| Commodity: |
Cotton |
| Traits: |
Bromoxynil tolerance,Kanamycin resistance |
| Name of product applicant: |
Aventis CropScience Pty Ltd and the Stoneville Pedigreed Seed Company |
| Summary of application: |
Rhone Poulenc Rural Australia Pty Ltd (now trading as Aventis CropScience Pty Ltd after its merger with AgrEvo) and the Stoneville Pedigreed Seed Company (formerly owned by Monsanto Co.) have made a joint application to ANZFA to amend Standard A18 of the Australian Food Standards Code to include food derived from cotton which has been genetically modified to be tolerant to the oxynil family of herbicides comprising bromoxynil and ioxynil. The genetically modified cotton is known commercially either as OXY cotton or BXN cotton.
The oxynil family of herbicides act by inhibiting electron transport in photosystem II in
plants. Inhibition of electron transport causes superoxide production resulting in the
destruction of cell membranes and an inhibition of chlorophyll formation, leading to plant death. Tolerance to either bromoxynil (3,5-dibromo-4- hydorxybenzonitrile) or ioxynil (3,5-di-iodo-4-hydroxybenzonitrile) is achieved through expression in the plant of a bacterial nitrilase enzyme that hydrolyses the herbicide to aninactive, non-phytotoxic compound. The nitrilase is derived from the bacterium Klebsiella
pneumoniae subspecies ozaenae which is responsible for rapidly degrading bromoxynil in soil. The nitrilase enables the bacterium to utilise bromoxynil as a sole source of nitrogen.
The oxynil herbicides are primarily used on field corn, wheat and grain crops to control a variety of grasses and broadleaf weeds. Low concentrations of bromoxynil-containing
herbicides kill conventional cotton varieties. Therefore, current weed control practices in cotton involve either prophylactic pre-plant, pre-emergence herbicide application or postdirected herbicide sprays to avoid crop injury. The rationale for engineering cotton to be bromoxynil-tolerant is to enable bromoxynil-containing herbicides to be used for the postemergence control of dicotyledonous weeds in cotton crops.
The major human food products obtained from cotton are refined oil and linters. Cottonseed oil is a premium quality oil that may be used in a variety of foods including frying oil, mayonnaise, salad dressing, shortening, margarine and packing oil. Linters are short fibresremoved from the cottonseed during processing (delinting).
After extensive processing at alkaline pH and high temperatures, the linters may be used as high fibre dietary products, and thickeners in ice cream and salad dressings. The linters consist primarily of cellulose (>99%).
The BXN cotton lines currently in commercial production, or planned for future commercial release, are derived from transformation events 10222 (current lines) and 10211 (future lines). The currently available BXN cotton lines include BXN 47 and BXN 16. The first of these, BXN 47 cotton, was commercialised in 1997. Therefore, cottonseed oil derived from BXN cotton or processed products containing cottonseed oil or linters derived from BXNcotton may have been imported into Australia and New Zealand since that time. |
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| Date of authorization: |
09/05/2002 |
| 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
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| Summary of the safety assessment (food safety): |
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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: |
Application A379 - Bromoxynil tolerant cotton Event10211 and 10222
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| Authorization expiration date (a blank field means there is no expiration date) |
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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. 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)
| Name of product applicant: |
Aventis CropScience Pty Ltd and the Stoneville Pedigreed Seed Company |
| Summary of application: |
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| Date of authorization: |
20/12/2002 |
| 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): |
Food from bromoxynil tolerant cotton has been evaluated according to the safety assessment guidelines prepared by ANZFA. The assessment considered the following issues: (1) the nature of the genetic modification; (2) general safety issues such as novel protein expression and the potential for transfer of antibiotic resistance genes to micro-organisms in the human digestive tract; (3) toxicological issues; and (4) nutritional issues.
On the basis of the available information, it is concluded that food from bromoxynil tolerant cotton is as safe and wholesome as food from other commercial cotton 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: |
Application A379 - Bromoxynil tolerant cotton Event10211 and 10222
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| Authorization expiration date (a blank field means there is no expiration date) |
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E-mail:
Organization/agency name (Full name): Ministry for Primary Industries
Contact person name: john vandenbeuken
Website:
Physical full address: Pastoral House, 25 The Terrace, Wellington, 6012
Phone number: 0298942581
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:
| Name of product applicant: |
Calgene |
| Summary of application: |
Cotton
Trait 2 Added Protein or DNA: Nitrilase
Source: Klebsiella ozaenae
Intended Effect: Tolerance to the herbicide Bromoxynil |
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| Date of authorization: |
05/04/1995 |
| 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): |
Please consult the FDA website links below. |
| Upload: |
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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: |
FDA's webpage regarding this variety
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| Authorization expiration date (a blank field means there is no expiration date) |
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E-mail:
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:
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