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Risk Assessment
Record information and status
Record ID
Date of creation
2008-09-15 02:58 UTC (estaciojulietafe@gmail.com)
Date of last update
2012-08-16 22:59 UTC (tluzaransoriano@yahoo.com)
Date of publication
2012-08-17 02:45 UTC (estaciojulietafe@gmail.com)

General Information
  • Philippines
Title of risk assessment
Determination for the  Safety Assessment of Combined Trait Product Corn: Bt11x 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 MON-ØØØ21-9 - YieldGard™ Roundup Ready™ maize
Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate, Glyphosate
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 three proteins (Cry1Ab, PAT and EPSPS) show no homology to any known mammalian allergen or toxin.  There is no evidence suggesting that the three proteins will interact to form some new allergen or toxin.  The mode of action of each gene product of Bt11 protein and mEPSPS) protein are different.  The products of the Bt 11 gene and mepsps gene are involved in two distinctly metabolic pathways.  Stacked trait product corn Bt11 and GA21 do not pose any adverse effect on the metabolism of the plant as evidenced by the fact that the superiority in yield of the hybrid has been maintained.
Possible consequences:
Results of biochemical analyses have shown that the expression levels of the cry1Ab, pat and mepsps in the stacked hybrid are comparable with that of the counterpart genes in the single events.  The PAT protein in the stacked hybrid is present but as already noted, the amount is below the limit of quantitation.
Estimation of the overall risk
Combined trait product corn BT11x 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.
A biosafety notification for combined trait product corn Bt11 x GA21and 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 Bt11 X GA21 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
Corn Bt11 X GA21 is found to be safe as its conventional counterpart and does not pose any significant risk to human and animal health.
Receiving environment(s) considered
This application is not for the propagation of the combined trait product corn: Bt11 x GA21. This LMO will be directly used for food, feed and for processing.  
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 GA21 corn 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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