E7-16049. Pesticide Product Registrations; Conditional Approval

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces Agency approval of applications submitted by Syngenta Seeds, Monsanto Company, Pioneer Hi-Bred International (A Dupont Company), and Mycogen Seeds (c/o Dow AgroSciences), to conditionally register the pesticide products Agrisure^TM RW Rootworm-Protected Corn, MON 88017, MON 88017 x MON 810, Herculex Rootworm Insect Protection, and Herculex RW Insect Protection, 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:

Mike Mendelsohn, 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-2007-0597. 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 sheets and Biopesticide Regulatory Action Documents 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 Modified Cry3A protein and the genetic material necessary for its production (via elements of pZM26) in event MIR604 corn SYN-IR604-8, Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production (Vector ZMIR39) in Event MON 88017 corn (OECD Unique Identifier: MON-88O17-3), and Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic material necessary for their production (plasmid insert PHP 17662) in Event DAS-59122-7 corn, 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 Modified Cry3A protein and the genetic material necessary for its production (via elements of pZM26) in event MIR604 corn SYN-IR604-8, Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production (Vector ZMIR39) in Event MON 88017 corn (OECD Unique Identifier: MON-88O17-3), and Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic material necessary for their production (plasmid insert PHP 17662) in Event DAS-59122-7 corn during the period of conditional registrations 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 ensure that use of the pesticides will not result in unreasonable adverse effects to man and the environment.

III. Conditional Approval Form

EPA issued a notice, published in the Federal Register of October 27, 2004 (69 FR 62678) (FRL-7370-4), which announced that Syngenta Seeds, Inc., Field Crops-NAFTA, P.O. Box 12257, 3054 Cornwallis Rd., Research Triangle Park, NC 27709-2257, had submitted an application to conditionally register the pesticide product, Event MIR604 Rootworm-Protected Corn, Plant-Incorporated Protectant (EPA File Symbol 67979-L), containing Modified Cry3A protein and the genetic material necessary for its production (via elements of pZM26) in event MIR604 corn SYN-IR604-8 an active ingredient not included in any previously registered product. The application was approved on October 3, 2006, as Agrisure^TM RW Rootworm Protected Corn, (EPA Registration Number 67979-5). This product is a plant-incorporated protectant.

EPA also issued a notice, published in the Federal Register of December 22, 2004 (69 FR 76716) (FRL-7370-5), which announced that Monsanto Company, 800 North Lindbergh Blvd., St. Louis, MO 63167, had submitted an application to conditionally register the pesticide products, MON 88017 and MON 88017 x MON 810, Plant-Incorporated Protectant EPA File Symbols 524-LLR and 524-LLE), containing [Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production (Vector ZMIR39) in Event MON 88017 corn (OECD Unique Identifier: MON-88O17-3) an active ingredient not included in any previously registered product.The applications were approved on December 13, 2005, as MON 88017, (EPA Registration Number 524-551) and MON 88017 x MON 810, (EPA Registration Number 524-552). These products are plant-incorporated protectants.

EPA also issued a notice, published in the Federal Register of September 1, 2004 (69 FR 53434) (FRL-7370-2), which announced that Pioneer Hi-Bred International, A Dupont Company, 7250 N.W. 62nd Ave., P.O. Box 552, Johnston, IA 50131-0552 and Mycogen Seeds c/o Dow AgroSciences , had submitted an application to conditionally register the pesticide products, Pioneer Brand B.t. Cry34/35Ab1 Insect Resistant Corn Seed and Mycogen Brand B.t. Cry34/35Ab1 Construct 17662 Corn, Plant-Incorporated Protectants (EPA File Symbols 29964-U and 68467-L), containing Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic material necessary for their production (plasmid insert PHP 17662) in Event DAS-59122-7 corn an active ingredient not included in any previously registered product.The applications were approved on August 31, 2005 , as Herculex Rootworm Insect Protection, (EPA Registration Number 29964-4) and Herculex RW Insect Protection, (EPA Registration Number 68467-5). These products are plant-incorporated protectants.

List of Subjects

• Environmental protection
• Chemicals
• Pesticides and pests

Dated: August 2, 2007.

Janet L. Andersen,

Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs.