Order Code IB94036
CRS Issue Brief for Congress
Received through the CRS Web
The Role of Risk Analysis
and Risk Management
in Environmental Protection
Updated July 13, 2004
Linda-Jo Schierow
Resources, Science, and Industry Division
Congressional Research Service ˜ The Library of Congress

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CONTENTS
SUMMARY
MOST RECENT DEVELOPMENTS
BACKGROUND AND ANALYSIS
What Is Risk Analysis?
Views on Potential Uses of Risk Analysis
How Valuable a Tool?
Is It a Scientific Basis for Environmental Decisions?
Should It Be Used to Compare Costs and Environmental or Health Benefits?
Should Priorities Be Based on Relative Risks and Risk Reduction Opportunities?
The Information Value of Risk Analysis
Key Factors Determining the Quality of Information Provided
Quality of the Database
Risk Assessment Methods
Legislative Activity
Legislation in the 107th Congress
Legislation in the 108th Congress
LEGISLATION
CONGRESSIONAL HEARINGS, REPORTS, AND DOCUMENTS
FOR ADDITIONAL READING

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The Role of Risk Analysis and Risk Management
in Environmental Protection
SUMMARY
The outlook is uncertain in the 108th
argue it should be used to target federal pro-
Congress for legislation that would promote
grams to address the worst risks to health and
use of environmental risk analysis. So far,
the environment first, to achieve risk reduc-
there has been little legislative activity involv-
tion in more cost-effective and flexible ways
ing environmental risk analysis or broader
that minimize overall economic impacts, and
regulatory reform legislation. On May 18,
to ensure that risk reduction achieved by
2004, the House passed H.R. 2432, directing
regulations is worth the cost.
the President’s Office of Management and
Budget (OMB) to conduct a study of regula-

Other Members, some academics, and
tory budgeting focusing on programs at three
many environmentalists argue that excessive
of four designated agencies, including EPA,
reliance on risk analysis to evaluate problems
and to include the results of the study in the
and solutions related to human health and the
annual report to Congress on the costs and
environment, especially quantitative risk
benefits of federal regulations. Companion
analysis, ignores other important facets of
bills have been introduced into the House
policy decisions, such as environmental im-
(H.R. 936) and Senate (S. 448) that would
pacts, timeliness, fairness, effects on demo-
mandate research and evaluation of health
cratic rights and liberties, practicality, moral-
effects for “vulnerable sub-populations” and
ity, reversibility of effects, regulatory stability,
establish a U.S. policy of protecting them
flexibility, or aesthetic values. Critics charge
from pollution with “an adequate margin of
that quantitative methods cannot assess very
safety.” The health of children would be
long-term or newly discovered threats. They
protected by requiring an additional margin of
also believe that quantitative cost-benefit
safety, unless reliable data were available and
analyses (which are derived in part from risk
sufficient to evaluate the susceptibility and
analyses) undervalue environmental and
exposure of children to an environmental
health benefits, exaggerate costs, and focus on
pollutant. Administrative reforms promoting
relatively widespread but individually small
risk analysis that were begun during the 107th
costs and risks rather than on much larger
Congress have continued in the 108th.
costs and risks to smaller, and often more
vulnerable, groups. In addition, they charge,
Risk analysis is the systematic evaluation
risk analysis typically evaluates data for well-
of hazards and their possible effects. Views
studied and relatively well-understood haz-
on the potential uses of risk analysis differ.
ards, ignoring emerging concerns about haz-
Although, most experts and policy-makers
ards that are poorly understood.
agree that risk analysis is a valuable tool to in-
form decisions, they disagree about the extent
The quality of any risk analysis depends
to which risk estimates may be biased and
on adequacy of data and validity of method.
should be allowed to influence public policies
For environmental hazards and most health
to protect health and the environment.
and ecological effects, data are limited, meth-
ods are controversial, and consequently, quan-
Some Members, many academics, and
titative risk estimates are very imprecise and
regulated industries argue that risk analysis is
highly uncertain.
