FYI: Science Policy News

Science Committee Renews Scrutiny of EPA Science Transparency Rule

NOV 20, 2019
Members of the House Science Committee pressed EPA for details last week on how its proposed science transparency rule will affect regulations already in place after a New York Times report suggested the rule could apply retroactively.
Will Thomas
Spencer R. Weart Director of Research in History, Policy, and Culture

EPA sign

Image credit – Government Accountability Office

As the Environmental Protection Agency presses ahead with a proposed rule that would limit its ability to use studies with nonpublic data in crafting new regulations, congressional Democrats continue to condemn the effort as a disguised attempt to impede environmental rulemaking.

EPA first proposed the rule in spring 2018, stating it would increase the transparency and integrity of the agency’s regulatory process. However, EPA decided earlier this year to modify its original proposal after receiving almost 600,000 public comments on it, of which the agency indicates 9,200 were unique. Last week, controversy over the rule flared up again when the New York Times reported on a leaked draft of EPA’s modifications. EPA quickly condemned the Times’ characterization of the document, including its claim that the revised rule would apply to regulations already in place.

The next day, the House Science Committee held a previously scheduled hearing on the rule, at which the acting head of EPA’s Office of Research and Development, Jennifer Orme-Zavaleta, fielded questions about the agency’s intentions. She declined to comment in detail about the document leaked to the Times, stating it was an earlier version of a document EPA is preparing to release for public comment in early 2020. Following her testimony, a panel of expert witnesses argued against discounting studies with nonpublic data and suggested alternative ways to increase the soundness of the regulatory process.

Democrats remain skeptical as EPA reacts to public pushback

Opening the hearing, Science Committee Chair Eddie Bernice Johnson (D-TX) observed the committee has been debating proposals similar to EPA’s rule since 2014, when the then-Republican majority first introduced legislation it originally called the Secret Science Reform Act .

“I’ve said it many times in this very hearing room: the requirement for data to be publicly available is nothing more than an attempt to undercut EPA’s mandate to use the best available science,” Johnson remarked. “I believe this is part of an effort to destroy regulations that protect public health but are opposed by some regulated industries.”

Johnson argued that the past legislation and EPA’s current proposal had all been “met with the same passionate, negative response from the scientific community,” and submitted for the record a letter signed by 62 public health groups expressing concerns about the rule.

Committee Ranking Member Frank Lucas (R-OK), who cosponsored the committee’s legislative proposals, said he believes EPA’s rule is “well intended” and that he is pleased the agency is continuing to work on it. Given that its revisions have not yet been made public, he suggested the hearing was premature.

In her remarks, Orme-Zavaleta, a longtime career scientist at EPA, reviewed the progress of the rule, noting that commenters on it had generally favored the goal of enhancing transparency while raising “many complex topics” that she said the agency is addressing with its revisions. She also noted EPA has solicited feedback from its Science Advisory Board on how to handle confidential information when implementing the rule, and that the agency is expecting to soon receive comments on the entire rule that the board chose to offer on its own initiative .

Orme-Zavaleta also highlighted some of EPA’s objections to the New York Times story, saying the proposed rule “does not apply to already-established rules and regulations,” though it does apply to “dose response data and models that inform significant rules made in the future, including data and models that were previously developed.” She said EPA still expects to finalize the rule next year.

Probing the rule’s limitation to prospective regulations, Reps. Jim Baird (R-IN), Sean Casten (D-IL), and Bill Foster (D-IL) all drew evasive responses from Orme-Zavaleta as they sought to establish whether it could be applied to existing regulations when they come due for a statutorily required renewal.

Asked by Baird whether the rule could have any bearing on determinations that a “previous rule and decision was maybe in error,” Orme-Zavaleta reiterated it would not “undo existing rules or regulations,” while noting that renewals present opportunities where “new information can be considered.”

Pointing to such periodic renewals, Casten argued that “it’s fundamentally disingenuous to assert, as the EPA has, that the rule will not be applied retroactively to existing regulations.”

Pressed further by Foster on whether the renewal process would allow EPA to use the rule to reject studies it had previously used to justify a regulation, Orme-Zavaleta replied, “So, that’s also part of the kinds of comments that we received, and that’s currently what’s being discussed and debated. So, we’ll have to see how all of this weighs as we work towards finalizing that rule.”

Witnesses argue data availability should not disqualify studies

In justifying the need for its proposed rule, EPA has pointed to the widespread difficulties researchers in some fields have experienced when trying to reproduce others’ conclusions.

Many of the comments EPA received highlighted ambiguities in the agency’s assertion it would privilege studies that were possible to “replicate.” The leaked draft revisions suggest the agency plans to clarify its definitions to focus on the ability to “reanalyze” the study’s original data rather than, for example, repeat the entire study.

The panel of expert witnesses at the Science Committee hearing did not engage with the particulars of the leaked draft, but argued against the general idea that a lack of data availability should disqualify studies from consideration.

One of the witnesses was David Allison, dean of the Indiana University School of Public Health and a member of the National Academies study committee that completed a study on reproducibility and replicability in science this past spring. That report stressed that attempting to validate individual studies is generally a less useful way of gaining confidence in scientific knowledge than gathering “cumulative evidence” across studies.

Speaking generally, Allison told the committee, “a rule which made transparency and reproducibility jointly necessary or jointly sufficient for the admissibility of a study could result in the exclusion of high-quality studies that, for legitimate reasons, cannot be made fully transparent and reproducible.”

He said that while EPA’s proposed rule provides some leeway for making exceptions, the agency has been unclear in how it will adjudicate the admissibility of studies. He added that this raises the prospect such decisions are open to “bias,” which he said would lead to “diminished public trust.” As an alternative to the rule, he suggested EPA publish a “statement of principles on the valuing and weighting of evidence,” which he said is the approach taken by the Food and Drug Administration.

Similarly, Brian Nosek, executive director of the Center for Open Science and a vocal advocate for research transparency, lauded the movement toward open science practices, but argued, “There will always be occasions in which the best available evidence is not fully transparent or has unknown reproducibility, and there are many potential solutions for assuring credibility of findings when underlying data cannot be fully transparent.” He remarked,

The goal should not be ‘transparency or bust.’ The goal should be explicitly representing the uncertainty of evidence to help you, as policymakers, make better decisions.

The other three witnesses on the panel criticized the rule in stronger terms, arguing for instance that it could risk exposing confidential patient information. Mary Rice, a physician representing the American Thoracic Society, suggested the rule could have a chilling effect on individuals’ willingness to participate in epidemiological studies.

“It’s naive to argue that de-identification will fully protect the privacy of study participants in today’s era of big data,” she remarked, adding, “Imagine the long-term consequences of leaking private health and address information as a result of this proposal. Would you be willing to enroll yourself or your child in a study about toxins in the water, air, or food if you knew EPA would take your data and share it with the world?”

Asked by Rep. Suzanne Bonamici (D-OR) whether they would support EPA’s rule as originally written, none of the expert witnesses indicated that they would.

Allison Gasparini contributed to this bulletin.

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