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OECD Unique Identifier details

SYN-BTØ11-1xSYN-IR162-4xDAS-Ø15Ø7-1xMON-ØØØ21-9
Commodity: Corn / Maize
Traits: Glufosinate tolerance,Glyphosate tolerance,Lepidoptera resistance
Mexico
Name of product applicant: Maíz (Zea mays) resistente a insectos lepidópteros con tolerancia a los herbicidas glufosinato de amonio y glifosato.
Summary of application:

Maíz (Zea mays) resistente a insectos lepidópteros con tolerancia a los herbicidas glufosinato de amonio y glifosato.


Bt11 x MIR162 x TC 1507 x GA21


OECD: SYN-BTØ11-1 x SYN-IR162-4 x DAS-Ø15Ø7-1 x MON-ØØØ21-9


 


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 el maíz convencional.



 


Descripción del producto de transformación:









El híbrido de maíz   con combinación de genes SYN-BTØ11-1 x   SYN-IR162-4 x DAS-Ø15Ø7-1 x MON-ØØØ21-9 fue desarrollado   usando técnicas de cruzamientos convencionales.


 


Bt11


Le confiere a ese   híbrido de maíz la capacidad de codificar la proteína Cry1Ab, proteína que   producen ciertas subespecies de Bacillus   thuringiensis. La proteína Cry1Ab confiere la resistencia a ciertas   plagas de lepidópteros del maíz. El evento parental Bt11 también incluye el   gen pat derivado de Streptomyces viridochoromogenes,   este gen que codifica la enzima fosfonitricin acetiltransferasa, que confiere   la tolerancia al herbicida glufosinato, usando como marcador de selección.


 


Evento   MIR162 (SYN-IR162-4):


El evento fue obtenido por transformación   mediada por Agrobacterium, expresa   la proteína Vip3Aa19 que difiere de la proteína original Vip3Aa1 en un   aminoácido en la posición 284. Es codificada por el gen vip3Aa19, versión modificada del gen nativo vip3Aa1 de B. thuringiensis   cepa AB88.


 


TC1507 (DAS-Ø15Ø7-1)


Fue desarrollado   utilizando la técnica de bombardeo. El evento parental TC1507 expresa la   proteína insecticidaCry1F, de Bacillus thuringiensis variedad Aizawai, misma que confiere protección   a las plantas contra ciertas plagas de lepidópteros, como el gusano barrenador   europeo de maíz (Ostrinia nubilalis)   y Sesamia spp. El evento parental   TC1507 también produce la proteína fosfonitricin-N-acetiltransferasa (PAT)   proveniente de Streptomyces viridochromogenes, misma que provee   tolerancia al herbicida glufosinato de amonio, utilizándose sólo como   marcador de selección.


 


GA21


Las plantas de maíz   derivadas del evento de transformación GA21 producen la proteína doblemente   mutada 5-enol piruvilshikimato-3-fosfato sintasa (mEPSPS), proteína que le   confiere a las plantas la tolerancia a los productos que contienen glifosato.  


