Food safety and quality
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OECD Unique Identifier details

DP-Ø23211-2
Commodity: Corn / Maize
Traits: Herbicide tolerance,Insect resistance
Australia
Name of product applicant: Dow AgroSciences Australia
Summary of application:

Dow AgroSciences Australia Pty Ltd, a member of the Corteva Agriscience group of companies, submitted an application to FSANZ to vary Schedule 26 in the Australia New Zealand Food Standards Code (the Code). The variation is to include food from a new genetically modified (GM) corn line with OECD Unique Identifier DP-Ø23211-2 (herein referred to as DP23211). This corn line has been genetically modified to have tolerance to the herbicide glufosinate and be protected against the insect pest, corn rootworm.


Tolerance to the herbicide glufosinate is achieved with the expression of the phosphinothricin acetyltransferase (PAT) protein, encoded by the maize optimised mo-pat gene from the bacterium Streptomyces viridochromogenes. The PAT protein acetylates the free amino group of glufosinate to produce the herbicidally-inactive metabolite, 2-acetamido-4-methylphosphinico-butanoic acid (N-acetyl glufosinate). The PAT protein has been assessed by FSANZ in over twenty previous applications and globally is represented in six major crop species and over thirty approved single GM plant events (CERA 2011).


Protection from corn rootworm is achieved by expression of the IPD072Aa protein, encoded by the ipd072Aa gene from soil bacterium Pseudomonas chlororaphis. Corn rootworm protection is also achieved by introducing DNA sequences in which the expressed dsRNA silence the expression of a gene in western corn rootworm (WCR; Diabrotica virgifera virgifera) using a mechanism known as RNA interference or RNAi (Hannon, 2002). The introduced DNA sequences are derived from the smooth septate junction protein 1 (dvssj1) gene from D. virgifera. FSANZ has previously approved a large number of applications where insect-protection in crops was provided by the introduction of Bacillus thuringiensis Cry proteins. This is the first application where insect protection is based on the IPD072Aa protein and DvSSJ1 dsRNA.


DP23211 contains the phosphomannose isomerase(pmi) gene, which is derived from Escherichia coli strain K-12. Expression of the PMI protein allows plant cells to use mannose as a carbon source (Reed et al., 2001; Negrotto et al., 2000). This was used as a selectable marker to assist with identification of transformed plant cells in the early stages of selection. The PMI protein has been previously assessed by FSANZ in four corn applications - A564 (FSANZ 2006), A580 (FSANZ 2008b), A1001 (FSANZ 2008a), A1060 (FSANZ 2012) and one rice application – A1138 (FSANZ 2017)


If approved, food derived from DP23211 corn line may enter the Australian and New Zealand food supply as imported food products. 

Upload:
Date of authorization: 22/04/2021
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.): OECD BioTrack database
Summary of the safety assessment (food safety):
Please see link 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: A1202 - Food derived from herbicide-tolerant and insect-protected corn line DP23211
Upload:
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.

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: Dow AgroSciences Australia
Summary of application:

Dow AgroSciences Australia Pty Ltd, a member of the Corteva Agriscience group of companies, submitted an application to FSANZ to vary Schedule 26 in the Australia New Zealand Food Standards Code (the Code). The variation is to include food from a new genetically modified (GM) corn line with OECD Unique Identifier DP-Ø23211-2 (herein referred to as DP23211). This corn line has been genetically modified to have tolerance to the herbicide glufosinate and be protected against the insect pest, corn rootworm.

Upload:
Date of authorization: 06/07/2021
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):
In conducting the safety assessment, FSANZ had regard to information from a variety of sources including, but not limited to, a data package provided by the applicant (application and study reports), the scientific literature and other applications. The assessment of corn line DP23211 was restricted to human food safety and nutritional issues. This assessment therefore does not address any risks to the environment that may occur as the result of growing corn line DP23211, or any risks to animals that may consume feed derived from corn line DP23211. Cultivation in Australia or New Zealand would require separate regulatory assessment and approval, by the Gene Technology Regulator in Australia and by the EPA in New Zealand. No public health and safety concerns have been identified. Based on the data provided in the application, and other available information, food derived from corn line DP23211 is considered to be as safe for human consumption as food derived from non-GM corn cultivars.
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: A1202 – Food derived from herbicide-tolerant and insect-protected corn line DP23211
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)