Scientific Leaders Speak Out on EPA’s Proposed ‘Transparency’ Rule

Scientific journal editors comment on the need for evidence in policymaking and their publications’ data sharing policies. | Monkey Business/Adobe Stock

Editors of leading peer-reviewed scientific journals published a joint response on Monday to a proposed rule announced April 24 by the Environmental Protection Agency. The rule, if enacted, would limit the scientific research available to the agency’s policymakers drafting regulations governing everything from air quality to clean water and land contamination.

The joint response follows a statement that the American Association for the Advancement of Science issued April 20 raising concerns about the proposed rule’s potential impact on scientific advances.

“This proposal appears to be an attempt to remove valid and relevant scientific evidence from the rule-making process,” said Rush Holt, CEO of AAAS and the executive publisher of the Science family of journals, in the statement issued in anticipation of the EPA announcement.

The rule would block EPA from using any scientific research that is based on underlying scientific data not publicly available or made available in a manner that does not allow its findings and methods to be reproduced. The standard could exclude multiple, reputable scientific studies founded on epidemiological data that include information from study subjects promised confidentiality or private-sector generated research built on underlying data considered proprietary.

In a news release announcing the proposed rule, EPA said that it was “consistent with the data access requirements” of three named science journals – Science, Nature and the Proceedings of the National Academy of Sciences – as well as the recommendations of two policy organizations – an assertion that editors of the scientific journals, joined by others, presented as incomplete.

“Data sharing is a feature that contributes to the robustness of published scientific results,” and many peer-reviewed scientific journals have recently adopted data sharing policies that follow Transparency and Openness Promotion standards, wrote the editors in their statement.

“It does not strengthen policies based on scientific evidence to limit the scientific evidence that can inform them; rather, it is paramount that the full suite of relevant science vetted through peer review, which includes ever more rigorous features, inform the landscape of decision making,” the editors further noted. “Excluding relevant studies simply because they do not meet rigid transparency standards will adversely affect decision-making processes.”

The journal editors who signed the statement published in Science were Jeremy Berg, editor-in-chief of the Science family of journals; Phillip Campbell, editor-in-chief of Nature; Veronique Kiermer, executive editor of the Public Library of Science (PLOS) Journals; Natasha Raikhel, acting editor-in-chief of the Proceedings of the National Academy of Sciences; and Deborah Sweet, vice president of editorial of Cell Press and acting editor of Cell.

Unlike the EPA’s proposal, the TOP standards – first published in Science the in 2015 – recognize the realities of scientific research across disciplines and the need to permit “different levels of stringency” related to data access, the editors wrote. They said not in “every case can all data be fully shared. Exceptional circumstances, where data cannot be shared openly with all, include data sets featuring personal identifiers.”

Still, the editors noted that scientific reviewers can obtain “confidential access to key data” that is otherwise unable to be disclosed.

“We support maintaining the rigor of research published in our journals and increasing transparency regarding the evidence on which conclusions are based,” the editors wrote. “As part of these goals, we require that all data used in the analysis must be available to any researcher for purposes of reproducing or extending the analysis.”

Additionally, the editors noted that the scientific process itself provides trained scientists with fundamental skills to rigorously judge the merits of research from multiple vantage points, including how well studies are designed, how clearly data are collected, how carefully analyses are described and how thoroughly findings of related studies are cited. Such requirements mean “the merits” of studies necessarily lacking publicly available data “can still be judged,” wrote the journal editors.

In the separate statement that AAAS issued after EPA Administrator Scott Pruitt sent the proposed rule to the White House’s Office of Information and Regulatory Affairs on April 19, Holt said of the rule “If put into practice, EPA could prohibit, or make it incredibly costly, for the agency to use a wide swath of high-quality scientific research.” The proposed rule, published in the Federal Register on April 30, is now subject to a 30-day comment period.

The Congressional Budget Office had previously estimated the cost for EPA to redact personally identifiable information – which would be required to use relevant scientific studies if the proposed rule were enacted – would be $250 million annually.

In his recent remarks, Holt also questioned the necessity of the proposed rule, noting that the federal government already has “existing federal guidelines that require access to the scientific information used for federal policies and regulations.”

The proposed regulation draws closely from the Honest and Open New EPA Science Treatment Act, or “HONEST Act,” legislation long championed by Rep. Lamar Smith, chairman of the House Science, Space and Technology Committee.

The House of Representatives passed Smith’s bill last year, as it has twice before, but the measure has never advanced to the full Senate.

Last February, Holt strongly defended the integrity of the scientific process in testimony before the House science committee on the earlier version of the HONEST Act, known as the Secret Science Reform Act. He said political efforts to interfere with the way science is practiced would make the United States less attractive to the world’s brightest minds and stifle the nation’s scientific progress.

“I am here to say: don’t try to reform the scientific process,” said Holt. “It has served us well and will continue to serve us well.”

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