Food safety and quality
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OECD Unique Identifier details

BXN-1Ø211-9
Commodity: Cotton
Traits: Bromoxynil tolerance,Kanamycin resistance
Australia
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
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:
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)
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 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)

New Zealand
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.

Upload:
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.
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 A379 - Bromoxynil tolerant cotton Event10211 and 10222
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: 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.):
Summary of the safety assessment (food safety):
Please consult the FDA website links below.
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: FDA's webpage regarding this variety
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
cristina.soerensen@mag.gov.py
Organization/agency name (Full name):
Ministerio de Agricultura y Ganadería
Contact person name:
María Cristina Soerensen Gonzalez
Website:
Physical full address:
Yegros 437 entre 25 de mayo y Cerro Cora
Phone number:
+595 21 492948
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: