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Risk Assessment generated by a regulatory process (RA)
last updated: 01 Jun 2012
Determination for the Safety Assessment of the Combined Trait Product Corn MON 88017 x MON 810 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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MON-88Ø17-3 × MON-ØØ81Ø-6 - YieldGard™ VT Triple| Monsanto | Resistance to diseases and pests (Insects, Coleoptera (beetles), Lepidoptera (butterflies and moths), European corn borer (Ostrinia nubilalis)), Resistance to herbicides (Glyphosate)
- DA-BPI Biotech Website [ English ]
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Based on the different modes of action of the Cry3Bb1, Cry1Ab and CP4 EPSPS proteins, the likelihood of interaction or synergistic effects that would affect the biological activities of the individual proteins is considered highly unlikely.
Bioefficacy results demonstrate that MON 88017 x MON 810 is equivalent to MON 88017 for corn rootworm bioefficacy and glyphosate tolerance, and to MON 810 for corn borer efficacy. These results indicate that combining individual transformation events through traditional breeding does not alter their insecticidal efficacy or herbicide tolerance characteristics.
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Bioefficacy results demonstrate that MON 88017 x MON 810 is equivalent to MON 88017 for corn rootworm bioefficacy and glyphosate tolerance, and to MON 810 for corn borer efficacy. These results indicate that combining individual transformation events through traditional breeding does not alter their insecticidal efficacy or herbicide tolerance characteristics.
Because of the different sites of accumulation and mode of action of the products, unexpected effects of the stacked genes, cp4 epsps, cry1Ab and cry3Bb1, on the metabolism of the plant is less likely to occur.
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The combined trait product corn MON 88017 x MON 810 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 or feed or for processing is as safe and substantially equivalent to its unmodified counterpart. There is no evidence of interaction of the novel gene products leading to over expression/under expression and/or unintended effects.
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A biosafety notification for combined trait product corn MON 88017 x MON 810 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 and feed or for processing was issued to Monsanto Philippines Inc. Corn MON 88017 x MON 810 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 MON 88017 x MON 810 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 propagation of the combined trait product corn: MON 88017 x MON 810. This LMO will be directly used for food, feed and for processing.
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For the individual events, MON 88017 and MON 810 in the combined trait product MON 88017 x MON 810, diagnostic lateral flow strips, ELISA and PCR for routine qualitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR methods can be used.
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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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.
The combined trait product corn MON 88017 and MON 810 is intended for direct use as food and feed and/or 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 product.
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 product.
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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 product.
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 product.
- OECD Consensus Document on Corn [ English ]
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