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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. 158


Submission Date: Nov 14, 2016
Developer Name1: International Rice Research Institute
Developer Contact Information: DAPO Box 7777
Metro Manila 1301
Intended Use: Use in human and animal feed in certain countries
Trait 1 Added Protein or DNA: Phytoene synthase
Source: Zea mays
Intended Effect: Converts geranylgeranyl diphosphate to phytoene
Trait 2 Added Protein or DNA: Carotene desaturase I
Source: Pantoea ananatis
Intended Effect: Converts phytoene to lycopene
Trait 3 Added Protein or DNA: phosphomannose isomerase
Source: Escherichia coli
Intended Effect: selectable marker for transformation
Requires EPA Review?*: No
Event Designation: GR2E
Unique Identifier: IR-ØØGR2E-5
FDA Letter Date
(select to view letter):
May 24, 2018
(PDF, 66 kB)
FDA Memo Date
(select to view memo):
May 8, 2018
(PDF, 139 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