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OECD Unique Identifier details

MON-87429-9
Commodity: Corn / Maize
Traits: Herbicide tolerance
Argentina
Name of product applicant: MONSANTO ARGENTINA S.R.L.
Summary of application:

MON-87429-9 maize was obtained by transformation mediated by Agrobacterium tumefaciens using the plasmid vector PV-ZMHT519224, from immature embryos of the conventional maize line LH244, and presents the following characteristics:


- Tolerance to herbicides based on dicamba.
- Tolerance to the herbicide glufosinate ammonium.
- Tissue-selective tolerance to glyphosate-based herbicides. The application of glyphosate-based herbicides just before and / or during the panicle development stage induces male sterility, facilitating the production of hybrid seed.
- Tolerance to the herbicide Quizalofop, belonging to the family of FOPs (aryloxyphenoxypropionates).
- Tolerance to herbicides based on 2,4-D.


It should be noted that the developer declares that MON-87429-9 maize expresses the herbicide tolerance phenotype of the aryloxyphenoxypropionates (FOPs) family. However, the scientific evidence provided by the applicant regarding tolerance to herbicides of the FOPs family is based on the use of Quizalofop, so the evaluation and conclusion on food suitability was made on its use.

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Date of authorization: 25/06/2021
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.):
Summary of the safety assessment (food safety):
Organism subject to control: Maize has a history of safe consumption and does not represent a concern for human or animal health based on its intended use. Donor organisms and introduced genes: - dmo: Stenotrophomonas maltophilia. - pat: Streptomyces viridochromogenes. - cp4 epsps: Agrobacterium sp. strain CP4. - ft_t: modified version of the R-2,4-dichlorophenoxy-propionate dioxygenase (Rdpa) gene from Sphingobium herbicidovorans. Donor organisms have a history of food use and their allergenic and toxicological characteristics do not represent a concern for human or animal health. Characterization of the event: MON 87429 maize was obtained by Agrobacterium tumefaciens-mediated transformation of immature embryos of the conventional LH244 maize line, and has the following characteristics: - Tolerance to herbicides based on dicamba. - Tolerance to the herbicide glufosinate ammonium. - Tissue-selective tolerance to glyphosate-based herbicides. The application of glyphosate-based herbicides just before and / or during the panicle development stage induces male sterility, facilitating the production of hybrid seed. - Tolerance to the herbicide Quizalofop, belonging to the family of FOPs (aryloxyphenoxypropionates). - Tolerance to herbicides based on 2,4-D. Molecular characterization: The insertion occurred at a single locus, it did not interrupt any gene or other genetic element of the maize genome, it is stable and is inherited according to the principles of Mendelian inheritance. Compositional Analysis: The studies on the composition presented show that, although some statistically significant differences were found in the comparisons, the values ​​obtained were within the range of the natural variability of corn cited in the scientific literature and within the range of the commercial varieties used. as comparators. The results obtained show that the analyzed event is substantially equivalent to its non-transgenic counterpart. Furthermore, it shows that the expression of the DMO, PAT, CP4 EPSPS and FT_T proteins in maize plants does not result in unintentional modifications in the normal biological processes of the plant. Allergenic and Toxicological Characteristics: The allergenicity and toxicity of the DMO, PAT and CP4 EPSPS proteins expressed in MON 87429 maize have a history of evaluation in other events, and in all cases it has been concluded that these proteins lack allergenic and toxicological potential. There are no relevant sequence similarities to any possible peptide encoded in the insert or junctions between the inserted DNA and the plant genome. Regarding the FT_T protein, bioinformatic analyzes demonstrated that there is no structurally relevant sequence similarity with any known allergen or toxin. On the other hand, the FT_T protein expressed in MON 87429 does not show glycosylation. The FT_T protein was also evaluated through acute oral toxicity studies in mice, degradation studies and loss of enzymatic activity in simulated gastric fluids, and thermal stability studies, so it is considered unlikely to produce adverse effects on human health and animals before the consumption of it. Feeding studies with the whole food: The results obtained in the feeding studies of MON 87419 maize with fast-growing chickens allow us to determine that there were no biologically relevant differences in the development of the chickens, carcass performance or mortality of the individuals fed diets with MON 87429 maize. According to the above, based on the scientific knowledge currently available and the internationally accepted requirements and criteria, it is concluded that the MON 87429 maize event, tolerant to the herbicides dicamba, glufosinate ammonium, quizalofop, 2,4-D and tissue-selective tolerance to glyphosate herbicide, it is as safe and no less nutritious than its conventional counterpart, so there are no objections to its approval for human and animal consumption.
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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:
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)
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.

