This week, Chair of the ATS Environmental Health Policy Committee Mary Rice, MD, testified before the House Committee on Science, Space, and Technology in opposition to the EPA’s proposed rule titled, “Strengthening Transparency in Regulatory Science.” The proposed rule requires the EPA to make publicly available the underlying data from pivotal studies used to establish major regulatory policies. Studies that cannot meet this requirement due to concerns with revealing patient confidential information, would be excluded from EPA consideration.
ATS strongly favors transparency in research, but Dr. Rice discussed how the proposed rule would likely decrease transparency and restrict the use of scientific studies in the EPA rulemaking process. Dr. Rice argued that the rule, “excludes studies whose underlying data cannot be shared in a public database, for example, due to study participant privacy concerns, effectively blocking the use of many research studies from EPA rulemaking.” Blocking the use of such studies from informing the EPA rulemaking process are detrimental to future policies that affect public health.
In her testimony, Dr. Rice expressed concern that the proposed rule grants the EPA Administration unchecked authority to exempt studies from the proposed policy — essentially allowing the EPA Administration to include or exclude from EPA consideration whatever studies they choose with no accountability to the public.
Joining Dr. Rice in testifying at the hearing were former NIEHS Director Linda Birnbaum PhD; David Allison, PhD, dean of the School of Public Health at Indiana University and member of the National Academies of Sciences; Brian Nosek, PhD, executive director of the Center for Open Science; and Todd Sherer, PhD, of the Michael J. Fox Parkinson’s Foundation. All the witnesses expressed their concerns and opposition to EPA’s proposed transparency rule.
The proposed rule is still under review by the EPA. This week, a revised version of the rule was leaked by The New York Times. The leaked version of the proposed rule makes many changes to the original proposal, including expanding the rule to include all policy making decisions before EPA (the previous version appeared to be limited “dose-response data” and “dose-response models”), clarifying the proposed rule addresses prospective EPA policies only (though research studies accepted by EPA in previous regulatory actions would still be subjected to these requirements if EPA sought to use those studies as a basis for future policy making) and defines key terms like “data,” “re-analyze,” and “independent validation.” The EPA has sent the revised version of the proposed rule to the White House for final review and consideration. A revised version of the rule is expected to be available in early 2020 for public review and comment.
