July 27, 2018 Liz Borkowski, MPH 0Comment

Last week, EPA held a hearing about its proposed rule to restrict the research it can use in regulating, and scores of public health advocates attended to speak out against it. I was one of four from the George Washington University Milken Institute School of Public Health (GWSPH) who delivered public comments; words from my three colleagues are below, and my comments are here. I’ve written before about this rule, and those who want more background should check out this Scientific American piece by Union of Concerned Scientists executive director Kathleen Rest and American Public Health Association executive director Georges Benjamin.

Just before the hearing, Project TENDR (Targeting Environmental Neuro-Developmental Risks) released a letter signed by 40 environmental health professionals and organizations that describes examples of EPA actions that have reduced toxic chemical exposures but could be rolled back under the rule. It concludes (see the letter PDF for references):

As scientists and health professionals we recognize the importance of data sharing and replicability in scientific practice and discourse. We would welcome an open dialogue to improve science-based decisions across the federal government, including at EPA. However, as The Economist pointed out in an editorial last month, this proposed rule is about stifling science used by EPA, not improving it. The editors of Science, Nature, the PLOS journals and the Proceedings of the National Academies of Science have issued a joint statement of opposition of the Proposed Rule. The EPA Chartered Science Advisory Board (SAB) identified many of the problems we’ve detailed in this letter, and recommended that it merits review by the SAB. We share many of these concerns, and therefore strongly oppose the proposal.

Also, 69 public health, medical, academic, and scientific groups released a statement of concern about the rule, warning, “These efforts are misguided and will not improve the quality of science used by EPA nor allow the agency to fulfill its mandate of protecting human health and the environment.”

A handful of public commenters — including from the American Petroleum Institute and Heartland Institute, which have a history of pushing the idea that “uncertainty” about climate change science means we shouldn’t regulate to slow it — spoke in favor of the rule, but the vast majority opposed it. Three members of Congress spoke forcefully against the proposal: Representative Paul Tonko (D-NY), Representative Suzanne Bonamici (D-Oregon), and Representative Daniel Lipinski (D-IL). One of the points Representative Lipinski made was that Congress had already declined to pass legislation that would have applied these problematic standards across agencies, and that this EPA rule represents the Trump administration’s attempt to circumvent Congress by implementing a policy that couldn’t pass legislatively.

All of the commmenters who opposed the rule described harmful impacts it would have on public health. In addition to this fundamental problem that everyone addressed, I noticed a few themes.

 

The process for creating this rule has been shoddy and neglected key constituencies
Molly Rauch of Moms Clean Air Force described the rule as a flimsy proposal that was designed without the input of the scientific community and rushed through the regulatory process. Laura Kate Bender of the American Lung Association called it haphazard, rushed, and anything but transparent. John Bachmann, who worked at EPA for 33 years and is now with the Environmental Protection Network, pointed out, “The rushed and mostly secret process EPA followed in developing this proposal displays a complete disinterest in transparency in public policy, much less in science.” Sean Moulton of Project on Government Oversight predicted that EPA will be hard-pressed to prove that the rule isn’t arbitrary and capricious — the magic phrase in lawsuits that claim agency activities violated the Administrative Procedures Act.

Several commenters noted that EPA didn’t consult with its own scientific advisory board in developing the rule, or seek input from the National Academies of Sciences, Engineering, and Medicine. Ami Zota of GWSPH pointed out that the scientific sources EPA cites for this rule do not support what EPA proposes. Several commenters mentioned this editorial by editors of leading scientific journals, who explain that they support data-sharing but also recognize that it’s not always feasible and isn’t necessary for peer review. And Jennifer Sass of Natural Resources Defense Council pointed out that the Bipartisan Policy Center took issue with the rule’s attempt to position itself as consistent with recommendations from a BPC report.

What commenters found really disturbing, though, was the lack of consultation with the many communities who would likely suffer adverse impacts under the rule. Alexis Andiman of Earthjustice pointed out that communities of color and low-income communities would be harmed by the rule, and are the ones most in need of strong science-based protections. Several commenters pointed out that having only a single hearing and not allowing for remote participation made it impossible to have important voices in the room. EPA would no doubt respond that everyone is welcome to file a written comment, but I’m betting that hearing comments get more attention than those swimming amongst the more than 200,000 written ones already submitted — and reporters are certainly more likely to quote those who spoke at the hearing.

Pamela Miller of Alaska Community Action on Toxics said she traveled two days from her field research site, where she and her colleagues are examining effects of endocrine disruptors in Alaska Native communities, because EPA didn’t allow for remote hearing participation. Nurse Erica Bardwell swapped a shift to attend hearing, but pointed out that many of those who’ll be harmed by the rule couldn’t make it. Minnesota Department of Health Assistant Commissioner Paul Allwood and Minnesota Pollution Control Agency Commissioner John Linc Stine traveled 1,100 miles to tell EPA about studies on PFOA and air pollution that are important to Minnesotans’ health, but would likely be deemed off-limits for regulating under the EPA rule.

