Food safety and quality
| share
 

OECD Unique Identifier details

MON-877Ø5-6×MON-877Ø8-9×MON-89788-1
Commodity: Soyabean / Soybeans
Traits: Herbicide tolerance,High oleic acid,Low level of fatty acids
Colombia
Name of product applicant: Compañia Agricola S.A.S
Summary of application:

Authorization of the genetically modified soy MON87705 x MON87708 x MON89788 r tolerant to herbicides Dicamba and glyphosate, and modifies oil/fatty quantities

Upload:
Date of authorization: 04/07/2018
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 (food safety):
Based on the risk assessment, it can be concluded that the event shows the same risks as its conventional counterpart. Therefore the National Technical Biosafety Committee for GMO use exclusively in Health and human consumption (CTNSalud) recommends its authorization.
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 (a blank field means there is no expiration date)
E-mail:
drubio@minsalud.gov.co
Organization/agency name (Full name):
Ministerio de salud y proteccion social
Contact person name:
Daniel Rubio
Website:
Physical full address:
Carrera 13 No. 32- 76 piso 12, Bogotá
Phone number:
330 5000 ext 1256
Fax number:
Country introduction:

The 4525 decree of 2005, established the Ministry of Health and Social Protection as the competent authority for GMO for health and food purposes and creates the National Biosafety Technical Committee for GMO's used in health and food purposes (CTNSalud).

The CTNSalud is composed by the Ministry of Health and Social Protection, the National Food and Drug Surveillance Institute (INVIMA) and the Technology and Innovation Administrative Department (COLCIENCIAS). This committee is responsible for the assesment of risk assessments; to inquire for any additional information; assessment of any measurements in accordance to the Cartagena Protocol; and the recommendation for the authorization of GMO for health or food purposes.

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: Monsanto Japan Ltd.
Summary of application:

Soybean Lines Generated through Cross-breeding of MON87705, MON87708 and MON89788

Upload:
Date of authorization: 10/12/2016
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 (food safety):
Please see the 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: Food safety assessment performed by Food Safety Commission of Japan (in Japanese)
Food safety assessment performed by Food Safety Commission of Japan (in English)
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
fscj-secretariat.3a5@cao.go.jp
Organization/agency name (Full name):
Food Safety Commission Secretariat,Cabinet Office,
Contact person name:
Mari Kamogawa
Website:
Physical full address:
Akasaka 5-2-20 Minato Ward,Tokyo,Japan
Phone number:
81 3 6234 1122
Fax number:
81 3 3584 7392
Country introduction:
Safety assessments of GM foods are mandatory under the Food Sanitation Law in Japan. The Ministry of Health, Labour, and Welfare (MHLW) legally imposes safety assessments of GM foods so that those that have not undergone safety assessments would not be distributed in the country. MHLW receives application and requests the Food Safety COmmission of Japan (FSCJ) to evaluate the safety of GM foods in terms of human health. Safety assessments are carried out by FSCJ.
Useful links
Relevant documents
Stacked events:

With regard to stacked events, FSCJ conducts the safety assessment of GM food based on the “Policies Regarding the Safety Assessment of Stacked Varieties of Genetically Modified Plants”.

Even if single events that are stacked have already approved, some products will be considered as new products and some will not.

Please refer to Article 5 and 6 of the MHLW’s notice, which is available at the following URL, for the details.

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000053519.pdf

Article 6 was modified in 2014, and the modified version is available at the following URL.

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000049695.pdf

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. de R. L. de C.V.
Summary of application:

Authorization by COFEPRIS: 160


Soybean (Glycine max) genetically modified (877Ø5 × 877Ø8 × 89788). Tolerant to dicamba herbicides, glyphosate and changes in levels of fatty acid, with high content of oleic acid.

Upload:
Date of authorization: 24/01/2017
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 (food safety):
No toxic, allergic or substantial nutritional changes were observed. Therefore it can be ensured that the Genetically Modified Soybean (Glycine max). OCDE identifier: MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 is, based on the existing knowledge to date, as innocuous as its conventional counterpart.
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 (a blank field means there is no 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:

México ha buscado garantizar la inocuidad de los productos biotecnológicos para el uso y consumo de su población. Desde 1984 el artículo 282 bis 1 de la Ley General de Salud, contempló que la Secretaría de Salud debería regular aquellos productos biotecnológicos, o sus derivados, destinados al uso o consumo humano. En un inicio, con fundamento en este artículo, la Secretaria de Salud evaluó la inocuidad alimentaria de productos biotecnológicos, para su comercialización con fines de uso o consumo humano. A partir de 2005, con la entrada en vigor de la Ley de Bioseguridad de Organismos Genéticamente Modificados (LBOGM), se realizó la adecuación de la regulación para dar lugar a la Autorización que es el acto administrativo mediante el cual la Secretaría de Salud, a través de la Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), autoriza Organismos Genéticamente Modificados (OGMs), a efecto de que se pueda realizar su comercialización, así como su utilización con finalidades de Salud Pública o de Biorremediación.

