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 December 7, 2001
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 106th Congress
Legislation in the 107th 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
Far-reaching risk provisions are included
which risk estimates may be biased and should
in H.R. 2694, legislation that would elevate
be allowed to influence public policies to
the U.S. Environmental Protection Agency to
protect health and the environment.
cabinet status. Section 120 would require
quantitative risk assessment, cost assessment,
Some Members, many academics, and
and comparative risk assessment for each
regulated industries argue that risk analysis is
proposed or final regulation relating to public
objective and reflects sound science. They
health and safety or the environment. It also
argue it should be used to target federal pro-
mandates certification by the Secretary that the
grams to address the worst risks to health and
assessments have been evaluated by the Sci-
the environment first, to achieve risk reduction
ence Advisory Board and are supported by
in more cost-effective and flexible ways that
“the best available scientific data,” and that the
minimize overall economic impacts, and to
rule would produce benefits justifying the cost
ensure that risk reduction achieved by regula-
and would substantially advance public health
tions is worth the cost. O t h e r M e m b e r s ,
and safety or the environment.
some academics, and many environmentalists
argue that excessive reliance on risk analysis,
S. 855 would mandate evaluation of
especially quantitative analysis of risks to
health effects for “vulnerable sub-populations”
human health, to evaluate problems and solu-
and establish a U.S. policy of protecting them
tions ignores other important facets of policy
from pollution with “an adequate margin of
decisions, such as environmental impacts,
safety.” There were similar proposals in the
timeliness, fairness, effects on democratic
106th Congress (i.e., H.R. 199 and S. 1112).
rights and liberties, practicality, morality,
S. 940 in the 107th Congress would amend the
reversibility of effects, regulatory stability,
Emergency Planning and Community Right-
flexibility, or aesthetic values. Critics charge
To-Know Act to require additional reporting
that quantitative methods cannot assess very
of releases of persistent, bioaccumulative,
long-term or newly discovered threats. They
toxic substances and extend reporting require-
also believe that quantitative cost-benefit
ments to amounts of chemicals used as well as
analyses undervalue environmental and health
released. The bill also would require EPA and
benefits, exaggerate costs, and focus on
the Consumer Product Safety Commission to
relatively widespread but individually small
list substances toxic to children and to require
costs and risks rather than on much larger
new strategies for chemical testing and risk
costs and risks to smaller, and often more
assessment to ensure full understanding of
vulnerable, groups.
risks to children.
The quality of risk analysis depends on
Risk analysis is the systematic evaluation
adequacy of data and validity of method. For
of hazards and their possible effects. Views on
environmental hazards and most health and
the potential uses of risk analysis differ. Al-
ecological effects, data are limited, and meth-
though, most experts and policy-makers agree
ods are controversial.
that risk analysis is a valuable tool to inform
decisions, they disagree about the extent to
Congressional Research Service ˜ The Library of Congress

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MOST RECENT DEVELOPMENTS
The recent change in the leadership in the Senate affects the prospects in the 107th
Congress for comprehensive legislation that would that would increase use of risk analysis
by the U.S. Environmental Protection Agency (EPA). Although Senate proposals for such
risk legislation in the 105th and 106th Congresses had bipartisan sponsorship, they were
opposed by many Democrats, including party leadership. On the other hand, proposals to
use risk assessment to protect “vulnerable subpopulations” (e.g., S. 855 and S. 940) may be
more likely to receive action in the Senate. In the House, there are far-reaching risk
provisions included in H.R. 2694, legislation that would elevate the U.S. Environmental
Protection Agency to cabinet status. Section 120 would require 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 mandates certification by the
Secretary that the assessments have been evaluated by the Science Advisory Board and are
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.
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 decision, and evaluating the results.
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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.
S. 746, as reported in the 106th Congress, would require the President’s Office of
Management and Budget (OMB), in consultation with the Council of Economic Advisors, the
Director of the Office of Science and Technology Policy, and relevant agency heads, to
establish guidelines for cost-benefit analysis and risk assessments. The bill also would direct
agencies to adopt detailed guidelines for risk assessments, consistent with guidelines issued
by OMB, to identify research and training needs in risk assessment, and to develop a strategy
to meet those needs. Finally, the proposed legislation would require peer review of agencies’
risk analyses of proposed and final significant rules and their alternatives, as well as other risk
analyses with potentially significant effects on public policy, as determined by OMB.
Some proposals attempt to ensure scientific objectivity by mandating it. For example,
S. 746, as reported in the 106th Congress, would require scientists to consider “all relevant”
and “all reliable” scientific data and to perform an “objective” assessment “based on the
weight of the scientific evidence.” However, the effect of these 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, the validity of the
“weight-of-the-[scientific]-evidence” approach in practice depends on the quality and
comprehensiveness (or representativeness) of the data. Therefore, a legal requirement to rely
on the approach may be interpreted by scientists as a directive either to base decisions on
available data even if data are inadequate and misleading, or to collect additional data to meet
minimum data requirements, even if the aspect of the risk assessment for which data are
unavailable is unimportant to the risk analysis as a whole or to significant regulatory or policy
decisions. Such uncertainty is likely to lead to legal challenges.
