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

clear benefits for users. Beyond these economic benefits, EPA determines that Cry1Ab and Cry1F corn hybrids, to the extent they are an alternative to the use of other corn insecticides, will provide benefits in that use of Cry1Ab or Cry1F protein expressed in corn results in less human and environmental risk than chemical alternatives. In addition, EPA finds that the use of these products, subject to the specific terms and conditions set forth below, would not pose risks to human health or to non-target species. EPA also concludes that the use of Cry1Ab or Cry1F corn hybrids expressed in corn raises concerns with respect to: insect resistance management. As discussed below, the registrations for Cry1Ab and Cry1F proteins expressed in corn is subject to specific terms and conditions that effectively restrict the use of the product in ways that EPA determines will adequately mitigate these concerns. Therefore, EPA determines that the allowed use will not significantly increase the risk of unreasonable adverse effects on the environment. Finally, EPA has identified the need for certain confirmatory data on potential accumulation of Cry1Ab and Cry1F proteins in soil and field impacts of Cry1Ab and Cry1F proteins on non-target species. The registration of these products is specifically conditioned on submission of these data

8. Regulatory Position on Bt Cotton

The Bt cotton product was registered for commercial use in October 1995 as a conditional registration under FIFRA Section 3(c)(7)(B). The data reviewed for the initial registration as well as new data and reports received, results of public meeting, hearings, workshops, forums, and Scientific Advisory Panel meetings, and public comments received regarding the Bt crops reassessment have been taken into consideration. The scientific assessment has included product characterization, human health effects, gene flow, effects on non-target organisms, ecological exposure, insect resistance management, and benefits. Over the last six years, new data and information have been provided to the Agency in each of these areas and these data have been incorporated into the science assessment and been taken into account in making regulatory decisions.

The Cry1Ac product registration will automatically expire on midnight September 30, 2006 except for the external, unsprayed refuge option which will expire September 30, 2004. EPA intends to review the data specified in the data requirements concerning alternate hosts and chemical insecticide sprays on Bt cotton, and decide in 2004 whether the new data support continuation of an external, unsprayed refuge as part of a larger requirement that would also likely involve alternative host plants. If these data support the continued availability of the external, unsprayed refuge option, EPA may approve an amendment to this registration to maintain the availability of this option.

EPA’s finding that Cry1Ac protein expressed in cotton will not significantly increase the risk of unreasonable adverse effects on the environment is based on the analysis contained in the preceding sections of this BRAD and the specific terms and conditions that are imposed upon this registration, as set forth in Section III. In general terms, EPA concludes that use of Cry1Ac expressed in cotton is effective at controlling significant lepidopteran pests of cotton, including tobacco budworm, cotton bollworm, and pink bollworm. Therefore, this product has clear benefits for users. Beyond these economic benefits, EPA determines that Cry1Ac provides benefits as an alternative to the use

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