Title 40

SECTION 30.2

30.2 What definitions apply to this part

§ 30.2 What definitions apply to this part?

For the purposes of this part:

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 either the original researcher or an independent party.

Dose-response data means the data used to characterize the quantitative relationship between the amount of dose or exposure to a pollutant, contaminant, or substance and an effect.

Independent validation means the reanalysis of study dose-response data by subject matter experts who have not contributed to the development of the study to evaluate whether results similar to those reported in the study are produced.

Influential scientific information means scientific information the Agency reasonably can determine will have or does have a clear and substantial impact on important public policies or private sector decisions.

Pivotal science means the specific dose-response studies or analyses that drive the requirements or quantitative analyses of EPA significant regulatory actions or influential scientific information.

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. The public must be able to access the information on the date of publication of the proposed rule (or, as appropriate, a supplemental notice of proposed rulemaking, or notice of availability) for the significant regulatory action or on the date of dissemination of the draft influential scientific information for public review and comment.

Reanalyze means to analyze exactly the same dose-response data to determine whether a similar result emerges from the analysis by using the same methods, statistical software, models, or statistical methodologies that were used to analyze the dose-response data, as well as to assess potential analytical errors and variability in the underlying assumptions of the original analysis.

Science that serves as the basis for informing a significant regulatory action means studies, analyses, models, and assessments of a body of evidence that provide the basis for EPA significant regulatory actions.

Significant regulatory actions means final regulations determined to be “significant regulatory actions” by the Office of Management and Budget pursuant to Executive Order 12866.

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