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Risk Assessment
Record information and status
Record ID
Date of creation
2008-11-28 06:23 UTC (estaciojulietafe@gmail.com)
Date of last update
2012-10-11 09:48 UTC (tluzaransoriano@yahoo.com)
Date of publication
2012-10-11 14:27 UTC (estaciojulietafe@gmail.com)

General Information
  • Philippines
Title of risk assessment
Determination for the Safety Assessment of Combined Trait Product Corn: Bt11x MIR604 X GA21 for Direct Use as Food, Feed and for Processing
Date of the risk assessment
Competent National Authority(ies) responsible for the risk assessment
Department of Agriculture
Elliptical Road, Diliman
Quezon City
Philippines, 1100
Phone:+632 920-3986,+632 924-1278 local 2802
Fax:+632 920-3986
Risk assessment details
Living modified organism
SYN-BTØ11-1 x SYN-IR6Ø4-5 x MON-ØØØ21-9 - Agrisure™ 3000GT Maize
Mannose tolerance Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera), Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate, Glyphosate Selectable marker genes and reporter genes
Show detection method(s)
Scope of the risk assessment
  • LMOs for direct use as feed
  • LMOs for direct use as food
  • LMOs for processing
Risk assessment report / Summary
Methodology and points to consider
Likelihood that the potential adverse effects will be realized
The mode of action of each gene product (cry1Ab, mcry3A and mepsps), is different.Each protein has a different target, i.e., Cry1Ab on certain Lepidoptera (European corn borer), mCry3A on some species of Coleoptera (western and northern corn rootworm and mepsps on glyphosate.
Possible consequences:
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.
Estimation of the overall risk
BT11x MIR604 X GA21 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.
A biosafety notification for Bt11 x MIR604 X GA21 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 x GA21 corn is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
Need(s) for further information on specific issues of concern
Bt11 x MIR 604 x GA21corn is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
Receiving environment(s) considered
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 x GA21
LMO detection and identification methods proposed
Qualitative diagnostic lateral flow strips, ELISA and PCR for routine qualitative and semi-quantitative detection of transgenes. For higher sensitivity,real-time PCR.
Additional Information
Additional Information
Bt11 x 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.
Other relevant website address or attached documents

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