FIRST ANNUAL REPORT TO CONGRESS
BY
THE TASK FORCE ON
ENVIRONMENTAL CANCER AND HEART AND LUNG DISEASE
ENVIRONMENTAL POLLUTION
AND
CANCER AND HEART AND LUNG DISEASE
Washington, D.C.
August 7,1978
U.S. Environmental Protection Agency
National Cancer Institute
National Heart, Lung and Blood Institute
National Institute for Occupational Safety & Health
National Institute of Environmental Health Sciences
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FIRST ANNUAL REPORT TO CONGRESS
BY
THE TASK FORCE ON
ENVIRONMENTAL CANCER AND HEART AND LUNG DISEASE
ENVIRONMENTAL POLLUTION
AND
CANCER AND HEART AND LUNG DISEASE
Washington, D.C.
August 7,1978
U.S. Environmental Protection Agency
National Cancer Institute
National Heart, Lung and Blood Institute
National Institute for Occupational Safety & Health
National Institute of Environmental Health Sciences
Cooiea of this document m»y be obtained froa the Technical Intonation Office (R&-674). IJ.S. Envlronaental Protection Agency,
v Washington, D.C. 20460
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
AUG 1 0 1978
THE ADMINISTRATOR
President of the Senate
Speaker of the House of Representatives
Dear Sirs:
In accordance with Section 402 of Public Law 95-95,
The Clean Air Act Amendments of 1977, and on behalf of
the participating agencies, as Chairman I herewith submit
the first annual report of the Task Force on Environmental
Cancer and Heart and Lung Disease. The Report identifies
the problem of environmental pollution and its relationship
to these disease categories, the current efforts of
Federal agencies to characterize and deal with this problem,
and areas of research in which early interagency cooperation
can be expected to contribute to the resolution of the
problem.
The Task Force agencies-Environmental Protection
Agency, National Cancer Institute, National Heart, Lung,
and Blood Institute, National Institute for Occupational
Safety and Health, and National Institute for Environmental
Health Scienceshave coordinated their efforts to produce
the information contained in this report. The member
agencies assure me of their continuing support, and we
expect the work and products of the Task Force to grow
during the coming year.
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PREFACE
On August 7, 1977, in Section 402 of Public Law 95-95, the Clean
Air Act Amendments of 1977, Congress directed the establishment of a Task
Force on Environmental Cancer and Heart and Lung Disease, to include repre-
sentatives of the following agencies:
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.
The potential for addition of other agencies* concerned with prob-
lems of environmental cancer, heart and lung disease was implicit in the
legislation. The Task Force was directed to:
1. recommend a comprehensive research program to determine and
quantify the relationship between environmental 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 appro-
priate to prevent or reduce the incidence of environmentally
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 environmentally 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.
The First Annual Report of the Task Force is presented in pages which
follow. Chapter 1 of this report is an overview of the problem of environmen-
tally related cancer, heart and lung disease. The scope of the Task Force's
efforts is also described in Chapter 1. Chapter 2 summarizes current Federal
programs which address the problem. Chapter 3 describes Task Force objectives,
actions and plans. Appendices include information on Task Force organization,
on member agencies, and on other agencies and interagency groups with associ-
ated interests.
* At the first meeting of the Task Force it was decided to offer observer status, as a. prelude to possible full
membership at the request of Congress, to the National Center for Health Statistics and the Center for
Disease Control at Atlanta. Those agencies accepted.
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TABLE OF CONTENTS
EXECUTIVE SUMMARY
Page
vi i
Chapter 1 - THE PROBLEM
Introduction
Environment and Disease
A Chemical Era
Governmental and Public Awareness of the Problem
Evidence for an Environmental Cause of Cancer, Heart
and Lung Disease
The Costs of Environmental Disease
Summary
1
1
1
4
6
8
13
15
Chapter 2 - CURRENT FEDERAL ACTION
Introduction
Overview of Current Task Force Agency Programs
Overview of Observer Agency Programs
Funding of Current Federal Programs
17
17
18
36
39
Chapter 3 - THE TASK FORCE PROGRAM
Scope
Areas for Task Force Action
Next Steps
53
53
57
62
Appendices
A TASK FORCE ORGANIZATION
B TASK FORCE AGENCIES RESPONSIBILITIES AND LEGISLATIVE
BACKGROUND
C NON-TASK FORCE AGENCIES AND COMMITTEES WITH ASSOCIATED
INTERESTS IN TASK FORCE EFFORTS
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EXECUTIVE SUMMARY
This is the First Annual Report to Congress of the Task Force on
Environmental Cancer and Heart and Lung Disease, as required by Section 402
of Public Law 95-95.
Cancer;, heart and lung disease are dominant factors in our Nation's
health. Their contribution to total annual deaths in the United States has
increased from 12 percent in 1900 to nearly 60 percent in 1976. This is
due in large part to medical advances in controlling death from infection
and accident. But there is also evidence of links between the environment
and these three diseases.
The,problem facing the Nation today in regard to environmental
cancer, heart and lung disease can be summarized as follows:
/
9 There is evidence that risk and occurrence of cancer,
heart and lung disease increase with environmental
pollution, broadly defined to include all environ-
mental factors.
« The extent of illness, death, and costs to society
from environmentally related cancer, heart and lung
disease is a matter of national concern.
9 There is expectation that levels of illness, death,
and cost resulting from these environmentally related
diseases could be substantially reduced by preventive
measures.
Current preventive measures are believed to be
inadequate to obtain desired reductions of risk
and occurrence.
« Increased knowledge of pollution-disease relations
and improvements in strategies and preventive mea-
sures are needed for reduction of risk and
occurrence.
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The Federal Government has a central, critical role
to take in research and prevention of environmentally
related diseases; changes in current Federal efforts
may be necessary if desired reductions of risk and
occurrence of environmentally related cancer, heart
and lung disease are to be obtained.
The problem of environmentally related cancer, heart and lung disease
is very complex. The responsibilities assigned by Congress to the Task Force
are comprehensive. In order that the problem could be analyzed and acted
upon in sufficient depth, the Task Force limited its scope of activities for
this first year in two ways. First, only one etiological factor chemical
pollutants present in the ambient and workplace environment was considered.
Other factors such as smoking, nutrition, radiation, etc., were deferred for
future years. Secondly, with reference to the charges given by Congress, only
interagency coordination and research programs to determine and quantify rela-
tionships between pollution and diseases were addressed in this first year.
Questions of strategies to reduce risk and of measures to reduce incidence of
disease will be examined in the coming year.
Information on existing programs relevant to the Task Force's respon-
sibilities, and consistent with the above scope, was collected and is presented
in this report. The categories for information classification were designed so
that these would cover major aspects of the problem of environmentally related
cancer, heart and lung diseases and their control. The amounts of funding for
various programs in the five agencies were categorized in a common format. Total
expenditures by the agencies for research into relations between cancer, heart
and lung disease and chemical pollution were approximately 207 million dollars
in FY 1977. In order to see a short-term trend in the efforts, information
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on actual and planned funding for FY 1977, 1978, and 1979 was displayed.
Projected expenditures characteristically show small increases over each
previous year.
The Task Force considered possible approaches for evaluating the
effectiveness of various sectors of the overall Federal effort to resolve
problems of environmentally related cancer, heart and lung disease. It was
evident that much work must be done by the Task Force and others before
such evaluations are possible. The Task Force has identified six important
areas of research in which early interagency cooperation can be expected to
contribute substantially to the resolution of environmentally related cancer,
heart and lung disease problems. These areas, listed in no specific order
of priority, will receive special Task Force emphasis in the coming months:
o Standardization of Measurements and Tests
Exposure and Metabolic Mechanisms for Pollutants
Early Indicators of Disease
Risk Assessment
Education of the Public and Health Professionals
Strategies to Protect Public Health.
The Task Force will also consider the establishment of an interagency
information management system on environmentally related cancer, heart and lung
disease maximally utilizing existing agency information systems. From analysis
of these and other significant problem areas, and from evaluation of priorities
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and resource allocations, the Task Force will recommend to Congress -- in
interim reports and in its second annual report specific new initiatives
intended to reduce environmentally related cancer, heart and lung disease.
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Chapter 1
THE PROBLEM
INTRODUCTION
The environment we have created may now be a major cause of death
in the United States. Cancer, heart and lung disease, accounting for 12 per-
cent of deaths in 1900 and 38 percent in 1940, were the cause of 59 percent
of all deaths in 1976. Patterns of illness and death have changed over the
years. Medical advances have reduced the impact of infection and accident,
and life expectancy has increased. After other causes of illness and death
have been brought under control, cancer, heart and lung disease have emerged
as dominant factors in the public health. Growing evidence links much of the
occurrence of these diseases to the nature of the environment. National
levels of illness might be sharply reduced, and life prolonged, if we could
better manage our relations with the environment. This is the problem which
Congress has asked the Task Force on Environmental Cancer and Heart and Lung
Disease to address.
ENVIRONMENT AND DISEASE
What is the "environment" that we must manage to achieve this
improvement in life? It is the ambient air around us, the food we eat, the
water we drink, the streets and roads and land we build on. During our life-
times the environment reacts with us and upon us influencing our psychology,
our physiology and even our genes. Each factor acts independently or in con-
cert, directly or indirectly.
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Cancer, heart and lung diseases, like all other conditions, have
multiple causes. Genes and all aspects of the environment interact to pro-
duce the individual. Some of the etiological factors for cancer, heart and
lung disease include chemicals in the environment, radiation, infectious
agents, drugs, smoking, nutritional deficiency and other factors related to
diet. There is as yet no scientific consensus on the numerical contributions
of many of these factors to the disease process in the population as a whole.
The recommendation of research programs to improve quantitative information
on the role of environmental factors in the occurrence of cancer, heart and
lung disease is one of the major charges given to the Task Force by Congress.
The Task Force has not addressed the full range of environmental
factors in its first year of activity. In order to provide a field of action
v/hich could be analyzed and acted upon in sufficient depth in a short period
of tine, the Task Force has centered its initial efforts on one class of
causative factors, chemical pollution. A definition of this appears below.
In subsequent years, the Task Force will broaden its scope of action so that
other aspects of environmentally related cancer, heart and lung diseases may
be covered.
Environmental chemical pollution refers to compounds which impact
upon the human body through their occurrence in air, water, soil, or other
media. This definition implies the possibility of preventing adverse health
effects of pollutant exposure by measures v/hich eliminate the pollutant from
the environment or reduce its impact. Specifically for this year's report,
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the following categories are included in the definition of environmental
chemical pollution:
Airborne gases and particulates
Toxic substances in water supplies and in contact
surfaces such as clothing, foliage, and paint.
Pesticides and herbicides
Chemical contaminants in food
Occupational exposures to hazardous substances
Passive smoking (i.e., in exposure of nonsmokers to
smoking of others).
The following categories are excluded:
Aspects of normal nutrition and diet, including food
additives
Drugs in medicinal or customary nonmedicinal use
(e.g., hormones, alcohol)
t Active smoking
Ionizing and nonionizing radiation
Noise
Biological agents (e.g., viruses)
t Psychological stress
Heat and cold.
This definition is consistent with the types of public health pro-
tective strategies which the presently constituted Task Force might implement
through EPA's regulatory initiatives, but it is not necessarily consonant with
the broader view of environmental pollution taken by others. It should be
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again emphasized that the present definition should be regarded as provisional,
establishing a field of action for the Task Force at this time but not neces-
sarily limiting Task Force action at some future period.
A CHEMICAL ERA
Between 30 and 40 years ago this country entered a new chemical era
in which the uses of new chemicals in industrial processes, fuels, fabrics,
building materials, fertilizers, pesticides, food additives, drugs, and many
other aspects of life began to increase at rates greatly exceeding those
of previous years. This is dramatically shown for synthetic organic chemical
production (Figure 1). This coincided with a rapid expansion of our use of
fuels for electricity generation and for motor vehicles to produce a chemical
environment new in human history.
Industry has been able to create and distribute new chemical sub-
stances at a rate far faster than the one at which the medical and scientific
communities, with all available Federal support, have been able to determine
the possible adverse health effects of these chemicals. It is estimated that
approximately 2,000 new chemicals enter our environment to a significant
degree each year. Present chronic assay methods require three years or more
and substantial costs to test one chemical. The adverse effects and persis-
tence of some chemicals have been discovered only after they have been in
wide use for a number of years. Unfortunately, this experience will probably
be repeated, but action is being taken to minimize such occurrences through
a wide range of governmental activities, including research, regulation, and
education.
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GOVERNMENTAL AND PUBLIC AWARENESS OF THE PROBLEM OF ENVIRONMENTAL DISEASE
Recognition of the problem of environmentally related disease has
grown only in a slow and piecemeal fashion. The initial effort was directed
toward pollutants which had clearly evident adverse effects and then toward
pollutants potentially damaging and relatively simple to measure in air, water
and other media. Pollutants with clearly demonstrable health effects, such as
carbon monoxide which competes with oxygen in the blood and thus lessens the
amount of oxygen which is available for the human system, were examined and
regulated.- Thus, emissions and air quality standards for carbon monoxide exist.
Other pollutants sulfur dioxide, particulates, oxidants, and potential con-
taminants of our water supplies were treated in a similar fashion. Table 1
suggests the substantial regulatory effort which has grown with our knowledge of
the presence and effects of environmental pollution.
The increasing number of scientific and news reports on potentially
adverse effects of various aspects of our new levels of technology indicates
a growing government and public awareness of the hazards of environmentally
related chronic disease: news reports of asbestos as an occupational hazard,
threats from PCB'-s and Kepone, and suspected links between cancer rates and
chemical industry locations are examples. The public has learned, with grow-
ing concern, of the direct involvement of the American worker with toxic
effects .in the workplace environment. Reviews are being undertaken of past
environmental hazards to which our industrial workers and Armed Forces per-
sonnel have been subjected.
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Table 1. Federal Regulation of Levels of Environmental Pollutants
Ambient Air Quality Standards
- Particulates - Lead (proposed) - Hydrocarbons
- Sulfur dioxide - Nitrogen dioxide
- Carbon monoxide - Photochemical oxidants
Air Emission Standards:
»
- Acid mist - Nitrogen dioxide - Sulfur dioxide
- Carbon monoxide - Particulates - Total reduced sulfur
- Fluorides - Beryllium - Mercury
- Hydrocarbons - Vinyl chloride - Asbestos
Toxic Substances Control:
Several substances have been recommended to EPA by the TSCA Interagency
Testing Committee for further testing.
Occupational Standards:
- Permissible exposure limits for approximately 400 toxic and hazardous
substances
- Occupational Safety and Health Standards for 20 designated carcinogens
Drinking Water Standards:
- Arsenic - Cyanide - Nitrate
- Barium - Fluoride - Selected pesticides
- Cadmium - Lead - Selenium
- Chromium - Mercury - Silver
Others - Regulatory actions to limit environmental damage froi?.:
- Effects of food additives - Pesticides - Solid waste
- Radioactive materials - Noise - Effects of smoking
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THE EVIDENCE FOR AN ENVIRONMENTAL CAUSE OF CANCER, HEART AND LUNG DISEASE.
Much work has been done in research into cause, prevention, and
therapy of cancer, heart and lung disease. The broad environmental context
has not yet been fully assessed, but there is evidence of environmental asso-
ciation. The evidence is diffuse and in many cases inconclusive. Figure 2
displays some known or suspected cause-and-effect relationships. This reflects
a small part of the problem; there are several hundred known or suspected car-
cinogens and other toxic substances which are not included in the list. Avail-
able evidence demonstrates that the total problem is a complex of pollutants,
exposures, susceptibilities, and effects. When these are coupled with pro-
longed latency periods up to 40 years for cancer it is obvious that
special steps must be taken to determine the extent of the problem.
Some of the specific evidence relating cancer, heart and lung disease
to environmental factors is presented in the pages which follow.
Cancer and the Environment
The two leading causes of death in the United States are heart disease
and cancer. While there is evidence to indicate that many cancer rates have sta-
bilized or decreased, cancer incidence for some specific body sites has increased
since 1SOO at a rate much higher than can be accounted for by population growth
and aging of the population. Lung cancer rates have risen exponentially over
the past 30 years. Much of this increase has been attributed to smoking but
it is postulated that a part of the increase can be attributed to environmental
factors other than snoking. Approximately 20 percent of the American people
die of cancer. In 1972, 610,000 new cases were diagnosed and 1,000,000 people
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Pollutant
Disease
Aldehydes
Aldrin/Dieldrin
Arsenic
Asbestos
Benzene
Benzidine
Benzo-a-Pyrene
Beryllium
Cadmium
Calcium Chromate
Carbon Monoxide
DDT
Lead
Nickel Carbonyl
Oxidants
Oxides of Nitrogen
Particulates
Silica
Sulfates
Sulfur Oxides
Vinyl Chloride
Cancer
Heart
Lung
Figure 2. Known or Suspected Links Between Selected Pollutants and Disease
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were Deing treated. An enormous benefit to human health would be achieved by
controlling carcinogens responsible for even a small fraction of these cases.
Of the upwards of 100,000 known chemicals of potential toxicity,
only approxinately 6,000 have been laboratory tested for carcinogenicity. It
is estimated that 10 to 16 percent of the chemicals so tested provide some
evidence of animal carcinogenicity. To scratch the surface of the complexity
which researchers and regulators are faced with, a few inherent problems in
cancer research are listed below:
Cancer in nan usually has riultifactorial causes.
