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EPA/ORD RIN: 2080-AA13 Publication ID: Fall 2017 
Title: Harmonize 40 CFR 26 Subpart K With 40 CFR 26 Subpart A (the Common Rule) 45 CFR 46 of the Department of Health and Human Services 
Abstract:

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 is a one-year implementation deadline for most provisions. Beyond subpart A, 40 CFR 26 also contains several additional subparts that are unique to EPA, added in 2006 in response to Congressional mandate. The revision to subpart A creates a conflict within some of the EPA-specific subparts, which should now be corrected to reflect the revised Common Rule. In particular, subpart K of 40 CFR 26, which regulates third party pesticide research, contains several sections of text that were reproduced verbatim from the former Common Rule. 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, other subparts 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.

 
Agency: Environmental Protection Agency(EPA)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: Undetermined 
EO 13771 Designation: Other 
CFR Citation: 40 CFR 26   
Legal Authority: "Not Yet Determined"   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  11/00/2017 
Direct Final Rule  11/00/2017 
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
Email: staff_osa@epa.gov

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
Email: nelson.daniel@epa.gov