Food safety and quality
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OECD Unique Identifier details

NMK-89653-6
Commodity: Potatoes
Traits: Coleoptera resistance,Kanamycin resistance,Potato virus Y resistance
Australia
Name of product applicant: Monsanto Australia Ltd
Summary of application:
Monsanto Australia Ltd have made an application to ANZFA to amend Standard A18 of the Australian Food Standards Code to include food derived from potatoes which have been genetically modified to be protected against the Colorado potato beetle (Leptinotarsa decemlineata Say.), one of the major pests of potatoes in North America, and potato virus Y (PVY), a major viral pathogen of potatoes. The potatoes are known as New Leaf® Y potatoes (3 lines: RBMT15-101; SEMT15-02; SEMT15-15).

Protection against Colorado potato beetle is achieved through expression in the plant of the insecticidal protein, Cry3Aa. Cry3Aa is produced naturally by the tenebrionis subspecies of the spore-forming soil bacterium Bacillus thuringiensis (B.t.t.). The majority of described B. thuringiensis strains produce insecticidal proteins active against lepidopteran insects (larvae of moths and butterflies) and a few are reported to have activity against dipteran insects (mosquitos and flies). The Cry3Aa protein, however, is toxic to a narrow spectrum of coleopteran insects (beetles) and shows no activity against other groups of insects such as the lepidopterans or dipterans.

Two commercially available microbial pesticide products based on B.t.t. (M-One and
Foil®) have been in use in the United States since 1989. In addition, a bio-insecticide known commercially as MYX 1806 comprising Cry3Aa genetically engineered into the bacterium Pseudomonas fluorescens, which has been rendered non-viable, has been commerciallyavailable in the United States since 1991.

PVY is an RNA virus belonging to the potyvirus group of plant viruses. The virus is aphid transmissible and commonly infects potatoes, causing serious disease. Protection against PVY is produced through expression, in the plant, of a gene derived from PVY that encodes the viral coat protein. The coat protein forms a protective coat around the RNA genome of the virus. The expression of plant virus genes in plants has been shown to confer varying degrees of protection against subsequent infection by the plant virus from which the gene was derived. The exact mechanism by which this protection is conferred is unknown.

New Leaf® Y potatoes are not grown in Australia or New Zealand and are currently not
permitted to be imported into Australia and New Zealand as fresh produce. Rather, they are most likely to enter into the market in imported processed food commodities such as processed potato crisps, pre-cooked French fries, potato flour and potato starch.
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Date of authorization: 30/08/2001
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 A384 - Food produced using gene technology - Food from insect and virus resistant potatoes (New Leaf Y Potatoes)
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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 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)

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)

Canada
Name of product applicant: Monsanto Canada Inc.
Summary of application:
The NewLeaf-Y™ potato (Solanum tuberosum) lines SEMT15-02, SEMT15-15 and RBMT15-101 were developed through a specific genetic modification of cultivars Shepody and Russet Burbank to be CPB (Leptinotarsa decemlineata Say.) resistant and to resist infection by PVY. The novel lines produce a version of the insecticidal protein, CryIIIA, derived from Bacillus thuringiensis, as well as the coat protein (CP) from the ordinary (O) strain of potato virus Y (PVY-O). Delta-endotoxins, such as the CryIIIA protein expressed in Shepody and Russet Burbank NewLeaf-Y™ potatoes, act by selectively binding to specific receptors localized on the brush border midgut epithelium of susceptible insect species. Following binding, cation-specific pores are formed that disrupt midgut ion flow and thereby cause paralysis and death. CryIIIA and related endotoxins are insecticidal only to lepidopteran or coleopteran insects and their specificity of action is directly attributable to the presence of specific receptors in the target insects. There are no receptors for delta-endotoxins of B. thuringiensis on the surface of mammalian intestinal cells, therefore, livestock animals and humans are not susceptible to these proteins. PVY is the type member of the potyvirus group and is an aphid-transmissible RNA virus that commonly infects potato causing serious disease and economic loss. The introduced viral sequences do not result in the formation of any infectious particles, nor does their expression result in any disease pathology. The genetically modified potato cultivars exhibit the trait of resistance to infection and subsequent disease caused by PVY through a process that is related to viral cross-protection.