The long latent period of cancer has troublesome
medical, social and economic implications. Chemicals
may appear to be safe for human exposure after being
used for 10 to 15 years; this gives a false sense of
security.
t Mobility of society poses another problem collec-
tion of data for epidemiology studies is difficult.
Tests on animals are expensive and time consuming,
and extrapolation of animal data to effects in man
is difficult.
Concentrations of single chemicals in the environ-
ment are often low, requiring sensitive methods for
detection and analysis.
t Interactions between a given chemical and the rest
of the environment must be considered.
Once a carcinogen is identified, the mechanism of
carcinogenesis in the body presents another diffi-
cult phase of the problem.
Despite these research difficulties, substantial progress has been made in
recognizing environmental-cancer relationships.
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A link between cancer and exposure to soot was detected as
early as 1775 by Percival Pott in London; he found that chimney sweeps were
subject to cancer of the scrotum. In 1895, an association between cancer
of the bladder and the dye industry was reported. Later studies have firmly
established a cause-and-effect relationship between benzidine, a chemical
used in dye manufacture, and cancer of the bladder.
In 1950, occupational exposure to asbestos and increased lung can-
cer incidence was first noted. Mesothelioma, a rare type of cancer, has sub-
sequently been definitely linked to asbestos. Exposure of the individual has
often occurred in the workplace but cases have also been found in persons
living close to an asbestos-producing facility or in the same household as an
asbestos worker. In the case of vinyl chloride, studies of exposed workers
have revealed that these workers have a significant excess of liver angiosar-
coma and probably other more common cancers of the respiratory system, brain,
and lymphatic system. Studies of human cancer associated with workplace
situations, combined with a large body of work with animals and potential
carcinogenic agents, have demonstrated clear disease-pollutant associations
in many cases. The prestigious International Agency for Research on Cancer
(IARC) has identified by international consensus 26 chemicals or industrial
processes that cause cancer in the human population.
Heart Disease and the Environment
Morbidity and mortality rates for heart diseases have been found to
be higher in areas of high air pollution than in areas of low air pollution. At
present there is no evidence that environmental pollution is the direct cause of
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heart disease but many scientists believe that it may aggravate or compromise
a preexisting cardiovascular condition. Heart disease mortality began a
decline in 1970, but it is not known whether there is a parallel decline in
heart disease morbidity and the relationship of this decline to changing
environmental factors, if any, is as yet unknown.
Unlike lungs and other organs, the heart is not a direct target organ
of hazardous substances. Thus, quite often, knowledge from bioassay studies
of the general cellular toxicity of a substance in itself is not sufficient
to identify that substance as a cardiovascular factor. Furthermore, the lack
of a closely analogous animal model for human coronary heart disease limits the
value of animal toxicological studies. Hence, much of the work in the environ-
mental area has been in the areas of human descriptive epidemiology.
Statistical evidence that carbon monoxide can be responsible for
aggravated heart disease problems has been available since 1938. Although it
is difficult to sort out the independent effects of sulfur dioxide, nitrogen
dioxide, oxidants and other elements of our environment, evidence strongly
suggests an increased appearance of symptoms and acute cardiovascular events
during periods of high air pollution. Epidemiological studies have indicated
a statistical association between soft drinking water and elevated mortality
rates from cardiovascular disease. The relationship of smoking to heart dis-
ease mortality is well documented. Cadmium concentration has been correlated
with death rates from hypertension and arteriosclerotic heart disease in some
studies. There is enough evidence of an environmental impact upon heart dis-
ease to suggest environmental intervention as a preventive medicine measure.
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Lung Disease and the Environment
Respiratory diseases, which include emphysema, chronic bronchitis,
allergic and infectious pneumonitis, and asthma, are now the sixth most prev-
alent cause of death in the U.S. Current evidence shows cigarette smoking to
be the greatest environmental causative factor in most cases of lung disease,
but other environmental pollution may initiate and certainly exacerbate a
variety of respiratory diseases; epidemiological studies done on numerous
areas of the country support this. Studies have suggested that air pollution
alone accounts for between 2 to 4 percent of excess bronchitis rates.
Epidemiological findings suggest that there is a causal relation
between pollutants in the ambient and occupational environment and the fol-
lowing adverse effects on the respiratory system:
An increase in chronic respiratory disease mortality,
particularly during periods of high pollution levels
t Increase in chronic bronchitis morbidity
Reduced expiratory flow in adults
Failure of pulmonary function to improve during
growth in children
Pneumoconiosis.
THE COSTS OF ENVIRONMENTAL DISEASE
A recent estimate, 1972, places an approximate value for the total
annual costs of cancer, heart and lung disease at about 69 billion dollars
annually (Figure 3). These estimates comprise costs of treatment and the value
of lost earnings from illness and early death. If even a relatively small per-
centage of this amount could be saved through reduction of the environmentally
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H
H
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80--
70--
60 --
50-
40--
30--
20- -
10-
68.7
37.4
15.6
15.7
Total
Heart
Cancer
Lung
Figure 3. Estimated Health Care Costs for Heart, Cancer and Lung Diseases, 1972*
* National Center for Health Statistics, Department of Health, Education, and
Welfare, Health -- United States -- 1976-1977. Publication (HRA) 77-1232,
Washington, D.C., 1977.
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related components of these three diseases, the savings to the American public
would be immense. The present cost of these diseases, in medical expense and
taxes, is a burden which is unacceptable and at least partly avoidable.
The cost savings which might result from an effective solution of
environmentally related disease problems must be considered in conjunction
with the other costs, and social and economic dislocations, which must be
incurred if the levels of pollution in our environment are to be reduced.
The costs of eliminating some pollutants, through industrial source controls
or changing of industrial materials usages, may be small- in comparison with
potential benefits in health and health cost savings. The costs of other
environmental changes, with respect to major shifts in transportation patterns
and energy use, for example, may be large. There is a growing realization
within the government and medical and scientific communities that preventive
strategies are as essential as treatment programs in the effort to improve
the public health and to control medical expenditures. The mandate of the
Task Force reflects this realization.
SUMMARY
Against this background of the relationships between environment and
disease, and the impacts upon American society, the problem faced by the Task
Force may be summarized as follows:
0 There is evidence that risk and occurrence of cancer,
heart and lung diseases increase with environmental pollu-
tion, broadly defined to include all environmental factors.
The extent of illness, death, and costs to society from
environmentally related cancer, heart and lung disease is
a matter of national concern.
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There is expectation that levels of illness, death, and
cost resulting from these environmentally associated
diseases could be substantially reduced by preventive
measures.
Current preventive measures are believed to be inadequate
to obtain desired reductions of risk and occurrence.
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
direct research and the prevention of environmentally
related diseases; changes in current Federal efforts
may be necessary if desired reductions of risk and
occurrence of environmentally related cancer, heart
and lung disease are to be obtained.
The Task Force was created to address this problem.
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Chapter 2
CURRENT FEDERAL ACTION
INTRODUCTION
The Federal effort aimed at preventing environmentally related
cancer, heart and lung disease consists of a wide variety of research,
regulatory and prevention programs. The research programs are aimed at
improving the understanding of environmental factors and their relation-
ships with cancer, heart and lung disease. These research activities
provide the basis for the development of control programs designed to
reduce disease occurrence. Additionally, educational programs which are
directed toward reducing public exposure to environmental hazards are
included in the Federal effort. This chapter presents a summary of pro-
grams, conducted by the member and observer agencies* of the Task Force,
which are within the scope of the Task Force's effort for the first year -
namely, relationships of chemical pollution and disease.
Additional information, provided in the appendices, is outlined
below:
t An organizational history of the Task Force (Appendix A)
t Descriptions of the objectives and responsibilities of
the Task Force agencies as they relate to the problem
of environmental pollution and cancer, heart and lung
disease. Summaries of the legislative acts which
authorize the Task Force agencies to conduct research
and establish regulations for environmental pollutants
(Appendix B)
* Member agencies are the Environmental Protection Agency (EPA), National Cancer Institute (NCI), National
Heart, Lung and Blood Institute (NHLBI), National Institute for Occupational Safety and Health (NIOSH), and
National Institute of Environmental Health Sciences (NIEHS). Observer agencies include National Center for
Health Statistics (NCHS) and Center for Disease Control (CDC) at Atlanta
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Descriptions of other Federal agencies and committees
with associated interests in Task Force efforts
(Appendix C).
OVERVIEW OF CURRENT TASK FORCE AGENCY PROGRAMS
The current research performed by Task Force member and observer
agencies which is directed toward discovering and quantifying the relation-
ships between chemical pollutants and cancer, heart and lung disease, and
toward preventing or reducing the incidence of such disease, is described
below.
Environmental Protection Agency
The Environmental Protection Agency consists of the Office of
Research and Development, the Office of Air, Noise, and Radiation, the
Office of Toxic Substances, the Office of Water and Waste Management, and
the Office of Enforcement, in addition to various other administrative
offices. The programs of these offices are described separately below.
Office of Research and Development
The Environmental Protection Agency's research is conducted pri-
marily by the Office of Research and Development (ORD). The main objective
of this research is to determine the health risks to humans associated with
the discharge of pollutants into the environment, so that national land,
air and water quality standards may be established. Those research proj-
ects which investigate directly or indirectly the relationship of various
pollutants to cancer, heart and lung disease are categorized and summarized
below.
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Air Programs
Studies of the relationships of certain pollutants
and respiratory function impairment to provide data
to calculate and revise the primary ambient air
quality standards
lexicological investigations, controlled human exposure
studies, and epidemiological studies which evaluate the
health effects of sulfates, nitrates, oxidants, trace
metals and emissions from mobile sources, including
diesels
Assessment of the relationships of known or suspected
carcinogens, present in the air, to the incidence of
cancer in the general population.
Water Programs
t Epidemiological investigations of the relationships
between cancer rates and local public drinking water
constituents
Assessment of cancer risk from chlorination of water
Epidemiological investigations of the relationships of
inorganic water contaminants to cardiovascular disease
t Rapid screening techniques, toxicological and epidemio-
logical studies to determine the health effects of
drinking water contaminants. These studies provide
data to evaluate present standards and establish
new maximum levels for organic, inorganic and
microbiological contaminants of drinking water
Development of criteria for safe treatment and disposal
of wastewater and sludge.
Pesticides and Other Toxic Substances
t Studies which evaluate the health effects of pesticides
currently in use and other candidate pesticide chemicals
Studies which assess the toxicity, carcinogenicity, and
teratogenicity of metals, inorganic, and organic non-
pesticide pollutants that reach humans through different
exposure routes.
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Energy
Studies of possible carcinogenic, mutagenic, teratogenic
and respiratory effects on humans from existing and
emerging energy technologies, particularly the effects
of unanticipated pollutants related to fossil fuel com-
bustion.
Interdisciplinary
Investigations by the National Center for lexicological
Research, jointly funded by the FDA and the EPA, of the
long-term mutagenic effects of chronic low doses of chemical
toxicants
0 Aggregate epidemiological analyses to determine the benefits
derived froni reducing some contributing factors (such as
diet, lack of medical care, pollutants) to major diseases,
including cancer, heart and lung disease, in major U.S.
urban areas.
Office of Air, Noise, and Radiation
The Office of Air, Noise, and Radiation (OANR) is involved in inves-
tigations which estimate the rate of human exposure to known or suspected car-
cinogens. Two methods of investigation are utilized:
Data derived from direct sampling and analysis of air
conducted by ORD
0 Dispersion modeling for compounds which are not easily
measured directly in the environment.
These efforts are supported by a major research program with the Office of'
Research and Development aimed at risk assessment of atmospheric carcinogens.
Risk assessments are used for initial regulatory prioritization of both indi-
vidual compounds and significant source categories which emit multiple car-
cinogens. OAIIR is developing population data for significant sources which
will provide the basis for estimating risk and predicting incidence.
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Office of Toxic Substances
The Toxic Substances Control Act, which became effective January 1,
1977, gives EPA an important new tool for addressing toxic chemical problems.
The Act is designed to provide better information about the potential hazards
of chemical substances, prevent toxic problems through premarket screening
of new chemicals, and limit the manufacture and use of potentially harmful
chemicals.
The Office of Toxic Substances is engaged in a number of programs
which investigate the relationships between environmental pollutants and
disease. Programs related to cancer include the following:
t Short-term mutagenicity testing
Epidemiological studies to examine possible car-
cinogenicity associated with arsenic, vinyl
chloride, and vinylidine chloride.
Programs related to diseases in general, including cancer, heart and lung
diseases, include the following:
Development of methods (testing schemes, computer
searches for similar molecular structures, etc.)
for identifying agents and effects in both human
health and environmental spheres
Investigation of toxic residues found in human tissue
by means of literature searching and quick turn-around
analysis of chemicals associated with certain exposures
On-call investigations to determine the presence of
pollutants in specified areas.
The Office of Toxic Substances also has under its jurisdiction the
pesticides program. The EPA is directed by statute to strike the proper
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balance between necessary pest control and protection of the public health.
To meet this objective various control programs have been implemented (see
Appendix B).
Other EPA Offices
The two other major EPA divisions, the Office of Water and Waste
Management and the Office of Enforcement, do not conduct research related
to the scope of the Task Force's effort. These offices depend primarily on
EPA's Office of Research and Development for research support.
National Cancer Institute
The National Cancer Institute (NCI) operates a large number of
programs aimed at identifying environmental carcinogens, quantifying the
relationships between these carcinogens and cancer incidence, and preven-
tion of cancer incidence through educational and other programs.
NCI has a major epidemiological effort through its Field Studies
and Statistics Program, directed at identifying potential environmental
factors in populations with unusually high incidence of cancer. These
efforts are supported by extensive cancer surveys, including the Third
National Cancer Survey and the Surveillance, Epidemiology and End Results
(SEER) Program, in addition to mortality and morbidity data provided by
the NCHS and a number of specialized surveys. In addition to conducting
research which utilizes these data, NCI provides baseline data on cancer
incidence and mortality for use by the general research community in
identifying environmental carcinogens. These data are key to measuring
progress in efforts to prevent cancer incidence.
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Major study areas include:
Susceptibility of the fetus and child to environ-
mental agents. The objective has been to increase
the awareness of pediatricians and parents to the
potential hazards of environmental pollutants.
Mapping of cancer mortality across the Nation to
pinpoint areas of high incidence of cancer with
potential environmental causes. This mapping
program is a collaborative effort with the NCHS.
A series of correlation studies linking county
mortality rates with environmental data available
at a county level.
» Studies of the relationships between cancer inci-
dence and occupation. NCI provides funding for a
major NIOSH-managed program aimed at identifying
agents of the work environment responsible for
causing cancer, in addition to its own intramural
research in this area.
* Special field studies which include the surveying
of individuals in communities with high incidence
of cancer to determine environmental or other causal
factors which might explain the observed incidence.
Other programs within the Field Studies and Statistics Program have been
aimed at determining the relationships between reserpine and breast cancer;
fluorides and generalized cancer; chlorination of water supplies and
increased cancer; industrial hazards and cancer; and a number of environ-
mental contaminants, such as asbestos, TRIS, vinyl chloride, and cancer
incidence.
The development of our knowledge on the causative factors of
cancer in man can be projected along the following lines: a) epidem-
iologic studies to correlate specific exposures with incidence of certain
types of cancer in man with particular emphasis on occupational exposures;
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b) additional bioassays in animal models and in vitro systems which will
identify chemicals which are carcinogenic in animals or mutagenic and may
therefore be considered as potential carcinogens in man; c) studies of
animal-human correlations by comparisons of bioassay results with the
results of epidemiologic studies or by bioassays on isolated human tissues
by in vitro techniques; and d) by studies of pharmacological and metabolic
correlations among species.
The Carcinogenesis Research Program of NCI conducts research to:
a) develop better means for the removal of hazardous chemicals from the
environment; b) develop means to enhance the ability of the host to
detoxify environmental agents; c) determine the extent to which animals
act synergistically with viruses or with physical carcinogens; and
d) develop more rapid and more sensitive means to detect and bioassay
the cancer-inducing effects of chemicals for man.
Studies,of the carcinogenesis process include the following activv
ties: a) new emphasis has been given to the study of carcinogen metabolism
and toxicology; b) methods for pharmacologic inhibition of the formation of
carcinogens have been obtained by blocking nitrosation of amines and other
classes of carcinogens (e.g., hydrazines, metals); c) major metabolic steps
in the enzymatic activation of several classes of carcinogens are being
investigated with special emphasis on polynuclear hydrocarbons; d) micro-
methods, applicable to determination in small samples of human cells, have
been developed measuring carcinogen activation levels; e) inhibitors of
carcinogen activation have been identified; and f) the development and use
of high-pressure, liquid chromatography in the study of metabolism of
polynuclear hydrocarbon carcinogens.
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NCI's research in cancer biology includes basic laboratory studies
of the process by which cancer-causing agents interact with cell components
to cause cell transformation. Related studies are concerned with alteration
of the process to prevent cancer.
