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Science Transparency Rule Back on the Table in 2019

January 10, 2019

Acting US Environmental Protection Agency (EPA) Administrator Andrew Wheeler confirmed in a recent interview that the agency “feels strongly” that it will “move forward to finalize” its controversial proposed rule—Strengthening Transparency in Regulatory Science in 2019 (Science Transparency Rule)—this year. The Science Transparency Rule would fundamentally change the way the EPA regulates the environment by, among other things, mandating that the agency only rely upon scientific studies that are reproducible and where, with certain exceptions like personal health information, the underlying data can be made public. If approved, the practical result of the proposed rule may be that the EPA promulgates less overall regulations as fewer scientific studies become eligible to be relied upon.

At its core, the Science Transparency Rule requires that EPA make public the scientific studies that support its regulations as well as any underlying data, models, and assumptions. The proposal also encourages the use, when available and appropriate, of peer-reviewed information, standardized test methods, consistent data evaluation procedures, and good laboratory practices. The Science Transparency Rule also allows the EPA administrator to exempt certain regulations from these requirements, which could lead to exemptions being applied inconsistently from one administration to another.

In support of the proposed rule, EPA states that its goal is to improve science transparency and ensure that the best available science serves as the foundation of EPA’s regulatory actions. By publishing the information behind scientific studies, the EPA believes that it can increase public confidence in the agency’s decision making. Most notably, the EPA hopes that the regulation could help reverse what it sees as a secrecy problem within the scientific community—that too much information is kept from the public. Critics believe the proposed rule offers a solution to a problem that does not exist, pointing to safeguards already in place to ensure scientific integrity and reproducibility. Critics also claim the EPA is using this proposal to discount important medical studies, like epidemiological studies that by their nature cannot be reproduced. Because the proposal requires near-complete transparency of underlying data, critics worry that it may be difficult or even impossible for EPA to consult important medical studies that speak to potential health impacts from environmental exposure.

The fate of the Science Transparency Rule will likely be a point of contention for the EPA and the scientific community in 2019. While the proposal’s fate is uncertain, it is clear that the Science Transparency Rule could profoundly alter the EPA’s regulatory process, particularly for future regulations relating to public health.

Contacts

If you have any questions or would like more information on the issues discussed in this LawFlash, please contact any of the following Morgan Lewis lawyers:

San Francisco
Ella Foley Gannon

Los Angeles
David Brown