objective and reflects sound science. They
Congressional Research Service ˜ The Library of Congress

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MOST RECENT DEVELOPMENTS
The outlook is uncertain in the 108th Congress for legislation that would promote use
of environmental risk analysis. So far, there has been little legislative activity involving
environmental risk analysis or broader regulatory reform legislation. On May 18, 2004, the
House passed H.R. 2432, directing the President’s Office of Management and Budget (OMB)
to conduct a study of regulatory budgeting focusing on programs at three agencies,
potentially including EPA, and to include the results of the study in the annual report to
Congress on the costs and benefits of federal regulations. Companion bills have been
introduced into the House (H.R. 936) and Senate (S. 448) that would mandate research and
evaluation of health effects for “vulnerable sub-populations” and establish a U.S. policy of
protecting them from pollution with “an adequate margin of safety.” The health of children
would be protected by requiring an additional margin of safety of at least 10-fold in the
setting of all environmental standards, unless reliable data were available and sufficient to
evaluate the special susceptibility and exposure of children (including exposure before birth)
to an environmental pollutant. Administrative reforms promoting risk analysis that were
begun during the 107th Congress have continued in the 108th, particularly in the form of
directives from the Office of Information and Regulatory Affairs (OIRA) in OMB.
BACKGROUND AND ANALYSIS
As a potentially valuable tool for addressing concerns about the growing cost to
regulated industries and communities of compliance with environmental requirements, risk
analysis may be useful to EPA and Congress to set priorities among programs and evaluate
management options. However, considerable controversy revolves around the value of risk
analysis and the role it should play in environmental decision making. (For more detailed
information, see CRS Report 98-619, Risk Analysis: Background on Environmental
Protection Agency Mandates and CRS Report 98-618, Environmental Risk Analysis: A
Review of Public Policy Issues.)
What Is Risk Analysis?
Professional risk analysts do not agree on how key terms should be defined, but for the
purpose of discussion, this report uses the following specific definitions. In the context of
environmental issues, “risk” is defined as the probability of occurrence of a particular
adverse effect on human health or the environment as a result of exposure to a “hazard,”
which may be a hazardous chemical in the environment, a natural hazard, or a hazardous
technology. “Risk assessment” refers to a formal or informal procedure producing a
quantitative estimate of environmental risk. For example, risk assessment is often used to
estimate the expected rate of illness or death in a population exposed to a hazardous
chemical. “Risk analysis” is used more broadly to include quantitative and qualitative
evaluation of all relevant attributes of environmental hazards, risks, adverse effects, events
and conditions that lead to or modify adverse effects, and populations or environments that
influence or experience adverse effects. “Risk management” is the process of deciding what
should be done about a hazard, the population exposed, or adverse effects, implementing the
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decision, and evaluating the results. It also refers to decision making at the program or
agency level, for example, deciding which hazards should be managed and in what order.
Comparative (or relative) risk analysis and cost-benefit analysis are aids to risk management.
Views on Potential Uses of Risk Analysis
How Valuable a Tool?
Most people seem to agree that risk analysis is a potentially valuable tool for
summarizing scientific information obtained from animal experiments and studies of
accidental or occupational human exposures to hazards. But, people disagree about how risk
analysis should be used and how much influence it should have on government decisions.
Regulated industries and many academics support legislation that would increase use
by environmental policy makers of risk analysis, arguing that it is a scientific and objective
basis for making rational risk management decisions. It allows comparisons of the
importance of perceived problems and evaluation of the need for proposed solutions, they
maintain. Thus, it permits efficient allocation of limited resources.
Other academics and most environmentalists stress the limitations of risk analysis.
Activists for environmental justice (that is, avoidance of disproportionate risks to low-
income and minority communities) oppose efforts to increase the influence of risk analysis,
and especially quantitative risk estimates, on environmental decisions, because it tends to
focus attention on relatively small risks to large populations (for example, the U.S.
population as a whole) rather than on large risks to smaller groups, such as workers, the
economically disadvantaged, or ethnic minorities.
Is It a Scientific Basis for Environmental Decisions?
Some policymakers promote risk analysis as an objective scientific basis for
environmental planning and decisions by federal agencies, Congress, and the public. In their
opinion, more risk analysis would lead to more rational decisions and replace what they
regard as the piecemeal environmental policy that has grown in response to real and
imagined crises. They favor legislation mandating use of risk analysis of environmental,
health, and safety problems to inform Congress and the public, who may then evaluate and
prioritize problems based on sound science.
Opponents of mandated risk analysis argue that the science used in risk analysis is
immature and suitable only for assessing immediate threats or the risk of developing cancer.
