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Bt Plant-Incorporated Protectants October 15, 2001 Biopesticides Registration Action Document

I. Overview

This version of the Biopesticides Registration Action Document for the Bacillus thuringiensis (Bt) Plant-Incorporated Protectants is dated October 15, 2001. This version corresponds to the version issued on September 29, 2001, with the following changes. The Agency has revised portions of Section I. Overview and Section II. Science Assessment relating to Cry1Ab and Cry1F proteins expressed in corn (Bt corn), in light of public comments received as of September 21, 2001. The Agency has also added two new sections entitled: “V. Bt Corn Confirmatory Data and Terms and Conditions of Amended Registration” and “VI. Regulatory Position on Bt Corn.”

Syngenta Seeds, Inc. (formerly Novartis Seeds, Inc.) and Mycogen Seeds c/o Dow AgroSciences LLC came to the Agency indicating that as part of their business plans they would be phasing out their Event 176 corn products. Syngenta Seeds and Mycogen Seeds c/o Dow AgroSciences LLC Event 176 Cry1Ab corn registrations expired on April 1, 2001 and on June 30, 2001, respectively. Existing stocks for these products must be used before or during the 2003 growing season. EPA has determined that allowing use of existing stocks for Event 176 Bt corn products through the 2003 growing season will not result in unreasonable adverse effects on the environment and the plant- incorporated protectants will be gone from the environment long before resistance would have been predicted to develop. Both former registrants have agreed to comply with any increased IRM requirements that may result from this reassessment for any existing stocks.

Aventis requested voluntary cancellation of their Cry9C StarLink corn registration and this cancellation became effective on February 20, 2001.

The Event 176 and Cry9C products are not being considered for extensions. They will generally not be discussed in this reassessment document.

No regulatory changes are being required for Bt potato products.

A. Executive Summary

EPA has completed a comprehensive reassessment of the time-limited registrations for all existing Bt corn and cotton plant-incorporated protectants. As part of EPA’s reassessment, the Agency has decided to extend the registrations with additional terms and conditions for the Bt corn and cotton plant-incorporated protectants including requiring confirmatory data to ensure protection of non-target organisms and lack of accumulation of Bt proteins in soils, measures to limit gene flow from Bt cotton to wild (or weedy) relatives, and a strengthened IRM program, especially related to compliance. Although the Bt potato product does not have an expiring registration, EPA has also included information on this plant-incorporated protectant in Section II. Science Assessment section of the document. This reassessment has been designed to assure that the decisions on the renewal of these registrations are based on the most current health and ecological data.

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