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Notice

Pesticide Product Registrations; Conditional Approval

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces Agency approval of applications submitted by Monsanto Company, to conditionally register the pesticide products, Event MON 863: Corn Rootworm Protected Corn (ZMIR13L) and YieldGard Plus 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.

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FOR FURTHER INFORMATION CONTACT:

Mike Mendelsohn, Biopesticides and Pollution Prevention Division (7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-8715;e-mail address: mendelsohn.mike@epa.gov.

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SUPPLEMENTARY INFORMATION:

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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. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in Unit II. of this notice. 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 an official public docket for this action under docket identification (ID) number OPP-2004-0182. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket 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 available for public inspection in the Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, Rm. 119, Crystal Mall #2, Arlington, VA (703) 305-5805. 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.

A paper copy of the fact sheet, which provides more detail on this registration, may be obtained from the National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161.

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/​.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/​edocket/​ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

Electronic versions of the MON 863 Fact Sheet and Biopesticide Regulatory Action Document, as well as the YieldGard Plus Fact Sheet are available at http://www.epa.gov/​bioopesticides/​.

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 Cry3Bb1 protein and the genetic material necessary for its production (Vector ZMIR13L) in event MON 863 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 Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production Vector ZMIR13L in Event MON 863 corn 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.

The Agency has considered the available data on the risks associated with the proposed use of YieldGard Plus Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production (Vector ZMIR13L) in Event MON 863 corn stacked with Bacillus thuringiensis Cry1A(b) delta endotoxin and the genetic material necessary for its production in corn via conventional breeding, and information on social, economic, and environmental benefits to be derived from such use.

Based on these reviews, the Agency was able to make basic environmental, health, and safety determinations which show that use of YieldGard Plus [Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production (Vector ZMIR13L) in Event MON 863 corn stacked with Bacillus thuringiensis Cry1A(b) delta endotoxin and the genetic material necessary for its production in corn via conventional breeding], consistent with the terms and conditions of registration during the period of conditional registration, will not significantly increase the risk of unreasonable adverse effect on the environment.

The YieldGard Plus product is conditionally registered in accordance with FIFRA section 3(c)(7)(B). If the conditions are not complied with the registration will be subject to cancellation in accordance with FIFRA section 6(e).Start Printed Page 60828

III. Conditionally Approved Registrations

EPA issued a notice, published in the Federal Register of March 13, 2002 (67 FR 11333) (FRL-6827-3), which announced that Monsanto Company, 800 N. Lindberg Blvd., St. Louis, MO 63167, had submitted an application to conditionally register the pesticide product, Event MON 863: Corn Rootworm Protected Corn (ZMIR13L), a plant-incorporated protectant (EPA File Symbol 524-LEI), containing Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production (Vector ZMIR13L) in corn, an active ingredient not included in any previously registered product.

The application was conditionally approved on February 24, 2003 for the product listed below:

1. Event MON 863: Corn Rootworm Protected Corn (ZMIR13L) (EPA Registration Number 524-528) for use as a plant-incorporated protectant in corn.

EPA issued a notice, published in the Federal Register of April 2, 2003 (68 FR 16036) (FRL-7286-1), which announced that Monsanto Company, 800 N. Lindberg Blvd., St. Louis, MO 63167, had submitted an application to conditionally register the pesticide product, YieldGard Plus Corn, a plant-incorporated protectant (EPA File Symbol 524-LUL), containing Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production (Vector ZMIR13L) in corn and Bacillus thuringiensis CryBacillus thuringiensis Cry1A(b) delta endotoxin and the genetic material necessary for its production in corn via conventional breeding. The stacking of Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production (Vector ZMIR13L) in corn and Bacillus thuringiensis Cry1A(b) delta endotoxin and the genetic material necessary for its production in corn via conventional breeding resulted in a pesticide product involving a changed use pattern for its active ingredients pursuant to the provision of section 3(c)(4) of FIFRA.

The application was conditionally approved on October 25, 2003 for the product listed below:

2. YieldGard Plus Corn (EPA Registration Number 524-545) for use as a plant-incorporated protectant in corn.

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List of Subjects

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Dated: October 11, 2005.

Janet L. Andersen,

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

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[FR Doc. 05-20905 Filed 10-18-05; 8:45 am]

BILLING CODE 6560-50-S