Document ID: EPA-HQ-OPP-2007-0306-0040
Agency: epa
Document Type: Notice
Title: Pesticide Product Registration; Conditional Approval
Posted Date: 2008-10-29T04:00Z

[Federal Register: October 29, 2008 (Volume 73, Number 210)]
[Notices]               
[Page 64323-64324]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29oc08-58]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0306; FRL-8385-8]

 
Pesticide Product Registration; Conditional Approval

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces Agency approval of an application 
submitted by Syngenta Seeds, Inc., to conditionally register the 
pesticide product VipCot containing new active ingredients not included 
in any previously registered products pursuant to the provisions of 
section 3(c)(7)(C) of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), as amended.

FOR FURTHER INFORMATION CONTACT: Alan Reynolds, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 605-0515; e-mail 
address: reynolds.alan@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under 
docket identification (ID) number EPA-HQ-OPP-2007-0306. Publicly 
available docket materials are available either in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the Office of Pesticide Programs (OPP) Regulatory Public 
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal 
Dr., Arlington, VA. The hours of operation of this Docket Facility are 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The Docket Facility telephone number is (703) 305-5805.
    In accordance with section 3(c)(2) of FIFRA, a copy of the approved 
label, the list of data references, the data and other scientific 
information used to support registration, except for material 
specifically protected by section 10 of FIFRA, are also available for 
public inspection. Requests for data must be made in accordance with 
the provisions of the Freedom of Information Act and must be addressed 
to the Freedom of Information Office (A-101), 1200 Pennsylvania Ave., 
NW., Washington, DC 20460-0001. Such requests should: Identify the 
product name and registration number and specify the data or 
information desired.
    Electronic versions of the fact sheet and Biopesticide Regulatory 
Action Document are available at http://www.epa.gov/oppbppd1/
biopesticides/pips/pip_list.htm.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr.

II. Did EPA Conditionally Approve the Application?

    A conditional registration may be granted under section 3(c)(7)(C) 
of FIFRA for a new active ingredient where certain data are lacking, on 
condition that such data are received by the end of the conditional 
registration period and do not meet or exceed the risk criteria set 
forth in 40 CFR 154.7; that use of the pesticide during the conditional 
registration period will not cause unreasonable adverse effects; and 
that use of the pesticide is in the public interest. The Agency has 
considered the available data on the risks associated with the proposed 
use of Bacillus thuringiensis Vip3Aa19 (vector pNOV3001; OECD Unique 
Identifier SYN-IR102-7) and modified Cry1Ab (vector pNOV4641; OECD 
Unique Identifier SYN-IR67B-1) insecticidal proteins and the genetic 
material necessary for their production in VipCot cotton, and 
information on social, economic, and environmental benefits to be 
derived from such use. Specifically, the Agency has considered the 
nature and its pattern of use, application methods and rates, and level 
and extent of potential exposure. Based on these reviews, the Agency 
was able to make basic health and safety determinations which show that 
use of Bacillus thuringiensis Vip3Aa19 (vector pNOV3001; OECD Unique 
Identifier SYN-IR102-7) and modified Cry1Ab (vector pNOV4641; OECD 
Unique Identifier SYN-IR67B-1) insecticidal proteins and the genetic 
material necessary for their production in VipCot cotton during the 
period of conditional registration will not cause any unreasonable 
adverse effect on the environment, and that use of the pesticides are, 
in the public interest.
    Consistent with section 3(c)(7)(C) of FIFRA, the Agency has 
determined that these conditional registrations are in the public 
interest. Use of the pesticides are of significance to the user 
community, and appropriate labeling, use directions, and other measures 
have been taken to

[[Page 64324]]

ensure that use of the pesticides will not result in unreasonable 
adverse effects to man and the environment.

III. Approved Conditional Application

    EPA issued a notice, published in the Federal Register of May 30, 
2007 (72 FR 29999) (FRL-8131-7), which announced that Syngenta Seeds, 
Inc., 3054 Cornwallis Road, P.O. Box 12257, Research Triangle Park, NC 
27709, had submitted an application to conditionally register the 
pesticide product, VipCot, Plant-Incorporated Protectant (EPA File 
Symbol 67979-O), containing Bacillus thuringiensis Vip3Aa19 (vector 
pNOV3001) and modified Cry1Ab (vector pNOV4641) insecticidal proteins 
and the genetic material necessary for their production in VipCot 
cotton containing active ingredients not included in any previously 
registered product.
    The application was conditionally approved on June 26, 2008, as 
VipCot Cotton (EPA Registration Number 67979-9). The product is a 
plant-incorporated protectant for use on cotton.

List of Subjects

    Environmental protection, Chemicals, Pests and pesticides.

    Dated: October 9, 2008.
W. Michael McDavit,
Acting Director, Biopesticides and Pollution Prevention Division, 
Office of Pesticide Programs.
[FR Doc. E8-25314 Filed 10-28-08; 8:45 am]

BILLING CODE 6560-50-S