Philippines | BCH-RA-PH-46711 | 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-46711-5   |   PDF   |   Print   |  
last updated: 01 Jun 2012
General Information
Determination for the  Safety Assessment of  Combined Trait Product Corn: MIR604 x GA21 for Direct Use as Food, Feed and for Processing
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Risk assessment details
  • SYN-IR6Ø4-5 × MON-ØØØ21-9 - Agrisure™ RW Rootworm-Protected Roundup Ready™ maize
    | Mannose tolerance, Resistance to diseases and pests (Insects, Coleoptera (beetles)), Resistance to herbicides (Glyphosate), Selectable marker genes and reporter genes
Methodology and points to consider
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The two traits, insect resistance and herbicide tolerance are unrelated with different modes of action of different metabolic pathways. The three proteins (mCry3A, PMI and EPSPS) show no homology to any known mammalian allergen and toxin. There is no evidence suggesting that the three proteins will interact to form some new allergen or toxin. The gene products accumulate in different subcellular compartments of the plant. The site of mCry3A protein accumulation will be in the cytoplasm while the modified EPSPS enzyme is known to accumulate in the chloroplast.
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The modes of action of the mCry3A and mEPSPS proteins are different and no interaction has been detected.  There is no indication that either of the traits has any effect on plant metabolism.  Compositional analysis carried out on the grain and forage from the combined trait product indicated that the analytes measured are comparable to the single events.
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Combined trait product corn: MIR604 x GA21 applied for direct use has shown no evidence of interaction of the resulting gene products and is safe for human food, livestock feed and for processing as its conventional counterparts. 
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A biosafety notification for Stacked MIR604 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. Corn MIR 604 x GA21 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
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Corn MIR 604 x GA21 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
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This application is not for the propagation of the combined trait product corn: MIR604 x GA21. This LMO will be directly used for food, feed and for processing. 
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Qualitative diagnostic lateral flow strips, ELISA and PCR for routine qualitative and semi-quantitative detection of transgenes. For higher sensitivity,   real-time PCR.
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Additional information
Combined trait product corn: MIR604 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 during the evaluation of this combined trait.

All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members during the evaluation of this combined trait.
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