pathways and their burdens determined for one group of communities. Additional pollutants, such as PCB and pesticides, are also included in the CHESS program.

6. Results:

The knowledge gained through CHESS will be documented in a series of intramural and published technical reports relating health impact indicators and important health covariates to environmental quality. At least 8 reports per year are planned, one for each of the health indicators currently utilized. The technical reports will also summarize the progress in the research carried out as part of the health status evaluations and body burden studies. The reports will provide health effects intelligence for appraisal and setting of environmental standards.

7. Approach:

CHESS is an integrated series of epidemiologic studies designed, coordinated and largely funded by the Federal government. Under contract, local health departments, universities or survey research organizations operate special neighborhood environmental monitoring stations and collect data from citizen volunteers living in communities with an exposure gradient for specified pollutants. Bioenvironmental measurements are performed in the field and in a Federal laboratory. A federal research group synthesizes information from the data to produce intramural and published technical reports. This Federal group is also responsible for research and development to find more sensitive impact indicators suitable for field surveys, to improve bioenvironmental exposure monitoring and to refine statistical procedures.

No alternatives are available to the direct monitoring of the environment and data gathering by the Federal government. An alternative source of the data would be area mortality, but migration, occupation and medical care information would have to be made available by the Social Security Administration, which has gathered some of this information through the Medicare program; due to the confidentiality of this kind of information and the current pressures from Congress to preserve this confidentiality, it is foreseen that area mortality data will remain unusable for the near future. No alternatives are available to the direct epidemiological study of populations since there are no accurate ways to predict impact on populations by extrapolation from laboratory studies or studies on other species.

As feasibility studies proceed, new health impact indicators and pollutants will be integrated into the studies and indicators no longer found useful will be eliminated.

8. Supporting Contracts:

The studies utilize the data available through NADIS. Meteorologists required for analysis of the data are provided by the Meteorological Support Element. The Bio-Medical Research element consists of work closely related to CHESS; effects and pollutants identified and studied under Bio-Medical Research are utilized to guide epidemiological studies and vice-versa.

Contracts: The CRC-APRAC provides funds for carrying out studies that are the same as the CHESS; the CAPM 10 and 11 studies involve air quality monitoring by OAP and data collection by CRC. The Health Research Council of N.Y. provides approximately $20,000 a year for the New York area CHESS.

Interagency Agreements: The Bureau of Occupational Safety and Health provides trace metal analyses for one of the studies.

9. Special Facilities/Equipment:

Beyond the state of the art, there are requirements for developing procedures and instruments as follows: (a) compact instrument package to measure indoor air quality; (b) automated procedure for analysis of chromosomal aberration and exfoliative cytology; (c) direct telemetry capability from continuous ambient air monitors to the data bank; (d) better methods for trace elements analysis, i.e., alpha scatter, ASV; (e) personal air quality monitors; (f) better methods for particulate measurement, both as to the size and chemical composition; (g) capability to measure metallo-enzyme kinetics.

10. Intermedia Relationships:

Human pollutant burden studies of metals and synthetic organic materials involve the Water Quality, Solid Wastes, and Pesticides elements of EPA. Data from the food and milk sampling program of the Radiation element could be

integrated into CHESS. Monitoring exposure to ionizing and non-ionizing radiation and the effects of the latter might be approached through CHESS.

11. Coordination:

Research personnel from each media office have been briefed in CHESS. Very close working liaison is maintained with the Bio-Medical Research element. 12. Unresolved Policy Issues: None.

1. Program Element Code-110202

2. Program Element Title-Ecological Impact Research; Program Coordinator-Dr. Vaun Newill

3. Program Justification:

The study and determination of the effects of air pollution on soil, water, crops, vegetation, animals, and wildlife (defined as part of welfare effects in the Clean Air Act, Section 103) can only be realistically approached by comprehensive ecological investigations relating to the functions and interrelationships of environmental components within an ecosystem. These effects, which include damage to crops and materials, are economically significant, representing losses amounting to many billions of dollars every year. The better understanding of these effects will lead to realistic control through the setting of secondary ambient air quality standards and other control measures.

4. Objectives:

To determine the effects of air pollutants on biotic and abiotic components of the environment; to assess the economic magnitude of the effects; and to assess the effectiveness of control measures through the monitoring of selected ecosystems.

5. Scope:

Effects will be studied for those biotic and abiotic components of selected ecosystems for which effects are known and which require further elucidation or for which effects are suspected but have not been confirmed. Work will concentrate on those effects that are economically most significant. Research will be conducted on soils, crops, vegetation, animals, and wildlife; major natural and man-made materials. Economic values and water will be studied as they relate to these environmental components. Effects on weather, climate, and visibility is not carried out under this element, nor is research on human comfort and wellbeing.

6. Results/Products:

Ecosystem models with annual updates and effects criteria will be provided for urban oxidant complexes, fossil fuel combustion emission complexes, fluoride emission complexes, and hydrocarbon emissions. Pollutant pathway reports will be provided and updated for toxic elements and components as studies are completed and continued. Completed studies will be comprehensive reports documenting effects results, and, in some cases, depending on the nature of the studies, will include economic analysis. Progress reports will be issued annually on longterm projects. The economic impact model will be updated on an annual basis by introducing new knowledge derived from research; this updating will appear as a report.

