EPA Science Transparency Policy Should Enable Stakeholder Access to Study Data

Now that EPA prudently has extended the comment period on its proposal for Strengthening Transparency in Regulatory Science”, with comments due August 16th and a public hearing scheduled for July 1th, perhaps the additional time will allow for more reasoned evaluation of the eminently worthwhile goal of increasing the transparency of the science upon which the agency relies.

While critics of the policy have some valid points concerning the potential exclusion of certain critical studies if the policy were adopted as proposed, the vehemence of the uproar is puzzling and seemingly misses the more crucial point. At core, the policy reflects a fundamental precept of administrative law: agencies should disclose to the public, and allow public scrutiny and comment upon, the information upon which they rely to regulate or take enforcement action. Unfortunately, in practice, it is not uncommon for EPA to rely on scientific studies for which public scrutiny of the underlying data is denied, thereby depriving stakeholders of a full opportunity to scrutinize and potentially challenge the conclusions reported by the study authors. Third-party review, such as by a journal or similar publication, is simply no substitute for the critical analysis of a stakeholder whose actions may be regulated or subjected to penalty as a result of the study findings.

In particular, complaints about the policy based on the fear of potential disclosure of the personal health information of study participants are overstated and misguided. Similar concerns have been used by the agency for years as an excuse to stymie the release of underlying study data requested through the Freedom of Information Act (FOIA). At best, valid privacy concerns should be addressable through creative or conscientious masking of study data. In fact, the proposed policy references several approaches to ensuring confidentiality that should be implemented to enable the release of such information. At worst, such complaints are a fig leaf to inhibit scrutiny of scientific conclusions that may not pass muster if exposed to critical challenge. It is all too easy to forget that research data often is open to multiple interpretations and reported conclusions can reflect researcher bias, including the perennial desire to justify the need for additional research funding.

Ultimately, privacy concerns cannot be used to invalidate the fundamental requirement that government disclose the information upon which it chooses to rely and to allow the regulated community (or the target of an enforcement action) the opportunity to examine and test that information.