Protections for Subjects in Human Research Involving Pesticides

 
Docket ID: EPA-HQ-OPP-2010-0785
Agency: Environmental Protection Agency (EPA)
Summary:
On February 14, 2013, EPA finalized narrowly tailored amendments to 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 amendments broaden the applicability of the rules to cover human testing with pesticides submitted to EPA under any regulatory statute it administers. The amendments also disallow participation in third-party pesticide studies by subjects who cannot consent for themselves. Finally, the amendments 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). The amendments make no changes to 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. These rule revisions are effective on April 15, 2013.
RIN: 2070-AJ76
Impacts and Effects: None
CFR Citation: 40 CFR 26
Priority: Other Significant
UA and Regulatory Plan Information open glossary dialog  
Publication Period: Spring 2013
Agenda Stage of Rulemaking: Completed Action
Major Rule: No
Legal Authorities: PL 109-54, sec 201, 5 USC 301, 42 USC 300(v)-1(b), 7 USC 136 to 136(y), 21 USC 346(a)
Government Levels Affected: Federal
Federalism Implications: No
Unfunded Mandates: No
Requires Regulatory Flexibility Analysis: No
Small Entities Affected: No
International Impacts: No
Energy Effects: No
Included in Regulatory Plan: No
Legal Deadline
ActionSourceDescriptionDate
JudicialNPRMSettlement agreement deadline01/18/2011
JudicialOtherSettlement agreement deadline12/18/2011
Timetable
ActionDateFR Citation
NPRM02/02/201176 FR 5735
Final Rule02/14/201378 FR 10538
Final Rule Effective04/15/2013
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Type: Rulemaking
Location: HQ-OPP
 

Primary Documents

View All  (4)
Comment Period Closed
Apr 22, 2011 11:59 PM ET
Proposed Rule
Posted: 02/02/2011
ID: EPA-HQ-OPP-2010-0785-0002
Comment Period Closed
Rule
Posted: 02/14/2013
ID: EPA-HQ-OPP-2010-0785-0037
Comment Period Closed
Rule
Posted: 11/21/2011
ID: EPA-HQ-OPP-2010-0785-0036
Comment Period Closed
Proposed Rule
Posted: 10/13/2010
ID: EPA-HQ-OPP-2010-0785-0001

Supporting Documents

View All  (6)
Comments Not Accepted
Supporting & Related Material
Posted: 02/14/2013
ID: EPA-HQ-OPP-2010-0785-0038
Comments Not Accepted
Supporting & Related Material
Posted: 02/14/2013
ID: EPA-HQ-OPP-2010-0785-0039
Comments Not Accepted
Supporting & Related Material
Posted: 02/02/2011
ID: EPA-HQ-OPP-2010-0785-0006

Comments

View All  (29)

29
Comments Received*
Regulatory Timeline
Pre Rule
Current Stage
Proposed Rule
Current Stage
Final Rule
Current Stage
Completed
Current Stage
Agency Contact
Kelly Sherman
OPPTS
sherman.kelly@epa.gov
703 305-8401
703 308-7042 (Fax)
7501P, Washington, DC 20460
Washington, DC 20460
William Jordan
OPPTS
Jordan.William@epa.gov
703 305-1049
703 308-4776 (Fax)
7501P, Washington, DC 20460
Washington, DC 20460
*This count refers to the total comment/submissions received on this docket, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.