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Circular A-4

September 17, 2003

TO THE HEADS OF EXECUTIVE AGENCIES AND ESTABLISHMENTS

Subject: Regulatory Analysis

A. Introduction

B. The Need for Federal Regulatory Action

C. Alternative Regulatory Approaches

D. Analytical Approaches

E. Identifying and Measuring Benefits and Costs

F. Specialized Analytical Requirements

G. Accounting Statement

H. Effective Date

This Circular provides the Office of Management and Budget’s (OMB's) guidance to Federal agencies on the

development of regulatory analysis as required under Section 6(a)(3)(c) of Executive Order12866, "Regulatory

Planning and Review," the Regulatory Right-to-Know Act, and a variety of related authorities. The Circular also

provides guidance to agencies on the regulatory accounting statements that are required under the Regulatory

Right-to-Know Act.

This Circular refines OMB's "best practices" document of 1996

(http://www.whitehouse.gov/omb/inforeg/riaguide.html), which was issued as a guidance in 2000

(http://www.whitehouse.gov/omb/memoranda/m00-08.pdf), and reaffirmed in 2001

(http://www.whitehouse.gov/omb/memoranda/m01-23.html). It replaces both the 1996 "best practices" and the 2000

guidance.

In developing this Circular, OMB first developed a draft that was subject to public comment, interagency review, and

peer review. Peer reviewers included Cass Sunstein, University of Chicago; Lester Lave, Carnegie Mellon

University; Milton C. Weinstein and James K. Hammitt of the Harvard School of Public Health; Kerry Smith, North

Carolina State University; Jonathan Weiner, Duke University Law School; Douglas K. Owens, Stanford University;

and W. Kip Viscusi, Harvard Law School. Although these individuals submitted comments, OMB is solely

responsible for the final content of this Circular.

A. Introduction
A. Introduction

This Circular is designed to assist analysts in the regulatory agencies by defining good regulatory analysis B called

either "regulatory analysis" or "analysis" for brevity B and standardizing the way benefits and costs of Federal

regulatory actions are measured and reported. Executive Order 12866 requires agencies to conduct a regulatory

analysis for economically significant regulatory actions as defined by Section 3(f)(1). This requirement applies to

rulemakings that rescind or modify existing rules as well as to rulemakings that establish new requirements.

The Need for Analysis of Proposed Regulatory Actions1

Regulatory analysis is a tool regulatory agencies use to anticipate and evaluate the likely consequences of rules. It

provides a formal way of organizing the evidence on the key effects B good and bad B of the various alternatives that

should be considered in developing regulations. The motivation is to (1) learn if the benefits of an action are likely to

justify the costs or (2) discover which of various possible alternatives would be the most cost-effective.

A good regulatory analysis is designed to inform the public and other parts of the Government (as well as the

agency conducting the analysis) of the effects of alternative actions. Regulatory analysis sometimes will show that a

proposed action is misguided, but it can also demonstrate that well-conceived actions are reasonable and justified.

Benefit-cost analysis is a primary tool used for regulatory analysis.2 Where all benefits and costs can be quantified

and expressed in monetary units, benefit-cost analysis provides decision makers with a clear indication of the most

efficient alternative, that is, the alternative that generates the largest net benefits to society (ignoring distributional

effects). This is useful information for decision makers and the public to receive, even when economic efficiency is

not the only or the overriding public policy objective.

It will not always be possible to express in monetary units all of the important benefits and costs. When it is not, the

most efficient alternative will not necessarily be the one with the largest quantified and monetized net-benefit

estimate. In such cases, you should exercise professional judgment in determining how important the nonquantified benefits or costs may be in the context of the overall analysis. If the non-quantified benefits and costs are

likely to be important, you should carry out a "threshold" analysis to evaluate their significance. Threshold or "breakeven" analysis answers the question, "How small could the value of the non-quantified benefits be (or how large

would the value of the non-quantified costs need to be) before the rule would yield zero net benefits?" In addition to

threshold analysis you should indicate, where possible, which non-quantified effects are most important and why.

Key Elements of a Regulatory Analysis

A good regulatory analysis should include the following three basic elements: (1) a statement of the need for the

proposed action, (2) an examination of alternative approaches, and (3) an evaluation of the benefits and costs—

quantitative and qualitative—of the proposed action and the main alternatives identified by the analysis.

To evaluate properly the benefits and costs of regulations and their alternatives, you will need to do the following:

 Explain how the actions required by the rule are linked to the expected benefits. For example, indicate how

additional safety equipment will reduce safety risks. A similar analysis should be done for each of the

alternatives.

 Identify a baseline. Benefits and costs are defined in comparison with a clearly stated alternative. This

normally will be a "no action" baseline: what the world will be like if the proposed rule is not adopted.

Comparisons to a "next best" alternative are also especially useful.

 Identify the expected undesirable side-effects and ancillary benefits of the proposed regulatory action and the

alternatives. These should be added to the direct benefits and costs as appropriate.

With this information, you should be able to assess quantitatively the benefits and costs of the proposed rule and its

alternatives. A complete regulatory analysis includes a discussion of non-quantified as well as quantified benefits

and costs. A non-quantified outcome is a benefit or cost that has not been quantified or monetized in the analysis.

When there are important non-monetary values at stake, you should also identify them in your analysis so
When there are important non-monetary values at stake, you should also identify them in your analysis so

policymakers can compare them with the monetary benefits and costs. When your analysis is complete, you should

present a summary of the benefit and cost estimates for each alternative, including the qualitative and nonmonetized factors affected by the rule, so that readers can evaluate them.

As you design, execute, and write your regulatory analysis, you should seek out the opinions of those who will be

affected by the regulation as well as the views of those individuals and organizations who may not be affected but

have special knowledge or insight into the regulatory issues. Consultation can be useful in ensuring that your

analysis addresses all of the relevant issues and that you have access to all pertinent data. Early consultation can

be especially helpful. You should not limit consultation to the final stages of your analytical efforts.

You will find that you cannot conduct a good regulatory analysis according to a formula. Conducting high-quality

analysis requires competent professional judgment. Different regulations may call for different emphases in the

analysis, depending on the nature and complexity of the regulatory issues and the sensitivity of the benefit and cost

estimates to the key assumptions.

A good analysis is transparent. It should be possible for a qualified third party reading the report to see clearly how

you arrived at your estimates and conclusions. For transparency's sake, you should state in your report what

assumptions were used, such as the time horizon for the analysis and the discount rates applied to future benefits

and costs. It is usually necessary to provide a sensitivity analysis to reveal whether, and to what extent, the results of

the analysis are sensitive to plausible changes in the main assumptions and numeric inputs.

A good analysis provides specific references to all sources of data, appendices with documentation of models

(where necessary), and the results of formal sensitivity and other uncertainty analyses. Your analysis should also

have an executive summary, including a standardized accounting statement.

B. The Need for Federal Regulatory Action

Before recommending Federal regulatory action, an agency must demonstrate that the proposed action is

necessary. If the regulatory intervention results from a statutory or judicial directive, you should describe the specific

authority for your action, the extent of discretion available to you, and the regulatory instruments you might use.

Executive Order 12866 states that "Federal agencies should promulgate only such regulations as are required by

law, are necessary to interpret the law, or are made necessary by compelling need, such as material failures of

private markets to protect or improve the health and safety of the public, the environment, or the well being of the

American people ... ."

Executive Order 12866 also states that "Each agency shall identify the problem that it intends to address (including,

where applicable, the failures of private markets or public institutions that warrant new agency action) as well as

assess the significance of that problem." Thus, you should try to explain whether the action is intended to address a

significant market failure or to meet some other compelling public need such as improving governmental

processes or promoting intangible values such as distributional fairness or privacy. If the regulation is designed to

correct a significant market failure, you should describe the failure both qualitatively and (where feasible)

quantitatively. You should show that a government intervention is likely to do more good than harm. For other

interventions, you should also provide a demonstration of compelling social purpose and the likelihood of effective

action. Although intangible rationales do not need to be quantified, the analysis should present and evaluate the

strengths and limitations of the relevant arguments for these intangible values.

Market Failure or Other Social Purpose

The major types of market failure include: externality, market power, and inadequate or asymmetric information.

Correcting market failures is a reason for regulation, but it is not the only reason. Other possible justifications

include improving the functioning of government, removing distributional unfairness, or promoting privacy and

personal freedom.

1. Externality, common property resource and public good
1. Externality, common property resource and public good

An externality occurs when one party's actions impose uncompensated benefits or costs on another party.

Environmental problems are a classic case of externality. For example, the smoke from a factory may adversely

affect the health of local residents while soiling the property in nearby neighborhoods. If bargaining were costless

and all property rights were well defined, people would eliminate externalities through bargaining without the need

for government regulation.3 From this perspective, externalities arise from high transactions costs and/or poorly

defined property rights that prevent people from reaching efficient outcomes through market transactions.

Resources that may become congested or overused, such as fisheries or the broadcast spectrum, represent

common property resources. "Public goods," such as defense or basic scientific research, are goods where

provision of the good to some individuals cannot occur without providing the same level of benefits free of charge to

other individuals.

2. Market Power

Firms exercise market power when they reduce output below what would be offered in a competitive industry in

order to obtain higher prices. They may exercise market power collectively or unilaterally. Government action can be

a source of market power, such as when regulatory actions exclude low-cost imports. Generally, regulations that

increase market power for selected entities should be avoided. However, there are some circumstances in which

government may choose to validate a monopoly. If a market can be served at lowest cost only when production is

limited to a single producer B local gas and electricity distribution services, for example B a natural monopoly is

said to exist. In such cases, the government may choose to approve the monopoly and to regulate its prices and/or

production decisions. Nevertheless, you should keep in mind that technological advances often affect economies of

scale. This can, in turn, transform what was once considered a natural monopoly into a market where competition

can flourish.

3. Inadequate or Asymmetric Information

Market failures may also result from inadequate or asymmetric information. Because information, like other goods,

is costly to produce and disseminate, your evaluation will need to do more than demonstrate the possible existence

of incomplete or asymmetric information. Even though the market may supply less than the full amount of

information, the amount it does supply may be reasonably adequate and therefore not require government

regulation. Sellers have an incentive to provide information through advertising that can increase sales by

highlighting distinctive characteristics of their products. Buyers may also obtain reasonably adequate information

about product characteristics through other channels, such as a seller offering a warranty or a third party providing

information.

Even when adequate information is available, people can make mistakes by processing it poorly. Poor informationprocessing often occurs in cases of low probability, high-consequence events, but it is not limited to such

situations. For instance, people sometimes rely on mental rules-of-thumb that produce errors. If they have a clear

mental image of an incident which makes it cognitively "available," they might overstate the probability that it will

occur. Individuals sometimes process information in a biased manner, by being too optimistic or pessimistic,

without taking sufficient account of the fact that the outcome is exceedingly unlikely to occur. When mistakes in

information processing occur, markets may overreact. When it is time-consuming or costly for consumers to

evaluate complex information about products or services (e.g., medical therapies), they may expect government to

ensure that minimum quality standards are met. However, the mere possibility of poor information processing is

not enough to justify regulation. If you think there is a problem of information processing that needs to be

addressed, it should be carefully documented.

4. Other Social Purposes

There are justifications for regulations in addition to correcting market failures. A regulation may be appropriate

when you have a clearly identified measure that can make government operate more efficiently. In addition,
when you have a clearly identified measure that can make government operate more efficiently. In addition,

Congress establishes some regulatory programs to redistribute resources to select groups. Such regulations

should be examined to ensure that they are both effective and cost-effective. Congress also authorizes some

regulations to prohibit discrimination that conflicts with generally accepted norms within our society. Rulemaking

may also be appropriate to protect privacy, permit more personal freedom or promote other democratic aspirations.

Showing That Regulation at the Federal Level Is the Best Way to Solve the Problem

Even where a market failure clearly exists, you should consider other means of dealing with the failure before

turning to Federal regulation. Alternatives to Federal regulation include antitrust enforcement, consumer-initiated

litigation in the product liability system, or administrative compensation systems.

In assessing whether Federal regulation is the best solution, you should also consider the possibility of regulation

at the State or local level. In some cases, the nature of the market failure may itself suggest the most appropriate

governmental level of regulation. For example, problems that spill across State lines (such as acid rain whose

precursors are transported widely in the atmosphere) are probably best addressed by Federal regulation. More

localized problems, including those that are common to many areas, may be more efficiently addressed locally.

The advantages of leaving regulatory issues to State and local authorities can be substantial. If public values and

preferences differ by region, those differences can be reflected in varying State and local regulatory policies.

Moreover, States and localities can serve as a testing ground for experimentation with alternative regulatory policies.

One State can learn from another's experience while local jurisdictions may compete with each other to establish

the best regulatory policies. You should examine the proper extent of State and local discretion in your rulemaking

context.

A diversity of rules may generate gains for the public as governmental units compete with each other to serve the

public, but duplicative regulations can also be costly. Where Federal regulation is clearly appropriate to address

interstate commerce issues, you should try to examine whether it would be more efficient to retain or reduce State

and local regulation. The local benefits of State regulation may not justify the national costs of a fragmented

regulatory system. For example, the increased compliance costs for firms to meet different State and local

regulations may exceed any advantages associated with the diversity of State and local regulation. Your analysis

should consider the possibility of reducing as well as expanding State and local rulemaking.

The role of Federal regulation in facilitating U.S. participation in global markets should also be considered.

Harmonization of U.S. and international rules may require a strong Federal regulatory role. Concerns that new U.S.

rules could act as non-tariff barriers to imported goods should be evaluated carefully.

The Presumption Against Economic Regulation

Government actions can be unintentionally harmful, and even useful regulations can impede market efficiency. For

this reason, there is a presumption against certain types of regulatory action. In light of both economic theory and

actual experience, a particularly demanding burden of proof is required to demonstrate the need for any of the

following types of regulations:

 price controls in competitive markets;

 production or sales quotas in competitive markets;

 mandatory uniform quality standards for goods or services if the potential problem can be adequately dealt

with through voluntary standards or by disclosing information of the hazard to buyers or users; or

 controls on entry into employment or production, except (a) where indispensable to protect health and safety

(e.g., FAA tests for commercial pilots) or (b) to manage the use of common property resources (e.g.,

fisheries, airwaves, Federal lands, and offshore areas).

C. Alternative Regulatory Approaches

Once you have determined that Federal regulatory action is appropriate, you will need to consider alternative
Once you have determined that Federal regulatory action is appropriate, you will need to consider alternative

regulatory approaches. Ordinarily, you will be able to eliminate some alternatives through a preliminary analysis,

leaving a manageable number of alternatives to be evaluated according to the formal principles of the Executive

Order. The number and choice of alternatives selected for detailed analysis is a matter of judgment. There must be

some balance between thoroughness and the practical limits on your analytical capacity. With this qualification in

mind, you should nevertheless explore modifications of some or all of a regulation's attributes or provisions to

identify appropriate alternatives. The following is a list of alternative regulatory actions that you should consider.

Different Choices Defined by Statute

When a statute establishes a specific regulatory requirement and the agency is considering a more stringent

standard, you should examine the benefits and costs of reasonable alternatives that reflect the range of the

agency's statutory discretion, including the specific statutory requirement.

Different Compliance Dates

The timing of a regulation may also have an important effect on its net benefits. Benefits may vary significantly with

different compliance dates where a delay in implementation may result in a substantial loss in future benefits (e.g.,

a delay in implementation could result in a significant reduction in spawning stock and jeopardize a fishery).

Similarly, the cost of a regulation may vary substantially with different compliance dates for an industry that requires

a year or more to plan its production runs. In this instance, a regulation that provides sufficient lead time is likely to

achieve its goals at a much lower overall cost than a regulation that is effective immediately.

Different Enforcement Methods

Compliance alternatives for Federal, State, or local enforcement include on-site inspections, periodic reporting, and

noncompliance penalties structured to provide the most appropriate incentives. When alternative monitoring and

reporting methods vary in their benefits and costs, you should identify the most appropriate enforcement framework.

For example, in some circumstances random monitoring or parametric monitoring will be less expensive and

nearly as effective as continuous monitoring.

Different Degrees of Stringency

In general, both the benefits and costs associated with a regulation will increase with the level of stringency

(although marginal costs generally increase with stringency, whereas marginal benefits may decrease). You

should study alternative levels of stringency to understand more fully the relationship between stringency and the

size and distribution of benefits and costs among different groups.

Different Requirements for Different Sized Firms

You should consider setting different requirements for large and small firms, basing the requirements on estimated

differences in the expected costs of compliance or in the expected benefits. The balance of benefits and costs can

shift depending on the size of the firms being regulated. Small firms may find it more costly to comply with

regulation, especially if there are large fixed costs required for regulatory compliance. On the other hand, it is not

efficient to place a heavier burden on one segment of a regulated industry solely because it can better afford the

higher cost. This has the potential to load costs on the most productive firms, costs that are disproportionate to the

damages they create. You should also remember that a rule with a significant impact on a substantial number of

small entities will trigger the requirements set forth in the Regulatory Flexibility Act. (5 U.S.C. 603(c), 604).

Different Requirements for Different Geographic Regions

Rarely do all regions of the country benefit uniformly from government regulation. It is also unlikely that costs will be

uniformly distributed across the country. Where there are significant regional variations in benefits and/or costs, you

should consider the possibility of setting different requirements for the different regions.
Performance Standards Rather than Design Standards

Performance standards express requirements in terms of outcomes rather than specifying the means to those

ends. They are generally superior to engineering or design standards because performance standards give the

regulated parties the flexibility to achieve regulatory objectives in the most cost-effective way. In general, you should

take into account both the cost savings to the regulated parties of the greater flexibility and the costs of assuring

compliance through monitoring or some other means.

Market-Oriented Approaches Rather than Direct Controls

Market-oriented approaches that use economic incentives should be explored. These alternatives include fees,

penalties, subsidies, marketable permits or offsets, changes in liability or property rights (including policies that

alter the incentives of insurers and insured parties), and required bonds, insurance or warranties. One example of a

market-oriented approach is a program that allows for averaging, banking, and/or trading (ABT) of credits for

achieving additional emission reductions beyond the required air emission standards. ABT programs can be

extremely valuable in reducing costs or achieving earlier or greater benefits, particularly when the costs of achieving

compliance vary across production lines, facilities, or firms. ABT can be allowed on a plant-wide, firm-wide, or

region-wide basis rather than vent by vent, provided this does not produce unacceptable local air quality outcomes

(such as "hot spots" from local pollution concentration).

Informational Measures Rather than Regulation

If intervention is contemplated to address a market failure that arises from inadequate or asymmetric information,

informational remedies will often be preferred. Measures to improve the availability of information include

government establishment of a standardized testing and rating system (the use of which could be mandatory or

voluntary), mandatory disclosure requirements (e.g., by advertising, labeling, or enclosures), and government

provision of information (e.g., by government publications, telephone hotlines, or public interest broadcast

announcements). A regulatory measure to improve the availability of information, particularly about the concealed

characteristics of products, provides consumers a greater choice than a mandatory product standard or ban.

Specific informational measures should be evaluated in terms of their benefits and costs. Some effects of

informational measures are easily overlooked. The costs of a mandatory disclosure requirement for a consumer

product will include not only the cost of gathering and communicating the required information, but also the loss of

net benefits of any information displaced by the mandated information. The other costs also may include the effect

of providing information that is ignored or misinterpreted, and inefficiencies arising from the incentive that

mandatory disclosure may give to overinvest in a particular characteristic of a product or service.

Where information on the benefits and costs of alternative informational measures is insufficient to provide a clear

choice between them, you should consider the least intrusive informational alternative sufficient to accomplish the

regulatory objective. To correct an informational market failure it may be sufficient for government to establish a

standardized testing and rating system without mandating its use, because competing firms that score well

according to the system should thereby have an incentive to publicize the fact.

D. Analytical Approaches

Both benefit-cost analysis (BCA) and cost-effectiveness analysis (CEA) provide a systematic framework for

identifying and evaluating the likely outcomes of alternative regulatory choices. A major rulemaking should be

supported by both types of analysis wherever possible. Specifically, you should prepare a CEA for all major

rulemakings for which the primary benefits are improved public health and safety to the extent that a valid

effectiveness measure can be developed to represent expected health and safety outcomes. You should also

perform a BCA for major health and safety rulemakings to the extent that valid monetary values can be assigned to

the primary expected health and safety outcomes. In undertaking these analyses, it is important to keep in mind the

larger objective of analytical consistency in estimating benefits and costs across regulations and agencies, subject

to statutory limitations. Failure to maintain such consistency may prevent achievement of the most risk reduction for
to statutory limitations. Failure to maintain such consistency may prevent achievement of the most risk reduction for

a given level of resource expenditure. For all other major rulemakings, you should carry out a BCA. If some of the

primary benefit categories cannot be expressed in monetary units, you should also conduct a CEA. In unusual

cases where no quantified information on benefits, costs and effectiveness can be produced, the regulatory

analysis should present a qualitative discussion of the issues and evidence.

Benefit-Cost Analysis

A distinctive feature of BCA is that both benefits and costs are expressed in monetary units, which allows you to

evaluate different regulatory options with a variety of attributes using a common measure.4 By measuring

incremental benefits and costs of successively more stringent regulatory alternatives, you can identify the alternative

that maximizes net benefits.

The size of net benefits, the absolute difference between the projected benefits and costs, indicates whether one

policy is more efficient than another. The ratio of benefits to costs is not a meaningful indicator of net benefits and

should not be used for that purpose. It is well known that considering such ratios alone can yield misleading

results.

Even when a benefit or cost cannot be expressed in monetary units, you should still try to measure it in terms of its

physical units. If it is not possible to measure the physical units, you should still describe the benefit or cost

qualitatively. For more information on describing qualitative information, see the section "Developing Benefit and

Cost Estimates."

When important benefits and costs cannot be expressed in monetary units, BCA is less useful, and it can even be

misleading, because the calculation of net benefits in such cases does not provide a full evaluation of all relevant

benefits and costs.

You should exercise professional judgment in identifying the importance of non-quantified factors and assess as

best you can how they might change the ranking of alternatives based on estimated net benefits. If the nonquantified benefits and costs are likely to be important, you should recommend which of the non-quantified factors

are of sufficient importance to justify consideration in the regulatory decision. This discussion should also include a

clear explanation that support designating these non-quantified factors as important. In this case, you should also

consider conducting a threshold analysis to help decision makers and other users of the analysis to understand

the potential significance of these factors to the overall analysis.

Cost-Effectiveness Analysis5

Cost-effectiveness analysis can provide a rigorous way to identify options that achieve the most effective use of the

resources available without requiring monetization of all of relevant benefits or costs. Generally, cost-effectiveness

analysis is designed to compare a set of regulatory actions with the same primary outcome (e.g., an increase in the

acres of wetlands protected) or multiple outcomes that can be integrated into a single numerical index (e.g., units of

health improvement).

Cost-effectiveness results based on averages need to be treated with great care. They suffer from the same

drawbacks as benefit-cost ratios. The alternative that exhibits the smallest cost-effectiveness ratio may not be the

best option, just as the alternative with the highest benefit-cost ratio is not always the one that maximizes net

benefits. Incremental cost-effectiveness analysis (discussed below) can help to avoid mistakes that can occur

when policy choices are based on average cost-effectiveness.

CEA can also be misleading when the "effectiveness" measure does not appropriately weight the consequences of

the alternatives. For example, when effectiveness is measured in tons of reduced pollutant emissions, costeffectiveness estimates will be misleading unless the reduced emissions of diverse pollutants result in the same

health and environmental benefits.
When you have identified a range of alternatives (e.g., different levels of stringency), you should determine the costeffectiveness of each option compared with the baseline as well as its incremental cost-effectiveness compared

with successively more stringent requirements. Ideally, your CEA would present an array of cost-effectiveness

estimates that would allow comparison across different alternatives. However, analyzing all possible combinations

is not practical when there are many options (including possible interaction effects). In these cases, you should use

your judgment to choose reasonable alternatives for careful consideration.

When constructing and comparing incremental cost-effectiveness ratios, you should be careful to determine

whether the various alternatives are mutually exclusive or whether they can be combined. If they can be combined,

you should consider which might be favored under different regulatory budget constraints (implicit or explicit). You

should also make sure that inferior alternatives identified by the principles of strong and weak dominance are

eliminated from consideration.6

The value of CEA is enhanced when there is consistency in the analysis across a diverse set of possible regulatory

actions. To achieve consistency, you need to carefully construct the two key components of any CEA: the cost and

the "effectiveness" or performance measures for the alternative policy options.

With regard to measuring costs, you should be sure to include all the relevant costs to society B whether public or

private. Rulemakings may also yield cost savings (e.g., energy savings associated with new technologies). The

numerator in the cost-effectiveness ratio should reflect net costs, defined as the gross cost incurred to comply with

the requirements (sometimes called "total" costs) minus any cost savings. You should be careful to avoid doublecounting effects in both the numerator and the denominator of the cost-effectiveness ratios. For example, it would

be incorrect to reduce gross costs by an estimated monetary value on life extension if life-years are already used as

the effectiveness measure in the denominator.

In constructing measures of "effectiveness", final outcomes, such as lives saved or life-years saved, are preferred to

measures of intermediate outputs, such as tons of pollution reduced, crashes avoided, or cases of disease

avoided. Where the quality of the measured unit varies (e.g., acres of wetlands vary substantially in terms of their

ecological benefits), it is important that the measure capture the variability in the value of the selected "outcome"

measure. You should provide an explanation of your choice of effectiveness measure.

Where regulation may yield several different beneficial outcomes, a cost-effectiveness comparison becomes more

difficult to interpret because there is more than one measure of effectiveness to incorporate in the analysis. To

arrive at a single measure you will need to weight the value of disparate benefit categories, but this computation

raises some of the same difficulties you will encounter in BCA. If you can assign a reasonable monetary value to all

of the regulation's different benefits, then you should do so. But in this case, you will be doing BCA, not CEA.

When you can estimate the monetary value of some but not all of the ancillary benefits of a regulation, but cannot

assign a monetary value to the primary measure of effectiveness, you should subtract the monetary estimate of the

ancillary benefits from the gross cost estimate to yield an estimated net cost. (This net cost estimate for the rule

may turn out to be negative B that is, the monetized benefits exceed the cost of the rule.) If you are unable to

estimate the value of some of the ancillary benefits, the cost-effectiveness ratio will be overstated, and this should

be acknowledged in your analysis. CEA does not yield an unambiguous choice when there are benefits or costs

that have not been incorporated in the net-cost estimates. You also may use CEA to compare regulatory alternatives

in cases where the statute specifies the level of benefits to be achieved.

The Effectiveness Metric for Public Health and Safety Rulemakings

When CEA is applied to public health and safety rulemakings, one or more measures of effectiveness must be

selected that permits comparison of regulatory alternatives. Agencies currently use a variety of effectiveness

measures.

There are relatively simple measures such as the number of lives saved, cases of cancer reduced, and cases of

paraplegia prevented. Sometimes these measures account only for mortality information, such as the number of
paraplegia prevented. Sometimes these measures account only for mortality information, such as the number of

lives saved and the number of years of life saved. There are also more comprehensive, integrated measures of

effectiveness such as the number of "equivalent lives" (ELs) saved and the number of "quality-adjusted life

years" (QALYs) saved.

The main advantage of the integrated measures of effectiveness is that they account for a rule's impact on morbidity

(nonfatal illness, injury, impairment and quality of life) as well as premature death. The inclusion of morbidity effects

is important because (a) some illnesses (e.g., asthma) cause more instances of pain and suffering than they do

premature death, (b) some population groups are known to experience elevated rates of morbidity (e.g, the elderly

and the poor) and thus have a strong interest in morbidity measurement7, and (c) some regulatory alternatives may

be more effective at preventing morbidity than premature death (e.g., some advanced airbag designs may diminish

the nonfatal injuries caused by airbag inflation without changing the frequency of fatal injury prevented by airbags).

