Philippines | BCH-RA-PH-258567 | Risk Assessment generated by a regulatory process | Biosafety Clearing-House

Risk Assessment generated by a regulatory process (RA)
BCH-RA-PH-258567-1   |   PDF   |   Print   |  
last updated: 06 Jan 2022
General Information
Determination for the Safety Assessment of Soybean MON87708 x MON89788 x A5547- 127 for Direct Use as Food, Feed and for Processing
Date not available
Risk assessment details
  • MON-87751-7 × MON-877Ø1-2 × MON-877Ø8-9 × MON-89788-1 - Herbicide tolerant insect resistant soybean
    | Monsanto | Resistance to Diacamba, Resistance to diseases and pests (Insects, Coleoptera (beetles), Lepidoptera (butterflies and moths)), Resistance to herbicides (Glyphosate)
Glyphosate herbicide tolerance - decreases binding affinity for glyphosate, thereby conferring increased tolerance to glyphosate herbicide;
Glufosinate herbicide tolerance - eliminates herbicidal activity of glufosinate (phosphinothricin) herbicides by acetylation
Dicamba herbicide tolerance – confers tolerance to the herbicide dicamba (2-methoxy-3,6-dichlorobenzoic acid) by using dicamba as substrate in an enzymatic reaction
Methodology and points to consider
DMO, CP4 EPSPS and PAT are structurally and functionally different and they are independent from each other. Thus, even if they are bred together in a single hybrid, it is highly likely that they will function independently as in single events.

Genetic and molecular analyses showed that all three genes are inherited, expressed and functioning properly in MON 87708 x MON 89788 x A5547-127, as they did similarly in single events. The possibility of occurrence of an unexpected effect of the stacked genes on the metabolism of the hybrid in highly unlikely.
DMO, CP4 EPSPS and PAT are all expressed at low levels in MON 87708 x MON 89788 x A5547-127. In addition, protein expression level analysis did not show any indication that the marker genes were transferred and expressed in plants containing the combined genes.

The likelihood of interaction among the three (3) proteins (DMO, PAT, and CP4 EPSPS) is unlikely because their modes of action are different. In addition, allergen and toxicity analyses of the three proteins have shown that these proteins show no homology to any known mammalian allergen or toxin.

There is scientific evidence that soybean MON87708 x MON 89788 x A5547-127 applied for direct use has no evidence of interaction on the resulting gene products.
Scientific pieces of evidence from toxicity studies and references find that Soybean MON87708 x MON89788x A5547-127 will not cause significant adverse health effects to human and animal health. Dietary exposure to the regulated article is unlikely to result allergic reaction
The application of Soybean MON87708 x MON89788x A5547-127 is not for propagation. This LMO will be directly used for food, feed and for processing.

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.

Information sharing with other databases
Additional information
Soybean MON87708 x MON89788 x A5547-127 is intended for direct use as food, feed and for processing.
The effect of Soybean MON87708 x MON89788x A5547-127 on the environment depends largely on the viability of the product to be utilized for direct use. lf the article is transported in a non-viable form, there is no danger to the environment.