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OECD Unique Identifier details

DAS-44406-6
Commodity: Soyabean / Soybeans
Traits: Glyphosate tolerance,2 4-dichlorophenoxyacetic acid (2 4-D) tolerance,Glufosinate tolerance
European Union
Name of product applicant: Dow AgroSciences Distribution S.A.S.
Summary of application:

Soybean DAS-444Ø6-6 expresses the 2mEPSPS protein, which confers tolerance to glyphosate-based herbicides, the AAD-12 protein, which confers tolerance to 2,4-dichlorophenoxyacetic acid (2,4-D) and other related phenoxy herbicides, and the PAT protein, which confers tolerance to glufosinate ammonium-based herbicides.

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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:
Method for detection: Event specific real-time quantitative PCR based method for DAS-444Ø6-6 soybean; the detection method is validated on the single-trait event using genomic DNA extracted from seeds of DAS-444Ø6-6 soybean. Reference material: ERM®-BF436 accessible via the Joint Research Centre (JRC) of the European Commission. The relevant links are provided below.
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:
Organization/agency name (Full name):
European Union
Contact person name:
Alexandre Huchelmann
Website:
Physical full address:
European Commission B232 04/106 1047 Brussels
Phone number:
3222954092
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: Dow AgroSciences S.A.
Summary of application:

The event has tolerance to 2,4D herbicides, glufosinate-ammonium and glyphosate.
To achieve tolerance to herbicides, 3 genes were introduced: 1) the aad-12 gene, from the bacterium Delftia acidovorans, which codes for the protein AAD-12 (aryloxyalkanoate dioxygenase 12) and confers tolerance to the herbicide 2,4-D , 2) the pat gene, isolated from the bacterium Streptomyces viridochromogenes, which codes for the protein phosphinothricin-acetyl transferase (PAT) and confers tolerance to the herbicide glufosinate-ammonium, and 3) the 2mepsps gene, a modified version of the native maize gene which expresses an enzyme synthase 5-enolpiruvilshikimato-3 phosphate (2mEPSPS) with low affinity for glyphosate, providing tolerance to this herbicide.

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Date of authorization: 26/01/2015
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):
• Inheritance studies conducted indicated that Mendelian segregation exists. • New expression proteins are expressed in low levels. • It is compositionally equivalent to its non-transgenic counterpart. • No evidence of similarity or homology was found with known toxic proteins. • There is no evidence of expression of known allergenic substances for the proteins expressed in the event. It is concluded that the event is substantially equivalent to its conventional counterpart, therefore, it is as safe and no less nutritious than conventional commercial varieties.
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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: GMO commercial approvals in Argentina
GMO approvals for food/feed
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministerio de Agroindustria
Contact person name:
Andrés Maggi
Website:
Physical full address:
Paseo Colón Avenue 367, 3° floor, City of Buenos Aires
Phone number:
54 11 5222 5986
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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Relevant documents
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

Australia
Name of product applicant: Dow AgroScience Australia Ltd & MS Technologies LLCs
Summary of application:
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Date of authorization: 18/04/2013
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): OECD BioTrack Product Database
Summary of the safety assessment (food safety):
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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: Application A1073 - Food derived from Herbicide-tolerant Soybean DAS-44406-6
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Food Standards Australia New Zealand
Contact person name:
Website:
Physical full address:
Level 4, 15 Lancaster Place, Majura Park ACT 2609, Australia
Phone number:
+61 2 6271 2222
Fax number:
+61 2 6271 2278
Country introduction:

Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of food standards in Australia and New Zealand. The main office (approximately 115 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 10 staff) is located in Wellington on the North Island.

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Relevant documents
Stacked events:

FSANZ does not: Separately assess food from stacked event lines where food from the GM parents has already been approved; Mandate notification of stacked events by developers; Notify the public of stacked event ‘approvals’; List food derived from stacked event lines in the Code, unless the stacked event line has been separately assessed as a single line e.g. Application A518: MXB-13 cotton (DAS-21023-5 x DAS-24236-5)

No separate approval or safety assessment is necessary for foods derived from a stacked GM line that is the result of traditional breeding between a number of GM parent lines for which food has already been approved. Food from the parent lines must be listed in the Australia New Zealand Food Standards Code. The parent lines may contain any number of different genes. If food from any of the GM parent lines has not been approved, then a full pre-market safety assessment of food from the stacked line must be undertaken.

No separate approval is required for food derived from a line that is the product of a GM line, for which food has been approved, crossed traditionally with a non-GM line.

Where a single line containing a number of genes has been produced as a result of direct gene technology methods (rather than traditional crossing) then food derived from the line must undergo a full pre-market safety assessment before approval can be given

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

Food Standards Australia New Zealand (FSANZ) (http://www.foodstandards.gov.au)

Brazil
Name of product applicant: Dow AgroSciences Sementes & Biotecnologia Brasil Ltda
Summary of application:

Commercial release of soybean DAS-44406-6 for the purpose of its release into the environment, cultivation, production, handling, transfer, marketing, import, export, storage, consumption, disposal and any other activity of soybean DAS-44406-6 and progenies And its derivatives. Soybean DAS-44406-6 carries the aad-12 v1 gene encoding the aryloxyalkanoate dioxygenase (AAD-12) protein which gives soybeans tolerance to the herbicide 2,4-D (2,4-Dichlorophenoxyacetic acid), gene 2mepsps encoding the 2mEPSPS protein which confers tolerance to the glyphosate herbicide and the pat v6 gene encoding the PAT protein which confers tolerance to the herbicide glufosinate ammonium.