However, the main drawback of these integrated measures is that they must meet some restrictive assumptions to

represent a valid measure of individual preferences.8 For example, a QALY measure implicitly assumes that the

fraction of remaining lifespan an individual would give up for an improvement in health-related quality of life does

not depend on the remaining lifespan. Thus, if an individual is willing to give up 10 years of life among 50 remaining

years for a given health improvement, he or she would also be willing to give up 1 year of life among 5 remaining

years. To the extent that individual preferences deviate from these assumptions, analytic results from CEA using

QALYs could differ from analytic results based on willingness-to-pay-measures. Though willingness to pay is

generally the preferred economic method for evaluating preferences, the CEA method, as applied in medicine and

health, does not evaluate health changes using individual willingness to pay. When performing CEA, you should

consider using at least one integrated measure of effectiveness when a rule creates a significant impact on both

mortality and morbidity.

When CEA is performed in specific rulemaking contexts, you should be prepared to make appropriate adjustments

to ensure fair treatment of all segments of the population. Fairness is important in the choice and execution of

effectiveness measures. For example, if QALYs are used to evaluate a lifesaving rule aimed at a population that

happens to experience a high rate of disability (i.e., where the rule is not designed to affect the disability), the

number of life years saved should not necessarily be diminished simply because the rule saves the lives of people

with life-shortening disabilities. Both analytic simplicity and fairness suggest that the estimated number of life years

saved for the disabled population should be based on average life expectancy information for the relevant age

cohorts. More generally, when numeric adjustments are made for life expectancy or quality of life, analysts should

prefer use of population averages rather than information derived from subgroups dominated by a particular

demographic or income group.

OMB does not require agencies to use any specific measure of effectiveness. In fact, OMB encourages agencies to

report results with multiple measures of effectiveness that offer different insights and perspectives. The regulatory

analysis should explain which measures were selected and why, and how they were implemented.

The analytic discretion provided in choice of effectiveness measure will create some inconsistency in how agencies

evaluate the same injuries and diseases, and it will be difficult for OMB and the public to draw meaningful

comparisons between rulemakings that employ different effectiveness measures. As a result, agencies should use

their web site to provide OMB and the public with the underlying data, including mortality and morbidity data, the age

distribution of the affected populations, and the severity and duration of disease conditions and trauma, so that OMB

and the public can construct apples-to-apples comparisons between rulemakings that employ different measures.

There are sensitive technical and ethical issues associated with choosing one or more of these integrated

measures for use throughout the Federal government. The Institute of Medicine (IOM) may assemble a panel of

specialists in cost-effectiveness analysis and bioethics to evaluate the advantages and disadvantages of these

different measures and other measures that have been suggested in the academic literature. OMB believes that the

IOM guidance will provide Federal agencies and OMB useful insight into how to improve the measurement of

effectiveness of public health and safety regulations.
Distributional Effects

Those who bear the costs of a regulation and those who enjoy its benefits often are not the same people. The term

"distributional effect" refers to the impact of a regulatory action across the population and economy, divided up in

various ways (e.g., income groups, race, sex, industrial sector, geography). Benefits and costs of a regulation may

also be distributed unevenly over time, perhaps spanning several generations. Distributional effects may arise

through "transfer payments" that stem from a regulatory action as well. For example, the revenue collected through a

fee, surcharge in excess of the cost of services provided, or tax is a transfer payment.

Your regulatory analysis should provide a separate description of distributional effects (i.e., how both benefits and

costs are distributed among sub-populations of particular concern) so that decision makers can properly consider

them along with the effects on economic efficiency. Executive Order 12866 authorizes this approach. Where

distributive effects are thought to be important, the effects of various regulatory alternatives should be described

quantitatively to the extent possible, including the magnitude, likelihood, and severity of impacts on particular

groups. You should be alert for situations in which regulatory alternatives result in significant changes in treatment

or outcomes for different groups. Effects on the distribution of income that are transmitted through changes in

market prices can be important, albeit sometimes difficult to assess. Your analysis should also present information

on the streams of benefits and costs over time in order to provide a basis for assessing intertemporal distributional

consequences, particularly where intergenerational effects are concerned.

E. Identifying and Measuring Benefits and Costs

This Section provides guidelines for your preparation of the benefit and cost estimates required by Executive Order

12866 and the "Regulatory Right-to-Know Act." The discussions in previous sections will help you identify a

workable number of alternatives for consideration in your analysis and an appropriate analytical approach to use.

General Issues

1. Scope of Analysis

Your analysis should focus on benefits and costs that accrue to citizens and residents of the United States. Where

you choose to evaluate a regulation that is likely to have effects beyond the borders of the United States, these

effects should be reported separately. The time frame for your analysis should cover a period long enough to

encompass all the important benefits and costs likely to result from the rule.

2. Developing a Baseline

You need to measure the benefits and costs of a rule against a baseline. This baseline should be the best

assessment of the way the world would look absent the proposed action. The choice of an appropriate baseline

may require consideration of a wide range of potential factors, including:

 evolution of the market,

 changes in external factors affecting expected benefits and costs,

 changes in regulations promulgated by the agency or other government entities, and

 the degree of compliance by regulated entities with other regulations.

It may be reasonable to forecast that the world absent the regulation will resemble the present. If this is the case,

however, your baseline should reflect the future effect of current government programs and policies. For review of an

existing regulation, a baseline assuming "no change" in the regulatory program generally provides an appropriate

basis for evaluating regulatory alternatives. When more than one baseline is reasonable and the choice of baseline

will significantly affect estimated benefits and costs, you should consider measuring benefits and costs against

alternative baselines. In doing so you can analyze the effects on benefits and costs of making different assumptions

about other agencies' regulations, or the degree of compliance with your own existing rules. In all cases, you must

evaluate benefits and costs against the same baseline. You should also discuss the reasonableness of the
evaluate benefits and costs against the same baseline. You should also discuss the reasonableness of the

baselines used in the sensitivity analyses. For each baseline you use, you should identify the key uncertainties in

your forecast.

EPA's 1998 final PCB disposal rule provides a good example of using different baselines. EPA used several

alternative baselines, each reflecting a different interpretation of existing regulatory requirements. In particular, one

baseline reflected a literal interpretation of EPA's 1979 rule and another the actual implementation of that rule in the

year immediately preceding the 1998 revision. The use of multiple baselines illustrated the substantial effect

changes in EPA's implementation policy could have on the cost of a regulatory program. In the years after EPA

adopted the 1979 PCB disposal rule, changes in EPA policy -- especially allowing the disposal of automobile

"shredder fluff" in municipal landfills -- reduced the cost of the program by more than $500 million per year.

In some cases, substantial portions of a rule may simply restate statutory requirements that would be selfimplementing, even in the absence of the regulatory action. In these cases, you should use a pre-statute baseline. If

you are able to separate out those areas where the agency has discretion, you may also use a post-statute

baseline to evaluate the discretionary elements of the action.

3. Evaluation of Alternatives

You should describe the alternatives available to you and the reasons for choosing one alternative over another. As

noted previously, alternatives that rely on incentives and offer increased flexibility are often more cost-effective than

more prescriptive approaches. For instance, user fees and information dissemination may be good alternatives to

direct command-and-control regulation. Within a command-and-control regulatory program, performance-based

standards generally offer advantages over standards specifying design, behavior, or manner of compliance.

You should carefully consider all appropriate alternatives for the key attributes or provisions of the rule. The previous

discussion outlines examples of appropriate alternatives. Where there is a "continuum" of alternatives for a

standard (such as the level of stringency), you generally should analyze at least three options: the preferred option;

a more stringent option that achieves additional benefits (and presumably costs more) beyond those realized by the

preferred option; and a less stringent option that costs less (and presumably generates fewer benefits) than the

preferred option.

You should choose reasonable alternatives deserving careful consideration. In some cases, a regulatory program

will focus on an option that is near or at the limit of technical feasibility. In this case, the analysis would not need to

examine a more stringent option. For each of the options analyzed, you should compare the anticipated benefits to

the corresponding costs.

It is not adequate simply to report a comparison of the agency's preferred option to the chosen baseline. Whenever

you report the benefits and costs of alternative options, you should present both total and incremental benefits and

costs. You should present incremental benefits and costs as differences from the corresponding estimates

associated with the next less-stringent alternative.10 It is important to emphasize that incremental effects are simply

differences between successively more stringent alternatives. Results involving a comparison to a "next best"

alternative may be especially useful.

In some cases, you may decide to analyze a wide array of options. In 1998, DOE analyzed a large number of options

in setting new energy efficiency standards for refrigerators and freezers and produced a rich amount of information

on their relative effects. This analysis -- examining more than 20 alternative performance standards for one class of

refrigerators with top-mounted freezers -- enabled DOE to select an option that produced $200 more in estimated

net benefits per refrigerator than the least attractive option.

You should analyze the benefits and costs of different regulatory provisions separately when a rule includes a

number of distinct provisions. If the existence of one provision affects the benefits or costs arising from another

provision, the analysis becomes more complicated, but the need to examine provisions separately remains. In this

case, you should evaluate each specific provision by determining the net benefits of the proposed regulation with
case, you should evaluate each specific provision by determining the net benefits of the proposed regulation with

and without it.

Analyzing all possible combinations of provisions is impractical if the number is large and interaction effects are

widespread. You need to use judgment to select the most significant or relevant provisions for such analysis. You

are expected to document all of the alternatives that were considered in a list or table and which were selected for

emphasis in the main analysis.

You should also discuss the statutory requirements that affect the selection of regulatory approaches. If legal

constraints prevent the selection of a regulatory action that best satisfies the philosophy and principles of Executive

Order 12866, you should identify these constraints and estimate their opportunity cost. Such information may be

useful to Congress under the Regulatory Right-to-Know Act.

4. Transparency and Reproducibility of Results

Because of its influential nature and its special role in the rulemaking process, it is appropriate to set minimum

quality standards for regulatory analysis. You should provide documentation that the analysis is based on the best

reasonably obtainable scientific, technical, and economic information available. To achieve this, you should rely on

peer-reviewed literature, where available, and provide the source for all original information.

A good analysis should be transparent and your results must be reproducible. You should clearly set out the basic

assumptions, methods, and data underlying the analysis and discuss the uncertainties associated with the

estimates. A qualified third party reading the analysis should be able to understand the basic elements of your

analysis and the way in which you developed your estimates.

To provide greater access to your analysis, you should generally post it, with all the supporting documents, on the

internet so the public can review the findings. You should also disclose the use of outside consultants, their

qualifications, and history of contracts and employment with the agency (e.g., in a preface to the RIA). Where other

compelling interests (such as privacy, intellectual property, trade secrets, etc.) prevent the public release of data or

key elements of the analysis, you should apply especially rigorous robustness checks to analytic results and

document the analytical checks used.

Finally, you should assure compliance with the Information Quality Guidelines for your agency and OMB's

"Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by

Federal Agencies" ("data quality guidelines") http://www.whitehouse.gov/omb/fedreg/reproducible.html.

Developing Benefit and Cost Estimates

1. Some General Considerations

The analysis document should discuss the expected benefits and costs of the selected regulatory option and any

reasonable alternatives. How is the proposed action expected to provide the anticipated benefits and costs? What

are the monetized values of the potential real incremental benefits and costs to society? To present your results,

you should:

 include separate schedules of the monetized benefits and costs that show the type and timing of benefits

and costs, and express the estimates in this table in constant, undiscounted dollars (for more on discounting

see "Discount Rates" below);

 list the benefits and costs you can quantify, but cannot monetize, including their timing;

 describe benefits and costs you cannot quantify; and

 identify or cross-reference the data or studies on which you base the benefit and cost estimates.

When benefit and cost estimates are uncertain (for more on this see "Treatment of Uncertainty" below), you

should report benefit and cost estimates (including benefits of risk reductions) that reflect the full probability
should report benefit and cost estimates (including benefits of risk reductions) that reflect the full probability

distribution of potential consequences. Where possible, present probability distributions of benefits and costs and

include the upper and lower bound estimates as complements to central tendency and other estimates.

If fundamental scientific disagreement or lack of knowledge prevents construction of a scientifically defensible

probability distribution, you should describe benefits or costs under plausible scenarios and characterize the

evidence and assumptions underlying each alternative scenario.

2. The Key Concepts Needed to Estimate Benefits and Costs

"Opportunity cost" is the appropriate concept for valuing both benefits and costs. The principle of "willingness-topay" (WTP) captures the notion of opportunity cost by measuring what individuals are willing to forgo to enjoy a

particular benefit. In general, economists tend to view WTP as the most appropriate measure of opportunity cost,

but an individual's "willingness-to-accept" (WTA) compensation for not receiving the improvement can also provide

a valid measure of opportunity cost.

WTP and WTA are comparable measures under special circumstances. WTP and WTA measures may be

comparable in the following situations: if a regulation affects a price change rather than a quantity change; the

change being evaluated is small; there are reasonably close substitutes available; and the income effect is

small.11 However, empirical evidence from experimental economics and psychology shows that even when

income/wealth effects are "small", the measured differences between WTP and WTA can be large.12 WTP is

generally considered to be more readily measurable. Adoption of WTP as the measure of value implies that

individual preferences of the affected population should be a guiding factor in the regulatory analysis.

Market prices provide rich data for estimating benefits and costs based on willingness-to-pay if the goods and

services affected by the regulation are traded in well-functioning competitive markets. The opportunity cost of an

alternative includes the value of the benefits forgone as a result of choosing that alternative. The opportunity cost of

banning a product -- a drug, food additive, or hazardous chemical -- is the forgone net benefit (i.e., lost consumer

and producer surplus13) of that product, taking into account the mitigating effects of potential substitutes.