The office of the Scientific Coordinator for Environmental Cancer
serves as a focal point for development of program interests and collabora-
tive efforts in environmental cancer. Achievements in the identification
and classification of carcinogens in the environment include the following:
a) compilation of reports and publications on mutagens and carcinogens in
drinking water; b) preliminary reports on air pollutants that are classi-
fied as mutagens and carcinogens; c) acceleration of collaborative efforts
with EPA; d) cooperation with trade associations; and e) assistance to
the Carcinogenesis Testing Program and Clearinghouse on Environmental
Carcinogens.
The Carcinogenesis Testing Program conducts studies of chemicals
for their cancer-causing potential. NCI tests approximately 60 new chemicals
per year in animals and other laboratory systems for cancer-causing activity.
It is estimated that about 1,000 chemicals have been found carcinogenic in
animal bioassays out of 6,000 that have been tested.
The Clearinghouse on Environmental Carcinogens was established to
i
advise the Director of NCI on matters concerning the Institute's program to
identify and to evaluate environmental carcinogens to which humans might
be exposed. Members of the Clearinghouse are drawn from major communities
concerned with environmental cause of cancer: academia, industry, organized
labor, public interest groups, and state health officials. The Clearinghouse
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is responsible for providing expert advice on the selection of chemicals for
testing, the experimental designs of the conduct of testing, the evaluation
of the results of testing (see reference to the Chemical Selection Working
Group in Appendix C), as well as advising on other matters.
At the Frederick Cancer Research Center, NCI carries out tests of
the cancer-causing potential of chemicals in laboratory animals. A major
program there is the development of a cell culture technique to test chemi-
cals more quickly and at less expense. Other work there concerns safety
procedures and equipment used in carcinogenesis testing. In 1974, NCI began
to fund a new program of fundamental research at the Center, emphasizing the
role of the immune defense system in the prevention, causation and control of
cancer in animals. The theme of the program is the Immunobiology of Cancer,
featuring major projects on the interactions of an animal with its tumor,
spread of cancer within an animal and viral and chemical factors in causation.
The research concentrates on finding ways to stimulate the body's natural
defenses to fight both established cancers and cancer-causing agents.
Ongoing research in NCI's Division of Cancer Treatment includes
studies on the induction of tumors in primates by antitumor agents and other
materials, as well as therapy of the tumors induced. Other laboratory studies
are concerned with the mechanism of chemically induced hepatomas and ovarian
tumors, and studies on the mutagenicity and carcinogenicity of antitumor
agents and chemical carcinogens. The long-range emphasis is concentrated
on the problem of second tumors arising in patients as a result of therapy.
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As part of its Cancer Control Program, NCI is implementing pro-
grams specifically aimed at reducing environmentally caused cancer. This
includes an occupational cancer information alert program through an inter-
agency agreement with the Occupational Safety and Health Administration.
To facilitate dissemination of preventive cancer information, NCI supports
outreach activities of its Comprehensive Cancer Centers and is establishing
communication networks in the Centers. In addition, the International Cancer
Research Data Bank (ICRDB) was established to collect, analyze and disseminate
all data useful in the prevention, diagnosis, and treatment of cancer for use
by researchers throughout the world.
National Heart, Lung and Blood Institute
The following information briefly describes the focus of two divi-
sions of the National Heart, Lung and Blood Institute (NHLBI) whose efforts
are relevant to the Task Force's responsibilities.
Division of Heart and Vascular Disease
Programs which are aimed at identifying and quantifying the relation'
ships between diseases of the heart and environmental contaminants include:
Epidemiologic studies to identify environmental
factors which predispose persons to increased risk
of diseases of the heart
Investigations of environmental factors, such as
trace metals and the degree of water hardness which
might affect coronary heart disease morbidity and
mortality
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Division of Lung Diseases
There are numerous programs aimed at determining the relationships
between lung diseases and environmental pollutant agents. These are:
Studies to identify and better determine the relative
contribution of environmental risk factors to the
incidence and exacerbation of chronic bronchitis and
emphysema
Studies to determine the role of environmental factors
in increased risk of hyaline membrane disease
t Studies to identify specific agents responsible for
fibrotic lung diseases and hypersensitivity pneumonitis,
and establish dose-to-effect relationships between these
agents and resulting lung reactions
Studies to identify agents within the occupational
environment, which are responsible for fibrotic lung
diseases, and the development of corresponding dose-
response relationships
t Investigation of specific agents responsible for hyper-
sensitivity pneumonitis in working and home environments,
with special emphasis on measures to reduce or eliminate
exposures
t Epidemiologic studies of populations exposed to occupa-
tional hazards to the lung such as asbestos and silica
to elucidate the natural history of fibrotic lung
diseases
Epidemiologic studies of populations exposed to organic
dusts that cause hypersensitivity pneumonitis to eluci-
date the natural history of the disease
Investigations relative to the immunologic and bio-
chemical responses to organic and inorganic dusts that
lead to fibrotic lung diseases and hypersensitivity
pneumonitis
Investigations are underway into the etiology and
pathophysiology of environmentally -- as well as occupa-
tional ly -- induced asthmas, such as those caused by
cotton or coffee bean dust, toluene disocyanate, and
phthallic anhydride.
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The NHLBI has a major emphasis on the prevention of environmentally
caused or aggravated lung disease, including programs aimed at:
» Investigating occupational lung diseases such as
silicosis and farmer's lung, emphasizing epidemiology,
prevention and control in defined populations. Educa-
tional programs have been instituted to alert farmers
to the hazards of inhaling dusts that result in farmer's
lung and to urge them to take preventive steps to keep
from breathing the materials.
Developing measurement techniques to screen asymptomatic
individuals with early interstitial lung diseases. Pre-
liminary studies have shown that the course of such dis-
eases can be altered by removing the slightly impaired
worker from the polluted environment.
Improving prevention and prompt diagnosis of chronic
obstructive lung diseases by developing programs to
increase the responsiveness of health professionals
and the public to the importance of risk factors and
early symptoms.
Promoting the use of pulmonary function tests in routine
examinations of individuals at high risk of respiratory
disease.
National Institute for Occupational Safety and Health
The primary responsibility of the National Institute for Occupational
Safety and Health (NIOSH) is to provide research and standards-setting support
to the Occupational Safety and Health Administration under the Occupational
Safety and Health Act of 1970 and to the Mine Safety and Health Administra-
tion under the 1977 Amendments to the Federal Mine Safety and Health Act.
NIOSH's current programs are divided into four major areas: Cri-
teria Documentation and Standards Development, Research, Technical Assistance
and Manpower Development.
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Criteria Documentation and Standards Development
NIOSH provides recommended health and safety standards in the
form of criteria documents to the Secretary of Labor for promulgation and
enforcement. The order of hazards selected for criteria development is
determined by a NIOSH priority system based on severity of response, popula-
tion at risk, carcinogenicity, availability of an existing standard, and
advice from Federal agencies and involved industry, organized labor and pro-
fessional groups. For a selected hazard, available scientific, medical, and
engineering research information is systematically gathered and collated.
Throughout the preparation of a "criteria document, extensive and broadly
based review procedures are carried out with reviewers selected not only
from labor and industry but also from universities, research organizations,
professional groups, and various Federal and state agencies.
Research
The largest effort within NIOSH, both in terms of dollars and per-
sonnel, is directed at applied occupational health and safety research. Most
of this research addresses the development or modification of criteria for
recommended occupational safety and health standards. Other research is
directed at assessing interactions between chemical and physical agents, at
developing new monitoring techniques and analytical methods, and at methods
of diagnosing and preventing specific occupational diseases. Examples of
NIOSH's research effort related to the Task Force's mandate include:
Surveillance, control technology assessment, and
laboratory research aimed at identification and
prevention of occupational cancer
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Development of sensitive and specific diagnostic
tests for occupational diseases
Identification of dose-response relationships to
assure safe working conditions in industries
Development of personal protective equipment to
reduce exposure to industrial chemicals
Epidemiological and industrial hygiene studies
related to conventional and new energy sources.
Technical Services
NIOSH provides a variety of technical services to employers,
employees, universities and professionals in the field of occupational
safety and health. These include:
Medical examinations and autopsies of coal miners
Testing and certification of personal protective
equipment and hazard measuring devices (gas detector
tubes, noise level meters, etc.)
Technical information services
The development of model occupational safety and
health programs
Health hazard evaluations.
Manpower Development
NIOSH currently offers a series of 26 technical training courses
for representatives from Federal agencies, state and local governments,
private industry and unions. NIOSH also provides training project grants
to educational institutions for specific occupational safety and health
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training programs. Last year, NIOSH initiated the Educational Resource
Center concept. These Centers, funded through training grants, provide
for occupational medicine and associated professional occupational health
and safety training.
National Institute of Environmental Health Sciences
Work of the National Institute of Environmental Health Sciences
(NIEHS) relevant to prevention of environmentally related cancer, heart
and lung disease includes research over a spectrum from identification of
environmental disease agents to studies of health hazards and epidemiology.
There is also an emphasis upon development of environmental health science
resources through extramural grants and an Institute and grant training
program. Research supported by NIEHS can be divided into three primary
program areas:
1. Prediction, Detection and Assessment of Environmentally Caused
Diseases and Disorders. Research here provides scientific bases for devel-
oping methods for forecasting environmental health problems before they occur.
Uork in this program area includes:
Studies aimed at understanding the dynamics of
transport and conversions of pollutants in the
envi ronment
Development of new test methods for detecting
the effects of environmental agents on biological
systems
Development of methods for assessing and predicting
consequences of exposure to environmental agents in
the human population.
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2. Mechanisms of Environmental Diseases and Disorders. NIEHS
research in this program area aims to gain understanding of the biological
and biochemical mechanisms involved in environmentally related diseases.
Once the disease process is understood, steps can be taken to avoid, alter
or possibly correct the adverse biological effects which lead to morbidity
and mortality- Research in this area provides information regarding the
relative susceptibility of individuals who are at higher risk and contributes
r i
to a developing capability to predict long-term chronic effects of environ-
mental contaminants.
3. Environmental Health Research and Manpower Development
Resources. NIEHS support in this program area provides long-term stable
core support for broadly based multidisciplinary research and training
programs focused on a variety of environmental health problems. This sup-
port is provided through Environmental Health Science Centers and Marine
Freshwater Biomedical Centers. These centers serve as national focal points
and resources for research and manpower development in health problems
related to air, water and food pollution; occupational and industrial neigh-
borhood health and safety; heavy metal toxicity; agricultural chemical
hazards; the relationships of the environment to cancer, birth defects,
behavioral anomalies, respiratory and cardiovascular diseases, and diseases
of other specific organs; and basic aspects of toxicity mechanisms, body
defense mechanisms, and the influence of age, nutrition, and other factors
in chemically induced injury and disease.
In the three principal disease areas of interest, the NIEHS
programs may be summarized briefly as follows.
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Cancer
Extramural research supported by NIEHS extends from studies of
biological effects of known and suspected carcinogens, and mutagenicity-
carcinogenicity correlations, to epidemiological surveys to assess insult
from environmental exposures. Relevant intramural research includes studies
in five NIEHS laboratories and several NIEHS branches which are concerned
with such areas as:
a Microbial test systems for detection of chemical
mutagens
Environmental factors adversely affecting
reproduction and development including effects
such as carcinogenesis in offspring exposed to
chemicals in utero
Chemical metabolism in the mediation of carcino-
genesis
Metabolism of pollutants by marine species,
including identification of food sources of
carcinogens
t Animal studies of hormonal activity of chemi-
cally induced pulmonary neoplasms
Mechanisms of respiratory tract cancer inhib-
ited or accelerated by endogenous and exogenous
factors
Human population risk assessment
Methodology development and field studies in
neoplastic disease epidemiology
Animal studies on the carcinogenicity of
orally administered asbestos.
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Cardiovascular Diseases
NIEHS supports an extramural program in which grantees study
environmental aspects of cardiovascular diseases, ranging from impacts of
pollutant exposures on erythrocyte function to the possible role of envir-
onmental mutagenesis in the pathogenesis of arteriosclerosis. Population
studies are exploring the association between incidence and severity of
cardiovascular sequelae to acute and chronic exposures to high and low lev-
els of environmental agents alone and in multiple combinations. There is
also intramural work in hazard assessment for environmentally related
cardiovascular disease, as well as a research program in inhalation toxi-
cology which examines interactions of the cardiovascular and pulmonary sys-
tems resulting from inhalation of gases, particulates and fibers.
Lung Diseases
The extramural research program explores the environmental charac-
teristics of airborne pollutants, their transformations, their potentiative
interactions and their impacts on biological systems. The range of studies is
broad, from mechanisms of action at cellular and molecular levels to epidemio-
logical and biometric studies of human populations exposed to environmental
stresses. The intramural program includes: a) studies of mechanisms of
toxication and detoxication of chemicals such as polycyclic hydrocarbons in
lung and lung cells in order to further understand why the lung is often more
sensitive to chemical toxicity than other organs, and b) the animal studies
of the NIEHS Laboratory of Pulmonary Function and Toxicology addressed to pre-
vention of environmentally related respiratory diseases. The latter includes
research into prostaglandins in relation to inhaled gases, the relations
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between inhaled toxicants and the acellular lining of lung terminal airways,
hormonal activity of neoplastic pulmonary tissue and mechanisms of respira-
tory tract cancer.
Many NIEHS studies are relevant to the environmental aspects of
several diseases, for example, inhalation toxicology studies of interactions
among cardiovascular-pulmonary systems, kidneys and the liver. Also of this
character is work of the NIEHS Office of Health Hazard Assessment concerned
with technology and surveillance to identify unsuspected environmental chemi-
cal hazards to all aspects of human health, as well as NIEHS intramural work
in environmental biophysics and developmental toxicology which provide tech-
nical methods useful for the study of many environmental diseases.
Research Training
NIEHS extramural programs support research training (university-
based) programs that produce most of the doctoral level toxicologists.
Retraining programs are suppported.
NIEHS also publishes Environmental Health Perspectives. This
widely distributed journal provides rapid dissemination of information on
new or newly recognized environmental hazards.
OVERVIEW OF OBSERVER AGENCY PROGRAMS
National Center for Health Statistics
The National Center for Health Statistics (NCHS), through its
many data systems, routinely produces data on disease incidence, including
cancer, heart and lung disease. These valuable data systems frequently
provide the basis for research carried out by other Federal agencies, and
are aimed at determining and quantifying the relationships between cancer,
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heart and lung disease and environmental pollutant agents. Of particular
importance to environmental research are:
The Basic Vital Statistics (including the Current
Mortality Sample)
The Health Interview Survey
The Health and Nutrition Examination Survey
t The Hospital Discharge Survey.
These and other data systems of NCHS provide a national view of disease
incidence and mortality, permitting the isolation of populations with
special disease problems, potentially environmentally related. The con-
tinuing nature of the data collection effort permits monitoring of the
effectiveness of preventive programs in reducing disease incidence.
The MCHS has assisted NCI in the production of cancer atlases.
These atlases have been key to NCI's effort to pinpoint counties which
represent cancer hot spots requiring further epidemiological investiga-
tion to identify possible environmental causes of the disease incidence.
NCHS is now producing an atlas which will include all major diseases
including cancer, heart and lung disease. NCHS hopes to develop more
systematic monitoring of mortality and morbidity, by cause, to more
quickly identify unusual time and space patterns for disease which may
merit field investigations.
NCHS is currently working with EPA, through an interagency agree-
ment, examining methods to relate NCHS's disease-oriented data systems to
environmental systems of EPA. While most past effort of this type has
been limited in scope, carried out for a particular study, this effort is
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aimed at a general marriage of NCHS and EPA data systems to better deter-
mine the relationships between disease incidence and environmental pol-
lutant agents. NCHS estimates its total commitment to environmental
aspects of disease incidence, including surveillance, to be $3.7 million
for fiscal 1978.
Center for Disease Control at Atlanta
The Center for Disease Control (CDC), through the National Insti-
tute for Occupational Safety and Health (NIOSH) is engaged in major efforts
toward the understanding and prevention of environmentally related cancer,
heart and lung disease in occupational contexts; this work is summarized
elsewhere in this report under a separate heading for NIOSH.
CDC at its Atlanta headquarters is also concerned with the occur-
rence of chronic diseases in the general population and, through several of
its branches other than NIOSH, conducts research and preventive activities
relevant to the concerns of the Task Force on Environmental Cancer and Heart
and Lung Disease.
The Cancer Branch of CDC's Chronic Diseases Division supports
epidemiological studies of environmental causes of cancer. Some of this
work has been in general population surveillance in cooperation with NCI.
Other studies deal with such subjects as vinyl chloride, thorotrast and
arsenic as etiologic agents for angiosarcoma; vinyl chloride and lung can-
cer; and followup of cancer development in persons exposed to radiation
from the nuclear test Smokey.
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The Special Studies Branch of the Chronic Diseases Division conducts
studies of environmental hazards through epidemic investigations. Many of
these studies involve populations exposed to lead and result in information on
blood lead leavels in relation to environmental exposures. Continuing inter-
agency long-term studies of polybrominated biphenyls (PBB), in collaboration
with the Michigan Department of Public Health and NCI, NIEHS, and FDA, are
providing extensive information on possible dose-response relations between
symptomatology and serum PBB levels; the concern is that some of the exposed
persons may develop cancer. In other work the Special Studies Branch studies
human exposure to potentially carcinogenic pesticides, health hazards of
various heavy metals, and provides surveillance on environmental exposure
which may be related to cancer, heart and lung disease, among other diseases.