In addition, they warn that risk analysis oversimplifies the problems faced by policymakers
and managers of environmental programs, for example, by generally focusing on one hazard
and one effect at a time, or on problems or aspects of problems that already are well
understood. Critics of risk analysis also assert risk assessment methods are complex and
easily manipulated for political purposes. Thus, it is argued, the decision-making process
may be less democratic to the extent it is ostensibly based on risk.
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Many who promote the use of risk analysis acknowledge that it has limitations but
believe these can be overcome through data collection, research, peer review, or the
establishment of guidelines for the consistent conduct of analysis and presentation of results.
The 106th Congress enacted a provision (Section 515) in omnibus appropriations legislation
(P.L. 106-554) requiring the President’s Office of Management and Budget (OMB) to
establish guidelines to help agencies ensure data quality supporting rules. OMB recently
issued draft guidelines for peer review and data quality (68 Federal Register 54023,
September 15, 2003). OMB also revised guidance (OMB Circular A-4) for cost-benefit
analysis and risk assessments conducted by federal agencies. Agencies have been directed
to adopt detailed guidelines for risk assessments, consistent with OMB guidelines, to identify
research and training needs in risk assessment, and to develop a strategy to meet those needs.
However, the effect of these administrative measures and legislated mandates on agency
behavior is unpredictable due to the variety of circumstances surrounding risk assessments
and the legal consequences of EPA actions. For example, it is not yet known whether the
data quality act allows legal challenges to the scientific underpinnings of rules.
Should It Be Used to Compare Costs and
Environmental or Health Benefits?
Many policymakers want to use the results of risk analysis and cost analysis to identify
economically reasonable environmental management strategies. Various decision criteria
have been proposed for identifying such strategies, all of which would require comparisons
of the estimated costs and environmental or health benefits of existing or proposed
regulations and reasonable alternatives. However, proposals have differed in whether they
would have required 1) consideration of particular alternatives, 2) qualitative or quantitative
analysis, and 3) comparisons of risks to costs for each alternative, costs of one to costs of
another, or risks of one to risks of another. Different proposals also would provide EPA with
different levels of discretion. S. 746, as reported in the 106th Congress, would have required
consideration of “flexible” regulatory options, qualitative and quantitative costs and benefits,
and comparisons of risks to costs, costs to costs, and risks to risks of the alternatives.
Legislative proposals in earlier congresses (e.g., S. 2362, in the 106th Congress) would have
required cost-benefit analysis of proposed air quality standards and would have authorized
EPA to set a standard for which estimated benefits justified costs.
H.R. 2432, as passed by the House in the 108th Congress, would require a study on
“regulatory budgeting” for FY2006 and FY2007 focusing on programs in three of four
designated agencies: the Department of Labor, the Department of Transportation, the
Department of Health and Human Services, and EPA. According to the bill, the “study shall
address the preparation of regulatory budgets ... [which] shall include the presentation of the
varying estimated levels of benefits that would be associated with the different estimated
levels of costs with respect to the regulatory alternatives under consideration by the agency
(or office within the agency).” The OMB Director would be directed to include these
analyses in its annual report to Congress on the costs and benefits of federal regulations.
Some critics of EPA assert that environmental regulations adversely impact the national
economy and international competitiveness of American businesses. They want EPA to use
cost-benefit analysis to identify less expensive strategies to reduce only the greatest risks.
Some would prohibit promulgation of regulations expected to cost more than they save in
economic terms (that is, that were not expected to produce a net benefit) or that cost more
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than an alternative that would also achieve the statutory objective. In contrast, proposals that
advanced in the House and Senate of the 104th Congress did not require regulators to base
decisions on national net benefits. Rather, they promoted adoption of “flexible,” cost-
effective alternatives and authorized consideration of risks and costs borne by special
segments of the general population.
The Unfunded Mandates Reform Act (P.L. 104-4) requires all agencies to select from
a reasonable number of regulatory alternatives the least costly, most cost-effective, or least
burdensome alternative that achieves the objectives of the rule and is consistent with law or
to explain why such an alternative was not adopted. In the 106th Congress, S. 746, as
reported, would have directed agencies for major environmental rules —
! to perform a cost-benefit analysis;
! to make “a reasonable determination, based on the rule-making record as a
whole” as to whether the rule is likely to provide benefits that justify the
costs and whether it “is likely to substantially achieve the rule making
objective in a more cost-effective manner, or with greater net benefits, than
the other reasonable alternatives considered by the agency;” to conduct a
risk assessment; and
! to provide for peer review of risk assessments and, if the rule is likely to cost
more than $500 million, of the economic analysis.
