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Science Advisor Programs

Strengthening Transparency in Regulatory Science

A Proposed Rule by the Environmental Protection Agency on 04/30/2018

This action provides that EPA will ensure that the regulatory science underlying its actions is publicly available in a manner sufficient for independent validation. Where available and appropriate, EPA will use peer-reviewed information, standardized test methods, consistent data evaluation procedures, and good laboratory practices to ensure transparent, understandable, and reproducible scientific assessments. This action is consistent with the principles underlying the Administrative Procedure Act and programmatic statutes that EPA administers to disclose to the public the bases for agency rules and to rationally execute and adequately explain agency actions. This action is also consistent with Executive Orders 13777 and 13783, and the focus on transparency in OMB’s Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility and Integrity of Information Disseminated by Federal Agencies (the Guidelines) and OMB Memorandum 13-13: Open Data Policy – Managing Information as an Asset. It builds upon prior EPA actions in response to government-wide data access and sharing policies, as well as the experience of other federal agencies in this space.

The comment period for the proposed rule was open from April 30, 2018 to August 16, 2018.  A public hearing for the proposed rule was held on July 17, 2018 in Washington, DC.   ​

EPA received more than 590,000 comments on the proposed rule.

To read written comments posted to the docket, please visit Regulations.gov: Docket ID No. EPA-HQ-OA-2018-0259

A Supplemental Notice of Proposed Rulemaking by the Environmental Protection Agency on 03/03/2020

On March 3, 2020, EPA announced a supplemental notice of proposed rulemaking to the Strengthening Transparency in Regulatory Science proposed rule. This notice is not a new rulemaking; rather, it provides clarifications on certain terms and aspects of the 2018 proposed rule. This supplemental notice:

  • proposes that the scope of the rulemaking applies to influential scientific information as well as significant regulatory decisions;
  • defines and clarifies that the proposed rule applies to data and models underlying both pivotal science and pivotal regulatory science;
  • proposes a modified approach to the availability provisions for data and models that would underly influential scientific information and significant regulatory decisions, as well as an alternate approach; and,
  • clarifies the ability of the Administrator to grant exemptions.

Additionally, EPA is taking comment on whether to use its housekeeping authority independently or in conjunction with appropriate environmental statutory provisions as authority for taking this action.

The supplemental to the proposed rulemaking was published in the Federal Register on March 18, 2020 and is available at https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-9322

EPA is issuing an extension of the public comment period on the supplemental notice of proposed rulemaking. The public comment period will now be open until May 18, 2020. EPA is providing a pre-publication version of the extension of the public comment period. While EPA has taken steps to ensure the accuracy of this copy of the extension notice, it is not the official version of this action. Please refer to the official version in a forthcoming Federal Register publication, which will appear on the Government Printing Office's website.

Related Documents

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