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:
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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:
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)
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:
Please see decision document weblinks
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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: Novel Foods Decision
Novel Feeds Decision
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Authorization expiration date:
E-mail:
luc.bourbonniere@hc-sc.gc.ca
Organization/agency name (Full name):
Health Canada
Contact person name:
Luc Bourbonniere
Website:
Physical full address:
251 Sir Frederick Banting Driveway, Tunney's Pasture, PL 2204A1
Phone number:
613-957-1405
Fax number:
613-952-6400
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 (see Figure 1). 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 document 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:
Luc Bourbonniere, Section Head Novel Foods
Mexico
Name of product applicant: Monsanto Comercial, S.A. de C.V.
Summary of application:

Papa (Solanum tuberosum) resistente al escarabajo colorado (Leptinofarsa decemlineata Say) y al virus de la papa (PVY) Papa New Leaf® Y


RBMT 15-101 SEMT 15-02, SEMT 15-15


Identificador OECD: NMK-89653-6


NMK-89935-9; NMK-8993Æ-4


 


Información presentada (la documentación deberá presentarse en español y podrá estar contenida en archivo electrónico):






































1) Descripción de aplicaciones o usos propuestos del   alimento modificado



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2) Información concerniente a fuente, identidad y   función del material genético introducido, incluyendo pruebas de estabilidad



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3) Información sobre la descripción de la   modificación genética y su caracterización (descripción del método de transformación   genética, caracterización y descripción de los materiales genéticos   insertados)



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4) Información concerniente a la identidad y función   de la expresión de los productos modificados, incluyendo un estimado de la   concentración de la modificación en el cultivo modificado o su alimento   derivado



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5) Información concerniente a cualquier   alergenicidad esperada o conocida de la expresión del producto y el   fundamento para concluir que el alimento que la contiene pueda ser consumido   con seguridad



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6) Información comparando la composición o   características de los alimentos modificados con los alimentos derivados de   la variedad original u otras variedades comúnmente consumidas, con particular   énfasis sobre los nutrientes importantes y tóxicos que de manera natural   puedan presentarse en el alimento



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7) Información adicional (relevante para la   seguridad y evaluación nutricional del alimento modificado)



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8) Autorizaciones emitidas por otros países del   producto para consumo humano (copia)



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Usos propuestos:









Para ser procesado y usado en los alimentos de   consumo humano y animal, forraje y productos industriales en la misma forma   como los productos obtenidos con la papa convencional.



 


Descripción del producto de transformación:









La protección contra   el escarabajo de la papa se logra mediante la expresión en la planta de la   proteína insecticida Cry3Aa, la cual es producida naturalmente por la   bacteria Bacillus thuringiensis. La   proteína Cry3As es tóxica para un estrecho espectro de insectos coleópteros y   no tiene efecto en ningún otro insecto. La protección contra el virus PVY se   consigue a través de un gen obtenido del mismo virus, que codifica para   cápside del virus.



 

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:
Evaluación de la inocuidad: Alergenicidad: Los ensayos de digestión simulada y de estabilidad al calor, así como la comparación informática con alérgenos conocidos, demostraron que la probabilidad de alergenicidad de las proteínas insertadas es baja. Toxicidad: Los estudios de toxicidad aguda y subcrónica, así como la comparación informática con toxinas conocidas, demostraron que la toxicidad de las proteínas insertadas es baja. Nutricional: Los resultados de composición para la papa NMK-8993-4 confirman la equivalencia sustancial entre la papa genéticamente modificada y la papa convencional utilizada como control. Autorizaciones del producto para consumo humano emitidas por otros países: Autorizada para consumo humano en Australia (07-05-1999), Canadá (20-04-1999) y Estados Unidos (25-02-1999) Conclusión: No se observaron efectos tóxicos, alérgicos o cambios nutrimentales sustanciales en la papa genéticamente modificada evento NMK-8993-4. Por lo tanto puede asegurarse que el evento es, con base en los conocimientos existentes hasta la fecha, tan inocuo como su homólogo convencional.
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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:
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:

La Comisión Intersecretarial de Bioseguridad de los Organismos Genéticamente Modificados está integrada por los titulares de las Secretarías de Medio Ambiente y Recursos Naturales Renovables (SEMARNAT), Agricultura, Ganadería, Desarrollo Rural, Pesca y Alimentación (SAGARPA); Salud (SS); Hacienda y Crédito Público (SHCP); Economía (SE) y Educación Pública (SEP); así como por el Director General del Consejo Nacional de Ciencia y Tecnología (CONACYT).

La presidencia de la Comisión es rotatoria por periodos de dos años, entre los Secretarios de Salud, SAGARPA y SEMARNAT ya que son las Secretarías con un mayor ámbito de competencia en relación con el uso seguro de los Organismos Genéticamente Modificados (OGMs).

Ley de Bioseguridad de Organismos Genéticamente Modificados, estipula que para su implementación la Comisión debe coordinar las acciones pertinentes con las instancias del Gobierno para cumplir su objetivo.

La CIBIOGEM, cuenta con grupos de apoyo que son sus órganos técnicos y consultivos: Comité Técnico, Consejo Consultivo Científico, Consejo Consultivo Mixto y la Secretaría Ejecutiva.

¿Cuál es el propósito de la CIBIOGEM?

Coordinar las políticas de la administración pública federal referentes a diferentes actividades relacionadas con OGMs como son: la producción, importación, exportación, movilización, transporte, siembra, consumo y, en general uso y aprovechamiento de OGMs.

 

-Courtesy Translation-

The Intersecretarial Commission on Biosafety of Genetically Modified Organisms is made up of the heads of the Secreataries of Health (SSA); Agriculture, Livestock, Rural, Development, Fisheries and Food (SAGARPA); Environment and Natural Resources (SEMARNAT); Finance and Public Credit (SHCP); Economy (SE); Public Education, and the General Director of the National Council of Science and Technology.

The chair of the Commission rotates every two years among the Secretaries of Health, SEMARNAT and SAGARPA, the three entities most directly involved in policies concerning the use and biosafety of Genetically Modified Organisms (GMOs).

The Law on Biosafety of Genetically Modified Organisms states that the Commission aims to promote and coordinate the actions of Government agencies. CIBIOGEM receives support from the Executive Secretariat of CIBIOGEM, the Technical Committee, the Scientific Advisory Board and the Joint Advisory Council.

What is the purpose of the CIBIOGEM?

To coordinate the policies and federal regulation of activities related to Genetically Modified Organisms (GMOs) such as: production, import, export, mobilization, transportation, release into the environment, consumption, and general use of GMOs.

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: marriola@cofepris.gob.mx