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U.S. Department of Health and Human Services

Consultations on Food from New Plant Varieties

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BNF No. 118


Submission Date: Jan 12, 2009
Developer Name1: Bayer CropScience USA LP
Developer Contact Information: P.O. Box 12014
Research Triangle Park, NC 27709
Intended Use: For use in human food and animal feed
Trait 1 Added Protein or DNA: Cry1Ab
Source: Bacillus thuringiensis subsp. berliner
Intended Effect: Resistance to lepidopteran insects
Trait 2 Added Protein or DNA: Cry2Ae
Source: Bacillus thuringiensis subsp. dakota
Intended Effect: Resistance to lepidopteran insects
Requires EPA Review?*: Yes
Event Designation: T304-40
Unique Identifier: BCS-GHØØ4-7 x BCS-GHØØ5-8
FDA Letter Date
(select to view letter):
Aug 19, 2011
FDA Memo Date
(select to view memo):
Aug 12, 2011
*Plant-incorporated protectants are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. The DNA encoding the substances and the pesticidal substances are regulated by EPA.
1 At the time of conclusion of the consultation