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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. 161


Submission Date: Apr 26, 2017
Developer Name1: Submitted by Bayer CropScience LP, now BASF Agricultural Solutions Seeds US LLC
Developer Contact Information: 2 TW Alexander Drive
Research Triangle Park, NC 27709
Intended Use: Use in human and animal foods
Trait 1 Added Protein or DNA: Double mutant 5-enol pyruvylshikimate-3-phosphate synthase (2mEPSPS)
Source: Zea mays>/i> (corn, maize)
Intended Effect: Tolerance to the herbicide glyphosate
Trait 2 Added Protein or DNA: modified p-hydroxyphenylpyruvate dioxygenase (HPPD) W336
Source: Pseudomonas fluorescens
Intended Effect: Tolerance to HPPD inhibitors
Requires EPA Review?*: No
Event Designation: GHB811
Unique Identifier: BCS-GH811-4
FDA Letter Date
(select to view letter):
Nov 19, 2018
(PDF, 103 kB)
FDA Memo Date
(select to view memo):
Nov 7, 2018
(PDF, 100 kB)
*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