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OCR for page 15
CHAPTER 1
INTRODUCTION
Goals of the Planning Study
The effects of environmental factors on human health and
well-being have attracted increasing attention in recent years.1-3
Environmentally related health problems are of major concern because
they may contribute substantially to rising costs of illness, and
because most of them are--theoretically--preventable.2-5 But there
also is concern about costs of regulations designed to yield a
cleaner environment. Although estimates of such costs abound, they
are no t balanced by reliable e s timates of potent) a 1 bene f i ts.6-8
In an effort to improve estimations of benefits, Congress
enacted Public Law 95-623, the Health Services Research, Health
Statistics, and Health Care Technology Act of 1978.9 Section 7
calls for an "ongoing" study designed to improve the information on
and methodologies for estimating costs of illness caused by harmful
environmental exposures and for estimating benefits of improvements
in the environment. The benefits of concern are improved health and
decreased costs of illness.
Congress recognized that any estimates of such health benefits
made with existing data will be very imprecise, and that there is a
great need to more accurately evaluate benefits of programs to
improve the environment. A recent Supreme Court decision, in which
the Court fai led to uphold an Occupational Safety and Health
Administration (OSHA) standard for benzene on the grounds that
benefits had not been sufficiently demonstrated, is only one example
of the need for benefit analyses.l° Even crude estimates of
benefits can help policymakers set priorities and choose among
alternative strategies. As better data become available and
methodologies advance, uncertainties in the estimates should
diminish, affording improved policy decisions.
Congress asked the Institute of Medicine and the Department of
Healtt' and Human Services to conduct an ongoing study which is to
address "present and projected future health costs of pollution and
other environmental conditions resulting from human activi ty"
anyplace in the indoor or outdoor environment, including places of
employment and resi dance .9 The ongoing study would provide
-15-
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information on sources of environmental hazards, the health effects
attributable to those sources, and the costs of these health effects.
The law calls for biennial reports that identify deficiencies in
the availab le data, recommend corrective actions, and recommend ways
to facilitate evaluation of the health effects of environmental
hazards. Appropriate government agencies, such as the Environmental
Protection Agency, must be involved. Finally, the~law specifies a
wide variety of medical and social costs that must be considered.
(Sections 7 and 8 of the law are in Appendix A.)
Many aspects of environmental effects on health, as encompassed
by P.L. 95-623, will contribute to the complexity of the ongoing
study. In a broad context, the human environment includes all the
activities and outside factors (that is, non-genetic factors) that
can affect human health in beneficial or in harmful ways. These may
include activities that individuals undertake, such as smoking and
exercising, and substances to which people are unknowingly exposed,
such as trace substances in food or air. The social environment,
which includes socioeconomic factors as well as relationships among
family, friends, and work associates, can be included e Exposure to
beneficial or harmful environmental agents may occur from a variety
of sources and by various routes, singly or in combination.]
People may be exposed to agents by inhalation, ingestion, contact
with the skin, or through action on the sensory organs, for example,
loud noises. As explained later in this chapter, this report
recommends that the ongoing study initially emphasize involuntary
exposures to potentially hazardous chemical and physical agents
resulting from human activi ty.
Health effects to be studied also span a wide range. They may
include cancers, respiratory conditions, heart and circulatory
disorders, mental illness, reproductive disorders, and illness
associated with other organ systems.
Because of the ongoing study's broad scope, the Institute of
Medicine undertook this planning study to assure that the ongoing
study proceeds in an orderly and useful way. Major goals of the
planning study were to
o describe the basic information requirements necessary for
- the ongoing study and for the biennial reports
o provide a framework for the ongoing study and an assessment
of the feasibility of meeting the various requirements of
the law
o recommend administrative arrangements for carrying out the
ongoing study
-16-
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o recommend steps to maximize the usefulness of the biennial
reports.
The Institute of Medicine committee that prepared this report
has developed a conceptual framework for the ongoing study rather
than a step-by-step plan. This report describes the types of
information needed to conduct the ongoing study, discusses the
difficulties inherent in the congressional charge, and makes
recommendations for improving the data and methodologies needed to
provide the estimates Congress requested.
