| Commodity: |
Soyabean / Soybeans |
| Traits: |
Herbicide tolerance,High stearidonic acid |
| Name of product applicant: |
Monsanto Philippines Inc. |
| Summary of application: |
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| Upload: |
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| Date of authorization: |
22/08/2019 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
Gene Interaction
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 whilw 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.
Based on the list of genetic elements, 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.
Metabolic Pathways
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.
Gene Expression
The analysis of protein levels in soybean seeds produced in the United States (2007) showed that the expression of Pj. ∆6D Nc.Fad3 and CP4 EPSPS in MON 87769 x MON 89788 are equivalent to the protein expression in both single events, MON 87769 and MON 89788, which were detected in low levels (0.00043, 0.0023 and 0.037% total protein). The marker gene, cp4 epsps, used in the transformation of MON 87769 was segregated away from the T-DNA I of the single event by conventional breeding (Monsanto Philippines, Inc., 2017). This was being supported by the data on CP4 EPSPS expression in MON 87769 x MON 89788 which showed that the level of CP4 EPSPS in the combined trait product (70-160 µg/g dry weight) was equivalent to the MON 89788 (33-140 µg/g dry weight), the single event expressing the novel protein (Monsanto Philippines, Inc. 2014, Table 2. p. 10). The data indicates that the cp4 epsps marker gene in MON 87769 was not being expressed in MON 87769 x MON 89788 since the CP4 EPSPS expressed in the combined trait product was from MON 89788.
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.
Conclusion
After a thorough and scientific evaluation of the documents provided by Monsanto Philippines Inc. and other related literatures, scientific evidence indicates that the Combined Trait Product, Soybean MON 87769 x MON 89788 applied for direct use as food and feed or for processing has no evidence of interaction on the resulting gene products and as safe as it’s conventional counterpart.
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| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
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| Authorization expiration date (a blank field means there is no expiration date) |
August 21, 2024 |
E-mail:
Organization/agency name (Full name): Bureau of Plant Industry
Contact person name: Geronima P. Eusebio
Website:
Physical full address: San Andres St., Malate, Manila
Phone number: 632 404 0409 loc 203
Fax number:
Country introduction: In 1987, scientists from the University of the Philippines Los Banos (UPLB) and the International Rice Research Institute (IRRI), the Quarantine Officer of the Bureau of Plant Industry (BPI), and the Director for Crops of the Philippine Council for Agriculture, Forestry and Natural Resources Research and Development (PCARRD), recognizing the potential harm of the introduction of exotic species and genetic engineering, formed a committee and formulated the biosafety protocols and guidelines for genetic engineering and related research activities for UPLB and IRRI researchers. The committee went on to draft a Philippine biosafety policy, which was submitted to the Office of the President. On October 15, 1990, recognizing the potential for modern biotechnology both in improving the lives of the people and in creating hazards if not handled properly, President Corazon C. Aquino issued Executive Order 430 creating the National Committee on Biosafety of the Philippines (NCBP) that will formulate, review and amend national policy on biosafety and formulate guidelines on the conduct of activities on genetic engineering. The NCBP is comprised of representative of the Departments of Agriculture (DA); Environment and Natural Resources (DENR); Health (DOH); and Science and Technology (DOST), 4 scientists in biology, environmental science, social science and physical science; and 2 respected members of the community. On July 16, 2001, President Gloria Macapagal-Arroyo issued the Policy Statement on Modern Biotechnology, reiterating the government policy on promoting the safe and responsible use of modern biotechnology. On April 3, 2002, Department of Agriculture Administrative Order No. 8, Series of 2002 was issued implementing the guidelines for importation and release into the environment of Plants and Plant Products Derived from the Use of Modern Biotechnology. On March 17, 2006, President Gloria Macapagal-Arroyo issued Executive Order No.514 Establishing the National Biosafety Framework, prescribing guidelines for its implementation, reorganizing the National Committee on Biosafety of the Philippines, and for other purposes. On December 8, 2015, the Philippine Supreme Court declared DA AO8 null and void and any application for contained use, field testing, propagation and commercialization, and importation of GMOs was temporarily enjoined. In response to the nullification of DA AO8, the Technical Working Group composed of representatives from the Departments of Agriculture (DA), Science and Technology (DOST), Environment and Natural Resources (DENR), Health (DOH), and Interior and Local Government (DILG) drafted the Joint Department Circular No. 1, Series of 2016 (JDC No.1, S2016) titled 'Rules and Regulations for the Research and Development, Handling and Use, Transboundary Movement, Release into the Environment, and Management of Genetically-Modified Plant and Plant Products Derived from the Use of Modern Biotechnology'. There were series of meeting and five public consultations conducted before the JDC No.1, S2016 was approved and signed by the Secretaries of the abovementioned agencies on March 7, 2016 and took effect on April 15, 2016. Under this Circular, more government agencies were involved such as the Department of Science and Technology (DOST) to regulate applications for contained use and confined test of regulated articles; Department of Agriculture (DA) to evaluate applications for field trial, commercial propagation and transboundary movement of regulated articles; Department of Environment and Natural Resources (DENR) to evaluate environmental risks and impacts of regulated articles; Department of Health (DOH) to evaluate of environmental health impacts of regulated articles; and Department of the Interior and Local Government (DILG) to supervise public consultation during field trial.
Useful links
Relevant documents
Stacked events: Gene stacking in plants can be conferred either through genetic engineering or conventional breeding A full risk assessment as to food and feed or for processing shall be conducted to plant products carrying stacked genes conferred through genetic engineering or conventional breeding, where the individual traits have no prior approval for direct use as food and feed or processing from the Bureau of Plant Industry (BPI) A desktop or documentary risk assessment on the possible or expected interactions between the genes shall be conducted for stacked gene products with multiple traits conferred through conventional breeding and individual events granted prior approval by the Bureau of Plant Industry.
Plant Products Carrying Stacked Genes Conferred Through (a) Genetic Engineering or b) Conventional Breeding, with Individual Traits That Have No Prior Approval:
A full risk assessnent as to food and feed or processing shall be conducted,consistent with Part V of AO No. 8,"Approval Process For the Importation of Regulated Articles for Direct Use as Food and Feed or For Processing for plant products with multiple traits conferred through:
(a) genetic engineering, or
(b) conventional breeding, where the individual traits have no prior approval from the Bureau of Plant Industry (BPI) for direct use as food and feed or processing.
Plant Products Carrying Stacked Genes Conferred through Conventional Breeding:
For plant products with multiple traits conferred through conventional breeding,with all individual events granted prior approval and included in the Approval Registry, a notlfication shall be submitted by the technology developer to the BPI, which shall conduct an evaluation in accordance with the relevant criteria in Annex I of this Memorandum Circular. The list of data contained in Annex I will not preclude the inclusion of other issues and concerns that will be raised by the BPI and the Scientific and Technical Review Panel (STRP) during the course of the desktop review.
Notificatlon Requirement for Plant Products Carrying Stacked Genes
All technology developers shall submit a notification to the Bureau of Plant Industry of their developed plant products carrying stacked genes and shall be required to comply with the relevant approval process listed above.
The Bureau of Plant Industry shall issue a certiflcate as to the approval of the stacked gene product and shall likewise include the transformation event in the official approval registry of plant products for food and feed or processing. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Bureau of Plant Industry 692 San Andres St, Malate, Manila 1004
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