An evaluation of lung cancer incidence in U.S. counties containing smelters
is among planned CDC research programs.
The major environmental concern of CDC programs with respect to
Task Force concerns -- is with population studies of cancer (and of suspected
carcinogens such as PBB's) and with heavy metals which may be implicated in
cancer.
FUNDING OF CURRENT FEDERAL PROGRAMS
Categorization Scheme
Information on funding of programs relevant to the Task Force's
f
responsiblities was collected from the five member agencies. In order to have
a common basis for collecting and organizing information, a categorization
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scheme which covers the entire spectrum of relevant programs was con-
structed. This scheme, shown in Table 2, represents the initial base from
which a more complete structure can be built as the Task Force activities
continue in the future years.
The categorization scheme provides a common format for classifi-
cation of programs related to understanding and control of environmentally
caused cancer, heart and lung diseases. For each agency relevant projects
were classified into 15 categories shown in Table 2 for each disease and for
each media or pathway combination. In many cases where a project could be
included in more than one category, it was included under the category of
major emphasis. A project which could be applicable to more than one disease,
such as cancer, heart and lung disease, or might not be specific to any of
the three, was included under the disease category called "nonspecific."
Some of the terms and phrases given in Table 2 are defined below:
Media/pathway refers to the manner in which the environmental
insult reaches the host population. The preliminary designations used in
categorization are: air (inhalation), water (ingestion), oral intake, skin
contact, and occupational exposure. Occupational exposure may involve
other media/pathways but has been considered separately because of its spe-
cial nature.
Determination of Biological Effects includes studies which identify
the range and nature of biological effects associated with pollutants. Studies
of this type are often laboratory based, using test animals.
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TABLE 2
CATEGORIZATION FOR FEDERAL FUNDING OF PROGRAMS DIRECTED TOWARD
DETERMINATION AND QUANTIFICATION OF RELATIONSHIPS AND
REDUCTION OF RISK AND INCIDENCE OF
ENVIRONMENTAL CANCER AND HEART AND LUNG DISEASE
A gency
Disease
Media/Pathway
Determination and Quantification of Relationships
Determination of Biological Effects
Understanding Mechanism or Mode of Biological Effects
Development of Dose-Response Relationships
Identification of Environmental Pollutant Agents
Identification and Analysis of Sources
Environmental Transport and Transformation Analysis
Sampling, Analytic Methods and Monitoring
Human Exposure Estimation
Establishing Cause-and-Effect Association
Population Risk Assessment
Costs of Environmentally Related Illness
Reduction of Risk and Incidence
Preventive Health
Education of Public and Health Professionals
Surveillance
Source- Control Measures
Total Funding by A gency
Funds by Category
FY 1977
FY 1978
FY 1979
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Understanding Mechanism or Mode of Biological Effects focuses on
the mechanisms of environmental causes of disease and is often a sequel to
the previous category. Programs which evaluate the mode and extent of entry
into the human body, body pathways, toxin end points, and residence time in
the body are included in this category, as are studies of cellular or sub-
cellular interaction with pollutants.
Development of Dose-Response Relationships is concerned with quantita-
tive characterization of the relationship between varying dosages of a physical
agent and their effects in humans and animals. This is a key to establishing
standards for permissible levels of pollutants in air, water, food and other
media. These studies are laboratory or epidemiological in nature.
Identification of Environmental Pollutant Agents includes the
screening of chemicals for a preliminary assessment of toxic effects. The
objective is the identification of agents which require further research
because of potentially harmful health effects. The Ames test is an example
of this category.
Identification and Analysis of Sources concerns identification and
quantification of sources of environmental pollutants, both for evaluation of
health impact and for regulation. These studies are either pollutant-specific
or source-specific. The former includes the study of a particular pollutant
discharged by different sources and the latter addresses the type, amount,
and manner of release of contaminants from a single type of source.
Environmental Transport and Transformation studies predict environ-
mental concentrations of a pollutant based on the understanding of transport
processes and physical or chemical changes that occur during such transport.
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Primary tools are analytical or physical models of environmental transport
and transformation. Included in this category are studies which attribute
concentrations of pollutants in the environment to sources.
Sampling, Analytic Methods and Monitoring studies are aimed at
developing better environmental sampling techniques and equipment, including
improvements in laboratory analysis methods.
Human Exposure Estimation involves studies which estimate the
level of exposure of individuals to pollution through various pathways over
a defined period of time. Precise estimation of human exposures requires
extensive monitoring of ambient, residential, and occupational environments.
Establishment of Cause-and-Effect Association corresponds roughly
to 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.
Population Risk Assessment studies are aimed at estimation of
risk to the population in terms of excess morbidity or mortality due to
a particular pollutant or type of source. These studies assist in the
establishment of priorities for research and for regulation of environmental
pollutants. Risk assessment requires integration of results of studies on
human exposure and cause-effect association. Information on dose-response
relationships, if available, forms an important input to risk assessment.
Cost of Environmentally Related Illness includes studies which
evaluate direct and indirect economic impact of environmental pollution.
An example of a study in this category is an evaluation of human morbidity
costs attributable to air pollution.
-43-
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Preventive Health includes a range of programs aimed at avoidance
or minimization of harmful effects of pollutant agent exposure. Programs
which are specifically directed toward source-control, education, and surveil
lance are excluded. An example of preventive health is the screening of
workers with potential cardiovascular problems from a marginally hazardous
work environment.
Education of the Public and of Health Professionals consists of
programs directed toward improving the capability of the medical profes-
sional in recognizing and treating environmental disease, efforts to
educate the general public about environmental hazards as a means of pre-
vention of environmentally caused illness, and programs to educate the
public in environmental disease awareness. Grant programs to health pro-
fessional training institutions appear in this category.
Surveillance includes a range of programs aimed at the surveil-
lance of populations to provide early indication of an environmental' disease
problem. Programs of this type typically involve the routine collection of
medical data to provide baseline information and subsequent assessment of the
biological impact of pollutants found in the environment. An ancillary but
important function of surveillance programs is the accumulation of data for
analysis in other program categories.
Source Control Measures include efforts which establish or evalu-
ate measures of control. The most important measure is the setting of legal
standards to limit the permissible emissions or environmental concentrations
of agents. This category includes programs directed at improving control
devices or processes to reduce pollutants released into the environment.
-44-
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Categorized Funding
Tables 3 through 7 present summaries of each agency's funding which
is directed toward the concerns of the Task Force. The funding is presented
for each of the agencies, EPA, NCI, NHLBI, NIOSH and NIEHS, for each of the
diseases of concern (and for a general "nonspecific" category) by fiscal year
and as broken down in 15 categories. Data are available on funding by
media/pathway but are not included in this report.
The funding tables reveal the following general findings:
EPA's programs are directed toward understanding
the relationship between disease and pollutants in
the ambient environment as well as toward the reduc-
tion of disease incidence. Much effort is devoted
to the identification of sources, the development
methods to control sources, and the development of
pollutant sampling and analytic methods. Since many
pollutants relate to more than one disease, a large
portion of EPA's effort is not disease-specific.
There are, however, major research activities
specific to cancer and lung and heart disease.
NCI has major program activity directed toward identi-
fying, understanding, and quantifying the relation-
ship between cancer and environmental pollutants.
NCI also has major programs in cancer prevention
and in the creation and management of data bases
consisting of information on cancer incidence and
mortality across the Nation.
Within the NHLBI, most efforts are aimed at identify-
ing and quantifying the relationships between environ-
mental pollutants and heart and lung disease. Most of
this effort has been directed toward lung disease.
As in the case of EPA, efforts within NIOSH are not
generally disease-specific--that is, efforts tend to
relate to all diseases of concern. NIOSH efforts tend
to be prevention-oriented; the majority of NIOSH fund-
ing is included under preventive health. Substantial
resources are devoted to education of health profes-
sionals and worker population. Another major category
-45-
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TABLE 3. SUMMARY OF FUNDS (DOLLARS)
ENVIRONMENTAL PROTECTION AGENCY
Cancer
Heart
Lung
Nou Specific
(Includes cancer, heart
1. Determination of Biological Effects $
2. Understanding Mechanism or Mode 1,
of Biological Effects
3. Development of Dose-Response
Relationships
4. Identification of Environmental 1,
Pollutant Agents
5. Identification and Analysis
of Sources
6. Environmental Transport and 1,
_^ Transformation Analysis
| 7. Sampling, Analytic Methods and 1,
Monitoring
H. Human Exposure Estimation
9. Establishing Cause-aud-Effect 1,
Association
10. Population Risk Assessment
11. Costs of Environmentally
Related Illneis
12. Preventive Health
13. Education of the Public and of
Health Professionals
14. Surveillance 2,
15. Source-Control Measures
Total S12,
1977
337,000
450,800
500,000
565, 700
437,000
016,300
602, 600
712,000
353,600
240,000
--
147,600
--
156,000
919,400
438,000
1978*
$ 357, 000
1,500,800
600,000
1,681, 100
476,700
1,O85,8OO
1,743,900
967, 500
1,598,200
265,400
-
156,800
-
2, 767, 000
1,286,800
$14,487,000
1979*
$ 378,400
1, 183,400
600,000
1,898,800
513, OOO
1, 188,800
1,832,200
1,202,200
1,109,700
300,000
--
166, 200
-
3, 003, 000
1,113,400
$14,489, 100
1977 1978* 1979* 1977
$ 670,000 $ 710,200 $ 752,800 $2,837,000
102,200 102,200 42,000 156,000
235,900
..
75,000 125,000 60,000 125,000
125,000 175,000 1OO, OOO 125,000
153,000 162,200 171,900 611,500
50,000 75,000 40,000 200,000
347, 400 368, 200 390, 300 gQ2, 600
50,000
598,900
79,000
$1,522,600 $1,717,800 $1,557,000 $5,820,900
1978* 1979*
$3,007,200 $3,187,600
165,400 175,300
250, 000 265, OUO
-
75, 000 200, 000
100, OOO 300, 000
648, 100 687, 000
184,000 293,500
1,242,300 1,001,800
53, 000 56, 200
1,151,800 806,300
--
-.
83, 700 88, 700
*6, 960, 500 $7,061,400
1977
$1,301,600
187,000
1 85, 000
1,786,000
5, 754, 100
2,551,400
8, 755, 6OO
2, 1 14, 000
602, 000
1,447,900
--
-
26, 700
2,312,000
1 3, 605, 800
$40, 629, 100
1978*
$1,010,800
198,000
196, 100
2,515,900
6, oyy, ooo
2, 7W.500
9,435,900
2,341,800
638,000
1,582,500
--
588, 500
1 32, 300
2, 450, 700
14,422,000
$44,316,000
and Uuig)
1979*
$1,071,400
210, 100
207, 900
1,871,900
6,465,000
2, 806, 700
9, 388, 300
2, 206, 700
676,400
1,639,600
--
-
30,000
2,597,800
15.287,500
$44,519,300
* Estimated
The above table includes pass-through funds assigned to N1OSH: 1977, $1,469,000; 1978, $3,846,900; 1979, $1,977,700.
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TABLE 4. SUMMARY OF FUNDS (DOLLARS)
NATIONAL CANCER INSTITUTE
1.
2.
3.
4.
5.
6.
i. 7-
*>i
8.
9.
10.
11.
12.
13.
H.
IS.
Determination of Biological Effects
Understanding Mechanism or Mode
of Biological Effects
Development of Dose-Response
Relationships
Identification of Environmental
Pollutant Agents
Identification and Analysis
of Sources
Environmental Transport and
Transformation Analysis
Sampling, Analytic Methods and
Monitoring
Human Exposure Estimation
Establishing Cause-and-Effect
Association
Population Risk Assessment
Costs of Environmentally
Related Illness
Preventive Health
Education of the Public and of
Health Professionals
Surveillance
Source-Control Measures
Total
1977
$19,588,948
42,155,092
1,627,684
2, 474, 900
633,200
38,000
67,900
821, 075
6, 079, 105
1, 202, 600
--
2, 080, 700
2,168,700
7, 349, 200
105,000
$86, 392, 104
Cancer
1978
$21,332,500
43, 629, 042
2,372,841
2,817,900
907, 100
52,000
112,800
1,921,478
8,471,094
1,512,900
-
1,615,100
1,885,200
10,311,500
75,600
$97,017,055
Heart Limg Non Specific
(includes cancer, heart and lung)
1979 1977 1978 1979 1977 1978 1979 1977 1978 1979
$22, 143, 900
45,626,199
2, 573, 200
2,673,500
1,002,300
57,500
96, 7OO
1,527,200
8, 737, 200
1,528,200
--
1, 828, 200
1,882,200
10,936, 100
52,800
$100,665,199
The above table Includes NCI pass-through funds assigned to N1OSH: 1977, $2, 989, 200; 1978, $4, 093, SOO; 1979, $4,093, 500.
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TABLES. SUMMARY OF FUNDS (DOLLARS)
NATIONAL HEART, LUNG AND BLOOD INSTITUTE
1977
Cancer
1978
Heart
1979
1977
1977
Lung
1978
1979
Non Specific
(Includes cancer, heart and lung)
1977 1978 1979
oo
I
1. Determination of Biological Effects
2. Understanding Mechanism or Mode
of Biological Effect!
3. Development of Dose-Response
Relationships
4. Identification of Environmental
Pollutant Agents
5. Identification and Analysis
of Sources
6. Environmental Transport and
Transformation Analysis
7. Sampling, Analytic Methods and
Monitoring
8. Human Exposure Estimation
9. Establishing Cause-ajid-Effect
Association
10. Population Risk Assessment
H. Costs of Environmentally
Related Illness
12. Preventive Health
13. Education of the Public and of
Health Professionals
M. Surveillance
15. Source-Control Measures
$ 28,420 $ 28,420 $ 28,420
80,530 80,530 80,530
$ 140,500 $ 156,500 * 174,300
1,336,500 1,488,300 1,657,300
22,500 25,000 27,800
264,200 294,200 327,600
45,000
25,600
853,100
50, 100
28,500
55,800
31,700
950,000 1,057,900
114,300 127,300 141,800
615,600 685,500 763,300
Total
$108,950
$108,950
$108,950
$3,417,300 $3,805,400
$4,237,500
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TABLE 6. SUMMARY OF FUNDS (DOLLARS)
NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
Determination of Biological Effects
Understanding Mechanism of Mode of
Biological Effects
Development of Dose-Response Relationships
Identification of Environmental Pollutant A geiiti
Identification and Analysts of Sources
Environmental Transport and Transformation
Analysis
Sainpling> Analytic Methods and Monitoring
Human Exposure Estimation
Establishing Cause-and-Jiffect Association
Populatlon-at-RIsk Assessment
Costs of Environmentally-Related Illness
Preventive Itealrh
Education of Public and of Health Professionals
Surveillance
Source-Control Measures
Total
1977
51,433,800
332,900
442,500
14,200
1,198,100
580, 100
318,700
377, 700
14,200
633,700
337,700
$5,683,600
Cancer
1978
$1,629,300
378,300
502,900
16,100
1,361,500
659,200
362,100
429,200
16,100
720, 100
383,800
$6,458,600
1979 1977
$1,653,700 S 37,660
383,900
510,400
16,300
1,381,900
669,100 2,830
367,500 8,300
435,600 151,700
16,300
730,900
389,500
$6,555,100 $200,490
Heart
1978 1979 1977
$ 42,800 S 43,440 * 862,220
1,447,250
39,860
255,280
431,820
16,650
3,220 3,270 1,222,970
9,430 9,570 142,210
172,390 174,980 2,497,000
448,710
442,730
$227,840 $231,260 $7,806,700
Lung
1978
S 979, 800
1,644,600
45,300
256,000
490,700
12,100
1,389,700
161,600
2,837,500
509,900
503,100
$8,830,300
1979
S 993,690
1,669,270
45,980
259,840
498,060
12,280
1,410,550
164,020
2,880,060
517,550
510,650
$8,961,950
(includes
1977
$ 464,640
130,420
241,120
1,108,180
311,340
790
102,610
11,044,880
7,268,270
389,050
163,330
$21,224,630
Nun Specific
cancer, heart and luog)
1978
5 528,000
148,200
274,000
1,259,300
353,800
900
116,600
12,551,000
8,259,400
442 , 100
185,600
$24,118,900
1979
S 535,920
150,420
278,110
1,278,190
359,110
910
118,350
12,739,270
8,383,290
448,730
188,380
$24,480,680
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TARUi 7. SUMMARY OF FUNDS (DOLI.AR5)
NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
I., Determination of HloloRlcal Effects
7,. Undrrstanrllng Mechanism or Mode
of rtlologlcal F.ffirt!
