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OECD Unique Identifier details

MST-FGØ72-3 x ACS-GMØØ6-4
Commodity: Soyabean / Soybeans
Traits: Herbicide tolerance
European Union
Name of product applicant: BASF SE
Summary of application:

Soybean FG72 × A5547-127, as described in the application, expresses the PAT protein, which confers tolerance to glufosinate ammonium-based herbicides, the 2mEPSPS protein, which confers tolerance to glyphosate-based herbicides and the HPPD W336 protein, which confers tolerance to isoxaflutole.

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Date of authorization: 21/12/2017
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.): EU Register of authorised GMOs
Summary of the safety assessment (food safety):
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:
The method for detection for soybean FG72 x A5547-127 is based on the validated detection methods that are available for genetically modified soybeans FG72 and A5547-127. Certified reference material for genetically modified soybean FG72 and genetically modified soybean A5547-127 is available at the American Oil Chemists’ Society (AOCS): with the respective product code 0610-A3 and 0707-C5.
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Method for detection
Reference Material
Opinion of the European Food Safety Authority
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Authorization expiration date (a blank field means there is no expiration date) 22/12/2027
E-mail:
beatrice.marquez-garrido@ec.europa.eu
Organization/agency name (Full name):
European Union
Contact person name:
Béatrice Marquez-Garrido
Website:
Physical full address:
European Commission B232 04/106 1047 Brussels
Phone number:
00 32 2 296 78 07
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).

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Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Argentina
Name of product applicant: Bayer CropScience S. A.
Summary of application:

The event FG72 x A5547-127 confers soybean tolerance to glyphosate, isoxaflutole and glufosinate ammonium herbicides. This stacked event was obtained by conventional breeding of parental FG72 and A5547-127 events.


The genetic modification in FG72 soybean consists in the integration into Glycine max genome of an insert containing the expression cassettes of hppdw336 and 2mepsps genes as the only modification. The 2mEPSPS protein has two point mutations from its natural variant of maize EPSPS which gives a lower sensitivity to inhibition caused by glyphosate, without modifying their enzymatic activity, while HPPDW336 protein has a substitution (glycine for tryptophan) that provides tolerance to inhibition by isoxaflutole.


The genetic modification in the parental event A5547-127 consists in the integration into Glycine max genome of an insert containing the expression cassette of pat gene, resulting in the expression of the PAT protein as the only modification. The PAT protein is an acetyltransferase that specifically catalyzes the acetylation of phosphinothricin and dimetilphosphinotricin. It metabolizes glufosinate to an acetylated inactive derivative, thus conferring herbicide tolerance to glufosinate ammonium.


 


http://www.senasa.gob.ar/sites/default/files/ARBOL_SENASA/INFORMACION/24_.1_decision_document_soybean_fg72_x_a5547-1271.pdf

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Date of authorization: 02/03/2018
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):
• The soybean event FG72 x A5547-127 was obtained by conventional breeding of parental event already approved. • Molecular and phenotypic studies showed its molecular integrity and its genetic and phenotypic stability as well as a simple dominance Mendelian inheritance pattern. • The expressed proteins were evaluated (in the submission of the parental events) regarding toxicity and allergenicity and approved without identifying potential risks. • The expression pattern of 2mEPSPS, HPPDW336 and PAT proteins is equivalent in the parental and in the stack event. • The compositional analysis shows that it is substantially and nutritionally equivalent to its non-genetically modified counterpart and commercial varieties used as control. • There are no technical or experimental evidence to indicate that the expressed proteins may have a metabolic interaction resulting in unexpected effects, with no changes in the pattern or expression levels as well as its phenotypic aspects. It is concluded that soybean event FG72 x A5547-127 is substantially equivalent to its conventional counterpart, therefore, is as safe as and no less nutritional than soybean conventional commercial varieties. http://www.senasa.gob.ar/sites/default/files/ARBOL_SENASA/INFORMACION/24_.1_decision_document_soybean_fg72_x_a5547-1271.pdf
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Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Decision Document - Safety Assessment Summary
GMO approvals for food/feed
Food and feed safety asssessment of GMOs - Argentina
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
mlema@magyp.gob.ar
Organization/agency name (Full name):
Ministerio de Agroindustria
Contact person name:
Martín Lema
Website:
Physical full address:
Paseo Colón Avenue 367, 3° floor, City of Buenos Aires
Phone number:
54 11 4349 2200
Fax number:
Country introduction:

In Argentina, the food and feed risk assessment process of transformation events, as the result of modern biotechnology, is carried out by the National Service for Agrifood Health and Quality (Senasa). The General Office of Biotechnology, is the area responsible for carrying out this task. It has an specific professional team and the advise of a Technical Advisory Committee composed of experts from several scientific disciplines representing different sectors involved in the production, industrialization, consumption, research and development of genetically modified organisms.

