The U.S. Environmental Protection Agency's Science Advisory Board is expressing concern over several science transparency proposals that critics worry would exclude key health studies from consideration.
The first proposal, "Strengthening Transparency in Regulatory Science," was issued in April 2018 by former EPA Administrator Scott Pruitt. It would require "pivotal" science used in EPA rulemakings to be publicly available in a manner "sufficient for independent validation."
The seven-page proposed rule was met with a barrage of criticism from public health and environmental groups who cited numerous inconsistencies and a lack of definitions in the regulatory text. But the proposed rule also won praise from industry trade associations welcoming its stated goal of making more data underpinning the EPA's key regulatory actions publicly available.
In response to public comments, the EPA in March released a supplemental proposal that both clarified and broadened the scope of the August 2018 proposed rule in a way that could impact existing regulations.
Specifically, the supplemental proposal clarified that the proposed disclosure policy would apply to all data, models, and studies, regardless of when they were generated. The editors of six leading peer-reviewed scientific journals have worried that such a provision could undermine existing EPA regulations, such as the National Ambient Air Quality Standards, by causing the agency to discount or exclude studies that rely on confidential medical information.
After voting to review the original proposed rule last summer, the board, or SAB, on April 24 provided comments and advice on both proposals to EPA Administrator Andrew Wheeler. In an April 28 news release, the EPA's press office highlighted an excerpt of the comments expressing general support for a movement toward greater transparency within the scientific community.
"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," the SAB said. "The scientific community is moving toward adopting the precept of sharing accurate data and information to increase credibility, high-quality outcomes and public confidence in science. The SAB supports the adoption of this precept."
However, the EPA press office did not mention that the board also identified multiple perceived flaws in the proposed rule and supplemental proposal. Among them was the alleged need to further clarify terms such as "data" and "models."
The SAB also expressed concerns about a provision of the supplemental proposal that would allow the EPA administrator to grant exceptions for studies on a case-by-case basis. Granting such exceptions without a clear set of criteria "may create public concerns about the inappropriate exclusion of scientifically important studies," the SAB said.
In addition, the board said a final rule should address feasibility and implementation challenges associated with obtaining access to datasets while maintaining the privacy of study participants.
"If this issue is not clearly addressed, there is a risk of entirely excluding datasets containing personally identifiable information from being considered as pivotal regulatory science," the SAB said.
The EPA's press office said the agency will take the SAB's comments into consideration as it develops its final rule. In response to the COVID-19 pandemic, the agency has extended to May 18 the deadline for public comments on the supplemental proposal.