Jan 142021

EPA Publishes “Transparency in Science” Final Rule

Samuel B. Boxerman and Anushka N. Rahman

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.

This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.

Samuel B. Boxerman

Washington, D.C.

sboxerman@sidley.com

Anushka N. Rahman

arahman@sidley.com

You might also like
U.S. Fifth Circuit Reverses EPA’s Denial of Fuel Program Hardship Exemption for Refineries

In Calumet Shreveport Refining LLC v. EPA, Case No. 22-60266 (5th Cir. Nov. 22, 2023), the U.S. Court of Appeals for the Fifth Circuit struck down Environmental Protection Agency (EPA) denials of six small refineries’ petitions for hardship relief under the Clean Air Act Renewable Fuel Standard (RFS) program, holding that EPA used an “impermissibly retroactive” standard to deny the refineries’ petitions in violation of the Administrative Procedure Act. This ruling could serve as a basis for other refineries to challenge EPA’s retroactive denial of their hardship petitions — and provides support for similar petitions pending before the U.S. Court of Appeals for the D.C. Circuit.

U.S. EPA Publishes New Regulations Governing State Plans for Existing Sources of Emissions

On November 9, 2023, the U.S. Environmental Protection Agency (EPA) published implementing regulations that set timelines and other requirements for state plans to limit pollution from existing sources under Clean Air Act (CAA) Section 111. The amended provisions apply to all emissions guidelines published after July 8, 2019, and will affect the scope and pace of development of updated performance standards for existing facilities.

U.S. EPA Enforcement Office Issues a Climate Enforcement and Compliance Strategy Memorandum

On September 28, 2023, the U.S. Environmental Protection Agency (EPA) Office of Enforcement and Compliance Assurance (OECA) issued a memorandum outlining a Climate Enforcement and Compliance Strategy, identifying several steps the office plans to take to address climate change (the Strategy Memo). As part of the strategy, EPA plans to expand its efforts to address climate change by increased enforcement of rules governing greenhouse gas–forming pollutants and incorporating climate-related mitigation efforts, including renewable energy projects into settlements as mitigation or supplemental environmental projects. The Strategy Memo comes only a month after EPA issued its first-ever national enforcement and compliance initiative on climate change.