EPA’s scientific integrity in question over science rule

In the name of “transparency” in regulatory science, Environmental Protection Agency (EPA) Administrator Scott Pruitt very
un-transparently used my name and professional credentials to promote his ill-conceived proposal to significantly limit scientific studies the EPA considers in regulatory decision-making.

In April 2018, as the EPA proposed the Strengthening Transparency in Regulatory Science rule, I learned that the administrator had added my name and office to the rule, suggesting that I believed it was scientifically justified. I had not read the rule nor was I involved in its development. The so-called transparency rule wasn’t justified then as it isn’t now, as the EPA rushes to finalize last months of the Trump administration.

The proposed rule would require EPA to ensure that underlying data from pivotal scientific studies used in developing regulations are publicly available and can be independently validated. The rule covers all research, regardless of who funded it or when it was conducted. It gives the EPA administrator power to exempt research lacking accessible data, leading to the possibility that the agency’s political agenda — not scientific quality or relevance — could determine what pivotal research is used in rulemaking.

There is no need for the rule. No legislation requires it, and it conflicts with existing legislation calling for the EPA to use the best available science. There is no evidence that pivotal research used by the EPA in rulemaking has been hidden or that public access and re-analysis of underlying data improves rulemaking. Additionally, public access to government funded research data is a federal policy. I was the principal author of EPA’s 2016 published plan that requires data access to all EPA-funded research post-implementation and protects controlled unclassified information (CUI). 

Research involving human subjects is the most susceptible to being blocked. Yet, it is also the most informative. Human data include protected personal identifying information (PPI), such as people’s residential addresses. Even if epidemiological datasets were protected within a secure data enclave, PPI could not be independently validated. Thousands of epidemiologic studies funded by the federal government would potentially be disregarded by the EPA. A final rule
would allow politicians to ignore epidemiological studies that have been critical in setting protective air standards. Many of these studies rely on personal information that, if disclosed, would violate laws that protect study participants.

A final rule will cause chaos. How will each EPA program — air, water, toxic chemicals and others — apply this regulation? How will the sufficiency of public access be certified? Where will data be stored, managed and protected? What criteria would an administrator use to exempt research from the rule? How can this rule improve transparency when state regulators and the regulated community cannot predict what research will be used, or excluded from, rulemaking?

The proposed rule received 993,463 public comments. Commenters universally supported public access to data, but individuals, tribal and local governments, state regulators, academics, universities, some trade associations and nongovernmental organizations overwhelmingly rejected using data availability to exclude research from consideration in rulemaking. Critically, a final rule could seriously influence the next cycle of rulemaking on air pollution. People’s health could suffer if, for example, the administrator dismissed consideration of the pivotal study of the health impacts of air
pollution, because its data remain unavailable to the public, despite the fact the data have been reanalyzed and confirmed.

The EPA Scientific Integrity Policy calls for the EPA’s policymakers to involve science experts and states that “the scientific information and processes relied upon in policymaking manifest scientific integrity, quality, rigor and objectivity.” The placement of my name on the proposed rule without my involvement was disingenuous at best.

EPA scientists cannot do their jobs when blocked from considering high-quality relevant research. Any rule that diminishes or removes the consideration of pivotal research will be poorly developed. This rule is an assault on science; it does not increase transparency, compromises the validity of rulemaking, and endangers the health of the American people.

Thomas Sinks is the former director of the EPA Office of the Science Advisor and the Human Subjects Research Review Official. He is currently an adjunct professor at the Emory University Rollins School of Public Health and the University of Maryland School of Public Health.