 

This is more about advancing industry’s aims than transparency
Jennifer McPartland of Environmental Defense Fund offered this succinct critique: “EPA’s censored science proposal serves the interests of polluters, not the public.” Peter Lurie of Center for Science in the Public Interest called it the “wolf of pro-industry bias hiding in the sheep’s clothing of transparency in science.” Molly Rauch of Moms Clean Air Force warned, “this proposal is a cynical ploy to bolster polluting industries that don’t like the results of longitudinal research.”

Although a wide range of industries would theoretically benefit from regulatory rollbacks under this rule, many commenters credited the proposal’s genesis to one industry in particular: Big Tobacco. David Michaels — previously the longest-serving head of OSHA, now back at GWSPH — described the tobacco industry’s recognition that the growing body of research linking smoking to health problems would lead to regulation, and that they could slow it down by demanding the studies’ raw data. “Big Tobacco turned transparency, an important scientific principle, into a weapon,” he said. “Since then, polluters and manufacturers of deadly products have followed Big Tobacco’s playbook, first supporting legislation, and when that was unsuccessful, this proposed rule.” George Thurston of the International Society for Environmental Epidemiology noted that they’re still using this tactic; RJ Reynolds recently used a Georgia open records law to attack a study on tobacco advertising whose findings it disliked. Shortly before the hearing, Augusta Wilson of Climate Science Legal Defense Fund published an op-ed in The Hill describing where this all began: “In a memo written for R.J. Reynolds in 1996, lawyer Chris Horner explained that the goal of this so-called “secret science” strategy is to create “explicit procedural hurdles” that will hinder EPA and other agencies’ review of unfavorable scientific studies.”

For this strategy to work, Big Tobacco, polluting industries, and agencies that seek to assist them have to convince the public that it’s solving a problem. Commenters at the hearing weren’t buying it; several described the EPA proposal as a “solution in search of a problem” and pointed out that EPA’s current process already allows for extensive evaluation and input. Liz Hitchcock of Safer Chemicals, Healthy Families explained that EPA science assessments already involve exhaustive and critical review of relevant studies and are subject to public comment and peer review — so the supposed problem “is largely fiction.” Andrew Rosenberg of the Union of Concerned Scientists said, “As a frequent peer reviewer I do not review the raw data for studies, since that would tell me little. I review the research questions, the methods, the summarized data, the results and conclusions in order to assess the quality of the work.”

 

Under this rule, research participation would suffer even more
In addition to highlighting important studies that this rule would place off-limits for regulatory purposes, several commenters warned about impacts on future studies. Augusta Wilson of Climate Science Legal Defense explained:

In order to conduct such studies, scientists need participants willing to allow researchers access to their confidential health information. If enacted as currently proposed, this rule would make it much more difficult for scientists to credibly promise study subjects that their patient information will remain confidential.

This could have a deeply concerning chilling effect on the conduct of important human health studies. Privacy concerns could influence what science gets done and what does not. Lines of scientific inquiry that would have been pursued may not be. The quality of data may be poorer than it otherwise would have been.

Several commenters spoke about specific communities that should be involved in studies, but would be justifiably wary of participating if they knew a federal agency was pushing for raw data to publicly available. Brittany Meyer of the Michael J. Fox Foundation for Parkinson’s Research explained that studies of Parkinson’s patients can’t be adequately de-identified. Jeannie Economos of the Farmworker Association of Florida explained that the only way to do epidemiological studies of farmworkers is to gain their trust, and revealing their health data would compromise that. Virginia Ruiz of Farmworker Justice told EPA that there’s already a dearth of evidence on occupational and environmental health risks farm workers face, and this rule would deter farmworkers from research participation and make it even harder to get that evidence. Abigail Omojola of Breast Cancer Prevention Partners pointed out that damage to study recruitment will have a particularly negative impact for communities with historical reasons to distrust researchers.

 

Can we rely on EPA?
Several speakers shared personal stories about the importance of environmental regulations in their lives. Most memorably, Gretchen Goldman of the Union of Concerned Scientists attended the hearing with her infant, and noted on Twitter that she was currently on maternity leave but thought this hearing was worth showing up for. “How can EPA protect my family and others if they can’t use the best available science?” she asked.

If EPA proceeds with this rule, families and communities will see regulations weakened and pollution increased. The consequences will be far-reaching. Lynn Goldman, who served as EPA’s Assistant Administrator for Toxic Substances (1993-1998) before becoming dean of GW’s Milken Institute School of Public Health warned, “What is at stake is no less than the credibility of the agency with the American public and public confidence in the integrity of EPA’s science and decisions.”

For more about individual hearing speakers and their remarks, check out this Twitter moment. To comment on the rule (the deadline is August 16), go here.

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