2080-AA14 201910 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 2080 Office of Research and Development ORD 2000 Environmental Protection Agency EPA Strengthening Transparency in Regulatory Science

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.

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage No No Other 40 CFR 30 15 U.S.C. 2609 33 U.S.C. 1254 33 U.S.C. 1361 42 U.S.C. 11048 42 U.S.C. 300j-1 42 U.S.C. 300j-9(a)(1) 42 U.S.C. 6912(a)(1) 42 U.S.C. 6979 42 U.S.C. 7403 42 U.S.C. 7601(a) 42 U.S.C. 9616 42 U.S.C. 9660 5 U.S.C. 301 7 U.S.C. 136r(a) 7 U.S.C. 136w Yes

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.

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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.

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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.

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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.

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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.

]]> NPRM 04/30/2018 83 FR 18768 NPRM Comment Period Extended 05/25/2018 83 FR 24255 Supplemental NPRM 01/00/2020 No No None No No No No Maria Doa 2080 202 566-0718 doa.maria@epa.gov Washington DC 20460 Ted Berner 2080 202 564-7712 berner.ted@epa.gov Mail Code 8201R, 1200 Pennsylvania Ave NW, Washington DC 20460