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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):
Phenotypic and plant growth characteristics that respond to ecological stress factors, response to insect pressure and disease in the field conditions of the various environments and the characteristics of germination and dormancy of soybean DAS-44406-6 were not altered in relation Conventional soybean. Therefore, these data reinforce the conclusion that the agronomic and susceptibility characteristics of DAS-44406-6 soybean diseases and pests are not significantly different from those of control soybeans and there is no indication that soybean DAS-44406-6 could represent a risk To the environment distinct from the risks that may occur with the conventional soybean itself. That the analyzes of chemical composition carried out in planned releases at different locations in Brazil and the United States showed similar results and showed that transgenic soybeans are substantially equivalent to conventional soybeans. There is no experimental evidence that soy DAS-44406-6 is lower or presents any toxicological or nutritional risk to animals, which is distinct from the widely used conventional variety. Therefore, the modification introduced by genetic manipulation simply conferred resistance to the herbicides glufosinate ammonium, glyphosate and 2,4-D.
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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 (a blank field means there is no expiration date) Not Applicable
E-mail:
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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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)

Canada
Name of product applicant: DOW Agrosciences Canada Inc.
Summary of application:

DOW AgroSciences Canada Inc. has developed soybean event DAS-44406-6 to be tolerant to the herbicides 2,4-dichlorophenoxyacetic acid (2,4-D), glyphosate and glufosinate. Recombinant DNA techniques were used to confer tolerance to the herbicides.

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Date of authorization: 07/06/2013
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): BioTrack Product Database
Summary of the safety assessment (food safety):
Please see decision document weblinks
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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: Novel Foods Decision Document
Novel Feeds Decision Document
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Health Canada
Contact person name:
Neil Strand
Website:
Physical full address:
251 Sir Frederick Banting Driveway, Tunney's Pasture, PL 2204A1
Phone number:
613-946-1317
Fax number:
Country introduction:

Federal responsibility for the regulations dealing with foods sold in Canada, including novel foods, is shared by Health Canada and the Canadian Food Inspection Agency (CFIA). Health Canada is responsible for establishing standards and policies governing the safety and nutritional quality of foods and developing labelling policies related to health and nutrition. The CFIA develops standards related to the packaging, labelling and advertising of foods, and handles all inspection and enforcement duties. The CFIA also has responsibility for the regulation of seeds, veterinary biologics, fertilizers and livestock feeds. More specifically, CFIA is responsible for the regulations and guidelines dealing with cultivating plants with novel traits and dealing with livestock feeds and for conducting the respective safety assessments, whereas Health Canada is responsible for the regulations and guidelines pertaining to novel foods and for conducting safety assessments of novel foods.

The mechanism by which Health Canada controls the sale of novel foods in Canada is the mandatory pre-market notification requirement as set out in Division 28 of Part B of the Food and Drug Regulations.

Manufacturers or importers are required under these regulations to submit information to Health Canada regarding the product in question so that a determination can be made with respect to the product's safety prior to sale. The safety criteria for the assessment of novel foods outlined in the current guidance document (i.e. Canadian Guidelines for the Safety Assessment of Novel Foods) were derived from internationally established scientific principles and guidelines developed through the work of the Organization for Economic Cooperation and Development (OECD), Food and Agriculture Organisation (FAO), World Health Organisation (WHO) and the Codex Alimentarius Commission. These guidelines provide for both the rigour and the flexibility required to determine the need for notification and to conduct the safety assessment of the broad range of food products being developed. This flexibility is needed to allow novel foods and food products to be assessed on a case-by-case basis and to take into consideration future scientific advances.

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Stacked events:

Food: Consistent with the definition of "novel food" in Division 28 of the Food and Drug Regulations, the progeny derived from the conventional breeding of approved genetically modified plants (one or both parents are genetically modified) would not be classified as a novel food unless some form of novelty was introduced into such progeny as a result of the cross, hence triggering the requirement for pre-market notification under Division 28. For example, notification may be required for modifications observed in the progeny that result in a change of existing characteristics of the plant that places those characteristics outside of the accepted range, or, that introduce new characteristics not previously observed in that plant (e.g. a major change has occurred in the expression levels of traits when stacked). In addition, the use of a wild species (interspecific cross) not having a history of safe use in the food supply in the development of a new plant line may also require notification to Health Canada. However, molecular stacks are considered new events and are considered to be notifiable as per Division 28.

Feed:

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

Neil Strand, Section Head of Novel Foods

Colombia
Name of product applicant: Dow Agrosciences Colombia S.A
Summary of application:

Authorization of the genetically modified soy DAS44406-6 tolerant to herbicides glyphosate and glufosinate

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Date of authorization: 27/01/2016
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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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:
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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Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Japan
Name of product applicant: Dow Chemical JapanLtd.
Summary of application:

DAS-44406-6 soybean was modified with the insertion of a gene encoding aryloxyalkanoate dioxygenase and phosphinothricin N-acetyltransferase to confer tolerance to the herbicides 2,4-dichlorophenoxyacetic acid (2,4-D) and glufosinate respectively. Further more a gene encoding a modified version of the EPSPS gene was inserted to confer tolerance to glyphosate.

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Date of authorization: 15/12/2014
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.): BCH Database
Summary of the safety assessment (food safety):
Please see the link 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:
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
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Food Safety Commission Secretariat,Cabinet Office,
Contact person name:
Mariko Murakami
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)

Malaysia
Name of product applicant: DOW AGROSCIENCES (MALAYSIA) SDN. BHD.
Summary of application:

Please refer to the decision document of the National Biosafety Board

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Date of authorization: 19/10/2017
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.): Malaysia Biosafety Clearing House
CBD Biosafety Clearing House
Summary of the safety assessment (food safety):
Please refer to the Risk Assessment Report
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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:
Organization/agency name (Full name):
Department of Biosafety Malaysia
Contact person name:
Dr. Anita Anthonysamy
Website:
Physical full address:
Department of Biosafety Ministry of Environment and Water Level 4, Block F11, Complex F Lebuh Perdana Timur, Precinct 1 62000 Putrajaya, Malaysia
Phone number:
+60388861153
Fax number:
+60388904935
Country introduction:

GM food safety assessment is a requirement by law under the Biosafety Act 2007 in Malaysia. The National Biosafety Board reviews and makes decisions on events based on a scientific/technical risk assessment, policy considerations as well as public input. The decisions and its related documents made are publicly available through the Malaysian Department of Biosafety Website and the Convention of Biological Diversity Biosafety Clearing House.

