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Statement of Need: When EPA develops influential scientific information and final significant regulatory actions using public resources, including regulations for which the public is likely to bear the cost of compliance, EPA should ensure that the data and models underlying scientific studies that are pivotal to the influential scientific information and the final significant regulatory actions are available for independent validation. This rulemaking is designed to increase transparency in the use of pivotal science underlying influential scientific information and final significant regulatory actions.

Summary of the Legal Basis: The Agency is taking this action under its housekeeping authority.

Alternatives: EPA considered prior EPA actions in response to government-wide data access and sharing policies, as well as the experience of other federal agencies. EPA also considered the concepts and lessons learned from its ongoing implementation of the 2016 Plan to Increase Access to Results of EPA-Funded Scientific Research and the policies or recommendations of third-party organizations who advocated for open science.

Anticipated Costs and Benefits: EPA believes the benefits of the rule will justify the costs. The benefits of EPA ensuring that data and models underlying pivotal science are available in a manner sufficient for independent validation are that it will improve the data and scientific quality of the Agency's assessments and actions and facilitate expanded data sharing and exploration of key data sets. The rulemaking directs EPA to implement it in a cost-effective way.

Risks: This rulemaking would apply to influential scientific information and final regulations issued under the environmental statutes EPA implements that are determined to be significant regulatory actions by the Office of Management and Budget pursuant to Executive Order 12866. Thus, while this rulemaking will not directly address risks, it will increase transparency in the use of science in influential scientific information and final significant regulatory actions that address risks.