Las facultades que corresponden a la Secretaría de Salud se estipulan en el artículo 16 de la LBOGM y lo relativo a la Autorizaciones se describe en los artículos 91 al 98 de dicha Ley. Quienes pretendan obtener una Autorización para Comercialización e Importación de OGMs deben presentar ante COFEPRIS, una solicitud por escrito acompañada de la información a que se refiere los artículos 23 al 32 del Reglamento de la Ley de Bioseguridad de OGMs.

http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/LBOGM.pdf

http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/Reg_LBOGM.pdf

 

Courtesy translation

Mexico has sought to guarantee the safety of biotechnological products the use and consumption of its population. Since 1984, article 282 bis 1 from the General Law of Health, considered that the Secretary of Health should regulate those biotechnological products, or their derivatives, intended for food and feed use. Initially, the Secretary of Health evaluated the food safety of biotechnological products, based on this article, for commercialization with purposes of food, feed and processing. Subsequently in 2005, with the entry into force of the Law on Biosafety of Genetically Modified Organisms (LBOGM), the regulation was adapted to give rise to the Authorization, which is the administrative act through which the Secretary of Health, by means of the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), authorizes Genetically Modified Organisms (GMOs), to their commercialization, as well as their use for purposes of public health or bioremediation.

The faculties that correspond to the Secretary of Health are stipulated in Article 16 of the LBOGM and what is related to the Authorizations is described in Articles 91 to 98 of this Law. Those who seek to obtain an Authorization for GMOs merchandising and importation, must present to COFEPRIS, a written request accompanied by the information referred into articles 23 to 32 of the Regulation of the Law on Biosafety of Genetically Modified Organisms.

http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/LBOGM.pdf

http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/Reg_LBOGM.pdf

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%20

Philippines
Name of product applicant: Monsanto Philippines Inc.
Summary of application:

On December 5, 2016, Monsanto Philippines Inc. applied the stacked trait product soybean MON87705 x MON87708 x MON89788 for direct use as food and feed, or for processing as an original application under the DOST-DA-DENR-DOH-DILG Joint Department Circular No. 1 Series of 2016 (JDC No.1, S2016). After reviewing the Risk Assessment Report and attachments submitted by the applicant; the Scientific and Technical Review Panel (STRP) member, BPI-Plant Products Safety Services Division (BPI-PPSSD) and Bureau of Animal Industry (BAI) has found no interaction of the resulting gene product of the regulated article applied for direct use as food and feed, or processing based on scientific evidences provided. The STRP, BAI, and BPI-PPSSD concurred that the likelihood of interaction of the two proteins involved in the combined trait product: DMO and CP4EPSPS is highly unlikely to produce any known allergen or toxins to human and animals because of the difference on their mode of action. There is no known mechanism of interaction among the RNA-based suppression and the proteins that could lead to adverse effects in humans, animals or environment which is not likely to interact. Furthermore, the assessors affirmed that there are no possible unintended effects of stacked genes on the metabolism of the plant based on the previous assessments of individual transformation events. In addition, stability and expression of the gene will never be affected since molecular analyses also indicated the absence of any marker gene in MON87705 x MON87708 x MON89788 genome. After thorough scientific review and evaluation of Monsanto’s duly accomplished Environmental Risk Assessment (ERA) and Project Description Report (PDR) forms, the Department of Environment and Natural Resources – Biosafety Committee (DENR-BC), recommended for the issuance of a biosafety permit for this regulated event provided that the conditions set by DENR are complied. Also, the Department of Health – Biosafety Committee (DOH-BC), after a thorough scientific review and evaluation of the accomplished Environmental Health Risk Assessment form, concluded that soybean MON87705 x MON87708 x MON89788 will not pose any significant risk to the health and environment and that any hazards could be managed by the measures set by the department. Hence, the DOH-BC also recommended for the issuance of biosafety permit for the stacked trait product. Lastly, after assessing that there will be no negative socio-economic, ethical and cultural concerns that will arise from the adoption of Genetically Modified Organisms, the Socioeconomic, Ethical and Cultural (SEC) expert recommended for the approval and issuance of biosafety permit of soybean MON87705 x MON87708 x MON89788 for direct use as food and feed, or for processing

