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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations
when evaluating studies underlying pivotal regulatory science and pivotal science. Under the first approach, the Agency would have only used pivotal regulatory science or pivotal science where the underlying data and models were either publicly available for independent validation or, in the case of restricted data and models e.g., those that include CBI, proprietary data, or personally identifiable information PII
that cannot be sufficiently de-identified to protect the data subjects, available through restricted access in a manner sufficient for independent validation.
Under the second approach, the EPA
would have, other things equal, given greater consideration to studies where the underlying data and models were either publicly available in a manner sufficient for independent validation or, in the case of restricted data and models, available through restricted access in a manner sufficient for independent validation. Proposed 40
CFR 30.9 would have allowed the EPA
Administrator to grant an exemption to the requirements in proposed 40 CFR
part 30 if the Administrator determined that compliance was impracticable because technological barriers rendered sharing of the data or models infeasible;
the development of the data or model was completed or updated before the effective date of this final rule; or by making the data and models publicly available, it would have conflicted with laws governing privacy, confidentiality, CBI, or national security interests.
Finally, the EPA clarified in the 2020
SNPRM that it is authorized to promulgate this rulemaking under its housekeeping authority and revised the authority cited in proposed 40 CFR part 30 accordingly. The Agency solicited public comment on whether to use its housekeeping authority independently or in conjunction with the environmental statutory provisions cited as authority in the 2018 proposed rule, which were further clarified in the 2020 SNPRM.

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III. Description of Final Rule and Responses to Significant Comments A. Purpose and Effect of the Action 1. Purpose. The EPA is committed to its mission of protecting human health and the environment through sound policy decisions that are informed by robust scientific and technical research.
Because of the potential impact of the EPAs significant regulatory actions and influential scientific information on American lives and livelihoods, the American people deserve environmental decisions and policies that are based on the best scientific information. Only
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through continuous improvement to its procedures, especially those focused on transparency, can the EPA fully demonstrate that commitment.
The purpose of this action is to increase transparency by codifying internal procedural requirements for how the EPA will consider the availability of the underlying doseresponse data that it relies upon to promulgate significant regulatory actions and develop influential scientific information. These requirements build upon open data initiatives in the Federal Government and scientific community and advance the EPAs mission and commitment to the public by prioritizing transparency of the underlying dose-response data in pivotal science for the most impactful of EPAs assessments and regulatory actions. Where underlying doseresponse data in pivotal science are available, subject matter experts could independently reanalyze the data to affirm original research conclusions, check for errors, test alternative assumptions, and better understand and evaluate the implications of the uncertainty used in the original analysis. Such independent reanalyses will subsequently enable the EPA to make stronger, data-driven decisions in future rulemakings or in revisions to existing rules or influential scientific information. This could occur through standard cyclical reviews e.g., revisions to national ambient air quality standards, risk and technology reviews, national primary drinking water regulations, ad hoc revisions, or revisions through the information quality guidelines or other petition processes. Implementation of this rule will more effectively share pivotal science for external consideration and increase the opportunity for independent validation of pivotal science by subject matter experts. As data are better understood through independent reanalysis, the public will, if they so choose, be able to more effectively comment, engage, and hold the EPA accountable during the development of future significant regulatory actions and influential scientific information.
The transparency provisions in this final rule are intended to build upon existing Federal Government efforts and provide incremental progress toward the Agencys goal of greater transparency.
The EPA and the Federal Government have long encouraged open data initiatives, as the principle of transparency in regulatory decisionmaking and the other operations of government agencies is a fundamental behavior of good government that is
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inherently valuable to the public. For example, in 2002 the Office of Management and Budget OMB
released its Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies, which includes discussion of the importance of the reproducibility of analyses underlying influential information Ref. 3. The EPAs 2016
Plan to Increase Access to Results of EPA-Funded Scientific Research noted that transparency is a core EPA value and that increased availability of research data would accelerate scientific breakthroughs that support the Agencys mission and policymaking efforts Ref.
9. The EPAs Open Government Plan 5.0 Ref. 10 also details the EPAs progress in implementing the tenets of the numerous data transparency initiatives in the Federal Government prior to 2018, including the Office of Management and Budget OMB M10
06 Ref. 11, the Office of Science and Technology Policy Memorandum of February 22, 2013 Ref. 12, and OMB
M1313 Ref. 4. In 2019, Congress passed the Foundations for EvidenceBased Policymaking Act of 2018 or OPEN Government Data Act, Public Law 115435 into law, which included requirements for Federal agencies to prioritize making their data available to the public, and OMB has released additional guidance for implementing the act Refs. 13, 14.
The scientific community has also embraced greater data transparency, as evidenced by data sharing and availability requirements for many highimpact journals Ref. 15 and the emergence of organizations, such as the Center for Open Science, and international initiatives like Findable, Accessible, Interoperable, and Reusable FAIR data principles; Facilitate Open Science Training in European Research FOSTER; and Guidelines for Transparency and Openness Promotion TOP in Journal Policies and Practices that incentivize greater transparency in research Refs. 16, 17.
The EPA supports these efforts and is pursuing an incremental approach to maximizing transparency in the science that it relies upon to ensure that implementation is done in a thoughtful and deliberate way that focuses on the EPAs most impactful actions, minimizes unintended consequences, and informs future transparency requirements. As further described in Section II.B of this preamble, the EPA is focusing on the underlying doseresponse data for this rulemaking because of the influence these data have on particularly impactful decisions at
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