EPA’s Proposed Rule Strengthening Transparency in Regulatory Science

May 18, 2018

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Introduction

In this proposal, EPA aims to strengthen the transparency of the science it considers “pivotal” to its significant regulatory actions by ensuring that “the data and models underlying the science is publicly available in a manner sufficient for validation and analysis.” It cites existing authorities and policies, but acknowledges, “EPA has not previously implemented these policies and guidance in a robust and consistent manner.”

The rule would not directly regulate non-governmental entities, but instead would require “EPA to ensure that the regulatory science underlying its actions is publicly available in a manner sufficient for independent validation.” The preamble says the policy is “designed to provide a mechanism to increase access to dose response data and models underlying pivotal regulatory science in a manner consistent with statutory requirements for protection of privacy and confidentiality of research participants, protection of proprietary data and confidential business information, and other compelling interests.” In the long run, through this rule, EPA aims “to change agency culture and practices regarding data access so that the scientific justification for regulatory actions is truly available for validation and analysis.”

The proposal defines “dose response data and models” as those “used to characterize the quantitative relationship between the amount of dose or exposure to a pollutant, contaminant, or substance and the magnitude of a predicted health or environmental impact.” “Pivotal regulatory science” refers to “specific scientific studies or analyses that drive the requirements and/or quantitative analysis of EPA final significant regulatory decisions.” “Regulatory decisions” are limited to “significant regulatory actions” as defined in Executive Order 12866. “Regulatory science means scientific information, including assessments, models, criteria documents, and regulatory impact analyses, that provide the basis for EPA final significant regulatory decisions,” and research data is used as “defined in Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.”