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Risk Assessment
Record information and status
Record ID
46827
Status
Published
Date of creation
2008-09-18 02:10 UTC (estaciojulietafe@gmail.com)
Date of last update
2012-08-02 02:49 UTC (purisima78@yahoo.com)
Date of publication
2012-08-02 06:46 UTC (estaciojulietafe@gmail.com)

General Information
Country
  • Philippines
Title of risk assessment
Determination for the Safety Assessment of Corn MIR 604 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 Road, Diliman
Quezon City
Philippines, 1100
Phone:+632 920-3986,+632 924-1278 local 2802
Fax:+632 920-3986
Email:osec.da@gmail.com
Url:DA
Risk assessment details
Living modified organism
SYN-IR6Ø4-5 - Agrisure™ RW Rootworm-Protected maize
Mannose tolerance Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera) 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
Toxicity and allergenicity studies showed that both mCry3A and PMI proteins are readily degradable in gastric conditions and have no similarity to any known toxins or allergens. Toxicity studies showed that mCry3A and PMI did not exhibit adverse effects on laboratory animals. No significant adverse effects were noted on key nutrients and major analytes.Potential toxicant (DIMBOA) has been reported in maize leaves and roots but decline as the plants grow and therefore not a risk concern.
Possible consequences:
The expression of mCry3A and pmi genes do not alter the basic maize metabolism
Estimation of the overall risk
Corn MIR604 is as safe as its conventional counterpart and does not pose any significant risk to animal and human health.
Recommendation(s)
A biosafety permit for Corn MIR604 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 MIR604 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 MIR604 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 propagation of Corn MIR604. 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.
Additional Information
Additional Information
Corn MIR604 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 this event
Other relevant website address or attached documents

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