The U.S. Environmental Protection Agency on Jan. 5 released a final regulation that requires the public disclosure of certain medical data used to support its rules, a move that critics said could undermine public health protections.
In an op-ed published by The Wall Street Journal late Jan. 4, outgoing EPA Administrator Andrew Wheeler sought to push back on widespread criticism the rulemaking effort has received within the scientific community. Wheeler also defended the regulation in remarks during a live-streamed event hosted the following morning by the Competitive Enterprise Institute, a free-market-oriented libertarian think tank.
"The American public deserves to know which studies we are using to craft our regulations and which of those studies are key or pivotal for our decisions," Wheeler said during the event. "And to the extent possible, that data should be available for the public to see."
The rule was swiftly condemned by leading scientific advocacy groups such as the Union Of Concerned Scientists. The regulation "has no merits from the standpoint of science or transparency, and it will make it vastly harder for the agency to do its job of protecting public health and the environment," Dr. Andrew Rosenberg, director of the group's Center for Science and Democracy, said in a statement.
The final regulation marks the culmination of a rulemaking process initiated by Wheeler's predecessor, former EPA chief Scott Pruitt, that initially resembled a bill the U.S. House of Representatives passed in 2017 that failed to become law.
After meeting with the House bill's lead sponsor, retired Rep. Lamar Smith, R-Texas, Pruitt unveiled a proposal in April 2018 requiring the science used to develop EPA regulations, including dose-response data or models used in a scientific study, to be publicly available for independent verification. Dose-response data is used to measure the health risks associated with exposure to potentially harmful agents or pollutants, a task central to the EPA's mission of protecting human health and the environment.
The proposal drew harsh criticism from public health and environmental groups as well as the EPA's own science advisors over fears that it could limit the EPA's access to the best available science because many public health studies rely on confidential patient information. Some public health studies based on confidential data, such as Harvard University's landmark Six Cities study linking premature deaths to airborne soot pollution, are difficult or impossible to reproduce for practical and ethical reasons, experts noted.
The EPA eventually issued a supplemental proposal in March 2020 clarifying that the agency could still use studies with restricted data and models if that information is available through what is known as tiered access, which involves techniques designed to mitigate disclosure privacy risks. However, the supplemental proposal also sparked concerns over language stating the regulation would apply to "all data, models, and studies … regardless of when the data and models were generated."
Fate of final rule still unclear
The final rule released Jan. 5, dubbed the Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions rule, is limited to dose-response data when the EPA uses such data in "significant regulatory actions and influential scientific information." While the regulation applies to future rulemakings, it also covers "all dose-response data underlying studies used as pivotal science, regardless of when the study or the data is created."
Notably, the final rule requires the EPA to give "greater consideration" to science with underlying dose-response data that is either publicly available or available through tiered access.
During the Jan. 5 virtual event, Wheeler pushed back on the notion that the final rule will automatically disqualify datasets such as Harvard's Six Cities study.
"There is no study that will automatically be cut out from review by the agency going forward," Wheeler said. "Our goal in this is to make as many of these pivotal studies that we use for a regulatory decision, make that information available to the public."
But Chris Zarba, former director of the EPA's Science Advisory Board, maintained that significant EPA actions already go through a rigorous, public peer-review process.
"If left unchallenged, this rule would essentially bar the agency from using the most relevant medical studies when creating rules about air pollution, toxic chemicals, water contaminants, and more and could force the agency to revoke decades of clean air protections," Zarba said in a statement.
The Biden administration has been critical of the Trump administration's deregulatory environmental agenda but has yet to outline how it plans to deal with the science transparency rule.
Wheeler claimed during the Jan. 5 event that the final rule is not subject to the Congressional Review Act, a seldom-used law that allows the House and Senate to disapprove agency rules with simple majorities when they are finalized within 60 days of a Congress ending.
"This is an internal housekeeping regulation ... and so the Congressional Review Act is not applicable," Wheeler said. At the same time, Wheeler noted that the rule could open the EPA to lawsuits brought by outside parties if the agency fails to follow it.
Legal experts have expressed skepticism about the so-called housekeeping authority cited as the legal basis for the rule as well as "good cause" provisions in multiple recent EPA rules, including the science transparency rule, making them effective immediately upon publication in the Federal Register.