Philippines | BCH-RA-PH-115900 | Risk Assessment generated by a regulatory process | Biosafety Clearing-House

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Risk Assessment generated by a regulatory process (RA)

last updated: 19 Feb 2021
General Information
Determination for the Safety Assessment of Combined Trait Product Soybean MON87769 x MON89788  for Direct Use as Food, Feed and for Processing
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Risk assessment details
  • MON-87769-7 × MON-89788-1 - Soybeans with modified fatty acid profile and glyphosate tolerance
    | Monsanto | Changes in quality and/or metabolite content (Lipid and fatty acids), Resistance to herbicides (Glufosinate)
Methodology and points to consider
Soybean is considered to be a common allergenic food. Therefore, any potential change in the endogenous allergenicity of the GM plant when compared with that of its comparator(s) should be assessed. Such assessments were performed for the single-event soybeans MON 87769 and MON 89788, and no reasons for concern were identified.
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MON 87764 which contains the Pj. ∆6D and Nc.Fad3 proteins are members of a family of integral membrane fatty acid found in all eukaryotic organisms and some prokaryotes while MON 89788 which contains CP4 EPSPS belongs to the family of EPSPS synthases which are involved in the shikimic acid pathway producing aromatic amino acids in the chloroplasts of the plants.

The expression cassette of Pj∆6D and Nc.Fad3 does not have specific transit peptide unlike CP4 EPSPS which indicates that Pj∆6D and Nc.Fad3 will accumulate in the cytoplasm. CP4 EPSPS is targeted to accumulate in the chloroplast due to the presence of chloroplast transit peptide. This indicates that the gene products will accumulate in different subcellular compartments of the plant parts.
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Pj. ∆6D is a single polypeptide Δ6 desaturase which creates double bond at the 6th position from the carboxyl end of a fatty acid yielding significant levels of stearidonic Acid (SDA) in the seeds of MON 87769 while Nc.Fad3 is a single polypeptide ω3 desaturase which creates a double bond between the third and fourth carbon from the methyl end of a fatty acid yielding significant levels of SDA.

Pj∆6D is required to convert alpha linolenic acid (ALA) to SDA in the omega 3-fatty acid biosynthetic pathway. Expression of the introduced delta -6 desaturase gene (Pj.D6D) also results in the conversion of linoleic acid (LA) to gamma linolenic acid (GLA), in the omega-6 fatty acid pathway. While Nc∆15D catalyses the conversion of Linoleic acid (LA) to alpha linolenic acid (ALA), thereby increasing the pool of ALA available for conversion to SDA and gamma linolenic acid (GLA) to SDA.

CP4 EPSPS proteins are involved in the biochemical shikimic pathway producing aromatic amino acid in the chloroplasts. It catalyzes the transfer of enolpyruvyl group from phosphoenol pyruvate (PEP) to the 5-hydroxyl of shikimate3-phosphate (S3P) producing inorganic phosphate and 5 enolpyruvylshikimate-3-phosphate. This mechanism is being inhibited with glyphosate binding which blocks the binding of EPSPS to PEP. CP4 EPSPS, on the other hand, has higher affinity for PEP thus allowing the catalysis. This enzyme catalyzes the reaction wherein the enolpyruvyl group from phosphoenol pyruvate (PEP) is transferred to the 5-hydroxyl of shikimate-3-phosphate (S3P) to form 5-enolpyruvylshikimate-3-phosphate (EPSPS) and inorganic phosphate (Pi).  Based on these information, the gene products have different mode of action and are involved in different metabolic pathway.
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Upon extensive review and evaluation of the application for direct use as food and feed or for processing, including the scientific evidences from provided references, literature and other studies, soybean MON87769 x MON89788 is safe as its conventional counterpart and is not expected to pose any significant risk to the environment.
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Soybean MON87769 x MON89788 is as safe as its conventional counterpart and shall not pose any significant risk to human health and the environment. The regulated article does not require changes in the usual practices in transport, storage and processing. A biosafety permit for direct use can be issued for the said event.
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Based on the documents provided by the proponent, there is no possible interaction that would affect the stability and expression level of either one of the genes. The expression of the genes in the stacked trait is inherited and functioning properly indicating that there is no gene interaction.
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Soybean MON87769 x MON89788 application of is 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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Additional information
Soybean MON87769 x MON89788 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.
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