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Stacked events:

Stacked events with all single events approved, are assessed as a new event, but with much less requirements, always on a case-by-case basis.

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

National Service for Agrifood Health and Quality (Senasa)

https://www.argentina.gob.ar/senasa

 

https://www.argentina.gob.ar/senasa/programas-sanitarios/biotecnologia

Brazil
Name of product applicant: Bayer S.A
Summary of application:

Commercial release of Genetically modified soybean containing the Events FG72 x A5547-127 expressing the tolerance characteristic to the herbicides glyphosate, ammonium glufosinate and isoxaflutole

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Date of authorization: 10/12/2015
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):
A) The safety of the Event FG72 x A5547-127 was evaluated in several studies conducted in Brazil and abroad, in order to demonstrate that the combination of the Events through traditional breeding does not result in strains significantly different from those that originate (Parental events) and Nor of conventional varieties. B) Thus, the safety of soybean FG72 x A5547-127 is demonstrated not only by the information previously presented for the isolated events, but also through analyzes that showed no interaction between the inserts present in this lineage; C) The safety of the PAT protein, encoded by homologous genes pat or bar (isolated from bacteria Streptomyces viridochromogenes or Streptomyces hygroscopicus), has been extensively demonstrated and presented for the isolated events T25 (corn), LLCotton25 (cotton), A2704-12, A5547-127 (soybean), as well as for the Combined Events GHB614 x T304-40 x GHB119 and GHB614 x LLCotton25, approved for commercial use in Brazil. Safety approvals have already been granted for at least 43 different transformation events, which express PAT protein, of five plant species (soybean, corn, canola, beet, cotton) in different countries, (CERA, 2015); D) A5547-127 soybean (LibertyLink®) has already been APPROVED in 17 countries (Argentina, Australia, Brazil, Canada, China, Colombia, European Union, Japan, South Korea, Malaysia, Mexico, Philippines, Russia, Singapore, Taiwan, the United States and Uruguay) whether for planting, animal feed or human food (CERA, 2015); E) The 2mEPSPS protein is present in the Cotton GHB614 Event, and in the Combined Events GHB614 x LLCotton25 and GHB614 x T304-40 x GHB119, whose safety has been evaluated by this Technical Commission, all of which are approved for commercial use in Brazil ; F) The proteins 2mEPSPS and HPPDW336 are expressed in the genetically modified soybean GT72 Event, whose safety has already been evaluated by this Technical Commission, having been approved for commercial use in Brazil; (G) FG72 soy has already been APPROVED in 10 countries (Australia, Brazil, Canada, South Korea, Japan, Malaysia, Mexico, New Zealand and Taiwan), whether for planting, animal feed or human ISAAA, 2015); H) The additional results provided in the documentation forwarded to the event release request FG72 x A5547-127 confirm the safety of a process that combines products already previously determined as safe;
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Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date) Not Applicable
E-mail:
gutemberg.sousa@mctic.gov.br
Organization/agency name (Full name):
National Biosafety Technical Commission
Contact person name:
Maria Sueli Felipe Soares
Website:
Physical full address:
SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number:
556134115516
Fax number:
556133177475
Country introduction:

Brazil had the first biosafety law approved in 1995. After the identification of the need to improve the biosafety system of Brazilian genetically modified organisms, a new law was published. The Law 11.105 / 05 establishes a technical committee dedicated to the analysis of the safety aspects of genetically modified organisms and a council of ministers that is dedicated to the analysis of the socioeconomic aspects of the commercial release of genetically modified organisms. In this context, Brazil already has several commercial products that involve genetically modified organisms (plants, human and veterinary vaccines, microorganisms for fuel production) and products derived from new genetic modification techniques.

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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)

Colombia
Name of product applicant: Bayern Crop Science
Summary of application:

Authorization of the genetically modified soy FG72 x A5547-127 tolerant to herbicides isoxaflutole, glyphosate and glufosinate

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Date of authorization: 28/11/2016
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.
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Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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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.

