Transparency rule throws wrench into EPA’s world-class science considerations

The science that informs EPA’s actions is likely among the most scrutinized in the world. Even the hint of weak science risks legal action. The EPA has therefore developed rigorous processes and controls to ensure the science on which it relies for decision-making is as robust as possible. It’s baffling therefore to see the EPA persisting with a 2018 proposed rule that weakens EPA’s scientific process and undermines its mission to protect the environment and the health of the U.S. population. 

In March the EPA issued a supplemental notice to its 2018 proposed rule, Strengthening Transparency in Regulatory Science. The proposed rule and its supplement have their merits, namely the encouragement to make more research data publicly available, including EPA’s own data and that of EPA-funded research. The rule however does not actually require more data sharing and, in fact, duplicates intense federal data-sharing efforts that have been ongoing for more than a decade, including the Open Data title of last year’s Evidence Act and the EPA’s own blueprint, Plan to Increase Access to Results of EPA-Funded Scientific Research.

The crux of the proposed rule is to set arbitrary limits for what science EPA can consider and guidance for how it does so. The rule states, “the Agency will, other things equal, give greater consideration to studies where the underlying data and models are publicly available in a manner sufficient for independent validation.” 

Such action weakens the science informing EPA actions in three ways. 

First, there is no scientific justification for such a prioritization of studies. The EPA’s afore-mentioned document even acknowledges this saying, “Whether research data are fully available to the public or available to researchers through other means does not affect the validity of the scientific conclusions from peer-reviewed research publications.” Indeed, common sense tells us there is no reason to believe that research for which underlying material is publicly available is stronger. 

Second, there is strong reason to believe more insightful science would be discounted under the EPA’s rule. For example, the majority of health-related studies requires the consent of individuals who make their information, including personally identifiable information, available under the condition their privacy is protected. The EPA’s proposed rule would give less weight to such studies because such data are not publicly available. Yet, it is those very studies that help us best understand the effects of pollutants in our air, water and environment on us. 

Third, the “greater consideration” requirement sets back the EPA’s effective and advanced system of scientific checks and considerations that have evolved and improved over the decades. The requirement also blocks the EPA from taking advantage of advances in determining the best science. To determine the most solid science informing EPA’s work, the agency’s scientific staff employ the approach of the greater scientific community, a multifaceted process that emphasizes the body of evidence over individual studies, the application and combination of different research methods, replication of the findings across independent researchers and intense scrutiny and prodding over time. This process is also dynamic, constantly incorporating the most recent methods and frameworks found to be effective in evaluating science. EPA science assessment is further strengthened by consultation with EPA scientific advisory committees, which also serve to keep it in check. The proposed rule amounts to moving EPA scientific assessment from a dynamic multifaceted process to a robotic, narrower one.

Like science in general, EPA’s science assessment process is not perfect. It’s for this very reason that EPA’s science assessment should not be arbitrarily scripted in rule. 

Making data and models available for scrutiny is a worthwhile goal, but arbitrarily linking it with EPA’s approach to synthesizing evidence will lead to EPA basing decisions on a skewed version of the science. Weaker science informing EPA is troubling because it risks unnecessary regulations impeding our economy or the undermining of regulations protecting our health and environment. Just as concerning, weaker science could mean more legal challenges to EPA’s work, with similar risks. 

The EPA should drop its proposed rule, thereby allowing the best science possible to inform its work. Instead, it could focus on its efforts to make its data more publicly available and more transparent. 

Roger D. Peng is a professor of Biostatistics at the Johns Hopkins Bloomberg School of Public Health where his research focuses on the development of statistical methods for addressing environmental health problems. Follow him on Twitter at @rdpeng. Steve Pierson is director of science policy for the American Statistical Association (ASA). Follow him on Twitter at @asa_scipol. Pierson helped coordinate the ASA’s comments on the EPA Transparency Rule Supplemental, which expands on the points above and can be found here.