The use of any resource has an opportunity cost regardless of whether the resource is already owned or has to be

purchased. That opportunity cost is equal to the net benefit the resource would have provided in the absence of the

requirement. For example, if regulation of an industrial plant affects the use of additional land or buildings within the

existing plant boundary, the cost analysis should include the opportunity cost of using the additional land or

facilities.

To the extent possible, you should monetize any such forgone benefits and add them to the other costs of that

alternative. You should also try to monetize any cost savings as a result of an alternative and either add it to the

benefits or subtract it from the costs of that alternative. However, you should not assume that the "avoided" costs of

not doing another regulatory alternative represent the benefits of a regulatory action where there is no direct,

necessary relationship between the two. You should also be careful when the costs avoided are attributable to an

existing regulation. Even when there is a direct relationship between the two regulatory actions, the use of avoided

costs is problematic because the existing regulation may not maximize net benefits and thus may itself be

questionable policy. (See the section, "Direct Use of Market Data," for more detail.)

Estimating benefits and costs when market prices are hard to measure or markets do not exist is more difficult. In

these cases, you need to develop appropriate proxies that simulate market exchange. Estimates of willingness-topay based on revealed preference methods can be quite useful. As one example, analysts sometimes use

"hedonic price equations" based on multiple regression analysis of market behavior to simulate market prices for

the commodity of interest. The hedonic technique allows analysts to develop an estimate of the price for specific

attributes associated with a product. For instance, a house is a product characterized by a variety of attributes

including the number of rooms, total floor area, and type of heating and cooling. If there are enough data on

transactions in the housing market, it is possible to develop an estimate of the implicit price for specific attributes,

such as the implicit price of an additional bathroom or for central air conditioning. This technique can be extended,
such as the implicit price of an additional bathroom or for central air conditioning. This technique can be extended,

as well, to develop an estimate for the implicit price of public goods that are not directly traded in markets. An

analyst can develop implicit price estimates for public goods like air quality and access to public parks by

assessing the effects of these goods on the housing market. Going through the analytical process of deriving

benefit estimates by simulating markets may also suggest alternative regulatory strategies that create such

markets.

You need to guard against double-counting, since some attributes are embedded in other broader measures. To

illustrate, when a regulation improves the quality of the environment in a community, the value of real estate in the

community generally rises to reflect the greater attractiveness of living in a better environment. Simply adding the

increase in property values to the estimated value of improved public health would be double counting if the

increase in property values reflects the improvement in public health. To avoid this problem you should separate the

embedded effects on the value of property arising from improved public health. At the same time, an analysis that

fails to incorporate the consequence of land use changes when accounting for costs will not capture the full effects

of regulation.

3. Revealed Preference Methods

Revealed preference methods develop estimates of the value of goods and services -- or attributes of those goods

and services -- based on actual market decisions by consumers, workers and other market participants. If the

market participant is well informed and confronted with a real choice, it may be feasible to determine accurately and

precisely the monetary value needed for a rulemaking. There is a large and well-developed literature on revealed

preference in the peer-reviewed, applied economics literature.

Although these methods are well grounded in economic theory, they are sometimes difficult to implement given the

complexity of market transactions and the paucity of relevant data. When designing or evaluating a revealed

preference study, the following principles should be considered:

 the market should be competitive. If the market isn't competitive (e.g., monopoly, oligopoly), then you should

consider making adjustments such that the price reflects the true value to society (often called the "shadow

price");

 the market should not exhibit a significant information gap or asymmetric information problem. If the market

suffers from information problems, then you should discuss the divergence of the price from the underlying

shadow price and consider possible adjustments to reflect the underlying shadow price;

 the market should not exhibit an externality. In this case, you should discuss the divergence of the price from

the underlying shadow price and consider possible adjustments to reflect the underlying shadow price;

 the specific market participants being studied should be representative of the target populations to be

affected by the rulemaking under consideration;

 a valid research design and framework for analysis should be adopted. Examples include using data and/or

model specifications that include the markets for substitute and complementary goods and services and

using reasonably unrestricted functional forms. When specifying substitute and complementary goods, the

analysis should preferably be based on data about the range of alternatives perceived by market participants.

If such data are not available, you should adopt plausible assumptions and describe the limitations of the

analysis.

 the statistical and econometric models employed should be appropriate for the application and the resulting

estimates should be robust in response to plausible changes in model specification and estimation

technique; and

 the results should be consistent with economic theory.

You should also determine whether there are multiple revealed-preference studies of the same good or service and

whether anything can be learned by comparing the methods, data and findings from different studies. Professional

judgment is required to determine whether a particular study is of sufficient quality to justify use in regulatory

analysis. When studies are used in regulatory analysis despite their technical weaknesses (e.g., due to the

absence of other evidence), the regulatory analysis should discuss any biases or uncertainties that are likely to
absence of other evidence), the regulatory analysis should discuss any biases or uncertainties that are likely to

arise due to those weaknesses. If a study has major weaknesses, the study should not be used in regulatory

analysis.

1. Direct Uses of Market Data

Economists ordinarily consider market prices as the most accurate measure of the marginal value of goods and

services to society. In some instances, however, market prices may not reflect the true value of goods and

services due to market imperfections or government intervention. If a regulation involves changes to goods or

services where the market price is not a good measure of the value to society, you should use an estimate that

reflects the shadow price. Suppose a particular air pollutant damages crops. One of the benefits of controlling

that pollutant is the value of the crop yield increase as a result of the controls. That value is typically measured by

the price of the crop. However, if the price is held above the market price by a government program that affects

supply, a value estimate based on this price may not reflect the true benefits of controlling the pollutant. In this

case, you should calculate the value to society of the increase in crop yields by estimating the shadow price,

which reflects the value to society of the marginal use of the crop. If the marginal use is for exports, you should

use the world price. If the marginal use is to add to very large surplus stockpiles, you should use the value of the

last units released from storage minus storage cost. If stockpiles are large and growing, the shadow price may

be low or even negative.

Other goods whose market prices may not reflect their true value include those whose production or

consumption results in substantial (1) positive or negative external effects or (2) transfer payments. For example,

the observed market price of gasoline may not reflect marginal social value due to the inclusion of taxes, other

government interventions, and negative externalities (e.g., pollution). This shadow price may also be needed for

goods whose market price is substantially affected by existing regulations that do not maximize net benefits.

2. Indirect Uses of Market Data

Many goods or attributes of goods that are affected by regulation--such as preserving environmental or cultural

amenities--are not traded directly in markets. The value for these goods or attributes arise both from use and

non-use. Estimation of these values is difficult because of the absence of an organized market. However,

overlooking or ignoring these values in your regulatory analysis may significantly understate the benefits and/or

costs of regulatory action.

"Use values" arise where an individual derives satisfaction from using the resource, either now or in the future.

Use values are associated with activities such as swimming, hunting, and hiking where the individual makes

use of the natural environment.

"Non-use values" arise where an individual places value on a resource, good or service even though the

individual will not use the resource, now or in the future. Non-use value includes bequest and existence values.

General altruism for the health and welfare of others is a closely related concept but may not be strictly

considered a "non-use" value.14 A general concern for the welfare of others should supplement benefits and

costs equally; hence, it is not necessary to measure the size of general altruism in regulatory analysis. If there is

evidence of selective altruism, it needs to be considered specifically in both benefits and costs.

Some goods and services are indirectly traded in markets, which means that their value is reflected in the prices

of related goods and services that are directly traded in markets. Their use values are typically estimated through

revealed preference methods. Examples include estimates of the values of environmental amenities derived

from travel-cost studies, and hedonic price models that measure differences or changes in the value of real
from travel-cost studies, and hedonic price models that measure differences or changes in the value of real

estate. It is important that you utilize revealed preference models that adhere to economic criteria that are

consistent with utility maximizing behavior. Also, you should take particular care in designing protocols for

reliably estimating the values of these attributes.

4. Stated Preference Methods

Stated Preference Methods (SPM) have been developed and used in the peer-reviewed literature to estimate both

"use" and "non-use" values of goods and services. They have also been widely used in regulatory analyses by

Federal agencies, in part, because these methods can be creatively employed to address a wide variety of goods

and services that are not easy to study through revealed preference methods.

The distinguishing feature of these methods is that hypothetical questions about use or non-use values are posed

to survey respondents in order to obtain willingness-to-pay estimates relevant to benefit or cost estimation. Some

examples of SPM include contingent valuation, conjoint analysis and risk-tradeoff analysis. The surveys used to

obtain the health-utility values used in CEA are similar to stated-preference surveys but do not entail monetary

measurement of value. Nevertheless, the principles governing quality stated-preference research, with some

obvious exceptions involving monetization, are also relevant in designing quality health-utility research.

When you are designing or evaluating a stated-preference study, the following principles should be considered:

 the good or service being evaluated should be explained to the respondent in a clear, complete and objective

fashion, and the survey instrument should be pre-tested;

 willingness-to-pay questions should be designed to focus the respondent on the reality of budgetary

limitations and alerted to the availability of substitute goods and alternative expenditure options;

 the survey instrument should be designed to probe beyond general attitudes (e.g., a "warm glow" effect for a

particular use or non-use value) and focus on the magnitude of the respondent's economic valuation;

 the analytic results should be consistent with economic theory using both "internal" (within respondent) and

"external" (between respondent) scope tests such as the willingness to pay is larger (smaller) when more

(less) of a good is provided;

 the subjects being interviewed should be selected/sampled in a statistically appropriate manner. The

sample frame should adequately cover the target population. The sample should be drawn using probability

methods in order to generalize the results to the target population;

 response rates should be as high as reasonably possible. Best survey practices should be followed to

achieve high response rates. Low response rates increase the potential for bias and raise concerns about

the generalizability of the results. If response rates are not adequate, you should conduct an analysis of nonresponse bias or further study. Caution should be used in assessing the representativeness of the sample

based solely on demographic profiles. Statistical adjustments to reduce non-response bias should be

undertaken whenever feasible and appropriate;

 the mode of administration of surveys (in-person, phone, mail, computer, internet or multiple modes ) should

be appropriate in light of the nature of the questions being posed to respondents and the length and

complexity of the instrument;

 documentation should be provided about the target population, the sampling frame used and its coverage of

the target population, the design of the sample including any stratification or clustering, the cumulative

response rate (including response rate at each stage of selection if applicable); the item non-response rate

for critical questions; the exact wording and sequence of questions and other information provided to

respondents; and the training of interviewers and techniques they employed (as appropriate);

 the statistical and econometric methods used to analyze the collected data should be transparent, well

suited for the analysis, and applied with rigor and care.

Professional judgment is necessary to apply these criteria to one or more studies, and thus there is no mechanical

formula that can be used to determine whether a particular study is of sufficient quality to justify use in regulatory

analysis. When studies are used despite having weaknesses on one or more of these criteria, those weaknesses
should be acknowledged in the regulatory analysis, including any resulting biases or uncertainties that are likely to

result. If a study has too many weaknesses with unknown consequences for the quality of the data, the study should

not be used.

The challenge in designing quality stated-preference studies is arguably greater for non-use values and unfamiliar

use values than for familiar goods or services that are traded (directly or indirectly) in market transactions. The good

being valued may have little meaning to respondents, and respondents may be forming their valuations for the first

time in response to the questions posed. Since these values are effectively constructed by the respondent during

the elicitation, the instrument and mode of administration should be rigorously pre-tested to make sure that

responses are not simply an artifact of specific features of instrument design and/or mode of administration.

Since SPM generate data from respondents in a hypothetical setting, often on complex and unfamiliar goods,

special care is demanded in the design and execution of surveys, analysis of the results, and characterization of the

uncertainties. A stated-preference study may be the only way to obtain quantitative information about non-use

values, though a number based on a poor quality study is not necessarily superior to no number at all. Non-use

values that are not quantified should be presented as an "intangible" benefit or cost.

If both revealed-preference and stated-preference studies that are directly applicable to regulatory analysis are

available, you should consider both kinds of evidence and compare the findings. If the results diverge significantly,

you should compare the overall size and quality of the two bodies of evidence. Other things equal, you should prefer

revealed preference data over stated preference data because revealed preference data are based on actual

decisions, where market participants enjoy or suffer the consequences of their decisions. This is not generally the

case for respondents in stated preference surveys, where respondents may not have sufficient incentives to offer

thoughtful responses that are more consistent with their preferences or may be inclined to bias their responses for

one reason or another.

5. Benefit-Transfer Methods

It is often preferable to collect original data on revealed preference or stated preference to support regulatory

analysis. Yet conducting an original study may not be feasible due to the time and expense involved. One alternative

to conducting an original study is the use of "benefit transfer" methods. (The transfer may involve cost determination

as well). The practice of "benefit transfer" began with transferring existing estimates obtained from indirect market

and stated preference studies to new contexts (i.e., the context posed by the rulemaking). The principles that guide

transferring estimates from indirect market and stated preference studies should apply to direct market studies as

well.

Although benefit-transfer can provide a quick, low-cost approach for obtaining desired monetary values, the

methods are often associated with uncertainties and potential biases of unknown magnitude. It should therefore be

treated as a last-resort option and not used without explicit justification.

In conducting benefit transfer, the first step is to specify the value to be estimated for the rulemaking. You should

identify the relevant measure of the policy change at this initial stage. For instance, you can derive the relevant

willingness-to-pay measure by specifying an indirect utility function. This identification allows you to "zero in" on key

aspects of the benefit transfer.

The next step is to identify appropriate studies to conduct benefit transfer. In selecting transfer studies for either

point transfers or function transfers, you should base your choices on the following criteria:

 The selected studies should be based on adequate data, sound and defensible empirical methods and

techniques.

 The selected studies should document parameter estimates of the valuation function.

 The study context and policy context should have similar populations (e.g., demographic characteristics). The

market size (e.g., target population) between the study site and the policy site should be similar. For example,
a study valuing water quality improvement in Rhode Island should not be used to value policy that will affect

water quality throughout the United States.

 The good, and the magnitude of change in that good, should be similar in the study and policy contexts.