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Date of authorization: 07/05/1999
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.): BioTrack Product Database
Summary of the safety assessment (food safety):
Please see decision document weblinks
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: Novel Foods Decision
Novel Feeds Decision
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Neil.Strand@hc-sc.gc.ca
Organization/agency name (Full name):
Health Canada
Contact person name:
Neil Strand
Website:
Physical full address:
251 Sir Frederick Banting Driveway, Tunney's Pasture, PL 2204A1
Phone number:
613-946-1317
Fax number:
Country introduction:

Federal responsibility for the regulations dealing with foods sold in Canada, including novel foods, is shared by Health Canada and the Canadian Food Inspection Agency (CFIA). Health Canada is responsible for establishing standards and policies governing the safety and nutritional quality of foods and developing labelling policies related to health and nutrition. The CFIA develops standards related to the packaging, labelling and advertising of foods, and handles all inspection and enforcement duties. The CFIA also has responsibility for the regulation of seeds, veterinary biologics, fertilizers and livestock feeds. More specifically, CFIA is responsible for the regulations and guidelines dealing with cultivating plants with novel traits and dealing with livestock feeds and for conducting the respective safety assessments, whereas Health Canada is responsible for the regulations and guidelines pertaining to novel foods and for conducting safety assessments of novel foods.

The mechanism by which Health Canada controls the sale of novel foods in Canada is the mandatory pre-market notification requirement as set out in Division 28 of Part B of the Food and Drug Regulations.

Manufacturers or importers are required under these regulations to submit information to Health Canada regarding the product in question so that a determination can be made with respect to the product's safety prior to sale. The safety criteria for the assessment of novel foods outlined in the current guidance document (i.e. Canadian Guidelines for the Safety Assessment of Novel Foods) were derived from internationally established scientific principles and guidelines developed through the work of the Organization for Economic Cooperation and Development (OECD), Food and Agriculture Organisation (FAO), World Health Organisation (WHO) and the Codex Alimentarius Commission. These guidelines provide for both the rigour and the flexibility required to determine the need for notification and to conduct the safety assessment of the broad range of food products being developed. This flexibility is needed to allow novel foods and food products to be assessed on a case-by-case basis and to take into consideration future scientific advances.

Useful links
Relevant documents
Stacked events:

Food: Consistent with the definition of "novel food" in Division 28 of the Food and Drug Regulations, the progeny derived from the conventional breeding of approved genetically modified plants (one or both parents are genetically modified) would not be classified as a novel food unless some form of novelty was introduced into such progeny as a result of the cross, hence triggering the requirement for pre-market notification under Division 28. For example, notification may be required for modifications observed in the progeny that result in a change of existing characteristics of the plant that places those characteristics outside of the accepted range, or, that introduce new characteristics not previously observed in that plant (e.g. a major change has occurred in the expression levels of traits when stacked). In addition, the use of a wild species (interspecific cross) not having a history of safe use in the food supply in the development of a new plant line may also require notification to Health Canada. However, molecular stacks are considered new events and are considered to be notifiable as per Division 28.

Feed:

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

Neil Strand, Section Head of Novel Foods

Mexico
Name of product applicant: Monsanto Comercial, S.A. de C.V.
Summary of application:

Authorization by COFEPRIS: 13


The NewLeaf-Y™ potato (Solanum tuberosum) lines SEMT15-02, SEMT15-15 and RBMT15-101 were developed through a specific genetic modification of cultivars Shepody and Russet Burbank to be CPB (Leptinotarsa decemlineata Say.) resistant and to resist infection by PVY. The novel lines produce a version of the insecticidal protein, CryIIIA, derived from Bacillus thuringiensis, as well as the coat protein (CP) from the ordinary (O) strain of potato virus Y (PVY-O). Delta-endotoxins, such as the CryIIIA protein expressed in Shepody and Russet Burbank NewLeaf-Y™ potatoes, act by selectively binding to specific receptors localized on the brush border midgut epithelium of susceptible insect species. Following binding, cation-specific pores are formed that disrupt midgut ion flow and thereby cause paralysis and death. CryIIIA and related endotoxins are insecticidal only to lepidopteran or coleopteran insects and their specificity of action is directly attributable to the presence of specific receptors in the target insects. There are no receptors for delta-endotoxins of B. thuringiensis on the surface of mammalian intestinal cells, therefore, livestock animals and humans are not susceptible to these proteins. PVY is the type member of the potyvirus group and is an aphid-transmissible RNA virus that commonly infects potato causing serious disease and economic loss. The introduced viral sequences do not result in the formation of any infectious particles, nor does their expression result in any disease pathology. The genetically modified potato cultivars exhibit the trait of resistance to infection and subsequent disease caused by PVY through a process that is related to viral cross-protection.

