The U.S. Environmental Protection Agency (EPA or the Agency) has formally repealed regulations establishing how the Agency would consider the availability of dose-response data (“Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information,” 86 Fed. Reg. 469) (the Science Rule). The Science Rule, which was finalized and went into effect immediately on January 6, 2021, related specifically to studies describing the quantitative relationship between the dose or exposure of a pollutant, contaminant, or substance and its effect; the rule required, among other things, that EPA identify and give greater consideration to studies constituting “pivotal science” (defined as “the specific dose-response studies or analyses that drive the requirements or quantitative analyses of EPA significant regulatory actions or influential scientific information”) and make public all science that served as the basis for a significant regulatory action.
EPA’s repeal of the Science Rule effectuates a vacatur order by a federal district court judge in February 2021. The court ruled in that case that the EPA did not have the authority to promulgate the Science Rule under the Agency’s housekeeping authority because the rulemaking was substantive and not procedural. According to an Agency press release, full repeal of the Science Rule “ensures that EPA can utilize the best available science and data to support our work to protect the public from pollution.”
The Science Rule repeal is expected to be published in the Federal Register on Wednesday, June 2, 2021, and will be effective immediately.