However, existing laws would still determine the degree to which such cost-benefit
comparisons could affect the choice of regulatory options.
Some people object to quantitative comparisons of costs with the monetary value of
benefits of environmental or health laws and regulations. Whether they object on moral or
ethical grounds or for scientific reasons, they want benefits described in qualitative as well
as quantitative terms. Key proposals in the 104th, 105th , and 106th Congresses would have
permitted or required qualitative descriptions of benefits as well as costs.
Critics of cost-benefit analysis argue that the process is easily manipulated for political
purposes, and that evidence of manipulation is easy to conceal, especially from people who
lack economic or scientific training. Moreover, the quality of economic analyses varies
widely, they believe, and most quantitative cost-benefit analyses undervalue environmental
and health benefits and exaggerate costs. A Resources for the Future study found that cost
estimates for proposed environmental and occupational safety rules more often over-
estimated than under-estimated costs. Economic analysts also tend to focus on relatively
widespread but individually small costs and risks rather than on much larger costs and risks
to smaller, and often more vulnerable, groups, critics charge.
Many of these concerns about the quality of cost-benefit analyses might be addressed
through peer review, oversight by OMB or another agency, or other measures. OMB already
is required by P.L. 104-208 to assess costs and benefits for major federal regulations. In
addition, P.L. 106-312 directed the General Accounting Office (GAO, since renamed the
Government Accountability Office) to establish an office as part of a pilot project in which
GAO would independently evaluate an agency’s analysis of the potential benefits and costs
of a proposed or final, economically significant rule, alternative regulatory approaches, and
other aspects of the rule that the agency analyzed as required by law, if an evaluation were
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requested by a chairman or ranking member of a congressional committee of jurisdiction.
However, Congress has never appropriated funding for this project. In the 108th Congress,
H.R. 2432, as passed by the House, would permanently authorize appropriations for such an
office at GAO.
Another criticism aimed at proposals to require cost-benefit analysis is that they would
consume scarce EPA resources, sometimes to no purpose, because some authorizing statutes
do not permit EPA to consider costs.
Finally, many argue that cost-benefit analysis could delay EPA’s issuance of many
regulations, and delays would mean that lives or habitats might be irretrievably lost that
could have been saved had the regulation been in effect. Thus, the net benefit of regulating
would be reduced, they claim. In addition, some fear that delays will increase the cost of
analysis if the Agency misses statutory or judicial deadlines and environmental groups
respond, as they often do, by filing lawsuits. However, legislation could extend statutory
deadlines until its requirements for cost-benefit analysis were satisfied, or could authorize
agencies to request extension of court-ordered deadlines.
Should Priorities Be Based on Relative Risks
and Risk Reduction Opportunities?
The results of risk analysis also can be used to weigh the relative need for various
federal environmental programs. Some policymakers argue that EPA, the states, and
localities should prioritize expenditures based on relative opportunity for risk reduction.
Opponents of risk management based on relative risks and risk reduction potential contend
that comparative risk analysis is an unscientific, ad hoc procedure that lends a false air of
objectivity to the subjective judgments of scientists. Opponents question whether an exercise
that combines the diverse views of an unrepresentative sample of government scientists to
produce a single prioritized list of hazards is more informative than a thorough recitation of
the points on which scientists with diverse viewpoints agree and disagree, such as may occur
in a hearing or an advisory committee. Critics argue that priority setting requires value
judgments, and scientists are no more qualified than others to decide whether, for example,
the risk of a small decrement in intelligence for 3 to 4 million children exposed to lead-based
paint is more or less significant than the risk of approximately 13,600 deaths annually from
lung cancer due to indoor levels of radon gas. It is even more difficult and less scientific to
compare ecological risks with risks to human health, these critics contend.
