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Risk Assessment generated by a regulatory process (RA)
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BCH-RA-PH-46827-6   |   PDF   |   Print   |  
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published: 18 Sep 2008 last updated: 02 Aug 2012
General Information
Philippines
Determination for the Safety Assessment of Corn MIR 604 for Direct Use as Food, Feed and for Processing
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Risk assessment details
Methodology and points to consider
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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.
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The expression of mCry3A and pmi genes do not alter the basic maize metabolism
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Corn MIR604 is as safe as its conventional counterpart and does not pose any significant risk to animal and human health.
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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.
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Corn MIR604 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
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This application is not for propagation of Corn MIR604. This LMO will be directly used for food, feed and processing. 
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Quantitative diagnostic lateral flow strips, ELISA and PCR for routine quantitative and semi-quantitative detection of transgenes.  For higher sensitivity, real-time PCR.
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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
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Records referencing this document Show in search
Record type Field Record(s)
Country's Decision or any other Communication Risk assessment 1

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