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OECD Unique Identifier details

DAS-4Ø278-9
Commodity: Corn / Maize
Traits: 2 4-dichlorophenoxyacetic acid (2 4-D) tolerance,Aryloxyphenoxypropionate (AOPP) acetyl coenzyme A carboxylase (ACCase) inhibitor tolerance
European Union
Name of product applicant: Dow AgroSciences Distribution S.A.S.
Summary of application:

DAS-4Ø278-9 maize expresses the AAD-1 protein which confers tolerance to 2,4-dichlorophenoxyacetic acid (2,4-D) and aryloxyphenoxypropionate (AOPP) herbicides.

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Date of authorization: 04/07/2017
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-4Ø278-9 maize; the detection method is validated on the single-trait event using genomic DNA extracted from seeds of DAS-4Ø278-9 maize. Reference material: ERM®-BF433 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) 03/07/2027
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 protein expressed by the gene aad-1 from Sphingobium herbicidovorans confers tolerance to herbicides from the group of aryloxyphenoxides (also called phenoxypropionic or "fop") and to herbicides based on 2,4-D.

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Date of authorization: 29/11/2017
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
• 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 AgroSciences Australia Ltd
Summary of application:
Dow AgroSciences Australia Limited has submitted an application to FSANZ to vary
Standard 1.5.2 – Food produced using Gene Technology – in the Australia New Zealand Food Standards Code (the Code) to include food from a new genetically modified (GM) corn line, DAS-40278-9. The corn has been modified to be tolerant to 2,4-dichlorophenoxyacetic acid (2,4-D) and aryloxyphenoxypropionate (AOPP) acetyl coenzyme A carboxylase inhibitors (“fop” herbicides) such as quizalofop-P-ethyl.
Tolerance to these herbicides is conferred by expression in the plant of the aad-1 gene,
encoding aryloxyalkanoate dioxygenase (AAD-1), which inactivates herbicides having a
common aryloxyalkanoate structure The aad-1 gene is derived from Sphingobium
herbicidovorans, a common soil bacterium.
Corn is not a major crop in Australia or New Zealand. Domestic production is supplemented by the import of a small amount of corn-based products, largely as high-fructose corn syrup, which is not currently manufactured in either Australia or New Zealand. Such products are processed into breakfast cereals, baking products, extruded confectionery and food coatings. Other corn products such as cornstarch are also imported and used by the food industry for the manufacture of dessert mixes and sauces. Corn may also be imported in finished products such as corn chips and canned corn.
DAS-40278-9 corn will be grown in North America and is not intended for cultivation in
Australia or New Zealand. Therefore, if approved, food from this line may enter the
Australian and New Zealand food supply as imported food products.
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Date of authorization: 13/10/2011
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 A1042 - Food derived from herbicide-tolerant corn line DAS-40278-9
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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 Agroscience Sementes e Biotecnologia Ltda
Summary of application:

Commercial release of maize DAS-4Ø278-9

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Date of authorization: 05/03/2015
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.): ISAAA
Summary of the safety assessment (food safety):
The applicant requested from CTNBio technical advice for the commercial release of genetically modified maize DAS-40278-9 which confers tolerance to the herbicide 2,4-D (2,4-dichlorophenoxyacetic acid) and certain herbicides inhibitors of acetyl coenzyme A carboxylase (ACCase ) Aryloxyphenoxypropionate (AOPP) for the purpose of its release into the environment for the cultivation, production, handling, transfer, marketing, import, export, storage, consumption, release and disposal of the genetically modified organism and its derivatives for commercial purposes. CTNBio considers that: 1) The available information made it possible to properly evaluate the biosafety of genetically modified maize DAS-40278-9; 2) Scientific studies conducted to evaluate biosafety, agronomic and phenotypic characteristics, as part of the risk assessment of this GMO, included several ecosystems of representative regions for maize culture in Brazilian territory; 3) The phenotype of the transformed plants is equivalent to the original plant phenotype conventional in terms of human and animal health and safety for plants and the environment; (4) The commercial release of genetically modified maize DAS-40278-9 is not likely to cause significant degradation of the environment or human and animal health
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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:

DAS-40278-9 corn produces aryloxyalkanoate dioxygenase-1 (AAD-1), an enzyme which confers resistance to 2,4-dichlorophenoxyacetic acid (2,4-D) and certain aryloxyphenoxypropionate (AOPP, or "fop") herbicides. The herbicide tolerance was achieved through transformation of a conventional corn variety.

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Date of authorization: 16/05/2012
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
Novel Feeds Decision
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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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Relevant documents
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 maize DAS40278 tolerant to herbicide 2,4 D

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Date of authorization: 13/03/2014
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):
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 Japan Ltd.
Summary of application:

DAS-40278-9 has been modified to be tolerant to 2,4-dichlorophenoxyacetic acid (2,4-D) and aryloxyphenoxypropionate (AOPP) acetyl coenzyme A carboxylase inhibitors (“fop” herbicides) such as quizalofop-P-ethyl.

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Date of authorization: 30/05/2012
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):
Please see the link below (in Japanese).
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Food safety assessment performed by Food Safety Commission of Japan (in Japanese)
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Authorization expiration date (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: 01/08/2017
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.

Useful links
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: Híbridos Pioneer de México, S.A. de C.V. - Dow AgroSciences, S.A. de C.V.
Summary of application:

Authorization by COFEPRIS: 102


DAS-40278-9 corn produces aryloxyalkanoate dioxygenase-1 (AAD-1), an enzyme which confers resistance to 2,4-dichlorophenoxyacetic acid (2,4-D) and certain aryloxyphenoxypropionate (AOPP, or "fop") herbicides. The herbicide tolerance was achieved through transformation of a conventional corn variety.

