MON-87708-x-MON-89788-Decision-Document.doc - Determination...

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Determination of Safety of Monsanto’s Stacked Trait Product Soybean: MON87708 x MON89788 for Direct Use as Food and Feed or Processing Health and Environmental Safety, and Socio-Economic, Ethical and Cultural Considerations The product dossiers of Monsanto’s stacked trait soybean MON87708 x MON89788 were reviewed for safety and nutritional differences compared with the conventional soybean. The focus of the safety assessment is based on issues/concerns regarding stacked genes from different sources namely (a) gene interaction, (b) effect on metabolic pathways, and (c) differential gene expression due to stacking. In addition, socio-economic, ethical and cultural impact of the said stacked trait was also assessed. Biosafety permit for stacked trait product soybean: MON87708 x MON89788 conferred through conventional breeding was issued to Monsanto Philippines Inc. on February 1, 2017. This permit is valid for five years and shall expire on January 31, 2022 subject to the terms and conditions set forth in DOST-DA-DENR-DOH-DILG Joint Department Circular (JDC) No. 1, Series of 2016. The said stacked trait product will be included in the Approval Registry to be prepared by the Department of Agriculture – Bureau of Plant Industry. This approval is for direct use of stacked trait product soybean: MON87708 x MON89788 in the Philippines only. Direct use of stacked trait product soybean: MON87708 x MON89788 and its by-products are therefore authorized as of February 1, 2017. The biosafety permit for direct use (No. 17-001FFP) stated that stacked trait product soybean: MON877008 x MON89788 is as safe for human food, livestock feed, or for processing as its conventional counterparts. a. Brief Identification of the Genetically Modified Organism (Living Modified Organism) Designation: Stacked trait product soybean: MON87708 x MON89788 Applicant: MONSANTO PHILIPPINES INC. 23rd Flr. Tower II, Insular Life Corporate Centre, Insular Life Drive, Filinvest Corporate City, Alabang, Muntinlupa City Plant Species: Name: Soybean ( Glycine max) Parent Material: Soybean MON87708, and Soybean MON89788 Center of Origin: North and Central China
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Toxic Factors/Allergen(s): Soybeans naturally contain multiple endogenous protein allergens. Trypsin inhibitors, raffinose and stachyose, Soy saponins and lectins condensed tannins and phytates Trait Description: Herbicide Tolerant Trait Introduction Method: Agrobacterium -mediated transformation system (MON87708 and MON89788) Donor Organisms: Stenotrophomonas maltophilia ( S. maltophilia ) expressing a mono- oxygenase (dmo) that rapidly demethylates 3,6- dichloro-2- methoxybenzoic acid (dicamba) rendering it inactive metabolite, 3,6- dichlorosalicylic acid (DCSA) Agrobacterium sp. CP4 strain – source of cp4 epsps gene which confers resistance to Roundup family (glyphosate) of agricultural herbicide Pathogenicity: The donor organism, Stenotrophomonas maltophilia - an aerobic bacterium found in the environment and is found in the variety of foods and feeds, is safe. It can be found in healthy individuals without causing any harm to human health, and infections in humans caused by S.
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  • Spring '13
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  • Soybean, JDC, DENR

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