EPA has published a proposed regulation that is “intended to strengthen the transparency of EPA regulatory science.” Specifically, the proposed regulation limits science used in regulatory actions to data that are publicly available “in a manner sufficient for validation and analysis.” The Agency argues that the “proposal will help ensure that EPA is pursuing its mission of protecting public health and the environment in a manner that the public can trust and understand.” This proposed regulation is intended to apply prospectively to final regulations that are determined to be “significant regulatory actions” pursuant to E.O. 12866. Comments are due by May 30, 2018.
EPA argues that “enhancing the transparency and validity of the scientific information relied upon by EPA strengthens the integrity of EPA’s regulatory actions and its obligation to ensure the Agency is not arbitrary in its conclusions,” “will lead to better outcomes, and [will] strengthen public confidence in the health and environmental protections underpinning EPA’s regulatory actions.” The Agency explained in the Federal Register Notice that the “proposed rule 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.”
The proposed rule includes a provision allowing the Administrator to exempt significant regulatory decisions on a case-by-case basis if he or she determines that compliance is impracticable because it is not feasible to ensure that all dose response data and models underlying pivotal regulatory science are publicly available in a fashion that is consistent with law, protects privacy and confidentiality, and is sensitive to national and homeland security, or in instances where OMB’s Information Quality Bulletin for Peer Review provides for an exemption.
The proposal solicits comments on a number of issues including the following:
- The effects of this proposed rule on individual EPA programs, including whether certain activities are appropriate to be excepted.
- Should the proposal apply to other agency actions and promulgations in addition to “significant regulatory actions?”
- The definitions of “pivotal regulatory science,” and “dose response data and models” and how to implement such definitions.
- How to incorporate stronger data and model access requirements into the terms and conditions of cooperative agreements and grants.
- Methodologies and technologies designed to provide protected access to identifiable and sensitive data.
- How to balance appropriate protection for copyrighted or confidential business information with requirements for increased transparency of pivotal regulatory science.
- Whether the disclosure requirements applicable to dose response data and models in the proposed rule should be expanded to cover other types of data and information, such as for example economic and environmental impact data.