Others protest that risk-based prioritization focuses on death or disease rates in the
population as a whole, ignoring other equally important issues, such as the feasibility of
controlling a risk or the fairness of the result. All means of risk reduction are not equally
desirable, these critics contend, citing diverse examples such as the wearing of a gas mask
and modification of a production process to reduce use of toxic chemicals. The nature of
hazards also matters, according to some who point out that risk is sometimes desirable, and
many risks, such as driving a car or skydiving, are taken voluntarily either for the benefits
that may be obtained or for the thrill of the experience. Priorities should be based on all
relevant information about hazards and available management options, not on risk alone,
they argue. Since scientists are expert only at determining probabilities, the public or its
representatives should be asked to contribute their expertise to the process of priority setting.
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When EPA’s Science Advisory Board was asked to update its 1990 relative risk report
Reducing Risk,1 it instead initiated a project to define “the next step” in environmental
decision making. The Board failed to achieve the goal of this project, “to articulate a
complete and rational method for including all aspects of integrated environmental decision-
making in a single process,” but in its final report, Toward Integrated Environmental
Decision-Making, it provided a framework and challenged EPA to develop the necessary
tools to move in that direction. The Board described integrated environmental decision
making, in the cover letter to the final report to the EPA Administrator, as follows.
One of the principle features of “the next step” is the involvement of a wider range of
people — and their perspectives/values — in the decision-making process. The
Framework also emphasizes use of the best science (both natural and social sciences) to
assess cumulative, aggregate risks; to consider a broader range of options for managing
or preventing risks; to make clear the role of societal (public) values in deciding what to
protect; to clarify the trade-offs (including costs and benefits) associated with choosing
some management scenarios and not others; and to evaluate progress toward desired
environmental outcomes (page 6).
Thus, instead of producing a prioritized list of environmental risks, the SAB advocated
development of a wider range of tools for examining environmental issues and a more
consultative process for ranking.
The Information Value of Risk Analysis
There appears to be general agreement that more information is needed to inform
decisions. Views diverge, however, regarding the type of information needed and whether
it would be best provided by risk analysis.
Key Factors Determining the Quality of Information Provided
Under ideal conditions, a risk analysis gathers, organizes, and summarizes all of the
important information relevant to hazard management. It includes qualitative as well as
quantitative information about the characteristics of the hazard, exposed population, potential
effects, and available management strategies; describes scientific uncertainties; and provides
a range of forecasts based on alternative, scientifically plausible assumptions about the
relationship between exposure to the hazard and potential health or environmental effects.
In practice, however, the type of information provided by risk analysis varies from
comprehensive to superficial, accurate to biased, and quantitative to qualitative, because risk
analysis is a field of inquiry rather than a single method. Risk analysts use a variety of
procedures and models adapted from other fields of study such as sanitary and industrial
engineering, psychology, economics, sociology, statistics, and operations research. Methods
developed for other purposes (for example, to determine life insurance rates) sometimes are
difficult to apply to, and may be scientifically invalid for, environmental hazards.
1 For a summary of the 1990 report, see CRS Report 98-618, Environmental Risk Analysis:
A Review of Public Policy Issues.
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A second consideration is that risk analysis is a tool for evaluating what is known about
things that cannot be known with certainty — that is, it is only used to describe the effects
of hazards that are unpredictable due to their natural randomness or a lack of scientific
understanding of the principles that govern their occurrence. Risk analysis always produces
an estimate, never a prediction, and estimates vary in quality. (Weather forecasts, for
example, are relatively well-informed risk estimates.) Thus, risk analysts can only discuss
the likelihood of various outcomes and, at best, may present risks as statistical probabilities.
If there is no past experience with a hazard, there is no basis for any forecast, much less a
quantitative estimate. If there is experience but no record to ensure accurate recall, risk
estimates are likely to be unreliable.
Finally, sometimes risk analysis can provide no information at all, even when data are
abundant. Science cannot always explain complex or unusual relationships between the
exposures to hazards and the potential health and ecological effects.
Quality of the Database
The quality of available data on exposure levels and potential effects determines the
quality of information that can be provided by a risk analysis. The most effective way to
improve risk assessment, the National Academy of Sciences (NAS) has concluded, is to
improve the quality and comprehensiveness of knowledge. Data on human exposure to
chemicals generally is acknowledged to be inadequate. See, for example, Toxic Chemicals:
Long-Term Coordinated Strategy Needed to Measure Exposures in Humans by the U.S.
