The regulation, first proposed by former EPA Administrator Scott Pruitt in April 2018, would bar the use of scientific studies in crafting regulations unless the underlying data “are publicly available in a manner sufficient for independent validation.” The proposal received more than 600,000 comments during a public comment period last year, most of them critical of the proposal or opposing it, including from AIBS and other scientific and public health groups. In response to the comments, the agency has drafted a “supplemental proposal” intending to clarify “certain aspects” of the proposed rule.
The “supplemental proposal” would widen the scope of the original proposal by requiring scientists to disclose all raw data before the agency could consider the study’s findings in formulating regulations. According to EPA officials, the disclosure of raw data would allow research findings to be verified independently. In the previous version of the rule, the transparency requirement was applicable only to dose-response studies in which the reactions of animal or human subjects to increasing levels of pollutants or other chemicals are measured. The revised version, however, would require raw data disclosure for other types of studies as well. “Transparency of EPA’s science should not be limited to dose-response data and dose-response models, because other types of data and models will also drive the requirements and/or quantitative analysis of EPA final significant regulatory decisions,” the proposed rule states. In addition, an internal email obtained by the Times suggests that the proposed rule could be applied retroactively to regulations already in place.
The supplemental proposal received swift criticisms from scientific and public health groups.