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Risk Assessment generated by an independent or non-regulatory process (IRA)
  |  
BCH-IRA-PH-111736-1   |   PDF   |   Print   |  
last updated: 01 Mar 2017
General Information
Determination of Safety of Monsanto's Stacked Trait Product Corn: MON89034 x NK603 for Commercial Propagation
EN
30 Sep 2016
Risk assessment details
  • MON-89Ø34-3 × MON-ØØ6Ø3-6 - Genuity® VT Double Pro™ Maize
    | Resistance to antibiotics (Kanamycin), Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Resistance to herbicides (Glyphosate)
Methodology and points to consider
EN
The Cry proteins and EPSPS belong to very different classes of proteins. As such they have varying structures, functions, belong to different metabolic pathways, and have dissimilar modes of action. They can then be considered to be independent of each other. The genes have been found to be completely expressed and the proteins functional in MON89304 x NK603. Having the genes encoding for these different proteins and having the proteins fully functional in the same plant did not cause any adverse effect on the metabolism of the plant.  Furthermore, the Cry proteins and the CP4 EPSPS are structurally and functionally independent of each other. Any likely possible interaction between them may be considered to be insignificant and will not affect the stability and expression level of either one of the genes.
EN
Few anti-nutrients have been established to occur in corn, which has no relevance to its food use. Though trypsin inhibitor, phytic acid, and secondary metabolites such as raffinose, ferulic acid and p-coumaric acid have been established as anti-nutrients in corn, they are present in very low amount and are below the thresholds considered to raise a food safety concern. The amount of anti-nutrients present in MON89034 and NK603 fell within the range found in non-transgenic corn.
EN
Stacked Trait Corn MON89034 x NK603 is found substantially equivalent to its conventional counterpart and does not pose any significant risks to animal, human health and the environment.
EN
After reviewing the scientific data and information relevant to the combined traits product Corn MON89034 x NK603 application of Monsanto Philippines Inc., it is concluded that no interaction was found between/among the combined traits as well as serious socio-economic, ethical and cultural issues. Hence, this plant product was found to be as safe as the conventional corn and can substitute for its traditional counterpart for commercial propagation, and is therefore approved for commercial propagation.  Monsanto is hereby notified that it may proceed with the activities for the above propagation following all existing rules and regulations consistent with JDC No.1 Series of 2016.
EN
Stacked Trait Corn MON89034 x NK603 is found substantially equivalent to its conventional counterpart and does not pose any significant risk to animal, human health and the environment.
EN
This application is for commercial propagation of the MON89034 x NK603. This LMO is likewise evaluated for its safety for food, feed or for processing.
EN
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.
EN
Additional information
Corn MON89034 x NK603 is intended for commercial propagation.

All information and relevant references in support of their application were submitted by the technology developer to  the Scientific and Technical Review Panel (STRP) members,  the DA, DOH and DENR  for use during the the evaluation of this event.
EN