Philippines | BCH-RA-PH-258569 | Risk Assessment generated by a regulatory process | Biosafety Clearing-House

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BCH-RA-PH-258569-1   |   PDF   |   Print   |  

Risk Assessment generated by a regulatory process (RA)

last updated: 06 Jan 2022
General Information
Determination for the Safety Assessment of Soybean MON87705 x MON87708 x MON89788 for Direct Use as Food, Feed and for Processing
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Date not available
Risk assessment details
  • DP-3Ø5423-1 × MON-877Ø8-9 × MON-89788-1 - High oleic acid, herbicide tolerant soy
    | Dupont Poineer | Changes in quality and/or metabolite content (Lipid and fatty acids), Resistance to herbicides (Glyphosate, Sulfonylurea), Tolerance to dicamba (3,6-dichloro-2-methoxybenzoic acid) herbicide.
Glyphosate herbicide tolerance - decreases binding affinity for glyphosate, thereby conferring increased tolerance to glyphosate herbicide;
 
Modified oil/fatty acid - reduces desaturation of 18:1 oleic acid to 18:2 linoleic acid; increases the levels of monounsaturated oleic acid and decreases the levels of saturated linoleic acid in the seed; decreases the transport of saturated fatty acids out of the plastid, thereby increasing their availability to desaturation to 18:1 oleic acid; reduces the levels of saturated fatty acids and increases the levels of 18:1 oleic acid
 
Dicamba herbicide tolerance – confers tolerance to the herbicide dicamba (2-methoxy-3,6-dichlorobenzoic acid) by using dicamba as substrate in an enzymatic reaction
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Methodology and points to consider
The two (2) proteins being expressed in the combined trait product, DMO and CP4 EPSPS, will not interact to produce any known allergen or toxins to human and animals. There is no known mechanism of interaction among the RNA-based suppression and the proteins that could lead to adverse effects in humans, animals or environment which is not likely to interact.

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The mode of action and metabolic pathways of each protein are significantly different from each other. DMO belongs to a family of Rieske oxygenase proteins, which is part of a threecomponent system that includes a ferredoxin, a reductase, and an oxygenase. It catalyzes the NADH-dependent oxidative demethylation of the herbicide dicamba. The CP4 EPSPS protein belongs to the family of EPSP synthases involved in the penultimate step of the biochemical shikimate pathway producing aromatic amino acids in the chloroplasts of plants. 
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The structural differences of DMO and CP4EPSPS proteins as well as the distinct modes of action among these proteins are unlikely to produce a significant interaction. This lack of interaction will not lead to production of a new allergen or toxin in the combined trait product. The dmo and cp4epsps are designed to encode chloroplast transit peptides so that DMO and CP4EPSPS proteins are directed to chloroplast.
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The likelihood of interaction of the two proteins involved in the combined trait product: DMO and CP4EPSPS is highly unlikely to produce any known allergen or toxins to human and animals because of the difference on their mode of action. There is no known mechanism of interaction among the RNA-based suppression and the proteins that could lead to adverse effects in humans, animals or environment which is not likely to interact. Furthermore, there are no possible unintended effects of stacked genes on the metabolism of the plant based on the previous assessments of individual transformation events. In addition, stability and expression of the gene will never be affected since molecular analyses also indicated the absence of any marker gene in MON87705 x MON87708 x MON89788 genome.

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After thorough scientific review and evaluation, it was concluded that soybean MON87705 x MON87708 x MON89788 will not pose any significant risk to the health and environment and that any hazards could be managed by the measures indicated by the applicant.
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Soybean MON87705 x MON87708 x MON89788 applied for direct use for food and feed or for processing (FFP) does not require changes in the usual practices in unloading, loading, transport, storage and processing. As such, the regulated article is as safe as its conventional counterpart and is not expected to pose any significant risk to human and animal health and environment while in transit, storage and processing.
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The application of Soybean MON87705 x MON87708 x MON89788is not for propagation. This LMO will be directly used for food, feed and for processing.

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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.

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Information sharing with other databases
No
Additional information
Soybean MON87705 x MON87708 x MON89788 is intended for direct use as food, feed and for processing.

The effect of Soybean MON87705 x MON87708 x MON89788on 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.
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