Chapter 1 provides an overview of the problem. Chapters 2 and
describe the kinds of information needed and available to relate
hazards to health effects. Chapter 4 discusses the various costs
described in Section 7 of P.L. 95-623 and the methodologies available
for estimating them. These last three chapters appraise the
difficulties of attempting to arrive at numerical estimates, noting
that great uncertainty will attach to any numerical estimates
d eve loped .
Some of the practical admini strative i ssues of implementing the
ongoing study are reviewed in Chapter 5, which also describes how the
ongoing study might serve the needs of various groups. Chapter 6
recommends a series of phased activities for the ongoing study and an
administrative structure, suggests topics for detailed analysis, and
makes additional recommendations for improving available data.
Historical Background: Estimating Benefits
of Environmental Regulations
A brief review of the recent history of environmental regulation
indicates the need for benefit estimates.ll The decades of the
1950s, 1960s, and especially the 1970s were periods of major federal
legislative activity to control potential environmental hazards,
particularly pollutants.6 Appendix B briefly describes major
federal environmental statutes. In the periods preceding enactment
of virtually all of these laws, data were gathered to define the
magnitude of the environmental problem and, in many cases, its
qualitative association with health. Once a law was in place, the
responsible agency focused on showing improvement or deterioration of
pertinent environmental indicators. But the agencies made little
attempt to quantify relationships among environmental factors, health
effects, and costs of these health effects.
Although environmental legislation usually called for research,
it seldom provided for research that would help establish data bases
to reveal relationships between environmental variables and effects
on health. However, agencies have sponsored investigations, such as
-17-
OCR for page 18
epidemiologic studies,12~13 that have attempted to identify these
relationships and to discover mechanisms of action of harmful
environmental agents.
The agencies' major efforts went towards defining and
controlling environmental problems. The data collection systems that
evolved from the various pieces of legislation met at least partially
the needs for which they were intended, but they were not set up to
relate health effects to environmental measures.14 Beneficial
health effects were assumed, but not measured.l5 Also, there was
no particular attempt made to evaluate costs of these regulations, or
to develop cost/benefit estimates. For example, the OSHA Act
specifically excludes cost as a reason for obtaining a variance from
some provisions of the law.16 Now, however, increased concern with
costs of illness and costs of environmental regulations has led
Congress to seek evidence for health benefits of these
regulatiOns.17,18
Although the legislation calling for this planning study refers
to reducing health costs, the aim also can be considered in terms of
health bene fi ts that would result from reducing environmental
hazards. This is not the only information that decision makers
need,l9 but it helps those who must consider the cost effectiveness
of regulations or standards intended to improve the environment.
However, P.~. 95-623 does not ask the ongoing study to do
cost/benefit analyses or cost effectiveness analyses, or to provide
data on pollution abatement costs, all of which may be relevant for
making policy decisions. Therefore, this planning study is not
considering all relevant information, but only information related to
estimating health benefits.
Benefits of pollution abatement are often more difficult to
estimate than costs. One reason is that costs are incurred
in the short term, while benefits may appear only far in the
future.8~17~22,23 Benefits of a less hazardous environment,
besides improvements in health, could include better recreational
facilities or improvements in productivity.22 Not all types of
benefits are readily expressed in economic teens. Health benefits
are particularly difficult to document or to convert to dollars,
partially because of problems in attributing a dollar value to human
life and its quality.
Nonetheless, there have been numerous attempts to estimate the
benefits of a cleaner environment. Two recent reviews suggest that,
although the health benefits from controlling pollution and other
environmental hazards cannot be accurately quantified, they probably
are considerable.17~22 For example, if air quality has improved
20 percent from 1970 to 1978--an assumption that is consistent with
some analyses--the benefits are estimated at anywhere from $5 billion
to $58 billion per year, about 80 percent of which are to health.22
-18-
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Because methods and assumptions for estimating costs of
pollution abatement differ from those for estimating benefits, the
results are not necessarily comparable. Estimates of costs of
pollution control are more precise. For instance, expenditures for
abating pollution and improving environmental quality in the United
States totaled about $46.7 billion in 1978, which was about 2 percent
of the Gross National Product.6 of those expenditures,
approximately $20 billion each went to improving air quality and
water quality, and $6 billion went for control of solid wastes.
