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OECD Unique Identifier details

DAS-21Ø23-5xDAS-24236-5
Commodity: Cotton
Traits: Glufosinate tolerance,Lepidoptera resistance
Australia
Name of product applicant: Dow AgroSciences Australia Pty Ltd
Summary of application:
Cotton line MXB-13 has been genetically modified for protection against the cotton
bollworm (Heliothis zea), tobacco budworm (H. virescens) and pink bollworm (Pectinophora gossypiella), significant pests of cotton crops in Australia. Protection is conferred by the expression in the plant of bacterially derived protein toxins (Bt-δ-endotoxins) that are specific for these insects. Cotton line MXB-13 also contains two copies of a gene encoding resistance to the herbicide glufosinate ammonium.

Cotton line MXB-13 contains two insecticidal genes (cry1Ac and cry1F), derived from the common soil bacterium Bacillus thuringiensis (Bt). These genes express insecticidal proteins (Cry1Ac and Cry1F) that are toxic to specific lepidopteran caterpillar insects, including the major pests of cotton. The insecticidal genes were introduced separately into two cotton lines (MXB-7 and MXB-9) and these two traits were subsequently combined by crossing the two GM cotton lines using conventional breeding to produce cotton line MXB-13.

Using two B. thuringiensis derived insecticidal proteins, rather than one, in the same plant improves the spectrum of control, the seasonal efficacy and significantly reduces the chances of selecting insects resistant to the toxins. Bt formulations are widely used as biopesticides on a variety of cereal and vegetable crops grown organically or under conventional agricultural conditions.

In addition to the two cry genes, cotton line MXB-13 contains two copies of a selectable marker gene (pat) from the bacterium Streptomyces viridochromogenes, which produces an enzyme (phosphinothricin acetyltransferase, PAT) that detoxifies the herbicide glufosinate ammonium. PAT functions as a selectable marker in the initial laboratory stages of plant cell selection and thus cotton line MXB-13 is also tolerant to the herbicide glufosinate ammonium, however, this trait is not used in commercial production of cotton line MXB-13.

Cottonseed is processed into four major by-products: oil, meal, hulls and linters. Only the oil and the linters are used in food products in Australia and New Zealand. Cottonseed oil is used in a variety of food including cooking, salad and frying oils: mayonnaise, salad dressing, shortening, margarine and packaging oils. Cotton linters are used as a cellulose base in high fibre dietary products as well as viscosity enhancers in toothpaste, ice cream and salad dressing. Cottonseed meal is primarily used for stock food and is not currently sold for human consumption in Australia or New Zealand.

Cotton line MXB-13 is being developed for cultivation in Australia and the USA. Licences have been granted by the Office of the Gene Technology Regulator (OGTR) for field trials of this cotton (DIR 40/2003 and DIR 44/2003). None of the plants produced during the field trials will enter the human food chain. Cotton is not grown in New Zealand.

Food from cotton line MXB-13 may therefore enter the Australian and New Zealand food supply as imported food products or from cotton grown in Australia.
Upload:
Date of authorization: 28/04/2005
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 Product Database
Summary of the safety assessment (food safety):
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: Application A518 - Food derived from Insect Protected cotton line MXB-13
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
janet.gorst@foodstandards.gov.au
Organization/agency name (Full name):
Food Standards Australia New Zealand
Contact person name:
Janet Gorst
Website:
Physical full address:
Boeing Building, 55 Blackall Street, Barton ACT 2600, Australia
Phone number:
+61 2 6271 2266
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 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)

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)

Mexico
Name of product applicant: Dow AgroSciences, S.A. de C.V.
Summary of application:

Authorization by COFEPRIS: 66


Cotton (Gossypium hirsutum L.) Lepidoptera insect resistant and tolerant to the herbicide glufosinate ammonium.

OECD identifier: DAS-21Æ23-5 x DAS-24236-5

Submissions (documentation must be submitted in Spanish and may be contained in electronic file):

1) Description of applications or proposed uses of modified food
2) Information concerning source, identity and function of the introduced genetic material, including stability testing
3) Information on the description of the genetic modification and characterization (description of the method of genetic transformation, characterization and description of the inserted genetic material)
4) information concerning the identity and role of the expression of the modified products, including an estimate of the concentration of the modification in the modified crop or food derived
5) Information regarding any expected or known product expression and the basis for concluding that food containing it can be safely consumed allergenicity
6) Information comparing the composition or characteristics of foodstuffs modified foods derived from the original variety or other commonly consumed varieties, with particular emphasis on important nutrients and toxic which can occur naturally in food
7) Additional information (relevant for the safety and nutritional assessment of the modified food)
8) authorizations issued by other countries of the product for human consumption (copy)

Proposed use:

To be processed and used in food and feed, feed and industrial products in the same way as the products obtained with conventional cotton.

