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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations
response data are available in a manner sufficient for independent validation.
This action also requires the EPA to identify and make publicly available the science that serves as the basis for informing a significant regulatory action at the proposed or draft stage to the extent practicable; reinforces the applicability of peer review requirements for pivotal science; and provides criteria for the Administrator to exempt certain studies from the requirements of this rulemaking.
DATES: This final rule is effective on January 6, 2021.
ADDRESSES: The EPA has established a docket for this action under Docket ID
No. EPAHQOA20180259. All documents in the docket are listed on the http www.regulations.gov website.
Although listed in the index, some information is not publicly available, e.g., confidential business information CBI information or other information whose disclosure is restricted by statute.
Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form in the EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004. The Docket Centers hours are 8:30 a.m. to 4:30
p.m., Monday through Friday except Federal Holidays. Publicly available docket materials are available electronically through http
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Bennett Thompson, Office of Science Advisor, Policy and Engagement 8104R, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 202 5641071; email address:
osp_staff@epa.gov.
SUPPLEMENTARY INFORMATION:

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Table of Contents I. General Information A. Does this action apply to me?
B. What action is the Agency taking?
C. What is the Agencys authority for taking this action?
II. Background A. Summary of 2018 Proposed Rule B. Summary of 2020 Supplemental Notice of Proposed Rulemaking III. Description of Final Rule and Responses to Significant Comments A. Purpose and Effect of the Action 1. Purpose 2. Effect of This Rule on the Studies the EPA Uses To Support Significant Regulatory Actions and Influential Scientific Information 3. Effect of This Rule on Human Health and Environmental Protection B. Dose-Response Data C. Definitions
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1. Capable of Being Substantially Reproduced, Independent Validation, and Reanalyze 2. Data and Models 3. Dose-Response Data 4. Influential Scientific Information 5. Pivotal Science 6. Publicly Available 7. Research Data 8. Significant Regulatory Actions 9. Science That Serves as the Basis for Informing a Significant Regulatory Action D. Applicability of the Rule E. Availability of Dose-Response Data F. Proposed 40 CFR 30.6
G. Administrators Exemption H. Peer Review I. Changes to 40 CFR 30.4 What requirements apply to EPAs use of studies in significant regulatory actions?
J. Benefits and Costs K. Proposed 40 CFR 30.8 How is EPA to account for cost under this subpart?
IV. References V. Statutory and Executive Orders Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review B. Executive Order 13771: Reducing Regulations and Controlling Regulatory Costs C. Paperwork Reduction Act PRA
D. Regulatory Flexibility Act RFA
E. Unfunded Mandates Reform Act UMRA
F. Executive Order 13132: Federalism G. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments H. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks I. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use J. National Technology Transfer and Advancement Act NTTAA
K. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations L. Congressional Review Act CRA

I. General Information A. Does this action apply to me?
This final rule does not regulate any entity outside the EPA. Rather, the requirements modify the EPAs internal procedures regarding the transparency of pivotal science underlying significant regulatory actions 1 and influential scientific information. However, the Agency recognizes that any entity interested in the EPAs regulations may be interested in this final rule. For 1 Consistent with OMB guidance, this rule would not apply to the following regulatory actions:
Individual party adjudications, enforcement activities, site-specific actions, or permit proceedings.

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example, this final rule may be of interest to entities that conduct research or another scientific activity that is likely to be relevant to the EPAs regulatory activity or development of influential scientific information. This rule has no retrospective effect on either final significant regulatory actions or influential scientific information.
B. What action is the Agency taking?
The EPA is issuing this final rule to help strengthen the transparency of the dose-response data underlying certain EPA actions and to set the overarching structure and principles for transparency of pivotal science in significant regulatory actions and influential scientific information. This rule has a much narrower scope than the 2018 proposed rule Ref. 5 and the 2020 supplemental notice of proposed rulemaking Ref. 7. The rule describes how the EPA will determine the consideration to afford pivotal science of the EPAs significant regulatory actions and influential scientific information for which the conclusions are driven by the quantitative relationship between the amount of dose or exposure to a pollutant, contaminant, or substance and an effect based on the availability of the underlying dose-response data and other applicable factors. This rule builds upon prior EPA actions in response to Government-wide data access and sharing policies.
First, the EPA is requiring that, when promulgating significant regulatory actions or developing influential scientific information, the Agency will determine which studies constitute pivotal science and give greater consideration to those studies determined to be pivotal science for which the underlying dose-response data are available in a manner sufficient for independent validation.
Second, the EPA is establishing provisions for how the requirements of this part will apply. This rule sets the overarching structure and principles for transparency of pivotal science in significant regulatory actions and influential scientific information. The final rule provides that if implementing the rule results in any conflict between this rule and the environmental statutes that the EPA administers, and their implementing regulations, this rule will yield and the statutes and regulations will be controlling.
Third, this rule requires that the EPA
shall clearly identify all 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
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