EPA, DOE, NSF, NLM, NtH, NEHS, NIA, NICHD, NHLBI, NINCDS, LOC, NOAA, USDA Purposes are; (1) to provide a means for Interagency Information exchange on toxicology and related programs; (2) to coordinate these programs; (3) to enhance the Interagency sharing of certain kinds of resources; and (4) to provide advice to DHEW on lexicological Issues. CCERP Subcommittee on Environmental Mutngenesis Directive from DHEW Assistant Secretary for Health, May 1979 Executive Secretary of CCERP Fredrick J. de Serres, NIEHS Michael Shelby, NEHS (919-541-3492) NIEHS, FDA, NCI, NCTR, NICHD, NICMS, NIH, NLM, CDC, CPSC, DOD, EPA Purposes are- (1) to define problem areas In environmental motagenesls; (2) to foster complcmentan- and nonoverlapplng programs of research In environmental mutagenesis; (3) to propose mecTantas for effective action to stimulate research and development in Important problem areas; (4) to provide a forum for information exchange; and (S) to advise on the utility of new approaches and protocols for mutagenlcity testing. CCERP Laboratory Chemical Carcinogen Safety Standards (LCCSS) Subcommittee CCERP Toxicology Information Subcommittee (TIS) Directive from DHEW Assistant Secretary for Health, May 1979 Executive Secretary of CCERP w. EmmettBarkley, NCI Thomas Wllkenson, N1H {301-496-3261) NCI, EPA, NEHS, NCTR, FDA, DHEW, NIOSH, CDC, NIH Purpose, are- (1) to Identify specific chemical carcinogens that are used In DHEW laboratories; (2) to review Individual Carcinogen Safety Monograph, far completenessand accuracy; and mTrra^nit comnlet.d Carcinogen Safety Monographs to the Committee to Coordinate Environmental and Related Program, for submission to the Office of Safety, DHEW. Directive from DHEW Director of Office of Special Health Projects, May 1979 Executive Secretary of CCERP and DHEW Assistant Secretary for Health Henry M. Klssman, NLM Henry M. Kissman, NLM (301-496-3147) NLM, CDC, FDA, NCI, NCTR, NIEHS, NICMS, NIMH, NIOSH, CPSC, EPA, DOE, DOI Purpose Is the collection, storage, and dissemination of appropriate Information on toxicologlc and related activities, concentrating in two area,: (1) creation and maintenance of new toxicology information services Important to the health and environmental agencies in the government and to the scientific community; and (2) establishment of communication channel, through which the participating agencies can keep each other Informed about ongoing Information activities in toxicology and related fields. * See page Iv for a list of abbreviations of agencies and organizations. ------- Table I. Interagency Committees of Relevance to Task Force Work (Continued) Committee Name CCERP Subcommittee to Coordinate Polybromlnated Blpbenyls within the PHS Authority Directive from OHEW Assistant Secretary for Health, May 1979 Reports to Executive Secretary of CCER? Chairperson Clark Heath, CDC Information Contact Clark Heath, CDC (4O1-329-3961) Members* CDC, N1OSH, NIZHS, FDA, NCI, N1AMDD, NINCDS, N1CHD, NIAtD, HSA, EPA, USDA, OSHA Purposes arc: (I) to provide national focus for Federal efforts on the PBB problem; (2) to provide a means for cooidhiation between the lead agencies responsible for generating scientific information needed to understand and evaluate effects reported In exposed individuals; (3) to provide an overview of the operational acpccu of each arc4 of research; «nd (4) to determine what addition areas of research may have to be explored and to recommend necessary action to the Assistant Secretary for Heahh through the Chairman, CCERP. CCERP Subcommittee to Coordinate Asbestos/ "Asbesdformn Research within the PHS Directive from DHEW Assistant Secretary for Health, Ntay 1979 Executive Secretary of CCERP Raymond Shapiro, NtEHS Raymond Shapiro, NEHS (919-541-4S06) DOI, EPA, FDA, DOL, NIH, CDC, NIOSH, NCI, CPSC, N1AMDD, NHIBI, OSHA, HUD Purposes arc: (1) to identify means by which interagcncy cooperation can be furthered within the Public Health Service concerning research into the health effects of asbestos; and (2i coordinate interagcncy investigations of such effects. Executive Committee of the National Toxicology Program (NTP) Directive from DHEW Secretary for Health, Nov. 15, 1978 Secretary of Health Eola Klngharn, OS HA Eula Blngham, OSHA 1202-523.9362) NEHS, FDA, OSHA, CPSC, EPA, NIOSH, NIH, NCI, NCTR Purposes arc: (!) to strengthen HEW's activities in the testing of chemicals of public health concern; and (2) to promote the development and validation of new and better Integrated test methods. Federal Interagcncy Committee on Education's Subcommittee on Environmental Education Executive Order No. 11761, Jan. 21, 1974 Secretary of OHEW Walter Jcske, USDA William Oliver!, DHEW (202-24S-8220) USDA, DOC, DOD, CEO, DOE, DHEW, ADAMHA, NIH, HUD, DOI, DOS, EPA, NASA, NSF, SI, OASH and others Purpose is lot ( 1 ) identify the needs and objectives of Federal programs in environmental education; (2) provide advice and recommendations on Federal educational policies and program planning activities; (3) Improve coordination, cooperation, and Information exchange among agencies; and (4) act ai a linkage and exchange mechanism among Federal groups in environ- mental education. Federal Interagency Committee on the Health and Environmental Effects of Energy Technologies Interagcncy Collaborative Croup on Environmental Carcinogens (tCCEC) President's Environmental Message of May 2), 1977 The President Not Designated Richard D. Brown Mitre Corp. (703-827-6217) EPA, DOE, HEW/ NIOSH, HEW/ NCHS Purpose is to review and identify specific health and environmental Issues and potential problem* associated with the development and commercialization of conventional and advanced energy technologies, to identify the research information required to resolve the uncertainties of assessing relevant impacts, and to specify potential future research prospects to provide luch information. National Cancer Act of 1971 Scientific Coordinator for Environmental Cancer of NCI Herman Krayblll, NCI Inge Btackwood, NCI (301-496-162S) NCI, FDA, EPA, NIOSH, NIH, CPSC, USDA, DOC, DOD, DOE, DHEW, CDC, NCHS, NIEHS, NLM, DOI, DOI, DOS, DOT, NASA, NOAA, NSF, SI Purpose If to establish a forum to provide for the coordination of Information exchange among Federal agencies concerned with environment at health and environmental carcinogens Issues. See page iv for a list of abbreviations of agencies and organisations. ------- Table 1. Interagency Committed and Relevance to Talk Force Work (Continued) Committee Name Interagency Regulatory Liaison Croup (1RLC) tnteragency Task Force on Environmental Data and Monitoring Interagency Technical Committee on Heart, Blood Vessel, Lung and Blood Diseases and Blood Resources Interagency Toxic Substances Data Committee (ITSDC) ITSDC Chemcial Substances Information Network Subcommittee PHS Health Statistics Coordinating Committee's Environmental Health Statistics Subcommittee Authority Interagency Agreement, October 1977 Reports to Congress Chairperson Allen Helm, FDA Information Contact Susan Cucnettc, CPSC (202-634-4350) Members* FDA, CPSC, EPA, OSHA, FSQS >urpose is to improve the regulation of threats to the public health through intcragency sharing of information avoiding duplication of effort, and developing consistent regulatory policies. light working groups foster these overall objectives In the areas oft (J) compliance and enforcement; (2) education and communications; (3) epidemiology; (4) Information exchange; S) regulatory development; (6) research planning; (7) risk assessment; and (8) testing standards and guidelines. The President's Environmental Message of May 23, 1977 The President John D. Busstrtgton, CD? John D. Busslngton, CEO (202-395-5760) CEO, USDA, NRC, DOI, DOE, EPA, HUD, DHEW, NOAA 'uiposes arc to review present environmental monitoring and data programs, and to recommend Improvements that would make these programs more effective. Section 416 of Pub. Law 92-423, The Public Health Service Act Secretary of Health Robert Levy, NHLBI Daniel Rubin, NHLBI (301*496.5031) DHEW, NIMH, USDA, VA, NSF, SSA, HRA, DOE, HSA, NIH, DOT, CDC, EPA, NASA, FDA >urpose Is to coordinate aspects of all Federal health programs and activities related to heart, blood vessel, lung and blood diseases and blood resources to assure the adequacy and technical loundncs J of all programs; and to provide full communication and information exchange for maintaining adequate coordination of such activities. Sect. 10fb)(l) and 25(b) of Pub. Law 94-469, The Toxic Substances Control Act Administrator of EPA and Chairman of CEP Marilyn C. Bracken, EPA Carol! L. Haitian, CEO Roger M. Connor, EPA (202-755-9336) EPA, CEO, OSHA, DOT, DOC, NIEHS, OSTP, CPSC, ACDA, FDA, ITC, DOE, NLM, NtOSH, DOI, NCHS, NIH, NCI, DHEW, NAVY/ DOD Purpose Is to design, establish, and coordinate an efficient and effective system within the Environmental Protection Agency for the collection, dissemination to other Federal departments and agencies, and use of data submitted to the Administrator, EPA, under the Toxic Substances Control Act. Chairman of ITSDC Chairman of ITSDC Sidney Siegcl, EPA Roger M. Connor, EPA (202-755-9336) EPA, CEO, OSHA, DOT, DOC, NEHS, OSTP, CPSC, ACDA, FDA, ITC, DOE, NLM, N1OSH, DOI, NCHS, NIH, NCI, DHEW, NAVY/DOD *urpose is to develop and coordinate a network of online information systems to: (1) identify chemical information on substances' composition, structure, nomenclature; (2) access bibliographic abstracts of published materials on chemical substances; (3) track Information on government regulatory activity; (4) make available information on laboratory experiments; (5) provide data on production and uses of chemicals. Public Law 95-623, The Health Statistics and Health Care Technology Act of 1978 PHS Committee Paul E. Leaverton, NCHS Jcffcry Perhnan, NCHS (301-436-7135) FDA, ADAMHA, HRA, HSA, NIOSH, CDC, NIH, NCI, NCHS, NIEHS, NHLBI, OASH *urpose is to collect and coordinate statistical and epidemic logics I data from PHS agencies on die effects of the environment on health and to study the feasibility of Unking PHS agency data bases. 00 * See page iv for a list of abbreviations of agencies and organizations. (Continued) ------- Table 1. Intcragcocy Committees of Relevance to Task Force Work (Concluded) Committee Name Task Force on Environmental Cancer and Heart and Lung Disease Toxic Substances Strategy Committee Authority Sect. 402 of Pub. Law 95-95. The Clean Air Act Amendments of 1977; and Section 9 of Pub, Law 95-623, Health Statistic! and Health Cue Technology Act of 1978 Reports to Congress Chairperson Douglas M. Costlc, EPA Information Contact George R. Simon, EPA (202-426-2275) Members* EPA, NCI, NHLBI, NIOSH, NIEHS, CDC, NCHS, FDA *urpose is to (1) recommend a comprehensive research program to quantify the relationship between environmental pollution and human cancer and heart and lung diseases, (2) recommend strategies to eliminate the risks of cancer or such other diseases, (3) recommend research and other measures to prevent or reduce the incidence of these environmentally related diseases, 4) coordinate and stimulate cooperation between EPA, HEW, and other Federal agencies, and (5) report to Congress on the problems and progress of the Task Force. The President's Environmental Message of May 23, 1977 The President Cut Speth, CEQ Nathan]. Karch, CEQ (202-395-4980) CEQ, USD A, DOC, CPSC, EPA, DOE, DHEW. FDA, NCI, NEHS, NIOSH, DOI, NSF, OSHA, DOT, DOS, NRC Purpose te to develop a coherent Federal approach for(l) eliminating overlaps and filling gaps In the collect ioifof data on toxic chemical*; and (2) coordinating Federal research ind regulatory activities affecting the collection of such data. TSCA Interagcncy Testing Committee Sec. 4(c)Pub. Law 91-469, The Toxic Substances Control Act Administrator of EPA Carter Schuth, NSF Walter Rosen, EPA (202-755-4891) NSF, EPA, CEQ, DOC, NCI, N1EHS, OSHA, CPSC, DOD, DOI, FDA Purpose I* to moke recommendations to the Administrator, Environmental Protection Agency, concerning chemica