3. Drvclopmcnt of Dose-Response
Relationships
4. Irlc ntlflrntlon of Environmental
Pollutant ARt-nls
5. Identification and Analysis
of Sources
fi, Knvlronmrnlal Transport and
Transformation Analysis
. 7, Sampling, Analytic Mctlio«Is and
LT1 MonltortnR
CD
* R. Htmian Exposure F-sllmcrtlon
P. Estnhllshlng Canse-aiKl-EffBct
Association
10. Population Risk Assessment
1977
$4,665,861
2,802,402
243,85-1
67,99)
3,000
3,000
"
109,988
271,236
446,042
Cancer
1978
$ 5,052,941
3,283,743
256,108
69,000
3,300
3,300
--
110,300
272,613
447,148
Heart
1979 1977 1978 1979 1977
$ 5,115,941 $1,222,801 $1,266,376 $1,269,376 $2,983,387
3,305,743 1,817,853 1,823,464 1,824,464 2,541,236
256,108 155,231 155,000 155,000 109,612
69,000 57,865 58,000 58,000 212,123
3,300 3,000 3,300 3,300 3,000
3,300 -- 71,445
112,300 31,107 31,300 31,300 1,051,298
271,613 57,135 60,613 60,613 729,336
449,148 209,518 210,000 210,000 493,644
Lung Non Specific
(Includes cancer, heart and lunR)
1978 1979 1977 1978 1979
$3,374,369 $ 3,390,369
3,363,617 3,421,617 5484,051 $532, «7 SS32.4S7
33,000 43,000
213,000 214,000
3,300 3,300
72,000 72,000
--
1,053,300 1,057,300
736,000 737,000
497,300 498,300
J I. Costs of Environmentally
Rpl,ite
-------
includes sampling and analytical methods. This par-
ticular category reflects efforts aimed at identifying
the presence of known toxins in the work environment.
NIEHS efforts are primarily directed toward under-
standing the relationship between disease occurrence
and environmental pollutants. This effort is devoted
mostly to cancer and lung disease, with some attention
to cardiovascular disease.
Overview of Funding for Task Force Agency Programs
The program and fiscal summaries provided by each agency lend
themselves to a variety of interpretations for various purposes. To illus-
trate, and to provide an overall summary of the preliminary findings,
Table 8 has been prepared. This table summarizes the overall level of
effort by agency in dollars for each of the three major disease categories.
The Federal Government currently funds approximately $207 million
per.year on research and strategy programs aimed at understanding relations
between chemical pollution and cancer, heart and lung disease and developing
programs of prevention. Of the funds that are directed specifically towards a
disease, the majority are directed toward cancer. Very little funding is cur-
rently directed toward environmentally related heart disease, although a sig-
nificant portion (approximately 20 percent) is directed toward lung disease.
During the first year of its work the Task Force has focused on
research into relations between chemical pollution and cancer, heart and
lung disease. Funding levels reported in Table 8 thus refer primarily to
research and do not yet represent the full range of concerns -- including con-
trol strategies and preventive measures which the Task Force will address
in the following years.
-51-
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TABLE 8. 1977 FUNDING BY AGENCY FOR DISEASES OF CONCERN TO THE TASK FORCE
1
en
ro
i
EPA NCI NHLBI NIOSH
Cancer $12,438,000 $86,392,104 -- $5,683,600
Heart Disease 1,522,600 -- $ 108,950 200,490
Lung Disease 5,820,900 3,417,300 7,806,700
Nonspecific (Cancer, 40,629,100 -- -- 21,224,630
Heart, Lung)
Total $60. 410. 600 $86.392.104 $3.526.250 $34.915.420
NEEHS Total
$ 9,272,028 $113,785,732
3,604,991 5,437,031
8,784,276 25,829,176
484,051 62,337,781
$22.145.346 >t?n7 38Q 7?n
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Chapter 3
THE TASK FORCE PROGRAM
SCOPE
As directed by Congress in Public Law 95-95, the Task Force on
Environmental Cancer and Heart and Lung Disease will:
1. Recommend a comprehensive research program to determine
and quantify the relationships between environmental
pollution and the occurrence of those three classes of
disease in man
2. Recommend comprehensive strategies to reduce or eliminate
the risks of those diseases occurring as a result of
environmental pollution
3. Recommend research and other appropriate measures to
prevent or reduce the incidence of those diseases
occurring as a result of environmental pollution
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 environmentally related
cancer, heart and lung diseases
5. Report to Congress, annually, on problems and progress in
carrying out its charge.
This scope is too broad to address all at once. In its first year,
the Task Force has concentrated upon research into relationships between
environmental chemical pollution and the three classes of disease (Item 1
of the Congressional directive to the Task Force) and upon establishing coor-
dinative and cooperative actions between the agencies (Item 4 of the directive).
Items 2 and 3 of the directive, concerning recommendations for strategies,
research and other measures to reduce risks and incidence of environmentally
-53-
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related cancer, heart and lung disease, will be added to the thrust of the
Task Force's work in the coming years. In planning effective strategies, the
Task Force will, in the future, examine a wider range of environmental factors
and will make plans and recommendations in fields extending from basic health
research to considerations of control measures for pollutant and related
disease.
Earlier in this report, a scheme was introduced for categorizing
current Federal expenditures for environmentally related cancer, heart and
lung disease research and control (see page 39). That categorization scheme,
restated and expanded, is shown in Figure 4 as a flow chart embracing all
Federal activities required to accomplish Task Force objectives. In this
chart the interrelations of research strategy and control measures are dis-
played. The structure shown here is not only a means of describing the
total Federal program in environmentally related cancer, heart and lung
disease, but also will become a means for evaluating it, as will be discussed
subsequently.
In Figure 4, the 15 categories of the funding tables of Chapter 2
appear as numbered boxes. They constitute the areas, currently within the
Task Force's purview, in which Federal effort is required. Federal activities
in several other important areas, not currently under examination by the Task
Force, are also essential to the effective control of environmental disease.
These -- appearing in unnumbered boxes at the right of the chart -- include
considerations of availability and costs of pollutant control technology,
and broad considerations of national economy, law, and political acceptability.
-54-
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Pis case-Oriented
RESEARCH IN AREAS OF CURRENT TASK FORCE CONCERN
Population-Oriented Pollutant-Oriented
Methodology-Orient ad
1. Determination of Biologi-
cal Effects of Pollutants
and Cofacton
2, Understanding Mechanism or
Mode of Biological Effects
3. Development of Dove
Response Relationships
cn
CJl
4. Identification of Environmental
Pollutant* BB Potential Disease
Agenti
5. Identification and Analysis
of Pollutant Sources
7. Development of Sampling,
Analytic and Monitoring
Methods
9. Epidemiologies! Studies
of Exposure-Health
Effect Associations
6. Analysis of Environmental
Transport and Transformation
of Pollutants In Various Media
and Pathways (e*g*t Air,
Water, Ingest Ion, Dermal)
10. Population Risk
Assessment
11. Estimation of Costs of
Environmentally
Related Disease
OTHER FEDERAL ACTIVITIES
(Beyond Scope of Current
Ta»k Force Activity)
Development of Pollutant
Control Technology
STRATEGY PLANNING FOR REDUCTION OF RISK AND INCIDENCE
CONTROL MEASURES TO REDUCE RISK AND INCIDENCE
1 3. Education of Public
and Health
Professional*
14. Surveillance of
General Population
and Special Popula-
tions at Risk
Figure 4. Flow of Research, Strategy and ControlFederal Efforts with Respect to Environmental Cancer and Heart and Lung Disease
-------
Research and other considerations shown in the upper part of this
chart enter into the strategy planning -- by EPA and the other agencies repre-
sented on the Task Force required for the selection of effective control
measures to reduce risk and incidence. The flow of effort is not simply one
way through the sequence of research-strategy-control but involves a continu-
ous iterative review. The results of research in one area impact upon
research objectives and methods in another. The outcome of strategy planning
will impact upon research as well as upon control measures. The continued
evaluation of the effects of control measures will result in new research
directions and in modifications of strategy. The Task Force sees its major
long-term function as the identification and management of the linkage activ-
ities needed to make this interactive process work.
A categorization scheme of the kind expressed in Figure 4 will in
time become a basis for evaluating the effectiveness of the total program,
and hence for recommending measures to improve it. Each category of this
structure requires action. Each linkage requires information exchange and
managed coordination between and within agencies to make the linkage work.
There is no simple way of assigning, a priori, relative rankings of importance
to the various categories and linkages. All are essential. Some categories
of research and control require much greater effort than others, hence
greater funding and other resources; or they may require earlier initiation
than others. This may be true either because of the role of a category of
effort in the overall program, the paucity of existing knowledge, the diffi-
culty of performance or the magnitude of work to be done. The optimal
resource levels for expenditures in each category can be determined only
-56-
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through iterative evaluation of the effectiveness of the research-strategy-
control continuum. The development of methods for making that evaluation,
and the continuous future performance of that evaluation, will be a major
element of Task Force work in the coming months and years. However, the
Task Force has recognized through discussion and consensus of its members
that there are important action areas upon which it can now move forward.
AREAS FOR TASK FORCE ACTION
An early thrust of the Task Force, as a body created to coordinate
research and stimulate cooperation among agencies, has been toward identifying
and reinforcing the existing interagency groups already at work on aspects of
the environmentally related cancer, heart and lung disease problem. These
include:
t Interagency Regulatory Liaison Group
t Interagency Collaborative Group on Environmental
Carcinogenesis
Toxic Substances Strategy Committee
t Toxic Substances Control Act Interagency Testing
Commi ttee
Interagency Toxic Substances Data Committee
DHEW Committee to Coordinate Toxicology and
Related Programs.
A brief description of the work and membership of these groups appears
in Appendix C. These existing cooperative bodies will be asked to work
with the Task Force toward common objectives.
-57-
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The Task Force has also identified examples of specific existing
interagency cooperation at the project level, such as the fund assigned to NCI
by the Office of Management and Budget for use in 24 NCI/EPA-managed studies of
environmental carcinogenesis, and current work on carcinogens in the occupational
environment being performed by NIOSH with NCI support. Such studies are being
examined as prototypes of effective interagency cooperation.
The Task Force has considered the current individual agency disease-
oriented and population-oriented programs for the purpose of identifying problem
areas in environmentally related cancer, heart and lung disease in which all
cooperating agencies of the Task Force have significant concerns. Six such
areas have been selected for detailed examination in the coming months:
Standardization of Measurements and Tests
Exposure and Metabolic Mechanisms for Pollutants
Early Indicators of Disease
Risk Assessment
Education of the Public and of Health Professionals
Strategies to Protect Public Health.
A brief description of the subject matter of each of these areas
appears subsequently, beginning on page 59. The order of presentation is
not intended to suggest a priority ranking.
It is important to note that these areas have not been selected on
the basis of a detailed analysis of overall needs in the national effort to
reduce risk and incidence of cancer, heart and lung disease. The Task
Force is not yet equipped to make such an analysis. The development of methods
-58-
-------
for systematic evaluation of overall objectives, programs and achievements is
\
still ahead. The Task Force hopes to have and use such methods in its later
work. But'concerted interagency action need not wait upon evaluative metho-
dology development, and it should not wait.
In each of the six identified problem areas there are unresolved
questions which currently impede progress toward disease reduction. These are
problem areas, important to each of the Task Force agencies, in which inter-
agency cooperation can make an effective early contribution. The Task Force
has begun an examination of these areas to determine: (1) ways in which inter-
agency cooperation can be made to improve performance and results, (2) the nature
and degree of improvement which could be expected, and (3) the likely contribu-
tion of the resulting improvements to overall solutions of the environmentally
related cancer, heart and lung disease problem. On the basis of these criteria,
the Task Force is in the process of deciding what further action it will take in
the coming year in each of the six areas. The Task Force expects to establish
special Working Groups for further studies of these areas.
The relationship of these areas to the national program to reduce
environmentally related cancer, heart and lung disease is as follows:
Standardization of Measurements and Tests
All five Task Force agencies perform research
involving measurements of chemical, physical and
biological factors -- in a wide range of labora-
tory, clinical and community conditions which
may ultimately be used to support common conclu-
sions and common positions with respect to control
of environmentally related cancer, heart and
lung disease. Standardization of measurement and
test methods would insure a common understanding
-59-
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of results. Through inclusion of accepted quality
assurance procedures it would insure comparability;
such procedures could involve collaborative inter-
change of "blind" samples for analysis. It would
facilitate reproducibility of results when required
for related research or regulatory enforcement
monitoring. It would also assist in the develop-
ment of improved methods for areas now inadequately
served, such as assays of pollutant chemical forms
in tissue.
Exposure and Metabolic Mechanisms for Pollutants
There are a number of disease agents and disease
mechanisms which are of important concern to all
Task Force agencies; the role of cadmium in can-
cer and heart disease is an example. A common,
shared approach to the study of exposure and meta-
bolic processes for such agents could improve the
effectiveness of all agency programs. Such an
approach would examine how the agent appears in
various forms (different compounds, different
valences) as an exposure hazard in various media
(air, water, different types of foods); how it
enters the body; how it is metabolized; and its
fate and biological effects. The Working Group
in this area could inventory the available knowl-
edge for selected pollutants, assemble the docu-
mented information on quantified processes and
effects, appraise the value of available knowl-
edge and use this information to identify new
research required.
Early Indicators of Disease
The diseases of concern to the Task Force have
latent periods of many years between pollutant
exposure and occurrence of manifest disease. The
course of disease may be irreversible by the time
it is discovered. Early indicators of disease
(e.g, small bodily changes or signals which would
indicate that exposure had occurred and a chain
of pathological events set in motion) could be of
immense value in identifying a patient-at-risk for
cancer, or heart or lung disease. Knowledge and
detection of early signals might permit therapy to
arrest or reverse disease processes at an early
stage. Early indicators of disease would permit
agencies to devise screening techniques to assess
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various chemicals for chronic disease potential
without waiting years for the development of mani-
fest diseases. Existing knowledge is inadequate
to permit significant use of these approaches for
most diseases of concern to the Task Force. It
is a logical area in which to utilize resources
for a combined approach to a promising line of
preventive medicine.
Risk Assessment
Resource limitations impose the need for priorities.
In determining what forms of pollutions and what
environmentally related disease to address on a
priority basis it is necessary to have an assess-
ment of the risk to the general population, and
to specific populations, of disease incidence and
mortality. Such assessments would aid all Task
Force agencies in determining their research prior-
ities. The sharing of the iterative work of risk
assessment can produce an effective use of resources
and can establish a common basis for priority set-
ting in arenas of research, strategy and control.
The work already in motion at the National Center
for Health Statistics (through the United States
National Committee on Vital and Health Statistics),
to assess statistics needed for determining the
effects of the environment on health, can be
valuable in improving interagency capability for
risk assessment.
Education of the Public and of Health Professionals
The education of the public and health profes-
sionals in awareness, recognition and means
of avoidance of environmentally related disease
and environmental pollution is an effective
way of reducing disease. This is particularly
the case with respect to nutritionally related
diseases, hazards of smoking, drugs and medicines,
and occupational hazards; awareness of the need for
containment is critical to occupational hazards.
Physicians cannot treat or prevent environmentally
related diseases with full effectiveness if they
are not trained to recognize their nature.
Strategies to Protect Public Health
The ultimate purpose of most investigations into
diseases and pollution is the protection of public
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health through prevention of illness. By monitoring
trends in mortality or morbidity, it is possible to
identify emerging problems and initiate research
actions to solve these problems. The Task Force
agencies could find it valuable in directing their
own internal activities, to constantly consider their
plans and programs in the light of common strategies
to protect public health.
These six areas do not exhaust the possibilities of early cooper-
ative interagency actions through the Task Force's work. A number of other
areas have also been identified in Task Force discussions, but these con-
stitute the core program with which the Task Force enters its second year.
NEXT STEPS
The Task Force will continue the organizational and program actions
now underway. The Task Force will meet in plenary sessions at approximately
3-month intervals throughout the coming year, with the next regular plenary
session scheduled for September 20, 1978. The agenda for that meeting will
include the following:
Formulation of systematized approaches for development
of cooperative interagency projects, with plans for
implementing these approaches
Organization of working groups to address the six
problem areas already identified
t Consideration of evaluative methodologies for assess-
ing priorities, program effectiveness and resource
allocation in the future overall environmentally
related cancer, heart and lung disease program
Strengthening of working relations between the Task
Force and existing relevant Federal interagency bodies
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§ Addition of the National Center for Health Statistics
and the Center for Disease Control at Atlanta as full
members of the Task Force, and consideration of member
or observer status for other agencies
Organization of a Task Force information management
system, maximally utilizing existing information
management systems in the participating agencies,
which will provide ready Task Force access to a
continuously updated complete file of information
about the objectives, scope, results and resource
requirements of all federally funded activities
relevant to Task Force objectives.
These are large subjects and may be expected to carry forward from
the agenda of the September 20, 1978 meeting into the agendas of subsequent
meetings. The Task Force will carry on the detailed planning, coordination
and implementation of this work and of other work as it may enter into Task
Force agendas through specially delegated working groups. These working
groups will meet as frequently as required to perform their work. In general, it
is expected that the plenary sessions of the Task Force will determine policy and
priorities, will review work performed by working groups, and will reach formal
decisions. The active performance of Task Force work on a continuing basis will
be carried on through the working groups. The Task Force and its working groups
will be assisted in all their activities by the EPA staff for Environmental
Preventive Medicine and Health, which will continue to act as its technical
secretariat.