Upload:
Date of authorization: 26/09/2001
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.):
Summary of the safety assessment (food safety):
UI OECD: NMK-89653-6 During the risk assessment of this GMO based on existing knowledge to date, no toxic or allergic effects neither substantial nutritional changes are observed. The event is as safe as its conventional counterpart. For more detail please find attached the risk assessment summary in this page.
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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:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
sortiz@conacyt.mx
Organization/agency name (Full name):
CIBIOGEM
Contact person name:
Dra. Sol Ortiz García
Website:
Physical full address:
San Borja #938, Col. Del Valle • Del. Benito Juárez C.P. 03100, México, D.F.
Phone number:
+52 (55) 5575-6878
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:

Secretaría de Salud / Phone: +52 55 5080 5200 /Email: ralatorre@cofepris.gob.mx%20

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

Monsanto Australia Ltd have made an application to ANZFA to amend Standard A18 of the Australian Food Standards Code to include food derived from potatoes which have been genetically modified to be protected against the Colorado potato beetle (Leptinotarsa decemlineata Say.), one of the major pests of potatoes in North America, and potato virus Y (PVY), a major viral pathogen of potatoes. The potatoes are known as New Leaf® Y potatoes (3 lines: RBMT15-101; SEMT15-02; SEMT15-15).

Protection against Colorado potato beetle is achieved through expression in the plant of the insecticidal protein, Cry3Aa. Cry3Aa is produced naturally by the tenebrionis subspecies of the spore-forming soil bacterium Bacillus thuringiensis (B.t.t.). The majority of described B. thuringiensis strains produce insecticidal proteins active against lepidopteran insects (larvae of moths and butterflies) and a few are reported to have activity against dipteran insects (mosquitos and flies). The Cry3Aa protein, however, is toxic to a narrow spectrum of coleopteran insects (beetles) and shows no activity against other groups of insects such as the lepidopterans or dipterans.

Two commercially available microbial pesticide products based on B.t.t. (M-One and Foil®) have been in use in the United States since 1989. In addition, a bio-insecticide known commercially as MYX 1806 comprising Cry3Aa genetically engineered into the bacterium Pseudomonas fluorescens, which has been rendered non-viable, has been commerciallyavailable in the United States since 1991.

PVY is an RNA virus belonging to the potyvirus group of plant viruses. The virus is aphid transmissible and commonly infects potatoes, causing serious disease. Protection against PVY is produced through expression, in the plant, of a gene derived from PVY that encodes the viral coat protein. The coat protein forms a protective coat around the RNA genome of the virus. The expression of plant virus genes in plants has been shown to confer varying degrees of protection against subsequent infection by the plant virus from which the gene was derived. The exact mechanism by which this protection is conferred is unknown.

New Leaf® Y potatoes are not grown in Australia or New Zealand and are currently not permitted to be imported into Australia and New Zealand as fresh produce. Rather, they are most likely to enter into the market in imported processed food commodities such as processed potato crisps, pre-cooked French fries, potato flour and potato starch.

Upload:
Date of authorization: 25/10/2001
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):
The New Leaf® Y potatoes have been evaluated according to ANZFA’s safety assessment guidelines. This involves an extensive analysis of the nature of the genetic modification together with a consideration of general safety issues, toxicological issues and nutritional issues associated with the new GM food. This approach can establish whether the food produced from the New Leaf® Y potatoes is as safe and nutritious as food produced from non-GM varieties of potatoes. The detailed information available on the genetic modification indicates that no unintentional changes have taken place at the molecular level and that the novel genetic material is stably inserted in the potato genome and maintained and expressed over several generations. Data on the potential toxicity and allergenicity of the proteins encoded by the transferred genes have been reviewed and indicates that the new proteins expressed in the New Leaf® Y potatoes are non- toxic and unlikely to have allergenic potential. Compositional analyses demonstrate no significant differences between the New Leaf® Y potatoes and their conventional counterparts. This constitutes further evidence that no unintentional effects have occurred as a result of the genetic modification. The impact on human health from the potential transfer of novel genetic material to cells in the human digestive tract has also been considered. The presence of novel genetic material, including two antibiotic resistance genes, in the New Leaf® Y potatoes is not considered to pose any additional safety concerns. In assessing all of the above data, ANZFA has concluded that the New Leaf® Y potatoes do not raise any public health and safety concerns.
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 A384 - Food produced using gene technology - Food from insect and virus resistant potatoes (New Leaf Y Potatoes)
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:

Potato
Trait 1 Added Protein or DNA: CryIIIA
Source: Bacillus thuringiensis subsp. tenebrionis (Btt)
Intended Effect: Resistance to Colorado potato beetle
Trait 2 Added Protein or DNA: Potato virus Y (PVY) coat protein
Source: Potato virus Y
Intended Effect: Resistance to potato virus Y
Event Designation: RBMT15-101

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Date of authorization: 08/01/1998
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
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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