On April 24, 2020, EPA’s Science Advisory Board (SAB) published its final report for the agency’s proposed rule, Strengthening Transparency in Regulatory Science. This proposal requires EPA to ensure that the data underlying the scientific studies it relies on is publicly available.
The SAB published a draft report on October 16, 2019 based on EPA’s original proposed rule. The draft report questioned multiple aspects of the scientific transparency rule. The report highlighted the lack of definitions for important terms and missing or ambiguous guidelines for which studies would be subject to the rule and how exemptions would be granted. The SAB offered multiple objections, stating that as structured the rule “is not consistent with sound scientific practice,” and could be “viewed as a license to politicize the scientific evaluation required under the statute based on administratively determined criteria for what is practicable.”
On March 18, 2020, EPA released a Supplemental Notice of Proposed Rulemaking, an in-depth analysis of which can be found here. EPA broadened the scope of the proposed regulation while also failing to respond to many of the SAB’s concerns outlined in the draft report.
In the final report, which takes into account the changes made in the supplemental proposal, the SAB continued to question how thoroughly EPA has considered the impacts of the proposed rule, stating that “key considerations” are missing from the proposal or “presented without analysis and explanation of scope.” The Board also found that key terms are still not defined, and the implementation issues the draft report raised haven’t been fixed. In an effort to address the “scientific and technical challenges and feasibility of implementing some requirements of the Proposed Rule,” the Board provided specific recommendations for the final rule, including “the development of additional policy and/or guidance documents.” The Board also continued to question the proposed rule’s general purpose and urged EPA to identify a scientifically-sound justification and implementation process for the rule.
The report’s specific recommendations remain similar to those in the draft report
In the final report, the SAB included recommendations for nine main areas of concern, all of which were present in a similar form in the draft report, suggesting that EPA needs to heed these expert recommendations for fixing serious scientific flaws in the proposal before issuing a final rule.
The original proposed rule required EPA to identify all studies relied upon for significant regulatory actions and make them publicly available. The supplemental proposal expanded the scope of the rule to include all studies EPA relies on in all “influential scientific information,” not just in significant regulatory action. “Influential scientific information” is defined as any scientific information the agency believes will have a “substantial impact on important public policies or private sector decisions.” The SAB’s final report repeated its concern over this foundational requirement of the rule. The final report states that it may be “complex and/or impractical” for the agency to identify and make available all relevant studies, as the agency may use some studies in its initial rulemaking process but not as part of the rule final justification.
The supplemental proposal also expanded the rule to include not just dose-response models and data, but all data and models the agency relies on for “pivotal regulatory science.” In both the 2019 draft and the final report, the SAB questioned the ambiguity of these terms and suggested the definitions be “expanded and supported” through a guidance document.
Similarly, the SAB maintained its prior suggestions that EPA work with data management experts to develop best practices for implementing the rule and “ consider establishing an office…on data sharing and a peer review panel or workgroup to assist EPA….” The SAB also encouraged EPA to fund a competition to encourage “subject matter experts” to conduct data reanalysis of studies the agency relies on and noted that EPA would need to create a mechanism for approving or disapproving requests for data access.
The Board also expanded on its previous recommendation that EPA develop specific criteria for how the EPA Administrator will grant exceptions to the rule. The Board stated that developing such criteria would “help ensure that the principles of transparency outlined in the Proposed Rule are accomplished.” And the board pointed out that the lack of such criteria “may create public concerns about inappropriate exclusion of scientifically important studies” and “could allow systematic bias to be introduced with no easy remedy.” Ultimately, the Board suggested that EPA take recommendations from an advisory committee over when exemptions should be granted.
Finally, the report recognized the supplemental proposal’s addition of definitions for “data” and “independent validation” that weren’t present in the initial proposed rule, but found that both definitions couldn’t be straightforwardly implemented. The final report suggests that “data” be replaced with “analysis dataset” to more clearly set the boundaries of what data must be provided. And, the final report more explicitly calls on EPA to address how the rule will be implemented without entirely excluding datasets that contain confidential and/or personal data, as is often the case with medical studies, including those that are essential to setting pollution standards.
The report continues to push for a final rule that reflects scientific norms and a legitimate purpose
In addition to the specific technical recommendations for the proposed rule, the final report continued to question the thoroughness of EPA’s justification for the rule and prodded the agency to strengthen the rule’s stated purpose in a manner consistent with scientific norms. The letter accompanying the report states:
The SAB recognizes the importance of this rule and its purpose, establishing transparency of the influential scientific information used for significant regulations and enhancing public access to scientific data and analytical methods to help ensure scientific integrity, consistency and robust analysis. Strengthening transparency by improving access to data can lead to an increase in the quantity and the quality of evidence that informs important regulatory science and policy decisions.
Yet in the report, the SAB found there to be “minimal justification provided in the Proposed Rule for why existing procedures and norms . . . are inadequate, and how the Proposed Rule will improve transparency and the scientific integrity of the regulatory outcomes in an effective and efficient manner.” The Board found that the rule may actually “decrease efficiency and reduce scientific integrity,” and that EPA hasn’t done the work necessary in its proposal to ensure these “serious and perverse outcomes” are avoided.
The Board goes on to suggest steps the agency can take to avoid this, including that the rule “should be explicitly prospective and follow evolving norms developed by the scientific community as well as federal agencies.” And, it should “state and/or compare its objectives with existing and evolving federal procedures to address the underlying purpose of the Proposed Rule, which is to increase transparency of scientific studies utilized in regulatory actions.”
Conclusion
The SAB’s final report contains no major shifts in substance from the draft report. The Board still believes that EPA is not sufficiently defining important terms in its rule or planning for the regulatory and procedural changes this rule would lead to. And, the Board re-emphasized its prior recommendation that EPA develop policy and guidance documents to flesh out the details of portions of the rule that are currently underdeveloped. Finally, the report shows how the SAB remains dissatisfied with EPA’s justification for the rule, and it pushes the agency to improve both the rule’s stated purpose and its technical elements or risk creating a rule that does significant harm to regulatory science.
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