substances to be given priority consideration for test rule* under Section 4 of the Toxic Substances Control Act. See page Iv for a Hit of abbreviations of agencies and organizations. ------- Charter, authority or justification for committee existence Purpose and responsibilities Major activities, accomplishments and products Schedule of meetings Information on operating funds, when available. Calendar of Events Conferences and workshops serve as important tools for the exchange of information. A calendar designed to provide a synopsis of meetings, sym- posia, conferences, seminars, courses and workshops related to environmental cancer and heart and lung diseases is being issued monthly by the Task Force. The purpose of this calendar is to keep Federal agencies informed of when and where these events are being held and how to obtain more detailed information on them. Information Bases Data Bases on Federal Research Programs Initial information on programmatic data bases used for program planning and related activities was compiled during the past year. A summary of these data bases, including the type and extent of information available, is presented in Table 2. Data bases listed here describe scope, schedule, staff and funding of ongoing federally sponsored programs. Efforts to assess information on future research plans were also initiated during the past year, but the feasibility of obtaining and disseminating such information has not yet been fully explored. -20- ------- Table 2. Data Sues on Federal Research Programs Agency EPA na NHLBI NIOSH NIEHS CDC FDA Contact/Title A. Fines Chief ofORDIS H. Cantor, Chief Research Ana MS J. Schneider Director, International Cancer Research Data Bank D. Saunden MIS Coordinator j. Balnbridge Chief, Program Planning and S. Von Albnen Bureau of B. Bell, Head Management Name of ORDIS GENIUS CANCERPROJ (CANCER LINE) Modified IMPAC,* CRISP* OCMF NIOSHT1C IMPAC* CRISP* FEDS IMPAC* CRISP* Information Provided by Data Base Principal Investigator X X X X X X X X X X X Performing Agency X X X X X X X X X Project Type X X X X X X X X X Dent./ Spec. X X X X X X X X X Total Funds X + X X ~ X X - X X Funds Expended byFY X + X X * X X X X X Future Funds Committed X + X X X X - X X Personnel Con X + - X X X X X Pcnwnnel byCS Level + + - X X X X X Equipment and Supplier X 4- - X x X X - X Facilities X -» - X x X x - X Milestones X X X X - X X Symposia, etc. + X - X - - Word Syit«m Uied Inhouf e C SSIE Inhouic C Free Text C laeili None Inhouce Inhouce Inhousc Inhousc Frequency of Update Dally for Annual Renewal Quarterly Annual or on Monthly Monthly ^Kiuterly Monthly Interface with Other Datt Bases No No MEDLARS SSIE No MEDLARS TOXUNE SSIE No MEDLARS TOXUNE tafonniticB w SSIE/NTIS Yei Yes Yci via IMPAC Yei Yei No Ye* Online PriDtOutl Limited Ye« Y«i Limited In FY 79 Limited * Syitcmt of the Division of Ret X Available. + Supplied by tape from a finan - Not available. urce Grants, N!H. ial* branch. ------- Environmental Health Data Bases During this past year, the Task Force worked with NCHS in its development of a plan for the collection and coordination of statistical and epidemiological data on effects of the environment on health. The plan is to be submitted to Congress by DHEW by January 1980 in accordance with Public Law 95-623. Task Force members provided assistance to NCHS in evaluating gaps and deficiencies in current environmental health data and in developing a compre- hensive plan for the collection and coordination of statistical and epidemio- logical effects of environment on health. Task Force members and staff also worked with NCHS in its presentation of a workshop in May 1979, where profes- sionals from government and private sectors reviewed work in progress and made recommendations. RISK ASSESSMENT Assessment of the risk related to adverse effects of environmental agents on human populations has a central role in the development of strategies to protect public health. As such, it is of major importance to the Task Force. Recognizing that the Interagency Regulatory Liaison Group (IRLG) had ongoing activity in this area, a representative from the IRLG work group on Risk Assessment was invited to brief the Task Force.* Subsequent to this briefing, the Task Force has been reviewing a report** by the IRLG Work Group on Risk Assessment. The specific conclusions of the IRLG Work Group, in addition to * Presentation by Dr. Elizabeth Anderson of EPA on activities of the IRLG Risk Assessment Working Group at the Task Force Working Group meeting, November 3, 1978. ** Interagency Regulatory Liaison Group. Scientific Bases for Identifying Potential Carcinogens and Estimating Their Risks. February 7, 1979. -22- ------- the positions taken by the various IRLG agencies in response to the issuance of this report, have been relevant to the Task Force's concerns. It intends to closely coordinate its activities with work being done by IRLG, the National Toxicology Program, and others in this field. FUNDING OF FEDERAL EFFORTS For identifying and classifying the levels of funding, the Task Force examined the broad scope of relevant ongoing and planned research programs and projects of its member agencies. A scheme was developed for classifying and quantifying Federal activities directed toward the reduction of risk of disease under 15 categories. These are listed as follows: Quantification of Relationships Between Environmental Pollution and Disease 1. Determination of biological effects and dose-response relationships 2. Understanding mechanism or mode of biological effects 3. Identification and monitoring of environmental pollutants 4. Identification and analysis of sources 5. Environmental transport and transformation analysis 6. Development of sampling, analytic and monitoring methods 7. Collection of health statistics 8. Human exposure estimation 9. Establishment of cause-and-effect association 10. Population risk assessment -23- ------- Reduction of Risk and Incidence 11. Estimation of costs of environmentally related illness 12. Estimation of costs of control and prevention 13. Preventive health measures 14. Education of the public and of health professionals 15. Pollutant-control measures. A description of the type of activity included under each of these categories appears in Appendix F. This appendix also includes detailed tables of the expenditures of each agency* for fiscal years 1978, 1979 and 1980. A table summarizing expenditures of Task Force agencies for 1978 by the 15- category classification scheme is given in Table 3. The seven agencies spent a total of approximately $270 million in 1978 on research and strategy planning relevant to Task Force objectives. A summary of the distribution of these expenditures by agency and disease appears in Table 4. Due to its observer status, the Food and Drug Administration was not included. -24- ------- Table 3. 1978 Summary of Funds by Categories for the Task Force Agencies (in thousands of dollars) Category 1. Determination of Biological Effects and Dose-Response Relationships 2. Understanding Mechanisms or Mode of Biological Effects 3. Identification and Monitoring of Environmental Pollutants 4. Identification and Analysis of Sources 5. Environmental Transport and Transformation Analysis 6. Sampling, Analytic and Monitoring Methods 7. Collection of Health Statistics 8. Human Exposure Estimation 9. Establishment of Cause- and- Effect Association 10. Population Risk Assessment 11. Estimation of Costs of Environ- mentally Related Illness 12. Estimation of Costs of Control and Prevention 13. Preventive Health Measures 14. Education of the Public and of Health Professionals 15. Pollutant- Control Measures TOTAL Cancer 22,332 49,234 5,761 1,076 554 2,773 10,675 2,097 10,723 4,548 55 1,774 3,303 424 115,329 Heart Disease 1,185 1,885 73 103 75 389 141 271 420 172 4,714 Lung Disease 5,228 7,671 857 2,602 700 3,231 586 1,325 4,238 2,069 10 IS 3,198 34 6,568 38,332 Nonspecific (includes cancer, heart and lung) 3,046 2,477 7,990 14,067 7,282 15,313 3,793 2,570 1,749 6,845 12 2,641 13,739 8,913 21,087 111,523 Total 31,791 61,267 14,681 17,848 8,611 21,706 15,053 6,133 16,981 13,882 22 2,711 18,883 12,250 28,079 269,898 rv> 01 ------- Table 4. 1978 Summary of Funds by Task Force Agencies (in thousands of dollars) Disease Cancer Heart Lung Nonspecific (Cancer, Heart, Lung) Total Agency EPA 12,678 1,348 16,946 79,059 110,031 NCI 85,837 85,837 NHLBI 443 3,852 4,295 NIOSH 6,458 227 8,832 25,018 40,535 NIEHS 10,356 2,696 8,702 4,178 25,932 CDC 268 268 NCHS 3,000 3,000 Total 115,329 4,714 38,332 111,523 269,898 -26- ------- Chapter 3 TASK FORCE PLANS ------- Chapter 3 TASK FORCE PLANS THE APPROACH TO STRATEGY DEVELOPMENT The development of strategies to protect public health consists of identification and selection of measures to reduce the risks of environ- mentally related cancer and heart and lung diseases. The development and recommendation of these strategies is the major responsibility of the Task Force. This was the significance of placing strategies to protect public health at the apex of the pyramidal structure of six areas of special concern. The selection of specific approaches for reduction of risk requires an assessment of health risks in the light of benefits, costs and feasibility of potential measures. In this context, research efforts directed toward a better understanding of environmental disease relationships have their prin- cipal utility as support for the assessment of health risk and the selection of measures for risk reduction. These concepts are expressed schematically in Figure 1. The real process of selecting strategies to protect the public health does not follow so simple and sequential a course. Available scien- tific information does not permit full determination and quantification of the relationships between environmental pollution and most diseases. Results of research now underway to improve our knowledge will become available only in future years. The selection of strategies to protect public health is an ongoing process and must necessarily proceed on the basis of partial knowledge. The -27- ------- implementation of protective measures cannot wait for full knowledge of disease risks; these measures will be modified and reevaluated as new infor- mation is developed. Testing and Modification of Strategies 1 » Research in Understanding and Quantifying Environmental Pollution/Disease Relationships Categories 1-10 0 / Identification \ i and Analysis \ 1 of Means for I I Risk / \ Reduction / o Consideration of Costs. Policy and Feasibility Categories 11-12 0 « Development of Strategies Categories 13-15 Figure 1. Elements of Development of Strategies to Reduce Risks of Environmental Disease Task Force actions described in Chapters 1 and 2 are elements that lead to a coherent approach to the development of comprehensive strategies. This approach began with an initial assessment of the problems to be addressed by the Task Force. Other early aspects of the approach included delineation of objectives to be attained through interagency efforts, and development of Task Force roles and capabilities. To attain its goal, the Task Force is moving forward in three parallel lines of activity: Development of information exchange among Task Force agencies -28- ------- Concerted agency actions to describe existing agency programs relevant to Task Force objectives Development of Task Force initiatives for action in significant problem areas. Actions planned in these specific areas for the next year are described in some detail beginning on page 31. In subsequent years, the Task Force will address the following additional major steps: t Build upon the initial inventory of Federal programs, and upon the statement of Task Force objectives, to identify areas needing further knowledge of pollutant/disease risks and means that can be useful in reduction of risks. Compare these needs with the inventory of the present pro- grams and their anticipated outcomes, in order to identify potential gaps