EPA Finalizes Rule Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information

U.S. Environmental Protection Agency (EPA) announced the finalization of a rule to strengthen the transparency of its significant regulatory actions and influential scientific information. The transparency provisions in this rule build upon data sharing efforts in the federal government, EPA, and the scientific community and provide incremental progress toward the Agency’s goal of greater transparency.

This 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. This rulemaking does not require the release of Personally Identifiable Information (PII) or Confidential Business Information (CBI) nor does it require EPA to collect, store, or publicly disseminate any PII/CBI data underlying pivotal science.

“I fundamentally believe that the American public has a right to know about EPA’s regulations and their scientific underpinnings,” said EPA Administrator Andrew Wheeler. “No one should be afraid of being transparent, especially if individual privacy is protected. Increased transparency has strengthened the Agency’s credibility with the public in the past, and I intend for this rule to do the same as we move forward.”

This is a rule of EPA internal procedure and does not direct the actions of any third parties. More specifically, the rule:

• States that EPA shall give greater consideration to studies determined to be pivotal science where the underlying dose-response data are available in a manner sufficient for independent validation.
• Applies to only future significant regulatory actions and influential scientific information. This rule has no retrospective effect on existing regulations or influential scientific information.
• Applies to all dose-response data underlying studies used as pivotal science, regardless of when the study or the data was created.
• Does not require the release of PII and CBI.
• The rule also establishes requirements for the independent peer review of pivotal science. If the individual studies identified as pivotal science have already undergone journal peer review, EPA is not required to conduct a second review but can evaluate whether or not to initiate additional peer review, consistent with the OMB Bulletin for Peer Review.
• In addition, when proposing a significant regulatory action, the Agency 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.

EPA is issuing this rule under its authority to promulgate housekeeping regulations governing its internal affairs.