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Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Mexico
Name of product applicant: Bayer de México, S.A. de C.V.
Summary of application:

Authorization by COFEPRIS: 152


Soybean (Glycine max) genetically modified (FG72 x A5547-127) with tolerance to the herbicides glyphosate, glufosinate of ammonium and inhibitors of the HPPD enzyme (such as isoxaflutole). OCDE identifier: MST-FGØ72-2 x ACS-GMØØ6-4.

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Date of authorization: 24/11/2015
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: MST-FGØ72-2 x ACS-GMØØ6-4 is, based on the existing knowledge to date, as innocuous as its conventional counterpart.
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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 (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

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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: Bayer CropScience
Summary of application:

 


Stacked soybean FG72 x A5547-127 is a product developed by crossing the single parental events FG72 and A5547-127 using traditional breeding methods. The FG72 soybean possesses the hppdPf W336 gene from Pseudomonas fluorescens which encodes the modified 4-hydroxyphenylpyruvate dioxygenase protein (HPPD W336) having tolerance to isoxaflutole and 2mepsps  gene from Zea mays which encodes a double mutant 5-enolpyruvyl-shikimate-3phosphate synthase protein (2mEPSPS) conferring tolerance to glyphosate. The A5547-127 soybean possesses the pat gene from Streptomyces viridochromogenes which encodes the enzyme phosphinothricin acetyltransferase (PAT) having tolerance to glufosinate-ammonium-containing herbicides.  FG72 x A5547-127 expresses all three proteins having tolerance to all three herbicides. 


 


The 2mepsps and hppdPfW336 genes are composed of the same basic nucleic acids as found in any DNA from known food constituents consumed as part of human or animal diets. Moreover, the likelihood that DNA from ingested food/feed could transfer and be functionally integrated by gut microflora and/or human cells is negligible. This indicates that FG72 soybean is considered as safe and nutritious as its non-GM counterpart.


 


In a study conducted by Bayer CropScience Inc., it concluded that there are neither allergenic nor toxicological in silico findings associated with PAT/pat protein.


 


In compliance with Article VII Section 22B of the Joint Department Circular No. 1 series of 2016 (JDC 1), Bayer has published a copy of the approved public information sheet (PIS) for direct use of the stacked soybean  FG127 x A5547-127 in the Manila Standard and Daily Tribune last July 18, 2017.


 


The assessment for the safety of the novel proteins focused on the gene interaction, metabolic pathways and gene expression. Further, the potential adverse effects of the regulated article to the environment and environmental health were also assessed consistent with the substantive requirements of the Environmental Impact Statement (EIS) System pursuant to P.D. No. 1586, the NBF and R.A. No. 10611. Moreover, the DOH assessment was based on the Philippine National Framework and Guidelines for Environmental Health Impact Assessment.

