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Risk Assessment generated by a regulatory process
(RA)
last updated: 14 Jun 2012
Determination for the Safety Assessment of Combined Trait Product Corn: Bt11x MIR604 n for Direct Use as Food, Feed and for Processing
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Competent National Authority:Department of Agriculture ()Elliptical Road, DilimanQuezon City,
1100, PhilippinesPhone: +632 920-3986, +632 924-1278 local 2802,Fax: +632 920-3986,Email: osec.da@gmail.com,Website: http://www.da.gov.ph,
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SYN-BTØ11-1 × SYN-IR6Ø4-5 - Agrisure™ CB/LL/RW maize| Syngenta | Resistance to diseases and pests (Insects, Coleoptera (beetles), Western corn rootworm (Diabrotica virgifera), Lepidoptera (butterflies and moths), European corn borer (Ostrinia nubilalis)), Resistance to herbicides (Glufosinate), Selectable marker genes and reporter genes
- DA-BPI Biotech Website [ English ]
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The four proteins (cry1Ab, PAT, mCry3A and PMI) are produced by different control systems and the possibility that the proteins will interact to form a new allergen or toxin is highly improbable. The four proteins do not have homology to any known allergen or toxin. Gene expression studies showed that the four proteins are not present in any subcellular compartment but are rather localized in the cytoplasm.
The mode of action of each gene product Cry1Ab and mCry3A, is different. Each protein has a different target, i.e., Cry1Ab on certain Lepidoptera (European corn borer) and mCry3A on some species of Coleoptera (western and northern corn rootworm.
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The mode of action of each gene product Cry1Ab and mCry3A, is different. Each protein has a different target, i.e., Cry1Ab on certain Lepidoptera (European corn borer) and mCry3A on some species of Coleoptera (western and northern corn rootworm.
The evaluation of the individual genes and gene products showed no unexpected effects on the metabolism of the plant. The stacked genes and stacked gene products are also not expected to show effects on the metabolism of the plant. Furthermore, the stacked hybrid has been achieved by conventional breeding 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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BT11x MIR604 corn 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 Bt11 x MIR604 corn 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. Bt11 x MIR 604 corn 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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Bt11 x MIR 604 corn 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 LMO will be directly used for food, feed and for processing. This application is not for the propagation of the combined trait product corn: Bt11 x MIR604.
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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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Bt11 x MIR604 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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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.
- OECD Consensus Document on Corn [ English ]
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