General Accounting Office (May 2000, GAO/HEHS-00-80). S. 1588/H.R. 852 would direct
the National Institute of Environmental Health Sciences to conduct and coordinate research
on the occurrence of hormone-disrupting chemicals in the environment.
The situation for toxicity data, which is needed to assess potential human health effects
of chemical exposures, was summarized in a 1993 report by the U.S. Office of Technology
Assessment (OTA). It estimated that 62,512 chemicals were in commerce in the United
States, and another 1500 new chemicals entered the market annually. Environmental experts
believed that “good” data on health effects existed for only 10% of commercial chemicals.
In a 1995 report, OTA estimated that roughly 30,000 of the chemicals that have been in U.S.
commerce since 1976 were polymers that present little health risk. Another 25,000 are
produced in low volume (less than 10,000 pounds per year, including some chemicals which
no longer are in production). There remained approximately 15,000 chemicals produced in
significant volumes. About 3 or 4 thousand chemicals were produced in amounts greater
than one million pounds per year. OTA reported, “For perhaps thousands of these chemicals
of potential concern, toxicity and exposure data remain inadequate for risk assessment.” Of
course, many of these may be harmless, but data were also inadequate for many chemicals
Congress has deemed “hazardous,” according to NAS. NAS evaluated the availability of
data for risk analyses of 189 hazardous air pollutants and concluded EPA did not have
“sufficient data to assess fully the health risks ... within the time permitted by the Clean Air
Act Amendments of 1990” (Science and Judgment in Risk Assessment, 1994, National
Academy Press, Washington, p. 8-13). At least 12 federal agencies were conducting health
risk assessment research to fill the gaps in scientific understanding, but according to OTA,
their efforts were poorly coordinated and supported at a level that was less than 0.5% of the
cost of complying with EPA regulations. The data situation has improved little if at all in
recent years, and it is much worse for environmental effects.
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The Environmental Defense (ED, formerly Environmental Defense Fund) reported in
1997 on research conducted to determine the adequacy of test data for chemicals produced
in amounts greater than one million pounds per year that have been identified as subjects of
regulatory attention. The adequacy of test data was determined based on the public
availability of the minimum screening information data set that was created by the
Organization for Economic Cooperation and Development (OECD) Chemicals Program in
1990. This data set is adequate to perform preliminary assessment of the potential human
health hazard of a chemical, but does not provide sufficient data to conduct a comprehensive
health risk assessment, according to ED. ED drew a random sample of 100 chemicals and
found that 71% did not meet the OECD minimum data requirement. Most of the chemicals
in the sample had been tested for their ability to cause mutations (genetic toxicity) and
developmental toxicity, but there were no reproductive toxicity data for 53% of the
chemicals. Most of the chemicals had not been tested for any form of toxicity due to chronic
exposure. According to the authors of the study, the Chemical Manufacturers’ Association
(CMA, since renamed the American Chemistry Council) independently concluded that only
53% of the chemicals lacked adequate public data, but acknowledged that a key international
chemical database had very recently become available for public scrutiny. Critics of the ED
study, however, charged that up to three-fourths of chemicals have been adequately
evaluated.
EPA evaluated the availability of toxicity data for industrial chemicals produced in high
volumes and reported that there was a complete set of health and environmental effects data
for only 7%. There were no publicly available data for 1,216 of the 2,863 chemicals
evaluated by EPA. EPA and Vice President Gore called on the chemical industry to produce
data to fill the gaps at an EPA-estimated total cost of $427 million. That cost represents
about 0.2% of total annual sales of the top 100 U.S. chemical companies, according to EPA.
The chemical industry has supported the voluntary high-production-volume (HPV) chemical
testing initiative, but estimates the cost could approach $765 million and place U.S.
companies at a competitive disadvantage internationally. More than 430 companies publicly
committed to make health and environmental hazard data available on approximately 2,080
HPV chemicals by 2005, but some companies have withdrawn sponsorship. Animal rights
groups criticized early descriptions of the HPV testing initiative for garnering information
of dubious value and requiring laboratory experiments for thousands of animals. EPA
responded by examining alternative test methods that could reduce the number of animals
needed and reduce the pain and suffering of any animals employed. The Agency produced
guidance for companies responsible for chemical testing which should reduce animal usage
by 68 to 80 percent, according to EPA. On December 26, 2000, EPA published a proposed
rule that would require manufacturers and processors of 37 additional HPV chemicals to
conduct toxicity testing (65 Federal Register 81,657). In the most recent semiannual
regulatory agenda, EPA estimated that the final rule would be issued in December 2004 (69
Federal Register 38268, June 28, 2004).