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Date of authorization: 22/06/2018
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):
A. STRP, PPSSD, BAI (Safety Assessment) After thorough review of the technical documents submitted by the applicant, the assessors’ findings were as follows: 1. Gene Interaction Any likelihood of interaction among the three proteins (2mEPSPS, HPPD W336 and PAT) is not significant because each protein has distinct mode of action. There is no new genetic modification involved in the development of FG72 x A5547-127 soybean. Likewise, production of a new toxin or allergen is also unlikely. The molecular analysis of the FG72 x A5547-127 soybean demonstrated the integrity of the inserts in FG72 x A5547-127 soybean when compared to the single parental lines. No new genetic modification was involved in the development of FG72 x A5547-127 soybean. The HPPD W336, PAT and 2mEPSPS will accumulate in the cytoplasm of the plant cells, however, there is no possible interaction among these proteins because of their specific individual roles in their respective separate metabolic pathways. 2. Metabolic Pathways The developer provided a complete description of the mode of action for each gene product, HPPD W336, PAT and 2mEPSPS genes. The HPPD enzymes catalyze the second step in the pathway for the catabolism of tyrosine and are responsible for the transformation of p-hydroxyphenylpyruvate into homogentisic acid. The plants expressing the HPPD W336 protein (encoded by the hppd W336 gene) are tolerant to isoxaflutole (IFT) containing herbicides. The pat gene, when expressed, enables the production of the enzyme PAT that metabolizes glufosinate to an inactive, acetylated derivative, thereby conferring tolerance to glufosinate-ammonium herbicide. The 5-enol-pyruvylshikimate-3-phosphate synthase (EPSPS) protein is the 6th enzyme of the shikimate pathway, the metabolic pathway for the biosynthesis of aromatic compounds found in microorganisms and in plants. The plants expressing the 2mEPSPS protein (encoded by the 2mepsps gene) are tolerant to glyphosate herbicides. Overall, HPPD W336, PAT and 2mEPSPS proteins are structurally and functionally different and have different mode of action; thus, interaction is unlikely. Consequently, there are no possible unexpected effects of the stacked genes on the metabolism of the plant. 3. Gene Expression The protein expression levels of 2mEPSPS, HPPD W336 and PAT were determined on a fresh weight (FW) and dry weight (DW) by sandwich Enzyme-Linked Immunosorbent Assays (ELISA) in leaf, root, forage, flower and grain matrices, collected at multiple developmental stages of untreated and trait-specific herbicide treated FG72 x A5547-127 soybean. Results showed that the proteins were expressed properly in the combined trait product as in its relevant single events. Moreover, protein expression level analysis did not show any indication that the marker genes were transferred and expressed in plants containing the combined genes. B. DENR BC (for Safety of Event to the Environment) The potential impact to the environment of the stacked FG72 x A5547-127 soybean was assessed in cases of accidental spillage or intentional planting. According to Bayer CropScience Inc., in case of accidental spillage or intentional planting during the loading/unloading, transport or processing of the stacked soybean, the chances of survival of the stacked product is unlikely, as majority of the areas near ports, storage facilities, and transportation routes are not suitable for soybean germination, growth and reproduction. More importantly, soybean FG72 x A5547-127 is safe as conventional soybean. Thus, the potential impact to the environment is not different from conventional soybean. Given these findings, the DENR BC recommended the approval and issuance of a biosafety permit for FFP for the stacked FG72 x A5547-127 soybean with the following conditions: a. Implementation of the EMP by the traders/importers involved in the import, handling, processing and transport of viable soybean commodity products. b. Strict monitoring of the regulated article from port of entry to the trader's/importer's storage/warehouse in accordance with Section 32 of the JDC 1 s.2016. C. DOH BC (for Environmental Health Safety) The DOH-BC assessed the potential environmental health impact of stacked soybean FG72 x A5547-127 using the technical dossier provided by the applicant. Based on their assessment, the DOH BC concluded that the potential environmental health impact from the exposure to FG72 x A5547-127 during grain handling operations or during food & feed processing will not be different from that of conventional soybean. The DOH BC recommended the approval and issuance of a biosafety permit for FFP for the stacked soybean with the following conditions: a. Strict monitoring of the regulated article from port of entry to the trader's/importer's storage/warehouse in accordance with Section 32 of the JDC 1 s.2016. b. To include in the issuance of the Sanitary and Phytosanitary Import Clearance (SPSIC) for the release of the stacked soybean the following conditions: 1) Any spillage (during unloading and loading/hauling and transport unloading and storage) shall be collected and cleaned up immediately. 2) Transportation of the consignment from the port of entry to any destination within the country shall be in closed containers. 3) It is recommended that the BPI ensure that there will be clear instructions indicating that the product is only for the purpose of direct use as food, feed or for processing, and is not to be used as planting material. D. SEC Expert The SEC expert recommended the approval of stacked soybean FG72 x A5547-127 with the following observations: • The share of soybean import to the total Philippine import is minimal, thus it will not significantly alter the Philippines patterns of trade with soybean exporter countries (e.g. USA). The increasing imports of soybean may reflect the continuous growth of the country’s livestock industry. In addition, importation of soybeans would help stabilize local prices of food products whose main ingredient is soybeans. Likewise, the approval of this event would also stabilize prices of feeds as soybeans is also a main ingredient in feed formulation for poultry and livestock sub-sector. It may also help develop the feed milling sub-sector in the Philippines, assuring them of continued supply of feed ingredient at a stable price. • Empirical studies show that food choice of consumers is influenced by a large number of factors. Thus, the approval of FG72 x A5547-127 would not affect the current patterns of consumption/utilization of products containing soybeans as ingredients. However, the approval of GM Soybean FG72 x A5547-127 would surely help improve the global trade. It will increase the exports of the soybean producing countries while allowing more imports of non-producing countries. • The main environmental benefit of FG72 x A5547-127 soybean in cultivating countries is the use of reduced and no-till production systems. These cultivation practices contribute to reductions in soil erosion from water and wind. Furthermore, it also contributes to reduced fossil fuel use, improved soil moisture retention and reduced soil compaction.
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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 (a blank field means there is no expiration date) June 21, 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
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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.

 

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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: Bayer Korea Ltd.
Summary of application:

Herbicide-tolerant

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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).
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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:
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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
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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
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Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: