[Federal Register Volume 74, Number 82 (Thursday, April 30, 2009)]
[Notices]
[Pages 19956-19957]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-10004]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0401; FRL-8409-5]


Pesticide Product Registrations; Conditional Approval

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces Agency approval of applications 
submitted by Syngenta Seeds, Incorporated - Field Crops - NAFTA, to 
conditionally register the pesticide products, MIR162 Maize, Bt11 x 
MIR162 Corn, and Bt11 x MIR162 x MIR604 Corn, containing a new active 
ingredient 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: Jeannine Kausch, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 347-8920; e-mail 
address: [email protected].

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-2008-0401. 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 Vip3Aa20 insecticidal protein and the 
genetic material for its production (via elements of vector pNOV1300) 
in Event MIR162 maize (OECD Unique Identifier SYN-IR162-4), 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 Vip3Aa20 insecticidal protein and the 
genetic material for its production (via elements of vector pNOV1300) 
in Event MIR162 maize (OECD Unique Identifier SYN-IR162-4) during the 
period of conditional registration will not cause any unreasonable 
adverse effect on the environment, and that use of the pesticide is, 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 ensure that use of the pesticides will not result in 
unreasonable adverse effects to man and the environment.

III. Conditional Approval

    EPA issued a notice, published in the Federal Register of July 23, 
2008 (73 FR 42799) (FRL-8365-4), which announced that Syngenta Seeds, 
Incorporated - Field Crops - NAFTA, P.O. Box 12257, 3054 Cornwallis 
Road, Research Triangle Park, NC 27709-2257, had submitted applications 
to conditionally register the pesticide products, MIR162 Maize, Bt11 x 
MIR162 Corn, and Bt11 x MIR162 x MIR604 Corn, Plant-

[[Page 19957]]

Incorporated Protectants (EPA File Symbols 67979-RU, 67979-RE, and 
67979-RG) respectively, containing Bacillus thuringiensis Vip3Aa20 
insecticidal protein and the genetic material for its production (via 
elements of vector pNOV1300) in Event MIR162 maize (OECD Unique 
Identifier SYN-IR162-4), an active ingredient not included in any 
previously registered product.
    The applications were conditionally approved on November 26, 2008, 
as MIR162 Maize (EPA Registration Number 67979-14), on February 13, 
2009, as Bt11 x MIR162 Corn (EPA Registration Number 67979-12), and as 
Bt11 x MIR162 x MIR604 Corn (EPA Registration Number 67979-13). These 
products are plant-incorporated protectants for use on corn.

List of Subjects

    Environmental protection, Chemicals, Pests and pesticides.

    Dated: April 17, 2009.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.
[FR Doc. E9-10004 Filed 4-29-09; 8:45 am]
BILLING CODE 6560-50-S