| Commodity: |
Corn / Maize |
| Traits: |
Glyphosate tolerance,Lepidoptera resistance,Coleoptera resistance,Dicamba tolerance,Glufosinate tolerance |
| Name of product applicant: |
Monsanto Argentina S.A.I.C. |
| Summary of application: |
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| Date of authorization: |
17/01/2019 |
| 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): |
• Inheritance studies conducted indicated that Mendelian segregation exists. • New expression proteins are expressed in low levels. • It is compositionally equivalent to its non-transgenic counterpart. • No evidence of similarity or homology was found with known toxic proteins. • There is no evidence of expression of known allergenic substances for the proteins expressed in the event. • There is no hypothesis of risk that indicates that there are effects of metabolic interactions and between the proteins of the events when they are accumulated. It is concluded that the stacked event is substantially equivalent to its conventional counterpart, therefore, it is as safe and no less nutritious than conventional commercial varieties. |
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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: |
GMO commercial approvals in Argentina
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E-mail:
Organization/agency name (Full name): Ministerio de Agroindustria
Contact person name: Andrés Maggi
Website:
Physical full address: Paseo Colón Avenue 367, 3° floor, City of Buenos Aires
Phone number: 54 11 5222 5986
Fax number:
Country introduction: In Argentina, the food and feed risk assessment process of transformation events, as the result of modern biotechnology, is carried out by the National Service for Agrifood Health and Quality (Senasa). The General Office of Biotechnology, is the area responsible for carrying out this task. It has an specific professional team and the advise of a Technical Advisory Committee composed of experts from several scientific disciplines representing different sectors involved in the production, industrialization, consumption, research and development of genetically modified organisms. Useful links
Relevant documents
Stacked events: Stacked events with all single events approved, are assessed as a new event, but with much less requirements, always on a case-by-case basis. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: National Service for Agrifood Health and Quality (Senasa)
https://www.argentina.gob.ar/senasa
https://www.argentina.gob.ar/senasa/programas-sanitarios/biotecnologia
| Name of product applicant: |
Monsanto Philippines, Inc. |
| Summary of application: |
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| Date of authorization: |
22/03/2022 |
| 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:
No interaction is expected on the resulting product, since safety conclusion of single events can be applicable to the safety of combined trait product produced by conventional breeding of two or more single events.[28]
Any likelihood of interaction will not likely lead to production of a new allergen or toxin in the combined trait product, since the modes of action are very different for the CP4 EPSPS, Cry1A.105, Cry2Ab2, Cry1Ab, Vip3Aa20, PMI, Cry3Bb1, DMO, and PAT (pat) proteins, and DvSnf7 RNA, suggesting that the proteins and RNA act independently. The likelihood of potential interaction with one another is not considered to be significant that could affect the stability and expression level of each gene nor lead to production of a new allergen or toxin in the combined trait product. Furthermore, there is no known mechanism of interaction among the proteins that could lead to adverse effects in humans, animals or environment. [28]
Given that the modes of action of each introduced gene are different from each other, each trait or protein will function independently as in single events. Therefore, it is unlikely that there are unintended adverse effects from inserted traits by combining them through conventional breeding. [28].
Metabolic Pathways:
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).[1][21][22][23][24][25][30].
Hofte and Whiteley (1989) had described the mode of actions of insecticidal crystal (Cry) proteins of Bacillus thuringiensis. Cry proteins have been divided into four (4) major classes and several subclasses characterized by both structural similarities and insecticidal spectra of the encoded proteins. Different classes and subclasses of Cry proteins bind selectively to specific sites in the midgut cells of susceptible insect species. The binding leads to the formation of cation-specific pores that disrupt the midgut ion flow, swelling of cells due to an influx of water, cell lysis, paralysis and death of insect. Cry1 proteins including Cry1Ac are specific to lepidopterans.[1][21][22][23][24][25][30].
Another protein that is toxic to lepidopteran insects is the Vip3Aa20. It has a different structural composition in contrast to its Cry protein counterparts, although Vip3Aa20 still has an equivalent toxicity towards lepidopteran species. It confers its mode of action by secretion into the extracellular environment, with its expressions manifested in the stationary phase, which is also a period of sporulation.[1][21][22][23][24][25][30].
PMI enzyme catalyzes the reversible conversion of mannose 6-phosphate and fructose 6-phosphate and enables many microorganisms to utilize mannose as a carbon and energy source. Transformed plant cells with pmi gene are able to survive and grow on mannose-containing selective media.[1][21][22][23][24][25][30].
DMO catalyzes the demethylation of dicamba to the non-herbicidal compound. DMO forms three component system comprised of a reductase, a ferredoxin, and a terminal oxygenase which functions together in a redox system, to transport electrons from nicotinamide adenine dinucleotide (NADH) to oxygen and catalyze the demethylation of dicamba.[1][21][22][23][24][25][30].
The gene product CP4 EPSPS in MON 87427; Cry1A.105, Cry2Ab2 in MON 89034; Cry1Ab in MON 810; Vip3Aa20 and PMI in MIR162; Cry3Bb1, CP4 EPSPS and DvSnf7 dsRNA in MON 87411; DMO, and PAT in MON 87419 have different modes of action and did not cause any interaction based on the protein expression.[1][21][22][23][24][25][30].
Gene Expression:
Validated multiplexed immunoassays and enzyme linked immunosorbent assays (ELISAs) for protein expression were used to assess the levels of CP4 EPSPS, Cry1A.105, Cry2Ab2, Cry1Ab, Vip3Aa20, PMI, Cry3Bb1, DMO, and PAT (pat) proteins in tissues of the combined trait product MON 87427 × MON 89034 × MON 810 × MIR162 × MON 87411 × MON 87419, and the singles MON 87427, MON 89034, MON 810, MIR162, MON 87411, and MON 87419. The CP4 EPSPS, Cry1A.105, Cry2Ab2, Cry1Ab, Vip3Aa20, PMI, Cry3Bb1, DMO and PAT (pat) proteins expression levels in the combined trait product MON 87427 x MON 89034 x MON 810 x MIR62 x MON 87411 x MON 87419 is same as to its corresponding single events.[23]. |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
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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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