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This action is intended to strengthen the transparency of EPA regulatory science. As a result of this action, EPA would ensure that the regulatory science underlying its actions is publicly available in a manner sufficient for independent validation. This action would increase transparency of the assumptions underlying dose-response data and models that support these EPA regulatory decisions. The Agency proposes to take this action under the authority of the Federal housekeeping statute, 5 U.S.C. section 301, and of the statutes it administers, including provisions providing general authority to promulgate regulations necessary to carry out the Agency's functions.

Statement of Need:

When EPA develops significant regulations 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 regulatory action are available to the public. This rulemaking is designed to increase transparency in the preparation, identification, and use of science in rulemaking.

Summary of the Legal Basis:

The Agency proposed to take this action under the authority of the Federal housekeeping statute, 5 U.S.C. section 301, and of the statutes it administers, including provisions providing general authority to promulgate regulations necessary to carry out the Agency's functions.

Alternatives:

EPA considered prior EPA actions in response to governmentwide 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 regulatory science are publicly available in a manner sufficient for independent validation are that it will improve the data and scientific quality of the Agency's 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 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 preparation, identification, and use of science in significant regulatory actions that address risks.