E9-10004. Pesticide Product Registrations; Conditional Approval

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces Agency approval of applications submitted by Syngenta Seeds, Incorporated - Field Crops - NAFTA, to conditionally register the pesticide products, MIR162 Maize, Bt 11 x MIR162 Corn, and Bt 11 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: [phone]; e-mail address: [e-mail].

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 [phone].

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, Bt 11 x MIR162 Corn, and Bt 11 x MIR162 x MIR604 Corn, Plant-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 Bt 11 x MIR162 Corn (EPA Registration Number 67979-12), and as Bt 11 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.