On January 6, 2021, the US Environmental Protection Agency (EPA) released the final rule "Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information," establishing how the agency "will consider the availability of dose-response data underlying pivotal science used in its significant regulatory actions and influential scientific information." This regulation to revise how EPA internally determines the utility "pivotal science" and "influential scientific information" (ISI) was proposed in 2018 and the final rule was revised after considering the almost one million comments submitted to the docket for this action.
In general, the rule has narrowed its scope from previous iterations in 2018 and 2020. Besides addressing how EPA will determine public availability and importance of pivotal science and ISI for significant regulatory actions, the final rule establishes peer review requirements for pivotal science as well as criteria for the administrator to consider when granting case-by-case exemptions. The focus is on "studies that describe the quantitative relationship between the dose or exposure of a pollutant, contaminant, or substance and an effect," which is a narrower focus than was proposed in 2020.
The rule does not apply to individual party adjudications, enforcement activities, site-specific actions, or permit proceedings and has no retrospective effect on previous final significant regulatory actions or ISI. If this final rule conflicts with existing environmental statutes, then "this rule will yield and the statutes and regulations will be controlling."
In short, specific studies or analyses that are required or drive significant regulatory actions (as determined by EO 12866) or ISI (information that has "a clear and substantial impact on important public policies or private sector decisions") are considered "pivotal science." EPA shall give greater consideration to pivotal science that include underlying data that is "publicly available in a manner sufficient for independent validation." EPA shall determine if independent peer review is necessary - consistent with the OMB Information Quality Bulletin for Peer Review requirements and exemptions. If justified, the reviewers are asked to provide information on the "strengths and weaknesses of the justification for assumptions applied and the implications of those assumptions for the results." Exemptions may be granted on a case-by-case basis if there are technological or other barriers to sharing the data, legal conflicts with sharing the data, if a third party has conducted independent validation, or if the data was completed or updated prior to January 6, 2021. In essence, pivotal science only includes studies that are critical to deriving quantitative dose-response relationships to establish a "point of departure" for risk assessment; however, the agency views its approach as incremental and reserves the right to issue future rulemakings that could interpret this more broadly.
EPA clarified in its response to comments that the final rule maintains the language regarding the dominance of "statutory requirements and corresponding implementing regulations" over this final rule in the case of any conflict. In addition, EPA is planning to promulgate "either statute-specific transparency regulations or programmatic actions implementing this procedural rule." Entities regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) would be advised to engage with the Office of Pesticide Programs with regard to its plans to issue specific transparency regulations to ensure the primacy of FIFRA and maintain the narrow focus on only those studies used to set PODs for risk assessment.
Along with today's final rule, the 44 references cited in the Federal Register announcement have been uploaded to the docket found here. The rule is effective as of January 6, 2021. EPA intends to next issue implementation guidelines to help standardize implementation across the various programs and offices and these many include the "process for designating key studies as pivotal science, documenting availability of dose-response data, and requesting an administrator's exemption.
It should be noted that this final rule is potentially subject to nullification under procedures outlined by the Congressional Review Act.