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e-CFR data is current as of March 4, 2021

Title 40Chapter ISubchapter A → Part 30


Title 40: Protection of Environment


PART 30—TRANSPARENCY IN SIGNIFICANT REGULATORY ACTIONS AND INFLUENTIAL SCIENTIFIC INFORMATION


Contents
§30.1   What is the purpose of this part?
§30.2   What definitions apply to this part?
§30.3   How do the provisions of this part apply?
§30.4   What requirements apply to the EPA's use of studies in significant regulatory actions?
§30.5   What requirements apply to the EPA's use of dose-response data underlying pivotal science?
§30.6   What role does independent peer review have in this part?
§30.7   May the EPA Administrator grant exemptions to this part?

Authority: 5 U.S.C. App.; Pub. L. 98-80, 84 Stat. 2086.

Source: 86 FR 491, Jan. 6, 2021, unless otherwise noted.

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§30.1   What is the purpose of this part?

This part directs the EPA to give greater consideration to pivotal science when the underlying dose-response data are available in a manner sufficient for independent validation.

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§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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§30.3   How do the provisions of this part apply?

(a) The provisions of this part apply to science that serves as the basis for informing a significant regulatory action or influential scientific information, as well as to dose-response data underlying pivotal science, regardless of the source of funding or identity of the party conducting the science. The provisions of this part apply to significant regulatory actions for which a proposed rule was published in the Federal Register after January 6, 2021 and influential scientific information submitted for peer review after January 6, 2021.

(b) The provisions of this part do not apply to physical objects (like laboratory samples), drafts, and preliminary analyses, and influential scientific information or pivotal science that meet one or more of the exemptions identified in Section IX of the OMB Final Information Quality Bulletin for Peer Review. In the event the procedures outlined in this part conflict with statutes the EPA administers, or their implementing regulations, the statutes and regulations will control. Except where explicitly stated otherwise, the provisions of this part do not apply to any other type of Agency action, including individual party adjudications, enforcement activities, site-specific actions, or permit proceedings.

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§30.4   What requirements apply to the EPA's use of studies in significant regulatory actions?

The EPA shall clearly identify the science that serves as the basis for informing a significant regulatory action. The EPA shall make all such science that serves as the basis for informing a significant regulatory action publicly available to the extent permitted by law.

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§30.5   What requirements apply to the EPA's use of dose-response data underlying pivotal science?

(a) When promulgating a significant regulatory action or developing influential scientific information that relies on dose-response data, the Agency shall follow best practices to evaluate potential links between exposure to a pollutant, contaminant, or substance and the effect and the nature of the dose-response relationship.

(b) The EPA will use the following factors to assess the quality of studies identified in the systematic review: soundness, applicability and utility, clarity and completeness, uncertainty and variability, and evaluation and review. The EPA will rely on the highest quality, most relevant studies in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance. Where there is convincing and well-substantiated evidence of a relationship between exposure and effect, the EPA will identify those studies based on the exposure situation being addressed, the quality of the studies, the reporting adequacy, and the relevance of the endpoints that would inform a dose-response assessment for those effect endpoints. From the subset in the preceding sentence, the specific dose-response studies or analyses that drive the requirements, quantitative analyses, or both of an EPA significant regulatory action or influential scientific information will be identified as pivotal science.

(c) The EPA shall give greater consideration to pivotal science where the underlying dose-response data are publicly available in a manner sufficient for independent validation. The Agency shall also give greater consideration to pivotal science based on dose-response data that include confidential business information, proprietary information or personally identifiable information if these data are available through restricted access in a manner sufficient for independent validation. For pivotal science where there is no access to dose-response data, or access is limited, the Agency may still consider these studies but will give them lesser consideration unless the Administrator grants an exemption under §30.7. The Agency will identify the pivotal science that was given lesser consideration and provide a short description of why lesser consideration was given.

(d) In determining the degree of consideration to afford pivotal science for which the dose-response data are not available for independent validation, the EPA shall consider the following factors and any other relevant factors, as applicable:

(1) The quality of the study relative to other studies for which the dose-response data are available;

(2) The extent to which there are other studies for which the dose-response data are available;

(3) The sensitivity of the conclusions in the significant regulatory action or influential scientific information based on the use of the study;

(4) The extent to which the study is fit for the purpose or intended use relative to other pivotal science for which the dose-response data are available;

(5) The use of exposures or doses in a range and duration that is relevant for the intended use and that minimizes the need for extrapolations;

(6) The extent to which the study is supported by other scientific evidence;

(7) The extent to which the study accounted for unique scientific considerations;

(8) The extent to which the study minimizes the use of defaults and assumptions, uses appropriate and strong statistical methods, and includes a robust representation of uncertainty and confidence intervals; and

(9) The study's consideration of a broad range of parametric dose-response or concentration-response models, a robust set of potential confounding variables, nonparametric models that incorporate fewer assumptions, various threshold models across the dose or exposure range, and models that investigate factors that might account for spatial heterogeneity.

(e) The EPA shall also describe critical assumptions and methods used in its dose-response assessment and shall characterize the variability and uncertainty of the assessment. The EPA shall evaluate the appropriateness of using default assumptions on a case-by-case basis. The EPA shall clearly explain the scientific basis for critical assumptions used in the dose-response assessment that the EPA relied on for the significant regulatory action or influential scientific information.

(f) Where the Agency is making dose-response data publicly available, it shall do so in a fashion that is consistent with law, protects privacy, confidentiality, confidential business information, and is sensitive to national security. Dose-response data is considered “publicly available in a manner sufficient for independent validation” when it includes the information necessary for the public to understand, assess, and reanalyze findings and may include, for example:

(1) Data (data would be made available subject to access and use restrictions);

(2) Associated protocols necessary to understand, assess, and extend conclusions;

(3) Computer codes and models involved in the creation and analysis of such information;

(4) Recorded factual materials; and

(5) Detailed descriptions of how to access and use such information.

(g) The provisions of this section apply to dose-response data underlying studies that are pivotal science, regardless of who funded or conducted the studies. The Agency shall make all reasonable efforts to explore methodologies, technologies, and institutional arrangements for making such data available before it concludes that doing so in a manner consistent with law and protection of privacy, confidentiality, national security is not possible.

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§30.6   What role does independent peer review have in this part?

The EPA shall conduct independent peer review consistent with the requirements of the OMB Final Information Quality Bulletin for Peer Review and the exemptions described therein. The EPA will evaluate whether or not to conduct additional peer review of individual studies identified as pivotal science if the studies have already undergone journal peer review. Because transparency in pivotal science includes addressing issues associated with assumptions used in analyzing dose-response data, the EPA shall ask peer reviewers to articulate the strengths and weaknesses of the justification for the assumptions applied and the implications of those assumptions for the results.

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§30.7   May the EPA Administrator grant exemptions to this part?

(a) The Administrator may grant an exemption to this part for a study on a case-by-case basis if he or she determines that greater consideration is warranted because:

(1) Technological or other barriers render sharing of the dose-response data infeasible;

(2) The development of the dose-response data was completed or updated before January 6, 2021;

(3) Making the dose-response data available would conflict with laws and regulations governing privacy, confidentiality, confidential business information, or national security;

(4) A third-party has conducted independent validation of the study's underlying dose-response data through reanalysis; or

(5) The factors used in determining the consideration to afford to the pivotal science indicate full consideration is justified.

(b) When making a decision to grant an exemption, the Administrator may consider input from EPA staff and public commenters. The EPA shall document the rationale for exemptions granted by the Administrator in the significant regulatory action or influential scientific information.

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