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Risk Assessment
Record information and status
Record ID
46711
Status
Published
Date of creation
2008-09-15 03:56 UTC (zen0555@yahoo.com)
Date of last update
2012-06-01 06:33 UTC (zen0555@yahoo.com)

General Information
Country
  • Philippines
Title of risk assessment
Determination for the  Safety Assessment of  Combined Trait Product Corn: MIR604 x GA21 for Direct Use as Food, Feed and for Processing
Date of the risk assessment
Date not available
Competent National Authority(ies) responsible for the risk assessment
Department of Agriculture
Elliptical Circle, Diliman
Quezon City
Philippines, 1100
Phone:+632 928-8762 to 65 loc. 2210/2214/2254 ;+632 920-4369
Fax:+632 920-3986
Email:spja_osec@da.gov.ph
Url:DA
Risk assessment details
Living modified organism
SYN-IR6Ø4-5 x MON-ØØØ21-9 - Agrisure™ RW Rootworm-Protected Roundup Ready™ maize
Mannose tolerance
Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera)
Resistance to herbicides - Glyphosate
Selectable marker genes and reporter genes
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 two traits, insect resistance and herbicide tolerance are unrelated with different modes of action of different metabolic pathways. The three proteins (mCry3A, PMI and EPSPS) show no homology to any known mammalian allergen and toxin. There is no evidence suggesting that the three proteins will interact to form some new allergen or toxin. The gene products accumulate in different subcellular compartments of the plant. The site of mCry3A protein accumulation will be in the cytoplasm while the modified EPSPS enzyme is known to accumulate in the chloroplast.
Possible consequences:
The modes of action of the mCry3A and mEPSPS proteins are different and no interaction has been detected.  There is no indication that either of the traits has any effect on plant metabolism.  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
Combined trait product corn: MIR604 x 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. 
Recommendation(s)
A biosafety notification for Stacked 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. Corn MIR 604 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 MIR 604 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 application is not for the propagation of the combined trait product corn: MIR604 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
Combined trait product corn: 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.

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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