 The relevant characteristics of the study and the policy contexts should be similar. For example, the effects

examined in the original study should be "reversible" or "irreversible" to a degree that is similar to the

regulatory actions under consideration.

 The distribution of property rights should be similar so that the analysis uses the same welfare measure. If

the property rights in the study context support the use of WTA measures while the rights in the rulemaking

context support the use of WTP measures, benefit transfer is not appropriate.

 The availability of substitutes across study and policy contexts should be similar.

If you can choose between transferring a function or a point estimate, you should transfer the entire demand

function (referred to as benefit function transfer) rather than adopting a single point estimate (referred to as benefit

point transfer).15

Finally, you should not use benefit transfer in estimating benefits if:

 resources are unique or have unique attributes. For example, if a policy change affects snowmobile use in

Yellowstone National Park, then a study valuing snowmobile use in the state of Michigan should not be used

to value changes in snowmobile use in the Yellowstone National Park.

 If the study examines a resource that is unique or has unique attributes, you should not transfer benefit

estimates or benefit functions to value a different resource and vice versa. For example, if a study values

visibility improvements at the Grand Canyon, these results should not be used to value visibility

improvements in urban areas.

 There are significant problems with applying an "ex ante" valuation estimate to an "ex post" policy context. If a

policy yields a significant change in the attributes of the good, you should not use the study estimates to

value the change using a benefit transfer approach.

 You also should not use a value developed from a study involving, small marginal changes in a policy context

involving large changes in the quantity of the good.

Clearly, all of these criteria are difficult to meet. However, you should attempt to satisfy as many as possible when

choosing studies from the existing economic literature. Professional judgment is required in determining whether a

particular transfer is too speculative to use in regulatory analysis.

6. Ancillary Benefits and Countervailing Risks

Your analysis should look beyond the direct benefits and direct costs of your rulemaking and consider any important

ancillary benefits and countervailing risks. An ancillary benefit is a favorable impact of the rule that is typically

unrelated or secondary to the statutory purpose of the rulemaking (e.g., reduced refinery emissions due to more

stringent fuel economy standards for light trucks) while a countervailing risk is an adverse economic, health, safety,

or environmental consequence that occurs due to a rule and is not already accounted for in the direct cost of the rule

(e.g., adverse safety impacts from more stringent fuel-economy standards for light trucks).

You should begin by considering and perhaps listing the possible ancillary benefits and countervailing risks.

However, highly speculative or minor consequences may not be worth further formal analysis. Analytic priority

should be given to those ancillary benefits and countervailing risks that are important enough to potentially change

the rank ordering of the main alternatives in the analysis. In some cases the mere consideration of these secondary

effects may help in the generation of a superior regulatory alternative with strong ancillary benefits and fewer

countervailing risks. For instance, a recent study suggested that weight-based, fuel-economy standards could

achieve energy savings with fewer safety risks and employment losses than would occur under the current

regulatory structure.

Like other benefits and costs, an effort should be made to quantify and monetize ancillary benefits and
Like other benefits and costs, an effort should be made to quantify and monetize ancillary benefits and

countervailing risks. If monetization is not feasible, quantification should be attempted through use of informative

physical units. If both monetization and quantification are not feasible, then these issues should be presented as

non-quantified benefits and costs. The same standards of information and analysis quality that apply to direct

benefits and costs should be applied to ancillary benefits and countervailing risks.

One way to combine ancillary benefits and countervailing risks is to evaluate these effects separately and then put

both of these effects on the benefits side, not on the cost side. Although it is theoretically appropriate to include

disbenefits on the cost side, legal and programmatic considerations generally support subtracting the disbenefits

from direct benefits.

7. Methods for Treating Non-Monetized Benefits and Costs

Sound quantitative estimates of benefits and costs, where feasible, are preferable to qualitative descriptions of

benefits and costs because they help decision makers understand the magnitudes of the effects of alternative

actions. However, some important benefits and costs (e.g., privacy protection) may be inherently too difficult to

quantify or monetize given current data and methods. You should carry out a careful evaluation of non-quantified

benefits and costs. Some authorities16 refer to these non-monetized and non-quantified effects as "intangible".

1. Benefits and Costs that are Difficult to Monetize

You should monetize quantitative estimates whenever possible. Use sound and defensible values or

procedures to monetize benefits and costs, and ensure that key analytical assumptions are defensible. If

monetization is impossible, explain why and present all available quantitative information. For example, if you

can quantify but cannot monetize increases in water quality and fish populations resulting from water quality

regulation, you can describe benefits in terms of stream miles of improved water quality for boaters and

increases in game fish populations for anglers. You should describe the timing and likelihood of such effects

and avoid double-counting of benefits when estimates of monetized and physical effects are mixed in the same

analysis.

2. Benefits and Costs that are Difficult to Quantify

If you are not able to quantify the effects, you should present any relevant quantitative information along with a

description of the unquantified effects, such as ecological gains, improvements in quality of life, and aesthetic

beauty. You should provide a discussion of the strengths and limitations of the qualitative information. This

should include information on the key reason(s) why they cannot be quantified. In one instance, you may know

with certainty the magnitude of a risk to which a substantial, but unknown, number of individuals are exposed. In

another instance, the existence of a risk may be based on highly speculative assumptions, and the magnitude of

the risk may be unknown.

For cases in which the unquantified benefits or costs affect a policy choice, you should provide a clear

explanation of the rationale behind the choice. Such an explanation could include detailed information on the

nature, timing, likelihood, location, and distribution of the unquantified benefits and costs. Also, please include a

summary table that lists all the unquantified benefits and costs, and use your professional judgment to highlight

(e.g., with categories or rank ordering) those that you believe are most important (e.g., by considering factors

such as the degree of certainty, expected magnitude, and reversibility of effects).

While the focus is often placed on difficult to quantify benefits of regulatory action, some costs are difficult to

quantify as well. Certain permitting requirements (e.g., EPA's New Source Review program) restrict the

decisions of production facilities to shift to new products and adopt innovative methods of production. While

these programs may impose substantial costs on the economy, it is very difficult to quantify and monetize these

effects. Similarly, regulations that establish emission standards for recreational vehicles, like motor bikes, may

adversely affect the performance of the vehicles in terms of driveability and 0 to 60 miles per hour acceleration.
Again, the cost associated with the loss of these attributes may be difficult to quantify and monetize. They need to

be analyzed qualitatively.

8. Monetizing Health and Safety Benefits and Costs

We expect you to provide a benefit-cost analysis of major health and safety rulemakings in addition to a CEA. The

BCA provides additional insight because (a) it provides some indication of what the public is willing to pay for

improvements in health and safety and (b) it offers additional information on preferences for health using a different

research design than is used in CEA. Since the health-preference methods used to support CEA and BCA have

some different strengths and drawbacks, it is important that you provide decision makers with both perspectives.

In monetizing health benefits, a WTP measure is the conceptually appropriate measure as compared to other

alternatives (e.g., cost of illness or lifetime earnings), in part because it attempts to capture pain and suffering and

other quality-of-life effects. Using the WTP measure for health and safety allows you to directly compare your results

to the other benefits and costs in your analysis, which will typically be based on WTP.

If well-conducted revealed-preference studies of relevant health and safety risks are available, you should consider

using them in developing your monetary estimates. If appropriate revealed-preference data are not available, you

should use valid and relevant data from stated-preference studies. You will need to use your professional judgment

when you are faced with limited information on revealed preference studies and substantial information based on

stated preference studies.

A key advantage of stated-preference and health-utility methods compared to revealed preference methods is that

they can be tailored to address the ranges of probabilities, types of health risks and specific populations affected by

your rule. In many rulemakings there will be no relevant information from revealed-preference studies. In this

situation you should consider commissioning a stated-preference study or using values from published statedpreference studies. For the reasons discussed previously, you should be cautious about using values from statedpreference studies and describe in the analysis the drawbacks of this approach.

1. Nonfatal Health and Safety Risks

With regard to nonfatal health and safety risks, there is enormous diversity in the nature and severity of impaired

health states. A traumatic injury that can be treated effectively in the emergency room without hospitalization or

long-term care is different from a traumatic injury resulting in paraplegia. Severity differences are also important

in evaluation of chronic diseases. A severe bout of bronchitis, though perhaps less frequent, is far more painful

and debilitating than the more frequent bouts of mild bronchitis. The duration of an impaired health state, which

can range from a day or two to several years or even a lifetime (e.g., birth defects inducing mental retardation),

need to be considered carefully. Information on both the severity and duration of an impaired health state is

necessary before the task of monetization can be performed.

When monetizing nonfatal health effects, it is important to consider two components: (1) the private demand for

prevention of the nonfatal health effect, to be represented by the preferences of the target population at risk, and

(2) the net financial externalities associated with poor health such as net changes in public medical costs and

any net changes in economic production that are not experienced by the target population. Revealed-preference

or stated-preference studies are necessary to estimate the private demand; health economics data from

published sources can typically be used to estimate the financial externalities caused by changes in health

status. If you use literature values to monetize nonfatal health and safety risks, it is important to make sure that

the values you have selected are appropriate for the severity and duration of health effects to be addressed by

your rule.

If data are not available to support monetization, you might consider an alternative approach that makes use of

health-utility studies. Although the economics literature on the monetary valuation of impaired health states is

growing, there is a much larger clinical literature on how patients, providers and community residents value

diverse health states. This literature typically measures health utilities based on the standard gamble, the time

tradeoff or the rating scale methods. This health utility information may be combined with known monetary
tradeoff or the rating scale methods. This health utility information may be combined with known monetary

values for well-defined health states to estimate monetary values for a wide range of health states of different

severity and duration. If you use this approach, you should be careful to acknowledge your assumptions and the

limitations of your estimates.

2. Fatality Risks

Since agencies often design health and safety regulation to reduce risks to life, evaluation of these benefits can

be the key part of the analysis. A good analysis must present these benefits clearly and show their importance.

Agencies may choose to monetize these benefits. The willingness-to-pay approach is the best methodology to

use if reductions in fatality risk are monetized.

Some describe the monetized value of small changes in fatality risk as the "value of statistical life" (VSL) or, less

precisely, the "value of a life." The latter phrase can be misleading because it suggests erroneously that the

monetization exercise tries to place a "value" on individual lives. You should make clear that these terms refer to

the measurement of willingness to pay for reductions in only small risks of premature death. They have no

application to an identifiable individual or to very large reductions in individual risks. They do not suggest that any

individual's life can be expressed in monetary terms. Their sole purpose is to help describe better the likely

benefits of a regulatory action.

Confusion about the term "statistical life" is also widespread. This term refers to the sum of risk reductions

expected in a population. For example, if the annual risk of death is reduced by one in a million for each of two

million people, that is said to represent two "statistical lives" extended per year (2 million people x 1/1,000,000 =

2). If the annual risk of death is reduced by one in 10 million for each of 20 million people, that also represents

two statistical lives extended.

The adoption of a value for the projected reduction in the risk of premature mortality is the subject of continuing

discussion within the economic and public policy analysis community. A considerable body of academic

literature is available on this subject. This literature involves either explicit or implicit valuation of fatality risks,

and generally involves the use of estimates of VSL from studies on wage compensation for occupational

hazards (which generally are in the range of 10-4 annually), on consumer product purchase and use decisions,

or from an emerging literature using stated preference approaches. A substantial majority of the resulting

estimates of VSL vary from roughly $1 million to $10 million per statistical life.17

There is a continuing debate within the economic and public policy analysis community on the merits of using a

single VSL for all situations versus adjusting the VSL estimates to reflect the specific rule context. A variety of

factors have been identified, including whether the mortality risk involves sudden death, the fear of cancer, and

the extent to which the risk is voluntarily incurred.18 The consensus of EPA's recent Science Advisory Board

(SAB) review of this issue was that the available literature does not support adjustments of VSL for most of these

factors. The panel did conclude that it was appropriate to adjust VSL to reflect changes in income and any time

lag in the occurrence of adverse health effects.

The age of the affected population has also been identified as an important factor in the theoretical literature.

However, the empirical evidence on age and VSL is mixed. In light of the continuing questions over the effect of

age on VSL estimates, you should not use an age-adjustment factor in an analysis using VSL estimates.19

Another way that has been used to express reductions in fatality risks is to use the life expectancy method, the

"value of statistical life-years (VSLY) extended." If a regulation protects individuals whose average remaining life

expectancy is 40 years, a risk reduction of one fatality is expressed as "40 life-years extended." Those who favor

this alternative approach emphasize that the value of a statistical life is not a single number relevant for all

situations. In particular, when there are significant differences between the effect on life expectancy for the

population affected by a particular health risk and the populations studied in the labor market studies, they prefer

to adopt a VSLY approach to reflect those differences. You should consider providing estimates of both VSL and

VSLY, while recognizing the developing state of knowledge in this area.
VSLY, while recognizing the developing state of knowledge in this area.

Longevity may be only one of a number of relevant considerations pertaining to the rule. You should keep in

mind that regulations with greater numbers of life-years extended are not necessarily better than regulations

with fewer numbers of life-years extended. In any event, when you present estimates based on the VSLY

method, you should adopt a larger VSLY estimate for senior citizens because senior citizens face larger overall

health risks from all causes and they may have accumulated savings to spend on their health and safety.20

The valuation of fatality risk reduction is an evolving area in both results and methodology. Hence, you should

utilize valuation methods that you consider appropriate for the regulatory circumstances. Since the literaturebased VSL estimates may not be entirely appropriate for the risk being evaluated (e.g., the use of occupational

risk premia to value reductions in risks from environmental hazards), you should explain your selection of

estimates and any adjustments of the estimates to reflect the nature of the risk being evaluated. You should

present estimates based on alternative approaches, and if you monetize mortality risk reduction, you should do

so on a consistent basis to the extent feasible. You should clearly indicate the methodology used and document

your choice of a particular methodology. You should explain any significant deviations from the prevailing state of

knowledge. If you use different methodologies in different rules, you should clearly disclose the fact and explain

your choices.

