EPA Issues Final Rule Intended to Strengthen Transparency in Pivotal Science – Update from Bergeson & Campbell, P.C.

On January 6, 2021, the U.S. Environmental Protection Agency (EPA) issued a final rule on “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information.”  86 Fed. Reg. 469.  EPA’s January 5, 2021, press release states the final rule establishes that when promulgating significant regulatory actions or developing influential scientific information, EPA will give greater consideration to studies where the underlying dose-response data are available in a manner sufficient for independent validation.  The final rule requires EPA to identify and make publicly available the science that serves as the basis for informing a significant regulatory action at the proposed or draft stage to the extent practicable; reinforces the applicability of peer review requirements for pivotal science; and provides criteria for the Administrator to exempt certain studies from the requirements of the rule.  The final rule was effective on January 6, 2021.  Its provisions apply to significant regulatory actions for which a proposed rule was published in the Federal Register after January 6, 2021, and influential scientific information submitted for peer review after January 6, 2021. For more information, please read the full memorandum.


2200 Pennsylvania Ave., N.W.
Suite 100W
Washington, D.C. 20037
(202) 557-3800
(202) 557-3836 (fax)