7. Approach:

Biome and ecosystems analysis will be used. Models of the systems will be conceptualized and areas of high sensitivity will be examined first. Initially, many basic facts are required to delineate the research areas. National Secondary Ambient Air Quality Standards must protect the public welfare from any known or anticipated adverse effects. Known acute (short-term) effects have been determined for selected individual receptors. Anticipated effects, both acute and chronic, must be examined relative to a total ecosystem. Within a system, effects of air pollution can be observed in their full and cascading context. The most sensitive links in the system can be delineated and adverse effects first. studied there. Dose-Response relationships and damage mechanisms will be determined. Community surveys that delineate observed damage and assess the sensitivity of property value components to air pollutant levels will be carried

out. The research results will be assessed and translated into economic terms suitable as input for the economic impact model.

The alternative approach would be to examine selected individual receptors and develop dose-response relationships; this approach would be the same type of work to be performed under the ecological systems approach proposed but without the benefit of an integrated approach to an eco-system.

8. Supporting Contracts:

The development of good, low-cost instrumentation is vital, as are detailed emission inventories and atmospheric models. Ways of measuring the value of man's environment with respect to man will ultimately be necessary (i.e., wilderness and recreation), as will studies of man as a species in the environment. Some knowledge developed within another program element (Economic Criteria) may be useful.

9. Special Facilities/Equipment:

For optimum planning for materials studies, 20 additional controlled environment chambers will be needed. Ecology studies will require growth chambers, exposure chambers, pollutant generation and control devices, research farm, analytical laboratories, monitoring equipment, data acquisition and reduction equip ment, and mobile laboratories.

10. Intermedia Relationships:

Pesticides and air pollutant interactions with respect to vegetation are being studied. Knowledge of pesticides research is being acquired for possible coordination. The Radiation elements of EPA has unused mobile laboratories at the Southwest Laboratory which could be used in biome studies; further contacts will be made as operations come closer to realization as will use of their air photography capabilities. As the acid rainfall problem is delineated, the Water Quality elements of EPA will be contacted regarding pH work in water. The Solid Wastes elements will be contacted regarding their work on open field and prescribed burning to see if this will be a continuing problem. Property value, deicing salts, and catastrophic failure of materials projects are multi-media related. 11. Coordination:

Coordination is underway with the Agricultural Research Service, Forest Service, Extension Service, and Tennessee Valley Authority.

12. Unresolved Policy Issues: None.

1. Program Element Code-110203

2. Program Element Title-Bio-Medical Research

3. Program Justification:

Program Coordinator-Dr. Vaun Newill

The furtherance of knowledge in this area is encouraged in the accelerated effects research provisions of Section 103 of the Clean Air Act. In order to assess the effects of air pollutants on public health and welfare direct studies on biological systems, both human and animal, are required. The current status of knowledge is such that it is necessary to study the effects of exposure to various levels of concentration and various combinations of air pollutants under laboratory conditions prior to and concurrently with studies in the field on the effects of ambient air concentrations, described under CHESS.

4. Objectives:

To develop health effects information for the development and revision of criteria and standards for air pollutants; to test the adequacy of primary standards already promulgated in protecting human health; to identify hazardous materials for possible control actions; and to define the biological effect of air pollutants in association with each other and other environmental factors.

5. Scope:

The Bio-Medical Research Program consists of laboratory and clinical studies on the effects of air pollution on human health. Four of the pollutants (sulfur oxides, nitrogen oxides, photochemical oxidants, and carbon monoxide) for which National Ambient Air Quality Standards (NAAQS) have been established are currently emphasized. Some effort is being directed toward assessing the toxicity

of automotive emissions and the carcinogenicity of airborne polycyclic organic matter. The pollutants currently covered by the NAAQS will be deemphasized. It is expected that epidemiological studies of the effects of these pollutants at ambient level concentration will provide the information requisite for the revision of the criteria and standards and to determine the effectiveness of control measures in protecting human health. The work on sulfur oxides acting nonsynergistically is expected to be phased out by 1973, with the work on ozone and photochemical oxidants halved in the next three to five years. Work on oxidant potentiation of carcinogenesis may go on beyond this period if it is feasible to conduct such studies. Work on nitrogen oxides is expected to continue at the current level until 1975. Priority for studies of pollutants will bet set by the results of reports and determinations related to the pollutants (classes) of high priority concern listed under pollutant characterization. Work will be expanded in the areas of trace substances, pesticides, and synthetic chemicals such as PCB. It is expected that the new studies will provide information that may lead to the integration of studies of certain pollutants, such as PCB, into the CHESS if found feasible.

6. Results:

The knowledge gained through Bio-Medical research will be made available in a series of intramural and published reports relating toxicological information to environmental quality. These reports will provide health effects information for application toward epidemiological studies as well as direct intelligence for the appraisal and setting of environmental standards. The studies on carcinogenic POM, oxidants, nitrogen oxides, and sulfur oxides- particulates will contribute to the revision of the respective criteria and NAAQS and contribute towards decisions on the control of POM.