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

Department of Biosafety Malaysia, Level 1, Podium 2, Wisma Sumber Asli No. 25, Persiaran Perdana, Precinct 4 Putrajaya, Federal Territory Malaysia, 62574. Phone: +603 8886 1746 / 1579. Fax: +603-8889 5604 Email: [email protected] Url: www. biosafety.gov.my

 

Food Safety and Quality Division, Ministry of Health, Level 4, Menara Prisma, No. 26, Persiaran Perdana, Putrajaya, Malaysia, 62675. Phone: +603 88850797 Fax: +603 88850790 Email: [email protected]
Mexico
Name of product applicant: Dow AgroSciences, S.A. de C.V.
Summary of application:

Authorization by COFEPRIS: 135


DAS-44406-6 soybean was modified with the insertion of a gene encoding aryloxyalkanoate dioxygenase and phosphinothricin N-acetyltransferase to confer tolerance to the herbicides 2,4-dichlorophenoxyacetic acid (2,4-D) and glufosinate respectively. Further more a gene encoding a modified version of the EPSPS gene was inserted to confer tolerance to glyphosate.

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Date of authorization: 02/07/2014
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):
UI OECD: DAS-444Ø6-6 During the risk assessment of this GMO based on existing knowledge to date, no toxic or allergic effects neither substantial nutritional changes are observed. The event is as safe as its conventional counterpart. For more detail please find attached the risk assessment summary in this page.
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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:
Organization/agency name (Full name):
CIBIOGEM
Contact person name:
Biól. Erica L. Hagman Aguilar
Website:
Physical full address:
San Borja #938, Col. Del Valle • Del. Benito Juárez C.P. 03100, México, D.F.
Phone number:
+52 (55) 53227700
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: [email protected]%20

New Zealand
Name of product applicant: Dow AgroScience Australia Ltd & MS Technologies LLCs
Summary of application:

A genetically modified (GM) soybean line DAS-44406-6, hereafter referred to as soybean 44406, has been developed that is tolerant to herbicides of the aryloxyalkanoate family including the phenoxy auxins such as 2,4-dichlorophenoxyacetic acid (2,4-D), and to the herbicides glufosinate ammonium and glyphosate. Tolerance to 2,4-D is achieved through expression of the enzyme aryloxyalkanoatedioxygenase-12 (AAD-12) encoded by the aad-12 gene derived from Delftia acidovorans, a gram-negative soil bacterium. The AAD-12 protein has previously been assessed in soybean by FSANZ. Tolerance to glufosinate ammonium is achieved through expression of the enzyme phosphinothricin acetyltransferase (PAT) encoded by the pat gene derived from another soil bacterium Streptomyces viridochromogenes. Tolerance to glyphosate is encoded through expression of a 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) encoded by the 2mepsps gene from corn (Zea mays). Both the pat and epsps genes have been widely used for genetic modification of a number of crop species, including soybean. It is anticipated that soybean 44406 will be grown in at least the United States of America (U.S.), Canada, Argentina and Brazil, subject to approval. There is currently no intention to grow the plant line in Australia or New Zealand.

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Date of authorization: 20/06/2013
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): OECD BioTrack Product Database
Summary of the safety assessment (food safety):
No potential public health and safety concerns have been identified in the assessment of soybean line DAS-44406-6. On the basis of the data provided in the present Application, and other available information, food derived from soybean line DAS-44406-6 is considered to be as safe for human consumption as food derived from conventional soybean cultivars
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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: Application A1073 - Food derived from Herbicide-tolerant Soybean DAS-44406-6
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministry for Primary Industries
Contact person name:
Fiapaipai Auapaau
Website:
Physical full address:
Pastoral House, 25 The Terrace, Wellington, 6012
Phone number:
+6448314946
Fax number:
Country introduction:

New Zealand and Australia share a joint food regulation system for the composition of labelling of most foods. Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of the joint food standards in Australia and New Zealand. The main office (approximately 120 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 15 staff) is located in Wellington on the North Island.

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Relevant documents
Stacked events:

FSANZ does not: Separately assess food from stacked event lines where food from the GM parents has already been approved; Mandate notification of stacked events by developers; Notify the public of stacked event ‘approvals’; List food derived from stacked event lines in the Code, unless the stacked event line has been separately assessed as a single line e.g. Application A518: MXB-13 cotton (DAS-21023-5 x DAS-24236-5)

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

Food Standards Australia New Zealand (FSANZ) (http://www.foodstandards.gov.au)

Philippines
Name of product applicant: Dow AgroSciences
Summary of application:

On January 20, 2017, Dow-Agro Sciences LLC’s Soybean DAS44406-6 for direct use as food and feed, or for processing, as original application under the DOST-DA-DENR-DOH-DILG Joint Department Circular (JDC) No. 1 Series of 2016.  After reviewing the Risk Assessment Report and attachments submitted by the applicant, the assessors namely: Scientific and Technical Review Panel (STRP), BPI Plant Products Safety Services Division (BPI-PPSSD) and Bureau of Animal Industry- Biotech Team (BAI-BT), concurred that soybean soybean DAS44406-6 is as safe for human food and animal feed as its conventional counterpart.

