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Risk Assessment generated by a regulatory process (RA)
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BCH-RA-PH-106009-2   |   PDF   |   Print   |  
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published: 30 Oct 2014 last updated: 25 Mar 2025
General Information
Determination of the Safety of Syngenta's Stacked trait product corn: Bt11 x MIR162 x GA21 for Direct use as Food, Feed, and Processing
EN
28 Jul 2010
Risk assessment details
  • SYN-BTØ11-1 × SYN-IR162-4 × MON-ØØØ21-9 - Agrisure® Viptera™ 3110 Maize
    | Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths), European corn borer (Ostrinia nubilalis)), Resistance to herbicides (Glufosinate, Glyphosate), Selectable marker genes and reporter genes
Methodology and points to consider
Each protein (cry1Ab, PAT, Vip3Aa20, PMI and mepsps) has distinct mode of action and are not likely to interact.
EN
The five proteins (cry1Ab, PAT, Vip3Aa20, PMI and mepsps) shows no amino acid sequence
homology to known or putative allergenic proteins.
EN
The five proteins (cry1Ab, PAT, Vip3Aa20, PMI and mepsps) show no homology to any known mammalian allergen or toxin.There is no evidence suggesting that the five proteins will interact to form some new allergen or toxin since each protein has distinct mode of action and are not likely to interact.
EN
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 and for processing and is therefore approved for direct use as food, or feed or for processing. 
EN
A biosafety notification for stacked trait product corn: Bt11 x MIR 162 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 were issued to Syngenta Philippines Inc.
EN
BT11 X MIR162 x GA21 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
EN
This LMO will be directly used for food, feed and for processing. This application is not for propagation of Corn bt11 X MIR162 X GA21.
EN
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
EN
Information sharing with other databases
Yes
Yes
Yes
Yes
Yes
Additional information
Corn BT11 X MIR 162 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 this event.
EN
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