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EPA/OCSPP RIN: 2070-AJ76 Publication ID: 2012 
Title: Protections for Subjects in Human Research Involving Pesticides 
Abstract: Under a settlement agreement resolving litigation on EPA's 2006 rule regarding protections for subjects in human research involving pesticides, EPA proposed changes in January 2011 that included broadening the applicability of the rules to cover human testing with pesticides submitted to EPA under any regulatory statute it administers; disallowing participation in third-party pesticide studies by subjects who cannot consent for themselves; and identifying considerations to be addressed in EPA science and ethics reviews of proposed and completed human research with pesticides. 
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 deadline requires expedited schedule  12/18/2011 
Timetable:
Action Date FR Cite
NPRM  02/02/2011  76 FR 5735   
Final Rule  02/00/2013 
Additional Information: Docket #:EPA-HQ-OPP-2010-0785. NPRM Settlement Agreement: 01/18/2011; Settlement Agreement Final Rule: 12/18/2011.
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