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Date of authorization: 16/12/2011
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-4Ø278-9 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 AgroSciences Australia Ltd
Summary of application:

Dow AgroSciences Australia Limited has submitted an application to FSANZ to vary
Standard 1.5.2 – Food produced using Gene Technology – in the Australia New Zealand Food Standards Code (the Code) to include food from a new genetically modified (GM) corn line, DAS-40278-9. The corn has been modified to be tolerant to 2,4-dichlorophenoxyacetic acid (2,4-D) and aryloxyphenoxypropionate (AOPP) acetyl coenzyme A carboxylase inhibitors (“fop” herbicides) such as quizalofop-P-ethyl.
Tolerance to these herbicides is conferred by expression in the plant of the aad-1 gene,
encoding aryloxyalkanoate dioxygenase (AAD-1), which inactivates herbicides having a
common aryloxyalkanoate structure The aad-1 gene is derived from Sphingobium
herbicidovorans, a common soil bacterium.
Corn is not a major crop in Australia or New Zealand. Domestic production is supplemented by the import of a small amount of corn-based products, largely as high-fructose corn syrup, which is not currently manufactured in either Australia or New Zealand. Such products are processed into breakfast cereals, baking products, extruded confectionery and food coatings. Other corn products such as cornstarch are also imported and used by the food industry for the manufacture of dessert mixes and sauces. Corn may also be imported in finished products such as corn chips and canned corn.
DAS-40278-9 corn will be grown in North America and is not intended for cultivation in
Australia or New Zealand. Therefore, if approved, food from this line may enter the
Australian and New Zealand food supply as imported food products.

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Date of authorization: 08/12/2011
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):
In conducting a safety assessment of food derived from herbicide-tolerant corn line DAS-40278-9, a number of criteria have been addressed including: a characterisation of the transferred gene, its origin, function and stability in the corn genome; the changes at the level of DNA, protein and in the whole food; compositional analyses; evaluation of intended and unintended changes; and the potential for the newly expressed protein to be either allergenic or toxic in humans. No potential public health and safety concerns have been identified in the assessment of insect-protected corn DAS-40278-9. On the basis of the data provided in the present application, and other available information, food derived from corn DAS-40278-9 is considered to be as safe for human consumption as food derived from conventional corn 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 A1042 - Food derived from herbicide-tolerant corn line DAS-40278-9
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Organization/agency name (Full name):
Ministry for Primary Industries
Contact person name:
Fiapaipai Auapaau
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Physical full address:
Pastoral House, 25 The Terrace, Wellington, 6012
Phone number:
+6448314946
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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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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 AgroSciences BV Philippine Branch submitted corn DAS 40278-9 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 DAS 40278-9 is as safe for human food and animal feed as its conventional counterpart.

