Philippines | BCH-RA-PH-109263 | Risk Assessment generated by a regulatory process | Biosafety Clearing-House

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Risk Assessment generated by a regulatory process (RA)
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BCH-RA-PH-109263-1   |   PDF   |   Print   |  
last updated: 16 Nov 2015
General Information
Determination of the Safety of Syngenta's Stacked trait product corn: Bt11 x MIR162 x TC1507 x GA21 for Direct use as Food, Feed, or Processing
EN
20 Dec 2010
Risk assessment details
  • SYN-BTØ11-1 × SYN-IR162-4 × DAS-Ø15Ø7-1 × MON-ØØØ21-9 - Agrisure™ Viptera 3220 Maize
    | Syngenta Seeds GmbH | Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths), European corn borer (Ostrinia nubilalis)), Resistance to herbicides (Glufosinate, Glyphosate)
Methodology and points to consider
The six proteins (Cry1Ab, PAT, Vip3Aa20, Cry1F, PMI and EPSPS) show no homology to any known mammalian allergen or toxin.
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There is no evidence suggesting that the six proteins will interact to form (some) new allergen or toxin since each has distinct mode of action and are not likely to interact. Allergenicity and toxicity reports on individual proteins in each event were provided when the single events were submitted for Biosafety assessment, all of which received Biosafety approvals for food, feed or for processing.
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There is no known mechanism of interaction among these proteins that could lead to adverse effects in humans or animals.
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After reviewing the scientific data and information relevant to the combined traits product corn Bt11 x MIR162 x TC1507 x GA21 application of Syngenta Philippines Inc., it is concluded that no interaction was found between/among the combined traits, hence this plant product was found to be as safe as its conventional corn and can substitute for its traditional counterpart for direct use as food, feed or for processing and is therefore approved for direct use as food, or feed or for processing. 
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A biosafety notification for combined trait product corn: Bt11 x MIR 162 x TC1507 x GA21 and all progenies derived from crosses of the product with any conventionally bred corn and corn containing approved-biotech events for direct use as food, feed or for processing was issued to Syngenta Philippines Inc.
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Bt11 x MIR162 x TC1507 x GA21 is as safe for human food, livestock feed and for processing as its conventional counterparts. 
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This LMO will be directly used for food, feed and 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.Methods and protocols for safe handling, storage, transport and use are all indicated in the implementing rules and regulations (IRRs), memo circulars supplementing Administrative Order No. 8 of the Department of Agriculture; also the general guidelines of the National Committee on Biosafety of the Philippines.
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Additional information
The combined trait product Bt11 x MIR162 x TC1507 x GA21 is intended for direct use as food, feed and for processing.

All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members and DA Regulatory Agencies during the evaluation of Bt11 x MIR162 x TC1507 x GA21.
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Country's Decision or any other Communication Risk assessment 1