 

Description from transformation:

Cry1Ac event

The transformation vector pMYC3006 was used for development of cotton Cry1Ac event 3006-210-23 and contains the coding sequences for cry1Ac and pat and regulatory elements. There is only one insertion of cry1Ac and pat genes in transgenic cotton event 3006-210-23.

 

Event Cry1F

The transformation vector used to develop pAGM281 cotton Cry1F event 281-24-236 containing the coding sequences for cry1F and pat and regulatory elements for expression in cotton. The cry1F gene was synthesized based on the peptide structure of the protein Cry1F. This gene is under the direction of the synthetic promoter (4OCS) Dmas2'. This chimeric promoter contains the promoter of the mannopine synthase derived from Agrobacterium tumefaciens strain LBA4404 and four copies plasmid pTi15955 intensifier cotopina (OCS) tumor synthase obtained from A. tumefaciens plasmid pTiAch5 induced. The pat gene coding for phosphinothricin acetyltransferase (PAT) from Streptomyces viridochromogenes. This gene is under the direction of one ubiquitin promoter (Ubi ZM1) of Zea mays and bidirectional terminator polyA ORF.

 

Stacked event

From the two developed transgenic events, it was created by conventional breeding, the stacked event.

Upload:
Date of authorization: 16/10/2008
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.):
Summary of the safety assessment (food safety):
UI OECD: DAS-21Ø23-5xDAS-24236-5 During the risk assessment of this GMO based on existing knowledge to date, no toxic or allergic effects neither substantial nutritional changes are observed. The event is as safe as its conventional counterpart. For more detail please find attached the risk assessment summary in this page.
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:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
sortiz@conacyt.mx
Organization/agency name (Full name):
CIBIOGEM
Contact person name:
Dra. Sol Ortiz García
Website:
Physical full address:
San Borja #938, Col. Del Valle • Del. Benito Juárez C.P. 03100, México, D.F.
Phone number:
+52 (55) 5575-6878
Fax number:
Country introduction:
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Secretaría de Salud / Phone: +52 55 5080 5200 /Email: ralatorre@cofepris.gob.mx%20

Mexico
Name of product applicant: Dow AgroSciences, S.A. de C.V.
Summary of application:

Authorization by COFEPRIS: 25


Cotton (Gossypium hirsutum L.) Lepidoptera insect resistant and tolerant to the herbicide glufosinate ammonium.

OECD identifier: DAS-21Æ23-5 x DAS-24236-5

Submissions (documentation must be submitted in Spanish and may be contained in electronic file):

1) Description of applications or proposed uses of modified food
2) Information concerning source, identity and function of the introduced genetic material, including stability testing
3) Information on the description of the genetic modification and characterization (description of the method of genetic transformation, characterization and description of the inserted genetic material)
4) information concerning the identity and role of the expression of the modified products, including an estimate of the concentration of the modification in the modified crop or food derived
5) Information regarding any expected or known product expression and the basis for concluding that food containing it can be safely consumed allergenicity
6) Information comparing the composition or characteristics of foodstuffs modified foods derived from the original variety or other commonly consumed varieties, with particular emphasis on important nutrients and toxic which can occur naturally in food
7) Additional information (relevant for the safety and nutritional assessment of the modified food)
8) authorizations issued by other countries of the product for human consumption (copy)

Proposed use:

To be processed and used in food and feed, feed and industrial products in the same way as the products obtained with conventional cotton.

 

Description from transformation:

Cry1Ac event

The transformation vector pMYC3006 was used for development of cotton Cry1Ac event 3006-210-23 and contains the coding sequences for cry1Ac and pat and regulatory elements. There is only one insertion of cry1Ac and pat genes in transgenic cotton event 3006-210-23.

 

Event Cry1F

The transformation vector used to develop pAGM281 cotton Cry1F event 281-24-236 containing the coding sequences for cry1F and pat and regulatory elements for expression in cotton. The cry1F gene was synthesized based on the peptide structure of the protein Cry1F. This gene is under the direction of the synthetic promoter (4OCS) Dmas2'. This chimeric promoter contains the promoter of the mannopine synthase derived from Agrobacterium tumefaciens strain LBA4404 and four copies plasmid pTi15955 intensifier cotopina (OCS) tumor synthase obtained from A. tumefaciens plasmid pTiAch5 induced. The pat gene coding for phosphinothricin acetyltransferase (PAT) from Streptomyces viridochromogenes. This gene is under the direction of one ubiquitin promoter (Ubi ZM1) of Zea mays and bidirectional terminator polyA ORF.

