For Release: December 6, 2018

On December 6, 2018, EPA published in the Federal Register a Notice of Proposed Rulemaking for public comment. The proposed rule seeks to harmonize EPA-specific human subjects research regulations with the revised Common Rule that goes into effect on January 21, 2019. EPA and other participating federal agencies follow the Common Rule on the ethical protection of human subjects participating in research projects.

The revisions to the Common Rule create a discrepancy within some EPA-specific regulations. EPA added those regulations in 2006 in response to a congressional mandate to provide additional protection to vulnerable populations by prohibiting intentional exposure studies on children and pregnant or breast-feeding women. The regulations apply to research conducted or sponsored by EPA or submitted to EPA for regulatory purposes.

The proposed rulemaking harmonizes EPA-specific regulations with revisions to the Common Rule to resolve those discrepancies; it does not change EPA’s protection of human subjects.Comments must be submitted to Docket # EPA–HQ–ORD–2018–0280 at www.regulations.gov on or before February 4, 2019.