Subpart A of the Federal policy for "Protection of Human Subjects" is known as the Common Rule, because this regulation is shared by 18 departments and agencies that conduct or support research involving human subjects (codified by EPA at 40 CFR 26). The Common Rule was revised through the Federal rulemaking process, and a final revised rule was jointly published in the Federal Register on January 19, 2017. There was a 1-year implementation deadline for most provisions. On January 19, 2018 an Interim Final Rule was published delaying implementation of the revised Common Rule for 6 months. A draft Notice of Proposed Rulemaking is currently being circulated to the agencies that would further delay implementation of the revised Common Rule until January 2019.

Beyond subpart A, 40 CFR 26 also contains several additional subparts that are unique to EPA, added in 2006 in response to Congressional mandate. In particular, EPA created subparts K through Q to regulate third party pesticide research. Subpart K borrowed heavily from the provisions of the Common Rule (and EPA’s subpart A). In this rulemaking, EPA is updating subpart K for consistency with the recent updates to the Common Rule. Without appropriate updates, once the new Common Rule becomes effective, there will be a disconnect between policies and procedures based on competing versions of the same rule. In addition to the textual issues in subpart K, subparts C and D contain minor numerical citations (i.e., regulatory reference numbers) that are no longer accurate and should also be updated. Failure to resolve these internal discrepancies will create confusion and, more seriously, potential compliance and/or legal liabilities for researchers, institutions, and sponsors who must follow EPA regulations. These updates are solely intended to resolve discrepancies created by the recent revision to subpart A and will not alter the fundamental protections for human subjects, including vulnerable populations.