 

Stacked event

From the two developed transgenic events, it was created by conventional breeding, the stacked event.

Upload:
Date of authorization: 07/09/2004
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.):
Summary of the safety assessment (food safety):
UI OECD: DAS-21Ø23-5xDAS-24236-5 During the risk assessment of this GMO based on existing knowledge to date, no toxic or allergic effects neither substantial nutritional changes are observed. The event is as safe as its conventional counterpart. For more detail please find attached the risk assessment summary in this page.
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:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
sortiz@conacyt.mx
Organization/agency name (Full name):
CIBIOGEM
Contact person name:
Dra. Sol Ortiz García
Website:
Physical full address:
San Borja #938, Col. Del Valle • Del. Benito Juárez C.P. 03100, México, D.F.
Phone number:
+52 (55) 5575-6878
Fax number:
Country introduction:
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Secretaría de Salud / Phone: +52 55 5080 5200 /Email: ralatorre@cofepris.gob.mx%20

New Zealand
Name of product applicant: Dow AgroSciences Australia Pty Ltd
Summary of application:

Cotton line MXB-13 has been genetically modified for protection against the cotton
bollworm (Heliothis zea), tobacco budworm (H. virescens) and pink bollworm (Pectinophora gossypiella), significant pests of cotton crops in Australia. Protection is conferred by the expression in the plant of bacterially derived protein toxins (Bt-δ-endotoxins) that are specific for these insects. Cotton line MXB-13 also contains two copies of a gene encoding resistance to the herbicide glufosinate ammonium.

Cotton line MXB-13 contains two insecticidal genes (cry1Ac and cry1F), derived from the common soil bacterium Bacillus thuringiensis (Bt). These genes express insecticidal proteins (Cry1Ac and Cry1F) that are toxic to specific lepidopteran caterpillar insects, including the major pests of cotton. The insecticidal genes were introduced separately into two cotton lines (MXB-7 and MXB-9) and these two traits were subsequently combined by crossing the two GM cotton lines using conventional breeding to produce cotton line MXB-13.

Using two B. thuringiensis derived insecticidal proteins, rather than one, in the same plant improves the spectrum of control, the seasonal efficacy and significantly reduces the chances of selecting insects resistant to the toxins. Bt formulations are widely used as biopesticides on a variety of cereal and vegetable crops grown organically or under conventional agricultural conditions.

In addition to the two cry genes, cotton line MXB-13 contains two copies of a selectable marker gene (pat) from the bacterium Streptomyces viridochromogenes, which produces an enzyme (phosphinothricin acetyltransferase, PAT) that detoxifies the herbicide glufosinate ammonium. PAT functions as a selectable marker in the initial laboratory stages of plant cell selection and thus cotton line MXB-13 is also tolerant to the herbicide glufosinate ammonium, however, this trait is not used in commercial production of cotton line MXB-13.

Cottonseed is processed into four major by-products: oil, meal, hulls and linters. Only the oil and the linters are used in food products in Australia and New Zealand. Cottonseed oil is used in a variety of food including cooking, salad and frying oils: mayonnaise, salad dressing, shortening, margarine and packaging oils. Cotton linters are used as a cellulose base in high fibre dietary products as well as viscosity enhancers in toothpaste, ice cream and salad dressing. Cottonseed meal is primarily used for stock food and is not currently sold for human consumption in Australia or New Zealand.

Cotton line MXB-13 is being developed for cultivation in Australia and the USA. Licences have been granted by the Office of the Gene Technology Regulator (OGTR) for field trials of this cotton (DIR 40/2003 and DIR 44/2003). None of the plants produced during the field trials will enter the human food chain. Cotton is not grown in New Zealand.

Food from cotton line MXB-13 may therefore enter the Australian and New Zealand food supply as imported food products or from cotton grown in Australia.