7. Approach:

The Bio-Medical research program is an integrated series of toxicological studies utilizing both animal and human inhalation exposure facilities. Specific pollutant atmospheres are generated, monitored, and provided to the experimental animals or subjects for specified periods of time. Exposures may be of an acute short-term nature or of the chronic long-term type. Effort is also directed toward defining the biologic fate of environmental contaminants as well as the development of improved methodology (animal model systems and measurement techniques) which may be applied for the detection of pre-clinical effects and subsequently utilized in epidemiological studies.

Animal toxicology is conducted to identify, quantitatively and qualitatively the primary effects and target system; examine pollutants of such character and/or concentration unsuitable for human studies due to ethical as well as medical-legal limitations; provide in vitro manipulative approaches to develop techniques for subsequent application to clinical and epidemiological investigations; and provide chronic exposure conditions for identifying potential carcinogenic, teratogenic and mutagenic effects. Laboratory clinical investigations are used to develop improved methodolgy for epidemiological studies; verify extrapolation of animal effects to man; and test, in a cause and effect manner under controlled conditions, correlative epidemiological results.

8. Supporting Contracts:

(a) Experimental planning utilizes data available through NADIS and Office of Fuels and Additives Reigstration; (b) Information from BMSPC is needed for facility design for toxicity assessment of mobile emissions; (c) Contracts: CRC-APRAC provides cooperative funds for effects studies related to carbon monoxide. Contracts with non-government organizations provide support to inhouse programs in the areas of pollutant interaction and carcinogenesis. The current contracts effort utilizes $443,000 per year; (d) Grants: Substantial amounts of money are utilized in the research grants area for the same type of work done under this element.

9. Special Facilities/Equipment:

The following special facilities are required: (a) Automotive engines, dynamometers, dilution systems, irradition chambers, animal exposure chambers; (b) Human environmental chambers. Beyond the state-of-the-art, the following is required: (a) Equipment for telemetering physiologic parameters; (b) Complex behavioral testing equipment for EEG, time, object and pattern discrimination; and task performance with associated program control computer.

64-737-71-pt. 2- -23

10. Intermedia Relationships:

Anticipate relationships with other EPA Offices on effects of pollution research. 11. Coordination: Liaison with AEC, NIEHS, FDA, NCI.

12. Unresolved Policy Issues: None.

Narrative: Fiscal Year 1972

510101001

Project Title: Metabolism and Biological Effects of Pesticides and Other Environmental Contaminants in Primates and Other Mammals.

I. Justification:

The exposure of the general population to an ever increasing number of pesticides and pesticide metabolites in conjunction with a host of other environmental pollutants necessitates studies, which mimic as closely as possible the human situation, to assess the hazards of this exposure to human health.

The metabolic and biological effects of chronic low-level exposure of nonhuman primates to these environmental contaminants will provide data, which will allow a more sound scientific basis for extrapolation of controlled laboratory findings to the human situation than is possible using other mammals. Information from the proposed work will be of significant value in making regulatory decisions concerning maximum permissible exposure of humans to individual pesticides, combinations of pesticides, and pesticides in combination with drugs and other environmental contaminants.

There is currently an acute need by the regulatory function of the office of pesticides for an animal study response capability. The capability of obtaining immediate toxicological answers for the decision-making process of registration and regulation would expedite the responsiveness of the agency. At present such response would completely disrupt the research activities of affected staff. The successful promotion of such an activity includes three factors: (1) technical competence and scientific maturity, (2) personnel to technically carry out the program and, (3) facilities. The PPL offers the most easily developed combination of these factors.

II. Objectives:

The ultimate objective of this research is to provide data necessary for the intelligent assessment of the hazard to human health of exposure to single pesticides, combinations of pesticides and pesticides in combination with other environmental factors. The studies will be concerned with the identification of pesticide metabolites and the effects of the parent pesticides and their metabolites on normal biological functions. The antagonistic or synergistic effects of combinations of pesticides, other environmental pollutants, common drugs and various stresses will also be investigated.

FISCAL YEAR 1972*

(a) Investigate the effects on liver microsomal enzymes, fat storage and metabolite excretion patterns of selected pesticides when fed singly and in combination with other environmental contaminants.

(b) To study interactions between nutritional status and toxic stress on various detoxification systems in mammals.

(c) Conduct experiments to detect and characterize pesticide-induced changes in normal cellular metabolism, energy production, permeability and other functions which could have adverse effects on human health.

(d) Investigation of the metabolic fate of pesticides in primates and other mammals and identification of metabolites. This work will be important when correlated with the results from Community Studies as an index of pesticide exposure in the general population.

(e) A group will be created, whose primary responsibility is to support the needs of the registration, regulation, and review activities of the Office of Pesticides. This group will (1) provide acute toxicity studies in rats, mice, rabbits, hamsters, guinea pigs, dogs, and primates, (2) be responsible for providing an effective interface between the long term research progress and • See results section for specific compounds to be studied.