05/01/2018 - EPA Mission Tracker

Changing What Science the EPA Will Consider – Part 2

by EELP Staff

The EPA intends to change which scientific studies it will consider in a thinly-veiled attempt to undermine settled conclusions about the health impacts of air pollution. This is Part 2 of 3. Click for Part 1 and Part 3.

On April 24, 2018, Administrator Pruitt followed through on his promise and signed a proposal to change how the EPA considers science. For more background how we got here, and why the stakes for public health are so high, see our previous post on this topic.

This proposal, which was originally open for public comment until May 30, 2018 (extended to Aug. 16, 2018), is an attempt to achieve goals that some Republican members of Congress have long been championing, but have failed to pass into law. Administrator Pruitt invokes “transparency” to support his proposal’s requirement on what data can be used in the science EPA considers, while barely explaining why he’s chosen the particular form of “transparency” he has or what benefit it would produce. What is clear, in contrast, is the intended effect: allowing the EPA to ignore two bedrock studies that definitively show that particle pollution, or soot, harms people’s health – and to delay or avoid consideration of other studies whose findings are inconvenient to his and his allies’ de-regulatory agenda.

While the proposal’s purpose is clear – limiting EPA’s consideration of scientific results that counsel more rigorous pollution control – its request for comments encompasses a list of issues so numerous and so elementary as to reveal just how little thought Pruitt and the EPA have given this beyond the evidently desired anti-scientific effect. Then, in addition, there are the issues Pruitt’s proposal does not even bother to address – chief among them its legality.

The proposal makes general reference to several statutes to explain why Pruitt thinks he has the legal authority, but it does not explain how any of those provisions empower the EPA to act in the way it’s proposing and it does not cite any specific language. In fact, in 2002, the D.C. Circuit dismissed challenges to the very same air pollution studies for the very same reasons, stating: “we agree with EPA that requiring agencies to obtain and publicize the data underlying all studies on which they rely ‘would be impractical and unnecessary.’” American Trucking Assn. v. EPA, 283 F.3d 355 (D.C. Cir. 2002). There, the court, citing the persuasiveness of the EPA’s argument, said:

“If EPA and other governmental agencies could not rely on published studies without conducting an independent analysis of the enormous volume of raw data underlying them, then much plainly relevant scientific information would become unavailable to EPA for use in setting standards to protect public health and the environment…. [S]uch data are often the property of scientific investigators and are often not readily available because of … proprietary interests … or because of [confidentiality] arrangements [with study participants].’”

With neither a fully articulated set of justifications for the action nor a practical explanation as to how the new policy would work, the document Pruitt signed barely musters the superficial trappings of a proposal; it has none of the substance needed to clear any legal threshold of seriousness.

That legal threshold is defined by the Administrative Procedures Act, by section 307 of the Clean Air Act (42 U.S.C. § 7607), and by decades of court decisions that require an agency to give the public notice of the who, what, when, where, why, and how of its plans when it wants to create or change a regulation. Only by doing that does the public have the information it needs to provide the agency with useful data, analysis, and feedback, which the agency, in turn, must genuinely consider and then address explicitly before issuing a regulation in final form. Prometheus Radio Project v. F.C.C., 652 F.3d 431, 449 (3d Cir. 2011); Horsehead Res. Dev. Co., Inc. v. Browner, 16 F.3d 1246, 1268 (D.C.Cir.1994); Home Box Office, Inc. v. FCC, 567 F.2d 9, 35–36 (D.C.Cir.1977).

The failure of Pruitt’s proposal to meet these requirements reflects its lack of validity on the merits. While it’s true the proposal reflects the longstanding practice that the EPA rely only on impeccably trustworthy science when formulating standards, performing benefit-cost analyses, and evaluating toxic substances, it fails to articulate either (i) that there is a problem with how the EPA has done its work over the past four decades or (ii) what are the requirements, methods, and practices Pruitt believes are necessary to achieve that goal beyond those long since in place at the agency. Instead, it simply asserts that making certain data available to the public in and of itself will increase the reliability of the science the agency incorporates in performing its various actions. Nowhere does it explain why or how the new data availability requirement would enhance the trustworthiness of the science the agency relies on.

In fact, as we described earlier, it is through the scientific peer-review process that the ostensible goals of the proposal can be, and are being, achieved. Since the EPA already relies almost exclusively on peer-reviewed science, it’s essential that the proposal explain exactly what its views are as to the adequacy of peer review and how, if the EPA believes current peer-review is inadequate, the proposal specifically addresses those inadequacies.

Even so, if Pruitt believes that scientific peer-review is inadequate, the remedy is not to impose entirely new data availability requirements. Rather, it is to instruct the EPA’s experts to engage directly with scientists, sharing their critique of current peer-review practices and suggestions for improvement. It is not EPA’s place to act unilaterally to fix Pruitt’s claimed deficiencies in peer review.

