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EPA/ORD RIN: 2080-AA13 Publication ID: Fall 2018 
Title: Harmonize 40 CFR Part 26 Subparts C, D, and K With Subpart A (the Common Rule) 

In 1991, several Federal departments and agencies that conduct or support research involving human subjects adopted a common "Federal Policy for Protection of Human Subjects" into each of their own respective regulations. This policy is known as the "Common Rule" by virtue of being shared currently by all these departments and agencies. 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. Implementation of the Common Rule will occur on January 21, 2019. The Common Rule was codified by EPA in 40 CFR 26. Beyond the Common Rule language, which is located in subpart A of part 26, 40 CFR 26 also contains several additional subparts that are unique to EPA, added in 2006 in response to a 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. 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 in subpart K, which will be based on the previous version of the Common Rule, and the revised version of the Common 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 the Common Rule, and will not alter the fundamental protections for human subjects, including vulnerable populations.

Agency: Environmental Protection Agency(EPA)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Not subject to, not significant 
CFR Citation: 40 CFR 26   
Legal Authority: Not Yet Determined   
Legal Deadline:  None
Action Date FR Cite
NPRM  10/00/2018 
Final Rule  04/00/2019 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Tom Sinks
Environmental Protection Agency
Office of Research and Development
1200 Pennsylvania Avenue NW,
Washington, DC 20460
Phone:202 564-0221

Daniel Nelson
Environmental Protection Agency
Office of Research and Development
109 T.W. Alexander Drive, Mail Code 58A,
Research Triangle Park, NC 27709
Phone:919 966-6217