The next regularly scheduled Task Force Report to Congress will be
submitted on August 7, 1979, and will describe the problems encountered and
progress achieved to that date in carrying out the directives of Section 402
of Public Law 95-95. The Task Force need not wait until then, however, to
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make formal recommendations for action to Congress. Out of the active examin-
ation of problem areas, priorities and resource allocations upon which the
Task Force is now embarking, early recommendations will appear for specific
new initiatives in the effort to reduce environmentally related cancer, heart
and lung disease. As these initiatives are developed, and as their resource
requirements, probable benefits, and expected impact upon other Federal activ-
ities are determined, the Task Force will make interim reports to Congress,
with specific programs and recommendations for action.
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Appendix A
TASK FORCE ORGANIZATION
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Appendix A
TASK FORCE ORGANIZATION
The Task Force on Environmental Cancer and Heart and Lung Disease
was formally established in November 1977, following an exchange of letters
between the Administrator of EPA and the Directors of NCI, NHLBI, NIOSH and
NIEHS. Task Force members were subsequently designated by each agency, as
follows:
EPA - Mr. Douglas Costle - Cha'irman
Dr. Stephen Gage - Alternate
Dr. Delbert Barth - Alternate
NCI - Dr. Herman Kraybill
Dr. John Munn - Alternate
NHLBI - Dr. Manning Feinleib
Dr. Claude Lenfant
Dr. Richey Sharrett - Alternate
Dr. Hugh Stamper - Alternate
NIOSH - Dr. Ralph Yodaiken
Dr. Jean French - Alternate
NIEHS - Dr. David Rail
Dr. Raymond Shapiro - Alternate
Observers assigned to the Task Force were Dr. Paul Leaverton for
NCHS and Dr. Clark Heath for CDC.
Within EPA, the Administrator has designated a Staff for Environ-
mental Preventive Medicine and Health, reporting to the Administrator through
the Assistant Administrator for Research and Development. This staff has as
a major responsibility the day-to-day organization and coordination of Task
Force activities, serving as a technical secretariat to the Task Force. It
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performs this function with regular EPA staff seconded from other parts of
EPA and assisted by an external consulting group.
After a period of organization and planning at supporting staff
levels, the Task Force convened its first meeting, chaired by Mr. Douglas
Costle for EPA, on April 26, 1978 at EPA Headquarters, Washington, D.C. This
meeting was attended by Representatives Paul Rogers and George Brown of the U.S.
Congress, by the heads of the participating agencies or their special represen-
tatives, and by the designated Task Force members and other senior members of
agency staffs. Objectives and plans for Task Force work were reviewed and a
program of Task Force Working Group activities was developed. The Task Force
Working Group met formally on three subsequent occasions -- May 12, June 7 and
June 16, 1978 discussing plans and concepts, reviewing support work by the
Staff for Environmental Preventive Medicine and Health, and developing Task Force
recommendations. The results of the Working Group's deliberations were reviewed
at the second meeting of the Task Force on June 29, 1978. Behind the formal
meetings was a continuing activity in each agency, throughout the period from
April through July, developing information for use of the Task Force.
With the preparation and submittal of this First Annual Report to
Congress the Task Force passes an important checkpoint. The Task Force has
spent its first months organizing, gathering information, and developing initial
recommendations. Task Force work will continue with a principal emphasis upon
examination of the problem areas described in Chapter 3.
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Appendix B
TASK FORCE AGENCIES ~ RESPONSIBILITIES AND
LEGISLATIVE BACKGROUND
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Appendix B
TASK FORCE AGENCIES RESPONSIBILITIES AND
LEGISLATIVE BACKGROUND
ENVIRONMENTAL PROTECTION AGENCY
Responsibilities
The Environmental Protection Agency (EPA) was established in 1970 by
a Presidential order which consolidated 15 Federal environmental programs into
a single agency. The mission of this agency is to protect and enhance the
quality of the environment through the development of a coordinated and com-
prehensive attack on environmental problems such as air and water pollution,
solid waste management, pesticide usage, radiation, noise, and toxic sub-
stances. EPA is primarily responsible for establishing and enforcing stan-
dards and regulations which are necessary to protect public health, welfare
and property and ecological systems from damage by environmental pollutants.
Through various legislative mandates, EPA has been given responsibility in
monitoring and analyzing the environment, conducting research and demonstra-
tion projects and assisting in the development and implementation of state
and local pollution control programs.
Legislative Framework
In 1970, President Nixon signed into law the National Environmen-
tal Policy Act (P.L. 91-190) which was created to establish a national policy
for the preservation of the environment, to assure that Federal policies
would take environmental factors into account in decision making, and to
create a Council of Environmental Quality within the Executive Office.
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The Council is charged with the following areas of responsibility:
The analysis of current information regarding
conditions and trends in the quality of the
envi ronment
The conduct of research regarding environmental
quality and ecological systems
Documentation and analysis of alterations in the
natural environment
0 The development of recommendations on national
environmental policy
The appraisal of the effects of Federal programs
on environmental quality.
Six months later the President transmitted to Congress a reorganiza-
tion plan to coordinate the administration of environmental programs through
the establishment of an independent agency, the Environmental Protection
Agency. This order (Reorganization Plan No. 3 of 1970) combined 15 programs
from 5 separate Federal agencies. The primary role of the EPA would be to
establish and enforce environmental quality standards, to provide technical
assistance to state and local governments in the developoment of environmen-
tal programs, and to conduct research, demonstration and monitoring programs.
The Water Pollution Control Advisory Board (from the Department of
Interior) and the Air Quality Advisory Board (from the Department of Health,
Education, and Welfare) were transferred to EPA thereby giving the agency the
authority to control air and water pollution. Additional transfer of author-
ity included:
0 All functions of the Federal Radiation Council
Functions of the Atomic Energy Commission regarding
the establishment of radiation hazard standards
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t Functions in the Department of Interior regarding
studies of the effects of pesticides upon wildlife
resources as well as the administration of the Gulf
Breeze Biological Laboratory
t Functions of the Department of Agriculture in the
Plant Protection Division of the Agricultural
Research Service, Federal Insecticide, Fungicide
and Rodenticide Act, and Federal Food, Drug and
Cosmetic Act
Functions of the Department of Health, Education
and Welfare included in the Federal Food, Drug,
and Cosmetic Act regarding pesticide research
and standards development and functions exercised
by the Bureaus of Solid Waste Management, Water
Hygiene and Radio!ogic Health
Functions of the Council on Environmental Quality
relating to the study of ecological systems.
A synopsis of the major pieces of legislation which authorize EPA
activities and programs follows.
AIR POLLUTION
«
Clean Air Act of 1963 (as amended through 1977)
Purpose: To protect the quality of the Nation's air resources, initiate
a research program to achieve control of air pollution, and encourac
research
and assist
control programs.
»tect the quality of the Nation's air resources, initiate
program to achieve control of air pollution, and encourage
the development of state, local and regional air pollution
trryamc .
Mandates:
Establish national research and development programs for
the prevention and control of air pollution.
Provide grants for the improvement or establishment of
air pollution control programs or implementation of
national ambient air quality standards.
Give states the primary responsibility for assuring air
quality within the state, and for enforcement of the pro-
visions of this responsiblity through EPA-approved
implementation plans.
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Issue air quality criteria for each pollutant which indicate
identifiable effects on public health or welfare expected
from its presence in the ambient air. Issue information on
air pollution control techniques and processes for each
pollutant.
Establish primary air quality standards (to protect public
health) and secondary air quality standards (to protect
public welfare) for each pollutant for which criteria have
been issued including a standard for M02 concentrations.
Establish a scientific review committee to evaluate criteria,
appraise standards, and describe necessary future research
efforts.
Publish a list of categories of stationary sources of pollution
which may endanger public health or welfare, and establish
standards of performance for new sources wi.thin each category
which reflect the degree of emission limitation "achievable
through application of the best technological system of con-
tinuous emission reduction."
Establish emission standards for hazardous air pollutants
to which no ambient air quality standard is applicable.
Provide procedures for Federal enforcement and penalty
assessment for violations of the Act and of State Imple-
mentation Plans. Require revision of implementation plan
by states if emission of air pollutant in the U.S. causes
or contributes to air pollution which endangers public
health or welfare in a foreign country.
Provide for establishment of advisory committees to assist
in the development of air quality criteria standards and
research.
Authorize EPA or state to issue not more than two orders
to permit delay in achievement of emission control stan-
dards for primary nonferrous smelters (but not beyond
January 1, 1988).
Require states to notify nearby states of a proposed new
source which may affect pollution levels.
Conduct a study of effect of substances and practices which
affect the stratosphere, particularly ozone. This shall
include physical, chemical and biomedical research to ascer-
tain effects on public health and welfare.
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Establish an interagency coordinating committee to plan and
review such research.
Regulate the practices, substances or activities which may be
anticipated to affect the stratosphere.
Set maximum allowable increases in concentrations of sulfur
dioxide and particulate matter for each class area where
air quality is cleaner than atnbient air standards.
Determine procedure for area redesignation.
Require permit for construction of any major emitting facility;
such facility to comply with emission limitations and particu-
late concentrations allowable.
Set regulations to "prevent the significant deterioration of
air quality" from emissions of hydrocarbons, carbon monoxide,
photochemical oxidants and nitrogen oxides.
Set regulations to assure the prevention of future impairment
of visibility in Class I Federal areas (national parks and
wilderness areas) resulting from air pollution.
Implement plans required to provide for attainment of ambient
air quality standards by 1982 for any nonattainment areas.
Establish emission standards for automobiles, heavy duty
vehicles (trucks, busses).
Establish procedure for issuance of certificates of conformity
to verify that a vehicle is in compliance with emission
standards.
Establish performance warranty of motor vehicle control devices
with replacement costs to be borne by the manufacturer.
Require registration of fuel additives and testing of such, if
necessary, to determine potential public health effects.
Promulgate regulations with respect to reduction of lead con-
tent per gallon of gasoline prior to October 1982.
Establish interagency Low-Emission Vehicle Certification Board
to certify any class or model of motor vehicle as low-emission
and to determine suitable substitutions for use by Federal
agencies.
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Establish fuel economy improvement standards for new motor
vehicles manufactured after 1980.
Require establishment of emission standards for any air
pollutant from aircraft engines.
Study effects on health and welfare of particulate emis-
sions from motor vehicles; and requirements of measures
to mitigate the effects.
Establish procedure for restraint in the case of any pol-
lutant presenting imminent and substantial endangerment to
public health.
Require preparation of economic and environmental impact
assessment concerning any standard or regulation.
Conduct interagency conference on air quality monitoring.
Evaluate employment shifts resulting from administration
of the Act.
Establish National Commission of Air Quality to study:
alternatives to protect air quality and prevent signifi-
cant deterioration; economic and environmental conse-
quences of achieving or not achieving purposes of the Act;
health effects of nonregulated air pollutants.
Establish Task Force on Environmental Cancer and Heart
and Lung Disease to recommend research to determine effects
of environmental pollution on human cancer and heart and
lung disease, and recommend strategies to reduce such
incidence.
With National Academy of Sciences, study endangerment to
public health presented by suspended particulate matter
and odorous emissions.
With Council of Economic Advisors, study and assess
economic measures for air pollution control that may
strengthen the Act and serve as incentives for control-
ling air pollution problems.
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WATER POLLUTION
Federal Water Pollution Control Act as Amended (Clean Water Act of 1977)
Purpose: To establish a comprehensive water pollution control program
in an effort to reduce and eliminate pollution and to restore and
preserve our water resources.
Mandates:
Develop effluent limitations to limit discharges
from industrial and municipal sources.
Wastewater discharge permit program to be
established by EPA or the states.
Develop water quality standards indicating
water use designation
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Establish manpower development and training programs in
water treatment and water quality control.
Establish Water Pollution Control Advisory Board within
EPA to make policy recommendations.
Establish Effluent Standards and Water Quality Advisory
Committee to provide and evaluate scientific data.
0 Implement a public education program.
t Establish a National Study Commission to investigate
technological aspects and economic, social and
environmental effects of effluent limitations and
goals of Act.
Marine Protection, Research and Sanctuaries Act of 1972 and Amendments
Purpose: To regulate dumping in ocean waters and to protect the terri
torial sea.
Mandates:
Issue permits for transport and dumping of any radio-
logical, chemical or biological warfare agent or radio-
active waste into territorial sea (or within 12 miles
of territorial sea baseline) based on minimal danger to
human health, marine environment, ecological systems and
economic potential, need and alternatives.
Secretary of the Army to issue permits for transport of
dredged material to be dumped into the ocean, based on
review criteria.
Secretary of the Department under which the Coast Guard
is operating to establish surveillance and enforcement
activities to prevent unlawful transportation and
dumping responsibilities.
Initiate program of monitoring and study of: effects
of dumping in ocean water; effects of pollution, over-
fishing and man-induced changes in ocean ecosystems; and
the Great Lakes.
Secretary of Commerce to designate marine sanctuaries
for preservation of their conservation, recreational,
ecological or esthetic values, and issue regulations
to control activities within the sanctuaries.
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Implement the provisions of the Convention on the
Prevention of Marine Pollution by Dumping of Wastes
and Other Matter, permits issued to include dumping
of material from outside the U.S. within the terri-
torial boundaries.
Safe Drinking Water Act (1974) and Amendments (1977)
Purpose: To assure safe drinking water to protect public health.
Mandates:
t Develop primary drinking water standards for pollutants
which may have an adverse effect on public health.
Develop secondary drinking water standards necessary
protect public welfare.
to
List contaminants which may have effect on public health
and maximum levels which allow for adequate margin of
safety.
Conduct study, in cooperation with the National Academy
of Sciences, to assess the maximum level of contaminants
to protect public health, determine which population
groups are more susceptible to adverse effects, deter-
mine exposure to contaminants in other than drinking
water, effects of interaction and exposure to two or
more contaminants and exposure and body burden levels
which alter physiological function and increase risk of
illness.
Give states the primary enforcement responsibilities
for public water systems if adequate procedures are
implemented. Grants available to assist in the
establishment and supervision of public water systems.
Publish regulations for state underground injection
control programs to prevent underground injection
which endangers drinking water sources.
Provide grants for manpower training in occupations
involving public health aspects of providing safe
drinking water.
Conduct research relating to:
- Causes, treatment and prevention of diseases
resulting from water contaminants
B-9
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- Waste disposal and means of controlling waste
- Methods of underground injection which do not
degrade underground drinking water sources
- Virus contamination
- Quantity, quality and availability of rural
drinking water supplies.
Authorize demonstration project for improved or new
technology for providing safe drinking water and for
health implications in reclamation, recycling and
reuse of waste waters.
Establish National Drinking Water Advisory Council
of 15 members to advise and make recommendations
regarding related EPA activities, functions and
policies.
SOLID WASTE
Resource Conservation and Recovery Act of 1976
Purpose: Provides for the regulation and control of hazardous waste,
and the development of plans for recovery of energy and other
resources from discarded materials.
Mandates:
Develop guidelines for solid waste management which:
- Describe levels of performance attainable by various
practices
- Provide protection to public health and welfare,
quality of surface and ground waters and ambient air
- Provide for disease and vector control.
Establish Office of Solid Waste within EPA to carry
out responsibilities of the Act.
Provide technical assistance to states on solid waste
management, resource recovery and resource conservation.
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Require permits be issued to each facility which treats,
Stores or disposes hazardous waste by October 1978.
EPA to publish criteria for identification of hazardous
waste and list specific wastes which require permit.
Establish standards for transporters of hazardous waste
to protect health and the environment.
Provide technical and financial assistance to states in
the development of hazardous waste programs and solid
waste management plans and authorize such plans if in com-
pliance with EPA regulations.
Inventory open dump sites in the United States, prohibit
establishment of new open dumps and issue regulations to
upgrade existing open dump sites to minimize potential
health hazards.
Secretary of Commerce to encourage resource recovery
technology by developing specifications for the
materials recovered from waste and provide such infor-
mation to Federal agencies for procurement purposes
(each agency "to procure items composed of highest per-
centage of recovered materials practicable consistent
with maintaining a satisfactory level of competition").
Commence legal suit if solid waste presents imminent
danger to health or the environment.
Investigate personnel requirements to carry out state
plans, utilization of existing training programs and
obstacles to employment in solid waste disposal and
resource recovery field.
Conduct and promote research relating to:
- Effects on health and welfare of solid waste
material release
- Solid waste disposal programs
- Planning and operation of resource recovery
systems and marketing recovered resources
- Development of new and improved methods of pro-
cessing solid waste
- Composition of solid waste stream and anticipated
future changes
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- Resource recovery from glass and plastic waste
- Effects of mining waste on humans, air, water,
health, welfare and natural resources.
Establish interagency Resource Conservation Committee
to evaluate consequences of resource conservation.
Establish library for data regarding solid waste management,
resource recovery facilities, research and development proj-
ects and develop educational programs to promote understanding.
« Provide grants for demonstration facilities of new technology
for solid waste disposal and resource recovery systems.
Enforce compliance of the Act.
TOXIC SUBSTANCES AND PESTICIDES
Toxic Substances Control Act (1976)
Purpose: To regulate commerce and protect human health and the environ-
ment by requiring testing and necessary use restrictions on
chemicals.
Mandates:
Require testing of chemical substances by manufacturers or pro-
cessors if EPA determines there may be an unreasonable risk to
public health or the environment or existing data on environ-
mental and health effects are insufficient.