and overlaps in existing and planned programs. The Task Force will describe options which would improve prospects for environmental disease risk reduction. t Analyze these options in the light of risks, costs, benefits and public policy, to identify the most effective choices for new Federal initiatives. Recommendations for the implementation of these options will be made to Congress and to the agencies. These actions, requiring several years for their performance, will complete the formal approach being taken by the Task Force for the carrying out of its mandate in Section 402 of Public Law 95-95. The main steps of this approach are shown schematically in Figure 2. Time flows from left to right in this diagram and several years are represented. The actions undertaken in each box of this diagram are continuing processes; no specific calendar dates can be assigned to them. The resulting recommenda- tions for a comprehensive research program and for risk-reduction strategies will be completed as rapidly as the identification and analysis of alternative options will permit. -29- ------- Time Identify Areas for Early Action HP Review and Needs in Specific Areas «»- Examine Feasibility of Action in Specific Areas Define Task Force Objectives and Fields of Action co o I Postulate Program Needs for Achievement of Obiectives Compare Available Programs with Needs Identify Potential New Emphases in Federal Programs Identify Proposals for New Actions by Agencies Examine Feasibility of Proposed Actions Develop Task Force Recommen- dations To Congress and Agencies Identify Needs in Interagency Information Exchange o» S9 Develop Methods for Interagency Information Exchange Or Develop and Maintain Information Exchange Task Force Coordination with Agencies Review and Overview by Task Force Member Agencies Figure 2. Flow Chart of Parallel and Sequential Actions to be Undertaken by the Task Force in Attaining Its Objectives ------- ACTIONS FOR THE NEXT YEAR During the year which begins in August 1979, the Task Force will move forward in its approach to strategy development with special attention to information exchange, concerted agency efforts to inventory existing programs, and action in significant special problem areas. The planned activities in these areas are described in the following. Information Exchange Numerous other Government groups are working with separate mandates and missions on aspects of the general problem of understanding and reducing the risks of environmental disease. The accomplishments and objectives of these groups are relevant to Task Force strategy planning. Information rele- vant to Task Force objectives must be exchanged within the Task Force member agencies and with these other groups. To further these aims during the next year the Task Force will: Publish a directory of interagency groups concerned with environmentally related disease and periodically update the directory. t Continue to issue a monthly calendar of meetings, con- ferences, and workshops of interest to the Task Force. Review information bases relating to the following areas and conduct feasibility studies on: - Plans, goals and schedules for current research activities of the Task Force agencies - Plans, goals and schedules for future research activities of the Task Force agencies - Areas of expertise of researchers and scientists Specialized research facilities and capabilities of laboratories -31- ------- - Results of selected relevant research projects - Environmental health data bases. Review the work of the National Academy of Sciences Institute of Medicine and the Department of Health, Education, and Welfare resulting from their jointly sponsored 1978 conference on Health Promotion and Disease Prevention, now the subject of a forthcoming report and recommendations from the Office of the Assistant Secretary for Health. Expand its awareness of the activities of, and exchange information with, such other interagency groups and programs in the environmental health field as the Interagency Regulatory Liaison Group and the National Toxicology Program. Concerted Agency Efforts in Program Inventory The Task Force will develop a descriptive inventory of ongoing agency programs in the area of environmentally related cancer and heart and lung diseases. The programs to be included in this inventory are those which have been defined in terms of funding in the 15 categories.* The following suggests one approach that has been considered by the Task Force, which it will refine and revise as necessary. Each agency will provide for major agency organizational units at the program and subprogram levels, information about: Objectives and mandated responsibilities t Activities t Resources applied Research and resource needs. See Appendix F for category definitions. -32- ------- The information will be obtained in response to a questionnaire to be developed by the Task Force Working Group. Information concerning each major unit will be assembled within the agency by its Task Force representa- tives and other senior staff. The assembly of this information in a common frame of reference pre- sents a challenge. Each agency has its own independent mandates and philoso- phy. Each approaches the Task Force mandate from its special point of view. The programs resulting from these varied points of view must be brought together in a common approach without losing* the values, insights and inde- pendence of thinking which each agency brings to the effort. In order that each agency has the opportunity to present its program in a manner appropriate to its own mandate and research orientation, each agency organization unit will be asked to consider aspects of its mission and program in a matrix such as that of Figure 3. Elements of Research for Quantification of Relation- ships and Risk Elements of Development of Strategies to Reduce Risk A Class of Substances i B Route of Exposure C Population Group at Risk D Disease Endpoints Figure 3. Program Information Collection Matrix -33- ------- The rows of this matrix could be some or all of the 15 categories of research and strategy development. The columns represent four principal ways of addressing the problems of environmental disease. Agencies differ sub- stantially in their orientation to these problems. For example, much of EPA's work is concerned primarily with the control and behavior of pollutants; plan- ners and researchers in such work approach their problems in terms of Columns A and B of this matrix, but there are also groups within EPA whose concerns address primarily population groups in Column C. NIOSH, primarily concerned with worker health, orients much of its work to populations at risk, Column C. The environmental aspects of NHLBI programs are oriented strongly toward disease etiology as seen from the viewpoint of Column D. The matrix thus recognizes that there are important differences in agency approaches to a com- mon problem, and provides a context in which each agency or entity can be encouraged to describe its work in terms most appropriate to its viewpoint. After each agency has described its program, the Task Force will assemble the results in a common format to produce an initial inventory of relevant ongoing, planned and needed actions as described by Task Force repre- sentatives from the member agencies. This initial inventory will provide the first systematic picture of agency efforts at ajevel of detail adequate to permit its use in approaches to a general coordination and development of strategies. Subsequent refinement and maintenance of this inventory will become a continuing Task Force action in the future. -34- ------- Actions in Special Problem Areas The Task Force plans the following actions in the coming year: Standardization of Measurements and Tests Continue to identify and maintain liaison with other Federal committees having relevant missions. Continue to collect and review documents and other materials on standardization; distribute key material for interagency review and potential use. Synthesize this information to assess current efforts and to identify areas which require greater emphasis on standardization. Explore applications of quality control and assurance in improving data intercomparability. Identify interagency approaches to address the above areas. t Report to the Task Force on findings and recommendations. Education of the Public and of Health Professionals Organize and conduct workshops to identify and assess the needs of health professionals in environmental education Continue to collect and review information on relevant education programs Examine program contents and determine areas in consulta- tion with health professionals where additional emphasis may be needed Analyze feasibility and effectiveness of various approaches for reaching different audiences t Evaluate results of the workshops and other activities and prepare recommendations for review by the Task Force. -35- ------- Exposure and MetabolicMechanisms Describe the importance and utility of this area with reference to the Task Force's responsibility and concerns. Identify other committees and groups which are actively working in this and associated areas, and initiate and maintain liaison with such groups. Review the approach of the feasibility report, earlier submitted to the Task Force, to determine if it is appropriate and optimum for determining research needs, especially considering - The feasibility of using this approach on a chemical- by-chemical basis - The feasibility of grouping chemicals - The ranking of chemicals or their groups in order of priorities. Develop and recommend preliminary research strategies and interagency approaches to address the research needs. Risk Assessment Continue to review and assimilate information on risk assessment developed by various organizations and inter- agency groups such as the Office of Science and Technol- ogy Policy, the National Academy of Sciences Board of Toxicology and Environmental Health Hazards, the Inter- agency Regulatory Liaison Group, and the National Toxicology Program. Evaluate the relevance of this work to the Task Force's mandate, recognizing that much of the prior work deals with risk assessment in the setting of specific standards for establishing permissible levels of toxic substances, especially carcinogenic substances. Consider the need for new approaches in risk assessment for the less-studied areas of environmentally related heart and lung diseases. -36- ------- Consider alternative approaches to risk assessment for their potential utility in the development of broad strategies to protect public health. Consider ways of sequentially using risk assessment and benefit-cost analysis of environmental disease control measures in development of strategies. Development of Recommendations The Task Force has not yet made any formal recommendation to the Congress or to the agencies under its mandate of Section 402 of Public Law 95-95. The preparation of a groundwork for the development of a consensus of approach has been the major thrusts of work to date. The Task Force is very cognizant of the need to make recommendations within the framework of its activities and is addressing its efforts in both general and special action areas toward that end. -37- ------- Appendix A PERTINENT SECTIONS OF PUBLIC LAWS 95-95 AND 95-623 ------- Appendix A PERTINENT SECTIONS OF PUBLIC LAWS 95-95 AND 95-623 PUBLIC LAW 95-95 Clean Air Act Amendments of 1977 "INTERAGENCY COOPERATION ON PREVENTION OF ENVIRONMENTAL CANCER AND HEART AND LUNG DISEASE Sec 402.