EPA's SCIENTIFIC TRANSPARENCY RULE
August 6, 2018
By: M. Shane Harvey
Can’t We All Agree That Some Part of This is Good?
In April 2918, the U.S. Environmental Protection Agency (EPA) unveiled its proposed rule on "Strengthening Transparency in Regulatory Science." As proposed, the rule would limit EPA’s ability to write regulations based upon data that is not made available to the public.
Hearings on the proposed rule were held on July 27, 2018. Feelings were decidedly mixed.
Several groups representing scientists argue that the rule will stifle science by requiring scientists to divulge information (such as medical information) that is confidential, which they cannot do. Several business groups, including the U.S. Chamber of Commerce, support the rule, arguing that it will provide transparency and reproducibility while including provisions designed to protect confidential information.
The issues of transparency and reproducibility have long been valid concerns of the regulated community. As we have documented in prior articles, while much of the science used to write regulations is “peer reviewed,” the peer review process is far from perfect. Peer reviewers do not replicate the author’s work and often do not even have access to the underlying data. As a result, published science is often simply wrong.
Take, for example, the case of Dr. Michael Hendryx, who we have written about before. Dr. Hendryx has written numerous articles suggesting that there are correlations between coal mining and health impacts. Many environmental groups have advocated additional regulation (or an outright halt) of mining based on his conclusions. But there have been serious questions raised about the accuracy of his work. And, in response to those questions, Dr. Hendryx has sought to shield his underlying data from review. One can understand the frustrations of mining companies facing potential regulation as a result of his work when the data have not been shared or examined.
For what it’s worth, FactCheck.org concluded that both sides to the debate over the rule have overstated their case:
Who’s right? We find fault with both characterizations of the proposed rule.
Studies that use confidential health information might still be considered by the EPA under the new rule — but not because private data can simply be redacted. Sometimes it can’t, including in the case of a 1993 Harvard study used to craft air pollution standards — a study cited by critics to support their argument.
Still, the rule includes a provision that would allow the EPA administrator to exempt regulations if releasing study data publicly conflicts with protecting privacy. The rule also allows for alternatives to full-on public release in cases where the data include confidential information.
Perhaps more protections could be put in place to make sure that confidential medical or proprietary information is not revealed as a result of the rule. But can we not agree that there is some merit to a rule that requires greater transparency in the regulatory process? Or that, when possible, businesses have access to data that will form the basis of regulations impacting them? The peer review process has is merits, but it is not a replacement for transparency or reproducibility.