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 require 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. S. 2362, as introduced
in the 106th Congress, would require cost-benefit analysis of proposed air quality standards
and would authorize EPA to set a standard for which estimated benefits justify costs.
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 direct 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. All the key proposals in the 104th Congress, as well as S. 981, as reported
in the 105th Congress, and S. 746, as reported in the 106th Congress, would permit or require
qualitative descriptions of benefits as well as costs. Because S. 981, as reported in the 105th
Congress, required a determination about “net benefits,” some argued that it would have
forced agencies to quantify benefits. In the 106th Congress, language was added to S. 746,
as reported, to ensure analysis of qualitative benefits.
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 recent study at Resources for the Future 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. H.R.
1074, as passed by the House in the 106th Congress, would mandate OMB analysis of the
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costs, benefits, and net benefits of major rules and alternatives for which costs and benefits
were considered in a regulatory impact analysis. S. 746, as reported in the 106th Congress,
would require OMB oversight of rule making and peer review of risk assessments with
potentially significant policy impacts, including for major rules, and of cost-benefit analyses
for rules likely to have an annual effect on the economy of at least $500 million. It also would
require periodic OMB evaluations of the quality of agencies’ analyses and OMB development
of guidelines for cost-benefit analysis, risk analysis, and peer review. S. 746, as reported in
the 106th Congress, also would require agencies to develop their own detailed guidelines for
risk and economic assessments. P.L. 106-312 establishes a pilot project authorizing an
independent General Accounting Office evaluation of 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 analyzed as required by law, if an evaluation is
requested by a chairman or ranking member of a congressional committee of jurisdiction.
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. During mark up of S. 981 on March 10, 1998 in the
105th Congress, an amendment was defeated which would have waived requirements if
agencies did not have the resources required to perform analyses and peer reviews.
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. S. 746, as reported in the 106th Congress, would extend statutory
deadlines occurring within 2 years of enactment for 6 months or until the requirements of the
new law were satisfied. The bill also would 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. In the 104th
Congress, the Senate Appropriations subcommittee with jurisdiction over EPA spending was
particularly concerned about what it described as EPA’s refusal to identify activities that
address the greatest risks. Supported by the recommendations of a National Academy of
Public Administration study, the subcommittee directed EPA to determine its highest
priorities and the funding needed to address them. EPA maintained that it was working on
setting priorities based on relative risks, statutory and judicial deadlines, legal mandates,
program costs and benefits and other factors.
EPA’s Science Advisory Board released a draft report suggesting a new risk-based
approach to making environmental decisions in April 1998. This report on the SAB’s
Integrated Risk Project was prepared in response to a request from EPA administrators for
an update to the SAB 1990 relative risk report Reducing Risk. For a summary of the draft
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report, see CRS Report 98-618, Environmental Risk Analysis: A Review of Public Policy
Issues.
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.
H.R. 3311, as introduced, and S. 746, as reported, in the 106th Congress, would require
a comparative risk analysis, a study of methodologies for comparing dissimilar risks, and
recommendations on the use of comparative risk analysis in setting priorities from an
accredited scientific institution under contract to OMB. This project would have to be
conducted through an open process providing peer review and opportunities for public
participation.
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
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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.
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. H.R. 3311, as introduced, and S. 746, as reported, in the
106th Congress, would require agencies to report on the uncertainties surrounding risk
estimates.
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). H.R. 3448 in the 106th Congress
aimed to improve collection and management of information about environmental quality,
which may be used to approximate human exposure.
The situation for toxicity data, which is needed to assess potential human health effects
of chemical exposures, was summarized in a report by the U.S. Office of Technology
Assessment (OTA). It estimated that 62,512 chemicals are in commerce in the United States
today, and another 1500 new chemicals enter the market annually. Environmental experts
believe that “good” data on health effects exist 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 are 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 remain approximately 15,000 chemicals produced in
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significant volumes. About 3 or 4 thousand chemicals are 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 are 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 are currently conducting health risk
assessment research to fill the gaps in scientific understanding, but according to OTA, their
efforts are poorly coordinated and supported at a level that is less than 0.5% of the cost of
complying with EPA regulations. The data situation is much worse for environmental effects.
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) 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 have
publicly committed to make health and environmental hazard data available on approximately
2,080 HPV chemicals by 2005. 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
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processors of 37 additional HPV chemicals to conduct toxicity testing (65 Federal Register
81,657).
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
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. All four provisions were included in S. 746, as reported to the Senate in the 106th
Congress. 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 106th Congress
The 106th Congress did not act on comprehensive regulatory reform legislation or major
provisions related to risk analysis by EPA. H.R. 3311, as introduced, and S. 746, as reported,
in the 106th Congress, would have codified requirements for cost-benefit analysis and risk
assessment (currently required by executive order) and executive oversight of rulemaking.