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Date of authorization: 07/05/2019
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):
STRP ASSESSMENT AND RECOMMENDATIONS Based on the documents submitted by the applicant: A. Host Organism The STRPs agree that Corn is a major item of grain grown for food and feed. Based on the combined compositional analysis from the literature, for human consumption , the grain contains (by dry weight basis) 63.3-89.8 % carbohydrates, 6.0- 17.3 % protein, 1.2-18.8 % total fat 8.3-35.3 % total dietary fiber and 0.62-6.28 % ash. For forage, it contains 66.9-94.5 % carbohydrates, 3.14-15.9 5 protein, 0.296-6.7 5 total fat. 19.0-62.8 % total dietary fiber and 1.3-10.5 % ash. Corn is also the source of some anti-nutrients like trypsin inhibitors, raffinose, phytic acid and secondary metabolites (coumaric acid, ferulic acid, furfural and inositol). The STRPs also agree that Corn in not known to be a toxicant, except for improperly stored grain that can be infested by insects and toxin-producing molds. Corn grain is not a source of allergen. However, the pollen of the corn plant is known be allergenic to hypersensitive individuals. According to Astwood et al, 1996. The potential pollen allergens known are Zea m1 and Clone C13. The pollen specific cDNAs of these are similar to those found in rye (Lol P1 sequence) and olives (ole e1) (Villalba et al, 1993). Pollen is shed at specific time points in the growing season. Since the subject of this application is corn grain, then pollen is not expected to be included in the importation. Further, the STRPs also noted that Corn has been used a primary source of food and consumed as food. In US, 90% of the total corn production is used as feed grain (meals, gluten feed, etc.). Estimates of both single serving (acute or short term intake) and repeat dose (chronic or average daily intake) corn exposures are available for consumption pattern that are relevant to the consumer. The intake of animal dietary burdens for livestock (beef, dairy, pig) and poultry are presented in tabulated form. Consumption pattern for livestock and poultry has been provided and described sufficiently. The introduction of the novel food (DAS 40278-9 Corn) is not expected to change as it was found to be substantially equivalent to conventional corn as a result of nutrient composition analyses. B. Donor Organism The STRPs concur that the inserted protein expressing aad-1 from a fragment of 6236 bp linear DNA was described. This was a fragment from the vector DNA plasmid pDAS1740. The regulatory sequences that included the promoter (Zm Ubi) the terminator (Zm Per 5 3’-UTR) were both from corn. The enhancers represented by the matrix attachment regions from tobacco (RB7 MAR v3 and v4 that flanked the aad-1 were adequately described in the patent documents. The promoter and terminator sequences were both expected to be recognized by the plant because they came from the same source and therefore ensure positive expression of the inserted gene. The MARS were included to increase consistency of expression and avoid any possible silencing (non-expression) of the inserted gene. The STRPs also agree that the aad-1 encodes Aryloxyalkanoate dioxygenase 1 which in the presence of α- ketoglutarate is known to degrade phenoxy auxins such as 2,4-D to dichlorophenol and eventually to succinate and carbon dioxide. These two products are common intermediated in cellular metabolism and are therefore not harmful by themselves. S. herbicidovorans could therefore use the phenoxy auxins and other xenobiotics as source of carbon for growth. Other substrates for this dioxygenase are the family of aryloxyphenoxypropionate (AOPP)–acetyl CoA inhibitors or “fop” pesticides. Further, they also agree that S. herbicidovorans, the source organism for the aad-1 gene is a gram-negative soil bacterium. Due to their biodegraduve and biosynthetic capabilities, the sphingomonads have been used for a wide range of biotechnological applications, including bioremediation of environmental contaminants and production of extracellular polymers such as sphingans which are used extensively in the food industry. There is no known pathogenicity and allergenicity of the encoded protein. C. Transformation System The STRPs all agree that the method of transformation was described and referenced as the Whisker-mediated direct DNA transfer using silicone carbide fiber directly penetrating the cell wall and directly incorporating the desired DNA. The target of genetic modification was the nuclear genome for stable and whole plant expression. The experimental procedure was adequately described and a schematic diagram was provided. A summary of the genetic elements are presented in tabulated form, indicating the locations on plasmid pDAS-1740 Tsp 1 fragment, size and description. he plasmid map of pDAS-1740 with all the genetic elements identified was presented. There was no carrier or helper DNA that was used in the introduction of the 8512 bp linear PTU from pDAS 1740 into the embryogenic cell suspension cultures to produce Event DAS 40278-9. E. Inserted DNA The molecular characterization of DAS-40278-9 corn was performed by Southern blot analyses. The result demonstrated that the transgene insert in DAS-40278-9 corn occurred as a single integration of a single intact copy of aad-1 expression cassette from plasmid pDAS 1740. The insert is stably integrated and inherited across and within the breeding generations. No plasmid backbone sequences are present in DAS-40278-9 corn. here was no indication of truncations in the Southern blots. The number and expected sizes of the specific hybridizing bands were consistently observed were consistently observed.There was also no indication of deletions in the Southern blots. F. Genetic Stability The STRPs concur that Southern blot analyses were conducted with five (5) distinct generations (T3, T4, BC3S3, and BC3S2) of DAS-40278-9 corn. Results across all DAS-40278-9 corn samples indicated stable inheritance of the intact single copy insert across multiple generations of DAS040278-9 corn. Segregation in T1, T2, BC1, BC2 BC3 and BC3S1 of DAS-40278- 9 corn were performed on leaf tissues through Southern blotting and immunoassay for the expressed AAD-1. The typical Mendelian inheritance ratio of 3:1 was observed. From the BC3S1 line for example, 65 tested positive for AAD-1 protein expression and 20 were null segregants. The aad-1 probe hybridized to each of the each 65 plants that tested positive for AAD-1. The 20 null segregants did not show this hybridization band, indicating the absence or non-inheritance of the inserted aad-1. G. Expressed Material A field expression study was conducted in 6 sites planted with DAS-40278-9 hybrid corn (BC3S1- A & E). Four treatments of the DAS-40278-9 corn expression study included 3 herbicide treatments as follows: AAD-1 Unsprayed, AAD-1 + Quizalofop, AAD-1 + 2,4-D, and AAD-1 + Quizalofop and 2,4-D. Results are presented showing the levels