[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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