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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

Australia
Name of product applicant: Monsanto
Summary of application:

FSANZ received an Application from Monsanto Australia, part of the Bayer group, to vary Schedule 26 in the Australia New Zealand Food Standards Code (the Code). The variation is to add food derived from a genetically modified corn line MON87429. This corn line has been genetically modified for herbicide tolerance. The herbicides include: glufosinate, dicamba, 2,4-dichlorophenoxyacetic acid (2,4-D) and the aryloxyphenoxypropionate (AOPP) acetyl coenzyme A carboxylase inhibitors (known as FOPs herbicides). MON87429 has also been genetically modified to provide tissue-specific tolerance to glyphosate to facilitate hybrid seed production.


Herbicide tolerance is achieved through introduction and expression of the:



  • pat gene from Streptomyces viridochromogenes, encoding the phosphinothricin-N-acetyltransferase (PAT) protein and providing tolerance to the herbicide glufosinate;

  • dmo gene from Stenotrophomonas maltophilia, encoding the dicamba mono-oxygenase (DMO) protein and providing tolerance to the herbicide dicamba;

  • ft_t gene, a modified version of the Rdpa gene from Sphingobium herbicidovorans, encoding the 2,4-D and FOPs dioxygenase protein (FT_T). This protein provides tolerance to 2,4-D and FOPs herbicides; and the

  • cp4 epsps gene from Agrobacterium sp. strain CP4, encoding a 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) protein and providing tolerance to the herbicide glyphosate.


The applicant has indicated that food derived from MON87429 may enter the Australian and New Zealand food supply as imported food products. These may include starch, grits, meal, flour, oil and sweetener products.

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Date of authorization: 03/12/2020
Scope of authorization: Food
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.): OECD Biotrack database
Summary of the safety assessment (food safety):
Please kindly refer to the attachment.
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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:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: A1192 – Food derived from herbicide-tolerant corn line MON87429
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Food Standards Australia New Zealand
Contact person name:
Website:
Physical full address:
Level 4, 15 Lancaster Place, Majura Park ACT 2609, Australia
Phone number:
+61 2 6271 2222
Fax number:
+61 2 6271 2278
Country introduction:

Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of food standards in Australia and New Zealand. The main office (approximately 115 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 10 staff) is located in Wellington on the North Island.

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Relevant documents
Stacked events:

FSANZ does not: Separately assess food from stacked event lines where food from the GM parents has already been approved; Mandate notification of stacked events by developers; Notify the public of stacked event ‘approvals’; List food derived from stacked event lines in the Code, unless the stacked event line has been separately assessed as a single line e.g. Application A518: MXB-13 cotton (DAS-21023-5 x DAS-24236-5)

No separate approval or safety assessment is necessary for foods derived from a stacked GM line that is the result of traditional breeding between a number of GM parent lines for which food has already been approved. Food from the parent lines must be listed in the Australia New Zealand Food Standards Code. The parent lines may contain any number of different genes. If food from any of the GM parent lines has not been approved, then a full pre-market safety assessment of food from the stacked line must be undertaken.

No separate approval is required for food derived from a line that is the product of a GM line, for which food has been approved, crossed traditionally with a non-GM line.

Where a single line containing a number of genes has been produced as a result of direct gene technology methods (rather than traditional crossing) then food derived from the line must undergo a full pre-market safety assessment before approval can be given

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Food Standards Australia New Zealand (FSANZ) (http://www.foodstandards.gov.au)

Canada
Name of product applicant: Bayer CropScience Inc.
Summary of application:

Bayer CropScience Inc. has developed a genetically modified Zea mays (maize) variety which exhibits exhibits tolerance to dicamba (3,6-dichloro-2-methoxybenzoic acid) herbicide; glufosinate (2-amino-4-(hydroxymethylphosphinyl) butanoic acid) herbicide; quizalofop (2-[4-(6-chloroquinoxalin-2-yl) oxyphenoxy] propanoic acid) herbicide; and 2,4-dichlorophenoxyacetic acid (2,4-D) herbicide. MON 87429 also produces the 5-enolpyruvylshikimate-3-phosphate synthase protein from Agrobacterium sp. strain CP4 (CP4 EPSPS). MON 87429 utilizes an endogenous maize regulatory element to target CP4 EPSPS mRNA for degradation in tassel tissues, resulting in reduced CP4 EPSPS protein expression in pollen. Appropriately timed glyphosate applications to MON 87429 produce a non-viable pollen phenotype and allow for desirable cross pollination in female inbred parents.

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Date of authorization: 23/04/2021
Scope of authorization: Food
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.): BioTrack Product Database
Summary of the safety assessment (food safety):
Please see the decision document weblink.
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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:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Novel Foods Decision Document
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Health Canada
Contact person name:
Neil Strand
Website:
Physical full address:
251 Sir Frederick Banting Driveway, Tunney's Pasture, PL 2204A1
Phone number:
613-946-1317
Fax number:
Country introduction:

Federal responsibility for the regulations dealing with foods sold in Canada, including novel foods, is shared by Health Canada and the Canadian Food Inspection Agency (CFIA). Health Canada is responsible for establishing standards and policies governing the safety and nutritional quality of foods and developing labelling policies related to health and nutrition. The CFIA develops standards related to the packaging, labelling and advertising of foods, and handles all inspection and enforcement duties. The CFIA also has responsibility for the regulation of seeds, veterinary biologics, fertilizers and livestock feeds. More specifically, CFIA is responsible for the regulations and guidelines dealing with cultivating plants with novel traits and dealing with livestock feeds and for conducting the respective safety assessments, whereas Health Canada is responsible for the regulations and guidelines pertaining to novel foods and for conducting safety assessments of novel foods.

The mechanism by which Health Canada controls the sale of novel foods in Canada is the mandatory pre-market notification requirement as set out in Division 28 of Part B of the Food and Drug Regulations.

Manufacturers or importers are required under these regulations to submit information to Health Canada regarding the product in question so that a determination can be made with respect to the product's safety prior to sale. The safety criteria for the assessment of novel foods outlined in the current guidance document (i.e. Canadian Guidelines for the Safety Assessment of Novel Foods) were derived from internationally established scientific principles and guidelines developed through the work of the Organization for Economic Cooperation and Development (OECD), Food and Agriculture Organisation (FAO), World Health Organisation (WHO) and the Codex Alimentarius Commission. These guidelines provide for both the rigour and the flexibility required to determine the need for notification and to conduct the safety assessment of the broad range of food products being developed. This flexibility is needed to allow novel foods and food products to be assessed on a case-by-case basis and to take into consideration future scientific advances.

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Relevant documents
Stacked events:

Food: Consistent with the definition of "novel food" in Division 28 of the Food and Drug Regulations, the progeny derived from the conventional breeding of approved genetically modified plants (one or both parents are genetically modified) would not be classified as a novel food unless some form of novelty was introduced into such progeny as a result of the cross, hence triggering the requirement for pre-market notification under Division 28. For example, notification may be required for modifications observed in the progeny that result in a change of existing characteristics of the plant that places those characteristics outside of the accepted range, or, that introduce new characteristics not previously observed in that plant (e.g. a major change has occurred in the expression levels of traits when stacked). In addition, the use of a wild species (interspecific cross) not having a history of safe use in the food supply in the development of a new plant line may also require notification to Health Canada. However, molecular stacks are considered new events and are considered to be notifiable as per Division 28.

Feed:

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Neil Strand, Section Head of Novel Foods

New Zealand
Name of product applicant: Bayer Australia Ltd
Summary of application:

To seek approval for food derived from herbicide-tolerant corn line MON87429, genetically modified to provide resistance to dicamba, glufosinate, 2,4-D and the aryloxyphenoxypropionate group of herbicides (‘FOPs’). MON87429 is also genetically modified to provide tissue-specific resistance to glyphosate to facilitate the production of hybrid seeds.

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Date of authorization: 13/12/2020
Scope of authorization: Food
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.): BioTrack Product Database
Summary of the safety assessment (food safety):
No potential public health and safety concerns have been identified in the assessment of herbicide-tolerant corn line MON87429. On the basis of the data provided in the application, and other available information, food derived from MON87429 is considered to be as safe for human consumption as food derived from conventional corn varieties.
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: A1192 – Food derived from herbicide-tolerant corn line MON87429
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministry for Primary Industries
Contact person name:
Fiapaipai Auapaau
Website:
Physical full address:
Pastoral House, 25 The Terrace, Wellington, 6012
Phone number:
+6448314946
Fax number:
Country introduction:

New Zealand and Australia share a joint food regulation system for the composition of labelling of most foods. Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of the joint food standards in Australia and New Zealand. The main office (approximately 120 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 15 staff) is located in Wellington on the North Island.

Useful links
Relevant documents
Stacked events:

FSANZ does not: Separately assess food from stacked event lines where food from the GM parents has already been approved; Mandate notification of stacked events by developers; Notify the public of stacked event ‘approvals’; List food derived from stacked event lines in the Code, unless the stacked event line has been separately assessed as a single line e.g. Application A518: MXB-13 cotton (DAS-21023-5 x DAS-24236-5)

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Food Standards Australia New Zealand (FSANZ) (http://www.foodstandards.gov.au)