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Date of authorization: 21/02/2019
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, BPI-PPSSD, BAI (Safety Assessment) After thorough review of the technical documents submitted by the applicants, the assesors’ findings were as follows: 1. Host Organism Soybean (Glycine max L.) has been grown world-wide as an important staple food for humans and feed ingredient for animals. Its major products are seeds, oil, and meal. Unprocessed soybeans are not suitable for food and their use for animal feed remains limited because they contain anti nutritional factors such as trypsin inhibitors and lectins which are inactivated by heat processing. Humans consume soybean mostly in processed form such as soy milk, milk curd/ tofu, whole cooked seed, edible soy oil, soy protein concentrate, isolated soy protein, hydrolyzed vegetable protein, textured soy protein and soy protein fibers. It is also being consumed by animals in the form of seed, forage/silage, hay, meal and hulls (OECD, 2012). Soybean is a source of key nutrients such as proteins, fat, ash, acid detergent fiber (ADF), neutral detergent fiber (NDF), total dietary fiber (TDF), crude fiber, carbohydrates, amino acids, fatty acids, minerals and vitamins (OECD, 2012). Anti-nutrients such as stachyose, raffinose, oligosaccharides, trypsin inhibitors, lectins and phytic acid (ILSI, 2010). History of safe use was attributed to soybean. Based on OECD report, soybeans are commonly consumed in processed form and primary source of oil and protein. Heat processing eliminates the anti-nutritional factors in soybean. Toxicants are not commonly found in soybean. 2. Transgenic Plant DAS-44406-6 soybean has been reviewed and approved for food and/or feed use in many countries including Argentina (Food and Feed, 2015), Australia (Food, 2013), Brazil (Food and Feed, 2015), Canada (Food and Feed, 2013), Colombia (Food, 2016), Japan (Food, 2014; Feed, 2013), Mexico (Food, 2014), New Zealand (Food, 2013), South Africa (Food and Feed, 2013), Taiwan (Food, 2014), South Korea (Feed, 2014) and United States of America (2014). Based on the documents provided by the developer, the consumption patterns by population subgroups are not expected to be altered. Analyses had identified that the only introduced trait that is being expressed in DAS-44406-06 was the tolerance to 2,4 D, glyphosate and glufosinate herbicides (Dow AgroSciences, 2016). 3. Donor Organism Delftia acidovorans is the donor organism of aad-12 gene. History of safe use was attributed to D. acidovorans since it is being used in the transformation of ferulic acid into vanillin and related flavor metabolites (Yoon et al., 2005). Zea mays is the donor organism for 2mepsps gene. History of safe use was attributed to Z. mays since it is widely being consumed as food and feed in several countries worldwide (OECD, 2002, Section I, pp. 12-18). Streptomyces viridochromogenes is the donor organism of pat gene. History of safe use is being attributed to S. viridochromogenes since it is a common soil bacterium known to produce tripeptide L-phosphinothricyl-L-alanyl-alanine (L-PPT) which was developed as a non-selective herbicide. No food safety concern with regards to the other donor organism used in the transformation including Arabidopsis thaliana, Nicotiana tabacum, Agrobacterium tumefaciens, Cassava Vein Mosaic Virus and Helianthus annuus since the genetic elements derived from these organisms are not detected in DAS-44406-6. The developer provided sufficient information on the donor organisms which are not known to be toxic. History of safe use was attributed to all donor organisms. 4. Transformation System The event, DAS-44406-6 was developed to express AAD-12 protein derived from Delftia acidovorans, 2mEPSPS protein derived from Zea mays L. and PAT protein derived from Streptomyces viridochromogenes. AAD-12 protein confers tolerance to 2,4-dichlorophenoxyacetic acid (2,4-D) and aryloxyphenoxypropionate (AOPP) acetyl coenzyme A carboxylase (ACCase) inhibitors (“fop” herbicides). The 2mEPSPS and PAT proteins confer tolerance to glyphosate-containing herbicides and glufosinate ammonium-containing herbicides, respectively. The transformation method is through Agrobacterium-mediated transformation with plasmid vector pDAB8264. The plasmid vector, is composed of three (3) gene expression cassettes for aad-12, 2mepsps and pat. The 2mepsps gene expression cassette is composed of histone promoter H4A748 3' UTR from Arabidopsis thaliana, 2mepsps gene from Zea mays L., optimized chloroplast transit peptide (Tpotp C) from maize and sunflower RuBisCO and intervening sequences. The aad-12 gene expression cassette is composed of histone promoter H4A748 from Arabidopsis thaliana including an intron from the Histone 3 gene from A. thaliana, promoter along with the 5’ untranslated region and an intron from the A. thaliana polyubiquitin 10 (UBQ10) gene (AtUbi10), aad-12 gene from Delftia acidovorans, 3' untranslated region (UTR) comprising the transcriptional terminator and polyadenylation site of open reading frame 23 (ORF23) of plasmid pTi15955 from Agrobacterium tumefaciens (AtuORF23 3' UTR) and intervening sequences. The pat gene expression cassette is composed of CsVMV promoter from Cassava Vein Mosaic Virus, pat gene from Streptomyces viridochromogenes, 3' untranslated region (UTR) comprising the transcriptional terminator and polyadenylation site of open reading frame 1 (ORF1) of plasmid pTi15955 from Agrobacterium tumefaciens (AtuORF1 3' UTR) and intervening sequences. 5. Inserted DNA Genetic Stability Southern blot analysis demonstrated that there is only one insertion site showing one intact copy of the t-DNA insert at a single locus. Southern blot analysis also showed that there are no specific hybridization bands detected in the negative control samples in any of the restriction enzyme and probe combinations. This indicates that the single insert in DAS-44406-6 soybean contains an intact single copy of each of the PTUs for 2mepsps, aad-12 and pat. A 3-bp insertion at the 5’ integration junction of the T-DNA insert in DAS-44406-6 was detected. There was also a deletion of 4383 bp identified from the Maverick genome in DAS-44406-6. For the observed 3’bp insertion, sequence analysis using BLASTn against the soybean scaffold sequence collection did not reveal any novel open reading frames (>=450 bp, 150 aa) spanning the junctions resulting from the T-DNA insertion. For the 4383 bp deletion, an open reading frame (ORF) of 666 bp was identified. Based on the dossier provided by the developer , BLASTp search of the ORF did not identified any significant homology to known proteins. There are no any plasmid backbone sequences present as demonstrated by Southern Blot Analysis. Six probes covering nearly the entire backbone region of pDAB8264 are used to hybridize the Southern blots containing genomic DNA samples digested with MscI/EcoRI, HindIII and PstI/XhoI. The results showed that no hybridization bands were detected in any samples tested and confirming that no vector backbone sequences from pDAB8264 were integrated into DAS-44406-6 soybean. 