(a) Not later than three months after the date of enactment of this section, there shall be established a Task Force on Environmental Cancer and Heart and Lung Disease (hereinafter referred to as the 'Task Force'). The Task Force shall include representatives of the Environmental Protection Agency, the National Cancer Institute, the National Heart, Lung, and Blood Institute, the National Institute [for] Occupational Safety and Health, and the National Institute [of] Environmental Health Sciences, and shall be chaired by the Administrator (or his delegate). (b) The Task Force shall (1) recommend a comprehensive research program to determine and quantify the relationship between envir- onmental pollution and human cancer and heart and lung disease; (2) recommend comprehensive strategies to reduce or eliminate the risks of cancer or such other diseases associated with environmental pollution; (3) recommend research and such other measures as may be appropriate to prevent or reduce the incidence of envir- omentally related cancer and heart and lung diseases; (4) coordinate research by, and stimulate cooperation between, the Environmental Protection Agency, the Department of Health, Education, and Welfare, and such other agencies as may be appropriate to prevent envir- onmentally related cancer and heart and lung diseases; and (5) report to Congress, not later than one year after the date of enactment of this section and annually thereafter, on the problems and progress in carrying out this section." A-l ------- PUBLIC LAW 95-623 Health Services Research, Health Statistics, and Health Care Technology Act of 1978 "STUDY OF COSTS OF DISEASES AND ADVERSE EFFECTS ON HUMANS WHICH ARE ENVIRONMENTALLY RELATED Sec. 7.' Section 304 (as amended by Section 3(d)) is amended by adding at the end the following: '(e) (1) The Secretary and the National Academy of Sciences (acting through the Institute of Medicine and other appro- priate units) shall, jointly and in cooperation with the Administrator of the Environmental Protection Agency, the Secretary of Labor, the Consumer Product Safety Commission, the Council of Economic Advisers, the Council on Wage and Price Sta- bility, the Council of Environmental Quality, and other entities of the Federal Government which the Secretary determines have the expertise in the subject of the study prescribed by this para- graph, conduct, with funds appropriated under section 308(i) (2), an ongoing study of the present and projected future health costs of pollution and other environmental conditions resulting from human activity (including human activity in any place in the indoor or outdoor environment, including places of employment and residence). In conducting the study, the Secretary and the National Academy of Science (hereinafter in this subsection referred to as the 'Academy') shall, to the extent feasible-- '(A) identify the pollution (and the pollutants respon- sible for the pollution) and other environmental conditions which are, or may reasonably be anticipated to be, responsi- ble for causing, contributing to, increasing susceptibility to, or aggravating human diseases and adverse effects on humans; '(B) identify each such disease and adverse effect on humans and specifically determine whether cancer, birth defects, genetic damage, emphysema, asthma, bronchitis, and other respiratory diseases, heart disease, stroke, and mental illness and impairment are such a disease or effect; '(C) identify (on a national, regional, or other geo- graphical basis) the source or sources of such pollutants and conditions and estimate the portion of each pollutant and the extent of each condition which can be traced to a specific type of source; A-2 ------- '(D) ascertain (i) the extent to which the pollutants and conditions identified under subparagraph (A) are, or may reasonably be anticipated to be, responsible, individu- ally or collectively, for causing, contributing to, increasing susceptibility to, or aggravating the diseases and effects identified under subparagraph (B), and (ii) the effect upon the incidence or severity of specific diseases and effects of individual or collective, as appropriate, incremental reductions in the pollutants and changes in such conditions; and '(E) quantify (i) the present and projected future health costs of the diseases and effects identified under subparagraph (B), and (ii) the reduction in health costs which would result from each incremental reductions and change referred to in subparagraph (D) (ii). '(2) The Secretary shall enter into appropriate arrangements with the Academy under which the Secretary shall be responsi- ble for expenses incurred by the Academy in connection with the study prescribed by paragraph (1). '(3) The first report on the study prescribed by paragraph (10) shall be made to the Committee on Human Resources of the Senate and the Committee on Interstate and Foreign Commerce of the House of Representatives by the Secretary and the Academy not later than eighteen months after the date of the enactment of this subsection. Subsequent reports on the study shall be made by the Secretary and the Academy every two years after the date the first report is submitted. Each report shall (A) identify deficiencies and limitations in the data on the matters considered in the study and recommend actions which may be taken to eliminate such deficiencies and limitations, (b) include such recommendations for legislation as the Secretary determines appropriate, (C) include recommenda- tions for facilitating studies of the effects of hazardous substances on humans, and (D) include a description of any administrative action proposed to be taken by the Secretary, the Administrator of the Environmental Protection Agency, the Secretary of Labor, and the Consumer Product Safety Commission to reduce the costs which have been quantified under paragraph (1) (E) (i). In conducting the study, the Secreatry and the Academy shall seek assistance from public and private health finanacing entities in securing the data needed for the study. '(4) For purposes of paragraph (1), the term 'health costs of pollution and other environmental conditions' means the costs of human diseases and other adverse effects on humans which pollution and other environmental conditions are, or may reasonably be anticipated to be, responsible for causing, contributing to, increasing susceptibility to, or aggravating, including the costs of preventing such diseases and effects, A-3 ------- the costs of the treatment, cure, convalescence, and rehabila- tation of persons afflicted by such diseases, costs reasonably attributable to pain and suffering from such diseases and effects, loss of income and future earnings resulting from such diseases and effects, adverse effects on productivity (and thus increases in production costs and consumer prices) resulting from such diseases and effects, loss of tax revenues resulting from such decreases in earnings and productivity, costs to the welfare and unemployment compensation systems and the programs of health benefits under titles XVIII and XIX of the Social Security Act resulting from such diseases and effects, the overall increases in costs throughout the economy resulting from such diseases and effects, and other related direct and indirect cost." "INFORMATION ON EFFECTS ON HEALTH OF THE ENVIRONMENT AND EMPLOYMENT CONDITIONS Sec. 8. (a) Section 306 (as amended by section 5) is amended by inserting after subsection (k) the following new subsection: '(1) (1) The Secretary, acting through the Center, shall develop a plan for the collection and coordination of statistical and epidemiological data on the effects of the environment on health. Such plan shall include a review of the data now available on health effects, deficiencies in such data, and methods by which existing data deficiencies can be corrected. The Secretary shall submit such plan to the Congress not later than January 1, 1980. '(2) (A) The Secretary, acting through the Center, shall establish, not later than two years after the date of the enactment of this subsection, guidelines for the collection, compilation, analysis, publication, and distribution of statistics and information necessary for determining the effects of conditions of employment and indoor and outdoor environmental conditions on the public health. Guidelines established under this subparagraph shall not (i) authorize or require the disclosure of any matter described in section 552(b) (6) of title 5, United States Code, and (ii) authorize or require the disclosure of any statistics or other information which is exempt from disclosure pursuant to subsection (a) of section 552 of title 5, United States Code, by reasons of , subsection (b) (4) of such section. The guidelines shall be reviewed and, if appropriate, revised at least every three years after the date they are initially established. Guide- lines shall take effect on the date of the promulgation of the regulation establishing or revising the guidelines or such later date as may be specified in the guidelines. A-4 ------- '(B) The guidelines shall be designed- '(i) to improve coordination of environmental and health studies, statistics, and information, and to prevent overlap and unnecessary duplication with respect to such studies, statistics, and information; 'ii) to assure that such studies, statistics, and information will be available to executive departments responsible for the administration of laws relating to the protection of the public health and safety or the government; '(iii) to encourge the more effective use by executive departments of such studies, statistics, and information; '(iv) to improve the statistical validity and reliability of such studies, statistics, and information; and '(v) to assure greater responsiveness by the Department of Health, Education, and Welfare and other executive departments in meeting informational and analytical needs for determining the effects of employment and indoor and outdoor environmental conditions on public health. '(C) In establishing and revising guidelines under subparagraph (A), the Secretary shall take into consideration the plan developed pursuant to paragraph (1). '(D) The Center shall serve as a clearinghouse for statistics and information with respect to which guidelines have been established under subparagraph (A) and shall assist executive departments in obtaining such statistics and information for purposes of administering laws under their jurisdiction relating to environmental health protection or the safety and health of employees. '(E) (i) Each executive department shall comply with the sub- stantive and procedural requirements of the guidelines. '(ii) The President shall by Executive order require each executive department to comply with requests, made in accordance with the guidelines, by the Secretary, the Administrator of the Environmental Protection Agency, the Consumer Product Safety Commission, or the Secretary of Labor for statistics and information. '(iii) The President may by Executive order exempt any executive department from compliance with a requirement of the guidelines respecting specific statistics or other information if the President determines that the exemption is necessary in the interest of national security. '(F) In carrying out his duties under this paragraph, the Secretary, acting through the Center, shall insofar as prac- ticable, provide for coordination of his activities with those of other Federal agencies and interagency task forces relating to the collection, analysis, publication, or distribution of statistics and information necessary for determining the effects of conditions of employment and indoor and outdoor environmental conditions on the public health. A-5 ------- '(G) For purposes of this paragraph, the term 'guidelines' means the guidelines, either as initially established or as revised, in effect under this paragraph. '(3) The Secretary, acting through the Center, shall con- duct a study of the issues respecting, and the recommenda- tions for, establishing a Federal system to assist, in a manner designed to avoid invasion of personal privacy, Federal, State, and other entities in locating individuals who have been or may have been exposed to hazardous substances to determine the effect on their health of such exposure and to assist them in obtaining appropriate medi- cal care and treatment. In conducting such study, the Secretary may consult