On January 6, 2021, the U.S. Environmental Protection Agency (EPA) issued a final rule on “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information.” 86 Fed. Reg. 469. EPA’s January 5, 2021, press release states the final rule establishes that when promulgating significant regulatory actions or developing influential scientific information, EPA will give greater consideration to studies where the underlying dose-response data are available in a manner sufficient for independent validation. The final rule requires 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 the rule. The press release notes that the final rule “does not require the release of Personally Identifiable Information (PII) or Confidential Business Information (CBI) nor does it require EPA to collect, store, or publicly disseminate any PII/CBI data underlying pivotal science.” The final rule was effective on January 6, 2021. Its provisions 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.

According to EPA, the final rule has a much narrower scope than the 2018 proposed rule and the 2020 supplemental notice of proposed rulemaking (SNPRM). Information on the proposed rule and SNRPM is available in our April 30, 2018, and March 9, 2020, memoranda, respectively. EPA states that the final rule builds upon its prior actions in response to government-wide data access and sharing policies. The final rule includes the following provisions:

• EPA requires that, when promulgating significant regulatory actions or developing influential scientific information, it 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;

• EPA is establishing provisions for how the rule requirements will apply. The 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 the rule and the environmental statutes that EPA administers, and their implementing regulations, the rule will yield and the statutes and regulations will be controlling;

• EPA must clearly identify all science that serves as the basis for informing a significant regulatory action. EPA shall make all such science that serves as the basis for informing a significant regulatory action publicly available to the extent practicable using standards for protecting identifiable information;

• EPA is establishing requirements for the independent peer review of pivotal science; and

The Administrator must consider certain criteria when granting case-by-case exemptions to the requirements of the final rule, including when:

• Technological or other barriers render sharing of the dose-response data infeasible;

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

• Making the dose-response data publicly available would conflict with laws and regulations governing privacy, confidentiality, CBI, or national security;

• A third-party has conducted independent validation of the study’s underlying dose-response data through reanalysis; or

• The factors used in determining the consideration to afford to the pivotal science indicate that full consideration is justified.

The final rule includes the following definitions (to be codified at 40 C.F.R. Section 30.2):

• 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”; and

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

According to the final rule, EPA intends to issue implementation guidelines that will help execute the final rule consistently in specific programs authorized under various statutes (e.g., the Clean Air Act (CAA), the Clean Water Act (CWA), the Safe Drinking Water Act (SDWA), the Resource Conservation and Recovery Act (RCRA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), and the Emergency Planning and Community Right-to-Know Act (EPCRA)). EPA states that this “may include the process for designating key studies as pivotal science, documenting the availability of dose-response data, and requesting an Administrator’s exemption.”

Commentary

While this final rule clarifies and responds to many of the questions raised regarding the proposed rule and SNPRM, including questions about the definition of important terms such as “pivotal science” and “significant regulatory actions,” the final rule will inevitably remain controversial since its origin is rooted in legislative proposals more clearly intended to challenge important regulatory requirements, particularly related to EPA’s air program. The final rule has refinements that track various long-standing science policies already established at EPA about peer review, rule development, and transparency. Despite EPA’s statements in the final rule that this rule is not politically motivated, there remains distrust of how exactly such requirements might impact past or future regulatory action.

Given the imminent arrival of the new Biden Administration, expected to conduct an early review of decisions made by the Trump Administration, this rule will likely be among the first items subject to reversal or “clarifying” guidance making it consistent with previously established science policies (see Bergeson & Campbell, P.C.’s (B&C^®) Forecast 2021 memo). With Democratic control of both houses of Congress, there might also be attempts to repeal the rule via action under the Congressional Review Act (CRA) of recently promulgated regulations. A lawsuit seeking to rescind this rule is also possible, including but not limited to challenging EPA’s authority to issue this rule as a procedural rule within the scope of EPA’s housekeeping authority and not under the authority of any substantive environmental statute, as well as issues regarding the potential retrospective impact of this rule.