EPA finalizes scientific transparency rule limiting which studies can be used to protect public health

While EPA Administrator Andrew Wheeler signed the final rule last week, he announced it Tuesday at a virtual session hosted by the Competitive Enterprise Institute, a think tank that advocates fewer federal regulations and disputes the idea that climate change poses a major threat to the United States.

“The American public deserves to know which studies we are using to craft our regulations,” Wheeler said. “We want to make all this information available to the public and shine some light on it.”

Many of the nation’s leading researchers and academic organizations, however, argue that the criteria will actually restrict the EPA from using some of the most consequential research on human subjects because it often includes confidential medical records and other proprietary data that cannot be released because of privacy concerns.

“The people pushing it are claiming it’s in the interest of science, but the entire independent science world says it’s not,” said Chris Zarba, a former director of the EPA’s Science Advisory Board who retired in 2018 after nearly four decades at the agency. “It sounds good on the surface. But this is a bold attempt to get science out of the way so special interests can do what they want.”

The new standards affect not just “significant regulatory actions,” according to the new rule, but also “influential scientific information” that the EPA shares with the public, on its websites and elsewhere.

The rule reflects the Trump administration’s dogged push to lock in as many policies as possible before President-elect Joe Biden takes office on Jan. 20. Although the new administration will probably seek to overturn it, such an effort will take months, if not longer. The EPA administrator is allowed to waive the requirement on a case-by-case basis, but it is possible that outside groups could challenge those waivers in court.

Forcing researchers to disclose their raw data has for years been a top priority for conservative Republicans — including some now working in the EPA’s upper ranks. The new rule was modeled on a bill championed by former House Science Committee chairman Lamar Smith (R-Tex.). One of the panel’s former staffers, Richard Yamada, helped write an early version of the regulation while serving at the EPA.

Conservatives have been particularly critical of two studies that have spurred increased regulation: a 1993 Harvard University “Six Cities” project that linked air pollution to premature deaths and a Columbia University analysis of a widely used pesticide, chlorpyrifos, that suggested the chemical causes neurological damage in babies.

According to a document obtained under the Freedom of Information Act, Trump officials discussed how to block such research in a Jan. 25, 2018, briefing on the proposed rule. Referring to Harvard’s Six Cities study and another pollution study conducted by the American Cancer Society, the notes read, “The scientific community has identified major shortcomings in the methodologies and findings of these studies, all of which could be addressed if EPA provided the underlying data for independent review.”

In the wake of protests from public health experts and congressional Democrats, the EPA revised the proposal so that it would not apply retroactively to past assessments of studies like the ones cited in the 2018 meeting.

But Environmental Defense Fund General Counsel Vickie Patton, whose group obtained the document, said in an email that it “reveals the Trump EPA is focused on attacking the peer-reviewed health science that has saved tens of thousands of lives each year from deadly air pollution and protected America’s children from pesticides.”

Andrew Rosenberg, who directs the Union of Concerned Scientists’ Center for Science and Democracy and regularly reviews scientific studies before they are published in academic journals, said that the agency’s emphasis on the need for raw data is misplaced.

“As a well-experienced peer reviewer, I very rarely scrutinize raw data,” he said. “Rather, I look at data collection and analysis methods, summary and other statistics and graphics and results and conclusions to determine the validity of a study and the strength of its scientific evidence.”

The EPA has not published estimates on how much it will cost to implement the rule and what effect it will have on public health.

Because researchers are particularly reluctant to release individual medical records used in human studies, Rosenberg said, the rule disproportionately affects “epidemiological studies, which is ironic in the midst of a pandemic. Because these data can’t be made public, EPA will ignore epidemiological evidence of population-level effects of contaminants, pollution and other environmental threats.”

Wheeler said critics of the rule had distorted both its intent and its impact. He said that a “pivotal study” like the Harvard one, which has influenced key federal pollution standards that have saved thousands of lives and been economically beneficial, might still be able to inform future policies if the next administrator determines it is justified and publishes the reasoning behind that decision.

“There is no study that will automatically be cut out from review by the agency,” he said. “What this new rule would undoubtedly do is provide transparency needed to allow the public the opportunity needed to check our work.”

The American Chemistry Council, the primary trade association for U.S. chemical companies, was among the supporters who welcomed the new rule.

“It will strengthen EPA’s regulatory process by helping ensure that it is relying on the best available science — science that is reliable and unbiased — and by making the underlying research and data publicly available in ways that protect personal privacy, confidential business information, proprietary interests and intellectual property rights,” ACC spokesman Jon Corley said in a statement.

Thomas Sinks, who previously led the Office of the Science Advisor at the EPA and oversaw its rules on research involving human subjects, is among numerous scientists who note that the EPA already has a robust scientific integrity policy and a long-standing peer-review process for any data upon which it relies.

“It is based on a conspiracy theory, which is that EPA practices secret science,” Sinks, who wrote a forceful rebuke of the new rule before his retirement in September, said of the effort. “But there’s no evidence EPA practices secret science. I’m unaware of an example where EPA hasn’t clearly stated what science it is using in its rulemaking.”

Sinks said he also worries that Tuesday’s final rule deepens the broader attack on science by the Trump administration, and that it could have a lasting impact that goes beyond any single regulation.

“I’m mostly concerned about the fact this rule and other actions like this rule are diminishing the efforts and the importance of science and scientists within the federal government,” he said. “That is a dangerous precedent.”

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