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Risk Assessment generated by a regulatory process (RA)
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BCH-RA-PH-44572-13   |   PDF   |   Print   |  
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published: 01 Apr 2008 last updated: 25 Mar 2025
General Information
Philippines
Determination for  the Safety Assessment of Corn T25 for Direct Use as Food, Feed and for Processing
EN
05 Dec 2003
Risk assessment details
Methodology and points to consider
EN
The inserted gene, phosphinothricin acetyltransferase (pat) which encodes for PAT enzyme 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.  PAT enzyme is present at very low level.  It is easily denatured under conditions at time and temperature required for corn processing.   It was found to be readily digested in conditions that mimic human digestion.  
EN
Compositionally, maize derived from Corn T25 is, with the exception of the expression of the phosphinothricin acetyltransferase PAT, substantially equivalent to maize derived through conventional breeding practices.  PAT is a highly specific enzyme that acetylates phosphinotricin, the herbicidally active component in glufosinate ammonium herbicide. No genetic modification was made to affect processing or that would require a change in established maize processing methods.
EN
Corn T25 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
EN
A biosafety permit for Corn T25and 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 and for processing was issued to Bayer CropScience. Corn T25 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
EN
Long time monitoring for unintended effects should be conducted (allergenicity and nutritional effects)
EN
This application is not for the direct propagation of this event. This LMO will be directly used and/or processed for animal feed. 
EN
Quantitative diagnostic lateral flow strips, ELISA and PCR for routine quantitative and semi-quantitative detection of transgenes.  For higher sensitivity, real-time PCR.
EN
Information sharing with other databases
Yes
Yes
Yes
Yes
Yes
Additional information
Corn 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
EN

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