Philippines | BCH-RA-PH-105048 | Risk Assessment generated by a regulatory process | Biosafety Clearing-House

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Risk Assessment generated by a regulatory process (RA)

last updated: 19 Sep 2013
General Information
Determination for the Safety Assessment of Combined Trait Product Corn NK603 x T25  for Direct Use as food and feed or for processing
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Risk assessment details
Methodology and points to consider
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The stacked corn hybrid NK603 X T25   which was combined through traditional plant breeding expresses two novel proteins: CP4 EPSPS which confers tolerance to the herbicide glyphosate, and phosphinothricin N-acetyltransferase (PAT) which confers tolerance to the herbicide glufosinate ammonium. The CP4 EPSPS protein is produced by the cp4 epsps gene from NK603, which is proven to be a safe source and no known pathogenicity in humans and animals because of the absence of the shikimic acid pathway in animals. The PAT protein by the pat  gene from T25 encodes for PAT enzyme which acts specifically on the herbicide phosphinothricin and the substrate for the enzyme is not found in humans.  PAT has no known pathogenicity and allergenicity.  It is not homologous with known toxins and allergens.
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No interactions were found between the stacked traits, hence the Corn NK603 x T25 is as safe for human food, livestock feed and for processing as its conventional counterpart.
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Corn NK603 x T25 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 and feed or for processing is as safe and substantially equivalent to its unmodified counterpart.
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A biosafety notification renewal for Corn NK603 x T25 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 and feed or for processing was issued to Monsanto Phils. Inc.
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Corn NK603 x T25 is as safe for human food, livestock feed and for processing as its conventional counterpart.
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This application is not for propagation of the combined trait product corn NK603 × T25. This LMO will be directly used for food, feed and for processing.  
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For individual events, Corn NK603 and T25, in the combined trait product NK603 × T25, Qualitative diagnostic lateral flow strips, ELISA and PCR for routine qualitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR methods may be used.
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Additional information
Corn NK603 x T25 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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