New rule could force EPA to ignore major human health studies

Research looking at everything from links between air pollution and disease to the impact a pesticide has on children’s brains could be banned from consideration by environmental regulators under a new policy proposed yesterday by the U.S. Environmental Protection Agency (EPA).

At an event at EPA headquarters in Washington, D.C., that was closed to the press, agency head Scott Pruitt touted the new policy as a way to increase transparency and enable the public to double-check research underpinning environmental regulations. The rule would require the agency to use only studies in which the underlying data are available for public scrutiny when formulating new “significant” regulations, which typically are regulations estimated to impose costs of $100 million or more.

Specifically, the proposed rule says that EPA is seeking transparency for “the dose response data and models that underlie what we are calling ‘pivotal regulatory science.’” The agency does not define pivotal regulatory science, but says it could include studies that “are critical to the calculation of a final regulatory standard or level, or to the quantified costs, benefits, risks, and other impacts on which a final regulation is based.”

“The era of secret science at EPA is coming to an end,” Pruitt said, speaking to an audience that included conservative lawmakers and advocates who have questioned the science underpinning climate and health regulations. “Americans deserve to assess the legitimacy of the science underpinning EPA decisions that may impact their lives.”

But a number of leading epidemiologists studying the effects of pollution say the new regulations could pose a problem for existing and new studies aimed at teasing out connections between pollution and large populations. “I think this rule is a thinly veiled attempt to undermine the science that’s available for the EPA to use in its decision-making,” says Peter Thorne, a toxicologist at The University of Iowa in Iowa City, and chairman of EPA’s science advisory board until late 2017, when his membership wasn’t renewed by Pruitt.

The new proposal would effectively block the use of key scientific studies and “help big polluters avoid regulations that protect human health,” warned the American Thoracic Society, a New York City–based medical association representing physicians and scientists involved in respiratory disease.

Other critics say EPA has failed to adequately calculate the costs of complying with its proposal, or clearly articulate its legal authority to issue the new rule, potentially opening the agency to a legal challenge.

Privacy concerns

The problem, critics say, is that human epidemiological studies often rely on gathering reams of sensitive information from thousands of individuals, such as their medical history and personal habits, along with exactly where they live and work. Those details are usually guarded by confidentiality agreements that bar researchers from sharing data that would allow an individual to be identified.

Existing studies could be bound by confidentiality agreements that make it impossible to give EPA the data it wants, Thorne says. And future researchers could have more trouble recruiting participants if they fear their information would be made public. “If those [confidentiality] documents say we will be required to release your private information to the U.S. government or to the public, [people] would be wise not to participate,” he says.

In its proposed rule, EPA says it wants to make data publicly available “in a manner that honors legal and ethical obligations to reduce the risks of unauthorized disclosure and reidentification” of anonymous study subjects. The agency says sensitive data could be shielded by a variety of measures, including storing them at special federal data centers and restricting who has access to them. And it suggests that the transparency requirement could, in certain circumstances, be waived if not practical to implement. It does not provide an estimate of the cost of complying with the rule.

In a press release the agency claimed the proposed provisions are consistent with data access requirements of major scientific journals include Nature , Science , and the Proceedings of the National Academy of Sciences . Science , along with many other journals, has recently adopted measures to encourage data sharing and increase transparency, Science Editor-in-Chief Jeremy Berg said in a prepared statement. Those measure can include requiring authors of published papers to deposit underlying data in a publicly available database. But he noted there are “exceptional circumstances, where data cannot be shared openly with all,” including cases where papers are based on data sets that include personal information. Journals will still publish those papers, but will tell researchers wishing to reanalyze or replicate the studies to negotiate directly with the authors to obtain the sensitive data.

In general, researchers who share their data usually first strip information such as name, date of birth, or place of residence that would enable people to trace it back to an individual, says Joel Kaufman, an epidemiologist at the University of Washington in Seattle who is studying air pollution and heart disease. He’s now preparing a “limited” data set for the roughly 7000 participants in his study, so that other researchers can work with it. “That’s the right thing to do,” Kaufman says. “But I fear that that’s not enough for what the proponents of this regulation are trying to do, which is to get data that we know we can’t provide.”

On the industry side, an American Chemistry Council (ACC) spokesperson says the Washington, D.C.–based trade group is looking at the new EPA rule, but has few detailed comments at this point. “Our industry is committed to working with EPA to help ensure the final rule increases transparency and public confidence in the agency’s regulations while protecting personal privacy, confidential business information, proprietary interest and intellectual property rights,” spokesperson Jon Corley said in a prepared statement. In the past, ACC has supported similar efforts to bar EPA from using nonpublic data in certain kinds of rulemakings, while noting that the agency often uses confidential or proprietary data provided by industry in doing its work.

For example, industries fund extensive research into the health effects of chemicals, often through private laboratories that rely on animal testing. In internal EPA emails released by the Union of Concerned Scientists in Cambridge, Massachusetts, the agency’s deputy administrator in the Office of Chemical Safety and Pollution Prevention, Nancy Beck, wrote that for a majority of industry studies, confidential business information “can be waived and the data can be made available.” (Beck was formerly a top official at the chemistry council.) But the EPA proposal also suggests such industry information could be exempted from the transparency rule.

Long history

The new EPA proposal is the latest in a long-running campaign to let the public and regulated industries sift through the raw data of epidemiologists whose work could affect pollution regulations.

In the 1990s, members of Congress pressed for legislation requiring scientists to disclose their raw scientific data, partly in response to a Harvard University study finding a correlation between more air pollution and lower life expectancy. Several times in recent years, the House of Representatives passed a bill requiring public disclosure of data from any new studies used by EPA to write regulations, but the proposal never made it out of Congress. The champion of that bill, Representative LamarSmith (R–TX), flanked Pruitt at Tuesday’s unveiling of the new proposal, smiling.

EPA will now accept public comments on the proposal for 30 days, then is expected to issue a final rule.

Environmental groups and others have already said they expect to challenge the rule in court. Potential lines of attack, attorneys say, include claims that EPA has not met the letter of federal law in evaluating the rule’s costs and benefits, or explained which federal law has provided it with the authority to issue the new requirements.

Correction, 4/26/2018, 12:00 p.m.: The lawmaker standing next to EPA Adminstrator Scott Pruitt was misidentified. It was Representative Lamar Smith (R-TX), not Senator Lamar Alexander (R-TN).