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Date of authorization: 02/05/2011
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 el maíz SYN-BTØ11-1 x SYN-IR162-4 x DAS-Ø15Ø7-1 x MON-ØØØ21-9 confirman la equivalencia sustancial entre el maíz genéticamente modificado y el maíz convencional utilizado como control. Autorizaciones del producto para consumo humano emitidas por otros países: El evento Bt11 ha sido aprobado desde 1996 por varios países entre los que se pueden mencionar: Canadá, que lo autorizó para consumo humano (1996) y animal (1996); Japón liberación al ambiente (1996), consumo humano (1996) y animal (1996); Unión Europea Consumo humano (1998) y consumo animal (1998); Suiza para consumo humano (1998) y animal (1998); Argentina para consumo humano (2001) y animal (2001), Filipinas para consumo humano (2003) y animal (2003), liberación al ambiente (2005); Sudáfrica para consumo humano y/o animal (2002), liberación al ambiente (2003); Uruguay para liberación al ambiente (2004), consumo humano y/o animal (2004); México para consumo humano y/o animal (2007); Colombia para consumo humano y/o consumo animal (2008). El evento MIR162 ha sido aprobado en los siguientes países: Australia para consumo humano (2009); Brasil para liberación al ambiente (2009), consumo humano y/o animal (2009); Taiwán para consumo humano (2009); Rusia para consumo humano (2010); Canadá para liberación del ambiente (2010), consumo humano (2010) y animal (2010); Japón para consumo humano (2010); México para consumo humano y/o animal (2010). El evento GA21: en Canadá aprobado para liberación al ambiente (1998), consumo humano (1999) y animal (1998); en Argentina se aprobó para liberación al ambiente (1998), para consumo humano y/o animal (2005); Australia aprobado para consumo humano (2000); aprobado en Japón para liberación al ambiente (1998), consumo humano (1999) y animal (1999); aprobado en Corea para consumo humano (2002) y animal (2005); aprobado en México para consumo humano y/o animal (2002); aprobado en Sudáfrica para consumo humano y/o animal (2002); aprobado en China para consumo humano y/o animal (2004); Unión Europea para consumo humano (2006) y animal (2005); aprobado en Brasil para la liberación al ambiente (2008), consumo humano y/o animal (2008); aprobado en Filipinas para liberación al ambiente (2009), consumo humano (2003) y animal (2003). El evento TC1507 se autorizó para consumo humano y/o animal en Sudáfrica (2002), además de haber sido aprobado en otros países como Canadá (2001), México (2003), China (2004), Argentina (2005) y Brasil (2008); entre otros. Conclusión: No se observaron efectos tóxicos, alérgicos o cambios nutrimentales sustanciales en el maíz genéticamente modificado evento SYN-BTØ11-1 x SYN-IR162-4 x DAS-Ø15Ø7-1 x MON-ØØØ21-9 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
Philippines
Name of product applicant: Syngenta Philippines
Summary of application:
Corn BT11 x MIR604 x TC1507 x GA21 is a stacked hybrid developed by crossing Event Bt 11, Event MIR162, Event TC1507 x Event GA21 using conventional breeding techniques.
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Date of authorization: 22/12/2010
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:
Syngenta Philippines had filed an application with attached technical dossiers to the Bureau of Plant Industry (BPI) for a biosafety notification for direct use as food, feed and for processing under Administrative Order (AO) No. 8 Part 5 for stacked trait product corn: Bt11 x MIR 162 x TC1507 x GA21 which has been genetically modified for insect resistance and herbicide tolerance. A safety assessment of combined trait product corn: Bt11 x MIR 162 x TC1507 x GA21 was conducted as per Department of Agriculture Administrative Order No. 8 Series of 2002 and Memorandum Circulars Nos. 6 and 8, Series of 2004. The focus of risk assessment is the gene interactions between/among the transgenes.
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:
Upload:
Authorization expiration date:
E-mail:
bpibiotechsecretariat@yahoo.com
Organization/agency name (Full name):
Bureau of Plant Industry
Contact person name:
Thelma L. Soriano
Website:
Physical full address:
San Andres St., Malate, Manila
Phone number:
632 521 1080
Fax number:
632 521 1080
Country introduction:
The Philippines is the first ASEAN country to establish a modern regulatory system for modern biotechnology. The country's biosafety regulatory system follows strict scientific standards and has become a model for member-countries of the ASEAN seeking to become producers of agricultural biotechnology crops. Concerns on biosafety in the Philippines started as early as 1987 when scientists from the University of the Philippines Los Banos (UPLB) and International Rice Research Institute (IRRI), the Quarantine Officer of the Bureau of Plant Industry (BPI) and the Director for Crops of the Philippine Council for Agriculture, Forestry and Natural Resources Research and Development (PCARRD) recognized the potential for harm of the introduction of exotic species and genetic engineering. The joint committee formed the biosafety protocols and guidelines for genetic engineering and related research activities for UPLB and IRRI researchers. This proposal was eventually adapted into a Philippine Biosafety policy by virtue of Executive Order No 430, Series of 1990, issued by then President Corazon C. Aquino on October 15, 1990, which created the National Committee on Biosafety of the Philippines (NCBP). The NCBP formulates, reviews and amends national policy on biosafety and formulates guidelines on the conduct of activities on genetic engineering. The NCBP comprised of representative from the Department of Agriculture (DA); Department of Environment and Natural Resources (DENR); Health (DOH); and Department of Science and Technology (DOST), 4 scientists in biology, environmental science, social science and physical science and 2 respected members of the community. The Philippines’ Law, Executive Order No.514 (EO514), Series of 2006 entitled “Establishing the National Biosafety Framework (NBF), Prescribing Guidelines for its Implementation, Strengthening the National Committee on Biosafety of the Philippines, and for Other Purposes was also issued. This order sets the establishment of the departmental biosafety committees in the DA, DENR, DOH and DOST. The mandates jurisdiction and other powers of all departments and agencies in relation to biosafety and biotechnology is guided by the NBF in coordination with the NCBP and each other in exercising its power. The Department of Agriculture (DA) issued Administrative Order No 8, Series of 2002, (DA AO8, 2002), which is part of EO 514, for the implementation of guidelines for the importation and release into the environment of plants and plant products derived from the use of modern biotechnology. The DA authorizes the Bureau of Plant Industry (BPI) as the lead agency responsible for the regulation of agricultural crops developed through modern biotechnology. The BPI has adopted a protocol for risk assessment of GM crops for food and feed or for processing based on the Codex Alimentarius Commission’s Guideline for the Conduct of Food Safety assessment of Foods Derived from Recombinant-DNA plants and a protocol for environmental risk assessment in accordance with the Cartagena Protocol on Biosafety and with the recommendation of the Panel of Experts of the Organization for Economic Cooperation and Development (OECD). DA AO8, 2002 ensures that only genetically food crops that have been well studied and found safe by parallel independent assessments by a team of Filipino scientists and technical personnel from the concerned regulatory agencies of the Department are allowed into our food supply and into our environment. The DA AO 8, 2002 has a step by step introduction of GM plant into the environment. The research and development phase would require testing the genetically modified (GM) crop under controlled conditions subject to regulation by the government agencies. The first stage of evaluation for GM crops is testing under contained facilities such as laboratories, greenhouses and screenhouses. After satisfactory completion of testing under contained facilities, confined environmental release or field trial is done. Confined field trial (CFT) is the first controlled introduction of the GM crop into the environment. The approval for field trial shall be based on the satisfactory completion of safety testing under contained conditions. Unconfined environmental release or commercialization of the product would follow after the safe conduct of the CFT. Approval for propagation shall only be allowed after field trials and risk assessment show no significant risk to human and animal health and the environment.
Useful links
Relevant documents
Stacked events:
Gene stacking in plants can be conferred either through genetic engineering or conventional breeding A full risk assessment as to food and feed or for processing shall be conducted to plant products carrying stacked genes conferred through genetic engineering or conventional breeding, where the individual traits have no prior approval for direct use as food and feed or processing from the Bureau of Plant Industry (BPI) A desktop or documentary risk assessment on the possible or expected interactions between the genes shall be conducted for stacked gene products with multiple traits conferred through conventional breeding and individual events granted prior approval by the Bureau of Plant Industry.
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Bureau of Plant Industry 692 San Andres St, Malate, Manila 1004