The Biobased and Renewable Products Advocacy Group (BRAG) helps members develop and bring to market their innovative biobased and renewable chemical products through insightful policy and regulatory advocacy. BRAG is managed by B&C® Consortia Management, L.L.C., an affiliate of Bergeson & Campbell, P.C.

By Lynn L. Bergeson

On March 3, 2020, EPA announced the availability of a supplemental notice of proposed rulemaking (SNPRM) to the Strengthening Transparency in Regulatory Science proposed rule. EPA notes that the SNPRM “is not a new rulemaking; rather, it provides clarifications on certain terms and aspects of the 2018 proposed rule.” The SNPRM:

  • Proposes that the scope of the rulemaking applies to influential scientific information, as well as significant regulatory decisions;
  • Defines and clarifies that the proposed rule applies to data and models underlying both pivotal science and pivotal regulatory science;
  • Proposes a modified approach to the availability provisions for data and models that would underlie influential scientific information and significant regulatory decisions, as well as an alternate approach; and
  • Clarifies the ability of the Administrator to grant exemptions.

EPA published the SNPRM in the Federal Register on March 18, 2020. 85 Fed. Reg. 15396. EPA states that it “is taking comment on whether to use its housekeeping authority independently or in conjunction with appropriate environmental statutory provisions as authority for taking this action.” On April 2, 2020, EPA announced that it would extend the comment period to May 18, 2020. EPA anticipates promulgating a final rule later in 2020. More information is available in our March 9, 2020, memorandum, “EPA Releases Supplemental Proposed Rule to the Proposed Rule on Strengthening Transparency in Regulatory Science.”


 

By Lynn L. Bergeson

On March 3, 2020, EPA announced that a supplemental notice of the proposed rulemaking (SNPRM) titled “Strengthening Transparency in Regulatory Science” will be published in the Federal Register in the near future. While the notice would only modify EPA internal procedures, industry stakeholders are asked to comment on the proposed rule during a 30-day period after the date of publication in the Federal Register. The supplemental notice proposes the following changes to the 2018 proposed rulemaking:

  • A scope that applies to influential scientific information and significant regulatory decisions;
  • A modified approach to the availability provisions for data and models that would underlie influential scientific information and significant regulatory decisions as well as an alternate approach;
  • Clarification on the ability of the EPA Administrator to grant exemptions; and
  • Definitions and clarifications that the proposed rule applies to data and models underlying both pivotal science and pivotal regulatory science.

These proposed modifications are in response to some of the public comments received by EPA on the 2018 proposed rulemaking. Under the alternate approach to the use of data and models, EPA will also use restricted studies that are not available to the public. The proposal would apply to reviews of data, models, and studies regardless of when the data and models were generated. EPA plans to identify studies that are given greater consideration and provide a short explanation of why greater consideration was given.

EPA is seeking comment on each of the proposed changes. In particular, EPA is asking for feedback on whether this approach may improve consistency between this proposed rulemaking and certain provisions of those statutes that refer to standards for data availability.

EPA’s announcement includes a pre-publication version of the proposed supplemental rulemaking, which can be accessed here. Interested parties may wish to review Bergeson & Campbell, P.C.’s (B&C®) March 9, 2020, memorandum on the SNPRM.


 

On Wednesday, November 13, 2013, EPA Administrator Gina McCarthy testified as the sole witness before the House Committee on Science, Space, and Technology on "Strengthening Transparency and Accountability within the Environmental Protection Agency."


While the hearing was held as part of the Committee's annual oversight of EPA, it provided Committee Chair Lamar Smith (R-TX) an opportunity to question McCarthy on several concerns he reportedly had with EPA and appropriate transparency at the Agency. These included reports of EPA officials' use of outside e-mail addresses to conduct business, and questions following EPA's "insufficient" response to a subpoena last summer requesting information about the Agency's confidential health studies that form the basis for EPA regulation of greenhouse gas (GHG) emissions.


Assessments of EPA's performance during the hearing fell along party lines. Committee Democrats led by Ranking Member Eddie Bernice Johnson (D-TX) have publicly criticized Chair Smith for his criticisms of the Agency.


Administrator McCarthy's nomination was held up for several months due to concerns by the Senate Committee on Environment and Public Works Ranking Member David Vitter (D-LA) over sufficient transparency at EPA. It was allowed to go through after Administrator McCarthy pledged to bolster transparency at EPA under her leadership.