Philippines | BCH-RA-PH-116101 | Risk Assessment generated by a regulatory process | Biosafety Clearing-House

Loading...
  |  
BCH-RA-PH-116101-1   |   PDF   |   Print   |  

Risk Assessment generated by a regulatory process (RA)

last updated: 11 Jun 2021
General Information
Determination for the Safety Assessment of Combined Trait Product CORN TC1507x MON810 x MIR162 x NK603 for Direct Use as Food, Feed and for Processing
EN
Risk assessment details
  • DAS-Ø15Ø7-1 × MON-ØØ81Ø-6 × SYN-IR162-4 × MON-ØØ6Ø3-6 - Herbicide tolerant, insect resistant corn
    | Pioneer Hi-Bred International Inc. | Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate, Glyphosate)
Methodology and points to consider
Sufficient information and references were provided which support that the presence of Cry1F, PAT, Cry1Ab, VipAa20, PMI.  and CP4 EPSPS proteins will not interact to produce any new allergen or toxins.
EN
The different modes of action of Cry1F, PAT, Cry1Ab, VipAa20, PMI and CP4 EPSPS are not likely to interact. All the proteins except CP4 EPSPS are not targeted to any subcellular compartment and will accumulate in the cytoplasm as per report submitted. Meanwhile, CP4 EPSPS targets the chloroplast and will accumulate in the chloroplast.
EN
There are no possible unexpected effects on the metabolism of the plant due to the stacked genes introduced. The GMO product with the four stacked genes was produced through traditional breeding and the reference provided results of works clearly showing that the nutritional composition and agronomic traits are comparable to non-genetically modified reference maize and non-GM near-isoline control maize.
EN
The expression levels of the individual protein products are significantly similar to the individually approved transformation events. Interaction among the genes is not possible, thus, stability and expression level of either one of the genes would not be affected.
EN
Corn TC1507 x MON810 x MIR162 x NK603 will not pose any significant risk to the health and environment and that any hazards could be managed by the measures set by the department. A biosafety permit for direct use can be issued for the said event.
EN
Corn TC1507 x MON810 x MIR162 x NK603 has no evidence of interaction on the resulting gene products.
EN
The application of the combined trait product corn TC1507 x MON810 x MIR162 x NK603is not for propagation. This LMO will be directly used for food, feed and for processing.
The chances of unintended release or planting of the regulated article is very minimal and will not cause any damaging and lasting effects because the receiving environment (areas near port, roads, railways, etc.) is not conducive for plant growth. Also, corn is s highly domesticated plant that requires human intervention for it to persist in the environment
EN
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.
EN
Additional information
Combined trait product corn TC1507 x MON810 x MIR162 x NK603 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 during the evaluation of this combined trait product.

EN
Loading...