The Environmental Protection Agency has published a notice of proposed rule making in the Federal Register on data transparency in the studies used to inform its regulations and has asked for public comments. Faculty members in the Departments of Engineering and Public Policy and Civil and Environmental Engineering at Carnegie Mellon University have filed a comment that urges the EPA to correct deficiencies in its proposal. They explain that the mandate may undercut regulations based on past studies that used private medical data.

The EPA argues that data transparency—use of public data in studies—allows it to rationally explain its actions. It claims that the use of public data will allow for greater independent verification and accords with policies ensuring public participation in lawmaking. This claim undergirds how the policy evaluates “pivotal regulatory science,” a phrase describing studies, models, and analyses that underpin regulatory decisions and cost-benefit calculations.

While the faculty endorse use of public data, they take issue with the policy’s wording. They argue that this policy could be applied retroactively to studies that have long informed EPA regulations, such as those of the Clean Air Act, as they rely on private medical data. This new policy would render those well-vetted, peer-reviewed studies unusable. The faculty argue that factoring-in the privacy status of data sets would allow the EPA to ignore available and impactful studies.

Transparency is important, but the underlying mission of the Agency is to protect public health and the environment using the best available scientific evidence.

EPP/CEE Faculty Statement, Carnegie Mellon University

“Transparency is important,” the faculty attest in the comment, “but the underlying mission of the Agency is to protect public health and the environment using the best available scientific evidence.” 

The faculty recommend that the EPA apply their mandate only to new data and studies using standard methods for anonymizing data. The faculty reference how the FDA sets research standards that limit how secondary studies affect regulatory decisions, and they advise the EPA to consider a similar approach to setting standards.

Scott Pruitt, administrator of the EPA, declared that the policy would end “the era of secret science at EPA.” However, an article in the May 4 issue of the journal Science notes that the policy aligns with Republican objectives to loosen clean air regulations. Moreover, the studies based on private data that prompted the policy’s creation have been independently verified. Regardless, researchers have found workarounds to EPA’s policy. For example, Francesca Dominici’s team at Harvard’s T. H. Chan School of Public Health has used public data to create detailed findings on air pollution.

The CMU faculty maintain that protection of patient privacy and “a poorly conceived transparency requirement could preclude the use of any epidemiological data to support agency decision making.” The result would undermine the EPA’s mandate to set pollution standards that reflect and usefully implement the latest scientific knowledge.