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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

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

called either "regulatory analysis" or "analysis" for brevity, 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 Actions

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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, good and bad, 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 

non-quantified 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 "break-even" 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 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 non-monetized 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 highquality 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.

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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

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

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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 

information-processing 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, 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, consumerinitiated 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 

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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 

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

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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 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

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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 

non-quantified benefits and costs are likely to be important, you should recommend which of the nonquantified 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, costeffectiveness 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, cost-effectiveness 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 cost-effectiveness 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 costeffectiveness 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 

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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 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 "qualityadjusted 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 healthrelated 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 willingnessto-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 

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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,

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• 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 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 

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remains. In this 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 

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 "willingnessto-pay" (WTP) captures the notion of opportunity cost by measuring what individuals are willing to forgo to 

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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-to-pay 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, 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 welldeveloped literature on revealed preference in the peer-reviewed, applied economics literature.

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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 arise due to those weaknesses. If a study has major weaknesses, the study 

should not be used in regulatory analysis.

a. 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.

b. 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.

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"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 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 statedpreference 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 non-response 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 

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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.

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• 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, fueleconomy 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 

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 

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of non-quantified benefits and costs. Some authorities16 refer to these non-monetized and non-quantified 

effects as "intangible".

a. 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.

b. 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 revealedpreference studies. In this situation you should consider commissioning a stated-preference study or using 

values from published stated-preference studies. For the reasons discussed previously, you should be 

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cautious about using values from stated-preference studies and describe in the analysis the drawbacks of 

this approach.

a. 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 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.

b. 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 

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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 lifeyears 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.

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 

literature-based 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.

c. 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 

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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.

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 A-94 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.

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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 presentvalue 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 highlevel 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 presentvalue 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

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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 short-term 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 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 

cost-effectiveness 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 

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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 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

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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 benefitcost 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 

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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 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.

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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.

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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 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

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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 (93 kb)

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.

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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.

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23 Portney PR and Weyant JP, eds. (1999), Discounting and Intergenerational Equity, Resources for the 

Future, 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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