[Federal Register Volume 76, Number 224 (Monday, November 21, 2011)]
[Rules and Regulations]
[Pages 71880-71881]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-29910]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 26

[EPA-HQ-OPP-2010-0785; FRL-9325-5]
RIN 2070-AJ76


Protections for Subjects in Human Research Involving Pesticides; 
Notification of Submission to the Secretary of Agriculture

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notification of submission to the Secretary of Agriculture.

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SUMMARY: This document notifies the public that the Administrator of 
EPA has forwarded to the Secretary of the United States Department of 
Agriculture (USDA) a draft final rule as required by section 25(a) of 
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2010-0785. All documents in the 
docket are listed in the docket index available in http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Kelly Sherman, Immediate Office of the 
Director (7501P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-8401; email address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Does this action apply to me?

    This action is directed to the public in general. It simply 
announces the submission of a draft final rule to the Secretary of USDA 
and does not otherwise affect any specific entities. This action may, 
however, be of particular interest to pesticide registrants (NAICS code 
325320) who sponsor or conduct human research for pesticides, and to 
other entities that sponsor or conduct human research for pesticides 
(NAICS code 541710). Since other entities may also be interested, the 
Agency has not attempted to describe all the specific entities that may 
be interested in this action. If you have any questions regarding this 
action, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

II. What action is EPA taking?

    As described in the Agency's semi-annual Regulatory Agenda, the 
draft final rule would take final action with regard to the proposed 
rule issued on February 2, 2011 (76 FR 5735). The amendments would make 
no changes to the Common Rule or EPA's codification of the Common Rule. 
EPA proposed these amendments as a result of a settlement agreement.
    Section 25(a)(2)(B) of FIFRA requires the EPA Administrator to 
provide the Secretary of USDA with a copy of any draft final rule at 
least 30 days before signing it in final form for publication in the 
Federal Register. The draft final rule is not available to the public 
until after it has been signed by EPA. If the Secretary of USDA 
comments in writing regarding the draft final rule within 15 days after 
receiving it, the EPA Administrator shall include in the final rule, 
when published in the Federal Register, the comments of the Secretary 
of USDA, if requested by the Secretary of USDA, and the EPA 
Administrator's response to those comments. If the Secretary of USDA 
does not comment in writing within 15 days after receiving the draft 
final rule, the EPA Administrator may sign the final rule for 
publication in the Federal Register any time after the 15-day period.

III. Do any statutory and Executive Order reviews apply to this 
notification?

    No. This document is not a rule. It is merely a notification of 
submission to the Secretary of USDA. As such, none

[[Page 71881]]

of the regulatory assessment requirements apply to this document.

IV. Will this notification be subject to the Congressional Review Act?

    No. This action is not a rule for purposes of the Congressional 
Review Act (CRA), 5 U.S.C. 804(3), and will not be submitted to 
Congress and the Comptroller General. EPA will submit the final rule to 
Congress and the Comptroller General as required by CRA.

List of Subjects in 40 CFR Part 26

    Environmental protection, Human research, Pesticides.

    Dated: November 4, 2011.
Steven Bradbury,
Director, Office of Pesticide Programs.
[FR Doc. 2011-29910 Filed 11-18-11; 8:45 am]
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