6. Genetic Stability The multigenerational stability of the introduced traits is assessed by Southern Blot Analysis of genetic samples from five generations (T2, T3, T4, T6 and F2) of DAS-44406-6 (Dow AgroSciences, 2016). Segregation is assessed by Event-Specific PCR. One population of F2 and three populations of BC1F2 are assessed. Chi-square analysis indicated that the segregation ratio of the plants with positive transgene insert versus negative transgene insert is consistent with the 3:1 segregation ratio characteristic of Mendelian inheritance pattern of a single dominant trait. 7. Expressed Material AAD-12 protein has specific mode of action on 2,4-dichlorophenoxyacetic acid (2,4-D) and arylophenoxypropionate (AOPP) acetyl coenzyme A carboxylase (ACCase) inhibitors (“fop” herbicides). The protein have no metabolic role in plants (Dow AgroSciences, 2016). The 2mEPSPS is an enzyme involved in the shikimic biosynthesis of aromatic amino acids and is present in plants, bacteria and fungi, but not in animals (Padgette et al., 1996). It catalyzes the reversible reaction of shikimate-3-phosphate (S3P) and phosphoenolpyruvate (PEP) to produce EPSPS and inorganic phosphate (Pi) (Alibhai and Stallings, 2001). History of safe use has been attributed to 2mepsps as it was being used to induce glyphosate tolerance in other approved single events as listed in ISAAA GM ApprovalDatabase (2017). PAT protein is involved in the acetylation of L-phosphinothricin, the active isomer of the glufosinate-ammonium herbicide, resulting in tolerance of transgenic plants to post-emergent application of the non-selective herbicide (Herouet et al., 2005). The expression of novel protein in different plant parts is measured using ELISA methods. The measurements are in dry weight basis (ng/mg dry weight). The expression level of AAD-12, 2mEPSPS and PAT in grain is 27.3 ng/mg dry weight, 21.97 ng/mg dry weight and 2.12 ng/mg dry weight, respectively. 8. Toxicological and Allergenicity Assessment The safety assessment of novel proteins, AAD-12, 2mEPSPS and PAT, includes digestibility, heat inactivation, oral toxicity and amino acid sequence comparison studies to determine its potential to cause toxicity or allergenicity to humans. Digestibility study using Simulated Gastric Fluid (SGF) with pepsin demonstrated that AAD-12 and 2mEPSPS is readily degraded within 30 seconds and I minute of incubation with SGF, respectively, in presence of 0.32% w/v pepsin at pH 1.2, a characteristic of most non-toxic proteins. According to OECD (1999) PAT proteins are rapidly digested n SGF and is readily denatured by heat. Heat stability of AAD-12 and 2mEPSPS was evaluated by monitoring the change in protein bands in SDS-PAGE of the protein solutions heated for 30 minutes at 4 °C, 50°C, 70°C and 95°C for AAD-12 and at 25 °C, 37°C, 55°C, 75°C and 95°C for 2mEPSPS (Schafer, 2012; Embrey, 2012). Results of the SDS-PAGE analysis indicated no change in protein bands on all heated proteins at 30 minutes incubation. Heat inactivation of AAD-12 and 2mEPSPS was evaluated through monitoring the enzymatic activity and immunoreactivity of the proteins subjected to heat for 30 minutes at the assigned temperature variants (Schafer, 2012; Embrey, 2012). For AAD-12, enzymatic activity was determined through monitoring the phenol production resulted from the conversion of Dichlorprop (2-(2,4-dichlorophenoxy) propanoic acid to 2,4-dichlorophenol (DCP). For 2mEPSPS enzymatic activity was determined through determining the presence or absence of inorganic phosphate. Immunoreactivity of the two (2) proteins was determined through ELISA using an immobilized anti-AAD-12 and anti-2mEPSPS polyclonal antibodies. Complete loss of enzymatic activity and immunoreactivity was observed in AAD-12 upon subject to temepratures at 50°C, 70°C and 95°C for 30 minutes. At 55°C, 90% loss in immunoreactivity was observed for 2mEPSPS. BLASTp search algorithm against the GenBank showed that AAD-12, 2mEPSPS and PAT has no biologically relevant identities to toxic proteins. Amino acid sequence comparison of AAD-1, 2mEPSPS and PAT protein to toxins and allergens was conducted using BLASTp search algorithm against the GenBank and FASTA program (Dow AgroSciences, 2016). Results of bioinformatics analyses indicated that AAD-1 protein is not homologous to any toxin and allergen. Bioinformatics tools and comparison to FARRP Allergen Database Version 12 indicates that the AAD-12, 2mEPSPS and PAT has no amino acid sequence similarity to known allergens. An acute oral gavage studies for AAD-12 and 2mEPSPS were included in the dossier indicating that the No Observed Effect Level of AAD-12 and 2mEPSPS is > 2000 mg/kg body weight and >5000 mg/kg body weight, respectively. However, the actual data of the studies were not provided by the developer. Weight of evidences approach indicates that AAD-12 and 2mEPSPS are not likely to cause toxicity to humans and animals. Hence, the data on acute oral gavage study are no longer required. The safety of PAT by Acute oral gavage was already assessed. No mortality is observed and there are no observable adverse or non-adverse effects in male and female treated mice at 5000 mg/kg body weight (OECD, 1999). The AAD-12 and 2mEPSPS proteins used for the toxicological studies were obtained from Pseudomonas and were found biochemically and functionally equivalent to AAD-12 and 2mEPSPS expressed in DAS-44406-6 soybean. PAT protein used for toxicological study was obtained from Streptomyces viridochromogenes and is 100% identical in amino acid sequence to the PAT protein expressed in several transgenic plants that has been previously deregulated. The novel proteins are expressed independently of each other. List of genetic elements provided by the developer indicated that the three novel proteins are being regulated by different promoters. They are expressed in same plant tissues as indicated in the specific ELISA method of determining the level of expression of the proteins in different plant parts. They do not interact to express the phenotype. The percent of total protein of AAD-12, 2mEPSPS and PAT is estimated to be <0.003%, <0.002% and <0.0002%, respectively. Results of the toxicological and allergenicity assessment indicate that AAD-1, 2mEPSPS and PAT protein being expressed in DAS-44406-6 soybean are not toxic or allergenic to humans. 9. Nutritional Data Compositional analysis provided by the developer indicating the nutritional data of DAS-44406-6 in comparison with the non-transgenic soybean (Maverick), commercial varieties and range of literature values. The trials were conducted at ten sites located in Georgia, Iowa, Illinois, Indiana, Michigan, Missouri and Nebraska at same environmental conditions. Results of the analysis indicated that there is no differences in the proximate, fiber, mineral, amino acid, fatty acid, vitamins, anti-nutrient and secondary metabolite levels of DAS-44406-6 and the non-transgenic soybean that can be considered biologically relevant. 10. Recommendation For the transgenic DAS-44406-6 soybean, enough evidence is provided to support the equivalence of the genetically modified crop, in terms of the nutritional composition and food safety, with the conventional soybean other than tolerance to 2,4-dichlorophenoxyacetic acid- (2,4-D), glyphosate- and glufosinate ammonium-containing herbicides. After reviewing the provided material of the applicant, it is therefore concluded that DAS-44406-6 soybean is as safe 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:
Upload:
Authorization expiration date (a blank field means there is no expiration date) February 20, 2024
E-mail:
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.

