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OECD Unique Identifier details

MON-87411-9
Commodity: Corn / Maize
Traits: Glyphosate tolerance,Coleoptera resistance
Australia
Name of product applicant: Monsanto Australia Ltd
Summary of application:

A genetically modified (GM) corn line with OECD Unique Identifier MON-87411-9, hereafter referred to as MON87411, has been developed by Monsanto Company (Monsanto).


 


The corn has been modified to be both tolerant to the herbicide glyphosate and protected against corn rootworm (CRW) (Diabrotica spp.), an insect pest.


 


Tolerance to glyphosate is achieved through expression of the enzyme 5-enolpyruvyl-3-shikimatephosphate synthase (CP4 EPSPS) encoded by the cp4 epsps gene derived from the common soil bacterium Agrobacterium sp. strain CP4. The safety of the CP4 EPSPS protein has previously been assessed by FSANZ.


 


Protection against CRW occurs via two genetic modifications:


 


 The expression of a cry3Bb1 gene that produces a modified Bacillus thuringiensis (subsp. kumamotoensis) Cry3Bb1 protein to protect against CRW larval feeding. The safety of the Cry3Bb1 protein has previously been assessed by FSANZ.


 


 The expression of a suppression cassette containing an inverted repeat sequence that corresponds to a region of the DvSnf7 gene from western corn rootworm (Diabrotica virgifera virgifera). Expression of the inverted repeat results in the formation of a double-stranded RNA (dsRNA) transcript containing a fragment of the DvSnf7 gene. When ingested by CRW, it is recognised by the insect’s RNA interference (RNAi) machinery leading to the down regulation of the CRW DvSnf7 gene and ultimately death of the insect.


 


According to the Applicant, MON87411 will not be offered for commercial use as a stand-alone product, but will be combined, through traditional breeding, with other approved GM corn lines (a process known as ‘stacking’). It is further intended that any lines containing the MON87411 event will be grown in North America, and approval for cultivation in Australia or New Zealand is not being sought. Therefore, if approved, food derived from this line may enter the Australian and New Zealand food supply as imported food products.

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Date of authorization: 06/08/2015
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 A1097 - Food derived from herbicide-tolerant & insexct-protected corn line MON87411
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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)

Japan
Name of product applicant: Monsanto Japan Ltd.
Summary of application:

MON 87411 line, a Maize Tolerant to Glyphosate and Resistant to Coleoptera

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Date of authorization: 16/02/2017
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 see the 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: Food safety assessment performed by Food Safety Commission of Japan (food) (in Japanese)
Food safety assessment performed by Food Safety Commission of Japan (feed) (in Japanese)
Food safety assessment performed by Food Safety Commission of Japan (food) (in English)
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
fscj-secretariat@cao.go.jp
Organization/agency name (Full name):
Food Safety Commission Secretariat,Cabinet Office,GOJ
Contact person name:
Emi Takagi
Website:
Physical full address:
Akasaka 5-2-20 Minato Ward,Tokyo,Japan
Phone number:
81 3 6234 1122
Fax number:
81 3 3584 7392
Country introduction:
Useful links
Relevant documents
Stacked events:

With regard to stacked events, FSCJ conducts the safety assessment of GM food based on the “Policies Regarding the Safety Assessment of Stacked Varieties of Genetically Modified Plants”.

Even if single events that are stacked have already approved, some products will be considered as new products and some will not.

Please refer to Article 5 and 6 of the MHLW’s notice, which is available at the following URL, for the details.

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000053519.pdf

Article 6 was modified in 2014, and the modified version is available at the following URL.

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000049695.pdf

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

Food Safety Commission of Japan (http://www.fsc.go.jp/english/index.html), Ministry of Health, Labour and Welfare (http://www.mhlw.go.jp/english/policy/health-medical/food/index.html)

New Zealand
Name of product applicant: Monsanto Australia Ltd
Summary of application:

A genetically modified (GM) corn line with OECD Unique Identifier MON-87411-9, hereafter referred to as MON87411, has been developed by Monsanto Company (Monsanto).


The corn has been modified to be both tolerant to the herbicide glyphosate and protected against corn rootworm (CRW) (Diabrotica spp.), an insect pest.


Tolerance to glyphosate is achieved through expression of the enzyme 5-enolpyruvyl-3-shikimatephosphate synthase (CP4 EPSPS) encoded by the cp4 epsps gene derived from the common soil bacterium Agrobacterium sp. strain CP4. The safety of the CP4 EPSPS protein has previously been assessed by FSANZ.


Protection against CRW occurs via two genetic modifications:


The expression of a cry3Bb1 gene that produces a modified Bacillus thuringiensis (subsp.kumamotoensis) Cry3Bb1 protein to protect against CRW larval feeding. The safety of the Cry3Bb1 protein has previously been assessed by FSANZ.


The expression of a suppression cassette containing an inverted repeat sequence that corresponds to a region of the DvSnf7 gene from western corn rootworm (Diabrotica virgifera virgifera). Expression of the inverted repeat results in the formation of a double-stranded RNA (dsRNA) transcript containing a fragment of the DvSnf7 gene. When ingested by CRW, it is recognised by the insect’s RNA interference (RNAi) machinery leading to the down regulation of the CRW DvSnf7 gene and ultimately death of the insect.


According to the Applicant, MON87411 will not be offered for commercial use as a stand-alone product, but will be combined, through traditional breeding, with other approved GM corn lines (a process known as ‘stacking’). It is further intended that any lines containing the MON87411 event will be grown in North America, and approval for cultivation in Australia or New Zealand is not being sought. Therefore, if approved, food derived from this line may enter the Australian and New Zealand food supply as imported food products.

Upload:
Date of authorization: 31/12/2015
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):
In conducting a safety assessment of food derived from MON87411, a number of criteria have been addressed including: a characterisation of the transferred gene sequences, their origin, function and stability in the corn genome; the changes at the level of DNA, protein and RNA in the whole food; compositional analyses; and evaluation of intended and unintended changes. No potential public health and safety concerns have been identified in the assessment of herbicide-tolerant and insect-protected corn line MON87411-9. On the basis of the data provided in the present Application, and other available information, food derived from MON87411 is considered to be as safe for human consumption as food derived from conventional corn 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: A1097 – Food derived from Herbicide-tolerant & Insect-protected Corn Line MON87411
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: Monsanto Company
Summary of application:

Corn
Trait 1 Added Protein or DNA: double stranded RNA with the partial sequence of the Snf7 transcript from the western corn rootworm
Source: Diabrotica virgifera virgifera
Intended Effect: Resistance to Corn Rootworm
Trait 2 Added Protein or DNA: Cry3Bb1
Source: Bacillus thuringiensis
Intended Effect: Resistance to Corn Rootworm
Trait 3 Added Protein or DNA: 5-Enolpyruvylshikimate-3-phosphate synthase (EPSPS) from cp4 epsps gene
Source: Agrobacterium strain CPR
Intended Effect: Tolerance to the herbicide glyphosate

Upload:
Date of authorization: 23/10/2015
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 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
EPA Registered Plant Incorporated Protectants
EPA Registered Plant Incorporated Protectants
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