Food safety and quality
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OECD Unique Identifier details

MON-877Ø5-6
Commodity: Soyabean / Soybeans
Traits: Glyphosate tolerance,Increased oleic acid content,Low level of fatty acids
Australia
Name of product applicant: Monsanto Australia Ltd
Summary of application:
Soybean line MON87705 has been genetically modified (GM) to produce an altered fatty acid profile and for tolerance to glyphosate. The intended nutritional change, to increase the level of oleic acid (C18:1) in soybean oil, was brought about by silencing two endogenous genes involved in fatty acid biosynthesis in soybean plants. The net effect of the modification also results in decreased levels of linoleic acid (C18:2), and saturated fatty acids palmitic acid (C16:0) and stearic acid (C18:0), relative to conventional soybean oil. Due to the higher oleic acid levels, soybean oil from MON87705 is suitable for a greater range of food applications compared with conventional soybean oil.
The glyphosate tolerance trait introduced into MON87705 plants has been described
previously by FSANZ. Tolerance to glyphosate herbicides is conferred by expression of cp4 epsps, a gene derived from the common soil bacterium, Agrobacterium sp. strain CP4.
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Date of authorization: 11/07/2011
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 A1049 - Food from herbicide-tolerant, high oleic acid soybean Line MON 87705
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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)
Mexico
Name of product applicant: Soya (Glycine max) con niveles altos de ácido oleico y bajos niveles de ácidos grasos poli-insaturados y tolerante al herbicida glifosato
Summary of application:

Soya (Glycine max) con niveles altos de ácido oleico y bajos niveles de ácidos grasos
poli-insaturados y tolerante al herbicida glifosato  OECD: MON 877Æ5-6


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 soya convencional.



 


Descripción del producto de transformación:









La compañía Monsanto   desarrollo la soya transgénica MON 87705 para generar un aceite de soya   nutricionalmente mejorado, con niveles disminuidos de grasas saturadas (ácido   palmítico 16:0, y ácido esteárico 18:0) y niveles incrementados de ácido   oleico (18:1). De manera específica, para generar la soya MON 87705 se aplicó   la tecnología de supresión de genes para disminuir los niveles de RNA y por   consiguiente de las proteínas FATB y FAD2, que participan en la ruta   biosintética de los ácidos grasos referidos.  


El evento MON 87705   también contiene en su construcción genética el gen que codifica a la enzima   5-enolpiruvilshiquimato-3-fosfato sintasa, derivado de Agrobacterium sp. cepa CP4 (cp4epsps).   La expresión de la proteína CP4EPSPS le confiere a la soya MON 87705 la   capacidad de ser tolerante al glifosato, el cual es el ingrediente activo del   herbicida Roundup®, usado normalmente en los cultivos.


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Date of authorization: 03/11/2011
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 soya MON 8775-6 confirman la equivalencia sustancial entre la soya genéticamente modificada y la soya convencional utilizada como control. Autorizaciones del producto para consumo humano emitidas por otros países: El evento MON 87701 (OCDE: MON-877Ø1-2) obtuvo la carta de autorización del país de origen, E.U.A., el 24 de Agosto del 2010 • El evento MON 89788 (OCDE: MON-89788-1) ha sido Autorizado para alimento y pienso en el 2007 en los Estados Unidos, en Filipinas y en el 2008 en México, Unión Europea, China y Australia. Conclusión: No se observaron efectos tóxicos, alérgicos o cambios nutrimentales sustanciales en la soya genéticamente modificada evento MON 8775-6. 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:
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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
United States of America
Name of product applicant: Monsanto Company
Summary of application:
Soybean
Trait 1 Added Protein: Gene segments from fatb1-a (gene encoding fatty acid acyl carrier protein thioesterase) and fad2-1a (gene encoding fatty acid desaturase) expressed as dsRNA to induce RNAi-based suppression of the endogenous genes
Source: Glycine max
Intended Effect: Increased levels of oleic acid and reduced levels of linoleic, palmitic, and stearic acid
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Date of authorization: 20/01/2011
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
Upload:
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. 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:
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