Upload:
Date of authorization: 12/08/2005
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 Product Database
Summary of the safety assessment (food safety):
FSANZ has completed a comprehensive safety assessment of food derived from cotton line MXB-13 as required under the Food Standards Australia New Zealand Act 1999 (the FSANZ Act). The assessment included consideration of: (i) the genetic modification to the plant; (ii) the safety of any transferred antibiotic resistance genes; (iii) the potential toxicity and allergenicity of any new proteins; and (iv) the composition and nutritional adequacy of the food, including whether there had been any unintended changes. No potential public health and safety concerns were identified in the assessment of food derived from cotton line MXB-13. Therefore, on the basis of all the available evidence, including detailed studies provided by the Applicant, it has been concluded that food, namely oil and linters, derived from cotton line MXB-13 is as safe and wholesome as food derived from other cotton 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: Application A518 - Food derived from Insect Protected cotton line MXB-13
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
andrew.pearson@mpi.govt.nz
Organization/agency name (Full name):
Ministry for Primary Industries
Contact person name:
Andrew Pearson
Website:
Physical full address:
Pastoral House, 25 The Terrace, Wellington, 6012
Phone number:
+6448942535
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)

United States of America
Name of product applicant: Dow AgroSciences
Summary of application:

Please see EPA BRAD and FDA consultations.

Upload:
Date of authorization: 30/09/2004
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.): EPA BRAD
FDA Consultation 1
FDA Consultation 2
Summary of the safety assessment (food safety):
Please see EPA BRAD and FDA consultations.
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:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
jason.dietz@fda.hhs.gov
Organization/agency name (Full name):
Food and Drug Administration
Contact person name:
Jason Dietz
Website:
Physical full address:
5100 Paint Branch Parkway, College Park MD 20740
Phone number:
240-402-2282
Fax number:
Country introduction:

The United States is currently in the process of populating this database. The Food and Drug Administration regulates food and feed (food for humans and animals) from genetically engineered crops in conjunction with the Environmental Protection Agency (EPA). EPA regulates pesticides, including those that are plant incorporated protectants genetically engineered into food crops, to make sure that pesticide residues are safe for human and animal consumption and do not pose unreasonable risks of harm to human health or the environment. FDA In the Federal Register of May 29, 1992 (57 FR 22984), FDA published its "Statement of Policy: Foods Derived from New Plant Varieties" (the 1992 policy). The 1992 policy clarified the agency's interpretation of the application of the Federal Food, Drug, and Cosmetic Act with respect to human and animal foods derived from new plant varieties and provided guidance to industry on scientific and regulatory issues related to these foods. The 1992 policy applied to all foods derived from all new plant varieties, including varieties that are developed using genetic engineering (also known as recombinant deoxyribonucleic acid (rDNA) technology). In the 1992 policy, FDA recommended that developers consult with FDA about foods from genetically engineered plants under development and developers have routinely done so. In June 1996, FDA provided additional guidance to industry on procedures for these consultations (the consultation procedures). These procedures describe a process in which a developer who intends to commercialize food from a genetically engineered plant meets with the agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the genetically engineered food and then submits to FDA a summary of its scientific and regulatory assessment of the food. FDA evaluates the submission and if FDA has questions about the summary provided, it requests clarification from the developer. At the conclusion of the consultation FDA responds to the developer by letter. The approach to the safety assessment of genetically engineered food recommended by FDA during consultations, including data and information evaluated, is consistent with that described in the Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants. EPA The safe use of pesticidal substances is regulated by EPA. Food from a genetically engineered plant that is the subject of a consultation with FDA may contain an introduced pesticidal substance, also known as a plant-incorporated protectant (PIP), that is subject to food (food for humans and animals) safety and environmental review by EPA. PIPs are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. Both the PIP protein and its genetic material are regulated by EPA. When assessing the potential risks of PIPs, EPA requires studies examining numerous factors, such as risks to human health, non-target organisms and the environment, potential for gene flow, and insect resistance management plans, if needed. In regulating PIPs, decisions are based on scientific standards and input from academia, industry, other Federal agencies, and the public. Before the first PIP product was registered in 1995, EPA required that PIP products be thoroughly tested against human safety standards before they were used on human food and livestock feed crops. EPA scientists assessed a wide variety of potential effects associated with the use of PIPs, including toxicity, and allergenicity. These potential effects were evaluated in light of the public's potential exposures to these pesticides, taking into account all potential combined sources of the exposure (food, drinking water, etc.) to determine the likelihood that a person exposed at these levels would be predisposed to a health risk. Based on its reviews of the scientific studies and often peer reviews by the Federal Insecticide, Fungicide and Rodenticide Scientific Advisory Panel, EPA determined that these genetically engineered PIP products, when used in accordance with approved label directions and use restrictions, would not pose unreasonable risk to human health and the environment during their time-limited registration.

Useful links
Relevant documents
Stacked events:

Stacked events that are each plant incorporated protectants, as defined by the Environmental Protection Agency, must be registered by the Envriornmental Protection Agency before they can be commercialized.  Food/feed safety asssessment of single events are generally sufficient to ensure the safety of food/feed from stacked events.   

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

Food and Drug Administration (premarkt@fda.hhs.gov); Environmental Protection Agency