Information Needed by the Ongoing Study
P.L. 95-629 enumerates explicitly the kinds of information the
ongoing study should provide. Section 7(e)~1~(A-E) calls for an
ongoing study that shall, to the extent feasible
(A) identify the pollution (and the pollutants responsible for
the pollution) and other environmental conditions which are,
or may reasonably be anticipated to be,.responsible for
causing, contributing to, increasing susceptibility to, or
aggravating human diseases and adverse effects on humans;
(B) identify each such disease and adverse effect on humans and
specifically determine whether cancer, birth defects,
genetic damage, emphysema, asthma, bronchitis and other
respiratory diseases, heart disease, stroke, and mental
illness and impairment are such a disease or effect;
(C) identify (on a national, regional, or other geographical
basis) the source or sources of such pollutants and
conditions and estimate the portion of each pollutant and
the extent of each condition which can be traced to a
specific type of source;
(D) ascertain (i) the extent to which the pollutants and
conditions identified under subparagraph (A) are, or may
reasonably be anticipated to be, responsible, individually
or coil ec t ive ly, for caus i ng, contribut i ng to, i ncreas ing
susceptibi lity to, or aggravating the diseases and effects
identified under subparagraph (B), and (ii) the effect upon
the incidence or severity of specific diseases and effects
of individual or collective, as appropriate, incremental
reductions in the pollutants and changes in such conditions
and
(E) quantify (i) the present and projected future health costs
of the diseases and effects identified under subparagraph
(B), and (ii) the reduction in health costs which would
result from each incremental reduction and change referred
to in subparagraph (~) (ii).
-19-
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To obtain the estimates Congress has requested, it will be
necessary to ascertain:
o sources and amounts of environmental hazards
o their dispersion into the environment
levels of human exposure from contact with and absorption of
the substances in question
health effects, expressed quantitatively, resulting from a
given exposure
o costs of the resulting health effects.
Figure 1-1 depicts these requirements schematically. The chart
shows the data needed and methodologies used to derive the relevant
information and to develop relationships among the different kinds of
information. Chapters 2, 3, and 4 of this report will discuss the
chart in greater detail.
Sources and Dispersion of Substances
Boxes 1 and 2 in the figure represent information related to the
sources of a substance and the amounts of it or its derivatives
entering the various parts of the environment. Much of this
information comes from environmental monitoring activities carried
out in response to regulatory requirements.24 Monitoring
information is useful for determining pathways of exposure and for
taking steps to decrease exposures arising from human activities.*
Despite the vast amount of these data available,24~25 there is
little information on exposures to individuals from the various
sources.
Human Exposure
Boxes 3 and 3a relate to exposure measurements. Direct
measurement of exposure would be most desirable, but such information
is rarely available. Instead, exposure calculations often are based
on concentrations of substances measured in air, water, food, and
pollution and other environmental conditions resulting from human
activities," the phrase used in P.L. 95-623, can encompass a broad
spectrum of hazards. It is often not possible to distinguish natural
hazards from "man-made hazards," and this report does not attempt a
sharp distinction.
-20-
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FIGURE 1-1. CAT OF INFORMATION NEEDED TO ESTATE THE COSTS OF
ENVIRONMENT-RELATED HEALTH EFFECTS AS MANDATED BY PUBLIC
LAW 95-623
1. PRIMARY SOURCES OF HAZARDS
A
NOTE: This chart assumes
a simple substance-by-
~ubstance approach, ignoring,
for example, synergistic
effects
~ ,
3a. TYPES OF DATA
Direct exposure--
personal monitoring
Surrogate measures
of exposure
4a. TYPES OF DATA
In vitro tests
Animal evidence
Clinical studies
Epidemiologic data
(Can include lifestyle.
socioeconomic factors)
Other
1
1 5a. METHODOLOGIES
Output accounting*
Willingness-to-pay
*Often called human capital
Man-made sources
Production processes
products
by-products
Natural sources
_ _ , ~
2. DISPERSION INTO ENVIRONMENT,
including transportation and
transformation processes
Concentration of substances,
which may vary locally, in:
Air
Food
Water
Soil
Other materials used
by people
___ .~
3. HUMAN CONTACT AND ABSORPTION
(Exposure)
—21—
Level in people (Amount or
concentration)
4. QUANTIFYING HEALTH EFFECTS
(Dose-response information)
Health problems
Cancer
Cardiovascular problems
Respiratory problems
Heritable defects
Other
5. ESTIMATING COSTS OF ILLNESS
Medical costs
Physicians
Hospitalization
Drugs
Lost productivity
Lost workdays
Bed days
Home expenses
Pain and suffering
Years of life lost
Other
OCR for page 22
other materials, combined with estimates of the amounts ingested or
inhaled by an average person. In some cases, elaborate models have
been developed to estimate exposure.
Relating Exposure to Health Effects
. . .
The step from Box 3 to Box 4 is perhaps the most difficult in
the scheme. Information for determining the environmental causes of
the health problems in Box 4 comes from several kinds of studies,
including in vitro and animal studies and studies in human
populations (Box 4a).
Many attempts have been made to quantify health impacts of
various environmental factors.6~26-29 Table 1-1 and Appendix C
indicate the range of environmental factors and health effects that
might be considered. Table 1-1 is not comprehensive; it omits, for
example, possible environmental factors in mental illness.
Quantitative assessment of health effects of the environment is
complicated by uncertainty about dose/response relationships,
especially at low doses. Much testing for toxic effects employs high
doses of single substances in animals, but the environment of human
beings constitutes exposures to many substances at-once, and at
varying doses and times, during which susceptibility may
vary.~30~32 For chronic diseases or those with long latency
periods, relating exposure to health effect is particularly
difficult. Nonetheless, dose/response information is necessary for
meeting the requirements of Pet. 95-623, which asks for the change in
health status that would result from various changes in exposure.
Estimating Costs of the Health Effects
-
Boxes 5 and 5a of Figure 1-1 list some of the costs that need to
be considered and the two methodologies most often used in
cost-of-illness studies. Difficulties in determining these costs are
caused by the extensive variety of costs that the law wants evaluated
and by the requirement that future health costs, as well as present
ones, be quantified. Furthermore, the reduction in health costs that
would result from incremental reductions in pollutants and other
hazards must be ascertained. Thus, a systematic approach is needed
to examine health effects-costs relationships by
0 defining the array of costs, including those mentioned in
the law, that can reasonably be expected to derive from a
particular health effect
-22-
OCR for page 23
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o determining which of these can be calculated with reasonable
accuracy, assessing current methods for calculating costs,
and suggesting ways that the methods may be refined or more
broadly appl fed
o suggesting new sources of data and/or new methodologies for
determi ni ng the re levant hea 1 th cos t s .
Various procedures exist for estimating costs of illness, none
of them entirely satisfactory.23~33 Using the output-accounting
(or human-capital) approach developed by Cooper and Rice,34 cost of
illness studies estimate direct and indirect health costs. Direct
costs are medical care expenses, such as those for hospitalization
and physi clans .35 ~ 35 Total direct medical care costs are fairly
readily estimated and allocated among the various health services and
supplies. Allocating direct costs by disease is much less precise,
and attempting to correct for the portion of illness attributed to
environmental factors introduces still greater uncertainty. For
1979, national health care expenditures were $212.2 billion, which
was about 9 percent of the Gross National Product.37 Indirect
costs are more difficult to calculate. They include estimates of the
loss of earnings and the assumed market value of unperformed
housekeeping services.
Table 1-2 shows the estimated direct and indirect costs in 1975
for 16 diagnostic categories, and Table 1-3 ranks them using several
burden of illness criteria.35 Thus, diseases of the circulatory
system ranked first in potential years of life lost, second in number
of inpatient days, and first in total economic burden.
The output-accounting method does not encompass such factors as
pain and suffering, effects of bereavement on family and friends, or
special transportation or clothing costs incurred because of
illness. Other methods, such as the willingness-to-pay approach,
attempt to develop values for illness and death that include factors
not considered by the output-accounting approach,23 but these
attempts also introduce new difficulties.
