05/01/2018 - EPA Mission Tracker

Legal Shortcomings in EPA’s So-Called “Secret Science” Proposed Rule

EPA intends to limit which scientific studies it will consider in an attempt to undermine settled conclusions about the health impacts of air pollution. This is Part 2 of 4. Click for Part 1, Part 3, and Part 4.

On April 24, 2018, Administrator Pruitt signed a proposed rule, Strengthening Transparency in Regulatory Science, that would change how EPA considers science. This proposal, which was open for public comment until May 30, 2018 (extended to Aug. 16, 2018), attempts to achieve goals that some Republican members of Congress have long been championing but have failed to pass into law. It would require EPA to only consider studies in its rulemaking process if the underlying data can be made publicly available. As a result, EPA would ignore essential studies linking negative health outcomes to increased pollution exposure in its rulemaking process. This would weaken the agency’s imperative to strengthen public health protections.

Administrator Pruitt invokes “transparency” to support this proposal. Yet the proposed rule does not adequately explain the legal or policy justifications for this form of “transparency,” nor does it explain the benefit it would produce. Instead, EPA makes general reference to several statutes to assert its legal authority, but it does not explain how any of those provisions empower the agency 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 targeted by this proposal for the very same reasons EPA is now advancing to ignore those studies. The court stated: “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). The court continued:

“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].’”

Legal Concerns

The proposed rule lacks the substance needed to clear the legal threshold for regulatory changes because it lacks a fully articulated set of justifications as well as a practical explanation as to how the new policy would work.

That legal threshold for changes to clean air standards is defined through a combination of the Administrative Procedures Act (APA), Section 307 of the Clean Air Act (42 U.S.C. § 7607), and decades of court decisions that require an agency to give the public notice of the “who, what, when, where, why, and how” of its plan to create or change a regulation. This clear process provides the public and interest groups with the information needed to provide the agency with useful data, analysis, and feedback, which the agency must then genuinely consider and explicitly address before issuing a final rule. 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 the proposal reflects the longstanding practice that EPA rely only on impeccably trustworthy science, it fails to articulate either (i) that there is a problem with how EPA has done its work previously or (ii) what are the requirements, methods, and practices Pruitt believes are necessary to achieve that goal beyond those already in place at the agency. Instead, the proposed rule simply asserts that making certain data available to the public in and of itself will increase the reliability of the science the agency uses.

Through EPA’s scientific peer-review process, the agency already meets the ostensible goals of the proposal. Since EPA 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 if deemed inadequate, how the proposal specifically addresses those inadequacies. Even if Pruitt believes that scientific peer-review is lacking, the remedy may not be to impose entirely new data availability requirements. Rather, it may be to instruct EPA’s experts to engage directly with scientists and provide constructive critique of current peer-review practices.

Additionally, the proposal includes a “requests for comment” section that indicates EPA itself has not thoroughly considered the proposed rule. The agency states 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
  • How the proposed rule will be applied to its regulatory actions
  • 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
  • Whether to add stronger data access requirements to the terms of research grants

For most of these issues, EPA does not propose a solution or approach. In failing to do that, the proposal again falls short of the legal threshold established by the APA 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 for the public to comment.

Avoiding the Results of Critical Public Health Studies

The intended effect of the policy is clear: allowing EPA to ignore two bedrock studies that show that particle pollution harms people’s health and to delay or avoid consideration of other critical studies. The two studies in question, one by Harvard University and one by the American Cancer Society, definitively show a link between air pollution and premature death, heart disease, respiratory disease, and lung cancer. These studies followed tens of thousands of people over nearly two decades, and the researchers made confidentiality agreements with the study participants stating that their private information would not be made public. The studies 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.

Opponents of environmental regulation have long 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.

Administrator Pruitt asserts that he would never wish to jeopardize patient confidentiality, but the policy provides only two options: make private details publicly available or ignore the results of the science. The proposal, meanwhile, offers few details on what public availability would look like, stating that EPA “shall [make data public] in a fashion that is consistent with law, protects privacy, confidentiality, [and] confidential business information…” [§ 30.5], but it is silent as how that will be accomplished.

The policy may empower EPA to ignore many more peer-reviewed, entirely reliable studies. The proposal includes language that goes beyond the “transparency” justification, inviting the agency to ignore peer-reviewed studies for other reasons. At the very least, it would compel EPA itself to reanalyze studies, even if the cost and delay impaired the agency from considering critical conclusions linking public health impacts to pollution or exposure to toxic substances.

The proposal could also threaten the process by which EPA approves chemicals and pesticides, since that depends on industry data that is treated as “confidential business information.” Emails obtained through the Freedom of Information Act (FOIA) show that Pruitt’s hand-picked EPA appointee 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.”

Finally, 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 hundreds of millions of dollars.

The absence of any other sustainable justification removes any doubt that the result of this proposal – the exclusion of peer-reviewed science from EPA consideration, and consequently, decreased prospect for stronger public health protections – was its sole purpose.

For more information on other changes to science at EPA, please see our other Mission Tracker posts, including:

This post was edited for clarity on Jan. 17, 2020.

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