Establish eight-member interagency committee to make recom-
mendations to EPA Administrator regarding priority lists of
chemicals to be evaluated based on quantities produced, extent
of exposure, existence of data regarding health and environ-
mental effects, with specific attention to those substances
known to cause or contribute to birth defects.
Require notification by manufacturers of intent to manu-
facture new substances or significant new use of existing
substance.
Prohibit sale, manufacture, processing or use of chemical
substance if it presents a risk of injury to health or the
environment. EPA may require limitation of amount manufac-
tured or limitations on the way the chemicals are used.
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Require labeling of chemicals with instructions on use and
adequate warnings.
Require records of manufacture process, monitoring tests,
quality control procedures.
Require labeling and disposal regulations for polychlorinated
biphenyls (PCBs) by July 1977. The Act prohibits manufacture
by January 1979 and distribution by July 1979.
Commence civil action for seizure of imminently hazardous
substances.
Require reporting of adverse health or environmental effects
caused by chemical substances or mixtures.
Conduct research, development and monitoring activities
with Department of Health, Education, and Welfare regarding:
screening techniques for carcinogenic, mutagenic and eco-
logical effects; feasibility of establishing standard classi-
fication system for chemical substances and standard means
for storage; development of methods to evaluate health and
environmental effects of chemical substances, their toxicity
and persistence.
Provide technical assistance to manufacturers and processors
respecting requirements of the Act.
Make grants to states for establishment of programs to pre-
vent unreasonable risks to health or environment associated
with chemical substances.
Federal Insecticide, Fungicide and Rodenticide Act (1972) and Amendments (1975)
Purpose: To establish a comprehensive program to regulate the manufacturing,
distribution and use of pesticides.
Mandates:
Register all pesticides, their labeling and classifi-
cation by use; approval based on ability to perform
as warranted without adverse environmental effects.
Certify those individuals who use or supervise the use
of pesticides classified for restricted use. States
may administer certification plan.
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Issue permits for testing of experimental pesticides.
Register establishments that produce pesticides.
t Enforcement authority to EPA or states to establish
civil and criminal penalties for violation of the Act.
Establish procedures and regulations to be implemented
for storage, transportation and disposal of pesticides.
t Conduct research on pesticides, alternatives for pest
control and monitoring pesticide use.
Establish advisory panel of seven members to study the
effects of regulations and classifications on health and
the environment.
Provide assistance for the development of state plans for
enforcement and state training and certification pro-
grams for applicators.
NOISE POLLUTION
Noise Control Act of 1972
Purpose: To control the emission of noise detrimental to the human
envi ronment.
Mandates:
Develop criteria reflecting effects of noise on public
health and welfare and specify reduction necessary for
protection with an adequate margin of safety.
Identify and categorize major sources of noise and
develop standards for levels of noise emissions.
Study adequacy of Federal Aviation Administration flight
and operational noise controls and measures available
to control aircraft noise with recommendations for
amending regulations and standards for aircraft noise
or sonic boom to protect public health and welfare.
Require labeling of all products which emit noise capable
of affecting public health or welfare or which are sold
on the basis of reducing noise.
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Conduct research regarding effects and measurement
of noise on public health and welfare and techniques
for noise control.
Provide technical assistance to states to facilitate
development and enforcement of ambient noise standards.
Establish Low-Noise Emission Product Advisory Committee
to certify low noise emission products and suggest
suitable substitutions for Federal procurement.
Establish noise emission standards for railroads and
motor carriers engaged in interstate commerce which
reflect the degree of noise reduction achievable
through the application of the best technology avail-
able with consideration of cost of compliance.
NATIONAL CANCER INSTITUTE
Responsibilities
The National Cancer Institute (NCI) of the National Institutes
of Health coordinates the National Cancer Program with the advice of the
National Cancer Advisory Board. The Program encompasses NCI's own efforts
in cancer research and cancer research done in other NIH Institutes as
well as by other Federal and non-Federal programs.
The National Cancer Institute supports research and demonstra-
tion programs aimed at uncovering the causes of, and the best therapeutic
approaches to, the cure of cancer. Its primary focus is on the prevention
and cure of cancer. Because many of the causes of cancer are now believed
to be of environmental origin, NCI devotes considerable effort to the
screening and evaluation of chemicals in the environment which might cause
cancer. It also conducts research on the geographical distribution of
cancer in search of clues to the environmental causes of cancer. Basic
research on the metabolism and mechanism of action of various types of
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environmental carcinogens, as well as on the interactions of biological,
chemical or physical environmental agents such as radiation, is carried on
by NCI. The National Cancer Institute participates with EPA and NIOSH in
major cooperative research programs aimed at determining and quantifying
environmental causes of cancer.
Legislative Framework
NCI was created in 1937 by the National Cancer Institute Act (P.L.
75-244). This Act provided for the first Federal research program established
for the study of disease control. In 1944 NCI was made a division of the
National Institutes of Health by the Public Health Service Act.
The authorities of NCI and the National Institutes of Health
were enlarged by the National Cancer Act of 1971 "in order to advance the
national effort against cancer." This Act provided for the development of
the National Cancer Program (NCP) to coordinate, expand and intensify
research efforts by NCI, related programs of other research institutes, and
other Federal and non-Federal programs. In addition to national efforts,
the NCP is to support cancer research in foreign countries, collaborative
research efforts between American and foreign scientists, and training
of foreign scientists in the United States.
The Act provides for the establishment of cancer centers for
"clinical research, training, and demonstration of advanced diagnostic
and treatment methods relating to cancer." Cancer control programs were
to be established in cooperation with state and other hea'th agencies.
The administration of the NCP is the responsibility of the Director
of the National Cancer Institute, who shall be appointed by the President.
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The Act created the National Cancer Advisory Board (to supersede the previous
National Advisory Cancer Council) to advise and assist the NCI Director
regarding the program. The Board has the responsibility to investigate all
NCR programs and activities and submit an annual report to the President
for transmittal to Congress regarding progress toward NCR objectives and
a plan for the program for the next five years.
The President's Cancer Panel was established to monitor the
development and execution of the NCR. The three-member Panel, appointed
by the President, presents periodic progress reports directly to the
President.
4
To provide for a scientific review of all research grants and
programs authorized by the NCI Director, peer review groups were to be
established within the NIH when deemed necessary by the Advisory Board
and the Director of NIH.
In 1974, amendments to the National Cancer Act extended the
National Cancer Program appropriations and amended the provisions to expand
the scope of the national program. Research in the area of nutrition was
encouraged by Congress including investigation of the role of nutrition
in the treatment and rehabilitation of individuals with cancer and the
role of nutrition in cancer cause. Expansion in the cancer control program
was also mandated to include trials of such programs as routine exfoliative
cytology tests to diagnose uterine cancer.
Amendments to the National Cancer Act removed the limitation on
the number of Comprehensive Cancer Centers. This change allows the Director
of NCI to establish the centers he deems appropriate in order to provide
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quality cancer care throughout the country by way of effective demonstra-
tion and outreach programs. The ceiling on the number of professional or
scientific consultants available to the Director was increased from 50 to
100. Personnel needs for the operation of the NCR are to be included in the
annual report to Congress in order to assess the estimated manpower needs and
available resources.
Additionally, the Director of the NCI was given the responsibility
to disseminate new and existing cancer knowledge regarding the cause, preven-
tion, diagnosis and treatment of the disease to practitioners, health pro-
fessionals, scientists and the general public. Activities of this program
are to be .included in the President's annual report.
The Amendments established the President's Biomedical Research Panel
to monitor the complete range of research activities of the NIH and to iden-
tify any obstacles that may threaten the development of an effective biomedical
research effort. Composed of seven presidential appointees, including the
chairman of the President's Cancer Panel, this panel is to make recommendations
regarding the subject, contents, organization and operation of the biomedical and
behavioral research conducted and supported by the National Institutes of Health
and the National Institute of Mental Health.
New regulations required that all grant applications as well as
research and development contract projects in the area of biomedical and behav-
ioral research administered by the National Institutes of Health (including
NCI), National Institute of Mental Health, National Institute of Alcohol Abuse
and Alcoholism and National Institute on Drug Abuse be reviewed by a scientific
peer review group. This review will provide feedback that will assure an effec-
tive, coordinated effort to achieve a comprehensive cancer program.
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NATIONAL HEART, LUNG. AND BLOOD INSTITUTE
Responsibilities
The National Heart, Lung, and Blood Institute (NHLBI) of the National
Institutes of Health was created to advance a national program focusing on the
cause, prevention, and cure of diseases affecting the cardiovascular and pul-
monary systems of the body. Within its mandate, NHLBI funds and administers
studies of environmental factors related to these diseases. These programs focus
on risk factors, epidemiologic analysis of the incidence-of heart and lung
diseases, identification of the cause-effect relationship between environmental
conditions and specific diseases and control of the disease process.
Legislative Framework
In 1948, a national program to prevent and treat cardiovascular
disease was implemented by the passage of the National Heart Act (P.L. 80-655).
This legislation, which amended the Public Health Service Act of 1944, provided
for the establishment of the National Heart Institute (NHI) to support research
and training relating to the cause, prevention, diagnosis and treatment of heart
disease.
The purpose of this Act was to "improve the health of the people
of the United States through the conduct of researches, investigations, experi-
ments and demonstrations relating to the cause, prevention, and method of diag-
nosis and treatment of diseases of the heart and circulation." The NHI was to
support and coordinate similar research by public and private agencies, provide
manpower training, and assist the states in utilization of the most effective
methods of prevention, diagnosis and treatment of heart disease.
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In 1948, the Surgeon General established the NHI as one of the
Institutes of the National Institutes of Health. All research activities
related to heart disease were transferred to the NHI.
With increased attention on the effects of lung and respiratory
diseases, the Secretary of Health, Education, and Welfare expanded the role
of the Institute by redesignating it the National Heart and Lung Institute
in 1969. Additional responsibilities included research and training efforts
in the area of lung disorders.
A major legislative thrust occurred in 1972 with the passage
of the National Heart, Blood Vessels, Lung and Blood Act which provided
the authority to expand the research efforts to combat blood vessel and
blood disorders as well as intensify and coordinate efforts in cardio-
vascular and lung diseases. These enlarged programs included research in
diseases of children such as asthma, cystic fibrosis, and hemolytic and
hemophilic diseases. Clinical research and demonstration centers were
established to provide demonstrations of advanced methods in diagnosis,
prevention and treatment of cardiovascular and chronic lung diseases and
to provide resources for training scientists and medical personnel. This
legislation provided for the development of a Health Information Program
to disseminate relevant information to medical professionals and the
public regarding the numerous factors, such as diet, stress and cigarette
smoking, affecting the prevention of these diseases.
The Act called for the development of a National Program to
expand, intensify and coordinate efforts regarding heart, blood vessel,
lung and blood diseases. The Director of the Institute, with the advice
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of a 23-member advisory council, the National Heart and Lung Advisory
Council, was given the responsibility to plan and implement new research
programs as well as to coordinate programs and activities of other research
institutes of the National Institutes of Health. This Council was required
to report to Congress and the President on the activities and accomplish-
ments achieved in the past year.
Increased emphasis on programs in the areas of blood research
and blood resource management was the result of the 1976 Amendments to
the Act. Testing and evaluation of newly acquired knowledge which may be
of value in the control of diseases affecting the heart, lung and blood
systems were promoted.
Ten additional research and demonstration centers were authorized
for "advanced diagnostic, prevention and treatment methods for blood, blood
vessel diseases, research in the use of blood products and research in the
management of blood resources."
The Amendments increased the number of consultants available
to assist the Council. The Congressional report was to include Council
appropriation recommendations and estimates of manpower requirements to
carry out the program. The 1976 Act (P.L. 94-278) created the name change
of the Institute to the present National Heart, Lung and Blood Institute
(NHLBI) with a corresponding change in the name of the advisory council.
In 1977, authorization under the National Heart, Lung and Blood
Act was extended by Congress through the fiscal year ending 1978 with no
substantive changes.
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NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH
Responsibl1itles
The National Institute for Occupational Safety and Health (NIOSH),
a division of the Center for Disease Control, is involved in the effort to
reduce or eliminate workplace hazards for every working person. As such NIOSH
has major responsibilities in the areas of research, standards development,
technical assistance and manpower development. NIOSH conducts research on
chemicals, industrial processes and job hazards which endanger workers' health
and safety. NIOSH prepares criteria documents on occupational hazards and
recommends occupational health and safety standards to the Occupational Safety
and Health Administration and the Mine Safety and Health Administration for
promulgation and enforcement of standards. NIOSH also has responsibilities in
providing technical assistance to workers, industries and governmental agencies
concerned with worker safety and health.
Legislative Franework
Occupational safety and health has been a public concern since the
early part of this century. Recent interest in this area has been prompted
by the abundance of data regarding the effects of industrial chemicals on
employee health. In 1970, Congress passed the Occupational Safety and Health
Act (P.L. 91-596) in an effort to eliminate on-the-job deaths, injuries and
illnesses, and to assure safe and healthful workplace environments.
Due to the complexity and magnitude of this problem, the Act provided
that several agencies be responsible for the specific policies and programs
involved. The Occupational Safety and Health Administration (OSHA) within the
Department of Labor was designated as the agency responsible for the promulgation
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of occupational safety standards to provide for worker protection. Compliance
and enforcement of these safety standards is an essential part of OSHA's role.
The enforcement of the standards has been realized by physical inspection of the
workplace by an OSHA officer. The Act encouraged the states to develop their own
occupational health and safety programs with OSHA serving as the agency for
evaluation and approval of such plans.
Authorization to develop and recommend occupational safety and health
standards was given to the National Institute for Occupational Safety and Health
(NIOSH) in the Department of Health, Education, and Welfare. The Director of
NIOSH was given the responsibility to conduct any research and experimental
programs deemed necessary for the development of criteria for new occupational
safety and health standards. These criteria documents, which review the scien-
tific basis for a standard and suggested provisions, are forwarded to OSHA for
review. The 1970 legislation provides that these suggested standards then be
published in the Federal Register prior to approval by the Secretary of Labor
so that objections may be filed and assessed prior to the final draft of the
standard.
The 1969 Federal Coal Mine, Safety and Health Act authorized the
development of health standards for the protection of life and the prevention of
occupational diseases of miners. The Secretary of Health, Education, and Welfare
transferred this responsibility to NIOSH with the passage of the 1970 Act.
Additional mandates were given to NIOSH for all mines (metal, stone, clay and
gravel) under the Mine Safety and Health Amendments Act of 1977.
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In addition to standard development, the legislation provides
that NIOSH be responsible for applied research, manpower development, and
technical assistance and consultation services to Federal, state and pri-
vate agencies. The Act requires that NIOSH develop educational programs
to assure an adequate supply of qualified medical personnel to carry out
the requirements of the legislation. Additional training is to be provided
to employers and employees regarding the recognition, avoidance and preven-
tion of unsafe working conditions due to both physical and human factors.
The Institute must provide technical assistance and consultative
services to Federal, state and local agencies upon request. Support for
health hazard evaluations, development of occupational safety and health
programs for small businesses and industrial hygiene and engineering
assistance is to be made available. The dissemination of occupational
safety and health technical information is an additional NIOSH responsi-
bility.
To carry out the adjudicatory functions under the Act, the Occu-
pational Safety and Health Review Commission (OSAHRC) was created. This
Commission, an independent adjudicatory agency of the United States, serves
as a court system where employees, employers or their representatives may
seek relief when there is disagreement with any enforcement action taken
by the Secretary of Labor-* Any part may then appeal the decision of the
Commission to the appropriate United States Court of Appeals.
- Those areas in which decisions have been made include penalties, conduct of workplace inspections,
abatement requirements, interpretation of safety and health standards, and employment relationship
to job safety requirements.
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NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
Responsibilities
The National Institute of Environmental Health Sciences (NIEHS)
was established in 1966 as a biomedical research organization within NIH.
It is the principal Federal agency for the support of research and training
of manpower to carry out research in the area of effects of chemical, physi-
cal, and biological environmental agents on human health. NIEHS's goal is
to provide the scientific information base, advanced scientific methodology,
and trained scientific manpower to reach an understanding of the total
impact of environmental factors on human health.
To meet its objective, NIEHS sets research priorities developed
through a program planning process that takes into account the changing
nature of environmental health problems, the rapidly evolving state-of-the-
art in the field, and the opportunities available to the Institute. This
process permits the Institute to take advantage of the best thinking of the
academic and scientific communities in addition to that of its own staff.
Initially, this process involved planning undertaken to describe the NIEHS
mission. Thereafter, concurrent planning, strengthened by two major environ-
mental health task force reports, followed to.provide ongoing and future
guidelines for NIEHS research programs.
The mission of the Institute takes into account several considera-
tions. First, NIEHS takes a broad view. It does not consider only disease
end-points, vehicles by which hazards are transmitted, or particular popula-
tion groups affected. Its approach is holistic, requiring multidisciplinary
research efforts. Such an approach is necessary to identify the consequences
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of the interaction of biological systems with chemical, biological, and
physical agents in the environment. In this connection, the need is two-
fold: a) there must be vigorous and integrated study of the effects of
environmental factors on human health and well-being; and b) there is an
overriding need to establish the basic information upon which realistic
control measures could be based.
