26 March 2020

U.S. EPA Publishes Supplemental “Transparency in Science” Proposed Rule

On March 18, the U.S. Environmental Protection Agency (EPA or the Agency) published a supplemental notice of proposed rulemaking in its “Strengthening Transparency in Regulatory Science” rulemaking. EPA’s original “Transparency in Science” proposal, published in April 2018, proposed that “for the science pivotal to its significant regulatory actions, EPA will ensure that the data and models underlying the science is publicly available in a manner sufficient for validation and analysis.” Among the adjustments from the supplemental notice:

  • The original proposal would have excluded from EPA’s regulatory consideration any scientific studies based on data that could not be made publicly available. The supplemental notice now proposes to build in a tiered approach for considering studies with underlying data that cannot be made public, with an express preference for studies with publicly available data.
  • EPA proposes to expand the scope of the rule to apply “broadly to data and models underlying pivotal regulatory science and pivotal science which support significant regulatory decisions and influential scientific information, respectively, rather than simply to dose-response data and models.” As such, EPA proposes to extend the rule to cover “environmental fate studies, bioaccumulation data, water-solubility studies, environmental fate models, engineering models, data on environmental releases, exposure estimates, quantitative structure activity relationship data, and environmental studies.”
  • As to the newly included phrase “influential scientific information,” EPA proposes to define this as “scientific information the agency reasonably can determine will have or does have a clear and substantial impact on important public policies or private sector decisions.”
  • EPA has also included a proposed definition of “publicly available” to mean “lawfully available to the general public from federal, state, or local government records; the internet; widely distributed media; or disclosures to the general public that are required to be made by federal, state, or local law.”
  • Finally, EPA is now articulating an independent basis on which it can promulgate this rule under its “housekeeping” authority, and the Agency is also soliciting public comment on this issue.

The public comment period ends on April 17, 2020.