March 15, 2019

EPA’s Controversial Proposed “Secret Science” Rule

Maurissa J. Rushton and Thomas J. Grever

The Trump administration may soon overhaul the U.S. Environmental Protection Agency’s (EPA) use of science in the rulemaking process. See Strengthening Transparency in Regulatory Science, 83 Fed. Reg. 18,768 (proposed Apr. 30, 2018) (to be codified at 40 C.F.R. pt. 30). As proposed, the new EPA rule would exclude from agency consideration any scientific studies that are not publicly available in a manner sufficient for independent validation. The rule is designed to change agency culture and practices, and ultimately could lead to vast changes in environmental regulation. Not surprisingly, responses toward this bold and aggressive rule have been widely polarized.

Former EPA administrator Scott Pruitt unveiled the proposal on April 24, 2018, to bar the use of scientific research, including data, that is not or cannot be made public. Under the proposed regulation, EPA will ensure that the underlying scientific data and models used to inform its significant regulatory actions are publicly available in a manner sufficient for validation and analysis. The proposed rule is “designed to increase transparency in the preparation, identification, and use of science in policymaking” and, according to EPA, “will help ensure that EPA is pursuing its mission of protecting public health and the environment in a manner that the public can trust and understand.” 83 Fed. Reg. 18,769. EPA’s stated goal is transparency. Using scientific information that can be independently validated by the public could lead to better outcomes and could strengthen public confidence in the regulatory process. “Ensuring that dose response data and models underlying pivotal regulatory science are publicly available . . . will improve the data and scientific quality of the Agency’s actions and facilitate expanded data sharing and exploration of key data sets.” 83 Fed. Reg. 18,772. Pruitt called the move an effort to remove “secret science” from the agency’s decision-making process, stating that “[t]he ability to test, authenticate, and reproduce scientific findings is vital for the integrity of the rulemaking process. Americans deserve to assess the legitimacy of the science underpinning EPA decisions that may impact their lives.” Stephanie Ebbs, Pruitt Wants EPA to Stop Basing Rules on what He Calls “Secret Science” ABA News (Apr. 24, 2018, 6:56 PM), https://abcnews.go.com/Politics/pruitt-epa-stop-basing-rules-calls-secret-science/story?id=54698926.

EPA purports to undertake this action under the authority of the statutes it administers, “including provisions providing general authority to promulgate regulations necessary to carry out the Agency’s functions under these statutes and provisions specifically addressing the Agency’s conducting of and reliance on scientific activity to inform those functions.” 83 Fed. Reg. 18,769. EPA also states that the “proposed rule is consistent with the principles underlying the Administrative Procedure Act” and further asserts that “[n]othing in the proposed rule compels the disclosure of any confidential or private information in a manner that violates applicable legal and ethical protections.” 83 Fed. Reg. 18,770.

During the comment period, thousands of comments rolled in, indicating significant differences in views over whether the rule will improve the EPA regulatory process and whether the proposal can withstand legal scrutiny. Proponents believe that the public should have access to the data used by agencies in passing regulations that impose significant economic burdens, arguing that the proposed rule will vastly improve regulated industries’ ability to challenge costly and impactful regulations. Many believe that the current data policy has made it difficult for affected parties to challenge the results of scientific research and further insist that “hidden” data has masked the flaws in the rulemaking process and fostered a culture of scientific mischief. This culture, according to supporters of the rule, has led to an abundance of fake and fabricated data.

Supporters also argue that the rule is consistent with statutory requirements for the protection of privacy and confidentiality. The proposed rule allows the EPA administrator to grant an exemption on a case-by-case basis if he or she determines that compliance is impracticable because (1) it is not feasible to ensure that all data is publicly available in a fashion that is consistent with law; protects privacy, confidentiality, and confidential business information; and is sensitive to national and homeland security; or (2) it is not feasible to conduct independent peer review on all pivotal regulatory science. 83 Fed. Reg. 18,744. Supporters assert that this exemption provides EPA with the flexibility to ensure that the rule is consistent with statutory requirements for protection of privacy and confidentiality.

In contrast, the proposed rule prompted an uproar from scientists, environmentalists, and other critics who are concerned that the rule may undermine EPA’s ability to protect public health. Opponents argue that much of the data used in research cannot be released without breaching the privacy of the people involved. They argue that independent validation of research could be legally complicated or outright unethical. The rule also could block regulators from citing critical, relevant research into the health effects of pollution because the raw data cannot be released due to privacy concerns. Restrictions on data could prevent EPA from considering potentially crucial research including epidemiological data, exposure studies, and other scientific research papers, thus making it harder to promulgate effective environmental regulations. Opponents also are concerned about the rule’s potential retroactive application and believe that it could overturn critical scientific reports such as the Harvard Six Cities Study of 1993, a study that heavily influenced federal air pollution standards when it revealed an association between air pollution and mortality.

Furthermore, critics assert that EPA does not have the statutory authority to enact such a rule, stating that it violates numerous public health and environmental provisions and leaves EPA vulnerable to legal challenge. Under Executive Order 13,783 issued by President Trump, the best available science must serve as the foundation of EPA’s regulatory actions. The executive order states that “[i]t is the policy of the United States that necessary and appropriate environmental regulations comply with the law, are of greater benefit than cost, when permissible, achieve environmental improvements for the American people, and are developed through transparent processes that employ the best available peer-reviewed science and economics.” 82 Fed. Reg. 16,093 (March 28, 2017). Congress also has emphasized that “Federal agencies conducting assessments of risks to human health and the environment . . . shall consider the best available science.” 42 U.S.C. § 13557. Furthermore, the mandate to use the “best available science” also is set forth in statutes that EPA administers including the Toxic Substances Control Act and the Safe Drinking Water Act. See 15 U.S.C. § 2625(h); 42 U.S.C. § 300g-1(b)(3)(A). EPA purports to issue this rule under the authority of these statutes; however, opponents argue that by limiting the science it considers in rulemaking, EPA is violating these very statutes. Opponents, including Representative Suzanne Bonamici (D–OR), argue that the proposed rule limits regulators from considering all available information, which could have “chilling consequences for EPA and every person who benefits from clean air and clean water.” EPA Public Hearing, Strengthening Transparency in Regulatory Science Proposed Rule, statement of Suzanne Bonamici, Congresswoman (July 17, 2018), available at https://bonamici.house.gov/media/press-releases/bonamici-defends-science-epa-hearing. Opponents also believe that the proposal is impermissibly misleading and vague and thereby thwarts the Administrative Procedure Act’s fundamental goal of keeping the public informed. Opponents argue that the policy could undo years of EPA practices and regulations and undermine EPA’s ability to use the best available science to protect public health and the environment.

In the coming months, EPA will consider the over 500,000 public comments filed and decide whether to implement the rule. If enacted, the rule will certainly impact government regulation under all EPA environmental programs. The voices on both sides of the debate are loud, and only time will reveal the full impact of the rule on environmental regulation. But due to the vast polarization of interested parties and the increasingly unclear legal landscape, if passed as it stands, the rule almost certainly will be subject to immediate scrutiny and litigation.

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Maurissa J. Rushton and Thomas J. Grever

Ms. Rushton is an associate and Mr. Grever is a partner at the law firm of Shook, Hardy & Bacon in Kansas City, Missouri. They may be reached at mrushton@shb.com and tgrever@shb.com, respectively.