Philippines | BCH-RA-PH-109749 | Risk Assessment generated by a regulatory process | Biosafety Clearing-House

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BCH-RA-PH-109749-1   |   PDF   |   Print   |  

Risk Assessment generated by a regulatory process (RA)

last updated: 03 Mar 2016
General Information
Decision for the Safety Assessment of Syngenta's corn GA21 x T25,  for Direct Use as food and feed or for processing
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28 Oct 2014
Risk assessment details
Methodology and points to consider
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The modes of action of GA21 and T25 are different hence, the gene products will not be involved in the same metabolic pathway. PAT protein has an enzymatic activity, but no endogenous substrate for the PAT protein has been identified in the maize plant.  The modified EPSPS enzyme is involved in the production of the aromatic amino acids: tyrosine, phenylalanine, and tryptophan. 
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There is no possible unexpected effect of the combined genes on the metabolism of the corn plant.
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Combined trait product cotton: GA21 x T25 applied for direct use shows no evidence of interaction of the resulting gene product and is safe for human food, livestock feed and for processing as its conventional counterparts.
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A biosafety notification for combined trait product: corn GA21 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, feed or for processing was issued to Syngenta Philippines Inc. Corn GA21 x T25 is found to be safe as its conventional counterpart and does not pose any significant risk to human and animal health.
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Corn GA21 x T25 is found to be 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 the corn GA21 x T25. This LMO will be directly used for food, feed and for 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 may be used.
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Additional information
Corn GA21 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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