Risk Assessment Methods
Environmental risk assessment is a relatively new and immature field; this is evident
in the state of development of its analytic methods for assessing exposure levels and their
potential adverse effects. Current methods of estimating human or ecological exposure
levels generally focus on individual hazards (e.g., arsenic or repetitive motions) and isolated
incidents or constant long-term exposures. Therefore, they inadequately account for
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common, real-life conditions, such as fluctuating exposures to multiple hazards. The most
developed and well established methods of estimating potential adverse effects probably are
those used to analyze acute human health effects of high short-term risks (e.g., many
occupational injuries). Methods also are fairly well developed for assessing human cancer
risks of chemicals, although gaps in scientific understanding of cancer make these risk
estimates very uncertain. These methods evaluate and model the results of animal
experiments and human studies to estimate cancer risk due to exposure to individual
chemicals. Due to the variety of models that may be used, estimates of cancer risk usually
vary widely. Methods to evaluate risks of other health effects (such as impaired immunity,
reproductive problems, or birth defects) are less well established. Methods for ecological
risk analysis are still primitive.
There are at least four ways to promote the development and use of the best available
methods for risk analysis: peer review, research and training, oversight, and provision of
guidelines. Such methods help to ensure that risk assessments are conducted consistently
and are, therefore, more easily evaluated by independent experts. However, they do not
ensure that scientists will agree with the resulting risk estimates. The NAS has identified at
least 50 decisions required in conducting a cancer risk assessment that cannot be made on
a scientific basis. Thus, controversy grows from the subjective judgments, the science
policies, that make risk assessment possible and from the high stakes that ride on risk
estimates.
Legislative Activity
Legislation in the 107th Congress
In the 107th Congress there was little legislative activity involving environmental risk
analysis or broader regulatory reform legislation, especially after September 11, 2001. On
the other hand, there were administrative reforms promoting risk analysis in the Executive
Branch, particularly in the form of directives from the Office of Information and Regulatory
Affairs (OIRA) of the Office of Management and Budget. Far-reaching risk provisions were
included in one introduced bill, H.R. 2694, which would have elevated the U.S. Environmen-
tal Protection Agency to cabinet status. Section 120 would have required quantitative risk
assessment, cost assessment, and comparative risk assessment for each proposed or final
regulation relating to public health and safety or the environment. It also would have
mandated certification by the Secretary that the assessments have been evaluated by the
Science Advisory Board and were supported by “the best available scientific data,” and that
the rule would produce benefits justifying the cost and would substantially advance public
health and safety or the environment.
For information about proposals in the 103rd through the 105th Congresses, see CRS
Report RL30031. Environmental Risk and Cost-Benefit Analysis: A Review of Proposed
Legislative Mandates, 1993-1998.
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Legislation in the 108th Congress
The outlook for legislation in the 108th Congress is unclear. In the first session, no
legislation was proposed that would have promoted environmental risk analysis. However,
administrative reforms continued at OMB, which published proposed final peer review
requirements April 28, 2004, allowing 30 days for public comment (until May 28, 2004).
Final guidelines for cost-benefit analysis were issued September 17, 2003, as Circular A-4.2
On May 18, 2004, the House passed H.R. 2432, directing OMB to conduct a study of
regulatory budgeting focusing on programs at three of four designated agencies, including
EPA, and to include the results of the study in the annual report to Congress on the costs and
benefits of federal regulations. The bill also would permanently authorize a GAO office to
independently evaluate an agency’s analysis of the potential benefits and costs of a proposed
or final economically significant rule, alternative regulatory approaches, and other aspects
of the rule that the agency analyzed as required by law, if an evaluation were requested by
a chairman or ranking member of a congressional committee of jurisdiction. Companion
bills have been introduced into the House (H.R. 936) and Senate (S. 448) that would mandate
research and evaluation of health effects for “vulnerable sub-populations” and establish a
U.S. policy of protecting them from pollution with “an adequate margin of safety.” The
health of children would be protected by requiring an additional margin of safety of at least
10-fold in the setting of all environmental standards, unless reliable data were available and
sufficient to evaluate the special susceptibility and exposure of children (including exposure
before birth) to an environmental pollutant. H.R. 199 and S. 1112 in the 106th Congress and
