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.