3. Valuation of Reductions in Health and Safety Risks to Children

The valuation of health outcomes for children and infants poses special challenges. It is rarely feasible to

measure a child's willingness to pay for health improvement and an adult's concern for his or her own health is

not necessarily relevant to valuation of child health. For example, the wage premiums demanded by workers to

accept hazardous jobs are not readily transferred to rules that accomplish health gains for children.

There are a few studies that examine parental willingness to pay to invest in health and safety for their children.

Some of these studies suggest that parents may value children’s health more strongly than their own health.

Although this parental perspective is a promising research strategy, it may need to be expanded to include a

societal interest in child health and safety.

Where the primary objective of a rule is to reduce the risk of injury, disease or mortality among children, you

should conduct a cost-effectiveness analysis of the rule. You may also develop a benefit-cost analysis to the

extent that valid monetary values can be assigned to the primary expected health outcomes. For rules where

health gains are expected among both children and adults and you decide to perform a benefit-cost analysis, the

monetary values for children should be at least as large as the values for adults (for the same probabilities and

outcomes) unless there is specific and compelling evidence to suggest otherwise.21

Discount Rates

Benefits and costs do not always take place in the same time period. When they do not, it is incorrect simply to add

all of the expected net benefits or costs without taking account of when the actually occur. If benefits or costs are

delayed or otherwise separated in time from each other, the difference in timing should be reflected in your

analysis.

As a first step, you should present the annual time stream of benefits and costs expected to result from the rule,

clearly identifying when the benefits and costs are expected to occur. The beginning point for your stream of

estimates should be the year in which the final rule will begin to have effects, even if that is expected to be some

time in the future. The ending point should be far enough in the future to encompass all the significant benefits and

costs likely to result from the rule.

In presenting the stream of benefits and costs, it is important to measure them in constant dollars to avoid the

misleading effects of inflation in your estimates. If the benefits and costs are initially measured in prices reflecting

expected future inflation, you can convert them to constant dollars by dividing through by an appropriate inflation

index, one that corresponds to the inflation rate underlying the initial estimates of benefits or costs.
index, one that corresponds to the inflation rate underlying the initial estimates of benefits or costs.

1. The Rationale for Discounting

Once these preliminaries are out of the way, you can begin to adjust your estimates for differences in timing. (This

is a separate calculation from the adjustment needed to remove the effects of future inflation.) Benefits or costs that

occur sooner are generally more valuable. The main rationales for the discounting of future impacts are:

(a) Resources that are invested will normally earn a positive return, so current consumption is more expensive than

future consumption, since you are giving up that expected return on investment when you consume today.

(b) Postponed benefits also have a cost because people generally prefer present to future consumption. They are

said to have positive time preference.

(c) Also, if consumption continues to increase over time, as it has for most of U.S. history, an increment of

consumption will be less valuable in the future than it would be today, because the principle of diminishing

marginal utility implies that as total consumption increases, the value of a marginal unit of consumption tends to

decline.

There is wide agreement with point (a). Capital investment is productive, but that point is not sufficient by itself to

explain positive interest rates and observed saving behavior. To understand these phenomena, points (b) and (c)

are also necessary. If people are really indifferent between consumption now and later, then they should be willing

to forgo current consumption in order to consume an equal or slightly greater amount in the future. That would

cause saving rates and investment to rise until interest rates were driven to zero and capital was no longer

productive. As long as we observe positive interest rates and saving rates below 100 percent, people must be

placing a higher value on current consumption than on future consumption.

To reflect this preference, a discount factor should be used to adjust the estimated benefits and costs for

differences in timing. The further in the future the benefits and costs are expected to occur, the more they should be

discounted. The discount factor can be calculated given a discount rate. The formula is 1/ (1+ the discount rate)t

where "t" measures the number of years in the future that the benefits or costs are expected to occur. Benefits or

costs that have been adjusted in this way are called "discounted present values" or simply Apresent values". When,

and only when, the estimated benefits and costs have been discounted, they can be added to determine the overall

value of net benefits.

2. Real Discount Rates of 3 Percent and 7 Percent

OMB's basic guidance on the discount rate is provided in OMB Circular A-94

(http://www.whitehouse.gov/omb/circulars/index.html). This Circular points out that the analytically preferred method

of handling temporal differences between benefits and costs is to adjust all the benefits and costs to reflect their

value in equivalent units of consumption and to discount them at the rate consumers and savers would normally

use in discounting future consumption benefits. This is sometimes called the "shadow price" approach to

discounting because doing such calculations requires you to value benefits and costs using shadow prices,

especially for capital goods, to correct for market distortions. These shadow prices are not well established for the

United States. Furthermore, the distribution of impacts from regulations on capital and consumption are not always

well known. Consequently, any agency that wishes to tackle this challenging analytical task should check with OMB

before proceeding.

As a default position, OMB Circular A-94 states that a real discount rate of 7 percent should be used as a base-case

for regulatory analysis. The 7 percent rate is an estimate of the average before-tax rate of return to private capital in

the U.S. economy. It is a broad measure that reflects the returns to real estate and small business capital as well

as corporate capital. It approximates the opportunity cost of capital, and it is the appropriate discount rate whenever

the main effect of a regulation is to displace or alter the use of capital in the private sector. OMB revised Circular A94 in 1992 after extensive internal review and public comment. In a recent analysis, OMB found that the average rate

of return to capital remains near the 7 percent rate estimated in 1992. Circular A-94 also recommends using other

discount rates to show the sensitivity of the estimates to the discount rate assumption.
discount rates to show the sensitivity of the estimates to the discount rate assumption.

Economic distortions, including taxes on capital, create a divergence between the rate of return that savers earn and

the private rate of return to capital. This divergence persists despite the tendency for capital to flow to where it can

earn the highest rate of return. Although market forces will push after-tax rates of return in different sectors of the

economy toward equality, that process will not equate pre-tax rates of return when there are differences in the tax

treatment of investment. Corporate capital, in particular, pays an additional layer of taxation, the corporate income

tax, which requires it to earn a higher pre-tax rate of return in order to provide investors with similar after-tax rates of

return compared with non-corporate investments. The pre-tax rates of return better measure society's gains from

investment. Since the rates of return on capital are higher in some sectors of the economy than others, the

government needs to be sensitive to possible impacts of regulatory policy on capital allocation.

The effects of regulation do not always fall exclusively or primarily on the allocation of capital. When regulation

primarily and directly affects private consumption (e.g., through higher consumer prices for goods and services), a

lower discount rate is appropriate. The alternative most often used is sometimes called the "social rate of time

preference." This simply means the rate at which "society" discounts future consumption flows to their present

value. If we take the rate that the average saver uses to discount future consumption as our measure of the social

rate of time preference, then the real rate of return on long-term government debt may provide a fair approximation.

Over the last thirty years, this rate has averaged around 3 percent in real terms on a pre-tax basis. For example, the

yield on 10-year Treasury notes has averaged 8.1 percent since 1973 while the average annual rate of change in

the CPI over this period has been 5.0 percent, implying a real 10-year rate of 3.1 percent.

For regulatory analysis, you should provide estimates of net benefits using both 3 percent and 7 percent. An

example of this approach is EPA's analysis of its 1998 rule setting both effluent limits for wastewater discharges

and air toxic emission limits for pulp and paper mills. In this analysis, EPA developed its present-value estimates

using real discount rates of 3 and 7 percent applied to benefit and cost streams that extended forward for 30 years.

You should present a similar analysis in your own work.

In some instances, if there is reason to expect that the regulation will cause resources to be reallocated away from

private investment in the corporate sector, then the opportunity cost may lie outside the range of 3 to 7 percent. For

example, the average real rate of return on corporate capital in the United States was approximately 10 percent in

the 1990s, returning to the same level observed in the 1950s and 1960s. If you are uncertain about the nature of the

opportunity cost, then you should present benefit and cost estimates using a higher discount rate as a further

sensitivity analysis as well as using the 3 and 7 percent rates.

3. Time Preference for Health-Related Benefits and Costs

When future benefits or costs are health-related, some have questioned whether discounting is appropriate, since

the rationale for discounting money may not appear to apply to health. It is true that lives saved today cannot be

invested in a bank to save more lives in the future. But the resources that would have been used to save those lives

can be invested to earn a higher payoff in future lives saved. People have been observed to prefer health gains that

occur immediately to identical health gains that occur in the future. Also, if future health gains are not discounted

while future costs are, then the following perverse result occurs: an attractive investment today in future health

improvement can always be made more attractive by delaying the investment. For such reasons, there is a

professional consensus that future health effects, including both benefits and costs, should be discounted at the

same rate. This consensus applies to both BCA and CEA.

A common challenge in health-related analysis is to quantify the time lag between when a rule takes effect and

when the resulting physical improvements in health status will be observed in the target population. In such

situations, you must carefully consider the timing of health benefits before performing present-value calculations. It

is not reasonable to assume that all of the benefits of reducing chronic diseases such as cancer and

cardiovascular disease will occur immediately when the rule takes effect. For rules addressing traumatic injury, this

lag period may be short. For chronic diseases it may take years or even decades for a rule to induce its full

beneficial effects in the target population.
When a delay period between exposure to a toxin and increased probability of disease is likely (a so-called latency

period), a lag between exposure reduction and reduced probability of disease is also likely. This latter period has

sometimes been referred to as a "cessation lag," and it may or may not be of the same duration as the latency

period. As a general matter, cessation lags will only apply to populations with at least some high-level exposure

(e.g., before the rule takes effect). For populations with no such prior exposure, such as those born after the rule

takes effect, only the latency period will be relevant.

Ideally, your exposure-risk model would allow calculation of reduced risk for each year following exposure

cessation, accounting for total cumulative exposure and age at the time of exposure reduction. The present-value

benefits estimate could then reflect an appropriate discount factor for each year's risk reduction. Recent analyses of

the cancer benefits stemming from reduction in public exposure to radon in drinking water have adopted this

approach. They were supported by formal risk-assessment models that allowed estimates of the timing of lung

cancer incidence and mortality to vary in response to different radon exposure levels.22

In many cases, you will not have the benefit of such detailed risk assessment modeling. You will need to use your

professional judgment as to the average cessation lag for the chronic diseases affected by your rule. In situations

where information exists on latency but not on cessation lags, it may be reasonable to use latency as a proxy for the

cessation lag, unless there is reason to believe that the two are different. When the average lag time between

exposures and disease is unknown, a range of plausible alternative values for the time lag should be used in your

analysis.

4. Intergenerational Discounting

Special ethical considerations arise when comparing benefits and costs across generations. Although most

people demonstrate time preference in their own consumption behavior, it may not be appropriate for society to

demonstrate a similar preference when deciding between the well-being of current and future generations. Future

citizens who are affected by such choices cannot take part in making them, and today's society must act with some

consideration of their interest.

One way to do this would be to follow the same discounting techniques described above and supplement the

analysis with an explicit discussion of the intergenerational concerns (how future generations will be affected by the

regulatory decision). Policymakers would be provided with this additional information without changing the general

approach to discounting.

Using the same discount rate across generations has the advantage of preventing time-inconsistency problems.

For example, if one uses a lower discount rate for future generations, then the evaluation of a rule that has shortterm costs and long-term benefits would become more favorable merely by waiting a year to do the analysis.

Further, using the same discount rate across generations is attractive from an ethical standpoint. If one expects

future generations to be better off, then giving them the advantage of a lower discount rate would in effect transfer

resources from poorer people today to richer people tomorrow.

Some believe, however, that it is ethically impermissible to discount the utility of future generations. That is,

government should treat all generations equally. Even under this approach, it would still be correct to discount future

costs and consumption benefits generally (perhaps at a lower rate than for intragenerational analysis), due to the

expectation that future generations will be wealthier and thus will value a marginal dollar of benefits or costs by less

than those alive today. Therefore, it is appropriate to discount future benefits and costs relative to current benefits

and costs, even if the welfare of future generations is not being discounted. Estimates of the appropriate discount

rate appropriate in this case, from the 1990s, ranged from 1 to 3 percent per annum.23

A second reason for discounting the benefits and costs accruing to future generations at a lower rate is increased

uncertainty about the appropriate value of the discount rate, the longer the horizon for the analysis. Private market

rates provide a reliable reference for determining how society values time within a generation, but for extremely long

24
time periods no comparable private rates exist. As explained by Martin Weitzman24, in the limit for the deep future,

the properly averaged certainty-equivalent discount factor (i.e., 1/[1+r]t) corresponds to the minimum discount rate

having any substantial positive probability. From today's perspective, the only relevant limiting scenario is the one

with the lowest discount rate B all of the other states at the far-distant time are relatively much less important

because their expected present value is so severely reduced by the power of compounding at a higher rate.

If your rule will have important intergenerational benefits or costs you might consider a further sensitivity analysis

using a lower but positive discount rate in addition to calculating net benefits using discount rates of 3 and 7

percent.

5. Time Preference for Non-Monetized Benefits and Costs

Differences in timing should be considered even for benefits and costs that are not expressed in monetary units,

including health benefits. The timing differences can be handled through discounting. EPA estimated costeffectiveness in its 1998 rule, "Control of Emissions from Nonroad Diesel Engines," by discounting both the

monetary costs and the non-monetized emission reduction benefits over the expected useful life of the engines at

the 7 percent real rate recommended in OMB Circular A-94.

Alternatively, it may be possible in some cases to avoid discounting non-monetized benefits. If the expected flow of

benefits begins as soon as the cost is incurred and is expected to be constant over time, then annualizing the cost

stream is sufficient, and further discounting of benefits is unnecessary. Such an analysis might produce an

estimate of the annualized cost per ton of reduced emissions of a pollutant.

6. The Internal Rate of Return

The internal rate of return is the discount rate that sets the net present value of the discounted benefits and costs

equal to zero. The internal rate of return does not generally provide an acceptable decision criterion, and regulations

with the highest internal rate of return are not necessarily the most beneficial. Nevertheless, it does provide useful

information and for many it will offer a meaningful indication of regulation's impact. You should consider including

the internal rate of return implied by your regulatory analysis along with other information about discounted net

present values.