of AAD-1 protein (ng/mg tissue dry weight) measured in DAS-40278-9 corn indicating the range, mean and standard deviation. The average expression values ranged from 2.87 ng/mg dry weight in R1 stage root to 127 ng/mg in pollen tissue. For the plots sprayed and unsprayed with 2,4-D and quizalofop herbicides, no AAD-1 protein was detected in the control tissues across the 6 locations. A summary of the AAD-1 protein concentrations (average across sites) in various corn matrices are shown in tabulated form. The expression values were similar for the sprayed treatments as well as for the plots sprayed and unsprayed with 2,4-D and quizalofop herbicides. No AAD-1 protein has been detected in the control tissue across the 6 locations. H. Toxicological Assessment The STRPs agree that the digestibility of AAD-1 protein was tested in vitro using simulated gastric fluid (SGF). Samples were analyzed via SDS-PAGE and Western blot. The results demonstrated that AAD-1 protein was readily digested or inactivated (not detected at 30 seconds in SGF). Heat inactivation tests were also done, the lowest temperature used was 50oC for 30 min. These conditions already inactivated 97 % of the enzyme activity. The common cooking conditions applied to corn processing covers this and with the average field expression level of the AAD-1 present at 4.81 ng/mg tissue, processed products from DAS-40278-9 corn can be expected to be inactivated. Human consumption of raw corn is not the norm. The STRPs also agree that BLASTp Search summary of proteins in the alignmenmts with AAD-1 is presented and adequately described. None of the protein alignments returned by the BLASTp search are associated with toxicity. It was concluded that the AAD-1 proteins expressed in DAS-40278-9 corn contains no significant sequence similarity with any known toxic protein that is harmful to man and animals. Further, an acute oral toxicity study was conducted with AAD-1 protein in mice at a dose loevel of 2000 mg AAD-1/kg b.w. All the animals survived and gained weight. No adverse effects and clinical signs were observed by study termination on day 15. It was concluded that the acute oral LD50 of AAD-1 protein in mice was greater than 2000 mg/kg b.w., hence AAD-1 protein is not a health risk concern. The protein equivalency was also done by comparing aad-1 expression in transgenic corn with that of the Pseudomonas fluorescens using SDS-PAGE/Western blot/glycoprotein detection/MALDI-TOF MS/ and tandem mass spectrometry. The products of the analyteshave been shown to be biochemically equivalent. Biochemical equivalency was established by the procedures previously described. I. Allergenicity Assessment The STRPs agree that the digestibility of AAD-1 protein was tested in vitro using simulated gastric fluid (SGF). Samples were analyzed via SDS-PAGE and Western blot. The results demonstrated that AAD-1 protein was readily digested or inactivated (not detected at 30 seconds in SGF). Heat inactivation tests were also done, the lowest temperature used was 50oC for 30 min. These conditions already inactivated 97 % of the enzyme activity. The common cooking conditions applied to corn processing covers this and with the average field expression level of the AAD-1 present at 4.81 ng/mg tissue, processed products from DAS-40278-9 corn can be expected to be inactivated. Human consumption of raw corn is not the norm. The STRPs also agree that BLASTp Search summary of proteins in the alignmenmts with AAD-1 is presented and adequately described. None of the protein alignments returned by the BLASTp search are associated with toxicity. It was concluded that the AAD-1 proteins expressed in DAS-40278-9 corn contains no significant sequence similarity with any known toxic protein that is harmful to man and animals. The AAD-1 protein is not glycosylated as proven by glycoprotein staining. The AAD-1 has a molecular weight of 33 kDa as shown by electrophoretic separation. Further, an acute oral toxicity study was conducted with AAD-1 protein in mice at a dose loevel of 2000 mg AAD-1/kg b.w. All the animals survived and gained weight. No adverse effects and clinical signs were observed by study termination on day 15. It was concluded that the acute oral LD50 of AAD-1 protein in mice was greater than 2000 mg/kg b.w., hence AAD-1 protein is not a health risk concern. No serum screening was reported in the references possibly because of no evidence of similarity in sequence to known allergens. Please see above. J. Nutritional Data The STRPs agree that proximate analysis for grain show no differences across the six sites between control and transgenic lines were observed for fat ash, NDF and TDF. Fiber was within the reported literature range. A significant overall treatment effect was found for moisture but this did not show significance in the paired t-test or after adjustment for FDR. The differences in the values are not considered biologically meaningful because these were statistically low and in most cases was resolved after applying adjustment for false discovery rate (chance). Lastly, the values obtained still fall within those reported in the literature. Corn grain from Event DAS-40278-9 can therefore be considered substantially equivalent to conventionally-bred corn in terms of proximate. They also agree that there were also no significant differences in proximate analysis of forage, in control and transgenic lines for moisture, ADF, NDF, Ca and P. In comparison with the control line, protein content was lower in the transgenic line unsprayed and sprayed with quizalofop. On the other hand, ash content in the transgenic line sprayed with 2,4-D and quizalofop was highest. Carbohydrate was higher in the unsprayed and quizalofop-sprayed transgenic line. The differences are not of biological significance because there was no calculated treatment effect and the values still fall under the range of literature values. The value for carbohydrates was estimated by difference and has no significant FDR adjusted p-value and should therefore be of no biological concern. Furthermore, across –site analysis for levels of fatty acids in the grain gave values for 8:0 to 15:1 and 16:1 to 17:1 fatty acids that were below the limit of quantitation (LOQ). Values for 16:0 palmitic and 18:0, stearic acids where not significantly different and showed no overall treatment effect for the control and transgenic lines. Additionally the values were within the literature ranges. Anti-nutrients like raffinose was below the LOQ for the transgenic and non-transgenic control lines, as presented in table 24 of the summary. There was no significant difference found in the levels of trypsin inhibitor in the transgenic lines (4.87 to 5.45 % d.w.b) as compared to the non-transgenic line (5.08 %d.w.b). K. Recommendation Find scientific evidence that the regulated article applied for human food and animal feed use is as safe as its conventional counterpart and shall not pose any significant risk to human and animal