The Role of Risk Analysis and Risk Management in Environmental Protection

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 March 1, 2005

Linda-Jo Schierow

Resources, Science, and Industry Division

Congressional Research Service ˜ The Library of Congress

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 108th Congress

Legislation in the 109th 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

At this time, it is not clear whether the

109 Congress will consider new proposals to

require environmental risk analysis or broader

regulatory reform legislation. No such legislation was enacted by the 108th Congress.

However, administrative reforms promoting

risk analysis continued, building on efforts

begun during the 107th Congress.

th

Risk analysis is the systematic evaluation

of hazards and their possible effects. Views

on the potential uses of risk analysis differ.

Although, most experts and policy-makers

agree that risk analysis is a valuable tool to inform decisions, they disagree about the extent

to which risk estimates may be biased and

should be allowed to influence public policies

to protect health and the environment.

Some Members, many academics, and

regulated industries argue that risk analysis is

objective and reflects sound science. They

argue it should be used to target federal programs to address the worst risks to health and

the environment first, to achieve risk reduction in more cost-effective and flexible ways

that minimize overall economic impacts, and

to ensure that risk reduction achieved by

regulations is worth the cost.

Other Members, some academics, and

many environmentalists argue that excessive

reliance on risk analysis to evaluate problems

and solutions related to human health and the

environment, especially quantitative risk

analysis, ignores other important facets of

policy decisions, such as environmental impacts, timeliness, fairness, effects on democratic rights and liberties, practicality, morality, reversibility of effects, regulatory stability,

flexibility, or aesthetic values. Critics charge

that quantitative methods cannot assess very

long-term or newly discovered threats. They

also believe that quantitative cost-benefit

analyses (which are derived in part from risk

analyses) undervalue environmental and

health benefits, exaggerate costs, and 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. In addition, critics charge,

risk analysis typically evaluates data for wellstudied and relatively well-understood hazards, ignoring emerging concerns about hazards that are poorly understood.

The quality (and value) of any risk analysis depends on adequacy of data and validity

of method. For environmental hazards and

most health and ecological effects, data are

limited, methods are controversial, and consequently, quantitative risk estimates are very

imprecise and highly uncertain, offering little

guidance to policy makers.

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MOST RECENT DEVELOPMENTS

The outlook for legislation related to risk analysis that might be proposed in the 109th

Congress is unclear. In the 108th Congress, there was little legislative activity involving

environmental risk analysis or broader regulatory reform legislation. 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, but no further action occurred prior to adjournment. On the

other hand, administrative reforms promoting risk analysis that were begun during the 107th

Congress continued and intensified in the 108th, particularly in the form of directives from

the Office of Information and Regulatory Affairs (OIRA) in OMB. OIRA is likely to

continue to support regulatory reform during the 109th Congress.

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. For a broader perspective on the role of risk analysis, see

CRS Report RL31781, Risk Assessment and Regulation in the Federal Government: A Brief

Overview.)

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. 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.

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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 lowincome 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.

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

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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

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,” costeffective alternatives and authorized consideration of risks and costs borne by special

segments of the general population.

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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 overestimated 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

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.

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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 decisionmaking 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 in the 108th

Congress would have directed 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

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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.

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 fall 2004 semiannual regulatory

agenda, EPA estimated that the final rule would be issued in December 2004 (69 Federal

Register Part II, Dec. 13, 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

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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. 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 108th Congress

In the 108th Congress, there was little legislative activity involving environmental risk

analysis or broader regulatory reform legislation. 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, but no further action occurred prior to adjournment. On the other hand,

administrative reforms promoting risk analysis that were begun during the 107th Congress

continued and intensified in the 108th, particularly in the form of directives from the Office

of Information and Regulatory Affairs (OIRA) in OMB. Final guidelines for cost-benefit

analysis were issued September 17, 2003, as Circular A-4.2 OIRA is likely to continue to

support regulatory reform during the 109th Congress.

Legislation in the 109th Congress

The outlook for legislative proposals promoting risk analysis is unclear in the 109th

Congress. No legislation has been proposed that would significantly promote environmental

2

OMB, Circular A-4, Regulatory Analysis, at [http://www.whitehouse.gov/omb/circulars/a004/a-4.

html], visited Feb. 25, 2004.

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risk analysis. However, OMB plans to continue its administrative reforms, according to a

recent press release. OMB published final peer review requirements December 17, 2004.

LEGISLATION

No relevant legislation has been proposed yet in the 109th Congress.

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.

CRS Report 98-619. Risk Analysis: Background on Environmental Protection Agency

Mandates.

CRS Report RL31781. Risk Assessment and Regulation in the Federal Government: A Brief

Overview.

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