EPA Proposes Increased Transparency For Scientific Studies | Williams Mullen - JDSupra

"EPA has proposed a major change in how it uses and relies upon scientific data and analysis for its rulemakings.  The proposed rule would increase the transparency and availability of such data and analysis “pivotal to [EPA’s] significant regulatory actions,” so that third parties may independently validate the agency’s scientific support for such actions.  EPA states that this increased transparency will help EPA fulfill its core mission with better scientific analysis and increased public trust in its regulatory actions.  While EPA’s objectives seem laudable in several respects, the agency will need to balance transparency with legal protections that may apply to disclosure of the information. More specifically, the proposed rule targets “dose response data and models underlying pivotal regulatory science that are used to justify significant regulatory decisions regardless of the source of funding or identity of the party conducting the regulatory science.”  The net effect of these defined terms is that the proposed rule would apply to the data and modeling used in support of “significant regulatory actions” as defined by Executive Order 12866 (issued by President Clinton in 1993) to establish standards for allowable exposure to pollutants or contaminants.  These standards are in turn used to set or otherwise influence emission and discharge limits, chemical and waste management criteria, and cleanup risk standards.  Therefore, this standard-setting process affects pollution control requirements and costs for facility compliance and site remediation under many federal environmental statutes and regulatory programs.  The proposed rule would not apply to other agency actions, such as enforcement or permitting matters...."