Food safety and quality
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OECD Unique Identifier details

ACS-BNØØ1-4
Commodity: Canola / Oilseed rape / Rape Seed
Traits: Fertility restoration,Glufosinate tolerance,Kanamycin resistance
Australia
Name of product applicant: Aventis CropScience Pty Ltd
Summary of application:
Aventis Crop Science Pty Ltd have submitted an application to ANZFA to vary Standard A18 to include all food products derived from glufosinate-ammonium tolerant and pollination controlled canola. The lines encompassed by this application are known commercially in North America as LibertyLink open pollinated and InVigor hybrid canola.
Seven lines (known as Topas 19/2, T45, Ms1, Ms8, Rf1, Rf2 and Rf3) of canola (Brassica napus, B. rapa and crosses) have been genetically modified to confer tolerance to the broad-spectrum herbicide, glufosinate-ammonium. Five of these lines have been generated primarily for use in a hybrid seed production system by expressing one of two genes that enable control of pollen production, in conjunction with the herbicide tolerance trait. Two lines of open pollinated canola have been genetically modified with the herbicide tolerance trait only. Three traits may be contained within an individual transformed canola line, however not all lines contain all the traits. The genes coding for the new traits are the bacterial genes bar (or pat), barnase, barstar and npt II.

The bar and pat genes produce an enzyme, phosphinothricin acetyl transferase (PAT), that metabolises the herbicide phosphinothricin (PPT) into an inactive form. Phosphinothricin is the active ingredient of the commercial herbicide glufosinate-ammonium. Glufosinate-ammonium is currently registered in Australia under the commercial name of Basta for non-selective uses, or Finale for turf and home garden uses, and as Buster in New Zealand.

The mode of action of glufosinate-ammonium (or phosphinothricin) is to inhibit the plant enzyme glutamine synthetase (GS), an essential enzyme in nitrogen metabolism and amino acid biosynthesis in plants. The result of GS inhibition is the over accumulation of inorganic ammonia leading to the death of plant cells.

In addition to the herbicide tolerance gene, five of the GM canola lines for use in hybrid
production contain either of the genes, barnase and barstar. Expression of the barnase gene in specific plant cells induces male sterility (Ms) and when these plants are crossed with fertility restorer (Rf) canola plants expressing the barstar gene, fertility is restored in the hybrid offspring. Hybrids produced from conventional crosses between the Ms and Rf lines are reported to have significantly higher yields of oil-bearing seeds.

Canola oil and meal are the two major products produced from oilseed rape plants. Canola oil is used extensively in the food industry as vegetable oil and in products such as margarine, salad dressings, bakery products, low-fat foods and confectionery. It is also used in pharmaceuticals and nutritional supplements. Canola meal is used only as a protein supplement in animal feed.
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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:
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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 A372 - Glufosinate ammonium tolerant canola Topas 19/2..
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Authorization 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. The Food Standards Australia New Zealand Act 1991 establishes the mechanisms for the development and variation of joint food regulatory measures and creates FSANZ as the agency responsible for the development and maintenance of a joint Australia New Zealand Food Standards Code (the Code). The Code is read in conjunction with corresponding NZ and State & Territory food legislation as well as other appropriate legislative requirements (e.g. Trade Practices; Fair Trading). Within the Code, Standard 1.5.2 deals with Foods produced using Gene Technology. Applicants seeking to have a GM food approved, request a variation to Std 1.5.2 to have the GM food (from a particular line) included in the Schedule to Std 1.5.2. Only those GM foods listed in the Schedule can legally enter the food supply. An Application Handbook provides information that is required to make an application to vary the Code. This Handbook is a legal document and therefore the specified mandatory information must be supplied. For GM foods, there is also a Guidance Document that, as the name suggests, provides applicants with further details and background information on the data needed for the safety assessment of GM foods. The assessment process must be completed within a statutory timeframe (9 - 12 months depending on the complexity of the application) and involves at least one public consultation period. All GM applications involve an Exclusive Capturable Commercial Benefit i.e. applicants are required to pay a fee (outlined in the Application Handbook). Following the last public consultation, an Approval Report is prepared and is considered by the FSANZ Board who make a decision about whether the requested variation to the Code should be approved or not. The Board's decision is then passed on to the Legislative and Governance Forum on Food Regulation (the Forum), a committee comprising senior goevernment Ministers from Australia and NZ. This Committee has approximately 2 months to review the Board's decision. If the Board's approval is accepted by the Forum, the approval is then gazetted and becomes law.
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: Plant Genetic Systems, N.V.
Summary of application:
Canola
Trait 1 Added Protein: Barstar
Source: Bacillus amyloliquefaciens
Intended Effect: Fertility restorer
Trait 2 Added Protein: Phosphinothricin acetyl transferase (PAT)
Source: Streptomyces hygroscopicus
Intended Effect: Tolerance to glufosinate-ammonium
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Date of authorization: 04/04/1996
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:
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
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Authorization 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.
Useful links
Relevant documents
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