EPA Releases Strengthening Transparency in Regulatory Science Proposed Rule


On April 30, 2018, the U.S. Environmental Protection Agency (EPA) proposed the “Strengthening Transparency in Regulatory Science” (Science Rule) that EPA states is intended to “strengthen the transparency of EPA regulatory science.”  83 Fed. Reg. 18768. EPA states in the preamble that “[t]he proposed regulation provides that when EPA develops regulations, including regulations for which the public is likely to bear the cost of compliance, with regard to those scientific studies that are pivotal to the action being taken, EPA should ensure that the data underlying those are publicly available in a manner sufficient for independent validation.”  EPA further states that “EPA is proposing to establish a clear policy for the transparency of the scientific information used for significant regulations:  specifically, the dose response data and models that underlie what we are calling ‘pivotal regulatory science.’ ‘Pivotal regulatory science’ is the studies, models, and analyses that drive the magnitude of the benefit-cost calculation, the level of a standard, or point-of-departure from which a reference value is calculated.”

The proposed rule poses significant potential issues for pesticide registrants under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and is expected to impact rulemakings under the Toxic Substances Control Act (TSCA).  Our full memorandum contains details on the proposed rule and potential impacts to stakeholders.

Read the full memorandum online by clicking here.

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