EPA Finalizes Rule Strengthening Transparency in Science for Regulatory Actions

Today, the U.S. Environmental Protection Agency (EPA) released the prepublication for the final rule to strengthen the transparency of significant regulatory actions and influential scientific information. The rule requires EPA to give greater consideration to studies where the underlying dose-response data are available for independent validation when used as pivotal science, for example when promulgating significant regulatory actions or developing influential scientific information. The rule does not require the release of Personally Identifiable Information (PII) or Confidential Business Information (CBI). The rule is not retrospective and only applies to future regulatory actions.

Additional rule provisions include:

• Requirements for independent peer review of pivotal science. Individual studies that have already undergone journal peer review are not required to undergo a second, EPA directed review, but the Agency can evaluate whether to initiate additional peer review.
• When proposing a significant regulatory action, EPA is required to clearly identify and make publicly available the science informing the rule.
• Under certain criteria outlined in the rule, the Administrator can grant case-by-case exemptions to the requirements of this rule.

On March 18, 2020, EPA published a supplemental notice of proposed rulemaking to the Strengthening Transparency in Regulatory Science Proposed Rulemaking originally published on April 30, 2018. ASDWA provided comments on the rulemaking and supplemental notice, available here.