Other Key Considerations

1. Other Benefit and Cost Considerations

You should include these effects in your analysis and provide estimates of their monetary values when they are

significant:

 Private-sector compliance costs and savings;

 Government administrative costs and savings;

 Gains or losses in consumers' or producers' surpluses;

 Discomfort or inconvenience costs and benefits; and

 Gains or losses of time in work, leisure and/or commuting/travel settings.

Estimates of benefits and costs should be based on credible changes in technology over time. For example,

retrospective studies may provide evidence that "learning" will likely reduce the cost of regulation in future years. The

weight you give to a study of past rates of cost savings resulting from innovation (including "learning curve" effects)

should depend on both its timeliness and direct relevance to the processes affected by the regulatory alternative

under consideration. In addition, you should take into account cost-saving innovations that result from a shift to

regulatory performance standards and incentive-based policies. On the other hand, significant costs may result

from a slowing in the rate of innovation or of adoption of new technology due to delays in the regulatory approval

process or the setting of more stringent standards for new facilities than existing ones. In some cases agencies
process or the setting of more stringent standards for new facilities than existing ones. In some cases agencies

are limited under statute to consider only technologies that have been demonstrated to be feasible. In these

situations, it may be useful to estimate costs and cost savings assuming a wider range of technical possibilities.

When characterizing technology changes over time, you should assess the likely technology changes that would

have occurred in the absence of the regulatory action (technology baseline). Technologies change over time in both

reasonably functioning markets and imperfect markets. If you assume that technology will remain unchanged in the

absence of regulation when technology changes are likely, then your analysis will over-state both the benefits and

costs attributable to the regulation.

Occasionally, cost savings or other forms of benefits accrue to parties affected by a rule who also bear its costs. For

example, a requirement that engine manufacturers reduce emissions from engines may lead to technologies that

improve fuel economy. These fuel savings will normally accrue to the engine purchasers, who also bear the costs

of the technologies. There is no apparent market failure with regard to the market value of fuel saved because one

would expect that consumers would be willing to pay for increased fuel economy that exceeded the cost of providing

it. When these cost savings are substantial, and particularly when you estimate them to be greater than the cost

associated with achieving them, you should examine and discuss why market forces would not accomplish these

gains in the absence of regulation. As a general matter, any direct costs that are averted as a result of a regulatory

action should be monetized wherever possible and either added to the benefits or subtracted from the costs of that

alternative.

2. The Difference between Costs (or Benefits) and Transfer Payments

Distinguishing between real costs and transfer payments is an important, but sometimes difficult, problem in cost

estimation. Benefit and cost estimates should reflect real resource use. Transfer payments are monetary payments

from one group to another that do not affect total resources available to society. A regulation that restricts the supply

of a good, causing its price to rise, produces a transfer from buyers to sellers. The net reduction in the total surplus

(consumer plus producer) is a real cost to society, but the transfer from buyers to sellers resulting from a higher

price is not a real cost since the net reduction automatically accounts for the transfer from buyers to sellers.

However, transfers from the United States to other nations should be included as costs, and transfers from other

nations to the United States as benefits, as long as the analysis is conducted from the United States perspective.

You should not include transfers in the estimates of the benefits and costs of a regulation. Instead, address them in

a separate discussion of the regulation's distributional effects. Examples of transfer payments include the following:

 Scarcity rents and monopoly profits

 Insurance payments

 Indirect taxes and subsidies

Treatment of Uncertainty

The precise consequences (benefits and costs) of regulatory options are not always known for certain, but the

probability of their occurrence can often be developed. The important uncertainties connected with your regulatory

decisions need to be analyzed and presented as part of the overall regulatory analysis. You should begin your

analysis of uncertainty at the earliest possible stage in developing your analysis. You should consider both the

statistical variability of key elements underlying the estimates of benefits and costs (for example, the expected

change in the distribution of automobile accidents that might result from a change in automobile safety standards)

and the incomplete knowledge about the relevant relationships (for example, the uncertain knowledge of how some

economic activities might affect future climate change).25 By assessing the sources of uncertainty and the way in

which benefit and cost estimates may be affected under plausible assumptions, you can shape your analysis to

inform decision makers and the public about the effects and the uncertainties of alternative regulatory actions.

The treatment of uncertainty must be guided by the same principles of full disclosure and transparency that apply to

other elements of your regulatory analysis. Your analysis should be credible, objective, realistic, and scientifically
balanced.26 Any data and models that you use to analyze uncertainty should be fully identified. You should also

discuss the quality of the available data used. Inferences and assumptions used in your analysis should be

identified, and your analytical choices should be explicitly evaluated and adequately justified. In your presentation,

you should delineate the strengths of your analysis along with any uncertainties about its conclusions. Your

presentation should also explain how your analytical choices have affected your results.

In some cases, the level of scientific uncertainty may be so large that you can only present discrete alternative

scenarios without assessing the relative likelihood of each scenario quantitatively. For instance, in assessing the

potential outcomes of an environmental effect, there may be a limited number of scientific studies with strongly

divergent results. In such cases, you might present results from a range of plausible scenarios, together with any

available information that might help in qualitatively determining which scenario is most likely to occur.

When uncertainty has significant effects on the final conclusion about net benefits, your agency should consider

additional research prior to rulemaking. The costs of being wrong may outweigh the benefits of a faster decision.

This is true especially for cases with irreversible or large upfront investments. If your agency decides to proceed

with rulemaking, you should explain why the costs of developing additional information—including any harm from

delay in public protection—exceed the value of that information.

For example, when the uncertainty is due to a lack of data, you might consider deferring the decision, as an explicit

regulatory alternative, pending further study to obtain sufficient data. Delaying a decision will also have costs, as will

further efforts at data gathering and analysis. You will need to weigh the benefits of delay against these costs in

making your decision. Formal tools for assessing the value of additional information are now well developed in the

applied decision sciences and can be used to help resolve this type of complex regulatory question.

"Real options" methods have also formalized the valuation of the added flexibility inherent in delaying a decision. As

long as taking time will lower uncertainty, either passively or actively through an investment in information gathering,

and some costs are irreversible, such as the potential costs of a sunk investment, a benefit can be assigned to the

option to delay a decision. That benefit should be considered a cost of taking immediate action versus the

alternative of delaying that action pending more information. However, the burdens of delay—including any harm to

public health, safety, and the environment—need to be analyzed carefully.

1. Quantitative Analysis of Uncertainty

Examples of quantitative analysis, broadly defined, would include formal estimates of the probabilities of

environmental damage to soil or water, the possible loss of habitat, or risks to endangered species as well as

probabilities of harm to human health and safety. There are also uncertainties associated with estimates of

economic benefits and costs, such as the cost savings associated with increased energy efficiency. Thus, your

analysis should include two fundamental components: a quantitative analysis characterizing the probabilities of the

relevant outcomes and an assignment of economic value to the projected outcomes. It is essential that both parts

be conceptually consistent. In particular, the quantitative analysis should be conducted in a way that permits it to be

applied within a more general analytical framework, such as benefit-cost analysis. Similarly, the general framework

needs to be flexible enough to incorporate the quantitative analysis without oversimplifying the results. For example,

you should address explicitly the implications for benefits and costs of any probability distributions developed in

your analysis.

As with other elements of regulatory analysis, you will need to balance thoroughness with the practical limits on

your analytical capabilities. Your analysis does not have to be exhaustive, nor is it necessary to evaluate each

alternative at every step. Attention should be devoted to first resolving or studying the uncertainties that have the

largest potential effect on decision making. Many times these will be the largest sources of uncertainties. In the

absence of adequate data, you will need to make assumptions. These should be clearly identified and consistent

with the relevant science. Your analysis should provide sufficient information for decision makers to grasp the

degree of scientific uncertainty and the robustness of estimated probabilities, benefits, and costs to changes in key

assumptions.
For major rules involving annual economic effects of $1 billion or more, you should present a formal quantitative

analysis of the relevant uncertainties about benefits and costs. In other words, you should try to provide some

estimate of the probability distribution of regulatory benefits and costs. In summarizing the probability distributions,

you should provide some estimates of the central tendency (e.g., mean and median) along with any other

information you think will be useful such as ranges, variances, specified low-end and high-end percentile

estimates, and other characteristics of the distribution.

Your estimates cannot be more precise than their most uncertain component. Thus, your analysis should report

estimates in a way that reflects the degree of uncertainty and not create a false sense of precision. Worst-case or

conservative analyses are not usually adequate because they do not convey the complete probability distribution of

outcomes, and they do not permit calculation of an expected value of net benefits. In many health and safety rules,

economists conducting benefit-cost analyses must rely on formal risk assessments that address a variety of risk

management questions such as the baseline risk for the affected population, the safe level of exposure or, the

amount of risk to be reduced by various interventions. Because the answers to some of these questions are directly

used in benefits analyses, the risk assessment methodology must allow for the determination of expected benefits

in order to be comparable to expected costs. This means that conservative assumptions and defaults (whether

motivated by science policy or by precautionary instincts), will be incompatible with benefit analyses as they will

result in benefit estimates that exceed the expected value. Whenever it is possible to characterize quantitatively the

probability distributions, some estimates of expected value (e.g., mean and median) must be provided in addition to

ranges, variances, specified low-end and high-end percentile estimates, and other characteristics of the

distribution.

Whenever possible, you should use appropriate statistical techniques to determine a probability distribution of the

relevant outcomes. For rules that exceed the $1 billion annual threshold, a formal quantitative analysis of uncertainty

is required. For rules with annual benefits and/or costs in the range from 100 million to $1 billion, you should seek

to use more rigorous approaches with higher consequence rules. This is especially the case where net benefits

are close to zero. More rigorous uncertainty analysis may not be necessary for rules in this category if simpler

techniques are sufficient to show robustness. You may consider the following analytical approaches that entail

increasing levels of complexity:

 Disclose qualitatively the main uncertainties in each important input to the calculation of benefits and costs.

These disclosures should address the uncertainties in the data as well as in the analytical results. However,

major rules above the $1 billion annual threshold require a formal treatment.

 Use a numerical sensitivity analysis to examine how the results of your analysis vary with plausible changes

in assumptions, choices of input data, and alternative analytical approaches. Sensitivity analysis is especially

valuable when the information is lacking to carry out a formal probabilistic simulation. Sensitivity analysis can

be used to find "switch points" -- critical parameter values at which estimated net benefits change sign or the

low cost alternative switches. Sensitivity analysis usually proceeds by changing one variable or assumption

at a time, but it can also be done by varying a combination of variables simultaneously to learn more about

the robustness of your results to widespread changes. Again, however, major rules above the $1 billion

annual threshold require a formal treatment.

 Apply a formal probabilistic analysis of the relevant uncertainties B possibly using simulation models and/or

expert judgment as revealed, for example, through Delphi methods.28 Such a formal analytical approach is

appropriate for complex rules where there are large, multiple uncertainties whose analysis raises technical

challenges, or where the effects cascade; it is required for rules that exceed the $1 billion annual threshold.

For example, in the analysis of regulations addressing air pollution, there is uncertainty about the effects of

the rule on future emissions, uncertainty about how the change in emissions will affect air quality, uncertainty

about how changes in air quality will affect health, and finally uncertainty about the economic and social value

of the change in health outcomes. In formal probabilistic assessments, expert solicitation is a useful way to

fill key gaps in your ability to assess uncertainty.29 In general, experts can be used to quantify the probability

distributions of key parameters and relationships. These solicitations, combined with other sources of data,

can be combined in Monte Carlo simulations to derive a probability distribution of benefits and costs. You

should pay attention to correlated inputs. Often times, the standard defaults in Monte Carlo and other similar
should pay attention to correlated inputs. Often times, the standard defaults in Monte Carlo and other similar

simulation packages assume independence across distributions. Failing to correctly account for correlated

distributions of inputs can cause the resultant output uncertainty intervals to be too large, although in many

cases the overall effect is ambiguous. You should make a special effort to portray the probabilistic results—

in graphs and/or tables—clearly and meaningfully.

New methods may become available in the future. This document is not intended to discourage or inhibit their use,

but rather to encourage and stimulate their development.

2. Economic Values of Uncertain Outcomes

In developing benefit and cost estimates, you may find that there are probability distributions of values as well for

each of the outcomes. Where this is the case, you will need to combine these probability distributions to provide

estimated benefits and costs.

Where there is a distribution of outcomes, you will often find it useful to emphasize summary statistics or figures

that can be readily understood and compared to achieve the broadest public understanding of your findings. It is a

common practice to compare the "best estimates" of both benefits and costs with those of competing alternatives.

These "best estimates" are usually the average or the expected value of benefits and costs. Emphasis on these

expected values is appropriate as long as society is "risk neutral" with respect to the regulatory alternatives. While

this may not always be the case, you should in general assume "risk neutrality" in your analysis. If you adopt a

different assumption on risk preference, you should explain your reasons for doing so.

3. Alternative Assumptions

If benefit or cost estimates depend heavily on certain assumptions, you should make those assumptions explicit

and carry out sensitivity analyses using plausible alternative assumptions. If the value of net benefits changes from

positive to negative (or vice versa) or if the relative ranking of regulatory options changes with alternative plausible

assumptions, you should conduct further analysis to determine which of the alternative assumptions is more

appropriate. Because different estimation methods may have hidden assumptions, you should analyze estimation

methods carefully to make any hidden assumptions explicit.

F. Specialized Analytical Requirements

In preparing analytical support for your rulemaking, you should be aware that there are a number of analytic

requirements imposed by law and Executive Order. In addition to the regulatory analysis requirements of Executive

Order 12866, you should also consider whether your rule will need specialized analysis of any of the following

issues.

Impact on Small Businesses and Other Small Entities

Under the Regulatory Flexibility Act (5 U.S.C. chapter 6), agencies must prepare a proposed and final "regulatory

flexibility analysis" (RFA) if the rulemaking could "have a significant impact on a substantial number of small

entities." You should consider posting your RFA on the internet so the public can review your findings.

