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OECD Unique Identifier details

MON-89Ø34-3xMON-88Ø17-3
Commodity: Corn / Maize
Traits: Coleoptera resistance,Glyphosate tolerance,Lepidoptera resistance
European Union
Name of product applicant: Monsanto
Summary of application:

The genetically modified MON-89Ø34-3 x MON-88Ø17-3 maize, as described in the application, expresses the Cry1A.105 and Cry2Ab2 proteins which provide protection to certain lepidopteran pests, Cry3Bb1 protein which provides protection to certain coleopteran pests and the CP4 EPSPS protein which confers tolerance to glyphosate herbicides.

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Date of authorization: 17/06/2011
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.): Biosafety Clearing House (BCH)
OECD BioTrack Product Database
Summary of the safety assessment:
Please see the EU relevant links below.
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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:
Event specific real-time quantitative PCR based method for genetically modified maize MON-89Ø34-3 x MON-88Ø17-3. - Validated by the Community reference laboratory established under Regulation (EC) No 1829/2003. Please see the EU relevant links below.
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Opinion of the European Food Safety Authority
Method for Detection
Reference Material
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Authorization expiration date: 16/6/2021
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:
Brazil
Name of product applicant: Monsanto do Brasil Ltda.
Summary of application:

Commercial release of maize MON 89034 × MON 88017 

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Date of authorization: 29/03/2011
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.): Center for Environmental Risk Assessment
Summary of the safety assessment:
Insect resistant and glyphosate herbicide tolerant, MON 89034 x MON 88017 is the result of crossing MON 89034 and MON 88017 through techniques of classical genetic improvement. Event MON 89034 has proteins Cry1A.105 and Cry2Ab2 derived from Bacillus thuringiensis that are active against lepidopteran pests important in this culture. Event MON 88017, as well as corn MON 88034 x MON 88017 produces protein 5-enolpyruvylshikimate-3-phosphate synthase of Agrobacterium sp. strain CP4 (CP4 EPSPS), which grants tolerance to glyphosate, and modified protein Cry3Bb1 from Bacillus thuringiensis subsp. kumamotoensis that selectively controls target coleopterans, such as coleopteran larvae of the genus Diabrotica. Events MON 89034 and MON 88017 were already passed by CTNBio for commercial release according to Technical Opinions EPT 2052/2009, in October 2009, and EPT 2764/2010, in December 2010, respectively. The combination of the two events has the purpose of granting farmers in Brazil the possibility of reducing yield losses under the pressure of pest plants and occurrence of root pests of the genus Diabrotica and lepidopteran pests. Comparative molecular analyses between the stacked event, individual events (MON 89034 and MON 88017 ) and conventional corn, showed that the molecular structure was preserved during the process of classical genetic improvement. Studies verified that there is no interaction between proteins Cry1A.105/Cry2Ab2 and Cry3Bb1, being their effect deemed to be additive in controlling pests, that is to say, that the event behaved independently in their contribution towards insect control On the other hand, protein CP4 EPSPS biological activity mode and location are different. While proteins Cry act in the cytoplasm, protein CP4 EPSPS is directed to the chloroplast. There is no known mechanism or possible interaction between these proteins that could lead to an adverse effect to human and animal health. Besides, no changes in the expression of the proteins were detected when compared to individual effects. This way, in order to verify that the stacked event MON 88034 x MON 88017 is equivalent to and as safe as the conventional corn, the applicant submitted data of the literature, results of previous experiments with the isolate events and results of essays conducted under contention and in the environment, following scientific methodologies, with the purpose of showing the absence of interaction between the genes introduced in the stacked event. Field data generated in Brazil enable concluding that corn MON 88034 x MON 88017, except for characteristics that are determined by the genetic modification, is not different from the control corn and, therefore, fails to present environmental risks, increased potential as a weed pest or expanded gene flow to conventional corn. Field experiments conducted in Brazil on ecological interactions of corn MON 88034 x MON 88017 compared to the conventional control corn to and other twelve commercial references. Analyses on damages to the leaf, ear, stem and root, as well as data on rot in ear and stem show that four out of six comparisons displayed significant differences; damages to leaves, ears, stems and roots were significantly lower in the corn analyzed. Besides, assessments on impacts of corn MON 88034 x MON 88017 in non-target organisms were conducted in four Monsanto do Brasil Experimental Stations. Data submitted corroborate the history of secure use of genetically modified cultures containing genes derived from Bacillus thuringiensis. Either in localized individual analyses and in the microbiota combined analyses, no significant differences were found between results of MON 88034 x MON 88017and the control corn. Therefore, the conclusion was that expression of the four heterologous proteins of the corn under examination has no potential to affect the soil microbiota in a significant way. Regarding alimentary safety, MON 88034 x MON 88017 corn had a behavior substantially similar to conventional corn, as well as to other commercial hybrid corns. Centesimal composition data failed to display significant differences between the genetically modified variety and controls and references, suggesting nutritional equivalence between the corns. Data submitted corroborate the results found in samples collected in Brazil for individual events, which are also equivalent in composition to conventional corn. A field study was conducted in Brazil with the purpose of generating samples to assess the levels of expression of proteins Cry1A.105, Cry2Ab2, Crfy3Bb1 and CP4 EPSPS on corn MON 88034 x MON 88017 in leaves during harvest, forage, grains and roots in two harvest times, using the ELISA quantification method. The combined analysis of data collected in Brazil, United States and European Union indicates that the expression levels of the four proteins are equivalent, that is to say, the majority of intervals (minimum values and maximum values) are superimposed in corn MON 88034 x MON 88017 cultivated in different places, as well as equivalent to those detected in individual events (corn MON 89034 and corn MON 88017). Regarding allergenicity and toxicity, it must be stressed that proteins Cry1A.105, Cry2Ab2, Crfy3Bb1 and CP4 EPSPS are rapidly absorbed in simulated gastric fluid. This fact makes improbable that the proteins may act as alimentary allergens. Bioinformatic analysis has verified that proteins Cry1A.105, Cry2Ab2, Crfy3Bb1 and CP4 EPSPS fail to share significant similarity in amino acid sequencing with known allergens, gliadins, glutenins or toxic proteins that may cause adverse effects to health. In studies of acute oral toxicity in mice, it was shown that proteins Cry1A.105, Cry2Ab2, Crfy3Bb1 and CP4 EPSPS failed to display acute toxicity and failed to cause adverse effects even in the highest doses tested. From the above, the conclusion is that consumption of MON 88034 x MON 88017 corn is not a potential cause of significant degradation to the environment and risks to human and animal health. For the above, there are no restrictions to the use of this corn or derivatives therefrom. CTNBio determines that post-commercial release monitoring shall be conducted in commercial cultures and not in experimental ones. Areas selected to be monitored shall not be isolated from other areas, possess borders or display any condition that may be different from the commercial pattern. Monitoring shall be conducted in a comparative model between the conventional and the GMO cultivation systems, where collection of date shall be conducted by sampling. The monitoring shall additionally be conducted in biomes that are representative of the main GMO cultivation areas and, if possible, include different types of producers. Monitoring shall be conducted for a period not shorter than five years. Monitoring reports submitted shall detail information on all activities of pre-sowing and sowing, execution thereof, reporting activities conducted in monitoring areas during the culture cycle, and activities of harvesting and climatic conditions. Any aggravation to human and animal health shall be notified through official adverse effect notification systems, including, without limitation, SINEPS (Sistema de Notificação de Eventos Adversos relacionados a Produtos de Saúde – Notification System of Adverse Effects related to Health Product) as regulated by ANVISA. Analytical methods, results achieved and interpretation thereof shall be developed according to principles of independence and transparency, except for commercial secrecy reasons previously justified and defined as such. A total of 21 monitoring actions are proposed: - sowing, management, and harvesting of corn culture; - soil physical and chemical characteristics; - corn nutritional conduction – corn plant sanity; - pest plant communities and field diaspores; resistance to glyphosate herbicide; - gene flow of MON 88034 x MON 88017 to conventional corn; - residues of glyphosate and AMPA in corn grains and soil; - residue of proteins Cry1A.105, Cry2Ab2, Crfy3Bb1 in maze straw and straw; - microbial diversity associated to the soil; - invertebrates in soil and soil surface; - visual inspection of non-target arthropods in the aerial part; - assessment of non-target arthropods in the aerial part by means of traps; - monitoring of Cry proteins in water; - assessment of target-insects and aggravations to human and animal health; and – complementary agricultural activities
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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:
molecular traditional methods
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: National Biosafety Commission
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Authorization expiration date: Not Applicable
E-mail:
gutemberg.sousa@mcti.gov.br
Organization/agency name (Full name):
National Biosafety Technical Commission
Contact person name:
Edivaldo Domingues Velini
Website:
Physical full address:
SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number:
556134115516
Fax number:
556133177475
Country introduction:
The Brazilian National Biosafety Commission – CTNBio , is responsible to the technical decision on biological risk as a response to a request from the proponent. The technical decision is given on a definitive basis. Only the National Biosafety Council (CNBS) can revoke the decision (in case of commercial release), based on social-economical reasons and not on biosafety reasons. Once a decision is taken by CTNBio favorable to the commercial release of a new GMO (being it a plant or any other organism), CNBS has 30 days to issue a revoke. After these steps, the new product must be evaluated for conformity to the Brazilian standards by the registration and enforcement agencies (ANVISA – Ministry of Health, Ministry of Agriculture, Ministry of Environment and Ministry of Fisheries, according to the intended use of the product). If it conforms to the standards, it may be offered to the market. Every institution dealing with GMOs (including universities and public research institutes) has to have an Internal Biosafety Commission (CIBio), which is legally responsible of everything that may happen to be done or caused by the GMO
Useful links
Relevant documents
Stacked events:
At the discretion of, and upon consultation with, CTNBio, a new analysis and issuance of technical opinion may be released on GMOs containing more than one event, combined through classic genetic improvement and which have been previously approved for commercial release by CTNBio
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Dr. Edivaldo Domingues Velini (President of national Biosafety Commission)
Japan
Name of product applicant: Monsanto Japan Ltd.
Summary of application:

MON89034 x MON88017 has genetically modified to resistant to Lepidoptera and Coleoptera and tolerant to glyphosate herbicide (cry1A.105, modified cry2Ab2, modified cp4 epsps, modified cry3Bb1, Zea mays subsp. mays (L.) Iltis)

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Date of authorization: 12/02/2008
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.): OECD BioTrack Product Database
Summary of the safety assessment:
Please see the link below (in Japanese).
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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: 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: Monsanto Comercial, S.A. de C.V.
Summary of application:

Maíz (Zea mays) Resistente a insectos lepidópteros y resistente al gusano de la raíz y tolerante a glifosato


Identificador OECD: MON 89Æ34-3 x MON 88Æ17-3


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 el maíz convencional.



 


Descripción del producto de transformación:









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.


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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:
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 MON 8934-3 x MON 8817-3 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 maíz evento maíz MON 8934-3 x MON 8817-3, fue aprobado para consumo humano en Estados Unidos en el año 2008. Conclusión: No se observaron efectos tóxicos, alérgicos o cambios nutrimentales sustanciales en el maíz genéticamente modificado evento MON 8934-3 x MON 8817-3. 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: Monsanto Philippines
Summary of application:
Monsanto has developed a biotechnology derived product corn MON 89034 through Agrobacterium mediated transformation to express the Bacillus thuringiensis insecticidal proteins, Cry1A.105 and Cry2Ab2. The introduction of corn MON 89034 is expected to provide enhanced benefits for the control of lepidopteran insects pests such as Ostrinia furnacalis (Asian corn borer, ACB), Spodoptera litura (CCW) and Helicoverpa zea (corn earworm, CEW) compared to existing products.

Corn 88017 expressed Cry3Bb1 protein encoded by the cry3Bb1 sequence from Bacillus thuringiensis subs kumamotoensis, which confers insecticidal activity against corn rootworm. It also contains cp4 epsps gene from Agrobacterium sp. Strain CP4, which confers tolerance to glyphosate herbicide

The transgenic corn traits from Event MON89034 and Event MON88017 were combined through conventional breeding to produce the Corn MON89034 x MON88017. This stacked hybrid produces the three transgenic proteins present in Corn MON89034 x MON88017 corn plants.
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Date of authorization: 19/10/2009
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 has 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 Department of Agriculture (DA)- Administrative Order (AO) No. 8 Part 5 for combined trait corn: corn MON89034 x MON88017 which has been genetically modified for insect protection and herbicide tolerance. A safety assessment of combined trait product corn: MON89034 x MON88017 was conducted as per 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 the transgenes. Review of results of evaluation by the BPI Biotech Core Team in consultation with DA-Biotechnology Advisory Team (DA-BAT) completed the approval process.
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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:
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