with any public and private entity which it determines has expertise on any matter to be con- sidered in the study. Not later than one year after the date of the enactment of this subsection, the Secretary shall complete the study and report to the Congress the results of the study and any recommendations for legislation or administrative action. '(4) In carrying out paragraphs (1), (2), and (3), the Secretary shall consult with and take into consideration any recommendations of the Task Force on Environmental Cancer and Heart and Lung Disease, the Administrator of the Environ- mental Protection Agency, the Secretary of Labor, the Consumer Product Safety Commission, the Council on Environmental Quality, the National Committee on Vital and Health Statistics, and the National Academy of Sciences (including the Institute of Medicine and any other unit of the Academy)." "(b) The first sentence of subsection (d) of section 308 is amended by inserting after "unless authorized" the following: by guidelines in effect under section 306 (1) (2) or...." "TASK FORCE ON ENVIRONMENTAL CANCER AND HEART AND LUNG DISEASE Sec. 9. The Director of the National Center for Health Statistics and the head of the Center for Disease Control (or the successor to such entity) shall each serve as members of the Task Force on Environmental Cancer and Heart and Lung Disease established under section 402 of Public Law 95-95." A-6 ------- Appendix B MEMBERS OF THE TASK FORCE, WORKING GROUP AND PROJECT GROUPS ------- Appendix B MEMBERS OF THE TASK FORCE, WORKING GROUP AND PROJECT GROUPS TASK FORCE EPA Douglas Costle, Administrator Chairman "" Stephen Gage, Assistant Administrator for Research and Development Alternate NCI Arthur Upton, Director Herman Kraybill, Scientific Coordinator for Environmental Cancer NHLBI Robert Levy, Director Claude Lenfant, Director, Division of Lung Diseases Manning Feinleib, Associate Director for Epidemiology and Biometry, Division of Heart Diseases NIOSH Anthony Robbins, Director Ralph Yodaiken, Senior Medical Officer, Office of Extramural Coordination and Special Projects (OECSP) NIEHS David Rail, Director Raymond Shapiro, Assistant Director for Toxicology Coordination CDC William Foege, Director Clark Heath, Director, Chronic Disease Division NCHS Dorothy Rice, Director Paul Leaverton, Associate Director for Research FDA Donald Kennedy, Commissioner Joseph Rodericks, Deputy Associate Commissioner for Health Affairs EPA George Simon, Senior Health Science Administrator Coordinator Health Effects Division B-l ------- WORKING GROUP EPA NCI NIEHS NIOSH NHLBI CDC NCHS FDA George Armstrong, Director, Health Effects Division George Simon, Senior Health Health Effects Division Chairman Science Administrator, Herman Kraybill, Scientific Coordinator for Environmental Cancer John Munn, Assistant to Scientific Coordinator Raymond Shapiro, Assistant Director for Toxicology Coordination Ralph Yodaiken, Senior Medical Officer, OECSP Jean French, Health Scientist, OECSP Claude Lenfant, Director, Division of Lung Diseases Hugh Stamper, Division of Lung Diseases, Interstitial Lung Diseases Branch Sydney Parker Division of Lung Diseases, Prevention, Education and Manpower Branch Manning Feinleib, Associate Director for Epidemiology and Biometry, Division of Heart Diseases Richey Sharrett, Division of Heart Diseases, Epidemiology Branch Clark Heath, Director, Chronic Diseases Division Philip Landrigan, Chief, Special Studies Branch, Chronic Diseases Division Paul Leaverton, Associate Director for Research Jeffery Perlman, Office of Statistical Research Joseph Rodericks, Deputy Associate Commissioner for Health Affairs Constantine Zervos, Director, Scientific Liaison Staff B-2 ------- PROJECT GROUPS Education of the Public and of Health Professionals NIOSH Ralph Yodaiken, OECSP Chairman Paul Pedersen, Division of Training and Manpower Development, Robert A. Taft Laboratories Bernadine Kuchinski, Division of Training and Manpower Development, Robert A. Taft Laboratories EPA Jack Keeve, Health Effects Division Karen Morehouse, National Workforce Development Staff Mary Averett Seelye, Office of Public Awareness NCI Margaret Sloan, Division of Cancer, Control and Rehabilitation NIEHS Wilford Nusser, Associate Director for Extramural Programs NCHS Jeffery Perlman, Office of Statistical Research POL Edward Bergin, Office of the Assistant Secretary for Policy, Evaluation and Research Quita Mullan, Office of the Assistant Secretary for Policy, Evaluation and Research Earl Heath, Director, Office of Training and Education HEW Max Lum, Health Resources Administration Louis Steinberg, Health Resources Administration William Holland, Health Resoures Administration Helen Nowlis, Director of Alcohol and Drug Abuse Education Program, Office of Education Standardization of Measurements and Tests EPA Robert Medz, Monitoring Technology Division Chairman NIAMDD Cyrus Creveling, Laboratory of Biorganic Chemistry NCI Robert Hoover, Environmental Epidemiology Branch Gerald Ward, Tumor Pathology Branch Cipriano Cueto, Toxicology Branch, Carcinogenesis Testing Program NIOSH Judd Posner, Robert A. Taft Laboratories Jean French, Office of Extramural Coordination and Special Projects B-3 ------- NIEHS Phillip Albro, Environmental Chemistry Branch CDC David Bayse, Clinical Chemical Division NCHS Jeffery Perlman, Office of Statistical Research FDA Constantine Zervos, Scientific Liaison Staff Exposure and Metabolic Mechanisms NCI John Munn, Assistant to Scientific Chairman Coordinator (Project Group being formed) B-4 ------- Appendix C MEETING DATES ------- Appendix C MEETING DATES Task Force September 25, 1978 February 6, 1979 June 11, 1979 forking Group September 15, 1978 November 3, 1978 January 17, 1979 March 14, 1979 April 23, 1979 May 23, 1979 July 11, 1979 Project Group on Education of the Public and Health Professionals October 25, 1978 December 1, 1978 March 15, 1979 April 12, 1979 May 29, 1979 Project Group on Standardization of Measurements and Tests January 26, 1979 March 30, 1979 C-l ------- PROPOSED MEETING DATES Meeting Working Group Task Force Working Group Working Group Task Force Working Group Working Group Working Group Task Force Working Group Day and Date Agency Wednesday, August 29, 1979 EPA Thursday, Oct. 18, 1979 EPA Wednesday, Nov. 14, 1979 NCI Wednesday, Jan 16, 1980 NIOSH Wednesday, Feb. 13, 1980 NHLBI Thursday, March 6, 1980 CDC Tuesday, April 15, 1980 NIEHS Thursday, May 15, 1980 NHLBI Thursday, June 12, 1980 NIOSH Tuesday, July 1, 1980 NCHS Location Washington, D.C. Washington, D.C. Bethesda, MD Rockville, MD Bethesda, MD Atlanta, GA Research Triangle Park, NC Bethesda, MD Rockville, MD Hyattsville, MD * Time, date and place will be confirmed approximately 2 months prior to each meeting. C-2 ------- Appendix D A RESPONSE TO THE FIRST ANNUAL REPORT FROM CONGRESSMAN PAUL G. ROGERS Chairman, Subcommittee on Health and the Environment U.S House of Representatives, The Ninety-Fifth Congress ------- .NINCTY-POUKTH CGNOtUtt3 . 5. nosrnn. ri A., DAVIO E. CAT1C RtCHAHDSON I JAMt;-J W. SVM JAMKS H. rc.iu HCNMY A, WAX JAMFS J. ri_OU CHARLHS J. CA ANDREW MAGU l*irl.D III. VA. AnLKY O. STAUCmS, W.VA. (EX orpicto) Tit-.: LIT CAitrr.ri. KY. JAMl'b T. IM;OYiHLL, N.C. M. JOHN HrtN7. Ill, PA. CDWAflD I*. MADir.AN. IM-. SAMUf.i. u. L>r:vim;, onto (ex orricio) ROOM 2/1f RAYDUPN HOUSE OFi-LC:. i;UiI_DirJ rT (202) 2J?5-V-r.2 tljc ^Iltu' of BA £niOcommiitcc on JOfall!) tmti tljc o( Iljc Comtudtcc en Jlntertflnle c.ub jforcioit Commerce Elac(jiHgtoit, JQ.C. 20515 September 8, 1978 The Honorable Douglas M. Costle Administrator Environmental Protection Agency 401 M Street, S. W. Washington, D. C. 20460 Dear Doug: I wish to congratulate you and your associates on the Task Force -- personally and on behalf of the Subcommittee -- on the First Annual Report of the Task Force on Environmental Cancer and Heart and Lung Disease. It is an excellent report and we are pleased" to note that it was submitted on schedule. Environmentally caused cancer, heart and lung disease is one of the most important health problems facing the Nation today. I am delighted that the Task Force, under your Chairmanship., has begun to address this scientifically difficult problem. Additionally, I note the interagency cooperation that is reflected in this report. I feel certain that the Task Force v.'ill make a worthwhile contribution to direct the Federal effort in reducing the incidence and severity of environmentally caused cancer, heart and lung diseases. The First Annual Report of the Task Force appears to be a useful beginning toward solving the problem of environmental cancer, heart and lung disease. The Task Force has shown prudence in considering a relatively narrow scope of the problem initially. The resulting recom- mendations of six areas for early interagency cooperation, as described on pages 59-62 of the report, should result in important progress toward problem resolution. We look forward to reports of the working groups to be established in these areas. I want to emphasize several specific concerns and questions raised by the First Annual Report: 0 As the report notes on p. 2, quantitative information on the role of environmental factors in causing cancer, heart and lung diseases is one of the major concerns of ------- The Honorable Douglas M. Costle September 8, 1978 Page 2 Section 402 of P.L. 95-95. We hope that the Task Force will be able to address the question of the relative contributions of different etiological factors to these diseases. This would assist in setting priorities and directing resources. Agency funding tables summarizing current Federal effort in a common format appear to be very useful. Is the distribution of funds among the various categories optimum? How should the amount and distribution of funds change in the future? What are the costs of illnesses to the Nation which are specifically related to environmentally caused diseases? We in Congress share your belief, as expressed on p. 13, that major health cost savings to the American public could be achieved by preventive measures in environmental health. But, the funding tables on pages 46-50 indicate that none of the Task Force agencies are investigating the critical area of the direct and indirect costs (and potential cost savings) involved in environmentally related cancer, heart and lung disease. What approaches are available to reduce the incidence of these diseases? Which ones would be most productive? What would their costs be to individuals and to society? (No category in the funding summaries seems to address this question.) Recognizing that our scientific understanding of the problem is less than ideal and will never be complete, are there any preventive heaHh measures that can be considered and applied now or in the near future? What are these measures? What are the needs of informational systems which can assist the Task Force in carrying out its mission efficiently? We welcome the initiative suggested on p. 63 for the organi- zation of a Task Force information management system. A very valuable purpose would be served if this, system can produce not only technical data for agency scientists but can also produce summaries, maps and graphic displays of problems and progress in environmental disease questions for the use of Congress and for the general public. The need for reliable, accurate yet simply presented data for nontechnical decision makers is urgent. ------- The Honorable Douglas M. Costle September 8, 1978 Page 3 0 Early expansion of the scope of the Task Force to include areas of nutrition, radiation and noise pollution, as noted on p. viii of the Summary is, in my view, critically important. I recognize that for some or many of the above questions wc3 may not have answers yet. But, I feel that efforts to find these answers must continue and be significantly strengthened. In closing, I want to again congratulate you and other members of the Task Force. I believe we are off to a good start. We look at the Task Force as a crucial element in the effort to prevent and reduce environmentally related diseases. Sincerely, r? ' V > : v .