health. BPI-PPSSD ASSESSMENT AND RECOMMENDATION Corn DAS 40278-9 was developed by Dow AgroSciences B.V., through the use of recombinant DNA technology. The said event was developed through Whisker’s – mediated direct DNA transformation of corn cells with pDAS1740 plasmid vector carrying, the aad-1 gene that encodes AAD-1 protein that provides herbicide tolerance to 2,4-dichlorophenoxyacetic acid (2,4-D) and aryloxyphenoxypropionate (AOPP) acetyl coenzyme A carboxylase (ACCase) inhibitors (“fop” herbicides). Host Organism (Zea mays L.) Corn (Zea mays L.) has been widely consumed as staple food for humans and feed ingredient for animals. It is used in food products such as oil, grit, meal, flour, ethanol, syrup and starch as well as feeds such as hulls, gluten and hominy (OECD, 2002). Humans consume corn mostly in the form of corn-based ingredients such as high fructose corn syrup, starch, sweeteners, cereals, oil and alcohol. In terms of the feeds, it is commonly consumed in the form of corn silage (forage), gluten meal, gluten feed and distillers dried grains. In 2014, the daily per capita consumption index of corn in the Philippines is 60.08 grams/day, while the daily per capita calories supply is 213.88 grams (PSA, 2015). Corn is a source of key nutrients such as amino acids, fatty acids, carbohydrates, vitamins, minerals, and fiber (OECD, 2002). It is also known to contain anti-nutrients such as phytic acid, 2,4-Dihydroxy-7-methoxy-2H-1,4-benzoaxin-3(4H)-one (DIMBOA), raffinose, trypsin and chymotrypsin inhibitors, and secondary plant metabolites such as furfural, ferulic acid and p-coumaric acid. These anti-nutrients and secondary metabolites have been historically present in corn at levels that would not cause the food to be unsafe. History of safe use was attributed to corn. It is known to produce no significant amount of toxins and anti-nutrients. It is not a common allergenic food; however, some reports had stated gastrointestinal and respiratory allergenic reactions. Transgenic Plant (DAS-40278-9 Corn) DAS-40278-9 corn has been reviewed and approved for food and/or feed use in many countries including Australia (Food, 2011), Brazil (Food and Feed, 2015), Canada (Food and Feed, 2012), Colombia (Food, 2014; Feed, 2013), European Union (Food and Feed, 2017), Japan (Food and Feed, 2012), Malaysia (Food and Feed, 2017), Mexico (2011), New Zealand (2011), South Africa (Food and Feed, 2012), South Korea (Food and Feed, 2014), Taiwan (2011), and United States of America (2011) (ISAAA). The event, DAS-40278-9 was developed to express AAD-1 proteins derived from Sphingobium herbicidovorans (Dow AgroSciences, 2014). The protein confers tolerance to 2,4-dichlorophenoxyacetic acid (2,4-D) and aryloxyphenoxypropionate (AOPP) acetyl coenzyme A carboxylase (ACCase) inhibitors (“fop” herbicides). The transformation method is through Whisker’s – mediated direct DNA transfer with plasmid vector pDAS1740 into the corn line Hi-II. The plasmid vector contains the aad-1 gene expression cassette which contains two (2) matrix attachment region (MAR) obtained from Nicotiana tobacum (RB7 MAR), ubiquitin promoter isolated from Zea mays, synthetic, plant optimized version of an aryloxyalkanoate dioxygenase gene isolated from Sphingobium herbicidovorans, 3’ untranslated region from Zea mays peroxidase gene, and six (6) intervening sequences. Donor Organisms (Sphingobium herbicidovorans) Sphingobium herbicidovorans is a gram negative soil bacterium which has the ability to use phenoxy auxin and AOPP herbicides as carbon sources for growth (Dow AgroSciences, 2014). Sphingomonads are widely distributed in nature and was found in land, water, plant root systems, clinical specimens, etc. It has history of use in terms of bioremediation of environmental contaminants and production of extracellular polymers such as sphingans which are extensively used in food industry. The donor organisms of other genetic elements included in the plasmid vector pDAS1740 includes Nicotiana tobacum and Zea mays (Dow AgroSciences, 2014). History of safe use has been attributed to Z. mays since it is being widely consumed as staple food of several countries worldwide and is not a common allergenic food nor a source of toxicants. No food safety concern with regards to the other donor organisms used in the transformation since the regulatory sequences obtained from these organisms are not being expressed in DAS-40278-9. The only protein expressed in DAS-40278-9 is the aryloxyalkanoate dioxygenase-1 (AAD-1) protein encoded by aad-1 gene. AAD-1 has an alpha ketoglutarate-dependent dioxygenase activity (Dow AgroSciences, 2014). Inserted DNA Southern blot analyses using restriction enzymes such as EcoR I, Nco I, Sac I and Fse I/Hind III and aad-1, ZmUbi1 promoter and ZmPer5 terminator probes confirmed that the observed fragment sizes of each probe corresponds with the predicted fragment sizes of each probe of DAS-40278-9 genomic DNA and pDAS1740 (Dow AgroSciences, 2014). The results of analyses showed that DAS-40278-9 genome contains only a single insertion of the T-DNA from the plasmid pDAS1740. Also, no specific hybridization bands were detected in the negative control samples in any of the restriction enzyme and probe combinations. This indicates that the single insert in DAS-40278-9 corn contains an intact single copy of aad-1 gene. No truncations, deletions or rearrangements were identified. Southern blot analyses using Nco I and Sac I restriction enzymes on the backbone probes confirmed that no plasmid backbone sequences from pDAB1740 were integrated into DAS-40278-9. Genetic Stability The multigenerational stability of the introduced traits was assessed through Southern Blot Analysis of genetic samples from five generations (T3, T4, BC3S1, BC3S2 and BC3S3) of DAS-40278-9 (Dow AgroSciences, 2014). Results showed that aad-1 gene is stably inherited across multiple generations of DAS-40278-9. Segregation is assessed by Southern blot analysis and protein detection of individual plants from a BC3S1 line of DAS-40278-9. 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. Expressed Material (Cry34Ab1, Cry35Ab1 and PAT proteins) AAD-1 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, 2014). Expression level of AAD-1 in different plant parts of corn DAS-40278-9 was measured using ELISA methods (Dow AgroSciences, 2014). The measurements are in dry weight basis (ng/mg dry weight). Margin of exposure of general population and children in Japan to AAD-1 protein was derived from the data of the food intake in Japan and the No Observed Effect Level (NOEL) of AAD-1 protein determined from the acute oral toxicity study. Computed margins of exposure of general population and children (<6 year) to AAD-1 protein in corn is greater than 102564 and 67340, respectively. Toxicological and Allergenicity Assessment The novel protein, AAD-1, was subjected to digestibility, heat inactivation, oral toxicity and amino acid sequence comparison studies to determine its potential to cause toxicity or allergenicity to humans (Dow AgroSciences, 2014). Digestibility study using Simulated Gastric Fluid (SGF) with pepsin demonstrated that AAD-1 is readily degraded within 30 seconds of incubation with SGF, in presence of 0.32% w/v pepsin at pH 1.2, a characteristic of most non-toxic proteins (Dow AgroSciences, 2014). Heat Inactivation of AAD-1 is evaluated by heating protein solutions for 30 minutes at 50°C, 70°C and 95°C (Schafer, 2008). Upon treatment, samples were analyzed through ELISA, SDS-PAGE and western blot. Activity of AAD-1 was assayed by colorimetric enzyme assay. Results of the SDS-PAGE analysis showed that the AAD-1 protein was undetectable upon heating at 50, 70 or 95°C for 30 minutes. This was observed upon centrifugation of the protein samples prior to addition of Laemmli buffer. Immunoreactivity and enzymatic activity of AAD-1 decreased by 100% upon heat treatment at 50°C. Only 0.2% immunoreactivity and 3.0% enzymatic activity was detected upon heat treatment at 90°C. Amino acid sequence comparison of AAD-1 protein to toxins and allergens was conducted using BLASTp search algorithm against the GenBank and FASTA program (Dow AgroSciences, 2014). Results of bioinformatics analyses indicated that AAD-1 protein is not homologous to any toxin and allergen. This was verified through conducting amino acid comparison using the same bioinformatics tool on August 23, 2017 (AIS-FRA-17-06-BIA). Acute oral toxicity study on mice showed no mortality, clinical signs and treatment-related gross pathological observations during the study (Wiescinski and Golden, 2007). The determined No Observed Effect Level for AAD-1 protein is greater than 2000 mg/kg body weight. The AAD-1 protein used in the studies was obtained from Pseudomonas fluorescens (Dow AgroSciences, 2014). Biochemical characterization, SDS-PAGE and wester blot analysis of crude extracts, MALDI-TOF and ESI/LC-MS tryptic and Asp-N peptide mass fingerprints, tryptic and Asp-N Peptide N- and C- terminal sequence analysis, and endogenous allergen analysis were conducted by the proponent to confirm that the P. fluorescens- produced AAD-1 protein is biochemically and functionally equivalent to AAD-1 expressed in DAS-40278-9. Levels of AAD-1 in DAS-40278-9 determined through ELISA and the crude protein content of DAS-40278-9 were used to compute the percent total protein for AAD-1 which is 0.0046%. Results of the digestibility, heat inactivation, amino acid sequence comparison and acute oral toxicity studies indicates that AAD-1 protein being expressed in DAS-40278-9 corn is not toxic or allergenic to humans (Dow AgroSciences, 2014). Nutritional Data Compositional analysis provided by the developer indicating the nutritional data of DAS-40278-9 in comparison with the non-transgenic corn and range of literature values (Dow AgroSciences, 2014). The trials were conducted in Iowa, Illinois, Indiana, Nebraska and Ontario. 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-40278-9 and the non-transgenic corn that can be considered biologically relevant. Conclusion For the transgenic DAS-40278-9 corn, 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 corn other than tolerance to 2,4-dichlorophenoxyacetic acid (2,4-D) and aryloxyphenoxypropionate (AOPP) acetyl coenzyme A carboxylase (ACCase) inhibitors (“fop” herbicides. After reviewing the provided material of Dow AgroSciences, it is therefore concluded that DAS-40278-9 corn is as safe as its conventional counterpart. BAI ASSESSMENT AND RECOMMENDATIONS Based on the documents submitted by the applicant, BAI made the following assessment: A. Host Organism Maize is a source of protein, amino acids, fatty acids, vitamins etc. It also contains low levels of several anti-nutrients including trypsin and chymotrypsin inhibitors, raffinose, phytic acid etc. Maize is consumed in various food forms including starch, oil, grits, meal and flour. Based on FAOSTAT data, consumption of maize intake by general population in ASEAN countries ranged from about 79-190g/person/day (Ranum et al., 2014) B. Transgenic Plant DAS 40278-9 is approved in: USA (USDA, 2014), Canada (CFIA, 2012; Health Canada, 2012), Brazil (CTNBio, 2015), Australia and New Zealand (FSANZ, 2011), Mexico (COFEPRIS, 2011), Columbia (ICA, 2013; INVIMA, 2014), South Africa (DAFF, 2012), Japan (MAFF, 2012; MHLW, 2012), Taiwan (DOH, 2011) and South Korea (MFDS, 2014; RDA, 2014). DAS-40278-9 maize is as safe and as nutritious as conventional maize. There is no need to change consumption pattern as a result of introduction of this Maize event. C. Donor Organism The AAD-1 protein is not known to possess potential pathogenic or allergenic properties. The introduced expressible sequence include AAD-1 protein conferring herbicide tolerance to 2,4dichlorophenoxyacetic acid (2,4-D) and aryloxyphenoxypropionate (AOPP) acetyl coenzyme A carboxylase (ACCase) inhibitors (“fop” herbicides). Sphingobium herbicidovorans is a donor of AAD-1 protein. Donor organisms of genetic elements including promoters, terminators and border sequences include Nicotiana tobacum and Zea mays. There are no publications concerning toxicity or allergenicity of these genetic elements in peer-reviewed journals. AAD-1 is the only protein expressed in DAS-40278-9 maize. The protein has specific mode of action and have no significant sequence similarity to known allergens or toxins D. Transformation System DAS-40278-9 maize was generated through direct insertion of the DNA fragment from plasmid pDAS1740 via Whiskers-mediated transformation. The genetic modification was intended to express AAD-1 protein in maize plants, thus provide tolerance to 2,4dichlorophenoxyacetic acid (2,4-D) and aryloxyphenoxypropionate (AOPP) acetyl coenzyme A carboxylase (ACCase) inhibitors (“fop” herbicides). The transformation protocol is described fully. The plasmid vector, pDAS1740 (including orientation and relative location of genetic elements), is described adequately. There is no carrier DNA used for the transformation of pDAS1740 into maize. Whiskers-mediated transformation is a direct DNA transfer method. E. Inserted DNA DAS-40278-9 maize contains one intact copy of the T-DNA insert at a single locus. The insert copy number was checked through Southern blot analysis. Integrity and order of genetic elements in DAS-40278-9 maize were demonstrated via Southern blot analysis. Southern blot analysis showed that DAS-40278-9 maize contains a single intact copy of the aad1 expression cassette integrated at a single locus. The T-DNA insert in DAS-40278-9 maize contains a single, intact copy of each of the expression cassette for aad-1 gene. No vector backbone sequences were detected in event DAS-40278-9. There were no re-arrangements of the cassette observed. There is no plasmid vector backbone sequence present in DAS-40278-9 maize as demonstrated by Southern blot analysis. Confirmation of lack of vector backbone using Southern blot analysis is a scientifically proven method and is sufficient. F. Genetic Stability Stability of the T-DNA insert across five generations was demonstrated by Southern blot analysis. Segregation was assessed using event-specific PCR. Populations of T1, T2 generations, 3 backcross populations (BC1, BC2, BC3) and one population of BC3F2 were assessed. Segregation result is consistent with the reported one copy TDNA insert. G. Expressed Material Expression levels of AAD-1 protein were determined using protein-specific ELISA methods with and without herbicide treatments. Expression values were similar for the sprayed treatments as well as for the plots sprayed and unsprayed with 2, 4-D and quizalofop herbicides. Mean AAD-1 protein levels in roots ranged from 2.87-3.92; in V9 stage leaf from 5.38-6.52; in forage from 6.84-7.32; in pollen from 108-127 and in grain from 4.61-5.00 ng/mg dry weight tissue. AAD-1 protein has specific mode of action on 2,4-dichlorophenoxyacetic acid (2,4-D) and aryloxyphenoxypropionate (AOPP) acetyl coenzyme A carboxylase (ACCase) inhibitors (“fop” herbicides). The protein does not play a role in endogenous plant metabolism. H. Toxicological Assessment The digestibility of the microbe-derived AAD-1 protein was tested in vitro using simulated gastric fluid (SGF) containing gastric enzyme pepsin. The estimated T50 result was less than 30 seconds with no large size fragments remaining. AAD-1 protein was also evaluated by heating protein solutions for 30 min at 50, 70 and 95 C and 20 min in an autoclave in a phosphate based buffer. Results showed that AAD-1 protein is immunochemically denatured when heated. The AAD-1 protein lost more than 97% of its immunoreactivity, with results showing that it was almost undetectable by ELISA after exposure to the heat treatment. Bioinformatics analysis through BLAST search showed AAD-1 has no significant sequence similarity with known toxins (Section 9.1.3.1 of the Food and Feed safety and Nutrition Assessment for Herbicide Tolerance DAS-40278-9 Maize dossier). Glycosylation analysis of AAD-1 isolated from DAS-40278-9 maize showed the protein is not glycosylated.AAD-1 protein used in the acute toxicity test was derived from Pseudomonas fluorescens. The microbial AAD-1 is biochemically and functionally equivalent to the AAD-1 expressed in DAS-40278-9 I. Allergenicity Assessment The digestibility of the microbe-derived AAD-1 protein was tested in vitro using simulated gastric fluid (SGF) containing gastric enzyme pepsin. The estimated T50 result was less than 30 seconds with no large size fragments remaining. AAD-1 protein was also evaluated by heating protein solutions for 30 min at 50, 70 and 95 C and 20 min in an autoclave in a phosphate based buffer. Results showed that AAD-1 protein is immunochemically denatured when heated. The AAD-1 protein lost more than 97% of its immunoreactivity, with results showing that it was almost undetectable by ELISA after exposure to the heat treatment. Bioinformatics analysis through BLAST search showed AAD-1 has no significant sequence similarity with known toxins (Section 9.1.3.1 of the Food and Feed safety and Nutrition Assessment for Herbicide Tolerance DAS-40278-9 Maize dossier). Glycosylation analysis of AAD-1 isolated from DAS-40278-9 maize showed the protein is not glycosylated. When the WHO “GC 645 maize” acute consumption information is coupled to the AAD-1 field expression level of 4.81 ng/mg tissue, the potential acute exposure to AAD-1 protein via maize is estimated as: (1) 0.0195 mg protein/kg bw/day, for general population (i.e. adults) and (2) 0.0297 mg protein/kg bw/day, for children of 6 years or younger. No serum screening was performed for the said application. AAD-1 has no evidence of allergenicity. J. Nutritional Data Differences were observed in moisture and carbohydrates in grain between DAS-40278-9 maize and comparator. However, levels were all within reference range and literature range. Nutrient composition analysis showed DAS40278-9 maize is substantially equivalent to comparator, the non-transgenic Maize, with no significant and biologically meaningful differences, both in grains and forage. K. Recommendation Find scientific evidence that the regulated article applied for animal feed use is as safe as its conventional counterpart and shall not pose any significant risk to human and animal health DOH ASSESSMENT AND RECOMMENDATION After a thorough review and evaluation of the documents provided by the proponent, Dow AgroSciences B.V., Philippines Branch through the Bureau of Plant Industry (BPI), in support of their application for approval for Direct Use for Food and Feed or for Processing (FFP) of Corn DAS 40278-9. I/We, Find that the regulated article applied for Direct Use for Food and Feed or for Processing (FFP) is safe as its conventional counterpart and shall not pose any significant risk to human and animal health, and environment. The following are the observations and recommendations: 1) Find that the regulated article applied for Direct Use for FFP does not require changes in the usual practices in unloading and loading, hauling, transport and storage, and processing. As such, the regulated article is as safe as its conventional counterpart and is not expected to pose any significant risk to human and animal and the environment while in transit, storage and processing. 2) Scientific pieces of evidence from provided references i.e. literatures show that the regulated article applied for Direct Use as FFP is as safe as its conventional counterpart and shall not pose any significant risk to human and animal health and on the environment. 3) It is suggested that the BPI ensure the following: a) Strict monitoring of the regulated article from port of entry to the traders/importers storage/warehouse as stated in Sec 32 of JDC 1 s2016 b) The BPI to include in the issuance of permit for release of this product the following conditions: i. Any spillage (during unloading and loading/hauling and transport unloading and storage) shall be collected and cleaned up immediately. ii. Transportation of the consignment from the port of entry to any destination shall be in closed containers. iii. There shall be a clear instructions that the product is only for the purpose of direct use for FFP and is not to be used as planting materials. Based on the above considerations and with the submitted sworn statement and accountability of the proponent, this recommendation is being submitted to the BPI related to the processing and issuance of a biosafety permit for Direct Use as FFP of corn DAS 40278-9.
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Authorization expiration date (a blank field means there is no expiration date) May 6, 2024
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Organization/agency name (Full name):
Bureau of Plant Industry
Contact person name:
Geronima P. Eusebio
Website:
Physical full address:
San Andres St., Malate, Manila
Phone number:
632 404 0409 loc 203
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Country introduction:

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

 

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Stacked events:

Gene stacking in plants can be conferred either through genetic engineering or conventional breeding A full risk assessment as to food and feed or for processing shall be conducted to plant products carrying stacked genes conferred through genetic engineering or conventional breeding, where the individual traits have no prior approval for direct use as food and feed or processing from the Bureau of Plant Industry (BPI) A desktop or documentary risk assessment on the possible or expected interactions between the genes shall be conducted for stacked gene products with multiple traits conferred through conventional breeding and individual events granted prior approval by the Bureau of Plant Industry.

 

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

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

(a) genetic engineering, or

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

Plant Products Carrying Stacked Genes Conferred through Conventional Breeding:

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

Notificatlon Requirement for Plant Products Carrying Stacked Genes

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

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

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

Bureau of Plant Industry 692 San Andres St, Malate, Manila 1004

Republic of Korea
Name of product applicant: Dow AgroSciences Int'l. Ltd.
Summary of application:

2,4-D herbicide tolerance

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Date of authorization: 03/07/2014
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.):
Summary of the safety assessment (food safety):
Please see the link below(in Korean).
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Organization/agency name (Full name):
Ministry of Food and Drug Safety
Contact person name:
Website:
Physical full address:
Osong Health Technology Administration Complex, 187, Osongsaengmyeong 2-ro, Osong-eup, Cheongwon-gun, Chungcheonbuk-do, 363-700, Korea
Phone number:
82-43-719-2360
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Stacked events:
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Russian Federation
Name of product applicant: Dow AgroSciences LLC
Summary of application:

There were submitted (1) data enabling to identify the matter of research (species, variety, and the transformation event); (2) data on the initial parental organism and the donor organism for introduced genetic sequences;  (3) data on the genetic modification method, genetic construction, and the level of gene expression; (4) data on identification of GM maize line DAS-40278-9 (identification methods, protocol of analysis, description of primers, reference materials); (5) data on registration of the GM line  in other countries and the results of safety assessment which conducted for registration purposes of GMO in other countries.

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Date of authorization: 13/03/2019
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):
Peer review of the data submitted by the applicant and the results of complex medical and biological studies of transgenic maize line DAS-40278-9 tolerant to 2,4-D and aryloxyphenoxypropionate herbicides, attest to the absence of any toxic, reprotoxic, genotoxic, or allergenic effects of this maize line. By biochemical composition, transgenic maize line DAS-40278-9 was identical to conventional maize. GM maize line DAS-40278-9 has been registered for food use, listed in the State Register, and licensed for use in the territory of The Eurasian Economic Union, import into the territory of The Eurasian Economic Union, and placing on the market without restrictions.
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Organization/agency name (Full name):
FSBI «Institute of Nutrition» RAMS
Contact person name:
Nadezhda Tyshko
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Physical full address:
109240, Russia, Moscow, Ustinsky Proezd, 2/14
Phone number:
+7(495)698-53-64
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Country introduction:

The development of the GMO safety assessment currently used in the Russian Federation started in 1995–1996. The methodological approaches to comprehensive complex medical and biological assessment of GMOs were developed in the Russian Federation with due regard for international and national experience as well as new scientific approaches based on the achievements of contemporary fundamental science: genomic and proteomic analysis, detection of DNA damage or mutagenic activity, identification of products of free-radical modifications of DNA or other sensitive biomarkers. GMO safety assessment is carried out for the state registration. Any novel food derived from plant GMO produced in Russia or imported into Russia for the first time is subject to the state registration . Guidance for safety assessment is specified in MU 2.3.2.2306-07 “Medico-Biological Safety Assessment of Plant Genetically Modified Organisms”. According to the accepted regulations,the human health assessment of a novel GMO to be placed on the domestic market includes the following: ■ Molecular assessment includes analysis of genetic construction, genetic modification method, and the gene expression level. ■ Technological assessment includes determination of organoleptic and functional properties, analysis of technological characteristics of the finished products. ■ Human health safety assessment includes several sections of required assessments: analysis of compositional equivalence and toxicological,genotoxicological, and allergological safety studies. ■ Methods for identification include qualitative and quantitative assay of GMO in food (studies targeted at determination of correspondence of these methods to those used in Russia in order to provide monitoring of use and labeling of GM food). The list and the scope of required studies is determined on the basis of analysis of information of the GMO submitted for registration; however, the above-mentioned studies are required. If significant changes in the GMO’s genome, proteome, or metabolome are shown, additional studies may be required to determine: biological value and absorbency reproductive effect; gonadotoxic, embryotoxic, teratotoxic effect; potential carcinogenic effect; lifetime, etc.

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Stacked events:

Russia follows the national Methodical Guidelines  2.3.2.3388-16 “Medical and biological safety assessment of genetically modified stack events of plant origin ”

Our position regarding GM stacks registration is very close to the EU approach.

 

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

Federal Research Centre of nutrition and biotechnology Viktor A. Tutelyan Ustinsky proezd, 2/14 109240 Moscow, RUSSIA E-mail: [email protected] Tel.:+7 495 698-53-60

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

Apply for direct 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):
Herbicide-tolerant corn line DAS-40278-9 has been genetically modified to tolerate 2,4-dichlorophenoxyacetic acid (2,4-D) and aryloxyphenoxypropionate (AOPP) acetyl coenzyme A carboxylase (ACCase) inhibitors such as quizalofop-P-ethyl. This has been achieved through the introduction of the aad-1 gene, from Sphingobium herbicidovorans, expressing the enzyme aryloxyalkanoate dioxygenase (AAD-1). Molecular analyses of corn DAS-40278-9 indicate there is one insertion site at a single genetic locus. This site contains one copy of the aad-1 gene and it is stably inherited from one generation to the next generation. Corn DAS-40278-9 expresses one new protein, AAD-1, which is non-toxic and non-allergenic to humans. Composition analyses showed that the levels of key components in seed from corn DAS-40278-9 are equivalent to conventional corn cultivars. Food derived from corn DAS-40278-9 is as safe as food derived from conventional corn cultivars.
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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
Fax number:
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 maize DAS-40278-9 is produced by direct whiskers mediated transformation. The maize expresses aad-1 protein which confers tolerance to herbicides containing 2,4-dichlorophenoxyacetic acid. 

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Date of authorization: 01/06/2012
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 maize DAS-40278-9 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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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
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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:
Corn
Trait 1 Added Protein: Aryloxyalkanoate dioxygenase-1 (AAD-1) protein encoded by the aad-1 gene
Source: Sphingobium herbicidovorans
Intended Effect: Tolerance to 2,4-dichlorophenoxyacetic acid (2,4-D) and certain aryloxyphenoxypropionate herbicides (e.g., quizalofop, cyhalofop, haloxyfop)
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Date of authorization: 13/04/2011
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Please consult the FDA website links below.
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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
Fax number:
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