Update: The District Court of Montana vacated the “Secret Science” rule on February 1, 2021. An update including analysis of that decision is available here.

The U.S. Environmental Protection Agency (EPA) issued a final rule establishing new standards for consideration of certain “pivotal” scientific studies, requiring that EPA give greater consideration to studies relying on dose-response data that has been made “available in a manner sufficient for independent validation.” Commonly known as the “Secret Science” rule, this measure was published in its final form under the title “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information.” The rule went into effect upon publication on January 6, 2021.

The rule is one of a series of EPA measures designed to improve transparency in decision-making, including a rule governing the adoption and rescission of significant guidance, and recent cost-benefit analysis requirements. The “Secret Science” rule sets forth principles and standards for identifying and weighing scientific studies that rely on “dose-response data,” defined as “data used to characterize the quantitative relationship between the amount of dose or exposure to a pollutant, contaminant, or substance and an effect.” The rule only affects “pivotal science,” defined as “specific dose-response studies or analyses that drive the requirements or quantitative analyses of EPA significant regulatory actions or influential scientific information.”

To ensure full consideration by EPA, it must be possible to “reanalyze . . . exactly the same dose-response data” using the same methods used by the authors of a study. The data must be “available to the general public” on the date that a proposed regulatory action is announced, or that scientific information is disseminated. Many epidemiological studies addressing the potential public health impacts of exposure to contaminants through air and water are based on dose-response data.

With this rule, EPA is finalizing requirements for independent peer review of pivotal science, based on standards for review set forth in the Office of Management and Budget (OMB), Final Information Quality Bulletin for Peer Review (2005). The rule also requires clear identification of all science that serves as the basis for informing a significant regulatory action, as defined by OMB. It limits the studies that EPA may rely upon to “the highest quality, most relevant studies in determining the potential for hazard due to exposure to a pollutant, contaminant, or substance,” with quality and relevance evaluated based on specified criteria.

EPA does have some discretion in implementing of the rule, and exemptions are allowed. Specifically, EPA may permit “lesser consideration” of pivotal science “where there is no access to dose-response data, or access is limited,” so long as EPA identifies the studies that are given lesser consideration and provides a justification for their consideration. The EPA administrator may exempt studies from the rule when “[m]aking the dose-response data available would conflict with laws and regulations governing privacy, confidentiality, confidential business information, or national security.” And, in the case of any conflict between the rule and environmental statutes or their implementing regulations, the environmental statutes and regulations will control.

The “Secret Science” rule has been controversial, garnering nearly a million written public comments since it was first proposed in 2018. Less than a week after the final rule was published, environmental groups filed a lawsuit in the U.S. District Court for the District of Montana challenging the rule and asking the court to enjoin its enforcement. Among other things, plaintiffs argued that the rule exceeds the scope of EPA’s “housekeeping” authority to establish rules to govern its internal affairs under 5 U.S.C. 301, which EPA identifies as the rule’s legal basis.

For more information on the rule, or for updates on pending legal challenges, please contact Louise Dyble at louise.dyble@troutman.com.