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OECD Unique Identifier details

MON-89Ø34-3xDAS-Ø15Ø7-1xMON-88Ø17-3xDAS-59122-7
Commodity: Corn / Maize
Traits: Coleoptera resistance,Glufosinate tolerance,Glyphosate tolerance,Lepidoptera resistance
European Union
Name of product applicant: Monsanto and Dow AgroSciences
Summary of application:

The genetically modified maize MON-89Ø34-3xDAS-Ø15Ø7-1xMON-88Ø17-3xDAS-59122-7 maize, as described in the application, is produced by crosses between maize containing MON-89Ø34-3, DAS-Ø15Ø7-1, MON-88Ø17-3 and DAS-59122-7 events and expresses the Cry1A.105, Cry2Ab2, Cry1F proteins which confer protection against certain lepidopteran pests such as the European corn borer (Ostrinia nubilalis) and species belonging to the genus Sesamia; Cry3Bb1, Cry34Ab1 and Cry35Ab1 proteins which confer protection against certain coleopteran pests such as corn rootworm larvae (Diabrotica spp.); pat protein which confers tolerance to the glufosinate-ammonium herbicide; cp4 epsps protein which confers tolerance to the glyphosate herbicide.


Transform Event


Maize (MON 89034×1507× MON88017×59122) MON-89Ø34-3xDAS-Ø15Ø7-1xMON-88Ø17-3xDAS-59122-7 and four related GM maizes combining three different single GM events: (MON89034×1507×MON88017) MON-89Ø34-3xDAS-Ø15Ø7-1xMON-88Ø17-3, (MON89034×1507×59122) MON-89Ø34-3xDAS-Ø15Ø7-1xDAS-59122-7, (MON89034×MON88017×59122) MON-89Ø34-3xMON-88Ø17-3xDAS-59122-7, (1507×MON88017×59122) DAS-Ø15Ø7-1xMON-88Ø17-3xDAS-59122-7 and four related GM maizes combining two different single GM events: (MON89034x1507) MON-89Ø34-3xDAS-Ø15Ø7-1, (MON89034x59122) MON-89Ø34-3xDAS-59122-7, (1507xMON88017) DAS-Ø15Ø7-1xMON-88Ø17-3, (MON88017x59122) MON-88Ø17-3xDAS-59122-7

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Date of authorization: 06/11/2013
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 see the EU relevant 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:
Event specific real-time quantitative PCR based methods for quantitative detection of genetically modified MON-89Ø34-3, DAS-Ø15Ø7-1, MON-88Ø17-3 and DAS-59122-7 maizes validated on the single-trait events and verified on MON-89Ø34-3xDAS-Ø15Ø7-1xMON-88Ø17-3xDAS-59122-7 maize. - Validated by the European Union Reference Laboratory established under Regulation (EC) No 1829/2003. Please see the EU relevant links below. -ERM®-BF424 (for DAS-59122-7) and ERM®-BF418 (for DAS-Ø15Ø7-1) accessible via the Joint Research Centre (JRC) of the European Commission, Institute for Reference Materials and Measurements (IRMM) at http://www.irmm.jrc.be/html/reference_materials_catalogue/index.htm and AOCS 0906-E and AOCS 0406-A (for MON-89Ø34-3) and AOCS 0406-D and AOCS 0406-A (for MON-88Ø17-3) accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm.
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Opinion of the European Food Safety Authority
Opinion of the European Food Safety Authority
Method for Detection
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Authorization expiration date: 5/11/2023
E-mail:
pablo.pindado-carrion@ec.europa.eu
Organization/agency name (Full name):
European Union
Contact person name:
Pablo PINDADO
Website:
Physical full address:
European Commission B232 04/106 1047 Brussels
Phone number:
00 32 2 298 67 06
Fax number:
Country introduction:
The process for authorising a new GMO is based on the EU regulation on GM food and feed (1829/2003). An application for authorising food or feed consisting of or made from a GMO must be submitted to the national authorities. The national authority then sends the application to the European Food Safety Agency (EFSA) for a risk assessment. EFSA then makes the application summary available to the public. No matter where in the EU the company applies, EFSA assesses the risks the GMO presents for the environment, human health and animal safety. If the application covers cultivation, EFSA delegates the environmental risk assessment to an EU country which sends EFSA its risk assessment report. After performing the risk assessment, EFSA submits its scientific opinion to the European Commission and to EU countries. The opinion is made available to the public, except for certain confidential aspects. Once EFSA publishes its risk assessment, the public has 30 days to comment on the Commission website for applications under Reg. 1829/2003, and on the Joint Research Centre website on the assessment report of the "lead" EU country for applications under Directive 2001/18. Within 3 months of receiving EFSA's opinion, the Commission grants or refuses the authorisation in a proposal. If it differs from EFSA’s opinion, it must explain why. National representatives approve the Commission’s proposal by qualified majority in: (1) The Standing Committee on the Food Chain and Animal Health if the application was submitted under Reg. 1829/2003; (2) The Regulatory Committee under Directive 2001/18/EC if the application was submitted under Dir. 2001/18. The proposal is adopted if the Committee agrees with it. If there is no opinion, the Commission may summon an Appeal Committee where EU countries can adopt or reject the proposal. If the Appeal Committee makes no decision, the Commission may adopt its proposal. Authorisations are valid for 10 years (renewable).
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Japan
Name of product applicant: Dow Chemical JapanLtd. Monsanto Japan Ltd.
Summary of application:

MON89034, TC1507, MON88017 and Corn 59122 conferring resistance to lepidopteran insects, corn rootworm and tolerance to glufosinate and glyphosate herbicides.

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Date of authorization: 18/12/2008
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:
Please see the link below (in Japanese).
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 (in Japanese)
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Authorization expiration date:
E-mail:
fscj-secretariat@cao.go.jp
Organization/agency name (Full name):
Food Safety Commission Secretariat,Cabinet Office,GOJ
Contact person name:
Hirotoshi Maehara
Website:
Physical full address:
Akasaka 5-2-20 Minato Ward,Tokyo,Japan
Phone number:
81 3 6234 1074
Fax number:
81 3 3584 7392
Country introduction:

The safety assessment of foods and food additives produced by recombinant DNA techniques (hereafter GM foods) is mandatory under the Food Sanitation Law. The Ministry of Health, Labour, and Welfare (MHLW) receives application from Applicant and requests the Food Safety Commission of Japan (FSCJ) to evaluate the safety of GM foods, and the FSCJ evaluates the safety in terms of human health. Within the FSCJ, the Expert Committee of Genetically Modified Foods conducts safety assessments based on following standards and policies
(1) Standards for the Safety Assessment of Genetically Modified Foods
(2) Policies Regarding the Safety Assessment of Stacked Varieties of Genetically Modified Plants
(3) Standards for the Safety Assessment of Food Additives Produced Using Genetically Modified Microorganisms
(4) Policies Regarding the Safety Assessment of Highly Purified Non-Protein Food Additives including Amino Acids Produced Using Genetically Modified Microorganisms It is forbidden to import or sell genetically modified foods or food products made from such foods that have not undergone safety assessment. After FSCJ submits a notification to MHLW, MHLW gives notice on the Official Gazette.

Useful links
Relevant documents
Stacked events:
With regard to stacked events, FSC conducts the Safety Assessment of GM Foods based on the “Policies Regarding the Safety Assessment of Stacked Varieties of Genetically Modified Plants”
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)
Mexico
Name of product applicant: Dow AgroSciences S.A. de C.V.
Summary of application:

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: Evento HX1 (TC1507, OCDE: DAS-Ø15Ø7-1)


El vector de transformación   PHP8999, fue usado para el desarrollo del maíz B.t. Cry1F evento 1507   y contiene las secuencias de codificación para cry1F y pat y   los elementos regulatorios necesarios para la expresión de los mismos. Las   plantas transgénicas fueron obtenidas mediante el método de bombardeo de   microproyectiles. Existe una sola inserción de los genes cry1F y pat   en el maíz evento 1507 más una copia adicional de la secuencia   codificadora de cry1F.


Evento HRW (DAS 59122, OCDE: DAS59122-7)


El evento DAS-59122-7 se produjo usando la transformación mediada por Agrobacterium. La línea receptora de maíz en la transformación fue la Hi-ll. Contiene transgenes cry34Ab1 y cry35Ab01 (además de pat).


Evento MON 88017:


El vector PV-ZMIR39 fue preparado para realizar la transformación en el evento MON 88017 mediante la transformación por Agrobacterium sp., conteniendo dos cassettes de expresión: cry3Bb1 y cp4 epsps.


MON-89Ø34-3


MON 89034 se desarrolló a través de la transformación vía Agrobacterium tumefaciens. Este vector contiene los cassettes de expresión cry1A.105 y cry2Ab2. Las proteínas Cry1A.105 y Cry2Ab2 son proteínas insecticidas de Bacillus thuringiensis (Bt) para el control de insectos plaga y actúan a través de una acción tóxica en el intestino de insectos lepidópteros específicos, tales como Ostrinia nubilalis (barrenador Europeo del maíz), Helicoverpa zea (gusano de la mazorca del maíz), y Spodoptera frugiperda.

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Date of authorization: 03/08/2010
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:
UI OECD: MON-89Ø34-3xDAS-Ø15Ø7-1xMON-88Ø17-3xDAS-59122-7 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.
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:
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: ralatorre@cofepris.gob.mx
Mexico
Name of product applicant: Monsanto Comercial, S.A. de C.V.
Summary of application:

Maíz (Zea mays) Resistente a insectos lepidópteros y coleópteros,  tolerante a glifosato y glufosinato de amonio


Identificador OECD:


MON-89Æ34-3 x DAS-Ø15Æ7 x MON 88Æ17-3 x DAS-59122-7


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



ü



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



ü



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)



ü



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



ü



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



ü



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



ü



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



ü



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



ü



 


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:









MON-89Æ34-3 x   DAS-Ø15Æ7 x MON 88Æ17-3 x   DAS-59122-7 es el resultado de la   cruza convencional entre los eventos parentales.


 


Evento DAS-Ø15Ø7-1


El fragmento lineal de ADN extraído del plásmido PHI8999, contiene las   secuencias de codificación cry1F y pat y sus funciones son las siguientes: La proteína Cry1F cuenta con   propiedades insecticidas contra algunos insectos lepidópteros. La versión   sintética truncada del transgén cry1F optimizada para ser utilizada en plantas se utilizó para   transformar la planta de maíz, resultando en expresiones del gen en plantas   transgénicas, a niveles suficientes para conferir protección contra las tres   principales plagas de lepidópteros que atacan al maíz en nuestro país:   resistencia a barrenador del tallo (Diatraea saccharalis), resistencia a gusano cogollero (Spodoptera frugiperda); y Resistencia moderada   de Gusano Elotero (Helicoverpa zeae).


La proteína fosfinotricina acetilasa (PAT), confiere tolerancia a una   forma de fosfinotricina sintetizada como la del glufosinato de amonio. Las plantas transgénicas fueron obtenidas mediante el método de   bombardeo de microproyectiles. Existe una sola inserción de los genes cry1F y pat en el maíz evento 1507 más una copia adicional de la   secuencia codificadora de cry1F.


 


DAS-59122-7


El ADN introducido en el evento DAS-59122-7 B.t. Cry34/35Ab1 fue generado usando el   plásmido PHP17662, el cual contiene el gen cry34Ab1, el gen cry35Ab1 y el gen pat. El maíz 59122 fue   obtenido por la transformación mediada por Agrobacterium.


 


Evento MON 88017:


El vector PV-ZMIR39 fue   preparado para realizar la transformación en el evento MON 88017 mediante la   transformación por Agrobacterium   sp., conteniendo dos cassettes de expresión: cry3Bb1 y cp4 epsps.


 


MON 89034 (MON-89Ø34-3):


El evento MON89034 se   produjo por medio de la transformación con Agrobacterium, el cual   tiene 2 regiones separadas de T-DNA. La primera, designada T-DNA I, contiene   las construcciones genéticas, las cuales comprenden los genes cry1A.105 y cry2Ab2.


Upload:
Date of authorization: 20/01/2010
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:
UI OECD: MON-89Ø34-3xDAS-Ø15Ø7-1xMON-88Ø17-3xDAS-59122-7 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.
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:
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: ralatorre@cofepris.gob.mx
Philippines
Name of product applicant: Monsanto Philippines and Dow AgroSciences
Summary of application:
Corn MON89034 x corn TC1507 x corn MON88017 x corn DAS 59122 is a combined trait product corn developed through conventional breeding techniques form the products MON89034, TC1507, MON88017 and Corn 59122 conferring resistance to lepidopteran insects, corn rootworm and tolerance to glufosinate and glyphosate herbicides
Upload:
Date of authorization: 09/02/2010
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:
Monsanto Philippines and Dow AgroSciences have 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: MON89034 x TC1507x MON88017 x DAS59122, which has been genetically modified for insect resistance and herbicide tolerance. A safety assessment of combined trait product corn: MON89034 x TC1507 x MON88017 x DAS59122 was conducted as per Department of Agriculture (DA) 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 interaction 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:
Merle B. Palacpac
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