S. 855 in the 107th Congress were precursors to these bills.
LEGISLATION
H.R. 936 (Miller)/S. 448 (Dodd)
Leave No Child Behind Act of 2003, Title I, Subtitle E, Children’s Environmental
Protection Act. Amends the Toxic Substances Control Act to establish U.S. policy of
protecting “vulnerable subpopulations” that are likely to experience special exposure to
environmental pollutants or associated health effects. Requires EPA to evaluate environmen-
tal health risks to vulnerable subpopulations separately and to protect them by providing an
adequate margin of safety. If sufficient, reliable data are lacking for children, requires EPA
to use at least a 10-fold safety factor in setting standards. Establishes a Children’s
Environmental Health Protection Advisory Committee and mandates research on exposure
and susceptibility to pollutants. Introduced February 26, 2003; referred to House
Committees on Environment and Public Works, Ways and Means, Education and the
Workforce, Agriculture, Judiciary, Government Reform, and Transportation and Infrastruc-
ture; referred to Senate Committee on Finance.
H.R. 2432 (Ose)
Paperwork and Regulatory Improvements Act of 2003. Amends the Truth in Regulating
Act of 2000 to permanently authorize a chairman or ranking member of a congressional
committee to request a GAO regulatory analysis of an economically significant rule. Also
2 OMB, Circular A-4, Regulatory Analysis
[http://www.whitehouse.gov/omb/circulars/a004/a-4.html], visited Feb. 25, 2004.
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amends the Treasury and General Government Appropriations Act, 2001, to direct OMB to
require each agency to the extent feasible to submit an annual estimate of the total annual
costs and benefits of federal rules and paperwork for the agency and each agency program.
Requires OMB to conduct a study of regulatory budgeting focusing on programs at three of
four designated agencies, including EPA, and to include the results of the study in the annual
report to Congress on the costs and benefits of federal regulations. Introduced June 11, 2003;
referred to Committee on Government Reform and Committee on the Budget. Reported,
amended, by the Committee on Government Reform May 14, 2004, H.Rept. 108-490, Parts
I, and May 17, 2004, H.Rept. 108-490, Part II. Discharged by Committee on the Budget May
14, 2004. Passed House May 18, 2004. Text was appended to H.R. 2728 and referred to the
Senate.
CONGRESSIONAL HEARINGS, REPORTS, AND DOCUMENTS
United States Congress. House. Committee on Commerce. Subcommittees on Commerce,
Trade, and Hazardous Materials and on Health and Environment. Risk Assessment and
Cost/Benefit Analysis for New Regulations. Joint Hearings, 104th Congress, 1st sess.,
February 1 - 2, 1995. Washington, U.S. Govt. Print. Off., 1995. 380 p.
United States Congress. House. Committee on Science. Subcommittee on Energy and
Environment. The Science of Risk Assessment: Implications for Federal Regulation,
Hearing, 105th Congress, 2nd sess., July 15, 1998. Washington, U.S. Govt. Print. Off.,
1998. 637 p.
United States Congress. Senate. Committee on Environment and Public Works. Regulatory
Reform and Environmental Laws. Hearing, 104th Congress, 1st sess., March 22, 1995.
Washington, U.S. Govt. Print. Off., 1995. 250 p.
United States Congress. Senate. Committee on Governmental Affairs. S. 981 — the
Regulatory Improvement Act of 1998. Hearing, 105th Congress, 2nd sess., February 24,
1998. Washington, U.S. Govt. Print. Off., 1998. 435 p.
FOR ADDITIONAL READING
CRS Products
CRS Report RL30116. Congressional Review of Agency Rulemaking: A Brief Overview and
Assessment After Three Years.
CRS Report RL30043. Environmental, Health, and Safety Tradeoffs: A Discussion of
Policymaking Opportunities and Constraints.
CRS Report 98-618. Environmental Risk Analysis: A Review of Public Policy Issues.
CRS Report RL30031. Environmental Risk and Cost-Benefit Analysis: A Review of
Proposed Legislative Mandates, 1993-1998.
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CRS Report 98-619. Risk Analysis: Background on Environmental Protection Agency
Mandates.
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