Additional Comments
Figure 1-1 assumes a substance-by-substance approach, but other
approaches exist. For example, the geographical distribution of
cancer can be compared to aggregate measures of industrial output, or
the health effects of air pollution or other aggregate factors could
be examined without definitive information on which substance or
substances are responsible for the health effect. Useful information
can be derived from the various parts of the scheme without going
through the entire set of boxes. At present, the most critical and
least available information concerns quantifying human exposure to
substances and determining subsequent health effects.
-24-
OCR for page 25
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The difficulties in obtaining the data and performing the
estimates depicted in Figure 1-1 should not be underestimated. There
seldom are identifiable, isolated cause and effect relationships
between environmental factors and health; inadequacies and gaps in
information and methodologies exist for measuring health costs. A
major purpose of this planning study was to recommend systems of
surveillance, monitoring, and data collection to improve the
information avai table, enable assessment of hazards that are not now
adequately understood, and facilitate assessment of associated costs
for known and yet-to-be-identified hazards.
Some of the data needed for the ongoing study already exist,
both in the federal government and elsewhere.14~35 However, these
data usually are collected for a specific purpose, without attempts
at coordinating efforts with other agencies or avoiding
duplication.14~39 Changes in organization of data and in methods
of data collection by agencies and others may be necessary to provide
the estimates required by P.J.. 95-623.
Early Phases of the Ongoing Study
Because the ongoing study cannot cover all environmental
hazards, health effects, and costs in each biennial report, this
planning study suggests criteria for choosing topics that might
receive the greatest attention, although the ongoing study will have
to set more explicit priorities. Each biennial report could discuss
a single health issue, route of exposure, type of hazard, or related
methodology.
The relationship between potential environmental hazards and
their health effects can be approached by starting with a possible
hazard (Box 1 in Figure 1-1) or with a health problem (Box 4 in
Figure 1-1~. In choosing a health problem, criteria that are
frequently used by health professional s for setting priori ties could
be considered. They include 40
o magnitude of health problem, including mortal ity rates,
years of li fe lost because of premature death, severity and
reversibility of effect, transmissibility of effects to
future generations, and other measures such as those in
Table 1-3
probability that additional obtainable information would be
useful
targets of opportunity, even if the problem affects
relatively few people
-27-
OCR for page 28
o public perception of importance
o need for information for policy purposes.
For purposes of the ongoing study, another criterion would be
o strength of evidence linking a health problem to particular
environmental factors.
In choosing a hazard to investigate, criteria could include
o potency of the hazard
o amount of the substance involved
o number of people exposed
o magnitude of the resulting health effects.
Various attempts have been made to set priorities for testing toxic
substances and pesticides according to these criteria.41~42
Areas of Initial Emphasis
The remaining chapters of the report will discuss the ongoing
study, taking into account the topics that the study committee
believes warrant early attention. The committee suggests that
initial emphasis be given to adverse health consequences of
involuntary exposures resulting from man-made changes in the physical
and chemical composition of the environment, including some effects
of noise and radiation. Consideration of life-style factors, such as
diet, exercise, smoking, and alcohol consumption, would largely be
deferred, as would the social environment, accidents, most aspects of
infectious diseases, and side effects of therapeutic actions. Issues
associated with particularly susceptible populations would receive
early attention. Nonetheless, data related to these additional
factors should be collected whenever possible for future analyses.
Also, the possibility of detecting beneficial effects of
environmental factors should be considered.
The suggestion that study of certain areas be deferred is not
intended to imply that they lack importance, but rather derives from
the committee's belief that such deferral will make the study more
workable, or that these areas are dealt with adequately in other
ways. In some cases the language of P.L. 95-623 and the report of
the House Committee on Interstate and Foreign Commerce guided these
decisions.9~18 As time, money, and personnel permit, the
additional areas could be treated. Those areas not receiving major
attention in the first few biennial reports could be included in
later reports.
-28-
OCR for page 29
In the broad areas of initial emphasis, several specific
questions arise. For example, should smoking and alcoholism, which
create a huge burden for society, be included in the study ' s scope?
