On January 6, 2021, the U.S. Environmental Protection Agency (EPA or the Agency) published a final rule, “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information.” EPA published the proposed rule in April 2018 and followed it with a supplemental notice in March 2020. The final rule establishes how EPA will consider the availability of dose-response data, and it is narrower in scope than both the proposed rule and the supplemental notice, as it is restricted to “those studies that describe the quantitative relationship between the dose or exposure of a pollutant, contaminant, or substance and an effect.” The rule, which went into effect the day it was published, requires that EPA do the following:
- when working on significant regulatory actions or influential scientific information, identify and give greater consideration to studies that constitute “pivotal science,” defined as “the specific dose-response studies or analyses that drive the requirements or quantitative analyses of EPA significant regulatory actions or influential scientific information”
- allow other statutes and regulations to control when they conflict with the rule
- identify and make public all science that serves as the basis for a significant regulatory action
- establish requirements for peer review of pivotal science
- provide case-by-case exemptions to the rule based on one or more of five criteria established in 40 C.F.R. § 30.7
- issue implementation guidelines to help execute the final rule
Opponents of the rule have been urging that the incoming Biden administration should reconsider and unwind the new requirements. Given its timing, the rule could be reviewed under the Congressional Review Act (CRA), but EPA described the rule as an internal, procedural rule, which, if sustained, would shield the rule from potential rescission by Congress under the CRA.