Second, NIEHS research objectives determine how environmental
agents produce deleterious effects in exposed persons and the circumstances
that influence the expression of these effects. This is intended to permit
principles to be developed through which the probable toxicity of new as
well as existing compounds can be predicted. Individual bioassay of every
agent is impossible because of the enormous expense involved in testing the
700 to 1,000 new compounds introduced in commercial quantities every year, as
well as the approximately 15,000 synthetic chemicals already in the environ-
ment. This meant interest must be focused upon the fundamental nature of the
body's response to these agents and the ultimate consequences for health and
longevity. In addition, programs are directed to investigate and identify
the opportunities that such basic knowledge may offer for preventing environ-
mentally related disease.
Several factors make achieving these objectives difficult. The
investigations of NIEHS are not directed only to exposure of overwhelming
concentrations of environmental agents producing immediate or short-term
responses that are relatively easy to detect and understand. Rather, and
more difficult, the Institute must determine the significance of the effect
of multiple, or combinations of, agents because additive or synergistic
effects interacting at a common site may be important in disease development.
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Finally, because of the broad nature of the problems to be addressed,
NIEHS is called on to carry out a wide range of coordination efforts, includ-
ing collaborative programs with other Federal and non-Federal organizations.
It also engages in a high degree of cooperation with academic institutions
to advance understanding of the relationship of environment to health and to
stimulate recruitment and training of research personnel.
NIEHS pursues its mission by supporting training in the areas of
environmental toxicology, environmental pathology, environmental mutagenesis,
and environmental epidemiology and funding basic and applied research on the
consequences of exposure of man and other biological systems to potentially
toxic or harmful agents in the environment. In its research, NIEHS attempts
to learn: (1) how and where potentially harmful environmental agents are
released into the environment; (2) how these agents move, and possibly change
as they move, through the environment; (3) how they come to affect man and
other biological systems in the environment; (4) the extent of exposure of
various population groups, especially sensitive populations, to these agents;
(5) what effects these agents cause by themselves and in combination with
other factors in the environment; (6) what happens in biological systems
after exposure to hazardous agents; and (7) what diseases are caused or
aggravated. In rounding out these activities NIEHS supports efforts to
identify hazardous environmental agents before they are released into the
environment. These efforts include developing, testing and validating bio-
logical assay systems that can be used to predict the toxic effects which
might occur in humans following exposure to these agents.
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The output of NIEHS programs is intended to aid those agencies and
organizations, public and private, with responsibilities for developing and
instituting regulations, policies, and procedures which will reduce the inci-
dence of environmentally induced diseases.
Legislative Framework
There is no single Congressional Act which provides specific legis-
lative mandates for NIEHS. Even before the NIEHS was created, the need for
special program development in environmental health was recognized; and a
number of planning activities followed that led to the definition of the
MIEHS mission and responsibilities.
The concept of a national research center dealing with the scientific
aspects of environmental health was first spelled out in a June 1958 report
prepared by a committee headed by Dr. Stanhope Bayne-Jones, entitled, "The
Advancement of Medical Research and Education Through the Department of Health,
Education, and Welfare." This report indicated the need for a strong Federal
public health research program to deal with the emerging health problems
related to the increasing number and variety of substances in the environment.
In November 1961, the Surgeon General of the U.S. Public Health
Service established a Committee on Environmental Health Problems, headed by
Dr. Paul Gross of Duke University, to develop long-range objectives for a PHS
environmental health program. The Committee recommended creation of an
environmental center and a new Office of Environmental Health Sciences. The
Committee's report said:
"It is the Office of Environmental Health Sciences,
in particular, which will make possible an integrated
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national environmental health program while avoiding
unnecessary duplication of effort. It offers a new
method of attacking those facets of environmental
health problems which are common to many of the
operational programs. By its integrated approach
it can identify and appraise environmental health
problems which are not under consideration. At the
same time it can develop a protection criteria which
are based on all aspects of the environment."
Congress approved funds in September 1964 for the planning of a
central environmental health facility with the understanding that it would
be limited to research and with the provision that it be located more than
50 miles from the District of Columbia.
At the suggestion of the Office of Science and Technology, staff
papers developing the proposal were submitted to a small group drawn from the
National Environmental Health Advisory Committee, headed by Detlev W. Bronk,
for comment on the mechanism by which such an undertaking would be best
activated. In April 1965 this group unanimously recommended that the center
be operated by the Public Health Service, that it seek the assistance of
qualified scientific organizations in developing its plans, and that it
solicit advice from appropriate advisory bodies. Arrangements were made
with consultants (in conjunction with a panel of scientists from several
national as well as neighboring universities, representing various disci-
plines relevant to the center's overall purpose) to review staff plans for
the center's mission, broad program, scientific components, facility
requirements, and staffing needs. This report, delivered on November 1,
1965, includes a statement of objectives and a guide to the development of
the NIEHS.
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A site for the new institute was selected at Research Triangle Park,
North Carolina.
The Division of Environmental Health Sciences was established as
part of the National Institutes of Health in 1966. The Division was elevated
to an Institute in 1969 by the Secretary of the Department of Health, Educa-
tion, and Welfare.
A Congressional appropriation of 2.5 million dollars in 1976 was
awarded to NIEHS for the construction of permanent facilities. Subsequently,
an additional 42 million dollars was allocated allowing completion of the
facility in mid-1980.
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Appendix C
NON-TASK FORCE AGENCIES AND COMMITTEES WITH
ASSOCIATED INTERESTS IN TASK FORCE EFFORTS
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Appendix C
NON-TASK FORCE AGENCIES AND COMMITTEES WITH
ASSOCIATED INTERESTS IN TASK FORCE EFFORTS
TASK FORCE OBSERVER AGENCIES
The Center for Disease Control at Atlanta (other than NIOSH,
which is also part of CDC) and the National Center for Health Statistics
have important roles relating to the efforts of the Task Force and have
participated in its effort as observers. It is anticipated that these
two agencies will join as full Task Force members in the future. Their
responsibilities in the area of environmentally related cancer, heart
and lung disease are described in the following paragraphs.
The National Center for Health Statistics (NCHS) has, since
1969, been responsible for producing baseline data on births, deaths,
injury, disease, illness and medical care in the population. Until 1974
the NCHS statistical output was oriented toward health in the United States
in relation to our social environment (urban/rural, income, education, etc.).
In 1974 the Secretary of DHEW was authorized by Congress to collect sta-
tistics on "other health hazards." NCHS has since worked closely with
the various agencies concerned with environmental problems to plan, con-
duct, and coordinate health information gathering activities related to
developing a data base which better illuminates the relationships of
health and environment.
The Center for Disease Control (CDC) at Atlanta serves as the
Public Health Service's focal point for the control and prevention of infec-
tious, vector-borne, preventable acute and chronic diseases and conditions;
occupational health and safety problems; and certain environmentally
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induced health problems. CDC is also charged with certain regulatory
activities, such as prevention of importation of disease from other
countries and the evaluation of occupational health hazards. This latter
task is carried out by NIOSH.
NON-TASK FORCE AGENCIES WITH MAJOR REGULATORY RESPONSIBILITIES
Other Federal agencies with primary regulatory or enforcement
roles whose activities have bearing on the work of this Task Force include
the Consumer Products Safety Commission, the Food and Drug Administration,
the Occupational Safety and Health Administration, and the Mine Safety and
Health Administration.
Formerly within the Food and Drug Administration, the Consumer
Products Safety Commission (CPSC) became an independent agency under
Congress in 1973. CPSC acts in a regulatory capacity to protect the public
from the use of products containing substances harmful to health. As a
regulatory agency, the Commission relies heavily on research done by
other Federal agencies to provide it with information on substances which
should be eliminated from products because they are toxic, carcinogenic
or possibly carcinogenic. In addition, the Commission conducts limited
research, including in vivo and in vitro screening of chemicals for muta-
genicity and carcinogenicity, animal inhalation studies and toxicological
studies. CPSC is of importance to the Task Force because it is respon-
sible for control and regulation of substances which become a part of our
environment through the manufacture and use of products which may cause
cancer or exacerbate heart and lung disease.
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The Food and Drug Administration (FDA) within the Department of
Health, Education, and Welfare supports research on a wide variety of chemical
and physical environmental agents. It has been given a mandate to regulate
and eliminate health hazards in food and harmful emissions from electronic
products. FDA's environmental health research is conducted principally
through its National Center of lexicological Research which develops test
protocols and conducts toxicological tests for environmental agents in the
food chain, the Bureau of Foods which researches hazards in food from micro-
organisms and chemicals, and the Bureau of Radiological Health which studies
hazards of radiation.
The Occupational Safety and Health Act (1970) designated the
Occupational Safety and Health Administration (OSHA) within the Department
of Labor as the agency which establishes occupational safety standards to
provide for worker protection. Compliance monitoring and enforcement of the
safety standards set is an essential part of OSHA's role. NIOSH provides
research and standard setting support to OSHA. This requires detailed coor-
dination between the two agencies. Through joint NIOSH/OSHA working groups,
technical standards are developed under the Supplemental Occupational Stan-
dards Program. The standards cover such areas as: education of employees
as to potential hazards, monitoring and engineering control mechanisms,
establishment of sampling techniques and sampling intervals and medical sur-
veillance and testing programs.
The Mine Safety and Health Administration (MSHA) is the Federal
agency responsible for the enforcement of statutes created to protect the
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health and safety of mine workers. This agency was created in 1973 by the
Secretary of the Interior as separate from the Bureau of Mines. The Fed-
eral Mine Safety and Health Amendments Act of 1977 transferred the authority
of this agency from the Department of Interior to the Department of Labor.
The primary role of MSHA is the enforcement of the provisions of the 1977
legislation and the promulgation and enforcement of mine health and safety
standards.
OTHER AGENCIES CONCERNED WITH ENVIRONMENTAL HEALTH
In addition to the agencies described above, numerous other
departments of the U.S. Government support environmental health research
as part of their missions and hence share in some part in the overall Fed-
eral program addressed to the study and control of environmental cancer,
heart and lung disease.
In 1970, the National Environmental Policy Act established the
Council on Environmental Quality in the Executive Office of the President.
The Council was charged with the task of coordinating all environmental
quality programs and with making thorough reviews of all Federal programs
related to the environment. Federal agencies are required to file state-
ments with the Council detailed statements on environmental implications
of all legislative proposals as well as on major activities they adminis-
ter which have significant environmental impact. The Council transmits
yearly reports to Congress on current environmental trends and its sugges-
tions concerning ways of remedying deficiencies in existing programs and
activities.
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The Department of Energy supports environmental health research
aimed at understanding the role of energy-related pollutants as a cause of
human health problems in order to design new and expanding energy technol-
ogies in ways which will minimize their side effects.
The Department of Agriculture is also involved in environmental
health-related research, principally done by its Agricultural Research Ser-
vice, Cooperative State Research Service and the Forest Service. These
services are concerned generally in assuring the safety of water and food
for human consumption. Its research includes investigation of the metab-
olism and fate of pesticides and insecticides in the food chain, studies on
methods for reducing bacteria, viruses and molds in our foods and develop-
ment of methods for soil and vegetation management which will protect the
quality of the drinking water.
The Department of Defense allocates funds to environmental health-
related research in support of its responsibilities to minimize and prevent
adverse health impacts from its facilities. Its attention has been directed
to such areas as studies of the effects, hazards, and disposal of toxic indus-
trial wastes, ambient air quality surveys at military air bases, studies of
contaminated land areas and land application of waste waters, and development
of criteria for direct recycling and reuse of treated waste waters.
The National Bureau of Standards within the Department of Commerce
is the principal Federal agency concerned with the development and promotion
of advanced measurement methods and evaluation of scientific data to ensure
accurate air, water and noise pollution measurements. Its research pro-
vides a technical data base which other agencies can use in determining
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regulations for pollution sources as well as aiding them in basic research
concerning rates of chemical reactions taking place in the environment and
measurement of low levels of chemicals in the air, water and food chain.
Other Federal agencies with ancillary concerns aimed at environ-
mental effects on our Nation's health include: The Department of the Interior,
principally through the Fish and Wildlife Service, Bureau of Mines and the
Office of Mater Research and Technology; the Nuclear Regulatory Commission;
the Department of Housing and Urban Development; and the Department of Trans-
portation.
INTERAGEHCY COMMITTEES AND TASK FORCES
In addition to work done in the field of environmental effects on
human health by individual Federal agencies, a number of interagency commit-
tees and task forces have been established to coordinate and help direct the
Federal effort.
The President's Environmental Message of May 23, 1977 established
prevention of harm from toxic substances as a high priority of his admin-
istration. The Council on Environmental Quality was instructed to coor-
dinate an interagency program to eliminate overlaps and fill gaps in the
collection of data on chemicals and to coordinate Federal research and
regulatory activities affecting them. As a result, an interageney Toxic
Substances Strategy Committee was formed to carry out the directive. This
Committee includes representatives from 11 agencies and the Domestic Coun-
cil, all with responsibilities relating to the control of potentially
hazardous chemicals in our environment. Task Force members participating
in this committee are EPA, MCI, NIOSH and NIEHS.
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Also in response to the President's Environmental Message of 1977,
the CEQ-led Interagency Task Force on Environmental Data and Monitoring was
established to review present environmental monitoring and data programs and
recommend improvements that would make these programs more effective.
Represented on this Task Force are all Federal agencies with significant
expertise and interest in environmental data and monitoring. EPA and HEW
are represented on this Task Force.
In response to the Toxic Substances Control Act, the TSCA
Interagency Testing Committee, was formed to make recommendations to the
Administrator of the Environmental Protection Agency respecting the chemi-
cal substances and mixtures to which EPA should give priority for requiring
testing. Its statutory members are CEQ, DOC, EPA, NSF, NIEHS, NIOSH, NCI
and OSHA with DOD, FDA, DOI and CPSC in a liaison role.
The Interagency Toxic Substances Data Committee, also mandated under
the Toxic Substances Control Act, is co-chaired by EPA and CEQ with other
members from the agencies concerned with toxic substances control. Its pur-
pose is to design and establish a data system for the efficient retrieval of
toxicological and other scientific data useful for industry and government
in carrying out the Act.
The PHEW Committee to Coordinate Toxicology and Related Programs
was established in 1973 by the Assistant Secretary for Health, Department
of Health, Education, and Welfare as a multi-agency group to-provide a
medium to assure exchange of information on toxicology and related programs,
to coordinate these programs, to enhance sharing of resources, and to pro-
vide advice to the Department to aid in establishing research priorities.
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The Committee's advice also guides decisions being made by regulatory
agencies, and its members serve as contacts with scientific and industrial
communities and state and local governments concerned with toxicology con-
cerns. Members and observers of this Task Force on the Committee include
representatives from NCI, NIEHS, CDC Atlanta, and NIOSH. EPA provides
liaison representatives on the Steering Subcommittee.
The Interagency Collaborative Group on Environmental Carcinogenesis
was established in early 1972 primarily as a mechanism for interfacing of NCI
with other Federal agencies that would permit a holistic approach to environ-
mental cancer (air pollutants, water pollutants, drugs, diet contaminants and
workplace exposures). It became obvious after initiation of this group that
the National Cancer Program was responsive to that section of the National
Cancer Act of 1971 which requires collaboration with Federal agencies. The
ICGEC also provides an exchange forum for data and information on environ-
mental cancers. It also has as an objective the stimulation of collaboration
and implementation of cooperative projects such as those now in existence
under the NCI/NIOSH and NCI/EPA collaborative programs on environmental can-
cer. The ICGEC draws on representation from 28 agencies or subagencies with
NCI's representative acting as chairman.
The Chemical Selection Working Group (CSWG) was established to
assist the NCI Carcinogenesis Bioassay Program in selecting chemicals for
test. Chemicals to be selected for testing are first discussed by the CSWG
before review by the Clearinghouse on Environmental Carcinogens (page 25).
The CSWG is composed of representatives from the following government agencies:
NCI, EPA, NIEHS, NIOSH, CDC, CPSC, FDA, OSHA, DOA, DOE, and DOD.
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In the regulatory area, EPA, CPSC, FDA, and OSHA have formed an
Interagency Regulatory Liaison Group to examine, assess, and redesign, if
necessary, the processes by which they regulate chemicals which impact upon
people and the environment and to coordinate their research programs. Cur-
rently there are eight active work goups with IRLG. In addition, the Depart-
ment of Labor and the Office of Management and Budget have announced a joint
effort to eliminate duplication and fill gaps in regulating workplace
hazards and to propose a system of incentives to supplement regulation.
The establishment of the above-mentioned committees and task
forces, all aimed at the coordination of our research in the environmental
research field as well as collation of information already collected, should
be of great importance to the mission of this Task Force. Combined efforts
by these groups may:
Be instrumental in developing a comprehensive research
program to determine and quantify the relationship
between environmental toxicants and cancer, heart and
lung disease.
t Coordinate information between agencies providing
information regarding environmental pollutants thought
to aggravate cancer, heart and lung disease and those
responsible for strategies designed to eliminate these
environmental risks.
Coordinate control efforts to reduce pollutants affect-
ing heart, lung and blood disease.
Identify monitoring programs which should be expanded
or initiated.
Advise the Task Force on substances considered to be
priority environmental pollutants, especially in rela-
tion to cancer, heart, lung and blood disease.
t Advise the Task Force on substances not yet tested or
requiring further study to fill gaps in information.
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