Upload:
Date of authorization: 09/07/2018
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 (food safety):
STRP ASSESSMENT AND RECOMMENDATION Gene Interaction MON87705 has the cp4epsps gene for glyphosate tolerance and the inverted repeat of FAD2-1A and FATB1-A which produces ds RNA that suppresses endogenous FATB and FAD 2 RNA levels leading to improve fatty acid profile. MON87708 contains DMO gene that expresses mono-oxygenase that rapidly demethylates dicamba which renders it inactive thereby conferring tolerance to dicamba. Lastly, MON89788 contains cp4epsps which produces CP4EPSPS protein confers tolerance to glyphosate. The STRP agreed that there is no interaction in the resulting products of the two proteins dmo and cp4epsps because the mode of action is totally different from each other. The STRP also stated that DMO and CP4EPSPS would accumulate in the plastids. These proteins are targeted specifically to the organelle because dmo and cp4epsps genes encodes chloroplast transit peptides that would direct the proteins to the chloroplast. Metabolic Pathways As presented in the request for review of MON87705 x MON87708 x MON89788, page 4 (paragraphs 3 to 6), STRP agreed that the technology developer provides the complete description of the mode of action of each gene product. Also, as stated earlier, the mode of action of each gene product is different. The products are not involved in the same metabolic pathway. Each single event will not alter the metabolism of soybean. RNA based suppression of FATB and FAD 2 to improve fatty acid composition is totally independent on the expression of DMO and CP4EPSPS proteins. Since the DMO and CP4EPSPS proteins are expressed in MON87705 x MON87708 x MON89788, this would indicate that the genes can also function properly in the stacked trait product. Gene Expression The expression levels of the individual protein products are the same as the individual approved transformation events as presented in table 2 page 9 of the paper request for review of MON87705 x MON87708 x 89788. It is also shown in the table that the protein level expression is within the range. In addition, the marker genes are not transferred and expressed in the stacked plants. The STRP affirmed that the interaction is unlikely to happen. Stability and expression of the genes will never be affected. BPI-PPSSD ASSESSMENT AND RECOMMENDATION Gene Interaction Based on the documents provided by the developer, the two (2) proteins being expressed in the combined trait product, DMO and CP4 EPSPS, will not interact to produce any known allergen or toxins to human and animals. There is no known mechanism of interaction among the RNA-based suppression and the proteins that could lead to adverse effects in humans, animals or environment which is not likely to interact. It is also highly unlikely that the RNA-based FAD2-1A/FATB1-A suppression cassette present in MON87705 x MON87708 x MON89788 produces a protein. The gene transcript with an inverted repeat produces double stranded RNA (dsRNA) that, via the RNA interference (RNAi) pathway, suppresses endogenous FATB and FAD2 RNA levels that leads to improved fatty acid composition. In terms of accumulation, the DMO and CP4 EPSPS proteins would accumulate in plastids because they are targeted specifically to these organelles. The dmo and cp4 epsps genes contained in MON 87705 × MON 87708 × MON 89788 are designed to encode chloroplast transit peptides so that the DMO and CP4 EPSPS proteins are directed to the chloroplast. Metabolic Pathways The mode of action and metabolic pathways of each protein are significantly different from each other. DMO belongs to a family of Rieske oxygenase proteins, which is part of a threecomponent system that includes a ferredoxin, a reductase, and an oxygenase. It catalyzes the NADH-dependent oxidative demethylation of the herbicide dicamba. The CP4 EPSPS protein belongs to the family of EPSP synthases involved in the penultimate step of the biochemical shikimate pathway producing aromatic amino acids in the chloroplasts of plants. Gene Expression Enzyme-Linked Immunosorbent Assays (ELISA) was used to quantify and determine the level of proteins. DMO and CP4 EPSPS proteins were expressed properly in the combined trait product MON 87705 x MON 87708 x MON 89788 and was comparable to each single event. The mean DMO protein levels in MON 87705 × MON 87708 × MON 89788 and MON 87708 were 13µg/g dwt and 19µg/g dwt in seed, respectively. The mean CP4 EPSPS protein levels in MON 87705 × MON 87708 × MON 89788, MON 87705, and MON 89788 are 140µg/g dwt, 130µg/g dwt and 63µg/g dwt in seed, respectively. Molecular analyses also indicated the absence of any marker gene in MON87705 x MON87708 x MON89788 genome. BAI ASSESSMENT AND RECOMMENDATION Gene Interaction The structural differences of DMO and CP4EPSPS proteins as well as the distinct modes of action among these proteins are unlikely to produce a significant interaction. BAI affirmed that this lack of interaction will not lead to production of a new allergen or toxin in the combined trait product. BAI agreed to the information provided by the developer the gene products will accumulate the same subcellular compartments. The dmo and cp4epsps are designed to encode chloroplast transit peptides so that DMO and CP4EPSPS proteins are directed to chloroplast. Metabolic pathways BAI agreed that the mode of action has been completely described in the previous safety assessment of each individual single event. CP4EPSPS protein confers tolerance to glyphosate and is involved in an enzymatic pathway producing aromatic amino acids in the chloroplasts of plants. On the other hand, DMO protein catalyzes the NADH-dependent oxidative demethylation of the herbicide dicamba rendering inactive, thereby conferring its tolerance. The two proteins are structurally and functionally different and not involved in the same metabolic pathway. The inserted genes, which are not designed to alter the plant metabolism are inherited and functioning properly when combined into the breeding stack. It indicates that any mechanisms