 

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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

Philippines
Name of product applicant: Dow AgroSciences
Summary of application:



On January 20, 2017, Dow-Agro Sciences LLC’s Soybean DAS44406-6 for direct use as food and feed, or for processing, as original application under the DOST-DA-DENR-DOH-DILG Joint Department Circular (JDC) No. 1 Series of 2016. After reviewing the Risk Assessment Report and attachments submitted by the applicant, the assessors namely: Scientific and Technical Review Panel (STRP), BPI Plant Products Safety Services Division (BPI-PPSSD) and Bureau of Animal Industry- Biotech Team (BAI-BT), concurred that corn soybean DAS44406-6 is as safe for human food and animal feed as its conventional counterpart.


In accordance with Article VII. Section 20 of the JDC, no regulated article, whether imported or developed domestically, shall be permitted for direct use as food and feed, or for processing, unless: (1) the Biosafety Permit for Direct Use has been issued by the BPI; (2) in the case of imported regulated article, the regulated article has been authorized for commercial distribution as food and feed in the country of origin; and (3) regardless of the intended use, the regulated article does not pose greater risks to biodiversity, human and animal health than its conventional counterpart.


The BPI Biotech Office provided the assessors the complete dossier submitted by Dow-Agro Sciences LLC. Upon receipt of the individual reports from the assessors, the BPI Biotech Secretariat prepared this consolidated risk assessment report for the information of the public.




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Date of authorization: 21/02/2019
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 safety assessment of novel proteins, AAD-12, 2mEPSPS and PAT, includes digestibility, heat inactivation, oral toxicity and amino acid sequence comparison studies to determine its potential to cause toxicity or allergenicity to humans. Digestibility study using Simulated Gastric Fluid (SGF) with pepsin demonstrated that AAD-12 and 2mEPSPS is readily degraded within 30 seconds and I minute of incubation with SGF, respectively, in presence of 0.32% w/v pepsin at pH 1.2, a characteristic of most non-toxic proteins. According to OECD (1999) PAT proteins are rapidly digested n SGF and is readily denatured by heat. Heat stability of AAD-12 and 2mEPSPS was evaluated by monitoring the change in protein bands in SDS-PAGE of the protein solutions heated for 30 minutes at 4 °C, 50°C, 70°C and 95°C for AAD-12 and at 25 °C, 37°C, 55°C, 75°C and 95°C for 2mEPSPS (Schafer, 2012; Embrey, 2012). Results of the SDS-PAGE analysis indicated no change in protein bands on all heated proteins at 30 minutes incubation. Heat inactivation of AAD-12 and 2mEPSPS was evaluated through monitoring the enzymatic activity and immunoreactivity of the proteins subjected to heat for 30 minutes at the assigned temperature variants (Schafer, 2012; Embrey, 2012). For AAD-12, enzymatic activity was determined through monitoring the phenol production resulted from the conversion of Dichlorprop (2-(2,4-dichlorophenoxy) propanoic acid to 2,4-dichlorophenol (DCP). For 2mEPSPS enzymatic activity was determined through determining the presence or absence of inorganic phosphate. Immunoreactivity of the two (2) proteins was determined through ELISA using an immobilized anti-AAD-12 and anti-2mEPSPS polyclonal antibodies. Complete loss of enzymatic activity and immunoreactivity was observed in AAD-12 upon subject to temepratures at 50°C, 70°C and 95°C for 30 minutes. At 55°C, 90% loss in immunoreactivity was observed for 2mEPSPS. BLASTp search algorithm against the GenBank showed that AAD-12, 2mEPSPS and PAT has no biologically relevant identities to toxic proteins. Amino acid sequence comparison of AAD-1, 2mEPSPS and PAT protein to toxins and allergens was conducted using BLASTp search algorithm against the GenBank and FASTA program (Dow AgroSciences, 2016). Results of bioinformatics analyses indicated that AAD-1 protein is not homologous to any toxin and allergen. Bioinformatics tools and comparison to FARRP Allergen Database Version 12 indicates that the AAD-12, 2mEPSPS and PAT has no amino acid sequence similarity to known allergens. An acute oral gavage studies for AAD-12 and 2mEPSPS were included in the dossier indicating that the No Observed Effect Level of AAD-12 and 2mEPSPS is > 2000 mg/kg body weight and >5000 mg/kg body weight, respectively. However, the actual data of the studies were not provided by the developer. Weight of evidences approach indicates that AAD-12 and 2mEPSPS are not likely to cause toxicity to humans and animals. Hence, the data on acute oral gavage study are no longer required. The safety of PAT by Acute oral gavage was already assessed. No mortality is observed and there are no observable adverse or non-adverse effects in male and female treated mice at 5000 mg/kg body weight (OECD, 1999). The AAD-12 and 2mEPSPS proteins used for the toxicological studies were obtained from Pseudomonas and were found biochemically and functionally equivalent to AAD-12 and 2mEPSPS expressed in DAS-44406-6 soybean. PAT protein used for toxicological study was obtained from Streptomyces viridochromogenes and is 100% identical in amino acid sequence to the PAT protein expressed in several transgenic plants that has been previously deregulated. The novel proteins are expressed independently of each other. List of genetic elements provided by the developer indicated that the three novel proteins are being regulated by different promoters. They are expressed in same plant tissues as indicated in the specific ELISA method of determining the level of expression of the proteins in different plant parts. They do not interact to express the phenotype. The percent of total protein of AAD-12, 2mEPSPS and PAT is estimated to be <0.003%, <0.002% and <0.0002%, respectively. Results of the toxicological and allergenicity assessment indicate that AAD-1, 2mEPSPS and PAT protein being expressed in DAS-44406-6 soybean are not toxic or allergenic to humans. Compositional analysis provided by the developer indicating the nutritional data of DAS-44406-6 in comparison with the non-transgenic soybean (Maverick), commercial varieties and range of literature values. The trials were conducted at ten sites located in Georgia, Iowa, Illinois, Indiana, Michigan, Missouri and Nebraska at same environmental conditions. Results of the analysis indicated that there is no differences in the proximate, fiber, mineral, amino acid, fatty acid, vitamins, anti- nutrient and secondary metabolite levels of DAS-44406-6 and the non-transgenic soybean that can be considered biologically relevant.
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) February 20, 2024
E-mail:
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.

