On January 06, 2021 (86 FR 469), the Environmental Protection Agency (EPA) published a final rule in the federal register to help strengthen the transparency of the dose-response data underlying certain EPA actions and to set the overarching structure and principles for transparency of pivotal science in significant regulatory actions and influential scientific information. The EPA will give greater consideration to studies where the underlying dose-response data are available in a manner sufficient for independent validation when promulgating significant regulatory actions or developing influential scientific information for which the conclusions are driven by the quantitative relationship between the amount of dose or exposure to a pollutant, contaminant, or substance and an effect. This action also requires the EPA to identify and make publicly available the science that serves as the basis for informing a significant regulatory action at the proposed or draft stage to the extent practicable; reinforces the applicability of peer review requirements for pivotal science; and provides criteria for the Administrator to exempt certain studies from the requirements of this rulemaking. This final rule is effective on January 6, 2021.

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EPA 01-06-2021 final rule dose-response data availability