Your agency should have guidelines on how to prepare an RFA and you are encouraged to consult with the Chief

Counsel for Advocacy of the Small Business Administration on expectations concerning what is an adequate RFA.

Executive Order 13272 (67 FR 53461, August 16, 2002) requires you to notify the Chief Counsel for Advocacy of any

draft rules that might have a significant economic impact on a substantial number of small entities. Executive Order

13272 also directs agencies to give every appropriate consideration to any comments provided by the Advocacy

Office. Under SBREFA, EPA and OSHA are required to consult with small business prior to developing a proposed

rule that would have a significant effect on small businesses. OMB encourages other agencies to do so as well.

Analysis of Unfunded Mandates
Under the Unfunded Mandates Act (2 U.S.C. 1532), you must prepare a written statement about benefits and costs

prior to issuing a proposed or final rule (for which your agency published a proposed rule) that may result in

aggregate expenditure by State, local, and tribal governments, or by the private sector, of $100,000,000 or more in

any one year (adjusted annually for inflation). Your analytical requirements under Executive Order 12866 are similar

to the analytical requirements under this Act, and thus the same analysis may permit you to comply with both

analytical requirements.

Information Collection, Paperwork, and Recordkeeping Burdens

Under the Paperwork Reduction Act (44 U.S.C. chapter 35), you will need to consider whether your rulemaking (or

other actions) will create any additional information collection, paperwork or recordkeeping burdens. These

burdens are permissible only if you can justify the practical utility of the information for the implementation of your

rule. OMB approval will be required of any new requirements for a collection of information imposed on 10 or more

persons and a valid OMB control number must be obtained for any covered paperwork. Your agency's CIO should

be able to assist you in complying with the Paperwork Reduction Act.

Information Quality Guidelines

Under the Information Quality Law, agency guidelines, in conformance with the OMB government-wide guidelines

(67 FR 8452, February 22, 2002), have established basic quality performance goals for all information

disseminated by agencies, including information disseminated in support of proposed and final rules. The data

and analysis that you use to support your rule must meet these agency and OMB quality standards. Your agency's

CIO should be able to assist you in assessing information quality. The Statistical and Science Policy Branch of

OMB's Office of Information and Regulatory Affairs can provide you assistance. This circular defines OMB's

minimum quality standards for regulatory analysis.

Environmental Impact Statements

The National Environmental Policy Act (42 U.S.C. 4321-4347) and related statutes and executive orders require

agencies to consider the environmental impacts of agency decisions, including rulemakings. An environmental

impact statement must be prepared for "major Federal actions significantly affecting the quality of the human

environment." You must complete NEPA documentation before issuing a final rule. The White House Council on

Environmental Quality has issued regulations (40 C.F.R. 1500-1508) and associated guidance for implementation

of NEPA, available through CEQ's website (http://www.whitehouse.gov/ceq/).

Impacts on Children

Under Executive Order 13045, "Protection of Children from Environmental Health Risks and Safety Risks," each

agency must, with respect to its rules, "to the extent permitted by law and appropriate, and consistent with the

agency's mission," "address disproportionate risks to children that result from environmental health risks or safety

risks." For any substantive rulemaking action that "is likely to result in" an economically significant rule that concerns

"an environmental health risk or safety risk that an agency has reason to believe may disproportionately affect

children," the agency must provide OMB/OIRA "an evaluation of the environmental health or safety effects of the

planned regulation on children," as well as "an explanation of why the planned regulation is preferable to other

potentially and reasonably feasible alternatives considered by the agency."

Energy Impacts

Under Executive Order 13211 (66 FR 28355, May 22, 2001), agencies are required to prepare and submit to OMB a

Statement of Energy Effects for significant energy actions, to the extent permitted by law. This Statement is to include

a detailed statement of "any adverse effects on energy supply, distribution, or use (including a shortfall in supply,

price increases, and increased use of foreign supplies)" for the action and reasonable alternatives and their effects.

You need to publish the Statement or a summary in the related NPRM and final rule. For further guidance, see OMB

Memorandum 01-27 ("Guidance on Implementing Executive Order 13211", July 13, 2001), available on OMB's
Memorandum 01-27 ("Guidance on Implementing Executive Order 13211", July 13, 2001), available on OMB's

website.

G. Accounting Statement

You need to provide an accounting statement with tables reporting benefit and cost estimates for each major final

rule for your agency. You should use the guidance outlined above to report these estimates. We have included a

suggested format for your consideration.

Categories of Benefits and Costs

To the extent feasible, you should quantify all potential incremental benefits and costs. You should report benefit

and cost estimates within the following three categories: monetized quantified, but not monetized; and qualitative,

but not quantified or monetized.

These categories are mutually exclusive and exhaustive. Throughout the process of listing preliminary estimates of

benefits and costs, agencies should avoid double-counting. This problem may arise if more than one way exists to

express the same change in social welfare.

Quantifying and Monetizing Benefits and Costs

You should develop quantitative estimates and convert them to dollar amounts if possible. In many cases,

quantified estimates are readily convertible, with a little effort, into dollar equivalents.

Qualitative Benefits and Costs

You should categorize or rank the qualitative effects in terms of their importance (e.g., certainty, likely magnitude,

and reversibility). You should distinguish the effects that are likely to be significant enough to warrant serious

consideration by decision makers from those that are likely to be minor.

Treatment of Benefits and Costs over Time

You should present undiscounted streams of benefit and cost estimates (monetized and net) for each year of the

analytic time horizon. You should present annualized benefits and costs using real discount rates of 3 and 7

percent. The stream of annualized estimates should begin in the year in which the final rule will begin to have

effects, even if the rule does not take effect immediately. Please report all monetized effects in 2001 dollars. You

should convert dollars expressed in different years to 2001 dollars using the GDP deflator.

Treatment of Risk and Uncertainty

You should provide expected-value estimates as well as distributions about the estimates, where such information

exists. When you provide only upper and lower bounds (in addition to best estimates), you should, if possible, use

the 95 and 5 percent confidence bounds. Although we encourage you to develop estimates that capture the 5 of

plausible outcomes for a particular alternative, detailed reporting of such distributions is not required, but should be

available upon request.

The principles of full disclosure and transparency apply to the treatment of uncertainty. Where there is significant

uncertainty and the resulting inferences and/or assumptions have a critical effect on the benefit and cost estimates,

you should describe the benefits and costs under plausible alternative assumptions. You may add footnotes to the

table as needed to provide documentation and references, or to express important warnings.

In a previous section, we identified some of the issues associated with developing estimates of the value of

reductions in premature mortality risk. Based on this discussion, you should present alternative primary estimates

where you use different estimates for valuing reductions in premature mortality risk.
Precision of Estimates

Reported estimates should reflect, to the extent feasible, the precision in the analysis. For example, an estimate of

$220 million implies rounding to the nearest $10 million and thus a precision of +/-$5 million; similarly, an estimate

of $222 million implies rounding to the nearest $1 million and thus, a precision of +/-$0.5 million.

Separate Reporting of Transfers

You should report transfers separately and avoid the misclassification of transfer payments as benefits or costs.

Transfers occur when wealth or income is redistributed without any direct change in aggregate social welfare. To

the extent that regulatory outputs reflect transfers rather than net welfare gains to society, you should identify them

as transfers rather than benefits or costs. You should also distinguish transfers caused by Federal budget actions -

- such as those stemming from a rule affecting Social Security payments -- from those that involve transfers

between non-governmental parties -- such as monopoly rents a rule may confer on a private party. You should use

as many categories as necessary to describe the major redistributive effects of a regulatory action. If transfers have

significant efficiency effects in addition to distributional effects, you should report them.

Effects on State, Local, and Tribal Governments, Small Business, Wages and Economic Growth

You need to identity the portions of benefits, costs, and transfers received by State, local, and tribal governments. To

the extent feasible, you also should identify the effects of the rule or program on small businesses, wages, and

economic growth. Note that rules with annual costs that are less than one billion dollars are likely to have a minimal

effect on economic growth.

Click here to access the form (93k)

H. Effective Date

The effective date of this Circular is January 1, 2004 for regulatory analyses received by OMB in support of proposed

rules, and January 1, 2005 for regulatory analyses received by OMB in support of final rules. In other words, this

Circular applies to the regulatory analyses for draft proposed rules that are formally submitted to OIRA after

December 31, 2003, and for draft final rules that are formally submitted to OIRA after December 31, 2004. (However,

if the draft proposed rule is subject to the Circular, then the draft final rule will also be subject to the Circular, even if

it is submitted prior to January 1, 2005.) To the extent practicable, agencies should comply earlier than these

effective dates. Agencies may, on a case-by-case basis, seek a waiver from OMB if these effective dates are

impractical.

1 We use the term "proposed" to refer to any regulatory actions under consideration regardless of the stage of the

regulatory process.

2 See Mishan EJ (1994), Cost-Benefit Analysis, fourth edition, Routledge, New York.

3 See Coase RH (1960), Journal of Law and Economics, 3, 1-44.

4 Mishan EJ (1994), Cost-Benefit Analysis, fourth edition, Routledge, New York.

5 For a full discussion of CEA, see Gold, ML, Siegel, JE, Russell, LB, and Weinstein, MC (1996), Cost

Effectiveness in Health and Medicine: The Report of the Panel on Cost-Effectiveness in Health and Medicine,

Oxford University Press, New York.

6 Gold ML, Siegel JE, Russell LB, and Weinstein MC (1996), Cost Effectiveness in Health and Medicine: The

Report of the Panel on Cost-Effectiveness in Health and Medicine, Oxford University Press, New York, pp. 284-

285.
7 Russell LB and Sisk JE (2000), "Modeling Age Differences in Cost Effectiveness Analysis", International Journal

of Technology Assessment in Health Care, 16(4), 1158-1167.

8 Pliskin JS, Shepard DS, and Weinstein MC (1980), "Utility Functions for Life Years and Health Status," Operations

Research, 28(1), 206-224.

9 Hammitt JK (2002), "QALYs Versus WTP," Risk Analysis, 22(5), pp. 985-1002.

10 For the least stringent alternative, you should estimate the incremental benefits and costs relative to the

baseline. Thus, for this alternative, the incremental effects would be the same as the corresponding totals. For each

alternative that is more stringent than the least stringent alternative, you should estimate the incremental benefits

and costs relative to the closest less-stringent alternative.

11 See Hanemann WM (1991), American Economic Review, 81(3), 635-647.

12 See Kahneman D, Knetsch JL, and Thaler RH (1991), "Anomalies: The Endowment Effect, Loss Aversion, and

Status Quo Bias," Journal of Economic Perspectives 3(1), 192-206.

13 Consumer surplus is the difference between what a consumer pays for a unit of a good and the maximum

amount the consumer would be willing to pay for that unit. It is measured by the area between the price and the

demand curve for that unit. Producer surplus is the difference between the amount a producer is paid for a unit of a

good and the minimum amount the producer would accept to supply that unit. It is measured by the area between

the price and the supply curve for that unit.

14 See McConnell KE (1997), Journal of Environmental Economics and Management, 32, 22-37.

15 See Loomis JB (1992), Water Resources Research, 28(3), 701-705 and Kirchoff, S, Colby, BG, and LaFrance,

JT (1997), Journal of Environmental Economics and Management, 33, 75-93.

16 Mishan EJ (1994), Cost-Benefit Analysis, fourth edition, Routledge, New York.

17 See Viscusi WK and Aldy JE, Journal of Risk and Uncertainty (forthcoming) and Mrozek JR and Taylor LO

(2002), Journal of Policy Analysis and Management, 21(2), 253-270.

18 Distinctions between "voluntary" and "involuntary" should be treated with care. Risks are best considered to fall

within a continuum from "voluntary" to "involuntary" with very few risks at either end of this range. These terms are

also related to differences in the cost of avoiding risks.

19 Graham JD (2003), Memorandum to the President’s Management Council, Benefit-Cost Methods and Lifesaving

Rules. This memorandum can be found at http://www.whitehouse.gov/omb/inforeg/pmc_benefit_cost_memo.pdf

20 Office of Information and Regulatory Affairs, OMB, Memorandum to the President’s Management Council, ibid.

21 For more information, see Dockins C., Jenkins RR, Owens N, Simon NB, and Wiggins LB (2002), Risk Analysis,

22(2), 335-346.

22 Committee on Risk Assessment of Exposure to Radon in Drinking Water, Board on Radiation Effects Research,

Commission on Life Sciences (1996), Risk Assessment of Radon in Drinking Water, National Research

Council, National Academy Press, Washington, DC.

23 Portney PR and Weyant JP, eds. (1999), Discounting and Intergenerational Equity, Resources for the Future,

Washington, DC.
Washington, DC.

24 Weitzman ML In Portney PR and Weyant JP, eds. (1999), Discounting and Intergenerational Equity, Resources

for the Future, Washington, DC.

25 In some contexts, the word "variability" is used as a synonym for statistical variation that can be described by a

theoretically valid distribution function, whereas "uncertainty" refers to a more fundamental lack of knowledge.

Throughout this discussion, we use the term "uncertainty" to refer to both concepts.

26 When disseminating information, agencies should follow their own information quality guidelines, issued in

conformance with the OMB government-wide guidelines (67 FR 8452, February 22, 2002).

27 Clemen RT (1996), Making Hard Decisions: An Introduction to Decision Analysis, second edition, Duxbury

Press, Pacific Grove.

28 The purpose of Delphi methods is to generate suitable information for decision making by eliciting expect

judgment. The elicitation is conducted through a survey process which eliminates the interactions between experts.

See Morgan MG and Henrion M (1990), Uncertainty: A Guide to Dealing with Uncertainty in Quantitative

Riskand Policy Analysis, Cambridge University Press.

29 Cooke RM (1991), Experts in Uncertainty: Opinion and Subjective Probability in Science, Oxford University

Press.

30 The Regulatory Flexibility Act (5 U.S.C. 603(c), 604).

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