- PAUL''G. ROGERS', M.C. Chairman, Subcommittee on Health and the Environment PGRicew ------- Appendix E SUMMARY OF RECOMMENDED RESEARCH IN EXPOSURE AND METABOLIC MECHANISMS OF FOUR TOXIC CHEMICALS* ------- Appendix E SUMMARY OF RECOMMENDED RESEARCH IN EXPOSURE AND METABOLIC MECHANISMS OF FOUR TOXIC CHEMICALS BENZENE AND TOLUENE Studies are needed to identify the best animal model for benzene metabolism in the human. The metabolism, disposition, and time course-concentra- tions of benzene and its metabolites in bone marrow during benzene intoxication should be further defined and char- acterized. Once the compounds present in bone marrow at the time of benzene intoxication are fully identified and quantitated, their effects on bone marrow activity should be determined in an effort to identify the active metabolite(s). Further and more detailed studies should be conducted on the synergistic and inhibitory effects on benzene metabolism of chemicals to which humans may be exposed coincident with expo- sure to benzene. A precise metabolic index for the level of human exposure to toluene should be developed. The currently used rate of hippuric acid excretion is not a quantitative measure of exposure. The pharmacokinetics of toluene requires further definition. Further and more detailed studies should be conducted on the synergistic and inhibitory effects of toluene on other chemi- cals to which humans may be exposed coincident with exposure to toluene. CARBON DISULFIDE Although it has been shown that CS? or its metabolites can interfere with several metabolic processes, neither the biochemical basis underlying the From "Exposure and Metabolic Mechanisms of Four Important Industrial Pollutants," prepared by W. T. Piver, W. Jurgelski, T. Damstra, H. L. Falk and J. Bemheim, National Institute of Environmental Health Sciences, Research Triangle Park, NC, December 20, 1978. E-l ------- toxic effects of chronic exposure nor the metabolism of CS~ and its derivatives is fully understood. Further information is needed on: The dermal absorption of CS?. The reactions of CS~ with hydrogen sulfide and ethylene dibromide. The reactions of CS~ metabolites with metals and metal - dependent enzymes. t The metabolic fate of dithiocarbamates and other CS? metabolites. The nature of the bond between CS~ sulfur and macromole- cules of microsomes. Species comparisons of the tissue distribution, pharmaco- kinetics, and excretory pathways of CS^ and its metabolites. The development of specific and quantitative indicators of early exposure to CS^. It may be possible to predict an individual's susceptibility to CS? by determining how effi- ciently a single dose of disulfiram (a drug apparently meta bolized by the same enzyme system as CS?) is metabolized and excreted. The reproductive, endocrine, and cardiovascular effects of CS in humans and animals. METHYLENE CHLORIDE The mechanisms involved in the formation metabolites of inhaled methy- lene chloride have been studied. It is of considerable interest that other dihalomethanes may be more readily metabolized to CO and may react more effec- tively with cofactors or enzymes, but the studies reported so far do not give a uniform picture. E-2 ------- It may be prudent to carry out additional research in the following areas: To elucidate the P. dependent metabolism of dihalo- methanes and the inhibitions of that system by the end product, CO. To study the P, independent inducible enzyme system that can convert dihalomethanes to CO. To clarify the toxicity of plasma-CO for cytochrome systems and myoglobin compared to the toxicity of high saturation with COHb. To get a clearer picture of the effects of dihalomethane resp. COHb on the CNS in causing toxicity. To find out whether fluorine substitution in dihalomethanes produces changes in metabolism, storage, and toxicity. E-3 ------- Appendix F CATEGORIZATION AND FUNDING OF FEDERAL PROGRAMS ------- Appendix F CATEGORIZATION AND FUNDING OF FEDERAL PROGRAMS INTRODUCTION The work of Task Force agencies directed toward quantification and reduction of the risks of environmental cancer, heart and lung disease has been classified in 15 categories. This appendix contains descriptions of these categories. It also contains tables summarizing agency funds expended in each category in FY 1978, and planned expenditures in FY 1979 and FY 1980, for programs relevant to cancer and heart and lung diseases. CATEGORIZATION SCHEME Chapter 2 describes a scheme for categorizing Federal expenditures. That categorization scheme is shown in Figure F-l as a flow chart embracing all Federal activities required to accomplish Task Force objectives. Although no attempt has been made to show a comprehensive flow, some of the important links among the various categories are displayed. DESCRIPTIONS OF CATEGORIES 1. Determination of biological Effects and Dose-Response Relationships includes research which identifies the nature and range of biological effects associated with pollutants and research concerned with the quantitative characterization of the relationship between varying dosages of pollutants and the biological effects of such dosages. Studies in this category are typically laboratory in nature. F-l ------- Research in Areas of Current Task Force Concern Population-Orie nted Pollutant-Oriented Olher Federal Activities (Beyond Scope of Current Task Force Activity) Methodology-Oriented 1. Determination ol Biological EHects and Dose-Response Relationships of Pollutants and Cofactors 3. Identification and Monitoring of Environmental Pollutants as Potential Disease Agents Development of Pollutant Control Technology 4. Identification and Analysis of Pollutant Sources Studies of Impacts of Pollutant Control Measures on National Economy 6. Development of Sampling Analytic and Monitoring Methods 2. Understanding Mechanism or Mode of Biological Effects 5. Analysis of Environmental Transport and Transfor- mation of Pollutants in Various Media and Pathways (e.g.. Air. Water, Ingestion. Dermal) 9. Epidemiological Studies of Exposure-Health Effect Associations Legal and Political Considerations 11. Estimation of Costs of Environmentally Related 12. Estimation of Costs of Control and Prevention 10. Population Risk Assessment Strategy Planning for Reduction of Risk and Incidence Measures to Reduce Risk and Incidence 14 Education of Public and Health Profes- sionals 15 Pollutant Control Measures 13. Preventive Health Measures Figure F-1. Flow of Research, Strategy and Control Federal Efforts with Respect to Environmental Cancer and Heart and Lung Disease ------- 2. Understanding Mechanism or Mode of Biological Effects includes research which evaluates the mode and extent of entry of environmental pollu- tants into the human body, their body pathways, toxin endpoints, and residence time. Studies of mechanisms of cellular or subcellular interactions with pollutants are also included. 3. Identification and Monitoring of Environmental Pollutants includes characterization, chemical analyses and monitoring of pollutants for research studies. Operational monitoring for regulatory purposes or for the fulfillment of legislative mandates is not considered to be within the purview of Task Force concerns at this time and is excluded from this defi- nition. Research on measurement of the presence and concentrations of pol- lutants in various media and various environmental settings is the principal aspect of work performed in this category. 4. Identification and Analysis of Sources refers to investiga- tions of sources of environmental pollutants which may impact on human health. These studies are either pollutant-specific or source-specific. The former includes research addressed to identifying and characterizing various sources from which a specific pollutant is emitted. The latter addresses the type, amount, and manner of release of various contaminants from a single source or type of source. 5. Environmental Transport and Transformation Analysis studies predict environmental concentrations of a pollutant based on understanding of its transport processes and the physical or chemical changes that occur during such transport. Primary tools in such studies are analytical or physical F-3 ------- models of environmental transport and transformation. Included in this cate- gory are studies which attribute concentrations of pollutants in the ambient environment to sources. 6. Development of Sampling, Analytic, and Monitoring Methods is aimed at developing better environmental sampling techniques, labora- tory analysis methods and monitoring equipment. 7. Collection of Health Statistics consists of all programs which involve the gathering of health information in order to create data bases of general utility. Morbidity, mortality and health status data collected for the purpose of providing baseline information are included in this category. The objective of these programs is often the reporting of statistics, in contrast to using them in assessment of cause-and-effect association and other research projects. (A separate category for cause- and-effect association is included below.) 8. Human Exposure Estimation involves studies which estimate the magnitude of the level of exposure of individuals to pollution through various pathways over defined periods of time. Precise estimation of human exposures requires modeling or monitoring of ambient, residential, and occupational environments. 9. Establishment of Cause-and-Effect Association encompasses epidemiological studies of disease incidence. This category of study seeks to associate variation in environmental exposure with the prevalence of disease while controlling for other factors which may influence the prevalence of disease. F-4 ------- 10- Population Risk Assessment studies integrate the results of various studies included in the categories defined above for estimation of risk to the population due to a particular pollutant or type of source. These studies can assist in the establishment of priorities for research and for regulation of environmental pollutants. 11- Estimations of the Costs of Environmentally Related Illness include studies which evaluate the direct and indirect economic impact of environmental pollution on human health. This category includes evalua- tions of human morbidity costs attributable to environmental pollution, and estimation of future health care costs which would be avoided if pollution could be reduced by specified amounts. 12. Costs of Control and Prevention studies estimate and evalu- ate the economic costs of implementing pollutant control programs. This category includes studies involved with the estimation of costs of control and prevention as well as cost-benefit analyses related to the implementa- tion of specific pollution control programs. 13. Preventive Health includes a range of programs aimed at the avoidance or minimization of harmful effects of pollutant agent exposure. Programs which are specifically directed toward education and pollution con- trol (discussed below) are excluded. An example of a preventive health pro- gram is the screening of workers with potential cardiovascular problems from work environments particularly hazardous to such persons. 14. Education of the Public and of Health Professionals consists of programs directed toward improving the capability of the medical professional F-5 ------- in recognizing and treating environmental disease, efforts to educate the general public about environmental hazards as a means of prevention of environ- mentally caused illness, and programs to educate the public in environmental disease awareness. Grant programs to health professional training institutions which have these objectives appear in this category. 