April 18, 2020 Liz Borkowski, MPH 1Comment

I’ve written before about EPA’s awful rule that claims to be promoting transparency but would primarily have the effect of preventing the agency from considering the best available science when regulating. In March, as the nation raced to slow transmission of the novel coronavirus, the agency released a supplement to their earlier proposal that made the rule even worse. The supplement expands the scope of the rule and states that EPA will restrict its consideration of studies not only when regulating, but when generating any kind of influential scientific information.

On the pretext of increasing transparency, the rule would allow EPA to give less weight to studies that don’t make their data available for re-analysis. The tobacco industry and others that harm public health have long pushed for such a policy, which would create new barriers for EPA’s consideration of studies that enroll human participants and promise them confidentiality. EPA could essentially ignore studies that show pollution harms health by claiming that it’s doing so because the studies haven’t made their data available — even if the real reason is that they care more about limiting regulation than about public health.

Given that the supplement dramatically expands the scope of the rule, EPA should be treating this as a major rule that merits a comment period of at least 90 days and multiple public hearings to receive input. Because we’re in the midst of a pandemic that’s occupying the energies of public health experts, the agency should extend the comment period further — e.g., for 90 days after the end of the declared public health emergency. EPA has done neither of these things.

The agency did extend the comment period from 30 days to 60, but it made no move to create a public forum for real-time input or modify the timeline in recognition of the COVID-19 pandemic. To make up for one of these shortcomings, the Union of Concerned Scientists held a virtual public hearing allowing any member of the public to weigh in on the supplement. (UCS took a similar action when EPA disbanded an expert panel that informs regulation of fine particulate matter.) The hearing took place on April 14, 2020 and was streamed on the group’s YouTube channel.

“We expect EPA to do its job and seek feedback on its proposals. But when the agency fails, as it has here, we will step in,” said UCS president Ken Kimmell when he opened the meeting. He noted that UCS had invited EPA to send staff to the virtual meeting so they could hear and ask questions of the commenters, but they did not accept the opportunity.

Dozens of experts weighed in on the supplement and explained problems both with EPA’s process and with the contents and likely outcomes of the rule. I was able to attend the first hour of both the morning and afternoon sessions, and noted some of the key points:

  • James Goodwin of the Center for Progressive Reform eviscerated EPA’s claim that it can adopt this sweeping rule under the housekeeping standard. The rule would fundamentally alter how the public can participate in EPA rulemaking, and that, Goodwin noted, is a far cry from the modest and noncontroversial standards Congress intended.
  • Paul Billings of the American Lung Association warned that under the EPA rule, studies that link air pollution with premature death would be excluded or downgraded — but that’s in keeping with the goal of the tobacco industry, which pushed this kind of approach when it sought to prevent regulation of secondhand smoke.
  • Andrew Rosenberg of the Union of Concerned Scientists explained that this is a deconstruction of EPA’s mandate, not a minor housekeeping change. He said it “clarifies that scientific evidence is less important than mollifying regulated industry and scoring political points.”
  • Christopher Frey, who previously served on EPA’s Science Advisory Board, described the rule as a solution in search of a problem that will create problems far worse than the one it claims to be solving.
  • Jennifer McPartland of the Environmental Defense Fund warned that EPA’s supplemental proposals for addressing concerns about making data public still threaten the agency’s use of the best available science. EPA doesn’t explain how these would be implemented or discuss associated costs or impacts, she noted.
  • Representative Paul Tonko said it was shameful behavior from EPA to rush this rule with a shortened comment period and no public hearings. He warned that the rule would be used to undermine landmark achievements in public health and environmental safety.
  • John Bachmann of the Environmental Protection Network looked at 40 studies that are key to clean air regulation, and found that at least 25 would be downgraded under EPA’s supplemental proposal.
  • Molly Rauch of Clean Air Moms emphasized that a global pandemic is no time to engage in a stealth operation aimed at the scientific underpinnings of our nation’s health regulations.
  • Vijay Limaye of the Natural Resources Defense Council pointed out that EPA’s current approach has delivered profound public health benefits over the past 50 years. “Any attempts to unsettle the agency’s proven process and cast doubt on overwhelming and thoroughly validated health evidence is simply not justified,” he said.
  • William Reilly, who served as EPA administrator in the George HW Bush administration, kicked off the afternoon session by emphasizing that EPA requires the confidence of the public and integrity of science, “and both have been put into question by the current proposed regulation.”
  • Nsedu Witherspoon of the Children’s Environmental Health Network pointed out that there are accepted metrics for evaluating the merits of a study; these include strengths of the study and design of methods, but not the availability of data. EPA’s cumbersome and costly rule is unnecessary, she said.
  • Surili Sutaria Patel of the American Public Health Association warned that EPA’s rule would stack the deck against low-income communities and communities of color that, due to social forces, face an elevated risk of health problems related to pollution.
  • Laura Kate Bender of the American Lung Association highlighted the lack of transparency in EPA’s process for a rule that claims to be about transparency. This included backdating the Office of Management and Budget clearance, failing to consult its Scientific Advisory Board, and allowing an inadequate amount of time for public comment on this significant revision.
  • Liz Hitchcock of Safer Chemicals, Healthy Families explained that the so-called problem the rule seeks to solve is largely imaginary, because EPA already has an extensive process for evaluating studies and disclosing information.
  • Gretchen Goldman of the Union of Concerned Scientists stated that the rule “stands to fundamentally alter how EPA can use science to protect public health and the environment,” and emphasized that the supplemental notice worsens its impact.
  • For the Jacobs Institute of Women’s Health, I commented that “The proposed changes are inadequate to address concerns about consideration of studies that involve confidential data.” The changes described in the supplement “fall far short of a system that would be practicable while engendering confidence among both researchers and potential study participants.”
  • Liz Mueller of the American Lung Association stressed that the science EPA uses is already transparent, and publishing a study is already a years-long process that involves intense scrutiny. “The EPA is trying to fix a problem that does not exist,” she said.

You can hear (and, in most cases, see) all the participant comments in videos from the morning, afternoon, and evening sessions. The rule is open for public comment until May 17, 2020, and UCS has prepared a comment guide. As commenters in the public hearing made clear, this rule is deeply misguided and has profound implications for public health. Will EPA listen?

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