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EPA/OCSPP RIN: 2070-AJ76 Publication ID: Fall 2011 
Title: Protections for Subjects in Human Research Involving Pesticides 
Abstract: EPA proposed to amend the portions of its rules for the protection of human subjects of research applying to third parties who conduct or support research with pesticides involving intentional exposure of human subjects and to persons who submit the results of human research with pesticides to EPA. The proposed amendments would broaden the applicability of the rules to cover human testing with pesticides submitted to EPA under any regulatory statute it administers. They would also disallow participation in third-party pesticide studies by subjects who cannot consent for themselves. Finally the proposed amendments would identify specific considerations to be addressed in EPA science and ethics reviews of proposed and completed human research with pesticides, drawn from the recommendations of the National Academy of Sciences (NAS). In seeking comments on these proposed amendments, EPA does not imply that the current Federal Policy for the Protection of Human Subjects (the "Common Rule"), which governs research with human subjects conducted or supported by EPA and many other Federal departments and agencies, is inadequate. Indeed, the amendments proposed here would make no changes to the Common Rule or EPA's codification of the Common Rule. Rather, EPA proposed these amendments to other portions of its regulation as a result of a settlement agreement, and is now seeking comment on these proposed amendments. The settlement agreement makes clear that EPA retains full discretion concerning what amendments are proposed, and what, if any, amendments are finalized. The settlement agreement also stipulates that the final rule will be signed by December 2011. 
Agency: Environmental Protection Agency(EPA)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 40 CFR 26   
Legal Authority: PL 109-54, sec 201    5 USC 301    42 USC 300(v)-1(b)    7 USC 136 to 136(y)    21 USC 346(a)   
Legal Deadline:
Action Source Description Date
NPRM  Judicial  Settlement Agreement Deadline for the Administrator's Signature.  01/18/2011 
Final  Judicial  Settlement Agreement Deadline for the Administrator's Signature.  12/18/2011 
Timetable:
Action Date FR Cite
NPRM  02/02/2011  76 FR 5735   
NPRM Comment Period End  04/04/2011    
Final Action  12/00/2011    
Additional Information: EPA publication information: NPRM - http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2010-0785-0002; EPA Docket information: EPA-HQ-OPP-2010-0785
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Information URL: http://www.epa.gov/oppfead1/guidance/human-test.htm  
Sectors Affected: 325320 Pesticide and Other Agricultural Chemical Manufacturing 
RIN Data Printed in the FR: No 
Agency Contact:
Kelly Sherman
Environmental Protection Agency
Office of Chemical Safety and Pollution Prevention
7501P,
Washington, DC 20460
Phone:703 305-8401
Fax:703 308-7042
Email: sherman.kelly@epa.gov

William Jordan
Environmental Protection Agency
Office of Chemical Safety and Pollution Prevention
7501P,
Washington, DC 20460
Phone:703 305-1049
Fax:703 308-4776
Email: Jordan.William@epa.gov