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US EPA aims to expand scope of former chief Scott Pruitt's 'secret science' rule

The U.S. Environmental Protection Agency March 3 unveiled a supplemental proposal that could force it to exclude or discount key health studies underpinning some of its most sweeping energy and climate rules.

The EPA posted the supplemental notice of proposed rulemaking on its website after receiving a flood of critical comments on the original April 2018 proposal, dubbed the Strengthening Transparency in Regulatory Science rule. Records indicate that Former EPA Administrator Scott Pruitt proposed the rule — also known as the "secret science" rule after meeting with former Rep. Lamar Smith, R-Texas, who authored a similar piece of legislation that Republicans declined to pass in the last Congress.

The initial proposed rule would have required the science used to develop EPA regulations, including dose-response data or models used in a scientific study, to be publicly available for independent verification. Dose-response data is used to measure the health risks associated with exposure to potentially harmful agents or pollutants.

The proposal received more than 600,000 public comments, with some commenters noting that the initial seven-page document issued in April 2018 failed to include a number of definitions for terms such as "replication" and "reproducibility." Moreover, the proposal's regulatory text appeared to limit the rule's provisions in some cases to only dose-response models, while in others, the requirements appeared to apply more broadly to all scientific models.

Following Pruitt's July 2018 resignation, his replacement, Andrew Wheeler, promised to push the rulemaking forward, arguing that making data and models publicly available would help build trust in the agency's regulations.

However, critics have contended that public health studies relying on confidential patient health records or are not otherwise easily reproducible would be especially at risk of exclusion from the regulatory process. Harvard University's landmark Six Cities Study, which EPA used to identify billions of dollars in public health co-benefits related to the Obama-era Clean Power Plan, has been cited as a prime example.

Responding to the harsh feedback, Wheeler in September 2019 told members of U.S. House of Representatives science committee that the agency plans to issue a supplemental proposal in early 2020 responding to some of the most pressing issues raised in public comments.

EPA's supplemental proposal

The supplemental proposal unveiled March 3 expands on the original proposed rule by specifying that the EPA will "only use pivotal regulatory science … if the data and models are available in a manner sufficient for independent validation" when developing and finalizing rules.

Under the supplemental proposal, the agency still could use studies with restricted data and models if that information is available through what is known as tiered access, which involves techniques designed to mitigate disclosure privacy risks. As an alternative, the EPA also proposed to give more weight to studies with data and models that are either public or available through tiered access.

The proposal would apply to "data, models, and studies … regardless of when the data and models were generated." Editors of scientific journals have argued such a provision could undermine existing EPA regulations such as the National Ambient Air Quality Standards, which are reviewed on a rolling basis.

Members of the Environmental Protection Network, a nonpartisan advocacy group composed of former EPA employees, blasted the proposal as an assault on the agency's mission of protecting human health and the environment.

"Under this rule, only one side, industry, can afford to hire consultants whose success is dependent on slicing and dicing the raw data to find trivial issues that can be artfully distorted and magnified," Bernie Goldstein, former assistant administrator in the EPA's Office of Research and Development, said a statement.

While the original proposal claimed eight different federal statutes gives the EPA the authority to take such action, a draft copy of the supplemental proposal leaked to The New York Times last fall cited authority under a single law pre-dating the EPA: the Federal Housekeeping Statute.

In the March 3 supplemental proposal, the EPA said it is proposing the option of relying on its housekeeping authority independently "or in conjunction with the environmental statutory provisions cited as authority in the 2018 proposed rulemaking."

Betsy Southerland, former director of science and technology in the EPA's Office of Water, argued the proposal is legally deficient on multiple grounds. The proposal rule "failed to: 1) identify the legal authority for the rule, 2) justify the need for the rule, 3) describe the scope of the rule; or 4) evaluate the rule's costs and benefits," she said in a statement.

An EPA spokesperson in a March 4 email said the agency is committed to ensuring that the science underlying the agency's actions is of the highest quality. "By requiring transparency, scientists will be required to publish hypothesis and experimental data for other scientists to review and discuss, requiring the science to withstand skepticism and peer review," the spokesperson said.

The supplemental proposal will be subject to a 30-day public comment period following its publication in the Federal Register. The agency has not said whether it plans to hold a public hearing on the proposal.