Title 40


83.1 What definitions apply to this subpart

§ 83.1 What definitions apply to this subpart?

Baseline means the best assessment of the way the world would evolve absent the regulation. It is the primary point of comparison for assessing the effects of the regulatory options under consideration.

Benefit-cost analysis (BCA) means an evaluation of the social benefits and social costs of a policy action and other policy alternatives. The social benefits of a policy are measured by society's willingness-to-pay for the policy outcome. The social costs are measured by the opportunity costs of adopting the policy. BCA addresses the question of whether the benefits for those who gain from the action are sufficient to, in principle, compensate those burdened by costs such that everyone would be at least as well off as before the policy. The calculation of net benefits (benefits minus costs) answers this question and helps ascertain the economic efficiency of the policy. Where all regulation attributable benefits and costs can be quantified and expressed in monetary units, BCA provides decision makers with a clear indication of the most economically efficient alternative, that is, the alternative that generates the largest net benefits to society (ignoring distributional effects).

Compliance cost means the private cost that a regulated entity incurs to comply with a regulation, such as through planning, design, installation, and operation of pollution abatement equipment.

Data means the set of recorded factual material commonly accepted in the scientific community as necessary to validate research findings in which obvious errors, such as keystroke or coding errors, have been removed and that is capable of being analyzed by both the original researcher and an independent party.

Endpoint is the specific manifestation of the documented effect that is to be quantified for the benefits analysis. It is a metric (e.g., number of hospital admissions) that acts as a surrogate for some aspect of a health or public welfare effect (e.g., respiratory system effects).

Expected value is the probabilistically weighted outcome that defines a statistical mean and a measure of the central tendency of a set of data. For a variable with a discrete number of outcomes, the expected value is calculated by multiplying each of the possible outcomes by the likelihood that each outcome will occur and then summing all of those values.

Model means a simplification of reality that is constructed to gain insights into select attributes of a physical, biological, economic, or social system. A formal representation of the behavior of system processes, often in mathematical or statistical terms. The basis can also be physical or conceptual.

Opportunity cost means the value of the next best alternative to a particular activity or resource.

Publicly available means lawfully available to the general public from federal, state, or local government records; the internet; widely distributed media; or disclosures to the general public that are required to be made by federal, state, or local law.

Regulatory options means:

(1) The proposed or finalized option, and at a minimum the following;

(2) A more stringent option which contributes to the stated objectives of the Clean Air Act and that achieves additional benefits (and presumably costs more) beyond those realized by the proposed or finalized option; and

(3) A less stringent option which contributes to the stated objectives of the Clean Air Act and that costs less (and presumably generates fewer benefits) than the proposed or finalized option.

Sensitivity Analysis means an analysis that is used to assess how the final results or other aspects of an analysis change as input parameters change, particularly when only point estimates of parameters are available. Typically, a sensitivity analysis measures how a model's output changes as one of the input parameters change. Joint sensitivity analysis (varying more than one parameter at a time) is sometimes useful as well.

Significant regulation means a proposed or final regulation issued pursuant to authority provided by the Clean Air Act that is determined to be a “significant regulatory action” pursuant to Section 3(f) of E.O. 12866 or is otherwise designated as significant by the Administrator.

Social benefits, or benefits, means the sum of all positive changes in societal well-being experienced as a result of the regulation or policy action.

Social costs, or costs, means the sum of all opportunity costs, or reductions in societal well-being, incurred as a result of the regulation or policy action. These opportunity costs consist of the value lost to society of all the goods and services that will not be produced and consumed as regulated entities reallocate resources to comply with the regulation.

Systematic Review Process is the process for evaluating the scientific literature that includes:

(1) Identification of the specific question to be addressed in the review;

(2) Pre-specified methods used to address the question, making these methods and the review process transparent);

(3) A search strategy written into the protocol that explicitly states the inclusion and exclusion criteria for studies; and

(4) A description of the structured approach used to draw conclusions considering all appropriate and available lines of evidence, including epidemiologic, toxicologic, and mechanistic lines of evidence.