 

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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: Dow AgroSciences Int'l. Ltd.
Summary of application:

 


Glufosinate herbicide tolerance, Glyphosate herbicide tolerance, 2,4-D herbicide tolerance

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Date of authorization: 04/12/2014
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):
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:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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E-mail:
Organization/agency name (Full name):
Ministry of Food and Drug Safety
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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
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Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Singapore
Name of product applicant: Dow AgroSciences
Summary of application:

Apply for use as food, feed and/or for processing 

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Date of authorization: 11/08/2020
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):
Soybean Line DAS-44406-6 has been developed to tolerate herbicides of the aryloxyalkanoate family including the phenoxy auxins such as 2,4-dichlorophenoxyacetic acid (2,4-D), and to the herbicides glufosinate ammonium and glyphosate. Tolerance to 2,4-D is achieved through expression of the enzyme aryloxyalkanoatedioxygenase-12 (AAD-12) encoded by the aad-12 gene derived from Delftia acidovorans. Tolerance to glufosinate ammonium is achieved through expression of the enzyme phosphinothricin acetyltransferase (PAT) encoded by the pat gene derived from Streptomyces viridochromogenes. Tolerance to glyphosate is encoded through expression of a 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) encoded by the 2mepsps gene from corn (Zea mays). Molecular analyses indicate that a single copy of T-DNA containing three expression cassettes for the genes 2m epsps, aad-12 and pat has been inserted at a single locus in the soybean genome. The introduced genetic elements are stably inherited from one generation to the next. Soybean line DAS-44406-6 expresses three new proteins, 2m EPSPS, AAD-12 and PAT, which are non-toxic and non-allergenic to humans. Composition analyses showed that there are significant differences in a number of constituents but the differences were typically small and all mean values were within both the tolerance range obtained for non-GM reference varieties grown at the same time and the literature range. Food derived from soybean line DAS-44406-6 is as safe as food derived from conventional soybean cultivars.
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Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Organization/agency name (Full name):
Agri-Food & Veterinary Authority of Singapore (AVA)
Contact person name:
Dr Wong Kwok Onn
Website:
Physical full address:
52 Jurong Gateway Road, #14-01, Singapore 608550
Phone number:
(65)68052895
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Country introduction:

The Singapore Food Agency (SFA) is a Statutory Board established under the Ministry of Sustainability and the Environment (MSE) to oversee food safety and security. SFA’s mission is to ensure and secure a supply of safe food.  SFA adopts a risk-based approach to food safety. Foods with foodborne hazards that may pose potential food safety risks to consumers are subjected to more stringent checks, regardless of their country of origin. SFA has in place an integrated system to ensure that both imported and domestically produced foods are safe for consumption.  The system comprises control measures such as source accreditation, inspection and surveillance of food, laboratory analysis, food legislation and recall of food products, which safeguard food safety from farm to fork.

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Stacked events:

More information on the guidelines for the safety assessment of stacked events can be found on GMAC’s website:

http://www.gmac.sg/Index_Singapore_Guidelines_on_the_Release_of_Agriculture_Related_GMOs.html

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

Singapore Food Agency (SFA)

South Africa
Name of product applicant: DowAgroSciences
Summary of application:

The GM soybean DAS-44406-6 is produced by Agrobacterium mediated transformation. The soybean expresses theaad-1, 2mepsps and pat proteins which confer tolerance to herbicides containing 2,4-dichlorophenoxyacetic acid, glyphosate and glufosinate. 

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Date of authorization: 01/02/2013
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): Biosafety Clearing House (BCH)
Summary of the safety assessment (food safety):
The GM soybean DAS-44406-6 has been assessed in terms of the Genetically Modified Organisms Act, 1997 by the Advisory Committee, a scientific panel and the Executive Council an intergovernmental decision making body. The assessment considered amongst others the following: The source of the gene, nature of host organism, protein expression, toxicology and allergenicity issues
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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:
Organization/agency name (Full name):
Department of Agriculture Forestry and Fisheries
Contact person name:
Nompumelelo Mkhonza
Website:
Physical full address:
30 Hamilton street, Harvest House building, Arcadia, Pretoria, 0001
Phone number:
+2712 319 6382
Fax number:
+2712 319 6298
Country introduction:
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Stacked events:

South Africa does not have a specific review/authorization mechanism for stacked events. Stacked events just like single events are subjected to a safety assessment as per the GMO Act.

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

Department of Agriculture,Forestry and Fisheries (DAFF) http://www.daff.gov.za

United States of America
Name of product applicant: Dow AgroSciences LLC
Summary of application:
Soybean
Trait 1 Added Protein: Aryloxyalkanoate dioxygenase-12 (AAD-12)
Source: Delftia acidovorans
Intended Effect: Tolerance to 2,4-dichlorophenoxyacetic acid (2,4-D) and certain aryloxyphenoxypropionate herbicides (e.g., quizalofop, cyhalofop, haloxyfop)
Trait 2 Added Protein: 2mepsps gene encoding a modified 5-enolpyruvylshikimate-3-phosphate synthase (2mEPSPS) protein
Source: Zea mays
Intended Effect: Tolerance to the herbicide glyphosate
Trait 3 Added Protein: pat gene encoding phosphinothricin N-acetyl transferase (PAT) protein
Source: Streptomyces viridochromogenes
Intended Effect: Tolerance to the herbicide glufosinate
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Date of authorization: 16/12/2013
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Please consult the FDA website 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:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: FDA's webpage regarding this variety
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Organization/agency name (Full name):
Food and Drug Administration
Contact person name:
Jason Dietz
Website:
Physical full address:
5100 Paint Branch Parkway, College Park MD 20740
Phone number:
240-402-2282
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Country introduction:

The United States is currently in the process of populating this database. The Food and Drug Administration regulates food and feed (food for humans and animals) from genetically engineered crops in conjunction with the Environmental Protection Agency (EPA). EPA regulates pesticides, including those that are plant incorporated protectants genetically engineered into food crops, to make sure that pesticide residues are safe for human and animal consumption and do not pose unreasonable risks of harm to human health or the environment. FDA In the Federal Register of May 29, 1992 (57 FR 22984), FDA published its "Statement of Policy: Foods Derived from New Plant Varieties" (the 1992 policy). The 1992 policy clarified the agency's interpretation of the application of the Federal Food, Drug, and Cosmetic Act with respect to human and animal foods derived from new plant varieties and provided guidance to industry on scientific and regulatory issues related to these foods. The 1992 policy applied to all foods derived from all new plant varieties, including varieties that are developed using genetic engineering (also known as recombinant deoxyribonucleic acid (rDNA) technology). In the 1992 policy, FDA recommended that developers consult with FDA about foods from genetically engineered plants under development and developers have routinely done so. In June 1996, FDA provided additional guidance to industry on procedures for these consultations (the consultation procedures). These procedures describe a process in which a developer who intends to commercialize food from a genetically engineered plant meets with the agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the genetically engineered food and then submits to FDA a summary of its scientific and regulatory assessment of the food. FDA evaluates the submission and if FDA has questions about the summary provided, it requests clarification from the developer. At the conclusion of the consultation FDA responds to the developer by letter. The approach to the safety assessment of genetically engineered food recommended by FDA during consultations, including data and information evaluated, is consistent with that described in the Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants. EPA The safe use of pesticidal substances is regulated by EPA. Food from a genetically engineered plant that is the subject of a consultation with FDA may contain an introduced pesticidal substance, also known as a plant-incorporated protectant (PIP), that is subject to food (food for humans and animals) safety and environmental review by EPA. PIPs are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. Both the PIP protein and its genetic material are regulated by EPA. When assessing the potential risks of PIPs, EPA requires studies examining numerous factors, such as risks to human health, non-target organisms and the environment, potential for gene flow, and insect resistance management plans, if needed. In regulating PIPs, decisions are based on scientific standards and input from academia, industry, other Federal agencies, and the public. Before the first PIP product was registered in 1995, EPA required that PIP products be thoroughly tested against human safety standards before they were used on human food and livestock feed crops. EPA scientists assessed a wide variety of potential effects associated with the use of PIPs, including toxicity, and allergenicity. These potential effects were evaluated in light of the public's potential exposures to these pesticides, taking into account all potential combined sources of the exposure (food, drinking water, etc.) to determine the likelihood that a person exposed at these levels would be predisposed to a health risk. Based on its reviews of the scientific studies and often peer reviews by the Federal Insecticide, Fungicide and Rodenticide Scientific Advisory Panel, EPA determined that these genetically engineered PIP products, when used in accordance with approved label directions and use restrictions, would not pose unreasonable risk to human health and the environment during their time-limited registration.

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Stacked events:

Stacked events that are each plant incorporated protectants, as defined by the Environmental Protection Agency, must be registered by the Envriornmental Protection Agency before they can be commercialized.  Food/feed safety asssessment of single events are generally sufficient to ensure the safety of food/feed from stacked events.   

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

Food and Drug Administration ([email protected]); Environmental Protection Agency

Uruguay
Name of product applicant: DasAgro Uruguay
Summary of application:

DAS-44406-6 soybean was modified with the insertion of a gene encoding aryloxyalkanoate dioxygenase and phosphinothricin N-acetyltransferase to confer tolerance to the herbicides 2,4-dichlorophenoxyacetic acid (2,4-D) and glufosinate respectively. Further more a gene encoding a modified version of the EPSPS gene was inserted to confer tolerance to glyphosate.

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Date of authorization: 15/12/2017
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.): BCH
Summary of the safety assessment (food safety):
Please refer to uploaded document
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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: Sistema Nacional de Bioseguridad
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Organization/agency name (Full name):
Ministerio de Ganadería, Agricultura y Pesca
Contact person name:
Alejandra Ferenczi
Website:
Physical full address:
Constituyente 1476, Piso 2, Of. 212B. Montevideo, Uruguay
Phone number:
+598 2 4104155 int 3
Fax number:
Country introduction:

The Uruguayan National Biosafety System (SNB for its acronym in Spanish) includes safety assessments of food end feed, environmental risk assessment, risk management, and risk communication. The National Biosafety Cabinet (GNBio) is the competent authority on biosafety of GMOs. Integrated by: The Minister of Agriculture, MGAP (chair); Minister of Health (MSP); Minister of Economy (MEF); Minister of Environment (MVOTMA); Minister of Foreign Affairs (MRREE); and Minister of Industry (MIEM). This Cabinet is the last responsible to make decisions over a submitted request. It has the authority to define policies to be followed with respect to biosafety in all scopes of GMO application. Other committees of experts and scientists give support to decisions of GNBio through risk analysis of biotechnological products. The Risk Management Commission (CGR) is composed by one delegate of each of the ministries represented within GNBio.  The CGR advises GNBio on GMO biosecurity issues; elaborates reference terms for risk assessments; manages the risk communication participation process; is responsible for follow-up and monitoring of authorized events. The Risk Assessment in Biosecurity (ERB) is composed of experts proposed by the CGR and designated by GNBio among specialists in the different areas of risk assessment. Is responsible for considering, on a case-by-case basis, the potential risks and benefits of each new biotech product; assure case-by-case risk assessment evaluation based on scientific methods; writes an operational plan (pre-report) of risk assessment according to CGR directives; advises CGR based on the results of the analysis of risk assessment, and provides information during the consultation process. The Institutional Articulation Committee (CAI) is a committee of technical experts from nine different national public and research institutions, which analyzes the risk assessment of new events and prepares a technical report. The technical analysis is coordinated by ERB organized in different ad hoc groups of experts. The Ad hoc experts groups are technical-scientific specialists in different areas of knowledge related to the analysis of GMO events like characterization and molecular identification of events, environmental and food safety aspects. 

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Stacked events:

GM vegetables from cross-pollinated species, such as corn, with stacked events are not considered as a new product. In the case of GM vegetables from self-pollinated species, such as soybean, are considered as a new product even if all single events stacked have already been approved. However, there is an abbreviated analysis procedure in cases where single events were already analyzed. Stacked events not yet analyzed must have the individual risk assessment report.

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

GNBio office. E-mail: [email protected]; Adress: Constituyente 1476, piso 2, oficina 212B, Montevideo 11200, Uruguay.