of interaction between these products are highly unlikely and that each gene product functions independently as in single event. Gene Expression In terms of gene expression, results obtained from ELISA performed on seed tissues of MON 87705 x MON 87708 x MON 89788, MON 87705, MON 87708 and MON 89788 collected from five field sites during Argentina field trials show that the proteins were expressed properly in the combined trait product as in its relevant single events. The proteins were expressed at low level also as demonstrated by ELISA. Also, it did not show any indication that the marker genes were transferred and expressed in plants containing the combined genes. Due to the different mode of action, any form of interaction is unlikely. This means that the stability and expression levels of all the genes will not be significantly affected. DENR ASSESSMENT AND RECOMMENDATION After thorough and scientific review and evaluation of the documents provided by the Bureau of Plant lndustry (BPl) to the DENR Biosafety Committee within the prescribed period pursuant to Joint Department Circular (JDC) No.1 s.2016 on the application of Monsanto Philippines, Inc. for direct use for feed, food or processing of Genetically Modified Soybean tolerant to glyphosate herbicide stacked trait product MON87705 x MON87708 x MON89788, the following are the observations and recommendations: 1. The effect of the regulated article on the environment depends largely on the viability of the product to be utilized for direct use. lf the article is transported in a nonviable form, there is no danger to the environment; 2. Due to the absence of a specified Environmental Management Plan (EMP) by the traders/importers, the Committee would like to recommend that it be added to the requirements for the issuance of an import permit by the Bureau of Plant lndustry (BPl) (Article Vlll, Section 26 of JDC No,1 s.2016); 3. It is suggested that BPI ensure the following: a) development of guidelines on the EMP in coordination with DENR; b) implementation of the EMP by the traders/importers involved in the import, handling, processing and transport of viable soybean MON87705 x MON87708 x MON89788 commodity products; and c) Strict monitoring of the regulated article from port of entry to the trader's/importer's storage/warehouse (Section 32 of the JDC No. 1 s.2016); Based on the above considerations and with the submitted sworn statement and accountability of the proponent, a biosafety permit may be issued to the proponent if the abovementioned recommendations are followed. DOH ASSESSMENT AND RECOMMENDATION After a thorough review and evaluation of the documents provided by proponent, Monsanto Philippines Inc., through the Bureau of Plant Industry (BPI) in support of their application for approval for direct use as food and feed or processing of soybean MON87705 x MON87708 x MON89788. DOH find that the regulated article applied for direct use as food and feed or processing is safe as its conventional counterpart and shall not pose any significant risk to human and animal health and environment. The following are the observations and recommendations: 1. Find that regulated article applied for direct use for food and feed or for processing (FFP) does not require changes in the usual practices in unloading, loading, transport, storage and processing. As such, the regulated article is as safe as its conventional counterpart and is not expected to pose any significant risk to human and animal health and environment while in transit, storage and processing. 2. Scientific pieces of evidences from provided references i.e. literatures show that regulated article applied for direct use as food and feed or for processing (FFP) is as safe as its conventional counterpart and shall not pose any significant risk to human and animal health and on the environment. 3. It is suggested that Bureau of Plant Industry (BPI) ensure the following: a. Strict monitoring of the regulated article from port of entry to the trader’s / importer’s storage/warehouse as stated in Section 32 of the JDC No. 1 series, 2016. b. The BPI to include in the insurance of permit for the release of this product the following conditions: b.1. Any spillage (during unloading and loading/hauling and transport unloading and storage) shall be collected and cleaned up immediately. b.2. Transportation of the consignment from the port of entry to any destination within the country shall be in closed containers. b.3. There shall be a clear labeling of the product from importation down to all levels of marketing stating that it is only for the purpose of direct use for food and feed or for processing and is not to be used as planting materials. 4. Based on the above considerations and with the submitted sworn statement and accountability of the proponent, this recommendation is being submitted to BPI related to the processing and issuance of a biosafety permit for direct use as food and feed or for processing of soybean MON87705 x MON87708 x MON89788. SEC ASSESSMENT AND RECOMMENDATION According to the SEC expert, the impact of GM Soybean MON 87705 X MON 87708 X MON 89788 to the feed industry and ultimately to the livestock, poultry and the aquaculture sub-sectors would be tremendous. Importation of soybeans will save millions of dollars for our country through lower prices. With the above scenario and observed consequences of MON 87705 X MON 87708 X MON 89788, the SEC expert recommend the renewal of permit of the MON 87705 X MON 87708 X MON 89788. The renewal of the utilization of GM Soybeans would help the feed industry and may result to lower production cost of poultry, livestock and aquaculture products in our country. Likewise, food and processing sub-sectors will also benefit the approval of this GM product. However, concern agencies, both government and nongovernment, should continue monitor and regularly assess the risk of any GM products introduced in the country. STRP ASSESSMENT AND RECOMMENDATION Gene Interaction MON87705 has the cp4epsps gene for glyphosate tolerance and the inverted repeat of FAD2-1A and FATB1-A which produces ds RNA that suppresses endogenous FATB and FAD 2 RNA levels leading to improve fatty acid profile. MON87708 contains DMO gene that expresses mono-oxygenase that rapidly demethylates dicamba which renders it inactive thereby conferring tolerance to dicamba. Lastly, MON89788 contains cp4epsps which produces CP4EPSPS protein confers tolerance to glyphosate. The STRP agreed that there is no interaction in the resulting products of the two proteins dmo and cp4epsps because the mode of action is totally different from each other. The STRP also stated that DMO and CP4EPSPS would accumulate in the plastids. These proteins are targeted specifically to the organelle because dmo and cp4epsps genes encodes chloroplast transit peptides that would direct the proteins to the chloroplast. Metabolic Pathways As presented in the request for review of MON87705 x MON87708 x MON89788, page 4 (paragraphs 3 to 6), STRP agreed that the technology developer provides the complete description of the mode of action of each gene product. Also, as stated earlier, the mode of action of each gene product is different. The products are not involved in the same metabolic pathway. Each single event will not alter the metabolism of soybean. RNA based suppression of FATB and FAD 2 to improve fatty acid composition is totally independent on the expression of DMO and CP4EPSPS proteins. Since the DMO and CP4EPSPS proteins are expressed in MON87705 x MON87708 x MON89788, this would indicate that the genes can also function properly in the stacked trait product. Gene Expression The expression levels of the individual protein products are the same as the individual approved transformation events as presented in table 2 page 9 of the paper request for review of MON87705 x MON87708 x 89788. It is also shown in the table that the protein level expression is within the range. In addition, the marker genes are not transferred and expressed in the stacked plants. The STRP affirmed that the interaction is unlikely to happen. Stability and expression of the genes will never be affected. BPI-PPSSD ASSESSMENT AND RECOMMENDATION Gene Interaction Based on the documents provided by the developer, the two (2) proteins being expressed in the combined trait product, DMO and CP4 EPSPS, will not interact to produce any known allergen or toxins to human and animals. There is no known mechanism of interaction among the RNA-based suppression and the proteins that could lead to adverse effects in humans, animals or environment which is not likely to interact. It is also highly unlikely that the RNA-based FAD2-1A/FATB1-A suppression cassette present in MON87705 x MON87708 x MON89788 produces a protein. The gene transcript with an inverted repeat produces double stranded RNA (dsRNA) that, via the RNA interference (RNAi) pathway, suppresses endogenous FATB and FAD2 RNA levels that leads to improved fatty acid composition. In terms of accumulation, the DMO and CP4 EPSPS proteins would accumulate in plastids because they are targeted specifically to these organelles. The dmo and cp4 epsps genes contained in MON 87705 × MON 87708 × MON 89788 are designed to encode chloroplast transit peptides so that the DMO and CP4 EPSPS proteins are directed to the chloroplast. Metabolic Pathways The mode of action and metabolic pathways of each protein are significantly different from each other. DMO belongs to a family of Rieske oxygenase proteins, which is part of a threecomponent system that includes a ferredoxin, a reductase, and an oxygenase. It catalyzes the NADH-dependent oxidative demethylation of the herbicide dicamba. The CP4 EPSPS protein belongs to the family of EPSP synthases involved in the penultimate step of the biochemical shikimate pathway producing aromatic amino acids in the chloroplasts of plants. Gene Expression Enzyme-Linked Immunosorbent Assays (ELISA) was used to quantify and determine the level of proteins. DMO and CP4 EPSPS proteins were expressed properly in the combined trait product MON 87705 x MON 87708 x MON 89788 and was comparable to each single event. The mean DMO protein levels in MON 87705 × MON 87708 × MON 89788 and MON 87708 were 13µg/g dwt and 19µg/g dwt in seed, respectively. The mean CP4 EPSPS protein levels in MON 87705 × MON 87708 × MON 89788, MON 87705, and MON 89788 are 140µg/g dwt, 130µg/g dwt and 63µg/g dwt in seed, respectively. Molecular analyses also indicated the absence of any marker gene in MON87705 x MON87708 x MON89788 genome. BAI ASSESSMENT AND RECOMMENDATION Gene Interaction The structural differences of DMO and CP4EPSPS proteins as well as the distinct modes of action among these proteins are unlikely to produce a significant interaction. BAI affirmed that this lack of interaction will not lead to production of a new allergen or toxin in the combined trait product. BAI agreed to the information provided by the developer the gene products will accumulate the same subcellular compartments. The dmo and cp4epsps are designed to encode chloroplast transit peptides so that DMO and CP4EPSPS proteins are directed to chloroplast. Metabolic pathways BAI agreed that the mode of action has been completely described in the previous safety assessment of each individual single event. CP4EPSPS protein confers tolerance to glyphosate and is involved in an enzymatic pathway producing aromatic amino acids in the chloroplasts of plants. On the other hand, DMO protein catalyzes the NADH-dependent oxidative demethylation of the herbicide dicamba rendering inactive, thereby conferring its tolerance. The two proteins are structurally and functionally different and not involved in the same metabolic pathway. The inserted genes, which are not designed to alter the plant metabolism are inherited and functioning properly when combined into the breeding stack. It indicates that any mechanisms of interaction between these products are highly unlikely and that each gene product functions independently as in single event. Gene Expression In terms of gene expression, results obtained from ELISA performed on seed tissues of MON 87705 x MON 87708 x MON 89788, MON 87705, MON 87708 and MON 89788 collected from five field sites during Argentina field trials show that the proteins were expressed properly in the combined trait product as in its relevant single events. The proteins were expressed at low level also as demonstrated by ELISA. Also, it did not show any indication that the marker genes were transferred and expressed in plants containing the combined genes. Due to the different mode of action, any form of interaction is unlikely. This means that the stability and expression levels of all the genes will not be significantly affected. DENR ASSESSMENT AND RECOMMENDATION After thorough and scientific review and evaluation of the documents provided by the Bureau of Plant lndustry (BPl) to the DENR Biosafety Committee within the prescribed period pursuant to Joint Department Circular (JDC) No.1 s.2016 on the application of Monsanto Philippines, Inc. for direct use for feed, food or processing of Genetically Modified Soybean tolerant to glyphosate herbicide stacked trait product MON87705 x MON87708 x MON89788, the following are the observations and recommendations: 1. The effect of the regulated article on the environment depends largely on the viability of the product to be utilized for direct use. lf the article is transported in a nonviable form, there is no danger to the environment; 2. Due to the absence of a specified Environmental Management Plan (EMP) by the traders/importers, the Committee would like to recommend that it be added to the requirements for the issuance of an import permit by the Bureau of Plant lndustry (BPl) (Article Vlll, Section 26 of JDC No,1 s.2016); 3. It is suggested that BPI ensure the following: a) development of guidelines on the EMP in coordination with DENR; b) implementation of the EMP by the traders/importers involved in the import, handling, processing and transport of viable soybean MON87705 x MON87708 x MON89788 commodity products; and c) Strict monitoring of the regulated article from port of entry to the trader's/importer's storage/warehouse (Section 32 of the JDC No. 1 s.2016); Based on the above considerations and with the submitted sworn statement and accountability of the proponent, a biosafety permit may be issued to the proponent if the abovementioned recommendations are followed. DOH ASSESSMENT AND RECOMMENDATION After a thorough review and evaluation of the documents provided by proponent, Monsanto Philippines Inc., through the Bureau of Plant Industry (BPI) in support of their application for approval for direct use as food and feed or processing of soybean MON87705 x MON87708 x MON89788. DOH find that the regulated article applied for direct use as food and feed or processing is safe as its conventional counterpart and shall not pose any significant risk to human and animal health and environment. The following are the observations and recommendations: 1. Find that regulated article applied for direct use for food and feed or for processing (FFP) does not require changes in the usual practices in unloading, loading, transport, storage and processing. As such, the regulated article is as safe as its conventional counterpart and is not expected to pose any significant risk to human and animal health and environment while in transit, storage and processing. 2. Scientific pieces of evidences from provided references i.e. literatures show that regulated article applied for direct use as food and feed or for processing (FFP) is as safe as its conventional counterpart and shall not pose any significant risk to human and animal health and on the environment. 3. It is suggested that Bureau of Plant Industry (BPI) ensure the following: a. Strict monitoring of the regulated article from port of entry to the trader’s / importer’s storage/warehouse as stated in Section 32 of the JDC No. 1 series, 2016. b. The BPI to include in the insurance of permit for the release of this product the following conditions: b.1. Any spillage (during unloading and loading/hauling and transport unloading and storage) shall be collected and cleaned up immediately. b.2. Transportation of the consignment from the port of entry to any destination within the country shall be in closed containers. b.3. There shall be a clear labeling of the product from importation down to all levels of marketing stating that it is only for the purpose of direct use for food and feed or for processing and is not to be used as planting materials. 4. Based on the above considerations and with the submitted sworn statement and accountability of the proponent, this recommendation is being submitted to BPI related to the processing and issuance of a biosafety permit for direct use as food and feed or for processing of soybean MON87705 x MON87708 x MON89788. SEC ASSESSMENT AND RECOMMENDATION According to the SEC expert, the impact of GM Soybean MON 87705 X MON 87708 X MON 89788 to the feed industry and ultimately to the livestock, poultry and the aquaculture sub-sectors would be tremendous. Importation of soybeans will save millions of dollars for our country through lower prices. With the above scenario and observed consequences of MON 87705 X MON 87708 X MON 89788, the SEC expert recommend the renewal of permit of the MON 87705 X MON 87708 X MON 89788. The renewal of the utilization of GM Soybeans would help the feed industry and may result to lower production cost of poultry, livestock and aquaculture products in our country. Likewise, food and processing sub-sectors will also benefit the approval of this GM product. However, concern agencies, both government and nongovernment, should continue monitor and regularly assess the risk of any GM products introduced in the country.
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 (a blank field means there is no expiration date) July 10, 2023
E-mail:
bpibiotechsecretariat@gmail.com
Organization/agency name (Full name):
Bureau of Plant Industry
Contact person name:
Geronima P. Eusebio
Website:
Physical full address:
San Andres St., Malate, Manila
Phone number:
632 404 0409 loc 203
Fax number:
Country introduction:

In 1987, scientists from the University of the Philippines Los Banos (UPLB) and the 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), recognizing the potential harm of the introduction of exotic species and genetic engineering, formed a committee and formulated the biosafety protocols and guidelines for genetic engineering and related research activities for UPLB and IRRI researchers. The committee went on to draft a Philippine biosafety policy, which was submitted to the Office of the President. On October 15, 1990, recognizing the potential for modern biotechnology both in improving the lives of the people and in creating hazards if not handled properly, President Corazon C. Aquino issued Executive Order 430 creating the National Committee on Biosafety of the Philippines (NCBP) that will formulate, review and amend national policy on biosafety and formulate guidelines on the conduct of activities on genetic engineering. The NCBP is comprised of representative of the Departments of Agriculture (DA); Environment and Natural Resources (DENR); Health (DOH); and Science and Technology (DOST), 4 scientists in biology, environmental science, social science and physical science; and 2 respected members of the community. On July 16, 2001, President Gloria Macapagal-Arroyo issued the Policy Statement on Modern Biotechnology, reiterating the government policy on promoting the safe and responsible use of modern biotechnology. On April 3, 2002, Department of Agriculture Administrative Order No. 8, Series of 2002 was issued implementing the guidelines for importation and release into the environment of Plants and Plant Products Derived from the Use of Modern Biotechnology. On March 17, 2006, President Gloria Macapagal-Arroyo issued Executive Order No.514 Establishing the National Biosafety Framework, prescribing guidelines for its implementation, reorganizing the National Committee on Biosafety of the Philippines, and for other purposes. On December 8, 2015, the Philippine Supreme Court declared DA AO8 null and void and any application for contained use, field testing, propagation and commercialization, and importation of GMOs was temporarily enjoined. In response to the nullification of DA AO8, the Technical Working Group composed of representatives from the Departments of Agriculture (DA), Science and Technology (DOST), Environment and Natural Resources (DENR), Health (DOH), and Interior and Local Government (DILG) drafted the Joint Department Circular No. 1, Series of 2016 (JDC No.1, S2016) titled 'Rules and Regulations for the Research and Development, Handling and Use, Transboundary Movement, Release into the Environment, and Management of Genetically-Modified Plant and Plant Products Derived from the Use of Modern Biotechnology'. There were series of meeting and five public consultations conducted before the JDC No.1, S2016 was approved and signed by the Secretaries of the abovementioned agencies on March 7, 2016 and took effect on April 15, 2016. Under this Circular, more government agencies were involved such as the Department of Science and Technology (DOST) to regulate applications for contained use and confined test of regulated articles; Department of Agriculture (DA) to evaluate applications for field trial, commercial propagation and transboundary movement of regulated articles; Department of Environment and Natural Resources (DENR) to evaluate environmental risks and impacts of regulated articles; Department of Health (DOH) to evaluate of environmental health impacts of regulated articles; and Department of the Interior and Local Government (DILG) to supervise public consultation during field trial.

 

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.

 

Plant Products Carrying Stacked Genes Conferred Through (a) Genetic Engineering or b) Conventional Breeding, with Individual Traits That Have No Prior Approval:

A full risk assessnent as to  food and feed or processing shall be conducted,consistent with Part V of AO No. 8,"Approval Process For the Importation of Regulated Articles for Direct Use as Food and Feed or For Processing for plant products with multiple traits conferred through:

(a) genetic engineering, or

(b) conventional breeding, where the individual traits have no prior approval from the Bureau of Plant Industry (BPI) for direct use as food and feed or processing.

Plant Products Carrying Stacked Genes Conferred through Conventional Breeding:

For plant products with multiple traits conferred through conventional breeding,with all individual events granted prior approval and included in the Approval Registry, a notlfication shall be submitted by the technology developer to the BPI, which shall conduct an evaluation in accordance with the relevant criteria in Annex I of this Memorandum Circular. The list of data contained in Annex I will not preclude the inclusion of other issues and concerns that will be raised by the BPI and the Scientific and Technical Review Panel (STRP) during the course of the desktop review.

Notificatlon Requirement for Plant Products Carrying Stacked Genes

All technology developers shall submit a notification to the Bureau of Plant Industry of their developed plant products carrying stacked genes and shall be required to comply with the relevant approval process listed above.

The Bureau of Plant Industry shall issue a certiflcate as to the approval of the stacked gene product and shall likewise include the transformation event in the official approval registry of plant products for food and feed or processing.

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

Republic of Korea
Name of product applicant: Monsanto Korea Ltd.
Summary of application:

Glyphosate herbicide tolerance, Modified oil/fatty acid, Dicamba herbicide tolerance

Upload:
Date of authorization: 22/12/2016
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 (food safety):
Please see the link below(in Korean).
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 (a blank field means there is no expiration date)
E-mail:
mytrue85@korea.kr
Organization/agency name (Full name):
Ministry of Food and Drug Safety
Contact person name:
Website:
Physical full address:
Osong Health Technology Administration Complex, 187, Osongsaengmyeong 2-ro, Osong-eup, Cheongwon-gun, Chungcheonbuk-do, 363-700, Korea
Phone number:
82-43-719-2360
Fax number:
Country introduction:
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: