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

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WASHINGTON (January 5, 2021) — Today, the 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.

House Committee on Oversight and Reform Ranking Member James Comer (KY-01): “I applaud President Trump and Administrator Wheeler for ensuring the EPA’s decision-making process is based on sound and transparent science. The EPA’s regulatory actions are often costly for American families and hamper small businesses with excessive red tape. Agencies like the EPA must use public and credible data when issuing any substantial regulatory decisions so Americans can decide if the regulation is justified. Clearly identifying scientific studies and making those conclusions publicly available will ensure any future regulatory action by the EPA comes with much needed transparency.”

House Committee on Science, Space, and Technology Ranking Member Frank Lucas (OK-03): “The EPA’s mission is to protect human health and the environment, and this work must be informed by transparent and robust scientific research. Transparency is essential to the scientific process and the foundation of public trust in policy decisions. This final rule allows for underlying data to be securely validated and evaluated by subject matter experts. I urge people to read the final rule as published. Administrator Wheeler and the EPA did extensive work developing this over the past two years, taking into consideration thousands of public comments. The final product takes the first steps towards greater trust and accountability in EPA’s decision making that impacts all Americans.” 

House Committee on Energy and Commerce Ranking Member Cathy McMorris Rodgers (WA-05): “You can't expect people to believe in science if data is kept secret. It's impossible. Transparency, public access to underlying data, rigorous review are all key to building trust. That's why we've worked to end secret science at the EPA. Thank you to EPA Administrator Andrew Wheeler for his leadership on this important rule.”


This rule was proposed on April 30, 2018. On March 3, 2020, EPA announced a supplemental notice of proposed rulemaking  that provided clarifications on certain terms and aspects of the 2018 proposed rule. This final rule addresses comments EPA received on the proposed rule and SNPRM.

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