Pruitt’s proposal includes a “requests for comment” section that amounts to a stark confession that the EPA has not even begun to think through the proposal itself. The issues for which comment is sought are abundant and basic. The agency admits that it’s unsure of:

  • Its legal authority to impose the proposed rule
  • When or how it will develop procedures for protecting private information such as patient health records of the sort currently kept confidential by researchers
  • How the proposed rule will be applied to its regulatory actions and under what circumstances
  • Whether other regulations might be necessary to implement the proposal, or whether statutory changes would be needed
  • Whether and how the agency should establish exceptions, including whether to provide case-by-case exceptions
  • Whether the proposal should apply to a broader or narrower set of regulatory proceedings than it would as currently drafted, or whether certain categories should be exempt
  • Whether to add stronger data access requirements to the terms of research grants

For virtually none of these issues does the EPA itself propose a solution or approach. In failing to do that, the proposal again falls short of the legal threshold established by the Administrative Procedures Act and prevailing case law; the agency is not informing the public of what its actual proposal is and is therefore failing to provide sufficient information on which the public can offer comment.

Prior to Mr. Pruitt’s arrival at the agency, it would have been unimaginable that the EPA would issue a document styled as a proposal with so many glaring deficiencies. This throws into vivid relief the purpose the proposed rule is attempting to serve, a purpose which – as the document itself demonstrates – Mr. Pruitt simply cannot justify.

We know from Steven Milloy – who, once again, as an invited guest at the proposal’s announcement commented favorably on it and explained the precise anti-regulatory reason for his support – and others in Pruitt’s anti-science and anti-regulatory community, that the real goal of this action is to undermine two foundational air pollution studies, and, in so doing, the foundation of pollution regulation.

The two studies in question, one by Harvard University and one by the American Cancer Society, were released in the 1990s, and definitively showed a link between air pollution and premature death, heart disease, respiratory disease, and lung cancer. They underwent a rigorous peer-review process before they were published, they were completely reanalyzed by an independent scientific organization years later, and their results have been confirmed by repeated similar studies from across the globe.

Despite that, opponents of environmental regulation have sought access to the raw data collected by the studies’ researchers. It has never been clear whether they have done so in the expectation that they could find a way to use the data to generate their own “benign” conclusions, or whether they believe that the unmet demand for the data could itself be used to discredit the use of the studies.

Both tactics were employed by the tobacco industry in its long fight against regulation, a fight in which it also employed Steve Milloy’s services. Regardless, these studies followed tens of thousands of people over nearly two decades, and linked personal medical histories, occupational histories, and home locations to detailed air quality data to show that people exposed to higher levels of particulate matter are more likely to die prematurely. To collect the information, the researchers made confidentiality agreements with the study participants stating that their private information would not be made public.

Pruitt and his allies assert that they would never wish to jeopardize patient confidentiality – but their policy provides only two options: making private details publicly available or ignoring the results of the science. Under the latter outcome, the EPA would be forced to close its eyes to peer-reviewed results showing pollution harms to human health, thus weakening the imperative to take action to reduce pollution.

The proposal, meanwhile, offers next to nothing on the former possible outcome. Beyond simply stating that when making data publicly available, the EPA “shall do so in a fashion that is consistent with law, protects privacy, confidentiality, [and] confidential business information…” [§ 30.5], it is silent as how that will be accomplished.

The two particle and health studies targeted for exclusion may be only the most prominent in a succession of peer-reviewed, entirely reliable studies the proposal empowers the EPA to ignore. The proposal includes language that goes beyond the “transparency” requirement and that invites the agency to ignore peer-reviewed studies for other reasons, or at the very least would compel EPA itself to take on the burden of reanalysis of studies, even if the attendant cost and delay impeded the agency from considering peer-reviewed work that showed large public health impacts from pollution or exposure to toxic substances.

Finally, the proposal could threaten the process by which EPA approves chemicals and pesticides, since that depends on industry data that is treated as “confidential business information.” Subsequently, emails obtained through FOIA show that even Pruitt’s hand-picked chemical industry lobbyist-turned-regulator Nancy Beck said the policy could “jeopardize our entire pesticide registration/re-registration review process and likely all TSCA [Toxic Substances Review Act] risk evaluations.”

Similarly, the proposal fails to make any real effort at estimating how much it would cost, in spite of an estimate from the Congressional Budget Office that similar legislation would cost in the hundreds of millions of dollars.

If there had been any doubt that the result of this proposal – the exclusion of peer-reviewed science from EPA consideration and, thereby, the diminution of the prospect for more rigorous public health protections – was its sole purpose, the absence of any other sustainable justification removes it.

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