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Risk Assessment generated by an independent or non-regulatory process
(IRA)
last updated: 01 Mar 2017
Determination of Safety of Monsanto's Stacked Trait Product Soybean: MON87708 x MON89788 for Direct Use as Food and Feed or Processing
EN
01 Feb 2017
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Competent National Authority:Department of Agriculture ()Elliptical Road, DilimanQuezon City,
1100, PhilippinesPhone: (02) 8928-8741 to 64 local 2118, 2214, 2215, 2240,Fax:Website: http://www.da.gov.ph, -
Competent National Authority:Department of Environment and Natural Resources ()Visayas Avenue, DilimanQuezon City, Metro Manila
1100, PhilippinesPhone: (02) 8925-8277,Fax:Email: actioncenter@denr.gov.ph, osec@denr.gov.ph,Website: http://www.denr.gov.ph, -
Competent National Authority:Department of Health ()Tayuman, Sta. CruzManila, Metro Manila
1003, PhilippinesPhone: (632) 8651-7800,Fax:Email: callcenter@doh.gov.ph,Website: http://www.doh.gov.ph,
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Person:Mr. Ariel J. BayotOfficer-In-Charge Chief, National Plant Quarantine Services DivisionSan AndresMalate, Manila
, PhilippinesPhone: +63 2 404-0409,Fax: +63 2 404-0409,Email: ajbayot@yahoo.com,Website:Related OrganizationBureau of Plant Industry (BPI)San Andres, MalateManila, Metro Manila
1004, PhilippinesPhone: 8524-9588 local 230,Fax:Email: bpibiotech@buplant.da.gov.ph,Website: https://biotech.buplant.da.com.ph/, -
Person:Ms. Ma. Lorelei U. AgbagalaSupervising Agriculturist, Post Entry QuarantineEconomic GardenLos Banos, Laguna
4030, PhilippinesPhone: +63 49 536 1678,Fax: +63 49 536 1678,Email: lorelieu5@gmail.com,Website: http://bpi.da.gov.ph,Related OrganizationBureau of Plant Industry (BPI)Economic GardenLos Banos, Laguna
4030, PhilippinesPhone: +63 49 536 1678,Fax: +63 49 536 1678,Email: lorelieu5@gmail.com,Website: http://bpi.da.gov.ph,
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MON-877Ø8-9 × MON-89788-1 - Herbicide tolerant soybean| Monsanto | Resistance to Dicamba, Resistance to herbicides (Glyphosate)
- MON-87708-x-MON-89788-Decision-Document.doc [ English ]
EN
The protein levels of the two protein products in MON87708 x MON89788 are equivalent to the protein levels expressed in both single events that were previously approved as validated by enzyme-linked immunosorbent assay (ELISA). DMO, in average was expressed in 41 ug/g of seed dry weight while CP4 EPSPS was expressed in 93 ug/g of seed dry weight.
In addition, the expressed proteins are not involved in the same metabolic pathway. DMO is a Rieske nonheme oxygenase which catalyzes the oxidative demethylation of dicamba to 3,6 dichlorosalicylic acid and formaldehyde. On the other hand, CP4 EPSPS is involved in the shikimic pathway of aromatic amino acid biosynthesis.
Lastly, occurrence of unexpected effects of the stacked genes is unlikely based on the compositional analysis of MON87708 x MON89788 seeds wherein there was no significant variation compared to the conventional variety of soybean (A3525).
EN
In addition, the expressed proteins are not involved in the same metabolic pathway. DMO is a Rieske nonheme oxygenase which catalyzes the oxidative demethylation of dicamba to 3,6 dichlorosalicylic acid and formaldehyde. On the other hand, CP4 EPSPS is involved in the shikimic pathway of aromatic amino acid biosynthesis.
Lastly, occurrence of unexpected effects of the stacked genes is unlikely based on the compositional analysis of MON87708 x MON89788 seeds wherein there was no significant variation compared to the conventional variety of soybean (A3525).
MON 87708 was compared to conventional soybean in eight anti-nutrient components. Statistically significant differences were observed in four namely, phytic acid, raffinose, stachyose, and daidzein. The levels of these antinutrients in seed of MON 87708 were within the range of natural variability of conventional commercial reference soybean varieties. The results further showed no health risk concern with the consumption of MON 87708 soybean. Soybean meal produced from MON 87708 compared to meal produced from conventional soybean through a broiler study showed no biologically meaningful differences in broiler performance, carcass yield or meat composition between the two groups. There was a comparable nutritional wholesomeness of the two diets.
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The Stacked Trait Soybean MON87707 x MON89788 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal, human health and the environment.
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After reviewing the scientific data and information relevant to the combined traits product Soybean MON87708 x MON89788 application of Monsanto Philippines Inc., it is concluded that no interaction was found between/among the combined traits as well as serious socio-economic, ethical and cultural issues. Hence this plant product was found to be as safe as its conventional soybean and can substitute for its traditional counterpart for direct use, and is therefore approved. Monsanto is hereby notified that it may proceed with the activities for the above product for direct use following all existing rules and regulations consistent with JDC No.1 Series of 2016.
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The Stacked Trait Soybean MON87707 x MON89788 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal, human health, environment, and no socio-economic, ethical and cultural concerns.
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This application is not for propagation of the Soybean MON87707 x MON89788. This LMO will be directly used for food, feed and for processing.
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Quantitative diagnostic lateral flow strips, ELISA and PCR for routine quantitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR may be used.
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Soybean MON87708 x MON89788 is intended for direct use as food, feed and for processing.
All relevant documents and references in support of their application were submitted by the technology developer to the Scientific and Technical Review Panel (STRP) members, DA, DOH, and DENR during the evaluation of this event. Socio-economic, Ethical and Cultural Considerations (SEECC) were taken into account during the review process.
EN
All relevant documents and references in support of their application were submitted by the technology developer to the Scientific and Technical Review Panel (STRP) members, DA, DOH, and DENR during the evaluation of this event. Socio-economic, Ethical and Cultural Considerations (SEECC) were taken into account during the review process.
