NEW EPA RULE WILL LIMIT USE OF HEALTH STUDIES
Researchers must disclose raw data involved in analyses
The Environmental Protection Agency has finalized a rule to limit what research it can use to craft public health protections, a move opponents say is aimed at impeding the agency’s ability to more aggressively regulate the nation’s air and water.
The “Strengthening Transparency in Regulatory Science” rule, which the administration began pursuing early in President Donald Trump’s term, would require researchers to disclose the raw data involved in their public health studies before the agency could rely upon their conclusions. It will apply this new set of standards to “dose-response studies,” which evaluate how much a person’s exposure to a substance increases the risk of harm.
In an opinion piece posted Monday night in The Wall Street Journal, EPA Administrator Andrew Wheeler said the rule “will prioritize transparency and increase opportunities for the public to access the ‘dose-response’ data that underlie significant regulations and inf luential scientific information.”
“Dose-response data explain the relationship between the amount of a chemical or a pollutant and its effect on human health and the environment — and are at the foundation of EPA’s regulations,” he continued. “If the American people are to be regulated by interpretation of these scientific studies, they deserve to scrutinize the data as part of the scientific process and American selfgovernment.”
Many of the nation’s leading researchers and academic organizations say the criteria will 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 “inf luential scientific information” that the EPA shares with the public.
Details of the rule, which Wheeler has already signed but has yet to make public, were first reported by The New York Times on Monday evening.
Wheeler plans to announce the final rule at a virtual session hosted today by the Competitive Enterprise Institute, a think tank that advocates for fewer federal regulations and disputes the idea that climate change poses a major threat to the United States.
Although the new Biden administration probably will seek to overturn the rule, 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 outside groups could challenge these 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-Texas. One of the panel’s former staffers, Richard Yamada, helped write an early version of the regulation while working at the EPA.
Conservatives have been particularly critical of two studies that have spurred increased regulation: a 1993 Harvard University project that linked air pollution to premature deaths and a Columbia University analysis of a widely used pesticide, chlorpyrifos, that suggested that 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 it would not apply retroactively to past assessments of studies such as the ones cited in the 2018 meeting.