15. Pollutant Control Measures include efforts which establish or evaluate measures of control and the development of pollutant control meth- odologies. This category includes research programs directed at improving control devices to reduce pollutants released into the environment as well as programs directed toward reducing exposure to pollutants by alteration of source or receptor patterns. AGENCY FUNDING OF PROGRAMS IN ENVIRONMENTAL CANCER AND HEART AND LUNG DISEASE The remainder of this appendix includes a summary of research funding and a brief narrative for each agency for FY 1978, 1979, and 1980. The funding information is classified by the 15 categories and by disease classes (Tables F-l through F-7). Headings of Cancer, Heart Disease and Lung Disease refer to programs relating wholly or principally to one of those diseases. Expenditures listed under the heading of Nonspecific are for programs which are substantially relevant to more than one of the major disease classes. F-6 ------- SUMMARY OF RESEARCH FUNDING ------- Table F-l. Summary of Funds for EPA (in thousands of dollars) Category 1. Determination of Biological Effects and Dose-Response Relationships 2. Understanding Mechanisms or Mode of Biological Effects 3. Identification and Monitoring of Environmental Pollutants 4. Identification and Analysis of Sources 5. Environmental Transport and Transformation Analysis 6. Sampling, Analytic and Monitoring Methods 7. Collection of Health Statistics 8. Human Exposure Estimation 9. Establishment of Cause- and- Effect Association 10. Population Risk Assessment 11. Estimation of Costs of Environ- mentally Related Illness 12. Estimation of Costs of Control and Prevention 13. Preventive Health Measures 14. Education of the Public and of Health Professionals 15. Pollutant- Control Measures TOTAL Cancer 1978 1979 2,296 2,424 1,378 577 300 1,261 163 191 1,251 2^837 12,678 7,900 6,219 4,121 1,321 413 2,155 1,000 2,774 2,865 1,335 130 30,233 1980 12,913 3,659 4,406 810 866 3,530 1,000 3,010 3,461 2,600 150 940 37,345 Heart 1978 1979 1980 89 143 73 100 75 389 138 25 316 1,348 bis 100 73 40 301 250 1,079 580 1,450 60 2,090 Lung 1978 1979 1980 667 756 371 2,535 645 2,330 76 1,296 665 1,348 10 15 210 2 6,020 16,946 1,616 891 600 744 111 16,146 20,108 900 2,848 885 200 70 25,240 30, 143 Nonspecific (includes cancer, heart, and lung) 1978 1979 1980 1,497 1,169 7,549 13,250 7,097 13,808 271 2,163 639 6,266 12 2,641 1,175 621 20,901 79,059 16,716 6,854 26,858 7,134 18,675 13,517 77 2,141 5,373 4,725 2,776 800 69 25,013 130,728 22,770 9,335 14,934 6,648 20,579 15,522 750 3,255 13,236 10,192 2,731 1,000 90 21,566 142,608 ------- EPA The Environmental Protection Agency (EPA) was established in the Executive Branch as an independent agency pursuant to Reorganization Plan No. J in 1970 It was created to protect and enhance the quality of the environment through the development of a comprehensive, coordinated attack on environmental pollution in the areas of air, water, solid waste, radia- tion, noise and toxic substances. Much of the environmental legislation that Congress has recently enacted has broadened EPA's mission. As a result, the Agency is now a preventive public health agency as well as an environ- mental one, and is thus greatly concerned with the problem of environmental cancer and heart and lung diseases. The Agency is specifically charged with protecting human health and the environment through the promulgation and enforcement of standards and regulations. To accomplish these goals, the Agency is organized into the following major offices: the Office of Air, Noise, and Radiation, the Office of Toxic Substances, the Office of water and Waste Management, and the Office of Research and Development. Research at EPA is managed through the Office of Research and Develop- ment (ORD) which is responsible for providing a sound scientific base for the promulgation, enforcement and review of environmental standards and regulations. The major objectives of ORD are to characterize pollution threats; define the health and ecological dangers from pollutant sources; and develop, test and evaluate appropriate means to control pollution. Overall, since 1978, the emphasis in the ORD budget has been shifting away from the identification, analysis, and monitoring of pollutants in the environment to health effects research, and long-range, anticipatory research. The focal point of EPA's increased emphasis on the health effects of pollutants is the 1980 "public health initiative" which totals $37 million. This money, which is divided among the air, drinking water, toxics and radiation media focuses on the following research and development activities that are of concern to the Task Force: 1. The development of short-term and screening tests to permit the rapid, inexpensive detection of toxic pollutants; 2. The development of exposure assessment techniques to help predict the concentrations of toxic pollutants as they reach man through various routes of exposure and are absorbed, trans- formed or accumulated in the body; and 3. The conduct of epidemiological studies to validate and improve the predictive capabilities of animal tests and exposure models. To supplement ORD's public health initiative, the Agency will continue to support a program of anticipatory research. This small basic research program will almost double in size from FY 1979 to FY 1980. It is designed to develop better exposure assessment methods and models, and support data on the trans- port and transformation of pollutants. It is also designed to permit explora- tion of long-term research needs in areas such as the relationship between the incidence of cancer and exposure to ambient environmental pollution. Table F-l summarizes EPA's research and development efforts in the areas of environmental cancer and heart and lung diseases. It should be noted that the figures in this table do not represent EPA's total budget, and that the figures for FY 1979 and FY 1980 are only proposed expenditures. F-9 ------- Table F-2. Summary of Funds for NCI (In thousands of dollars) Category 1. Determination of Biological Effects and Dose-Response Relationships 2. Understanding Mechanisms or Mode of Biological Effects 3. Identification and Monitoring of Environmental Pollutants 4. Identification and Analysis of . Sources 5. Environmental Transport and Transformation Analysis 6. Sampling, Analytic and Monitoring Methods 7. Collection of Health Statistic* 8. Human Exposure Estimation 9. Establishment of Cause- a nd- Effect Association 10. Population Risk Assessment 11. Estimation of Costs of Environ- mentally Related Illness 12. Estimation of Costs of Control and Prevention 13. Preventive Health Measures 14. Education of the Public and of Health Professionals 15. Pollutant- Control Measures TOTAL 1978 13,037 42,496 3,817 480 51 127 9,792 1,786 8,353 1,171 55 1,345 3,287 40 85,837 Cancer 1979 1980 19,432 38,231 3,378 686 56 111 11,632 1,761 9,059 1,359 J07 2,936 3,681 45 92,474 28,294 33,871 2,387 675 62 125 12,339 1,000 8,965 1,097 105 7,850 3,765 45 100,580 Heart 1978 1979 1980 Lung 1978 1979 1980 Nonspecific (Includes cancer, heart, and inng) 1978 1979 1980 ------- NCI The majority of the National Cancer Institute (NCI) monies for environ- mental cancer programs were from the Division of Cancer Cause and Prevention. Support for such activities also resides in the Divisions of Cancer Biology and Diagnosis, Cancer Treatment, Cancer Control and Rehabilitation, and Cancer Research Resources and Centers. Monies allocated for activities such as smoking and health, diet and nutrition, and co-carcinogenesis (viral chemi- cal) were excluded by limits of definition as set forth by the Task Force. In the Summary of Funds table for the first annual report to Congress, 15 categories were used to determine the general nature and distribution of support for environmental cancer activities of NCI. The table further showed that only about half of the categories represented major activities for expenditure of funds. Of these areas, the largest amounts were committed to studies on the mechanisms or mode of biological effects. Work on the deter- mination of biological effects, surveillance (collection of health statistics in this report) and cause-and-effect associations were next in order of importance. Table F-2 in this report shows that these same categories remained as principal areas for expenditures of funds. The dollar figures reflected in this report are somewhat reduced for years 1978 and 1979 from those reported last year. While last year's figures were derived from Program Managers, the present table was developed by coordinating the budget for these activities through NCI budget channels. The figure reported for 1978 represents actual obligations. Results from only two of the three NCI Council Meetings are reported for 1979. Figures for 1979 and 1980 are estimates based upon the 1980 President's budget. F-ll ------- Table F-3. Summary of Funds for NHLBI (in thousands of dollars) Category 1. Determination of Biological Effects and Dose-Response Relationships 2. Understanding Mechanisms or Mode of Biological Effects 3. Identification and Monitoring of Environmental Pollutants 4. Identification and Analysis of Sources S. Environmental Transport and Transformation Analysis 6. Sampling, Analytic and Monitoring Methods 7. Collection of Health Statistics 8. Human Exposure Estimation 9. Establishment of Cause-and- Effect Association 10. Population Risk Assessment 11. Estimation of Costs of Environ- mentally Related Illness 12. Estimation of Costs of Control and Prevention 13. Preventive Health Measures 14. Education of the Public and of Health Professionals IS. Pollutant-Control Measures TOTAL 1978 Cancer 1979 1980 Heart 1978 1979 1980 292 56 95 443 346 65 65 476 371 55 55 481 Lung 1978 1979 1980 426 2,068 96 118 613 349 ISO 32 3,852 436 1,932 96 119 620 234 148 29 3,614 434 1,431 121 129 642 272 129 30 3,188 Nonspecific (includes cancer, heart, and lung) 1978 1979 1980 ------- NHLBI The Division of Lung Dieases of the National Heart, Lung and Blood Institute (NHLBI} is responsible for planning, administering, coordinating and evaluating all extramural activities concerned with diseases of the lung and respiratory disorders. The Division's program encompasses basic research, targeted research, clinical trials and demonstration, National Pulmonary Centers, technological development, and application of research findings. Research on the. effects of the environment upon the respiratory system is continuing, through the regular research grant mechanism, with a total com- mitment of $3,852,000 in 1978. The projection for 1979 is similar, $3,614,000 already committed as of June 1979, which does not include the funds which will be committed as a result of investigator-initiated grants during the rest of FY 1979. Similarly, the Division has already committed $3,188,000 for research on environmental effects on the respiratory system in 1980. It is anticipated that this amount will be increased with the approval and funding of investigator- initiated grants awarded before the end of 1980. The Division of Heart and Vascular Diseases at NHLBI has funded research related to Task Force activity that has emphasized understanding the mechanism or mode of the biological effects induced by environmental agents that impact on heart disease. Project funding for cardiovascular research has included develop- ment of models for estimation of disease risk, as well as basic research on the etiology and development of heart disease relevant to environmental factors. The FY 1978 and 1979 funding represents projects paid or committed, and the FY 1980 figures represent estimates. F-13 ------- Table F-4. Summary of Funds for NIOSH (in thousands of dollars) C ategory 1. Determination of Biological Effects and Dose-Response Relationships 2. Understanding Mechanisms or Mode of Biological Effects 3. Identification and Monitoring of Environmental Pollutants 4. Identification and Analysis of Sources 5. Environmental Transport and Transformation Analysis 6. Sampling, Analytic and Monitoring Methods 7. Collection of Health Statistics 8. Human Exposure Estimation 9, Establishment of Cause-and- Effect Association 10. Population Risk Assessment 11. Estimation of Costs of Environ- mentally Related Illness 12. Estimation of Costs of Control and Prevention 13. Preventive Health Measures 14. Education of the Public and of Health Professionals 15. Pollutant-Control Measures TOTAL Cancer 1978 1979 1980 1,629 378 503 16 1,362 720 659 362 429 16 384 6,458 2,286 531 705 23 1,381 731 669 368 436 16 390 7,536 2,880 660 1,450 47 1,738 1,619 844 1,043 556 16 487 11,340 Heart 1978 1979 1980 43 3 9 172 227 60 3 10 175 248 79 4 31 221 335 Luiig 1978 1979 1980 1,025 1,645 256 491 510 12 1,390 162 2,838 503 8,832 1,437 2,307 359 498 518 12 1,411 164 2,880 511 10,097 1,729 2,810 735 626 1,142 41 1,778 467 3,626 646 13,600 Nonspecific (includes cancer, heart, and lung) 1978 1979 1980 528 148 274 1,259 442 354 900 117 12,551 8,259 186 25,018 741 208 384 1,278 449 359 910 118 12,739 10,783 188 28, 157 934 268 795 1,609 993 457 923 1,045 16,043 10,783 238 34,088 ------- NIOSH The National Institute for Occupational Safety and Health (NIOSH) is responsible for conducting research aimed at minimizing health and safety risks to employees from exposures to hazardous chemical and physical agents in the workplace. Research priorities are established through Congressional mandates, the needs of the standards development program, National Toxi- cology Program priorities, Occupational Safety and Health Administration/Mine Safety and Health Administration short-term research requests, and priorities defined by NIOSH researchers. Since FY 1977 NIOSH has accelerated its research to identify new work- place hazards and to define more adequately the scope of hazards that were already suspected or clearly recognized. 