Although exposure to alcohol and cigarette smoke is partially
voluntary, there are many cases of involuntary exposure. For
instance, exposure of the fetus is involuntary, and smoking and
alcohol consumption each adversely affect fetal growth and
development.2,43~45 Synergistic effects between smoking and
exposure to other environmental hazards magnify harmful
effects.46~47 Furthermore, recent studies indicate that measurable
physiologic changes occur in non-smokers in an environment with
smokers.48~51 The committee would not propose to deal with all
cigarette and alcohol problems, but only with those aspects that
relate to involuntary exposure and to potentiating effects of other
conditions. However, attempts to study effects of particular
environmental factors on individuals also require information on
their lifestyle, such as smoking habits, and other possible
influences on health. (See Chapter 3 for a fuller discussion.)
In the long term, the ongoing study could encompass the social
environment and the health effects resulting from social changes
during the past few decades. However, because addressing the social
environment at present might dilute the study's efforts toward
collecting and analyzing data related to the physical and chemical
environment, the committee would not advise concentration on it at
present. Certainly, the social environment influences both physical
and mental health. Areas that could be studied in greater detail for
health effects include socioeconomic status , changes in family
structure, social aspects of the occupational environment, and the
influence of television, movies, and other communication media.
Effects of bereavement, geographic mobility, and presence or lack of
social supports also require much s tudy .
With respect to nutrition, the study would not initially
investigate adverse effects of natural constituents of the diet,
notwithstanding their obvious importance in health and disease. Fat
content, total numbers of calories, overnutrition, and undernutrition
would not be studied in detail. However, effects of contaminants,
pollutants, and additives would fall early within the ongoing study's
purview.
Accidents and infectious disease also are generally deferred,
although they are important public health problems.2,52 Because
exposure to some environmental conditions may increase susceptibility
to infectious agents, this aspect of infectious disease could be
considered early. Accidents accounted for more than half of the
deaths that occurred among people aged 1-24 in 1978 in the United
States, and were the fourth leading cause of death in the country
o~rerall.53 Particularly in occupational settings, accidents are a
ma-; or cause of d i sabi 1 i ty . 54 ~ 5 S Furthermore, exposure to taxi c
chemicals may increase the probability that accidents will occur.
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However, after extensive discussion, this committee concluded that
accidents and infectious disease generally do not readily fall into
the category of environmental factors referred to in P.L. 95-623.
Known adverse effects of therapeutically administered treatments
and drugs would not be studied initially. Many medical treatments
have potential side effects, and physicians consider the risks and
benefits when they decide to use a particular treatment. Unintended
side effects of medical treatments could fall within the purview of
the ongoing study, but the Food and Drug Administration is
responsible for pre-market testing and post-market surveillance of
drugs and medical devices, and the committee believes that the
ongoing study may not have to study this area in detail. In a
related matter, effects of medical radiation would not receive early
consideration, in contrast to effects of other human activities, such
as use of nuclear power, that may increase background radiation.
However, total radiation exposure is relevant for assessing health
consequences.
Susceptible Populations
Interactions between factors related to individual
susceptibility and factors in the environment may largely determine
health outcome in many cases. Individuals may be more susceptible
because of hereditary factors, because they are in a particular stage
of life, or because of life-style and occupation, for example,
smokers who work with asbestos. Genetic factors are important in the
way individuals metabolize drugs, and many genetic conditions
predispose people to various cancers.56~61 The committee finds
that the issue of individual susceptibility cannot be ignored in
doing risk estimates or quantifying costs.
Usefulness of the Ongoing Study
This Institute of Medicine committee and the Congress recognize
that there will be great uncertainty in any estimates of the costs of
health effects--however expressed--that the ongoing study develops.
although no final or precisely quantitative attribution of health
costs to environmental factors is likely to be attained in the near
future, the ongoing study should help reduce uncertainties in the
values. If the estimates, however crude, contain a clear indication
of their limitations, the estimates will help Congress and federal
agencies make decisions that use limited regulatory and data
collection resources more effectively than is now possible.
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.
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Representative terms from entire chapter:
environmental hazards