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Risk Assessment
Record information and status
Record ID
Date of creation
2014-11-03 01:01 UTC (tluzaransoriano@yahoo.com)
Date of publication
2014-11-03 03:31 UTC (estaciojulietafe@gmail.com)

General Information
  • Philippines
Title of risk assessment
Decision for the Safety Assessment of Syngenta's corn Bt11 x MIR162 x MIR604 x GA21 for Direct Use as food and feed or 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-IR162-4 x SYN-IR6Ø4-5 x MON-ØØØ21-9 - Agrisure Viptera® 4 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
Potential adverse effects identified in the risk assessment
The six proteins (Cry1Ab, PAT,Vip3Aa20, mCry3A, PMI and EPSPS)  show no homology to any known mammalian allergen or toxin.
Likelihood that the potential adverse effects will be realized
Based on the modes of action of the Cry1Ab, PAT, Vip3Aa20, mCry3A, PMI and EPSPS proteins, and
the location of these proteins' accumulation in the plant cells, there is no known mechanism of interaction among the gene products that could lead to adverse effects in human and animals.
Possible consequences:
There is no evidence suggesting that the six proteins will interact to form some new allergen or toxin since each has distinct mode of action and are not likely to interact.
Estimation of the overall risk
After reviewing the scientific data and information relevant to the combined trait product corn Bt11 x
MIR162 x MIR604 x GA21 application of Syngenta Philippines, Inc.,it is concluded that no interaction found between/among the combined traits. Hence, this plant product was found to be as safe as its conv
entional corn and can substitute for its traditional counterpart for direct use as food, feed and for processing and is therefore approved for direct use as food, or feed or for processing.
A biosafety notification for combined trait product : corn Bt11 x MIR162 x 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.
Need(s) for further information on specific issues of concern
BT11 X MIR162 X MIR604 X GA21 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 processing.
LMO detection and identification methods proposed
Quantitative diagnostic lateral flow strips, ELISA and PCR for routine quantitative and semi-quantitative detection of transgenes.  For higher sensitivity, real-time PCR.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.
Additional Information
Additional Information
The combined trait product BT11 X MIR162 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 and DA Regulatory Agencies during the evaluation of BT11 X MIR162 X MIR604 XGA21.
Other relevant website address or attached documents

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