'For FY 1980 NIOSH has requested additional funding of approximately $12,000,000 over the FY 1979 level for four programs which will allow for a substantial increase in cancer and lung disease research. These project areas are: metal and nonmetallic mining, health hazard evaluations, occupational health and safety data collection, and synergistic and additive effects of tobacco smoke coupled with work- related exposure to toxic chemicals. Cancer Since its initiation in FY 1975 NIOSH1s Occupational Carcinogenesis Program has increased significantly. In FY 1975 $1,800,000 was expended on NIOSH's cancer-related activities while in FY 1980 it is expected that over $10,700,000 will be expended. In 1977 projects were implemented in three major areas of concentration which have continued to be expanded: recognition (surveillance and assessment), evaluation (epidemiological and laboratory studies) and control (engineering, medical and technology transfer). Lung Disease Funding for research concerning occupationally induced lung diseases is expected to increase approximately 75 percent from FY 1977 through FY 1980. The largest percent increase in funding is in the area of risk assessment where retrospective mortality and industrial hygiene studies are targeted to specific industries (e.g., coal mining) and agents (e.g., silica). Laboratory and clinical studies are aimed at determining the etiology and subsequent control mechanisms of various occupational lung diseases. Also, emphasis has been placed on defining biological effects, devising sensitive and specific diagnostic tests and sampling procedures, and developing and strengthening dose-response relationships. Heart Disease The amount of funds available for research concerning heart disease is expected to increase to $335,000 in FY 1980. In addition to mortality and mor- bidity studies, NIOSH also plans to fund research projects through its grant program concerning the cause and prevention of occupationally induced cardio- vascular disease. F-15 ------- Table F-S. Summary of Funds for NIEHS (in thousands of dollars) Category 1. Determination of Biological Effect* and Dose-Response Relationships 2. Understanding Mechanisms or Mode of Biological Effects 3. Identification and Monitoring of Environmental Pollutants 4. Identification and Analysis of Sources 5. Environmental Transport and Transformation Analysis 6. Sampling, Analytic and Monitoring Methods 7. Collection of Health Statistic* 8. Human Exposure Estimation 9. Establishment of Cause- and- Effect Association 10. Population Risk Assessment 11. Estimation of Costs of Environ- mentally Related Illness 12. Estimation of Costs of Control and Prevention 13. Preventive Health Measures 14. Education of the Public and of Health Professionals IS. Pollutant- Control Measures TOTAL 1978 5,370 3,936 63 3 203 23 120 460 -178 10,356 Cancer 1979 1980 5,868 4,280 68 4 220 25 130 498 193 11,286 5,590 4,108 63 4 203 23 120 465 180 10,756 Heart 1978 1979 1980 1,053 1,450 3 3 187 2,696 1,078 1,484 4 4 194 2,764 1,059 1,456 4 4 191 2,714 Lung 1978 1979 1980 3,110 3,202 134 67 55 292 17 1,570 210 45 8,702 3,420 3,522 147 73 61 321 18 1,727 231 49 9,569 3,210 3,333 134 67 55 292 17 1,576 214 45 8,943 Nonspecific (includes cancer, heart, and lung) 1978 1979 1980 996 1,160 107 759 185 144 79 53 210 439 13 33 4,178 1,361 1,416 116 828 202 157 86 58 229 479 15 35 4,982 1,136 1,458 107 760 185 144 79 54 210 439 13 33 4,618 ------- NIEHS The work of NIEHS, relevant to prevention of environmentally related cancer and heart and lung diseases, addresses research over a wide spectrum of topics ranging from identification of environmental pollutants to studies of health hazards and epidemiology. There is also an emphasis upon develop- ment of environmental health science resources through extramural grants and an Institute and grant training program. The funding levels for FY 1978 for the three disease categories reported in the Task Force's first annual report were quite accurate. However, the current estimate for FY 1979, in most cases, reflect about a 10 percent increase over FY 1979 estimates that were made last year. These increases were made possible by modest increases over FY 1978 in the intramural program budget. After correcting for inflation, the actual level of research effort in the activities described in the narrative would be about the same as for FY 1978. Likewise, it can be noted that there is no increase in level of funding for FY 1980 over FY 1979 reflect- ing current and short-term budgetary constraints. (The 1980 funding information is based on the 1980 President's budget.) In case of the disease category "nonspecific," there are significant increases from last year's submission which can be attributed to a large research contract associated with the National Toxicology Program. This program will be examining a broad spectrum of pathological outcomes (including cancer and cardiopulmonary disease) which may result from both perinatal and life-time exposure of animals to a variety of environmental chemicals. F-17 ------- Table F-6. Summary of Funds for NCHS (in thousands of dollars) Category 1. Determination of Biological Effects and Dose-Response Relationships 2. Understanding Mechanisms or Mode of Biological Effects 3. Identification and Monitoring of Environmental Pollutants 4. Identification and Analysis of Sources 5. Environmental Transport and Transformation Analysis 6. Sampling, Analytic and Monitoring Methods 7. Collection of Health Statistics 8. Human Exposure Estimation 9. Establishment of Cause- a ml - Effect Association 10. Population Risk Assessment 11. Estimation of Costs of Environ- mentally Related Illness 12. Estimation of Costs of Control and Prevention 13. Preventive Health Measures 14. Education of die Public and of Health Professionals 15. Pollutant-Control Measures TOTAL 1978 Cancer 1979 1980 Heart 1978 1979 1980 Lung 1978 1979 1980 Nonspecific (includes cancer, heart, and lung) 1978 1979 1980 3,000 3,000 3,400 3,400 4,400 4,400 ------- NCHS The National Center for Health Statistics (NCHS), through its many data systems, routinely produces data on disease incidence, including cancer and heart and lung diseases. These data systems frequently pro- vide the basis for research carried out by other Federal agencies and are aimed at determining and quantifying the relationships between cancer and heart and lung diseases and environmental pollutants. Environmentally related activities within NCHS include three major projects. Under Public Law 95-623, NCHS was mandated by Congress to determine the feasibility of establishing a central clearinghouse for environmental and health data systems and research within the Federal Government. This mandate also includes the identification of duplication of research between agencies as well as any existing gaps. A workshop was recently held in response to the mandate, and it resulted in recommendations by the members which would strengthen the area of environmental health research if implemented. NCHS is currently in the process of producing the first United States Atlas of Mortality. Separate maps for white males, white females, nonwhite males, and nonwhite females will be produced. Age will be accounted for by age-adjustment using 1940 as the standard population making these data comparable with other NCHS data. Each major cause of death will be mapped, indicating the geographic distribution of mortality. This project has environmental implications since several of the diseases have strong associations with environmental factors. The third project under progress involves calculating age-adjusted morbidity rates from the Health Interview Survey (HIS) for the 31 largest Standard Metropolitan Statistical Areas. The years 1973-1977 will be used, as well as the years 1963-1967. This enables comparisons to be made between cities and between time periods for individual cities. Both chronic and acute disease information will be used. However, at present only chronic disease age-adjusted rates for 1973-1977 have been calculated. Once all the calculations are made, the information will be incorporated into the Council on Environmental Quality's UPGRADE system. The data can then be linked to EPA water (STORET) and air (SAROAD) data already within the system. F-19 ------- Table F-7. Summary of Funds for CDC (in thousands of dollars) Category 1. Determination of Biological Effects and Dose-Response Relationships 2. Understanding Mechanisms or Mode of Biological Effects 3. Identification and Monitoring of Environmental Pollutants 4. Identification and Analysis of Sources 5. Environmental Transport and Transformation Analysis 6. Sampling, Analytic and Monitoring Methods 7. Collection of Health Statistics 8. Human Exposure Estimation 9. Establishment of Cause-and- Effect Association 10. Population Risk Assessment 1 1 . Estimation of Costs of Environ- mentally Related Illness 12. Estimation of Costs of Control and Prevention 13. Preventive Health Measures 14. Education of the Public and of Health Professionals 15. Pollutant- Control Measures TOTAL 1978 Cancer 1979 1980 11 146 30 187 Heart 1978 1979 1980 Lung 1978 1979 1980 Nonspecific (includes cancer, heart, and lung) 1978 1979 1980 25 60 58 102 23 268 42 115 195 209 200 56 6 823 45 126 215 220 94 700 ------- CDC The Center for Disease Control (CDC) is involved in studies related to the understanding and prevention of environmentally related diseases. Col- laborative studies with other Federal agencies and state health departments in the area of environmental disease reduction are also undertaken by CDC. A substantial amount of funding for the Chronic Disease Division is related to category 9, the establishment of cause-and-effect associations. This category includes the cancer surveillance and epidemiclogic-oriented investigations conducted by the Division. The funding information for FY 1978 and FY 1980 has not been included, but a slightly upward level of expenditure is anticipated in FY 1980 for this Division. The Bureau of Laboratories is engaged in identification, monitoring and analysis of sources of environmental pollutants, and in risk assessment studies. The funding information for this Bureau is reported in Table F-7 under the column "nonspecific." F-21 ------- |