In contrast to S. 746, as reported, H.R. 3311 would have required no determination by an
agency that compared costs and benefits, would not have required evaluation of risks to
subpopulations, would have more strongly encouraged quantitative analysis, and would have
defined more rules as major and allowed no exceptions, and therefore would have required
more analyses. The Thompson-Levin bill (i.e., S. 746) was similar to a bill that was reported
in the 105th Congress, as it would have been amended by an amendment proposed by
President Clinton. More limited proposals (i.e., H.R. 199, H.R. 525, and S. 1112) also were
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introduced, but few were acted upon. However, S. 1198 became P.L. 106-312 on October
17, 2000. It establishes a pilot project authorizing an independent General Accounting Office
evaluation of 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
analyzed as required by law, if an evaluation is requested by a chairman or ranking member
of a congressional committee of jurisdiction, and if funding for the project is appropriated.
The consolidated FY2001 appropriations act (P.L. 106-554) did not provide funding for the
project.
Legislation in the 107th Congress
Prospects are unclear for comprehensive legislation in the 107th Congress that would
increase use of risk analysis by EPA. In the House, there are far-reaching risk provisions
included in H.R. 2694, legislation that would elevate the U.S. Environmental Protection
Agency to cabinet status. Senate bills, S. 855 and S. 940, would use risk analysis to protect
vulnerable segments of the population.
LEGISLATION
H.R. 324 (Boehlert)
Recycle America’s Land Act of 2001. Would require risk assessments conducted under
the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (i.e.,
Superfund) to be objective, unbiased, based on all reasonably available, relevant, and reliable
scientific and technical information and on an analysis of the weight of scientific evidence
supporting conclusions about potential risk to health and the environment. Introduced
January 31, 2001; referred to Committees on Energy and Commerce, Transportation and
Infrastructure, and Ways and Means.
H.R. 2694 (Horn)
Department of Environmental Protection Act. Section 120 would require quantitative
risk assessment, cost assessment, and comparative risk assessment for each proposed or final
Department of Environmental Protection regulation relating to public health and safety or the
environment. It would mandate certification by the Secretary that such assessments have
been evaluated by the Science Advisory Board and are 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. Introduced August 1,
2001; referred to Committee on Government Reform.
S. 855 (Boxer)
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 environmental health risks to vulnerable subpopulations separately and to protect
them by providing an adequate margin of safety and, if data are lacking, at least a 10-fold
safety factor. Prohibits use of some pesticides in schools and daycare centers and requires
parental notification of pesticide use. Also requires EPA to identify pollutants common in
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areas frequented by children, to develop guidelines to reduce exposure to such pollutants, and
to list substances and products with suspected health risks to children as well as safer
alternatives. Mandates amendments to the Emergency Planning and Community Right-to-
Know Act Section 313 to require additional reporting of emissions for certain persistent,
bioaccumulative, toxic substances. Introduced May 9, 2001; referred to Committee on
Environment and Public Works.
S. 940 (Dodd)
Children’s Environmental Protection and Right to Know Act. Amends the Emergency
Planning and Community Right-To-Know Act of 1986, Section 313, to require additional
reporting of environmental releases of certain persistent, bioaccumulative, toxic substances.
Extends reporting requirements to amounts of covered chemicals used as well as released and
to all industrial sectors that use or release toxic chemicals in volumes similar to the volumes
used in covered industries. Requires consolidation of all federal reporting requirements for
regulated industries. Amends the Federal Hazardous Substances Act to require EPA and the
Consumer Product Safety Commission to list substances toxic to children and require new
long and short-term strategies for chemical testing and risk assessment to ensure that risks to
children are fully understood. Requires manufacturers to report on products containing
substances toxic to children. Authorizes civil enforcement action. Establishes a fund to
receive penalties assessed as a result of civil action that may be used to fund enforcement
activities. Introduced May 23, 2001 as Title II, Subtitle E, of the Leave No Child Behind Act
of 2001; referred to Committee on Finance.
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.
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FOR ADDITIONAL READING
CRS Products
CRS Issue Brief IB95035. Federal Regulatory Reform: An Overview. 13 p. Updated
regularly.
CRS Report RL30116. Congressional Review of Agency Rulemaking: A Brief Overview and
Assessment After Three Years. 18 p. March 31, 1999.
CRS Report RL30043. Environmental, Health, and Safety Tradeoffs: A Discussion of
Policymaking Opportunities and Constraints. 19 p. February 1, 1999.
CRS Report 98-618, Environmental Risk Analysis: A Review of Public Policy Issues. 40 p.,
Appendix. July 15, 1998.
CRS Report RL30031. Environmental Risk and Cost-Benefit Analysis: A Review of
Proposed Legislative Mandates, 1993-1998. 24 p. January 22, 1999.
CRS Report 98-619, Risk Analysis: Background on Environmental Protection Agency
Mandates. 23 p. Appendix. June 12, 1998.
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